Dott. Patrizio Mazzone

Pubblicazioni su PubMed

• Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.
  Catheter Cardiovasc Interv

  2023 Mar;():. doi: 10.1002/ccd.30629.
  
  Gallo Francesco, Ronco Federico, D'Amico Gianpiero, Della Rocca Domenico G, Mazzone Patrizio, Bordignon Stefano, Casu Gavino, Giannini Francesco, Berti Sergio, Horton Rodney P, D'Angelo Giuseppe, Urbanek Lukas, Merella Pierluigi, Ruggiero Rossella, Romeo Maria Rita, Bosica Francesco, Schmidt Boris, Atzori Enrico, Barbierato Marco, Natale Andrea, Themistoclakis Sakis
  
  Abstract
  
  AIMS:
  To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding.
  
  METHODS:
  Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month.
  
  RESULTS:
  Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p?=?0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p?=?0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p?=?0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p?=?0.047).
  
  CONCLUSIONS:
  Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.
  
  © 2023 Wiley Periodicals LLC.
  
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• Cardiac inflammation associated with COVID-19 mRNA vaccination in patients with and without previous myocarditis.
  Minerva Cardiol Angiol

  2023 Mar;():. doi: 10.23736/S2724-5683.22.06204-4.
  
  Kaufmann Christoph C, Villatore Andrea, Heugl Mira, Kvakan Heda, Zweiker David, Sala Simone, Mazzone Patrizio, Huber Kurt, Peretto Giovanni
  
  Abstract
  
  BACKGROUND:
  mRNA COVID-19 vaccines have been associated with myocarditis in the general population. However, application of gold standard techniques is often missing, and data about patients with history of myocarditis have not been reported yet.
  
  METHODS:
  We evaluated 21 patients (median age 27, 86% males) for suspected myocarditis after receiving mRNA COVID-19 vaccine. We divided cases with previous diagnosis of myocarditis (PM, N.=7), from naïve controls (NM, N.=14). All patients were investigated thoroughly by cardiac magnetic resonance (100%) with or without endomyocardial biopsy (14%).
  
  RESULTS:
  Overall, 57% of patients met updated Lake Louise criteria and none fulfilled Dallas criteria, with no remarkable differences between groups. Acute coronary syndrome-like presentation was more frequent in NM with earlier normalization of troponin than PM. NM and PM already healed from myocarditis were clinically comparable, whereas PM with active inflammation had subtle presentation and were evaluated for immunosuppressive therapy modulation. None had fulminant myocarditis and/or malignant ventricular arrhythmia at presentation. No major cardiac events occurred by 3 months.
  
  CONCLUSIONS:
  In this study, the suspicion of mRNA COVID-19 vaccine-associated myocarditis was inconstantly confirmed by gold standard diagnostics. Myocarditis was uncomplicated in both PM and NM patients. Larger studies with longer follow-up are needed to validate COVID-19 vaccination in this population.
  
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• Emergency Management of Electrical Storm: A Practical Overview.
  Medicina (Kaunas)

  2023 Feb;59(2):. doi: 405.
  
  Guarracini Fabrizio, Bonvicini Eleonora, Zanon Sofia, Martin Marta, Casagranda Giulia, Mochen Marianna, Coser Alessio, Quintarelli Silvia, Branzoli Stefano, Mazzone Patrizio, Bonmassari Roberto, Marini Massimiliano
  
  Abstract
  
  Electrical storm is a medical emergency characterized by ventricular arrythmia recurrence that can lead to hemodynamic instability. The incidence of this clinical condition is rising, mainly in implantable cardioverter defibrillator patients, and its prognosis is often poor. Early acknowledgment, management and treatment have a key role in reducing mortality in the acute phase and improving the quality of life of these patients. In an emergency setting, several measures can be employed. Anti-arrhythmic drugs, based on the underlying disease, are often the first step to control the arrhythmic burden; besides that, new therapeutic strategies have been developed with high efficacy, such as deep sedation, early catheter ablation, neuraxial modulation and mechanical hemodynamic support. The aim of this review is to provide practical indications for the management of electrical storm in acute settings.
  
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• A Referral Center Experience with Cerebral Protection Devices: Challenging Cardiac Thrombus in the EP Lab.
  J Clin Med

  2023 Feb;12(4):. doi: 1549.
  
  Berg Jan, Preda Alberto, Fierro Nicolai, Marzi Alessandra, Radinovic Andrea, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Cerebral protection devices (CPD) are designed to prevent cardioembolic stroke and most evidence that exists relates to TAVR procedures. There are missing data on the benefits of CPD in patients that are considered high risk for stroke undergoing cardiac procedures like left atrial appendage (LAA) closure or catheter ablation of ventricular tachycardia (VT) when cardiac thrombus is present.
  
  PURPOSE:
  This work aimed to examine the feasibility and safety of the routine use of CPD in patients with cardiac thrombus undergoing interventions in the electrophysiology (EP) lab of a large referral center.
  
  METHODS:
  The CPD was placed under fluoroscopic guidance in all procedures in the beginning of the intervention. Two different CPDs were used according to the physician's discretion: (1) a capture device consisting of two filters for the brachiocephalic and left common carotid arteries placed over a 6F sheath from a radial artery; or (2) a deflection device covering all three supra-aortic vessels placed over an 8F femoral sheath. Retrospective periprocedural and safety data were obtained from procedural reports and discharge letters. Long-term safety data were obtained by clinical follow-up in our institution and telephone consultations.
  
  RESULTS:
  We identified 30 consecutive patients in our EP lab who underwent interventions (21 LAA closure, 9 VT ablation) with placement of a CPD due to cardiac thrombus. Mean age was 70 ± 10 years and 73% were male, while mean LVEF was 40 ± 14%. The location of the cardiac thrombus was the LAA in all 21 patients (100%) undergoing LAA-closure, whereas, in the 9 patients undergoing VT ablation, thrombus was present in the LAA in 5 cases (56%), left ventricle (n = 3, 33%) and aortic arch (n = 1, 11%). The capture device was used in 19 out of 30 (63%) and the deflection device in 11 out of 30 cases (37%). There were no periprocedural strokes or transitory ischemic attacks (TIA). CPD-related complications comprised the vascular access and were as follows: two cases of pseudoaneurysm of the femoral artery not requiring surgery (7%), 1 hematoma at the arterial puncture site (3%) and 1 venous thrombosis (3%) resolved by warfarin. At long-term follow-up, 1 TIA and 2 non-cardiovascular deaths occurred, with a mean follow-up time of 660 days.
  
  CONCLUSIONS:
  Placement of a cerebral protection device prior to LAA closure or VT ablation in patients with cardiac thrombus proved feasible, but possible vascular complications needed to be taken into account. A benefit in periprocedural stroke prevention for these interventions seemed plausible but has yet to be proven in larger and randomized trials.
  
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• Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry.
  Medicina (Kaunas)

  2022 Dec;59(1):. doi: 67.
  
  Schiavone Marco, Filtz Annalisa, Gasperetti Alessio, Breitenstein Alexander, Palmisano Pietro, Mitacchione Gianfranco, Gulletta Simone, Chierchia Gian Battista, Montemerlo Elisabetta, Statuto Giovanni, Russo Giulia, Casella Michela, Vitali Francesco, Mazzone Patrizio, Hofer Daniel, Arabia Gianmarco, Tundo Fabrizio, Ruggiero Diego, Fierro Nicolai, Moltrasio Massimo, Bertini Matteo, Dello Russo Antonio, Pisanò Ennio C L, Della Bella Paolo, Rovaris Giovanni, de Asmundis Carlo, Biffi Mauro, Curnis Antonio, Tondo Claudio, Saguner Ardan M, Forleo Giovanni B
  
  Abstract
  
  Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED?)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED?, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45?80) mins vs. 50 (40?65) mins, p
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• Outcomes of leadless pacemaker implantation following transvenous lead extraction in high-volume referral centers: Real-world data from a large international registry.
  Heart Rhythm

  2023 Mar;20(3):395-404. doi: 10.1016/j.hrthm.2022.12.002.
  
  Mitacchione Gianfranco, Schiavone Marco, Gasperetti Alessio, Arabia Gianmarco, Breitenstein Alexander, Cerini Manuel, Palmisano Pietro, Montemerlo Elisabetta, Ziacchi Matteo, Gulletta Simone, Salghetti Francesca, Russo Giulia, Monaco Cinzia, Mazzone Patrizio, Hofer Daniel, Tundo Fabrizio, Rovaris Giovanni, Russo Antonio Dello, Biffi Mauro, Pisanò Ennio C L, Chierchia Gian Battista, Della Bella Paolo, de Asmundis Carlo, Saguner Ardan M, Tondo Claudio, Forleo Giovanni B, Curnis Antonio
  
  Abstract
  
  BACKGROUND:
  Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available.
  
  OBJECTIVE:
  The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation.
  
  METHODS:
  Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes.
  
  RESULTS:
  Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found.
  
  CONCLUSION:
  LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted.
  
  Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
  
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• Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study.
  J Cardiovasc Electrophysiol

  2023 Mar;34(3):728-737. doi: 10.1111/jce.15767.
  
  Migliore Federico, Pittorru Raimondo, Dall'Aglio Pietro Bernardo, De Lazzari Manuel, Rovaris Giovanni, Piazzi Elena, Dentico Alessia, Ferrieri Alessandra, D'Angelo Giuseppe, Marzi Alessandra, Sawaf Basma El, Bertaglia Emanuele, Iliceto Sabino, Gerosa Gino, Tarzia Vincenzo, Carretta Domenico, Mazzone Patrizio
  
  Abstract
  
  INTRODUCTION:
  Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ?10 years.
  
  METHODS:
  A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures.
  
  RESULTS:
  The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p?=?.002). Four major complication (2%) were encountered. During a mean time follow-up of 31?±?27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p?=?.001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p?=?.045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p?=?.005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p?=?.022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up.
  
  CONCLUSION:
  Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.
  
  © 2022 Wiley Periodicals LLC.
  
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• Long-Term Follow-Up of Catheter Ablation for Premature Ventricular Complexes in the Modern Era: The Importance of Localization and Substrate.
  J Clin Med

  2022 Nov;11(21):. doi: 6583.
  
  Gulletta Simone, Gasperetti Alessio, Schiavone Marco, Paglino Gabriele, Vergara Pasquale, Compagnucci Paolo, Bisceglia Caterina, Cireddu Manuela, Fierro Nicolai, D'Angelo Giuseppe, Sala Simone, Rampa Lorenzo, Casella Michela, Mazzone Patrizio, Dello Russo Antonio, Forleo Giovanni Battista, Della Bella Paolo
  
  Abstract
  
  Background: Large-scale studies evaluating long-term recurrence rates in both idiopathic and non-idiopathic PVC catheter ablation (CA) patients have not been reported. Objective: To evaluate the efficacy and safety of idiopathic and non-idiopathic PVC CA, investigating the predictors of acute and long-term efficacy. Methods: This retrospective multicentric study included 439 patients who underwent PVC CA at three institutions from April-2015 to December-2021. Clinical success at 6 months? follow-up, defined as a reduction of at least 80% of the pre-procedural PVC burden, was deemed the primary outcome. The secondary aims of the study were: clinical success at the last available follow-up, predictors of arrhythmic recurrences at long-term follow-up, and safety outcomes. Results: The median age was 51 years, with 24.9% patients being affected suffering from structural heart disease. The median pre-procedural PVC burden was 20.1%. PVCs originating from the RVOT were the most common index PVC observed (29.1%), followed by coronary cusp (CC) and non-outflow tract (OT) LV PVCs (23.1% and 19.0%). The primary outcome at 6 months was reached in 85.1% cases, with a significant reduction in the 24 h% PVC burden (?91.4% [?83.4; ?96.7], p
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• Cardiac implantable electronic device infections: impact of initiation of antimicrobial treatment before or after device removal on microbiological yield.
  Clin Microbiol Infect

  2023 Feb;29(2):260-262. doi: 10.1016/j.cmi.2022.10.031.
  
  Ponta Giacomo, Ranzenigo Martina, Marzi Alessandra, Oltolini Chiara, Tassan Din Chiara, Spagnuolo Vincenzo, Mazzone Patrizio, Carletti Silvia, Mancini Nicasio, Uberti-Foppa Caterina, Della Bella Paolo, Scarpellini Paolo, Castagna Antonella, Ripa Marco
  
  
  
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• Exercise Stress Test Late after Arrhythmic versus Nonarrhythmic Presentation of Myocarditis.
  J Pers Med

  2022 Oct;12(10):. doi: 1702.
  
  Peretto Giovanni, Gulletta Simone, Slavich Massimo, Campochiaro Corrado, Vignale Davide, De Luca Giacomo, Palmisano Anna, Villatore Andrea, Rizzo Stefania, Cavalli Giulio, De Gaspari Monica, Busnardo Elena, Gianolli Luigi, Dagna Lorenzo, Basso Cristina, Esposito Antonio, Sala Simone, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  Background. Exercise stress test (EST) has been scarcely investigated in patients with arrhythmic myocarditis. Objectives. To report the results of EST late after myocarditis with arrhythmic vs. nonarrhythmic presentation. Methods. We enrolled consecutive adult patients with EST performed at least six months after acute myocarditis was diagnosed using gold-standard techniques. Patients with ventricular arrhythmia (VA) at presentation were compared with the nonarrhythmic group. Adverse events occurring during follow-up after EST included cardiac death, disease-related rehospitalization, malignant VA, and proven active myocarditis. Results. The study cohort was composed of 128 patients (age 41 ± 9 y, 70% males) undergoing EST after myocarditis. Of them, 64 (50%) had arrhythmic presentation. EST was performed after 15 ± 4 months from initial diagnosis, and was conducted on betablockers in 75 cases (59%). During EST, VA were more common in the arrhythmic group (43 vs. 4, p
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• Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: Insights from a multicenter European registry.
  Int J Cardiol

  2023 Jan;371():197-203. doi: 10.1016/j.ijcard.2022.09.026.
  
  Gulletta Simone, Schiavone Marco, Gasperetti Alessio, Breitenstein Alexander, Palmisano Pietro, Mitacchione Gianfranco, Chierchia Gian Battista, Montemerlo Elisabetta, Statuto Giovanni, Russo Giulia, Casella Michela, Vitali Francesco, Mazzone Patrizio, Hofer Daniel, Arabia Gianmarco, Moltrasio Massimo, Lipartiti Felicia, Fierro Nicolai, Bertini Matteo, Dello Russo Antonio, Pisanò Ennio C L, Biffi Mauro, Rovaris Giovanni, de Asmundis Carlo, Tondo Claudio, Curnis Antonio, Della Bella Paolo, Saguner Ardan M, Forleo Giovanni B
  
  Abstract
  
  BACKGROUND:
  Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation.
  
  METHODS:
  Two cohorts of younger and older patients (?50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes.
  
  RESULTS:
  1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p 
  CONCLUSION:
  When considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up.
  
  Copyright © 2022 Elsevier B.V. All rights reserved.
  
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• Arrhythmogenic Cardiomyopathy: One, None and a Hundred Thousand Diseases.
  J Pers Med

  2022 Jul;12(8):. doi: 1256.
  
  Peretto Giovanni, Mazzone Patrizio
  
  Abstract
  
  According to the most recent expert consensus statement, arrhythmogenic cardiomyopathy (AC) is defined as an arrhythmogenic heart muscle disorder, not explained by ischemic, hypertensive, or valvular heart disease, presenting clinically as symptoms or documentation of atrial fibrillation, conduction disease, and/or right ventricular (RV) and/or left ventricular (LV) arrhythmia [...].
  
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• Step by Step through the Years-High vs. Low Energy Lead Extraction Using Advanced Extraction Techniques.
  J Clin Med

  2022 Aug;11(16):. doi: 4884.
  
  Zweiker David, El Sawaf Basma, D'Angelo Giuseppe, Radinovic Andrea, Marzi Alessandra, Limite Luca R, Frontera Antonio, Paglino Gabriele, Spartalis Michael, Zachariah Donah, Nakajima Kenzaburo, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  Background: Limited data is available about the outcome of TLE in patients with vs. without high energy leads in the last decade. Methods: This is an analysis of consecutive patients undergoing TLE at a high-volume TLE centre from 2001 to 2021 using the stepwise approach. Baseline characteristics, procedural details and outcome of patients with high energy lead (ICD group) vs. without high energy lead (non-ICD group) were compared. Results: Out of 667 extractions, 991 leads were extracted in 405 procedures (60.7%) in the ICD group and 439 leads in 262 procedures (39.3%) in the non-ICD group. ICD patients were significantly younger (median 67 vs. 74 years) and were significantly less often female (18.1% vs. 27.7%, p 0.2 for both). Discussion: Using the stepwise approach, overall procedural success was high and complication rate was low in a high-volume centre. In patients with a high energy lead, the TLE procedure was more complex, but outcome was similar to comparator patients.
  
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• Significance of abnormal and late ventricular signals in ventricular tachycardia ablation of ischemic and nonischemic cardiomyopathies.
  Heart Rhythm

  2022 Dec;19(12):2075-2083. doi: 10.1016/j.hrthm.2022.08.008.
  
  Zachariah Donah, Nakajima Kenzaburo, Limite Luca Rosario, Zweiker David, Spartalis Michael, Zirolia Davide, Musto Martina, D'Angelo Giuseppe, Paglino Gabriele, Baratto Francesca, Cireddu Manuela, Bisceglia Caterina, Radinovic Andrea, Marzi Alessandra, Sala Simone, Peretto Giovanni, Vergara Pasquale, Gulletta Simone, Mazzone Patrizio, Della Bella Paolo, Frontera Antonio
  
  Abstract
  
  BACKGROUND:
  Abnormal ventricular signals (AVS) are the cornerstone of substrate-based ventricular tachycardia (VT) ablation in sinus rhythm. Signal characterization of AVS in ischemic and nonischemic cardiomyopathies has never been performed.
  
  OBJECTIVE:
  The purpose of this study was to describe ventricular signal abnormalities in 3 different pathologies and examine their association with the diastolic component of VT circuits.
  
  METHODS:
  A total of 45 patients (15 ischemic cardiomyopathy [ICM], 15 arrhythmogenic cardiomyopathy [ACM], 15 dilated cardiomyopathy [DCM]) who had undergone VT ablation with >50% of the diastolic pathway of the VT circuit recorded were studied. AVS were classified into late potentials (LPs) and continuous fractionated ventricular signals (CFVS), and their characteristics and correlation with the diastolic pathway of VT circuits were analyzed.
  
  RESULTS:
  Seventy-five VT circuits were analyzed. Bipolar scars were greatest in ICM endocardially (53 cm ICM vs 36 cm ACM vs 25 cm DCM; P = .010) and in ACM epicardially (98 cm ACM vs 25 cm ICM vs 24 cm DCM; P = .005). Location of the VT diastolic interval coincided with AVS location in 54% of VTs in ICM, 89% in ACM, and 72% in DCM (P = .036). There was a trend toward a greater association of diastolic intervals coinciding with LPs than with CFVS (78% vs 57%; P = .052) (69% diastolic intervals in ICM coincided with LPs, 33% with CFVS; P = .063). All patients (100%) with CFVS in ACM had VT diastolic components arising from CFVS (33% ICM, 64% DCM; P = .049). Positive predictive value for LPs vs CFVS was 77.8% vs 56.7%, and sensitivity was 67.3% vs 32.7%, respectively.
  
  CONCLUSION:
  The nature of abnormal signals in different cardiomyopathies reflects underlying pathology. LPs rather than CFVS seem to be more linked to diastolic components of VT circuits, especially in ICM. LPs have greater sensitivity and specificity for VT; however, CFVS may be of more relevance in ACM.
  
  Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
  
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• Effective Antitachycardia Therapy by Temporary External Defibrillator Utilized as Bridge to Reimplantation.
  J Cardiovasc Imaging

  2022 Apr;30(2):149-150. doi: 10.4250/jcvi.2021.0146.
  
  Falasconi Giulio, D'Angelo Giuseppe, Pannone Luigi, Marzi Alessandra, Radinovic Andrea, Mazzone Patrizio
  
  
  
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• Use of Cerebral Protection Device in Patients Undergoing Ventricular Tachycardia Catheter Ablation.
  JACC Clin Electrophysiol

  2022 Apr;8(4):528-530. doi: 10.1016/j.jacep.2022.01.001.
  
  Zachariah Donah, Limite Luca Rosario, Mazzone Patrizio, Marzi Alessandra, Radinovic Andrea, Baratto Francesca, Italia Leonardo, Ancona Francesco, Paglino Gabriele, Della Bella Paolo
  
  
  
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• Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.
  Pacing Clin Electrophysiol

  2022 May;45(5):658-665. doi: 10.1111/pace.14501.
  
  Akhtar Zaki, Gallagher Mark M, Elbatran Ahmed I, Starck Christoph T, Gonzalez Elkin, Al-Razzo Omar, Mazzone Patrizio, Delnoy Peter-Paul, Breitenstein Alexander, Steffel Jan, Eulert-Grehn Jürgen, Lanmüller Pia, Melillo Francesco, Marzi Alessandra, Leung Lisa Wm, Domenichini Giulia, Sohal Manav
  
  Abstract
  
  BACKGROUND:
  With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce.
  
  OBJECTIVE:
  We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units.
  
  METHOD:
  Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality.
  
  RESULTS:
  CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p 
  CONCLUSION:
  TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.
  
  © 2022 Wiley Periodicals LLC.
  
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• Bi-atrial characterization of the electrical substrate in patients with atrial fibrillation.
  Pacing Clin Electrophysiol

  2022 Jun;45(6):752-760. doi: 10.1111/pace.14490.
  
  Giorgios Tsitsinakis, Antonio Frontera, Limite Luca Rosario, Felicia Lipartiti, Zweiker David, Cireddu Manuela, Vlachos Kostantinos, Hadjis Alexios, D'Angelo Giuseppe, Baratto Francesca, Bisceglia Caterina, Vergara Pasquale, Marzi Alessandra, Peretto Giovanni, Paglino Gabriele, Radinovic Andrea, Gulletta Simone, Sala Simone, Mazzone Patrizio, Bella Paolo Della
  
  Abstract
  
  BACKGROUND:
  Little is known regarding the characterization of electrical substrate in both atria in patients with atrial fibrillation (AF).
  
  METHODS:
  Eight consecutive patients undergoing AF ablation (five paroxysmal, three persistent) underwent electrical substrate characterization during sinus rhythm. Mapping of the left (LA) and right atrium (RA) was performed with the use of the HD Grid catheter (Abbott). Bipolar voltage maps were analyzed to search for low voltage areas (LVA), the following electrophysiological phenomena were assessed: (1) slow conduction corridors, and (2) lines of block. EGMs were characterized to search for fractionation. Electrical characteristics were compared between atria and between paroxysmal versus persistent AF patients.
  
  RESULTS:
  In the RA, LVAs were present in 60% of patients with paroxysmal AF and 100% of patients with persistent AF. In the LA, LVAs were present in 40% of patients with paroxysmal AF and 66% of patients with persistent AF. The areas of LVA in the RA and LA were 4.8±7.3 cm and 7.8±13.6 cm in patients with paroxysmal AF versus 11.7±3.0 cm and 2.1±1.8 cm in patients with persistent AF. In the RA, slow conduction corridors were present in 40.0% (paroxysmal AF) versus 66.7% (persistent AF) whereas in the LA, slow conduction corridors occurred in 20.0% versus 33.3% respectively (p = ns). EGM analysis showed more fractionation in persistent AF patients than paroxysmal (RA: persistent AF 10.8 vs. paroxysmal AF 4.7%, p = .036, LA: 10.3 vs. 4.1%, p = .108).
  
  CONCLUSION:
  Bi-atrial involvement is present in patients with paroxysmal and persistent AF. This is expressed by low voltage areas and slow conduction corridors whose extension progresses as the arrhythmia becomes persistent. This electrophysiological substrate demonstrates the important interplay with the pulmonary vein triggers to constitute the substrate for persistent arrhythmia.
  
  © 2022 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.
  
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• Working on the dirty side-the ipsilateral subclavian access for temporary pacing after lead extraction.
  J Arrhythm

  2022 Apr;38(2):192-198. doi: 10.1002/joa3.12677.
  
  Zweiker David, Melillo Francesco, D'Angelo Giuseppe, Radinovic Andrea, Marzi Alessandra, Cianfanelli Lorenzo, Altizio Savino, Limite Luca R, Paglino Gabriele, Frontera Antonio, Nakajima Kenzaburo, Brugliera Luigia, Malatino Lorenzo, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Temporary pacing is necessary in pacemaker-dependent patients after transvenous lead extraction (TLE) for cardiac implantable electronic device infection. In case of unavailability of other accesses, we propose to use the ipsilateral subclavian access (ISA) combined with a standard permanent active fixation lead for the temporary pacemaker and present preliminary data.
  
  METHODS:
  We consecutively enrolled patients undergoing TLE who received a temporary pacemaker using the ISA between August 2016 and April 2020 at our centre.
  
  RESULTS:
  During the observation period, 36 patients undergoing TLE for pocket infection (72.2%), endocarditis (25.0%) or other causes received a temporary pacemaker over the ISA. Their mean age was 77.0 ± 10.7 years, and 13.9% were female. Complete TLE was achieved in 94.4%. There were no major periprocedural complications. Intra-hospital mortality was 11.1%. Pocket revision was performed in 19.4%. During long-term follow-up (23 ± 13 months), 8.3% had a relapse of local pocket infection and 2.8% needed rehospitalization for reintervention.
  
  CONCLUSIONS:
  Temporary pacing using a standard permanent active fixation lead using the ISA is a convenient alternative to conventional venous accesses. However, risks of implanting a lead into a previously infected area have to be taken into account.
  
  © 2022 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.
  
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• [Leadless pacemakers: results of a survey from implanter centers in the Lombardy region].
  G Ital Cardiol (Rome)

  2022 Feb;23(2):120-127. doi: 10.1714/3735.37214.
  
  Limite Luca Rosario, Baratto Francesca, Mantica Massimo, Sirico Giusy, Rovaris Giovanni, MOntemerlo Elisabetta, Pecora Domenico, Pagani Massimo, Fedele Luigi, Augello Giuseppe, Zuffada Francesca, Rordorf Roberto, Ambrosini Francesco, Gigli Lorenzo, De Filippo Paolo, Pani Antonio, Forleo Giovanni, Mitacchione Gianfranco, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Transvenous pacing is nowadays the cornerstone of interventional management of bradyarrhythmias. It is still associated, however, with significant complications, mostly related to indwelling transvenous leads or device pocket. In order to reduce these complications, leadless pacemakers have been recently introduced into clinical practice, but no guidelines are yet available to indicate who are those patients that might benefit the most and whether leadless pacing should be preferred in the old or young population. This survey aims to describe the use of leadless pacemaker devices in a real-world setting.
  
  METHODS:
  Eleven arrhythmia centers in the Lombardy region (out of a total of 17 participating centers) responded to the proposed questionnaire regarding patient characteristics and indications to leadless pacing.
  
  RESULTS:
  Out of a total of 411 patients undergoing leadless pacing during 4.2 ± 0.98 years, the median age was 77 years, with 0.18% of patients having less than 18 years, 29.9% 18-65 years, 34.3% 65-80 years and 35.6% >80 years. The most common indication was slow atrial fibrillation (49% of patients), followed by atrioventricular block and sinoatrial dysfunction. Two centers reported in-hospital complications.
  
  CONCLUSIONS:
  Leadless pacemakers proved to be a safe pacing strategy actually destined mostly to elderly patients.
  
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• Percutaneous left atrial appendage closure vs oral anticoagulation: The scariest might be the cheepest.
  Int J Cardiol

  2022 Apr;353():51-52. doi: 10.1016/j.ijcard.2022.01.052.
  
  Mazzone Patrizio, Della Bella Paolo, Baratto Francesca
  
  
  
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• Left atrial appendage occlusion: from guidelines to real life, where is the gap?
  J Cardiovasc Med (Hagerstown)

  2022 Mar;23(3):183-184. doi: 10.2459/JCM.0000000000001241.
  
  Mazzone Patrizio, Radinovic Andrea
  
  
  
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• Outcome of left atrial appendage closure using cerebral protection system for thrombosis: no patient left behind.
  Pacing Clin Electrophysiol

  2022 Jan;45(1):23-34. doi: 10.1111/pace.14398.
  
  Limite Luca Rosario, Radinovic Andrea, Cianfanelli Lorenzo, Altizio Savino, Peretto Giovanni, Frontera Antonio, D'Angelo Giuseppe, Baratto Francesca, Marzi Alessandra, Ancona Francesco, Ingallina Giacomo, Capogrosso Cristina, Stella Stefano, Melillo Francesco, Agricola Eustachio, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Left atrial appendage (LAA) thrombosis increases the risk of stroke and its management has to be assessed. The aim of the present study is to evaluate short and long-term safety and efficacy of a standardized approach of percutaneous LAA closure (LAAC) routinely using a cerebral protection device (CPD) in patients with LAA thrombosis or sludge (LAAT).
  
  METHODS:
  We prospectively enrolled 14 consecutive patients with atrial fibrillation complicated by LAAT presenting in a high-volume tertiary center. In seven patients (50%) LAAT was found after anticoagulant withdrawal for severe bleedings and in the remaining half LAAT was found despite appropriate anticoagulant therapy. All patients were treated with a standardized interventional approach of LAAC routinely using a CPD and guided by transoesophageal echocardiography.
  
  RESULTS:
  Mean age was 68 ± 14 years and nine patients (64%) were male. Mean CHA DS -VASc and HAS-BLED scores were 3.3 ± 1.6 and 2.3 ± 1.1, respectively. Six patients (42.8%) presented organized thrombi while eight LAA sludge (57.1%). In 13 patients (92.8%) CPD was positioned through a right radial arterial access. Procedural success was achieved in all patients. In one patient we assisted to embolization of the thrombus during deployment of the device in the absence of neurological consequences. During a mean follow up of 426 ± 307 days, one patient died for non-cardiac cause while no embolic event or major bleeding were reported.
  
  CONCLUSION:
  In an unselected cohort, LAAC with the systematic use of CPD was a feasible, safe and effective therapeutic option for LAAT both acutely and after long-term follow-up.
  
  © 2021 Wiley Periodicals LLC.
  
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• Autoimmune Myocarditis and Arrhythmogenic Mitral Valve Prolapse: An Unexpected Overlap Syndrome.
  J Cardiovasc Dev Dis

  2021 Nov;8(11):. doi: 151.
  
  Villatore Andrea, Sala Simone, Stella Stefano, Vignale Davide, Busnardo Elena, Esposito Antonio, Basso Cristina, Della Bella Paolo, Mazzone Patrizio, Peretto Giovanni
  
  Abstract
  
  BACKGROUND:
  both myocarditis and mitral valve prolapse (MVP) are known uncommon causes of ventricular arrhythmias in young patients.
  
  AIM:
  to report the first clinical case of endomyocardial biopsy (EMB)-proven autoimmune myocarditis and associated arrhythmogenic MVP in a patient with recurrent ventricular fibrillation (VF) episodes.
  
  METHODS:
  myocarditis was diagnosed both by cardiac magnetic resonance (CMR) and EMB. Arrhythmogenic MVP was documented by transthoracic echocardiogram, CMR, and electroanatomical mapping of the trigger premature ventricular contractions (PVCs).
  
  RESULTS:
  a 22-year-old woman underwent immunosuppressive therapy after EMB-proven diagnosis of autoimmune myocarditis with VF onset and early implantable cardioverter defibrillator (ICD) placement. Three years later, she experienced two VF recurrences and persistent PVCs, despite no signs of myocarditis recurrence. An echocardiogram revealed bileaflet MVP with high arrhythmic risk features. Finally, electroanatomical mapping and ablation of the trigger PVC were successfully performed.
  
  CONCLUSION:
  in patients with recurrent VF episodes despite evidence-based medical treatment for myocarditis, MVP should be considered as an alternative arrhythmogenic substrate, and warrants early ICD implant and PVC-targeted therapy.
  
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• Persistent left superior vena cava transvenous lead extraction: A European experience.
  J Cardiovasc Electrophysiol

  2022 Jan;33(1):102-108. doi: 10.1111/jce.15290.
  
  Akhtar Zaki, Sohal Manav, Starck Christoph T, Mazzone Patrizio, Melillo Francesco, Gonzalez Elkin, Al-Razzo Omar, Richter Sergio, Breitenstein Alexander, Steffel Jan, Rinaldi Christopher A, Mehta Vishal, Zuberi Zia, Zaidi Amir, Gallagher Mark M
  
  Abstract
  
  BACKGROUND:
  Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare.
  
  METHOD:
  Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported.
  
  RESULTS:
  Ten patients aged 73.4?±?7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95?±?39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4?±?74.7?min. There was no 30-day mortality.
  
  CONCLUSION:
  TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.
  
  © 2021 Wiley Periodicals LLC.
  
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• Continuous Electrical Monitoring in Patients with Arrhythmic Myocarditis: Insights from a Referral Center.
  J Clin Med

  2021 Nov;10(21):. doi: 5142.
  
  Peretto Giovanni, Mazzone Patrizio, Paglino Gabriele, Marzi Alessandra, Tsitsinakis Georgios, Rizzo Stefania, Basso Cristina, Della Bella Paolo, Sala Simone
  
  Abstract
  
  BACKGROUND:
  The incidence and burden of arrhythmias in myocarditis are under-reported.
  
  OBJECTIVE:
  We aimed to assess the diagnostic yield and clinical impact of continuous arrhythmia monitoring (CAM) in patients with arrhythmic myocarditis.
  
  METHODS:
  We enrolled consecutive adult patients ( = 104; 71% males, age 47 ± 11 year, mean LVEF 50 ± 13%) with biopsy-proven active myocarditis and de novo ventricular arrhythmias (VAs). All patients underwent prospective monitoring by both sequential 24-h Holter ECGs and CAM, including either ICD ( = 62; 60%) or loop recorder ( = 42; 40%).
  
  RESULTS:
  By 3.7 ± 1.6 year follow up, 45 patients (43%) had VT, 67 (64%) NSVT and 102 (98%) premature ventricular complexes (PVC). As compared to the Holter ECG (average 9.5 exams per patient), CAM identified more patients with VA (VT: 45 vs. 4; NSVT: 64 vs. 45; both
  CONCLUSION:
  In patients with arrhythmic myocarditis, CAM allowed accurate arrhythmia detection and showed a considerable clinical impact.
  
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• Left atrial appendage closure: a new strategy for cardioembolic events despite oral anticoagulation.
  Panminerva Med

  2021 Oct;():. doi: 10.23736/S0031-0808.21.04446-3.
  
  Falasconi Giulio, Gaspardone Carlo, Godino Cosmo, Gaspardone Achille, Radinovic Andrea, Pannone Luigi, Leo Giulio, Posteraro Giuseppe A, Slavich Massimo, Melillo Francesco, Marzi Alessandra, D'Angelo Giuseppe, Limite Luca R, Frontera Antonio, Brugliera Luigia, Agricola Eustachio, Margonato Alberto, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Patients with non-valvular atrial fibrillation (nvAF) who experienced a cardioembolic (CE) event despite adequate oral anticoagulation (OAC) are at high risk of recurrence, and further prevention strategies are deemed necessary. The present study aimed to evaluate the safety and efficacy of off-label use of left atrial appendage closure (LAAC) in this subset of patients.
  
  METHODS AND RESULTS:
  Seventy-five consecutive patients with nvAF who experienced a CE event despite adequate OAC therapy were retrospectively enrolled from two Italian centers. Patients were divided according to the treatment strategy following the index event: DOAC group (49 patients who continued OAC therapy with DOACs) and LAAC group (26 patients who underwent LAAC procedure). 1:1 propensity-score matching between the two groups was performed. LAAC group was made up of two subgroups according to the post-procedural pharmacological regimen: (a) dual antiplatelet therapy (DAPT) for 3 months followed by indefinite single antiplatelet therapy (LAAC+SAPT) or (b) aspirin plus DOAC for 3 months followed by indefinite DOAC therapy (LAAC+DOAC). The primary endpoint was a composite of CE event, major bleeding, or procedurerelated major complication. During a median follow-up of 3.4 years (IQR 2.0-5.3), LAAC was a predictor of primary endpoint-free survival (HR 0.28, 95%CI 0.08-0.97; p=0.044); within LAAC group, no procedure-related major complication occurred. Moreover, a trend toward a lower rate of both CE events and major bleedings was observed in LAAC group, particularly in the subgroup LAAC+DOAC.
  
  CONCLUSIONS:
  LAAC is a reasonable therapeutic option in nvAF patients who suffered a CE event despite adequate OAC therapy.
  
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• Long-term outcome of left atrial appendage occlusion with multiple devices.
  Int J Cardiol

  2021 Dec;344():66-72. doi: 10.1016/j.ijcard.2021.09.051.
  
  Radinovic Andrea, Falasconi Giulio, Marzi Alessandra, D'Angelo Giuseppe, Limite Luca, Paglino Gabriele, Peretto Giovanni, Frontera Antonio, Fierro Nicolai, Sala Simone, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  To evaluate long-term efficacy of left atrial appendage occlusion with multiple devices.
  
  METHODS:
  All consecutive patients who underwent left atrial appendage occlusion (LAAO) with a follow-up of at least 4 years, were included in this single center, retrospective registry. No specific exclusion criteria were applied. LAA occlusion was performed with the Watchman, Watchman FLX, Amplatzer Cardiac plug or Amplatzer Amulet occluder devices.
  
  RESULTS:
  A total of 224 consecutive patients underwent LAAO occlusion. Mean age was 72.5 ± 9.0 years. A history of stroke was present in 29%, TIA in 8.5% and a previous episode of bleeding in 64.7% of patients. In 63% there was a contraindication to oral anticoagulants. The average CHADS-VASc was 4.0 ± 1.6 and the average HAS-BLED was 3.4 ± 1.3. There was a reduction of strokes of 72.9%, thromboembolic events of 59.7% and major bleeding events of 70.9% compared to historic data. During follow-up, 48.3% of the ischemic and major bleeding events occurred within the first year. The annual mortality rate of 7.5 deaths/ 100 patients years. There were no significant differences in terms of outcome between the devices used and there were no late events associated with any device. The main antithrombotic regimen in the long term was with single antiplatelet therapy and the second one was no therapy.
  
  CONCLUSION:
  LAAO is a safe and effective procedure, that reduces ischemic and bleeding events in the long-term, regardless of the type of device used, in AF patients at high risk of ischemic stroke and major bleeding, without the need of anticoagulation.
  
  Copyright © 2021 Elsevier B.V. All rights reserved.
  
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• Check the Need-Prevalence and Outcome after Transvenous Cardiac Implantable Electric Device Extraction without Reimplantation.
  J Clin Med

  2021 Sep;10(18):. doi: 4043.
  
  D'Angelo Giuseppe, Zweiker David, Fierro Nicolai, Marzi Alessandra, Paglino Gabriele, Gulletta Simone, Matta Mario, Melillo Francesco, Bisceglia Caterina, Limite Luca Rosario, Cireddu Manuela, Vergara Pasquale, Bosica Francesco, Falasconi Giulio, Pannone Luigi, Brugliera Luigia, Oloriz Teresa, Sala Simone, Radinovic Andrea, Baratto Francesca, Malatino Lorenzo, Peretto Giovanni, Nakajima Kenzaburo, Spartalis Michael D, Frontera Antonio, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  after transvenous lead extraction (TLE) of cardiac implantable electric devices (CIEDs), some patients may not benefit from device reimplantation. This study sought to analyse predictors and long-term outcome of patients after TLE with vs. without reimplantation in a high-volume centre.
  
  METHODS:
  all patients undergoing TLE at our centre between January 2010 and November 2015 were included into this analysis.
  
  RESULTS:
  a total of 223 patients (median age 70 years, 22.0% female) were included into the study. Cardiac resynchronization therapy-defibrillator (CRT-D) was the most common device (40.4%) followed by pacemaker (PM) (31.4%), implantable cardioverter-defibrillator (ICD) (26.9%), and cardiac resynchronization therapy-PM (CRT-P) (1.4%). TLE was performed due to infection (55.6%), malfunction (35.9%), system upgrade (6.7%) or other causes (1.8%). In 14.8%, no reimplantation was performed after TLE. At a median follow-up of 41 months, no preventable arrhythmia-related events were documented in the no-reimplantation group, but 11.8% received a new CIED after 17-84 months. While there was no difference in short-term survival, five-year survival was significantly lower in the no-reimplantation group (78.3% vs. 94.7%, = 0.014).
  
  CONCLUSIONS:
  in patients undergoing TLE, a re-evaluation of the indication for reimplantation is safe and effective. Reimplantation was not related to preventable arrhythmia events, but all-cause survival was lower.
  
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• Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer? Amulet? Observational Study.
  Int J Cardiol Heart Vasc

  2021 Aug;35():100848. doi: 100848.
  
  De Caterina Alberto Ranieri, Nielsen-Kudsk Jens Erik, Schmidt Boris, Mazzone Patrizio, Fischer Sven, Lund Juha, Montorfano Matteo, Gage Ryan, Lam Simon Cheung Chi, Berti Sergio
  
  Abstract
  
  BACKGROUND:
  Percutaneous LAAO represents an alternative for stroke prevention in patients not tolerating anticoagulation. While women are at higher risk of complications during percutaneous coronary or valvular interventions, the impact of gender on LAAO outcomes is not well characterized. The current study assessed potential gender-related differences in procedural and long-term outcomes following left atrial appendage occlusion (LAAO).
  
  METHODS:
  1088 AF patients were enrolled in the prospective, multicenter, Amplatzer? Amulet? Observational Study and followed for 2 years with scheduled adverse event assessments. The prespecified primary outcome was ischemic stroke, systemic embolism or cardiovascular (CV) death at 2 years. We also compared the rate of procedural success, device-related thrombus (DRT) and major bleeding between genders.
  
  RESULTS:
  702 men and 386 women underwent LAAO. Implant successwas high, and similar between men and women (98.9 vs 99.5%, p = 0.58). Similarly, no difference was observed in the primary outcome (12.0 vs 12.5%, p = 0.82). Compared to the CHADS-VASc predicted rate, we observed a numerically greater absolute risk reduction of ischemic stroke in women (from 7.6 to 2.1%/year) than men (from 6.2 to 2.2%/year). DRT through 2 years was similar between groups (1.6%, p = 0.96). We found no significant gender difference in terms of periprocedural or long-term (7.1 vs 7.6%/year) major bleeding.
  
  CONCLUSIONS:
  In this large group of patients undergoing LAAO using the Amplatzer? Amulet? device we found no significant gender difference in terms of procedural or long-term clinical outcomes. Similarly to oral anticoagulation, device-based LAA occlusion renders AF-related stroke risk similar in women and men.
  
  CLINICAL TRIAL REGISTRATION:
  Clinicaltrials.gov Identifier: NCT02447081.https://clinicaltrials.gov/ct2/show/NCT02447081.
  
  © 2021 The Authors.
  
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• Length of stay following percutaneous left atrial appendage occlusion: Data from the prospective, multicenter Amplatzer Amulet Occluder Observational Study.
  PLoS One

  2021 ;16(8):e0255721. doi: e0255721.
  
  Piayda Kerstin, Afzal Shazia, Nielsen-Kudsk Jens Erik, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Hildick-Smith David, Gage Ryan, Zhao Hong, Zeus Tobias
  
  Abstract
  
  AIMS:
  To evaluate factors influencing the length of stay in patients undergoing percutaneous left atrial appendage occlusion (LAAO).
  
  METHODS AND RESULTS:
  Patient characteristics, procedural data and the occurrence of serious adverse events were analyzed from the AmplatzerTM AmuletTM Occluder Observational Study. Patients were divided into three groups: same day (S, 0day, n = 60, 5.6%) early (E, 1day, n = 526, 48.9%), regular (R, 2-3days, n = 338, 31.4%) and late (L, ?4days, n = 152, 14.1%) discharge and followed up for 60 days. Procedure and device related SAE during the in-hospital stay (S: 0.0% vs. E: 1.0% vs. R: 2.1% vs. L: 23%, p
  CONCLUSION:
  Over half of the subjects receiving an Amplatzer Amulet occluder were discharged within 1 day of the implant procedure. Serious adverse events were a major trigger for a late discharge after LAAO. Increased HAS-BLED score was associated with a prolonged in-hospital stay.
  
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• Direct oral anticoagulants in patients with nonvalvular atrial fibrillation and extreme body weight.
  Eur J Clin Invest

  2022 Jan;52(1):e13658. doi: 10.1111/eci.13658.
  
  Bodega Francesca, Russi Anita, Melillo Francesco, Blunda Fabiana, Rubino Claudia, Leo Giulio, Cappelletti Alberto, Mazzone Patrizio, Mattiello Paolo, Della Bella Paolo, Castiglioni Alessandro, Alfieri Ottavio, De Bonis Michele, Montorfano Matteo, Tresoldi Moreno, Filippi Massimo, Salerno Anna, Cera Michela, Zangrillo Alberto, Alberto Margonato, Godino Cosmo,
  
  Abstract
  
  BACKGROUND:
  Limited clinical data exist describing the use of direct oral anticoagulants (DOACs) in patient with extreme body weight. Thus, the International Society of Thrombosis and Haemostasis (ISTH) recommends avoiding DOACs in patients with weight >120 Kg, and on the contrary, no restrictions exist for underweight patients.
  
  OBJECTIVE:
  To evaluate the effects of extreme body weight on DOAC activity and to compare the clinical outcomes of patients with an extreme body weight versus patients with a normal weight (61-119 Kg) treated with DOACs.
  
  METHODS:
  Single tertiary care Italian centre multidisciplinary registry including nonvalvular atrial fibrillation (NVAF) patients treated with DOACs. Based on weight, three subcohorts were defined: (i) underweight patients (?60 Kg); (ii) patients with a normal weight (61-119 Kg, as control group); and (iii) overweight patients (?120 Kg). Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test.
  
  RESULTS:
  812 NVAF patients were included, 108 patients weighed ?60 Kg (13%, underweight), 688 weighed between 61 and 119 Kg (85%, normal weight), and 16 weighed ?120 Kg (2%, overweight). In particular, among underweight patients, dabigatran was prescribed in 26% patients, apixaban in 27%, rivaroxaban in 28% and edoxaban in 22% ones. Instead, among overweight patients, 44% were treated with dabigatran, 25% with apixaban, 25% with rivaroxaban and 4% with edoxaban. Underweight patients were older, more frequently women, with lower creatinine clearance and a history of previous strokes, resulting in higher CHA2DS2-VASc score than in both remaining groups. Up to 2 years, no statistically significant difference was observed between the three groups of weight for thromboembolic events (P = .765) and for overall bleeding (P = .125), but a trend towards decreased overall bleeding rates was noticed as weight increased (24.1% vs 16.7% vs 12.5%, respectively).
  
  CONCLUSION:
  In this tertiary care centre registry, 15% of patients treated with DOACs presented an extreme weight. Compared to patients with a normal weight, no significant rates of thromboembolic events were observed for underweight or overweight patients. A trend towards decreased overall bleeding frequency as weight increased was highlighted up to 2 years. The present results should be considered as preliminary and hypothesis generating.
  
  © 2021 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.
  
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• Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.
  J Am Coll Cardiol

  2021 Jul;78(4):297-313. doi: 10.1016/j.jacc.2021.04.098.
  
  Simard Trevor, Jung Richard G, Lehenbauer Kyle, Piayda Kerstin, Praco? Radoslaw, Jackson Gregory G, Flores-Umanzor Eduardo, Faroux Laurent, Korsholm Kasper, Chun Julian K R, Chen Shaojie, Maarse Moniek, Montrella Kristi, Chaker Zakeih, Spoon Jocelyn N, Pastormerlo Luigi E, Meincke Felix, Sawant Abhishek C, Moldovan Carmen M, Qintar Mohammed, Aktas Mehmet K, Branca Luca, Radinovic Andrea, Ram Pradhum, El-Zein Rayan S, Flautt Thomas, Ding Wern Yew, Sayegh Bassel, Benito-González Tomás, Lee Oh-Hyun, Badejoko Solomon O, Paitazoglou Christina, Karim Nabeela, Zaghloul Ahmed M, Agrawal Himanshu, Kaplan Rachel M, Alli Oluseun, Ahmed Aamir, Suradi Hussam S, Knight Bradley P, Alla Venkata M, Panaich Sidakpal S, Wong Tom, Bergmann Martin W, Chothia Rashaad, Kim Jung-Sun, Pérez de Prado Armando, Bazaz Raveen, Gupta Dhiraj, Valderrabano Miguel, Sanchez Carlos E, El Chami Mikhael F, Mazzone Patrizio, Adamo Marianna, Ling Fred, Wang Dee Dee, O'Neill William, Wojakowski Wojtek, Pershad Ashish, Berti Sergio, Spoon Daniel, Kawsara Akram, Jabbour George, Boersma Lucas V A, Schmidt Boris, Nielsen-Kudsk Jens Erik, Rodés-Cabau Josep, Freixa Xavier, Ellis Christopher R, Fauchier Laurent, Demkow Marcin, Sievert Horst, Main Michael L, Hibbert Benjamin, Holmes David R, Alkhouli Mohamad
  
  Abstract
  
  BACKGROUND:
  Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited.
  
  OBJECTIVES:
  This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT.
  
  METHODS:
  Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT.
  
  RESULTS:
  A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P 10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ?2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors.
  
  CONCLUSIONS:
  DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.
  
  Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Transvenous lead extraction: The influence of age on patient outcomes in the PROMET study cohort.
  Pacing Clin Electrophysiol

  2021 Sep;44(9):1540-1548. doi: 10.1111/pace.14310.
  
  Akhtar Zaki, Elbatran Ahmed I, Starck Christoph T, Gonzalez Elkin, Al-Razzo Omar, Mazzone Patrizio, Delnoy Peter-Paul, Breitenstein Alexander, Steffel Jan, Eulert-Grehn Jürgen, Lanmüller Pia, Melillo Francesco, Marzi Alessandra, Leung Lisa W M, Domenichini Giulia, Sohal Manav, Gallagher Mark M
  
  Abstract
  
  BACKGROUND:
  Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes.
  
  METHODS:
  Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [
  RESULTS:
  Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1% vs. 33.2%, respectively, p 
  CONCLUSION:
  TLE is safe and effective across all age groups. 30-day mortality risk is significantly higher in the older patients.
  
  © 2021 Wiley Periodicals LLC.
  
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• Safety and efficacy of Direct Oral Anticoagulants (DOACs) in very elderly patients (? 85 years old) with non-valvular atrial fibrillation. The Experience of an Italian tertiary care center.
  Minerva Med

  2021 Jun;():. doi: 10.23736/S0026-4806.21.07432-2.
  
  Rubino Claudia, Blunda Fabiana, Bodega Francesca, Melillo Francesco, Russi Anita, Mattiello Paolo, Salerno Anna, Cera Michela, Margonato Davide, Mazzone Patrizio, Della Bella Paolo, Castiglioni Alessandro, Alfieri Ottavio, DE Bonis Michele, Montorfano Matteo, Filippi Massimo, Tresoldi Moreno, Cappelletti Alberto, Zangrillo Alberto, Margonato Alberto, Godino Cosmo,
  
  Abstract
  
  BACKGROUND:
  Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (?85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians.
  
  OBJECTIVE:
  To evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (?85 years) compared to those non very elderly (
  METHODS:
  Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel test.
  
  RESULTS:
  908 NVAF consecutive patients were included, of these, 805 patients were
  CONCLUSIONS:
  This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.
  
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• The Spectrum of COVID-19-Associated Myocarditis: A Patient-Tailored Multidisciplinary Approach.
  J Clin Med

  2021 May;10(9):. doi: 1974.
  
  Peretto Giovanni, Villatore Andrea, Rizzo Stefania, Esposito Antonio, De Luca Giacomo, Palmisano Anna, Vignale Davide, Cappelletti Alberto Maria, Tresoldi Moreno, Campochiaro Corrado, Sartorelli Silvia, Ripa Marco, De Gaspari Monica, Busnardo Elena, Ferro Paola, Calabrò Maria Grazia, Fominskiy Evgeny, Monaco Fabrizio, Cavalli Giulio, Gianolli Luigi, De Cobelli Francesco, Margonato Alberto, Dagna Lorenzo, Scandroglio Mara, Camici Paolo Guido, Mazzone Patrizio, Della Bella Paolo, Basso Cristina, Sala Simone
  
  Abstract
  
  BACKGROUND:
  Myocarditis lacks systematic characterization in COVID-19 patients.
  
  METHODS:
  We enrolled consecutive patients with newly diagnosed myocarditis in the context of COVID-19 infection. Diagnostic and treatment strategies were driven by a dedicated multidisciplinary disease unit for myocarditis. Multimodal outcomes were assessed during prospective follow-up.
  
  RESULTS:
  Seven consecutive patients (57% males, age 51 ± 9 y) with acute COVID-19 infection received a de novo diagnosis of myocarditis. Endomyocardial biopsy was of choice in hemodynamically unstable patients ( = 4, mean left ventricular ejection fraction (LVEF) 25 ± 9%), whereas cardiac magnetic resonance constituted the first exam in stable patients ( = 3, mean LVEF 48 ± 10%). Polymerase chain reaction (PCR) analysis revealed an intra-myocardial SARS-CoV-2 genome in one of the six cases undergoing biopsy: in the remaining patients, myocarditis was either due to other viruses ( = 2) or virus-negative ( = 3). Hemodynamic support was needed for four unstable patients (57%), whereas a cardiac device implant was chosen in two of four cases showing ventricular arrhythmias. Medical treatment included immunosuppression (43%) and biological therapy (29%). By the 6-month median follow-up, no patient died or experienced malignant arrhythmias. However, two cases (29%) were screened for heart transplantation.
  
  CONCLUSIONS:
  Myocarditis associated with acute COVID-19 infection is a spectrum of clinical manifestations and underlying etiologies. A multidisciplinary approach is the cornerstone for tailored management.
  
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• Role of Different Antithrombotic Regimens after Percutaneous Left Atrial Appendage Occlusion: A Large Single Center Experience.
  J Clin Med

  2021 May;10(9):. doi: 1959.
  
  Mazzone Patrizio, Laricchia Alessandra, D'Angelo Giuseppe, Falasconi Giulio, Pannone Luigi, Limite Luca Rosario, Zweiker David, Regazzoli Damiano, Radinovic Andrea, Marzi Alessandra, Agricola Eustachio, Brugliera Luigia, Colombo Antonio, Della Bella Paolo, Montorfano Matteo
  
  Abstract
  
  BACKGROUND:
  Optimal antithrombotic therapy after left atrial appendage (LAA) occlusion is still not clear. The aim of this study was to investigate the role of different antithrombotic regimens after the procedure.
  
  METHODS AND RESULTS:
  We retrospectively analyzed data of 260 patients who underwent LAA occlusion and divided them into four groups according to therapy at discharge: dual antiplatelet therapy (group A, 71.5%); oral anticoagulants (group B, 19%); "minimal" antithrombotic therapy (single antiplatelet agent or without any antithrombotic therapy; group C, 4.5%) and other therapeutic regimens (such as a combination of antiplatelets and anticoagulants; group D, 4.5%). We analyzed baseline characteristics, procedural data, and clinical and transesophageal follow-up for each group. The incidence of adverse events was low in the whole population and had a similar distribution among groups. The majority of bleeding events was registered during the first 3 months after the procedure (34 out of 46, 70%). Ischemic events (2%), as well as silent left atrial thrombosis, were rare and not significantly higher in the population discharged with "minimal" antithrombotic therapy.
  
  CONCLUSION:
  Our experience seems to suggest that LAA occlusion was associated with a low incidence of adverse events, regardless of antithrombotic therapy. A "minimal" drug regimen may be feasible without losing efficacy on embolic prevention for patients with high bleeding risk.
  
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• Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study.
  BMJ Open

  2021 Mar;11(3):e040455. doi: e040455.
  
  Piayda Kerstin, Hellhammer Katharina, Nielsen-Kudsk Jens Erik, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Della Bella Paolo, Gage Ryan, Zeus Tobias
  
  Abstract
  
  OBJECTIVE:
  To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS).
  
  BACKGROUND:
  Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO.
  
  METHODS:
  Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7?days post implant were compared.
  
  RESULTS:
  Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22?min vs CS: 27±19?min, p
  CONCLUSIONS:
  In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases.
  
  TRIAL REGISTRATION NUMBER:
  NCT02447081; Results.
  
  © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
  
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• Characterization of cardiac electrogram signals in atrial arrhythmias.
  Minerva Cardiol Angiol

  2021 Feb;69(1):70-80. doi: 10.23736/S2724-5683.20.05431-6.
  
  Frontera Antonio, Limite Luca Rosario, Pagani Stefano, Hadjis Alexios, Cireddu Manuela, Sala Simone, Tsitsinakis Giorgios, Paglino Gabriele, Peretto Giovanni, Lipartiti Felicia, Bisceglia Caterina, Radinovic Andrea, D'Angelo Giuseppe, Marzi Alessandra, Baratto Francesca, Vergara Pasquale, DedÈ Luca, Gulletta Simone, Manzoni Andrea, Mazzone Patrizio, Quarteroni Alfio, Della Bella Paolo
  
  Abstract
  
  Despite significant advancements in 3D cardiac mapping systems utilized in daily electrophysiology practices, the characterization of atrial substrate remains crucial for the comprehension of supraventricular arrhythmias. During mapping, intracardiac electrograms (EGM) provide specific information that the cardiac electrophysiologist is required to rapidly interpret during the course of a procedure in order to perform an effective ablation. In this review, EGM characteristics collected during sinus rhythm (SR) in patients with paroxysmal atrial fibrillation (pAF) are analyzed, focusing on amplitude, duration and fractionation. Additionally, EGMs recorded during atrial fibrillation (AF), including complex fractionated atrial EGMs (CFAE), may also provide precious information. A complete understanding of their significance remains lacking, and as such, we aimed to further explore the role of CFAE in strategies for ablation of persistent AF. Considering focal atrial tachycardias (AT), current cardiac mapping systems provide excellent tools that can guide the operator to the site of earliest activation. However, only careful analysis of the EGM, distinguishing low amplitude high frequency signals, can reliably identify the absolute best site for RF. Evaluating macro-reentrant atrial tachycardia circuits, specific EGM signatures correspond to particular electrophysiological phenomena: the careful recognition of these EGM patterns may in fact reveal the best site of ablation. In the near future, mathematical models, integrating patient-specific data, such as cardiac geometry and electrical conduction properties, may further characterize the substrate and predict future (potential) reentrant circuits.
  
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• Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study.
  EuroIntervention

  2021 Oct;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.
  
  Aminian Adel, De Backer Ole, Nielsen-Kudsk Jens Erik, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Lam Simon Cheung Chi, Freixa Xavier, Gage Ryan, Diener Hans-Christoph, Schmidt Boris
  
  Abstract
  
  BACKGROUND:
  Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear.
  
  AIMS:
  This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high risk for bleeding and contraindicated to anticoagulation.
  
  METHODS:
  The two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality.
  
  RESULTS:
  The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two. The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34, 95% CI: 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; p
  CONCLUSIONS:
  In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.
  
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• Incidence, predictors and outcomes of device-related thrombus after left atrial appendage closure with the WATCHMAN device-Insights from the EWOLUTION real world registry.
  Catheter Cardiovasc Interv

  2021 Jun;97(7):E1019-E1024. doi: 10.1002/ccd.29458.
  
  Sedaghat Alexander, Nickenig Georg, Schrickel Jan Wilko, Ince Hüseyin, Schmidt Boris, Protopopov Alexey V, Betts Timothy R, Gori Tommaso, Sievert Horst, Mazzone Patrizio, Grygier Marek, Wald Christof, Vireca Elisa, Allocco Dominic, Boersma Lucas V A,
  
  Abstract
  
  BACKGROUND:
  In this analysis of the EWOLUTION registry, we evaluated the incidence, relevance and predictors of device-related thrombus in a large multi-center real-world cohort undergoing LAAc with the WATCHMAN device.
  
  METHODS AND RESULTS:
  We analyzed the 835 patients who underwent percutaneous LAA closure with the WATCHMAN device in the EWOLUTION registry in whom at least one TEE follow up was performed. Patients were 74?±?9 y/o and were at high risk for stroke and bleeding (CHA2DS2-VASC-Score 4.3 ±?1.7; HAS-BLED-Score 2.3 ±?1.2). Device-related thrombus was detected in 4.1% (34/835) after a median of 54?days (IQR 42-111?days) with 91.2% (31/34) being detected within 3 months after the procedure or at the time of first TEE. Hereby DRT occurred irrespective of postprocedural anticoagulation. Patients with DRT more frequently had long-standing, non-paroxysmal atrial fibrillation (82.4 vs. 64.9%, p .01), evidence of dense spontaneous echo contrast (26.5 vs. 11.9%, p =?.03) and larger LAA diameters at the ostium (22.8 ±?3.5 vs. 21.1 ±?3.5?mm, p .01) compared to patients without DRT. Left ventricular ejection fraction, device compression ratio and the incidence of renal dysfunction did not differ between the two groups. In a multivariate analysis, only non-paroxysmal atrial fibrillation identified as an independent predictor of developing DRT. Specific treatment of DRT was initiated in 62% (21/34) of patients whereas resolution was confirmed in 86% (18/21) of cases. Overall, no significant differences in annual rates of stroke/TIA or systemic embolism were observed in patients with or without DRT (DRT 1.7 vs. No-DRT 2.2%/year, p =?.8).
  
  CONCLUSIONS:
  In real-world patients undergoing LAAc with the WATCHMAN device, DRT is rare. DRT was most frequently detected within the first 3 months after LAAc regardless of post-procedural regimen and was not associated with an increased risk of stroke or SE. While long-standing atrial fibrillation was the only independent factor associated with DRT, medical treatment of DRT resulted in a resolution of thrombi in most cases.
  
  © 2021 Wiley Periodicals LLC.
  
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• Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer? Amulet? Occluder Observational Study.
  Europace

  2021 Feb;23(2):238-246. doi: 10.1093/europace/euaa262.
  
  Freixa Xavier, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Della Bella Paolo, Lam Simon Cheung Chi, Cruz-Gonzalez Ignacio, Gage Ryan, Omran Heyder, Tarantini Giuseppe, Aminian Adel, Nielsen-Kudsk Jens Erik
  
  Abstract
  
  AIMS:
  Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up.
  
  METHODS AND RESULTS:
  We compared subjects aged
  CONCLUSIONS:
  Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• Left atrial appendage occlusion in atrial fibrillation patients with previous intracranial bleeding: A national multicenter study.
  Int J Cardiol

  2021 Apr;328():75-80. doi: 10.1016/j.ijcard.2020.11.045.
  
  Casu Gavino, D'Angelo Giuseppe, Ugo Fabrizio, Ronco Federico, Simonetto Federico, Barbierato Marco, Magni Valeria, Boccuzzi Giacomo, Margonato Alberto, Moroni Francesco, Delitala Alessandro, Lorenzoni Giovanni, Beneduce Alessandro, Rametta Francesco, Mazzone Patrizio, Della Bella Paolo, Montorfano Matteo, Merella Pierluigi
  
  Abstract
  
  BACKGROUND:
  Intracranial hemorrhage (ICH) represents the most serious complication of oral anticoagulant therapy (OAT) in patients with atrial fibrillation (AF), and AF patients with previous ICH are a challenge for clinicians. Left atrial appendage (LAA) occlusion has emerged as an alternative option for AF patients not suitable for OAT. Currently, few data are available on long term outcomes after LAA occlusion in this population. We evaluated the safety and efficacy of LAA occlusion in a cohort of patients with AF and previous ICH.
  
  METHODS:
  This is a multicenter, observational, retrospective study involving 5 LAA occlusion centers in Italy. It includes all consecutive patients (n = 120) with previous ICH who underwent LAA occlusion for nonvalvular AF and high thromboembolic risk. Procedural outcomes, post-procedural therapies and 12-months follow-up data were analyzed.
  
  RESULTS:
  The device was successfully implanted in 100% of cases, with a 6% of major peri-procedural complications. 59% had a prior ICH during OAT. The sample had a high risk of stroke (5.18%/year) and bleeding (6.62%/year). 30% were discharged on single and 54.2% on dual antiplatelet therapy. The expected annual risk for thromboembolism was 5.1%. Excluding periprocedural ischemic complications, the stroke annual rate was 1.8%. The expected annual risk of bleeding was 6.7%. The observed annual bleeding rate was 5.45%.
  
  CONCLUSIONS:
  Percutaneous LAA occlusion is an effective option for AF patients and previous intracranial hemorrhage. After LAA occlusion, a single antiplatelet therapy strategy could be considered for patients with the highest risk of recurrent bleeding.
  
  Copyright © 2020. Published by Elsevier B.V.
  
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• Percutaneous Left Atrial Appendage Occlusion.
  Cardiology

  2021 ;146(1):116-118. doi: 10.1159/000511659.
  
  Sambola Antonia, Radinovic Andrea, Mazzone Patrizio
  
  
  
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• Procedural and Short-Term Results With the New Watchman FLX Left Atrial Appendage Occlusion Device.
  JACC Cardiovasc Interv

  2020 Dec;13(23):2732-2741. doi: 10.1016/j.jcin.2020.06.056.
  
  Cruz-González Ignacio, Korsholm Kasper, Trejo-Velasco Blanca, Thambo Jean Benoit, Mazzone Patrizio, Rioufol Gilles, Grygier Marek, Möbius-Winkler Sven, Betts Timothy, Meincke Felix, Sandri Marcus, Schmidt Boris, Schmitz Thomas, Nielsen-Kudsk Jens Erik
  
  Abstract
  
  OBJECTIVES:
  This study sought to report early experience with the new-generation Watchman FLX device (Boston Scientific, Marlborough, Massachusetts).
  
  BACKGROUND:
  The new-generation Watchman FLX features a reduced height, improved anchoring and fabric coverage, and a closed distal end. These design modifications aim to simplify implantation, allow full recapture and repositioning, and reduce peridevice leak and device-related thrombosis.
  
  METHODS:
  A total of 165 patients undergoing left atrial appendage (LAA) occlusion (LAAO) with Watchman FLX were enrolled in a prospective, multicenter registry at 12 centers participating in the European limited market release program.
  
  RESULTS:
  Mean age was 75.4 ± 8.9 years, and CHADS-VASc score 4.4 ± 1.4. A total of 128 patients (77.6%) had a history of major bleeding, including previous intracranial hemorrhage in 55 cases (33.3%). LAA landing zone minimal and maximal mean diameters were 19.1 ± 3.6 mm and 22.3 ± 3.7 mm, and 24.2% of LAA were considered complex by dimensions. Technical success was achieved in all patients. Successful implantation at first attempt was achieved in 129 cases (78.2%), and a second device was required in 6 cases (3.6%). Procedure-related complications occurred in 3 patients (1.8%): 2 access-related (1.2%) and 1 pericardial effusion (0.6%). No peri-procedural strokes, deaths, or device embolizations occurred. Forty-nine patients (29.7%) were discharged with single antiplatelet therapy, 105 (63.6%) on dual antiplatelet, and 11 (6.7%) on anticoagulation. Imaging follow-up displayed just 1 peridevice leak ?5 mm and 7 cases of device-related thrombosis (4.7%). During a median follow-up of 55 days (interquartile range: 45 to 148 days), there were 6 hemorrhagic complications (4.8%), 1 patient (0.8%) had an ischemic stroke, and 1 (0.8%) died. No late device embolizations occurred.
  
  CONCLUSIONS:
  LAAO with the Watchman FLX is safe and effective in a wide range of LAA morphologies, with a low procedural complication rate, high degree of LAA sealing, and favorable short-term efficacy.
  
  Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis.
  J Am Coll Cardiol

  2020 Oct;76(14):1644-1656. doi: 10.1016/j.jacc.2020.08.012.
  
  Peretto Giovanni, Sala Simone, Basso Cristina, Rizzo Stefania, Radinovic Andrea, Frontera Antonio, Limite Luca Rosario, Paglino Gabriele, Bisceglia Caterina, De Luca Giacomo, Campochiaro Corrado, Sartorelli Silvia, Palmisano Anna, Esposito Antonio, Busnardo Elena, Villatore Andrea, Baratto Francesca, Cireddu Manuela, Marzi Alessandra, D'Angelo Giuseppe, Gulletta Simone, Vergara Pasquale, De Cobelli Francesco, Dagna Lorenzo, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Little is known about the risk stratification of patients with myocarditis undergoing ventricular tachycardia (VT) ablation.
  
  OBJECTIVES:
  This study sought to describe VT ablation results and identify factors associated with arrhythmia recurrences in a cohort of patients with myocarditis.
  
  METHODS:
  The authors enrolled 125 consecutive patients with myocarditis, undergoing VT ablation. Before ablation, disease stage was evaluated, to identify active (AM) versus previous myocarditis (PM). The primary study endpoint was assessment of VT recurrences by 12-month follow-up. Predictors of VT recurrences were retrospectively identified.
  
  RESULTS:
  All patients (age 51 ± 14 years, 91% men, left ventricular ejection fraction 52% ± 9%) had history of myocarditis diagnosed by endomyocardial biopsy (59%) and/or cardiac magnetic resonance (90%). Furthermore, all had multiple episodes of drug-refractory VTs. Multimodal pre-procedural staging identified 47 patients with AM (38%) and 78 patients with PM (62%). All patients showed low-voltage areas (LVA) at electroanatomical map (97% epicardial or endoepicardial); of them, 25 (20%) had wide borderzone (WBZ, constituting >50% of the whole LVA). VT recurrences were documented in 25 patients (20%) by 12 months, and in 43 (34%) by last follow-up (median 63 months; interquartile range: 39 to 87). At multivariable analysis, AM stage was the only predictor of VT recurrences by 12 months (hazard ratio: 9.5; 95% confidence interval: 2.6 to 35.3; p 
  CONCLUSION:
  Our findings suggest that VT ablation should be avoided during AM, but is often of benefit for recurrent VT after the acute phase of myocarditis.
  
  Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Electrophysiology in the time of coronavirus: coping with the great wave.
  Europace

  2020 Dec;22(12):1841-1847. doi: euaa185.
  
  Li Jia, Mazzone Patrizio, Leung Lisa W M, Lin Weiqian, D'Angelo Giuseppe, Ma Jun, Li Jin, Akhtar Zaki, Li Yuechun, Della Bella Paolo, Lin Jiafeng, Gallagher Mark M
  
  Abstract
  
  AIMS:
  To chart the effect of the COVID-19 pandemic on the activity of interventional electrophysiology services in affected regions.
  
  METHODS AND RESULTS:
  We reviewed the electrophysiology laboratory records in three affected cities: Wenzhou in China, Milan in Italy, and London in the UK. We inspected catheter lab records and interviewed electrophysiologists in each centre to gather information on the impact of the pandemic on working patterns and on the health of staff members and patients. There was a striking decline in interventional electrophysiology activity in each of the centres. The decline occurred within a week of the recognition of widespread community transmission of the virus in each region and shows a striking correlation with the national figures for new diagnoses of COVID-19 in each case. During the period of restriction, workflow dropped to
  CONCLUSION:
  Interventional electrophysiology is vulnerable to closure in times of great social difficulty including the COVID-19 pandemic. Intense public health intervention can permit suppression of local disease transmission allowing resumption of some normal activity with stringent precautions.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• The Impact of CHADS-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study.
  JACC Cardiovasc Interv

  2020 Sep;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.
  
  Tarantini Giuseppe, D'Amico Gianpiero, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Lund Juha, Montorfano Matteo, Della Bella Paolo, Lam Simon Cheung Chi, Cruz-Gonzalez Ignacio, Gage Ryan, Zhao Hong, Omran Heyder, Odenstedt Jacob, Nielsen-Kudsk Jens Erik
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to evaluate the impact of CHADS-VASc and HAS-BLED scores on ischemic and bleeding events of patients enrolled in the Amplatzer Amulet Observational Study.
  
  BACKGROUND:
  Baseline CHADS-VASc and HAS-BLED scores have been validated in atrial fibrillation patients to guide about anticoagulation but not in patients treated by left atrial appendage occlusion (LAAO).
  
  METHODS:
  Subjects were stratified according to CHADS-VASc and HAS-BLED scores. Clinical outcomes were collected through 2 years and adjudicated by an independent committee.
  
  RESULTS:
  Subjects were considered at low (n = 156), moderate (n = 715), and high (n = 215) risk for ischemic stroke, corresponding to CHADS-VASc scores of 3 in 456 subjects, respectively. Non-peri-procedural major bleeding was reduced by 11% and 9% compared with predicted rates in the low and high bleeding risk groups, respectively.
  
  CONCLUSIONS:
  LAAO with the Amplatzer Amulet reduced the risk of ischemic stroke compared with the predicted rate, with a greater magnitude among patients at high thromboembolic risk without increasing the bleeding risk. (Amplatzer?Amulet? Post-Market Study [Amulet?PMS]; NCT02447081).
  
  Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• ILEEM-survey on the Heart Team approach and team training for lead extraction procedures.
  Cardiol J

  2022 ;29(3):481-488. doi: 10.5603/CJ.a2020.0106.
  
  Starck Christoph T, Bracke Frank, Delnoy Peter-Paul, Freedman Roger A, Kutarski Andrzej, Gallagher Mark, Shoda Morio, Peyton Robert, Sohal Manav, Gadler Frederik, Sedlacek Kamil, Hartikainen Juha, Mazzone Patrizio, Breitenstein Alexander, Lever Nigel
  
  Abstract
  
  BACKGROUND:
  The Heart Team approach has become an integral part of modern cardiovascular medicine. To evaluate current opinions and real-world practice among lead extraction practitioners, an online survey was created and distributed among a pool of lead extraction specialists participating in the International Lead Extraction Expert Meeting (ILEEM) 2018.
  
  METHODS:
  The online survey consisted of 10 questions and was performed using an online survey tool (www.surveymonkey.com). The collector link was sent to 48 lead extraction experts via email.
  
  RESULTS:
  A total of 43 answers were collected (89% return rate) from lead extraction experts in 16 different countries. A great majority (83.7%) of the respondents performed more than 30 lead extraction procedures per year. The most common procedural environment in this survey was the hybrid operating room (67.4%). Most procedures were performed by electrophysiologists and cardiologists (80.9%). Important additional members of the current lead extraction teams were cardiac surgeons (79.1%), anesthesiologists (95.3%) and operating room scrub nurses (76.7%). An extended Heart Team is regarded beneficial for patient care by 86.0%, with potential further members being infectious diseases specialists, intensivists and radiologists. Team training activities are performed in 48.8% of participating centers.
  
  CONCLUSIONS:
  This survey supports the importance of establishing lead extraction Heart Teams in specialized lead extraction centers to potentially improve patient outcomes. The concept of a core and an extended Heart Team approach in lead extraction procedures is introduced.
  
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• Cerebral protection in left atrial appendage closure in the presence of appendage thrombosis.
  Catheter Cardiovasc Interv

  2021 Feb;97(3):511-515. doi: 10.1002/ccd.29161.
  
  Boccuzzi Giacomo G, Montabone Andrea, D'Ascenzo Fabrizio, Colombo Francesco, Ugo Fabrizio, Muraglia Simone, De Backer Ole, Nombela-Franco Luis, Meincke Felix, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue.
  
  AIM:
  To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus.
  
  METHODS AND RESULTS:
  The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ±?9.7?years old, with median CHA DS -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded.
  
  CONCLUSIONS:
  In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.
  
  © 2020 Wiley Periodicals LLC.
  
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• Inappropriate dose of nonvitamin-K antagonist oral anticoagulants: prevalence and impact on clinical outcome in patients with nonvalvular atrial fibrillation.
  J Cardiovasc Med (Hagerstown)

  2020 Oct;21(10):751-758. doi: 10.2459/JCM.0000000000001043.
  
  Godino Cosmo, Bodega Francesca, Melillo Francesco, Rubino Francesca, Parlati Antonio L M, Cappelletti Alberto, Mazzone Patrizio, Mattiello Paolo, Della Bella Paolo, Castiglioni Alessandro, Alfieri Ottavio, De Bonis Michele, Montorfano Matteo, Tresoldi Moreno, Filippi Massimo, Zangrillo Alberto, Salerno Anna, Cera Michela, Margonato Alberto,
  
  Abstract
  
  BACKGROUND:
  Limited real-world data are available regarding the outcome of patients treated with inappropriate dose of nonvitamin-K antagonist oral anticoagulants (NOACs).
  
  OBJECTIVE:
  To assess the prevalence and factors associated with inappropriate dose prescription of NOACs and to evaluate adverse events that come from this inappropriate prescription.
  
  METHODS:
  Single-center multidisciplinary registry including nonvalvular atrial fibrillation patients treated with NOACs. Based on guidelines criteria for dose reduction, two subcohorts were defined as treated with appropriate or inappropriate NOACs dose. Primary efficacy endpoint was 2-year rate of thromboembolic events. Primary safety endpoint was 2-year rate of major bleeding. Event-free survival curves among groups were compared using Cox-Mantel test.
  
  RESULTS:
  A total of 760 nonvalvular atrial fibrillation patients were included; 32% patients were treated with dabigatran, 34% with apixaban, 24% with rivaroxaban and 10% with edoxaban. An inappropriate dose was prescribed in 96 patients (12.6%), and in most cases (68%) it was too low. Rivaroxaban (15%) and apixaban (18.5%) were the most frequently prescribed with an inappropriate dose. Patients treated with an inappropriate dose were elderly people, with low-creatinine clearance value, who had experienced previous bleeding and with a high CHADS2 VASc score. In 2 years, a trend for higher numbers of thromboembolic events (5.2 vs. 3.3%, P?=?0.348) and less major bleeding (2.1 vs. 4.2%, P?=?0.316) has been observed in patients with inappropriate NOACs prescriptions.
  
  CONCLUSION:
  Nearly 13% of patients were treated with an inappropriate dose of NOACs, in this single-center study. A trend for higher numbers of thromboembolic events was observed in these patients. The results should be considered as hypothesis generating.
  
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• High-Density Characterization of the Ventricular Electrical Substrate During Sinus Rhythm in Post-Myocardial Infarction Patients.
  JACC Clin Electrophysiol

  2020 Jul;6(7):799-811. doi: 10.1016/j.jacep.2020.04.008.
  
  Frontera Antonio, Melillo Francesco, Baldetti Luca, Radinovic Andrea, Bisceglia Caterina, D'Angelo Giuseppe, Foppoli Luca, Gigli Lorenzo, Peretto Giovanni, Cireddu Manuela, Sala Simone, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to characterize, during sinus rhythm, the electric activation abnormalities in post-myocardial infarction patients undergoing ablation of ventricular tachycardia (VT) in order to identify specific signatures of those abnormal electrograms (EGMs).
  
  BACKGROUND:
  In the setting of VT ablation, substrate characterization hinges on the identification of local abnormal ventricular activity (LAVA) and late potentials (LPs) that are considered to be related to the VT circuit.
  
  METHODS:
  Patients scheduled for VT ablation underwent high-density ventricular substrate mapping. The substrate map during sinus rhythm was then compared with the activation maps of the clinical VT. Abnormal EGMs (LAVA and LPs) during sinus rhythm were characterized according to their configuration, duration, and amplitude and distinguished as belonging to bystander region or to the re-entrant circuit. Underlying electrophysiological mechanisms (wave-front collision, slow conduction) were identified on the activation maps and assigned to corresponding EGMs.
  
  RESULTS:
  Ten patients satisfied the criteria to be enrolled in the study. A mean of 5 ± 1 slow-conduction areas and 4 ± 2 wave-front collisions were identified. LAVA was due to slow conduction in 60.5%, followed by wave-front collision (17.5%). LPs were caused by slow conduction in 52% of cases and by wave-front collision in 43% of cases. During sinus rhythm, entrance and exit sites were characterized by LAVA, while at the VT isthmus, only LPs were identified. Cutoff values of duration 
  CONCLUSIONS:
  In the setting of post-myocardial infarction cardiomyopathy, specific EGM signatures are expressions of distinct electrophysiological phenomena. LAVA and LPs may play a bystander or an active role in the VT circuit, but only LPs with low amplitude and short duration predicted the VT isthmus.
  
  Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Correction to: Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis.
  J Nephrol

  2021 Feb;34(1):75-76. doi: 10.1007/s40620-020-00800-6.
  
  Genovesi Simonetta, Porcu Luca, Slaviero Giorgio, Casu Gavino, Bertoli Silvio, Sagone Antonio, Buskermolen Monique, Pieruzzi Federico, Rovaris Giovanni, Montoli Alberto, Oreglia Jacopo, Piccaluga Emanuela, Molon Giulio, Gaggiotti Mario, Ettori Federica, Gaspardone Achille, Palumbo Roberto, Viazzi Francesca, Breschi Marco, Gallieni Maurizio, Contaldo Gina, D'Angelo Giuseppe, Merella Pierluigi, Galli Fabio, Rebora Paola, Valsecchi Mariagrazia, Mazzone Patrizio
  
  
  
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• Long-Term Outcome After Ventricular Tachycardia Ablation in Nonischemic Cardiomyopathy: Late Potential Abolition and VT Noninducibility.
  Circ Arrhythm Electrophysiol

  2020 Aug;13(8):e008307. doi: 10.1161/CIRCEP.119.008307.
  
  Okubo Kenji, Gigli Lorenzo, Trevisi Nicola, Foppoli Luca, Radinovic Andrea, Bisceglia Caterina, Frontera Antonio, D'Angelo Giuseppe, Cireddu Manuela, Paglino Gabriele, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  In patients with an ischemic cardiomyopathy (ICM), the combination of late potential (LP) abolition and postprocedural ventricular tachycardia (VT) noninducibility is known to be the desirable end point for a successful long-term outcome after VT ablation. We investigated whether LP abolition and VT noninducibilty have a similar impact on the outcomes of patients with non-ICMs (NICM) undergoing VT ablation.
  
  METHODS:
  A total of 403 patients with NICM (523 procedures) who underwent a VT ablation from 2010 to 2016 were included. The procedure end points were the LP abolition (if the LPs were absent, other ablation strategies were undertaken) and the VT noninducibilty.
  
  RESULTS:
  The underlying structural heart disease consisted of dilated cardiomyopathy (DCM, 49%), arrhythmogenic right ventricular dysplasia (ARVD, 17%), postmyocarditis (14%), valvular heart disease (8%), congenital heart disease (2%), hypertrophic cardiomyopathy (2%), and others (5%). The epicardial access was performed in 57% of the patients. At baseline, the LPs were present in 60% of the patients and a VT was either inducible or sustained/incessant in 85% of the cases. At the end of the procedure, the LP abolition was achieved in 79% of the cases and VT noninducibility in 80%. After a multivariable analysis, the combination of LP abolition and VT noninducibilty was independently associated with free survival from VT (hazard ratio, 0.45 [95% CI, 0.29-0.69], =0.0002) and cardiac death (hazard ratio, 0.38 [95% CI, 0.18-0.74], =0.005). The benefit of the LP abolition on preventing the VT recurrence in patients with ARVD and postmyocarditis appeared superior to that observed for those with DCM.
  
  CONCLUSIONS:
  In patients with NICM undergoing VT ablation, the strategy of LP abolition and VT noninducibilty were associated with better outcomes in terms of long-term VT recurrences and cardiac survival. Graphic Abstract: A graphic abstract is available for this article.
  
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• Left atrial appendage occlusion in patients with atrial fibrillation and a large prevalence of intracranial bleeding: a further confirmation.
  J Cardiovasc Med (Hagerstown)

  2020 Aug;21(8):592-594. doi: 10.2459/JCM.0000000000001013.
  
  Mazzone Patrizio, Della Bella Paolo, Radinovic Andrea
  
  
  
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• Bipolar radiofrequency ablation for ventricular tachycardias originating from the interventricular septum: Safety and efficacy in a pilot cohort study.
  Heart Rhythm

  2020 Dec;17(12):2111-2118. doi: 10.1016/j.hrthm.2020.06.025.
  
  Della Bella Paolo, Peretto Giovanni, Paglino Gabriele, Bisceglia Caterina, Radinovic Andrea, Sala Simone, Baratto Francesca, Limite Luca Rosario, Cireddu Manuela, Marzi Alessandra, D'Angelo Giuseppe, Vergara Pasquale, Gulletta Simone, Mazzone Patrizio, Frontera Antonio
  
  Abstract
  
  BACKGROUND:
  Interest has grown in recent years in bipolar radiofrequency ablation (B-RFA). However, indications and outcome in patients with ventricular tachycardia (VT) are still to be defined.
  
  OBJECTIVE:
  The purpose of this study was to describe patient selection, safety and effectiveness of B-RFA, in a pilot cohort study of patients with nonischemic dilated cardiomyopathy (NIDCM) and drug-refractory VT.
  
  METHODS:
  We enrolled 21 patients with NIDCM (mean age 66±10 years; 18/21 (86%) men; left ventricular ejection fraction 35%±14%; 100% redo procedures) scheduled for a B-RFA procedure because of drug-refractory VT of suspected septal (interventricular septum [IVS]) origin. After electroanatomic mapping by using the CARTO®3 system, B-RFA was performed in all patients. Short- and long-term outcomes, including procedural success, major complications, and occurrence of major ventricular arrhythmias (MVAs), were evaluated at 25±8 months of follow-up (FU).
  
  RESULTS:
  Endocardial mapping showed IVS scar in all patients and extra-IVS in 7 patients (33%). B-RFA was performed at an average power of 33 W, for 60-90 seconds, over a 4.1 cm area, with 13±3 mm distance between catheters tips. The impedance drop was 27±4 ?. The primary end point of noninducibility of the target clinical VT was obtained in 20 patients (95%). During FU, MVAs were documented in 7 patients (33%). FU MVAs occurred in all (100%) patients with extra-IVS localizations (7 of 7) or inflammatory nonischemic cardiomyopathy etiology (2 of 2). IVS thinning (tip-to-tip catheter distance
  CONCLUSION:
  B-RFA is feasible in patients with NIDCM and drug-refractory VT of septal origin. Extra-IVS substrate and inflammatory NIDCM etiology were associated with an adverse outcome.
  
  Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
  
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• Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis.
  J Nephrol

  2021 Feb;34(1):63-73. doi: 10.1007/s40620-020-00774-5.
  
  Genovesi Simonetta, Porcu Luca, Slaviero Giorgio, Casu Gavino, Bertoli Silvio, Sagone Antonio, Buskermolen Monique, Pieruzzi Federico, Rovaris Giovanni, Montoli Alberto, Oreglia Jacopo, Piccaluga Emanuela, Molon Giulio, Gaggiotti Mario, Ettori Federica, Gaspardone Achille, Palumbo Roberto, Viazzi Francesca, Breschi Marco, Gallieni Maurizio, Contaldo Gina, D'Angelo Giuseppe, Merella Pierluigi, Galli Fabio, Rebora Paola, Valsecchi Mariagrazia, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk.
  
  METHODS:
  Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n?=?114) and the other not taking any OAT (no-therapy cohort, n?=?148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors.
  
  RESULTS:
  The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43-6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32-31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31-5.86)] and No-Therapy [HR 3.09 (95% CI 1.59-5.98)] cohorts compared to LAA occlusion patients.
  
  CONCLUSIONS:
  The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.
  
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• Initial and long-term antithrombotic therapy after left atrial appendage closure with the WATCHMAN.
  Europace

  2020 Jul;22(7):1036-1043. doi: 10.1093/europace/euaa074.
  
  Ledwoch Jakob, Sievert Kolja, Boersma Lucas V A, Bergmann Martin W, Ince Hüseyin, Kische Stephan, Pokushalov Evgeny, Schmitz Thomas, Schmidt Boris, Gori Tommaso, Meincke Felix, Protopopov Alexey Vladimir, Betts Timothy R, Mazzone Patrizio, Foley David, Grygier Marek, De Potter Tom, Sievert Horst,
  
  Abstract
  
  AIMS:
  Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study.
  
  METHODS AND RESULTS:
  A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2?years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy.
  
  CONCLUSIONS:
  Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques.
  Europace

  2020 Jul;22(7):1103-1110. doi: 10.1093/europace/euaa103.
  
  Starck Christoph T, Gonzalez Elkin, Al-Razzo Omar, Mazzone Patrizio, Delnoy Peter-Paul, Breitenstein Alexander, Steffel Jan, Eulert-Grehn Jürgen, Lanmüller Pia, Melillo Francesco, Marzi Alessandra, Sohal Manav, Domenichini Giulia, Gallagher Mark M
  
  Abstract
  
  AIMS:
  Several large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques.
  
  METHODS AND RESULTS:
  Data were collected on a total of 2205 patients (age 66.0 ± 15.7?years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74?months [interquartile range (IQR) 41-112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106?months (IQR 66-145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%.
  
  CONCLUSION:
  Patient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.
  
  © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.
  
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• The COVID-19 challenge to cardiac electrophysiologists: optimizing resources at a referral center.
  J Interv Card Electrophysiol

  2020 ;59(2):321-327. doi: 10.1007/s10840-020-00761-7.
  
  Mazzone Patrizio, Peretto Giovanni, Radinovic Andrea, Limite Luca Rosario, Marzi Alessandra, Sala Simone, Cireddu Manuela, Vegara Pasquale, Baratto Francesca, Paglino Gabriele, D'Angelo Giuseppe, Cianfanelli Lorenzo, Altizio Savino, Lipartiti Felicia, Frontera Antonio, Bisceglia Caterina, Gulletta Simone, Bella Paolo Della
  
  Abstract
  
  PURPOSE:
  To describe how a referral center for cardiac electrophysiology (EP) rapidly changed to comply with the ongoing COVID-19 healthcare emergency.
  
  METHODS:
  We present retrospective data about the modification of daily activities at our EP unit, following the pandemic outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Italy. In particular, in the context of a pre-existing "hub-and-spoke" network, we describe how procedure types and volumes have changed in the last 3 months.
  
  RESULTS:
  Since our institution was selected as a COVID-19 referral center, the entire in-hospital activity was reorganized to assist more than 1000 COVID-positive cases. Only urgent EP procedures, including ventricular tachycardia ablation and extraction of infected devices, were both maintained and optimized to meet the needs of external hospitals. In addition, most of the non-urgent EP procedures were postponed. Finally, following prompt internal reorganization, both outpatient clinics and on-call services underwent significant modification, by integrating telemedicine support whenever applicable.
  
  CONCLUSION:
  We presented the fast reorganization of an EP referral center during the ongoing COVID-19 healthcare emergency. Our hub-and-spoke model may be useful for other centers, aiming at a cost-effective management of resources in the context of a global crisis.
  
  © Springer Science+Business Media, LLC, part of Springer Nature 2020.
  
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• Septal Late Gadolinium Enhancement and Arrhythmic Risk in Genetic and Acquired Non-Ischaemic Cardiomyopathies.
  Heart Lung Circ

  2020 Sep;29(9):1356-1365. doi: 10.1016/j.hlc.2019.08.018.
  
  Peretto Giovanni, Sala Simone, Lazzeroni Davide, Palmisano Anna, Gigli Lorenzo, Esposito Antonio, De Cobelli Francesco, Camici Paolo G, Mazzone Patrizio, Basso Cristina, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  In many genetic and acquired non-ischaemic cardiomyopathies (NICM) there have been frequent reports of involvement of the interventricular septum (IVS) by late gadolinium enhancement (LGE) at cardiac magnetic resonance (CMR). However, no studies have investigated the relationship between septal LGE and arrhythmias in different NICM subtypes.
  
  METHODS:
  This study enrolled 103 patients with septal LGE at baseline CMR and different NICM: hypertrophic (n=29) or lamin A/C gene (LMNA)-associated (n=23) cardiomyopathy, and acute (n=30) or previous (n=21) myocarditis. During follow-up, the occurrences of malignant ventricular arrhythmias (MVA) and major bradyarrhythmias (BA) were evaluated.
  
  RESULTS:
  At 4.9±0.7 years of follow-up, the occurrence of MVA and major BA in genetic vs acquired NICM were 10 of 52 vs 12 of 51, and 10 of 52 vs 4 of 51, respectively (both p=n.s.). However, MVA occurred more frequently in LMNA-NICM (eight of 23 vs two of 29 hypertrophic, p=0.015) and in previous myocarditis (nine of 21 vs three of 30 acute, p=0.016), while major BAs were particularly common in LMNA-NICM patients only (nine of 23 vs one of 29 hypertrophic, p=0.003). Different patterns of septal LGE were consistently retrospectively identified at baseline CMR: junctional and limited to the base in 79.3% of uneventful hypertrophic NICM; extended and focally transmural in LMNA-NICM with follow-up arrhythmias (both p
  CONCLUSION:
  Septal LGE was significantly associated with MVA at the 5-year follow-up in LMNA-NICM or previous myocarditis, and with major BA in LMNA-NICM only. These differences correlated with heterogeneous patterns of IVS LGE in different NICM.
  
  Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.
  
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• Use of the new rotating dilator sheath TightRail? for lead extraction: A bicentric experience.
  J Arrhythm

  2020 Apr;36(2):343-350. doi: 10.1002/joa3.12310.
  
  Mazzone Patrizio, Melillo Francesco, Radinovic Andrea, Marzi Alessandra, Paglino Gabriele, Della Bella Paolo, Mascioli Giosuè
  
  Abstract
  
  AIM:
  The aim of this study is to assess the safety and efficacy of the new bidirectional rotational mechanical sheath TightRail? (Spectranetics) for lead extraction.
  
  METHODS AND RESULTS:
  This is a bicentric prospective study that included patients who underwent a transvenous lead extraction (TLE) in two Italian centers (San Raffaele Hospital and Humanitas Gavazzeni Hospital). From November 2016 to December 2018, 26 patients underwent a TLE procedure in which the TightRail? was used. The new TightRail Sub-C was used in 20 (76%) patients to overcome the fibrosis between the vessel and the first rib. Median age was 69 (IQR 60.7-79.5) years. The indication for TLE were infection (57.7%) or lead dysfunction (42.3%). A total of 57 leads (range 1-4), 40 of which using the TightRail (range 1-4), were extracted. Overall mean implant duration was 98.2.0 ± 66.5 months. Mean age of the lead extracted with the TightRail sheath was 99.1 ± 70.2 months and was higher compared to that of the leads extracted manually (84.4 ± 60.3 months,  = .001). The overall clinical success was 100% and complete procedural success without the use of a snare was achieved in 98.3%. There were no cases of death or major complications and only two minor complications occurred. All patients were event-free at 6-month follow-up.
  
  CONCLUSION:
  This initial experience using the TightRail? suggests a high safety and efficacy profile for extractions in a wide range of lead age.
  
  © 2020 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.
  
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• The MB score: a new risk stratification index to predict the need for advanced tools in lead extraction procedures.
  Europace

  2020 Apr;22(4):613-621. doi: 10.1093/europace/euaa027.
  
  Bontempi Luca, Curnis Antonio, Della Bella Paolo, Cerini Manuel, Radinovic Andrea, Inama Lorenza, Melillo Francesco, Salghetti Francesca, Marzi Alessandra, Gargaro Alessio, Giacopelli Daniele, Mazzone Patrizio
  
  Abstract
  
  AIMS:
  A validated risk stratification schema for transvenous lead extraction (TLE) could improve the management of these procedures. We aimed to derive and validate a scoring system to efficiently predict the need for advanced tools to achieve TLE success.
  
  METHODS AND RESULTS:
  Between November 2013 and March 2018, 1960 leads were extracted in 973 consecutive TLE procedures in two national referral sites using a stepwise approach. A procedure was defined as advanced extraction if required the use of powered sheaths and/or snares. The study population was a posteriori 1:1 randomized in derivation and validation cohorts. In the derivation cohort, presence of more than two targeted leads (odds ratio [OR] 1.76, P?=?0.049), 3-year-old (OR 3.04, P?=?0.001), 5-year-old (OR 3.48, P?0.001), 10-year-old (OR 3.58, P?=?0.008) oldest lead, implantable cardioverter-defibrillator (OR 3.84, P?0.001), and passive fixation lead (OR 1.91, P?=?0.032) were selected by a stepwise procedure and constituted the MB score showing a C-statistics of 0.82. In the validation group, the MB score was significantly associated with the risk of advanced extraction (OR 2.40, 95% confidence interval 2.02-2.86, P?0.001) and showed an increase in event rate with increasing score. A low value (threshold?=?1) ensured 100% sensibility and 100% negative predictive value, while a high value (threshold?=?5) allowed a specificity of 92.8% and a positive predictive value of 91.9%.
  
  CONCLUSION:
  In this study, we developed and tested a simple point-based scoring system able to efficiently identify patients at low and high risk of needing advanced tools during TLE procedures.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• Percutaneous left atrial appendage closure versus non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk.
  EuroIntervention

  2020 Apr;15(17):1548-1554. doi: 10.4244/EIJ-D-19-00507.
  
  Godino Cosmo, Melillo Francesco, Bellini Barbara, Mazzucca Mattia, Pivato Carlo Andrea, Rubino Francesca, Figini Filippo, Mazzone Patrizio, Della Bella Paolo, Margonato Alberto, Colombo Antonio, Montorfano Matteo
  
  Abstract
  
  AIMS:
  A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for non-vitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED ?3).
  
  METHODS AND RESULTS:
  All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p
  CONCLUSIONS:
  In NVAF patients at HBR, LAAO and NOACs performed similarly in terms of thromboembolic and major bleeding events up to two-year follow-up. Our findings warrant further investigation in randomised trials and therefore can be considered as hypothesis-generating.
  
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• Left Atrial Appendage Occlusion in High Bleeding Risk Patients.
  J Interv Cardiol

  2019 ;2019():6704031. doi: 6704031.
  
  Merella Pierluigi, Lorenzoni Giovanni, Delitala Alessandro P, Sechi Filomena, Decandia Federica, Viola Graziana, Berne Paola, Deiana Gianluca, Mazzone Patrizio, Casu Gavino
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to investigate the outcomes of left atrial appendage occlusion (LAAO) in high bleeding risk patients suffering atrial fibrillation (AF) and to analyze the different antithrombotic therapies following the intervention.
  
  BACKGROUND METHODS:
  This monocentric study included 68 patients with nonvalvular AF with an absolute contraindication to OAT or at high bleeding risk. Follow-up was done with a clinical visit at 3-6-12 months.
  
  RESULTS:
  Successful LAAO was achieved in 67/68 patients. At discharge, 32/68 patients were on dual antiplatelet therapy (APT), 34/68 were without any antithrombotic therapy or with a single antiplatelet drug, and 2/68 were on anticoagulant therapy. At three-month follow-up visit, 73.6% of the patients did not receive dual APT, of whom 14.7% had no thrombotic therapy and 58.9% were on single antiplatelet therapy. During a follow-up of 1.4 ± 0.9 years, 3/62 patients had late adverse effects (2 device-related thrombus without clinical consequences and 1 extracranial bleeding). The device-related thrombosis was not related to the antithrombotic therapy.
  
  CONCLUSIONS:
  LAAO is feasible and safe and prevents stroke in patients with AF with contraindication to oral anticoagulant therapy. After LAAO, single antiplatelet therapy seems to be a safe alternative to dual antiplatelet therapy, especially in patients at high bleeding risk. No benefit has been observed with dual APT.
  
  Copyright © 2019 Pierluigi Merella et al.
  
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• Percutaneous Treatment of Persistent Left Atrial Appendage Thrombus Using Watchman FLX No-Touch Implantation Technique and Cerebral Protection System.
  JACC Clin Electrophysiol

  2019 Oct;5(10):1231-1232. doi: 10.1016/j.jacep.2019.06.015.
  
  Beneduce Alessandro, Ancona Francesco, Marzi Alessandra, Radinovic Andrea, D'Angelo Giuseppe, Agricola Eustachio, Della Bella Paolo, Mazzone Patrizio
  
  
  
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• Noninvasive ventilation during left atrial appendage closure under sedation: Preliminary experience with the Janus Mask.
  Ann Card Anaesth

  2019 ;22(4):400-406. doi: 10.4103/aca.ACA_145_18.
  
  Zangrillo Alberto, Mazzone Patrizio, Oriani Alessandro, Pieri Marina, Frau Giovanna, D'Angelo Giuseppe, Sartini Chiara, Capucci Riccardo, Belletti Alessandro, Bella Paolo Della, Monaco Fabrizio
  
  Abstract
  
  BACKGROUND:
  Percutaneous left atrial appendage occlusion (LAAO) is indicated in subjects with atrial fibrillation who cannot receive oral anticoagulants. This procedure requires transesophageal echocardiography guidance and is usually performed under general anesthesia. The Janus Mask is a new device designed to allow upper endoscopic procedures during noninvasive ventilation (NIV).
  
  AIMS:
  This study aims to assess the possibility of performing LAAO under sedation and NIV.
  
  SETTING:
  Cardiac electrophysiology laboratory.
  
  DESIGN:
  Case-control study.
  
  MATERIALS AND METHODS:
  Data from 11 subjects undergoing LAAO under sedation and NIV with the Janus Mask were retrospectively collected. Procedure duration, outcomes, and physicians' satisfaction were compared with those of 11 subjects who underwent LAAO under general anesthesia in the same period.
  
  STATISTICAL ANALYSIS:
  Univariate analysis and analysis of variance for between-groups comparison.
  
  RESULTS:
  The 11 subjects treated with sedation experienced a good outcome, with a high degree of satisfaction from the medical team. An increase in arterial partial pressure of carbon dioxide in the Janus group (45 [43-62] mmHg vs. 33 [30-35] mmHg in the general anesthesia group, P
  CONCLUSIONS:
  LAAO procedure under sedation and NIV through the Janus Mask is safe and feasible. This strategy might represent a valuable alternative to manage such a compromised and fragile population.
  
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• Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study.
  JACC Cardiovasc Interv

  2019 Jun;12(11):1003-1014. doi: 10.1016/j.jcin.2019.02.003.
  
  Aminian Adel, Schmidt Boris, Mazzone Patrizio, Berti Sergio, Fischer Sven, Montorfano Matteo, Lam Simon Cheung Chi, Lund Juha, Asch Federico M, Gage Ryan, Cruz-Gonzalez Ignacio, Omran Heyder, Tarantini Giuseppe, Nielsen-Kudsk Jens Erik
  
  Abstract
  
  OBJECTIVES:
  This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).
  
  BACKGROUND:
  DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.
  
  METHODS:
  A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.
  
  RESULTS:
  Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).
  
  CONCLUSIONS:
  Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.
  
  Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Real-world 2-year outcome of atrial fibrillation treatment with dabigatran, apixaban, and rivaroxaban in patients with and without chronic kidney disease.
  Intern Emerg Med

  2019 Nov;14(8):1259-1270. doi: 10.1007/s11739-019-02100-9.
  
  Godino Cosmo, Melillo Francesco, Rubino Francesca, Arrigoni Luca, Cappelletti Alberto, Mazzone Patrizio, Mattiello Paolo, Della Bella Paolo, Colombo Antonio, Salerno Anna, Cera Michela, Margonato Alberto,
  
  Abstract
  
  Patients with non-valvular atrial fibrillation (NVAF) and chronic kidney disease (CKD) are at increased risk of stroke and bleeding. Although direct oral anticoagulant (DOAC) trials excluded patients with severe CKD, a growing portion of CKD patients have been starting DOACs and limited data from real-world outcome in this high-risk setting are available. The INSigHT registry included 632 consecutive NVAF patients that started apixaban (256 patients, 41%), dabigatran (245, 39%) and rivaroxaban (131, 20%) between 2012 and 2015. Based on creatinine clearance, two sub-cohorts were defined: (1) non-CKD group (CrCl 60-89 mL/min, 413 patients) and (2) CKD group (15-59 ml/min, 219). Compared to non-CKD patients, those with CKD, were at higher ischemic (CHADS-VASc 4.5 vs 2.9, p?0.001) and hemorrhagic risk (HAS-BLED 2.4 vs 1.8, p?0.001). At 2-year follow-up, the overall ISTH-major bleeding and thromboembolic event rates were 5.2% and 2.3% and no significant difference between non-CKD and CKD patients for both efficacy and safety endpoints were observed. In non-CKD patients, the 2-year ISTH-major bleeding rates were higher in rivaroxaban group (HR 2.9, 95% CI 1.1-7.3; p?=?0.047) while dabigatran showed non-significant excess in thromboembolic events (HR 4.3, 95% CI 0.9-20.8; p?=?0.068). In CKD patients, a significantly higher rate of thromboembolic events was observed in rivaroxaban (HR 6.3, 95% CI 1.1-38.1; p?=?0.044). This real-world, non-insurance database registry shows remarkable 2-year safety and efficacy profile of DOACs even in patients with moderate to severe CKD. Head to head differences between DOACs are exploratory, hypothesis generating and warrant further investigation in larger studies.
  
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• Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.
  Pacing Clin Electrophysiol

  2019 Jul;42(7):989-997. doi: 10.1111/pace.13700.
  
  Migliore Federico, Testolina Martina, Sagone Antonio, Carretta Domenico, Agricola Tullio, Rovaris Giovanni, Piazzi Elena, Facchin Domenico, De Lazzari Manuel, Zorzi Alessandro, Melillo Francesco, Cataldi Claudia, Marzi Alessandra, Bottio Tomaso, Tarzia Vincenzo, Gerosa Gino, Iliceto Sabino, Bertaglia Emanuele, Mazzone Patrizio
  
  Abstract
  
  BACKGROUND:
  In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome.
  
  METHODS:
  A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach.
  
  RESULTS:
  The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036).
  
  CONCLUSIONS:
  Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.
  
  © 2019 Wiley Periodicals, Inc.
  
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• Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage.
  Circ Arrhythm Electrophysiol

  2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.
  
  Boersma Lucas V, Ince Hueseyin, Kische Stephan, Pokushalov Evgeny, Schmitz Thomas, Schmidt Boris, Gori Tommaso, Meincke Felix, Protopopov Alexey Vladimir, Betts Timothy, Mazzone Patrizio, Foley David, Grygier Marek, Sievert Horst, De Potter Tom, Vireca Elisa, Stein Kenneth, Bergmann Martin W,
  
  Abstract
  
  BACKGROUND:
  Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice.
  
  METHODS:
  One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years.
  
  RESULTS:
  Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHADS-VASc score ?5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ?3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (-76% and -41%) or hemorrhagic (-81% and 67%) stroke and prior bleeding (-85% and -30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up ( P=0.28).
  
  CONCLUSIONS:
  During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing.
  
  CLINICAL TRIAL REGISTRATION:
  URL: https://clinicaltrials.gov . Unique identifier: NCT01972282.
  
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• Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study.
  EuroIntervention

  2019 Jun;15(3):e225-e230. doi: 10.4244/EIJ-D-19-00128.
  
  Cresti Alberto, García-Fernández Miguel Angel, Sievert Horst, Mazzone Patrizio, Baratta Pasquale, Solari Marco, Geyer Alessia, De Sensi Francesco, Limbruno Ugo
  
  Abstract
  
  AIMS:
  The aim of our study was to evaluate the prevalence of left atrial cavity and appendage thrombosis in patients undergoing cardioversion for non-valvular atrial tachyarrhythmias. In persistent atrial tachyarrhythmias, 90% of thromboses are reported to be located inside the left atrial appendage. This prevalence refers to old studies and meta-analysis in a mixed population of valvular and non-valvular atrial fibrillation. Left atrial cavity thrombosis in non-valvular atrial fibrillation has not been investigated recently in large-scale studies.
  
  METHODS AND RESULTS:
  A total of 1,420 consecutive adult patients with paroxysmal or persistent atrial tachyarrhythmias, candidates to cardioversion, who opted for a transoesophageal echocardiography-guided strategy, were enrolled in the study. Mitral stenosis, rheumatic valve disease and mechanical prostheses were excluded. In total there were 91 thrombi in 87 patients with a prevalence of 6.13% (87/1,420). Patients with left atrial thrombosis had predisposing clinical and echo characteristics (heart failure, lower ventricular function and higher atrial volume). Except for one case in which the thrombus was located in the left atrial cavity (0.07%), and three in the right appendage, all thromboses were detected in the left atrial appendage.
  
  CONCLUSIONS:
  Extra-appendage thrombosis is a very rare finding in non-valvular persistent and paroxysmal atrial tachyarrhythmias and, when present, a left appendage thrombus is usually concomitant.
  
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• Predictors of Intensive Care Unit Admission in Patients Undergoing Lead Extraction: A 10-Year Observational Study in a High-Volume Center.
  J Cardiothorac Vasc Anesth

  2019 Jul;33(7):1845-1851. doi: 10.1053/j.jvca.2019.02.012.
  
  Monaco Fabrizio, Di Tomasso Nora, Landoni Giovanni, Nardelli Pasquale, Radinovic Andrea, Melillo Francesco, D'Angelo Giuseppe, Della Bella Paolo, Zangrillo Alberto, Mazzone Patrizio
  
  Abstract
  
  OBJECTIVE:
  To identify reliable predictors of periprocedural intensive care unit (ICU) admission after transvenous lead extraction (LE) in a high-volume center.
  
  DESIGN:
  Retrospective observational study.
  
  SETTING:
  University tertiary-care hospital.
  
  PARTICIPANTS:
  All patients undergoing LE at San Raffaele Scientific Institute, Milan, Italy, from 2005 to 2015.
  
  INTERVENTIONS:
  LE procedures were performed in the electrophysiology laboratories with a cardiac operating room on standby between the end of the morning surgical case and before the start of the afternoon surgical case. Most procedures were conducted with the patient under procedural sedation and analgesia. After LE, patients were admitted either to the ward or to the ICU. Medical history and intraprocedural data were recorded.
  
  MEASUREMENTS AND MAIN RESULTS:
  Of the 389 procedures performed during the study period, 50 patients (13%) were admitted to the ICU owing to persistent hemodynamic instability or intraoperative complications requiring endotracheal intubation. Complete procedural success was achieved in 370 patients (95%), and the clinical success rate was 98.4%. No deaths were recorded. Five complications requiring emergency surgery (1.3%) were reported. Preprocedural right ventricular dysfunction (odds ratio (OR) 7.41; confidence interval 1.85-29.7; p
  CONCLUSIONS:
  Preoperative identification of patients who need ICU admission after LE is crucial to increase patient safety and decrease hospital costs. Severe right ventricular dysfunction and need for general anesthesia identify patients with low cardiac reserve who are at increased risk for ICU admission after the procedure.
  
  Copyright © 2019 Elsevier Inc. All rights reserved.
  
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• [Atrial fibrillation in severe and end stage renal disease: from oral anticoagulation therapy to percutaneous left atrial appendage occlusion].
  G Ital Nefrol

  2019 Feb;36(1):. doi: 2019-vol1.
  
  Merella Pierluigi, Casu Gavino, Mazzone Patrizio, Lorenzoni Giovanni, D'Angelo Giuseppe, Genovesi Simonetta
  
  Abstract
  
  Non-valvular atrial fibrillation (AF) is the most frequent arrhythmia in the general population and its prevalence increases with age. The prevalence and incidence of AF is high in patients with chronic kidney failure (CKD). The most important complication associated with AF, both in the general population and in that with CKD, is thromboembolic stroke. For this reason, in patients with AF, the Guidelines indicate oral anticoagulant therapy (OAT) with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for thromboembolic risk prevention. Patients with severe CKD and, in particular, with end stage renal disease (ESRD) undergoing renal replacement therapy, often have both a high thromboembolic and hemorrhagic risk and therefore present both an indication and a contraindication to OAT. In addition, patients with severe or ESRD were excluded from trials that showed the efficacy of different antithrombotic drugs in patients with AF. Thus there is no evidence of the effectiveness of OAT in this population. This review deals with the issues related to OAT in patients with severe or end stage CKD and the possible use of percutaneous closure of the left auricula (LAAO), recently proposed as an alternative in patients with an absolute contraindication of OAT in this population.
  
  Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.
  
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• Phrenic Nerve Limitation During Epicardial Catheter Ablation of Ventricular Tachycardia.
  JACC Clin Electrophysiol

  2019 Jan;5(1):81-90. doi: 10.1016/j.jacep.2018.08.011.
  
  Okubo Kenji, Trevisi Nicola, Foppoli Luca, Bisceglia Caterina, Baratto Francesca, Gigli Lorenzo, D'Angelo Giuseppe, Radinovic Andrea, Cireddu Manuela, Paglino Gabriele, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  OBJECTIVES:
  This study sought to investigate the incidence of phrenic nerve (PN) limitation and the utility of displacing the PN with a balloon.
  
  BACKGROUND:
  The PN can limit the epicardial ablation of ventricular tachycardia (VT).
  
  METHODS:
  From 2010 to 2017, 363 patients undergoing VT epicardial ablation at a single center were studied. Before the ablation, we used high output (20-mA) pacing maneuvers to verify the course of the PN. When we observed its capture, we used 1 of 3 different approaches to protect it: 1) non-balloon strategy (nerve-sparing ablation); 2) PN displacement with a small balloon (6 mm × 20 mm); or 3) PN displacement with a large balloon (20 mm × 45 mm).
  
  RESULTS:
  PN capture occurred in 25 patients (7%) at the target ablation site. The most common cause was myocarditis (12 patients [48%]), and the incidence of the PN limitation was significantly higher in myocarditis than in other causes (19% vs. 4%, respectively; p = 0.0002). PN displacement was attempted in 7 patients by using large balloons and in 6 patients with small balloons, resulting in successful PN displacements and complete late potential (LP) abolition in 6 patients (86%) and 3 patients (50%), respectively. Among the 12 patients in whom the non-balloon strategy was used, only 1 patient (8%) achieved LP abolition (compared with the large balloon group; p = 0.002), whereas 3 patients experienced PN paralysis.
  
  CONCLUSIONS:
  The PN limited the epicardial ablation in 7% of patients. Because nerve-sparing ablations often resulted in PN injuries, a possible solution could be to displace the PN with a large balloon, leading to a safer procedure and completion of LP abolition.
  
  Copyright © 2019. Published by Elsevier Inc.
  
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• Percutaneous left atrial appendage occlusion with the Amulet device: The impact of device disc position upon periprocedural and long-term outcomes.
  Catheter Cardiovasc Interv

  2019 Jan;93(1):120-127. doi: 10.1002/ccd.27727.
  
  Oraii Yazdani Kaveh, Mitomo Satoru, Ruparelia Neil, Candilio Luciano, Giannini Francesco, Jabbour Richard J, Regazzoli Damiano, Mazzone Patrizio, Stella Stefano, Sora Nicoleta, Montorfano Matteo, Colombo Antonio, Latib Azeem
  
  Abstract
  
  OBJECTIVE:
  To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes.
  
  BACKGROUND:
  The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain.
  
  METHODS:
  Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n?=?45) had complete LAA ostium coverage; group B (n?=?42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention.
  
  RESULTS:
  Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P?=?0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P?=?0.03). There were no differences in reposition attempts (P?=?0.9) or long-term events (P?=?0.57).
  
  CONCLUSIONS:
  Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure.
  
  © 2018 Wiley Periodicals, Inc.
  
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• Incidence of pericardial effusion after left atrial appendage closure: The impact of underlying heart rhythm-Data from the EWOLUTION study.
  J Cardiovasc Electrophysiol

  2018 Jul;29(7):973-978. doi: 10.1111/jce.13626.
  
  Schmidt Boris, Betts Timothy R, Sievert Horst, Bergmann Martin W, Kische Stephan, Pokushalov Evgeny, Schmitz Thomas, Meincke Felix, Mazzone Patrizio, Stein Kenneth M, Ince Hüseyin, Boersma Lucas V A
  
  Abstract
  
  INTRODUCTION:
  Pericardial effusion/tamponade (PE/PT) is a rare but serious complication following left atrial appendage closure (LAAC). It may be speculated that LAA contraction during sinus rhythm (SR) exerts mechanical force on the device that eventually leads to PE. We sought to determine the incidence and predictors of PE following LAAC using Watchman with special emphasis on the underlying heart rhythm during implant.
  
  METHODS AND RESULTS:
  From 47 centers in 13 European countries 1,020 patients underwent LAAC and data on baseline rhythm were available from 1,010 patients (mean age 73 ± 9 years, 60% male, median CHA2DS2-VASc = 4). Data were collected via electronic case report forms. A Cox proportional hazard model was calculated adjusting for multiple variables: age, gender, number of recaptures, and device oversizing. During implant, 41% and 59% of patients were in SR and atrial fibrillation (AF), respectively. PE/PT rate was significantly lower in patients implanted during AF at day 30 postimplant (n = 1; 0.2% vs. n = 6; 1.5%; P = 0.02). No PE requiring intervention occurred in the AF group compared to 5 events (1.2%) in the SR group (P = 0.01). While univariate analysis identified SR and gender as predictors for PE/tamponade, multivariate analysis only showed a statistical trend for both variables.
  
  CONCLUSION:
  The overall incidence of PE/PT was very low after LAAC using Watchman. Although SR was not identified as an independent predictor of PE/PT, all events requiring intervention occurred in patients with SR. It may be advisable to perform an extended echocardiographic follow-up in that patient population.
  
  © 2018 Wiley Periodicals, Inc.
  
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• Implant success and safety of left atrial appendage occlusion in end stage renal disease patients: Peri-procedural outcomes from an Italian dialysis population.
  Int J Cardiol

  2018 Jul;262():38-42. doi: 10.1016/j.ijcard.2018.03.083.
  
  Genovesi Simonetta, Slaviero Giorgio, Porcu Luca, Casu Gavino, Bertoli Silvio, Sagone Antonio, Pieruzzi Federico, Rovaris Giovanni, Buskermolen Monique, Danna Paolo, Montoli Alberto, Oreglia Jacopo, Contaldo Gina, Mazzone Patrizio
  
  Abstract
  
  AIMS:
  To estimate the safety and the efficacy of the off label left atrial appendage (LAA) occlusion in chronic dialysis patients with atrial fibrillation (AF). In this preliminary paper, we report the design of the study and the data on peri-procedural complications.
  
  METHODS:
  This is a prospective cohort study. Primary endpoints are i) incidence of peri-procedural complications, ii) cumulative incidence of two-year thromboembolic events iii) cumulative incidence of two-year bleedings iiii) mortality at two years. Adverse events and death within 30?days of the procedure were recorded.
  
  RESULTS:
  Fifty patients who underwent LAA occlusion between May 2014 and September 2017 were recruited. Both the mean age of the sample study and the dialysis duration were high [71.8 (9.6) years and 59.4 (78.2) months, respectively]. Most patients (84%) were hypertensive and 62% suffered a previous major bleeding. About half of them presented cardiovascular diseases. CHADSVASCs and HASBLED scores were 4.0 (1.5) and 4.4 (0.9), respectively. Most patients (88%) showed atrial dilatation and 44% left ventricular hypertrophy; 32% had left ventricular ejection fraction
  CONCLUSIONS:
  Our preliminary data suggest the feasibility and safety of LAA occlusion in patients undergoing dialysis. Only the follow-up of these patients over time can provide evidence that LAA occlusion is effective in preventing of thromboembolic events in this very high-risk population.
  
  Copyright © 2018 Elsevier B.V. All rights reserved.
  
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• Percutaneous Left Atrial Appendage Closure with WATCHMAN? device: peri-procedural and mid-term outcomes from the TRAPS Registry.
  J Interv Card Electrophysiol

  2018 Jun;52(1):47-52. doi: 10.1007/s10840-018-0351-1.
  
  Mazzone Patrizio, D'Angelo Giuseppe, Regazzoli Damiano, Molon Giulio, Senatore Gaetano, Saccà Salvatore, Canali Guido, Amellone Claudia, Turri Riccardo, Bella Paolo Della
  
  Abstract
  
  PURPOSE:
  The WATCHMAN device for Left Atrial Appendage Occlusion (LAAO) has proven to be an effective alternative to oral anticoagulation (OAC) in patients with atrial fibrillation (AF), and has now been adopted in clinical practice. In the present study, we analyzed the safety and efficacy profile of the LAAO procedure at mid-term follow-up.
  
  METHODS:
  The TRAPS Registry is an observational, multicenter registry involving four Italian centers. Consecutive patients who had undergone LAAO with WATCHMAN device were enrolled. Clinical, demographic, and procedural data were collected at the time of implantation, and follow-up data were collected to assess the clinical outcome.
  
  RESULTS:
  A total of 151 patients were included in the Registry from May 2012 to October 2015. Implantation of the device was successful in 150/151 patients, with no or minimal (5 mm) leakage as assessed by peri-procedural transesophageal echo. In the remaining patient, early device embolization was reported, with no sequelae. Overall, intra-procedural events were reported in 5 (3.3%) patients. During a median follow-up of 16 months (25th and 75th percentile, 10-25), 5 patients died of any cause. The annual rate of all-cause stroke was 2.2% (95% CI, 0.7-5.1), the rate of transient ischemic attack was 1.3% (95% CI, 0.3-3.8), and that of major bleeding 0.4% (95% CI, 0.01-2.4).
  
  CONCLUSIONS:
  LAAO for stroke prevention was safely and effectively achieved by implantation of the WATCHMAN device in patients with non-valvular AF. Moreover, regardless of the risk profile of the population, we observed low rates of death and thromboembolic and bleeding events over a median follow-up of 16 months. These findings were obtained in an unselected group of consecutive patients who were variably eligible for chronic OAC therapy.
  
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• Percutaneous left atrial appendage occlusion in patients with atrial fibrillation and left appendage thrombus: feasibility, safety and clinical efficacy.
  EuroIntervention

  2018 Jan;13(13):1595-1602. doi: 10.4244/EIJ-D-17-00777.
  
  Tarantini Giuseppe, D'Amico Gianpiero, Latib Azeem, Montorfano Matteo, Mazzone Patrizio, Fassini Gaetano, Maltagliati Anna, Ronco Federico, Saccà Salvatore, Cruz-Gonzalez Ignatio, Ibrahim Reda, Freixa Xavier
  
  Abstract
  
  AIMS:
  The aim of this study was to investigate the feasibility, safety and efficacy of percutaneous closure for prevention of thromboembolic events in patients with atrial fibrillation (AF) and left atrial appendage (LAA) thrombus.
  
  METHODS AND RESULTS:
  The study included consecutive patients with AF and LAA thrombus who underwent transcatheter occlusion in eight high-volume centres. Clinical and transoesophageal echocardiography (TEE) follow-up was carried out as per each centre's protocol. Twenty-eight patients were included. The location of the LAA thrombus was distal in 100% of cases. Technical and procedural success was achieved in all patients. A cerebral protection device was used in six cases. There were no periprocedural adverse events. Follow-up was complete in all patients (total 32 patient-years). No death or thromboembolic events were reported. There was one major bleeding during follow-up. Among the 23 patients undergoing TEE, device thrombosis was present in one patient. No significant peri-device leaks were observed.
  
  CONCLUSIONS:
  In this multicentre study, percutaneous closure in selected patients with distal LAA thrombus appears to be feasible and safe, and is associated with high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Special implant techniques avoiding mechanical mobilisation of the thrombotic mass and the liberal use of cerebral embolic protection devices are recommended.
  
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• Lead extraction - Aspects beyond the procedure.
  Int J Cardiol

  2018 Jan;250():150-151. doi: 10.1016/j.ijcard.2017.09.007.
  
  Mazzone Patrizio, Radinovic Andrea
  
  
  
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• [Letter to the Editor].
  G Ital Cardiol (Rome)

  2017 Sep;18(9):675. doi: 10.1714/2741.27953.
  
  Merella Pierluigi, Mazzone Patrizio, Casu Gavino
  
  
  
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• ANMCO/AIAC/SICI-GISE/SIC/SICCH Consensus Document: percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation patients: indications, patient selection, staff skills, organisation, and training.
  Eur Heart J Suppl

  2017 May;19(Suppl D):D333-D353. doi: 10.1093/eurheartj/sux008.
  
  Casu Gavino, Gulizia Michele Massimo, Molon Giulio, Mazzone Patrizio, Audo Andrea, Casolo Giancarlo, Di Lorenzo Emilio, Portoghese Michele, Pristipino Christian, Ricci Renato Pietro, Themistoclakis Sakis, Padeletti Luigi, Tondo Claudio, Berti Sergio, Oreglia Jacopo Andrea, Gerosa Gino, Zanobini Marco, Ussia Gian Paolo, Musumeci Giuseppe, Romeo Francesco, Di Bartolomeo Roberto
  
  Abstract
  
  Atrial fibrillation (AF) is the most common arrhythmia and its prevalence is increasing due to the progressive aging of the population. About 20% of strokes are attributable to AF and AF patients are at five-fold increased risk of stroke. The mainstay of treatment of AF is the prevention of thromboembolic complications with oral anticoagulation therapy. Drug treatment for many years has been based on the use of vitamin K antagonists, but recently newer and safer molecules have been introduced (dabigatran etexilate, rivaroxaban, apixaban, and edoxaban). Despite these advances, many patients still do not receive adequate anticoagulation therapy because of contraindications (relative and absolute) to this treatment. Over the last decade, percutaneous closure of left atrial appendage, main site of thrombus formation during AF, proved effective in reducing thromboembolic complications, thus offering a valid medical treatment especially in patients at increased bleeding risk. The aim of this consensus document is to review the main aspects of left atrial appendage occlusion (selection and multidisciplinary assessment of patients, currently available methods and devices, requirements for centres and operators, associated therapies and follow-up modalities) having as a ground the significant evolution of techniques and the available relevant clinical data.
  
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• Recent Advances in Stroke Prevention in Patients with Atrial Fibrillation and End-Stage Renal Disease.
  Cardiorenal Med

  2017 Jun;7(3):207-217. doi: 10.1159/000470856.
  
  Ronco Federico, Mazzone Patrizio, Hosseinian Leila, Genovesi Simonetta
  
  Abstract
  
  BACKGROUND:
  Chronic kidney disease (CKD) is associated with a high prevalence of atrial fibrillation (AF), but in this population the risk/benefit ratio of anticoagulant therapy with vitamin K antagonists (VKA) for thromboprophylaxis is uncertain.
  
  SUMMARY:
  In end-stage renal disease (ESRD) patients undergoing hemodialysis, VKA seem less effective in stroke prevention than in the general population, with an increased risk of major bleeding. Recently, novel oral anticoagulant agents (NOACs) have proven to be effective for stroke prevention in AF and have demonstrated an improved safety profile compared to VKA. Limited data from post hoc analyses of controlled clinical trials suggest the safe and effective use of NOACs in patients with moderate renal impairment (i.e., estimated glomerular filtration rate, eGFR, between 30 and 50 mL/min). The question still remains whether NOACs can be used in patients with an eGFR
  KEY MESSAGES:
  Stroke prevention in patients with ESRD and AF represents a clinical challenge with poor evidence. LAA occlusion may become the standard of care for stroke prevention in patients with ESRD and AF.
  
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• Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial.
  Heart Rhythm

  2017 Sep;14(9):1302-1308. doi: 10.1016/j.hrthm.2017.05.038.
  
  Boersma Lucas V, Ince Hueseyin, Kische Stephan, Pokushalov Evgeny, Schmitz Thomas, Schmidt Boris, Gori Tommaso, Meincke Felix, Protopopov Alexey Vladimir, Betts Timothy, Foley David, Sievert Horst, Mazzone Patrizio, De Potter Tom, Vireca Elisa, Stein Kenneth, Bergmann Martin W,
  
  Abstract
  
  BACKGROUND:
  Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials.
  
  OBJECTIVE:
  EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry.
  
  METHODS:
  A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice.
  
  RESULTS:
  The baseline CHADS-VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related.
  
  CONCLUSION:
  LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation.
  
  Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
  
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• Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry.
  Europace

  2018 May;20(5):829-834. doi: 10.1093/europace/eux020.
  
  Mazzone Patrizio, Migliore Federico, Bertaglia Emanuele, Facchin Domenico, Daleffe Elisabetta, Calzolari Vittorio, Crosato Martino, Melillo Francesco, Peruzza Francesco, Marzi Alessandra, Sora Nicoleta, Della Bella Paolo
  
  Abstract
  
  AIMS:
  The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads).
  
  METHODS AND RESULTS:
  Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2?±?52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed.
  
  CONCLUSION:
  On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.
  
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• Different transseptal puncture for different procedures: Optimization of left atrial catheterization guided by transesophageal echocardiography.
  Ann Card Anaesth

  2016 ;19(4):589-593. doi: 10.4103/0971-9784.191548.
  
  Radinovic Andrea, Mazzone Patrizio, Landoni Giovanni, Agricola Eustachio, Regazzoli Damiano, Della-Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Left atrial catheterization through transseptal puncture is frequently performed in cardiac catheterization procedures. Appropriate transseptal puncture is critical to achieve procedural success.
  
  AIMS:
  The aim of the study is to evaluate the feasibility of selective transseptal punctures, using a modified radiofrequency (RF) transseptal needle and transesophageal echocardiography (TEE), in different types of procedures that require specific sites of left atrial catheterization.
  
  SETTING AND DESIGN:
  This was an observational trial in a cardiac catheterization laboratory of a teaching hospital.
  
  MATERIALS AND METHODS:
  Patients undergoing different percutaneous procedures requiring atrial transseptal puncture such as atrial fibrillation (AF) ablation, left atrial appendage (LAA) occlusion, and mitral valve repair were included in the study. All procedures were guided by TEE and an RF transseptal needle targeting a specific region of the septum to perform the puncture.
  
  STATISTICAL ANALYSIS:
  The statistical analysis was descriptive only.
  
  RESULTS:
  RF-assisted transseptal punctures were performed in six consecutive patients who underwent AF ablation (two patients), LAA closure (two patients), and mitral valve repair (two patients). In all patients, transseptal punctures were performed successfully at the desired site. No adverse events or complications were observed.
  
  CONCLUSIONS:
  Selective transseptal puncture, using TEE and an RF needle, is a feasible technique that can be used in multiple approaches requiring a precise site of access for left atrial catheterization.
  
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• [ANMCO/AIAC/SICI-GISE/SIC/SICCH Consensus document: Percutaneous left atrial appendage occlusion in patients with nonvalvular atrial fibrillation: indications, patient selection, competences, organization, and operator training].
  G Ital Cardiol (Rome)

  2016 ;17(7-8):594-613. doi: 10.1714/2330.25054.
  
  Casu Gavino, Gulizia Michele Massimo, Molon Giulio, Mazzone Patrizio, Audo Andrea, Casolo Giancarlo, Di Lorenzo Emilio, Portoghese Michele, Pristipino Christian, Ricci Renato Pietro, Themistoclakis Sakis, Padeletti Luigi, Tondo Claudio, Berti Sergio, Oreglia Jacopo Andrea, Gerosa Gino, Zanobini Marco, Ussia Gian Paolo, Musumeci Giuseppe, Romeo Francesco, Di Bartolomeo Roberto
  
  Abstract
  
  Atrial fibrillation (AF) is the most common arrhythmia and its prevalence is increasing due to the progressive aging of the population. About 20% of strokes are attributable to AF and AF patients are at 5-fold increased risk of stroke. The mainstay of treatment of AF is the prevention of thromboembolic complications with oral anticoagulation therapy. Drug treatment for many years has been based on the use of vitamin K antagonists, but recently newer and safer molecules have been introduced (dabigatran etexilate, rivaroxaban, apixaban and edoxaban). Despite these advances, many patients still do not receive adequate anticoagulation therapy because of contraindications (relative and absolute) to this treatment. Over the last decade, percutaneous closure of left atrial appendage, main site of thrombus formation during AF, proved effective in reducing thromboembolic complications, thus offering a valid medical treatment especially in patients at increased bleeding risk. The aim of this consensus document is to review the main aspects of left atrial appendage occlusion (selection and multidisciplinary assessment of patients, currently available methods and devices, requirements for centers and operators, associated therapies and follow-up modalities) having as a ground the significant evolution of techniques and the available relevant clinical data.
  
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• Left atrial appendage closure: A single center experience and comparison of two contemporary devices.
  Catheter Cardiovasc Interv

  2017 Mar;89(4):763-772. doi: 10.1002/ccd.26678.
  
  Figini Filippo, Mazzone Patrizio, Regazzoli Damiano, Porata Giulia, Ruparelia Neil, Giannini Francesco, Stella Stefano, Ancona Francesco, Agricola Eustachio, Sora Nicoleta, Marzi Alessandra, Aurelio Andrea, Trevisi Nicola, Della Bella Paolo, Colombo Antonio, Montorfano Matteo
  
  Abstract
  
  OBJECTIVES:
  To compare indications and clinical outcomes of two contemporary left atrial appendage (LAA) percutaneous closure systems in a "real-world" population.
  
  BACKGROUND:
  Percutaneous LAA occlusion is an emerging therapeutic option for stroke prevention in atrial fibrillation. Some questions however remain unanswered, such as the applicability of results of randomized trials to current clinical practice. Moreover, currently available devices have never been directly compared.
  
  METHODS:
  We retrospectively analyzed consecutive patients who underwent LAA closure at San Raffaele Hospital, Milan, Italy between 2009 and 2015. Clinical indications and device selection were left to operators' decision; routine clinical and transesophageal echocardiography (TEE) follow-up was performed.
  
  RESULTS:
  One-hundred and sixty-five patients were included in the study, of which 99 were treated with the Amplatzer Cardiac Plug (ACP) and 66 with the Watchman system. During the follow-up period (median 15 months, interquartile range 6-26 months) five patients died. The incidence of ischemic events was low, with one patient suffering a transient ischemic attack and no episodes recorded of definitive strokes. Twenty-six leaks ?1 mm were detected (23%); leaks were less common with the ACP and with periprocedural three-dimensional TEE evaluation, but were not found to correlate with clinical events. Clinical outcomes were comparable between the two devices.
  
  CONCLUSIONS:
  Our data show excellent safety and efficacy of LAA closure, irrespectively of the device utilized, in a population at high ischemic and hemorrhagic risk. The use of ACP and 3D-TEE minimized the incidence of residual leaks; however, the clinical relevance of small peri-device flow warrants further investigation. © 2016 Wiley Periodicals, Inc.
  
  © 2016 Wiley Periodicals, Inc.
  
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• Temporary Transvenous Pacemaker Implantation during Carotid Endarterectomy in Patients with Trifascicular Block.
  Ann Vasc Surg

  2016 Jul;34():206-11. doi: 10.1016/j.avsg.2015.12.025.
  
  Marrocco-Trischitta Massimiliano M, Mazzone Patrizio, Vitale Renato, Regazzoli Damiano, Laricchia Alessandra, Chiesa Roberto
  
  Abstract
  
  BACKGROUND:
  The risk of severe perioperative bradyarrhythmias in patients with chronic left bundle branch, or bifascicular block, and an additional first-degree atrioventricular block undergoing carotid endarterectomy (CEA) has never been specifically addressed. In this study, we aimed to investigate whether these conduction abnormalities entail an increased risk of hemodynamic compromise during CEA and the role of temporary transvenous pacemaker (TTVPM) implantation as a prophylactic measure in this subgroup of patients.
  
  METHODS:
  Between June 2006 and June 2013, 37 CEAs were performed in 31 patients (29 men, mean age 76 ± 6 years), in whom a TTVPM was implanted for a trifascicular block. Thirty-seven concurrent, consecutive patients operated for other vascular pathologies also with a prophylactic TTVPM for an asymptomatic trifascicular block served as controls. Adverse events were considered: pacemaker activation, block progression, bradycardia ?40 beats/min, and asystole.
  
  RESULTS:
  Study and control groups were overall comparable. No perioperative mortality was recorded. All patients undergoing CEA were asymptomatic for syncope preoperatively. Among them, in 34 cases, indication for TTVPM was based on preoperative EKG, and in 4, a pacemaker activation was recorded. Three additional patients were also included in the study group in whom TTVPM was implanted due to the occurrence of adverse advents, and not prophylactically. In 2 of these, severe bradycardia with eventual asystole occurred intraoperatively. In both cases, the procedure was discontinued and rescheduled for the following day after a TTVPM was implanted. In the last additional case, the patient had a block progression on day 1 after an uneventful CEA and was emergently treated with a TTVPM. Overall, 7 adverse events were recorded in the study group, and none in the control group (P 
  CONCLUSIONS:
  In our experience, TTVPM implantation was a clinically useful adjunct in patients with trifascicular block submitted to CEA, as compared with other vascular surgical procedures. However, the risks inherent to CEA in this subgroup of patients suggest that surgical treatment may not be warranted for those with asymptomatic carotid disease.
  
  Copyright © 2016 Elsevier Inc. All rights reserved.
  
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• Prolonged transesophageal echocardiography during percutaneous closure of the left atrial appendage without general anesthesia: the utility of the Janus mask.
  Can J Anaesth

  2016 Aug;63(8):962-5. doi: 10.1007/s12630-016-0659-1.
  
  Zangrillo Alberto, Mazzone Patrizio, Votta Carmine D, Villari Nicola, Della Bella Paolo, Monaco Fabrizio
  
  Abstract
  
  PURPOSE:
  Left atrial appendage (LAA) closure is an interventional procedure increasingly used to prevent stroke in patients with permanent atrial fibrillation and contraindications to anticoagulation therapy. As this procedure requires a relatively immobile patient and performance of continuous and prolonged transesophageal echocardiography (TEE), it is usually performed under general anesthesia. In this case series, we describe the feasibility of prolonged TEE for percutaneous LAA closure using a new noninvasive ventilation device that can avoid the need for endotracheal intubation and general anesthesia.
  
  CLINICAL FEATURES:
  Percutaneous LAA closure was performed under deep sedation in three elderly patients with permanent atrial fibrillation. Sedation was obtained with a combination of midazolam, propofol, and remifentanil. Continuous intraoperative TEE was performed through the port of the newly available Janus mask (Biomedical Srl; Florence, Italy), allowing for noninvasive ventilation (pressure support = 12-16 cm H2O; positive end-expiratory pressure = 7 cm H2O; FIO2 = 0.3) in these spontaneously breathing patients. The total procedure times ranged from 75-90 min. The patients reported excellent satisfaction with the sedation received in terms of discomfort experienced during the procedure, capacity to recall the procedure, and comfort with the mask. The operators also rated the procedural conditions as excellent.
  
  CONCLUSION:
  Deep sedation with noninvasive ventilation may be a reasonable and safe alternative to general endotracheal anesthesia in patients requiring prolonged TEE for noninvasive cardiac procedures, including LAA closure.
  
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• Incomplete surgical exclusion of the left atrial appendage.
  Eur Heart J

  2016 Jan;37(2):188. doi: 10.1093/eurheartj/ehv424.
  
  Pozzoli Alberto, Mazzone Patrizio, Benussi Stefano, Alfieri Ottavio
  
  
  
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• Left Atrial Appendage: Physiology, Pathology, and Role as a Therapeutic Target.
  Biomed Res Int

  2015 ;2015():205013. doi: 205013.
  
  Regazzoli Damiano, Ancona Francesco, Trevisi Nicola, Guarracini Fabrizio, Radinovic Andrea, Oppizzi Michele, Agricola Eustachio, Marzi Alessandra, Sora Nicoleta Carmen, Della Bella Paolo, Mazzone Patrizio
  
  Abstract
  
  Atrial fibrillation (AF) is the most common clinically relevant cardiac arrhythmia. AF poses patients at increased risk of thromboembolism, in particular ischemic stroke. The CHADS2 and CHA2DS2-VASc scores are useful in the assessment of thromboembolic risk in nonvalvular AF and are utilized in decision-making about treatment with oral anticoagulation (OAC). However, OAC is underutilized due to poor patient compliance and contraindications, especially major bleedings. The Virchow triad synthesizes the pathogenesis of thrombogenesis in AF: endocardial dysfunction, abnormal blood stasis, and altered hemostasis. This is especially prominent in the left atrial appendage (LAA), where the low flow reaches its minimum. The LAA is the remnant of the embryonic left atrium, with a complex and variable morphology predisposing to stasis, especially during AF. In patients with nonvalvular AF, 90% of thrombi are located in the LAA. So, left atrial appendage occlusion could be an interesting and effective procedure in thromboembolism prevention in AF. After exclusion of LAA as an embolic source, the remaining risk of thromboembolism does not longer justify the use of oral anticoagulants. Various surgical and catheter-based methods have been developed to exclude the LAA. This paper reviews the physiological and pathophysiological role of the LAA and catheter-based methods of LAA exclusion.
  
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• Electroanatomical voltage and morphology characteristics in postinfarction patients undergoing ventricular tachycardia ablation: pragmatic approach favoring late potentials abolition.
  Circ Arrhythm Electrophysiol

  2015 Aug;8(4):863-73. doi: 10.1161/CIRCEP.114.002551.
  
  Tsiachris Dimitris, Silberbauer John, Maccabelli Giuseppe, Oloriz Teresa, Baratto Francesca, Mizuno Hiroya, Bisceglia Caterina, Vergara Pasquale, Marzi Alessandra, Sora Nicoleta, Guarracini Fabrizio, Radinovic Andrea, Cireddu Manuela, Sala Simone, Gulletta Simone, Paglino Gabriele, Mazzone Patrizio, Trevisi Nicola, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Catheter ablation is an important therapeutic option in postmyocardial infarction patients with ventricular tachycardia (VT). We analyzed the endo-epicardial electroanatomical mapping (EAM) voltage and morphology characteristics, their association with clinical data and their prognostic value in a large cohort of postmyocardial infarction patients.
  
  METHODS AND RESULTS:
  We performed total and segmental analysis of voltage (bipolar dense scar [DS] and low voltage areas, unipolar low voltage and penumbra areas) and morphology characteristics (presence of abnormal late potentials [LPs] and early potentials [EPs]) in 100 postmyocardial infarction patients undergoing electroanatomical mapping-based VT ablation (26 endo-epicardial procedures) from 2010-2012. All patients had unipolar low voltage areas, whereas 18% had no identifiable endocardial bipolar DS areas. Endocardial bipolar DS area >22.5 cm(2) best predicted scar transmurality. Endo-epicardial LPs were recorded in 2/3 patients, more frequently in nonseptal myocardial segments and were abolished in 51%. Endocardial bipolar DS area >7 cm(2) and endocardial bipolar scar density >0.35 predicted epicardial LPs. Isolated LPs are located mainly epicardially and EPs endocardially. As a primary strategy, LPs and VT-mapping ablation occurred in 48%, only VT-mapping ablation in 27%, only LPs ablation in 17%, and EPs ablation in 6%. Endocardial LP abolition was associated with reduced VT recurrence and increased unipolar penumbra area predicted cardiac death.
  
  CONCLUSIONS:
  Endocardial scar extension and density predict scar transmurality and endo-epicardial presence of LPs, although DS is not always identified in postmyocardial infarction patients. LPs, most frequently located in nonseptal myocardial segments, were abolished in 51% resulting in improved outcome.
  
  © 2015 American Heart Association, Inc.
  
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• [Letter to the editor].
  G Ital Cardiol (Rome)

  2015 Mar;16(3):188-90. doi: 10.1714/1820.19832.
  
  Molon Giulio, Canali Guido, Casu Gavino, Mazzone Patrizio, Barbato Gaetano, Ramondo Angelo, Saccà Salvatore, Scaglione Marco, Senatore Gaetano, Solimene Francesco, Grassi Giuseppe, Nardi Stefano, Luise Raffaele
  
  
  
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• Electrophysiological findings and long-term outcomes of percutaneous ablation of atrial arrhythmias after surgical ablation for atrial fibrillation?.
  Eur J Cardiothorac Surg

  2016 Jan;49(1):273-80. doi: 10.1093/ejcts/ezv034.
  
  Trumello Cinzia, Pozzoli Alberto, Mazzone Patrizio, Nascimbene Simona, Bignami Elena, Cireddu Manuela, Della Bella Paolo, Alfieri Ottavio, Benussi Stefano
  
  Abstract
  
  OBJECTIVES:
  Percutaneous ablation (PA) for relapsing atrial tachyarrhythmias after surgical ablation is an emerging therapy. The aim of this study is to report the electrophysiological findings and the procedural long-term outcomes of reablation, in this particular clinical setting.
  
  METHODS:
  We retrospectively analysed all patients who were readmitted to our centre for relapsing atrial arrhythmias after surgical ablation for atrial fibrillation (AF).
  
  RESULTS:
  From 2000 to 2011, 36 patients with previous surgical ablation of AF received additional percutaneous management. Seven patients had had biatrial Maze, 18 left atrial ablation lesion set and 11 pulmonary vein isolation. Energy sources involved were unipolar radiofrequency (RF) (n = 13), bipolar RF (n = 19), combined bipolar RF and cryoenergy (n = 2), cryoenergy (n = 1) and high intensity focused ultrasound (n = 1). The median time to reablation was 34 months (interquartile range: 10-66). The relapsing arrhythmias were left atrial tachycardia (n = 17), AF (n = 15), right atrial flutter (n = 2), right atrial tachycardia (n = 1) and biatrial atrial tachycardia (n = 1). Origin of re-entrant circuits was perimitral (n = 27), around pulmonary veins (PV) including posterior left atrium (n = 15) and cavotricuspid isthmus (n = 3). Twenty-seven (75%) patients had left isthmus catheter ablation and 11 (30%) reablation of PV. Eighteen out of the 27 perimitral circuits were in patients with previous left-atrial Maze; in 17 patients the mitral line was performed with bipolar RF only, without the addition of cryoenergy. The importance of an appropriate energy source is also underlined by the prevalence of gaps in PV isolation that occurred for two-thirds of patients treated using unipolar RF only, which has been discontinued since 2001. Ten patients (27%) needed more than 1 PA for relapsing arrhythmia. At the last follow-up of 97 ± 42 months, freedom from arrhythmias was 53% after single PAs and 67% after more than one procedure. No morbidity, mortality or strokes were recorded during the follow-up.
  
  CONCLUSIONS:
  Percutaneous treatment of highly symptomatic patients with unsuccessful previous surgical ablation is feasible, and relatively effective at the late follow-up. A multidisciplinary approach significantly improves the outcomes in these challenging patients.
  
  © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
  
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• Impact of a chronic total occlusion in an infarct-related artery on the long-term outcome of ventricular tachycardia ablation.
  J Cardiovasc Electrophysiol

  2015 May;26(5):532-9. doi: 10.1111/jce.12622.
  
  Di Marco Andrea, Paglino Gabriele, Oloriz Teresa, Maccabelli Giuseppe, Baratto Francesca, Vergara Pasquale, Bisceglia Caterina, Anguera Ignasi, Sala Simone, Sora Nicoleta, Dallaglio Paolo, Marzi Alessandra, Trevisi Nicola, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  INTRODUCTION:
  In patients with a prior myocardial infarction (MI), angiographic predictors of ventricular tachycardia (VT) recurrence after ablation are lacking. Recently, a proarrhythmic effect of a chronic total occlusion (CTO) in a coronary artery has been suggested.
  
  METHODS AND RESULTS:
  A total of 191 patients with prior MI were referred to our Hospital between 2010 and June 2013 for a first ablation of VT. Of these, 84 patients (44%) with stable coronary artery disease that underwent a coronary angiography during the index hospitalization were included in this study. A CTO in an infarct-related artery (IRA-CTO) was present in 47 patients (56%). Patients with and without IRA-CTO did not differ in terms of comorbidities, severity of heart failure, presentation of VT or acute outcome of ablation, that was completely successful in 93% of cases. At electroanatomic mapping, IRA-CTO was associated with greater scar and especially with greater area of border zone (34 cm(2) vs. 19 cm(2) , P = 0.001). Median follow-up was 19 months (IQR 18). At follow-up, patients with IRA-CTO had a significantly higher rate of VT recurrence (47% vs. 16%, P = 0.003). At multivariate analysis, IRA-CTO resulted to be an independent predictor of VT recurrence after ablation (HR 4.05, P = 0.004).
  
  CONCLUSIONS:
  IRA-CTO is an independent predictor of VT recurrence after ablation and identifies a subgroup of patients with high recurrence rate despite a successful procedure. IRA-CTO is associated with greater scars and border zone area; however, this association does not completely justify its proarrhythmic effect.
  
  © 2015 Wiley Periodicals, Inc.
  
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• Electrical storm induced by cardiac resynchronization therapy is determined by pacing on epicardial scar and can be successfully managed by catheter ablation.
  Circ Arrhythm Electrophysiol

  2014 Dec;7(6):1064-9. doi: 10.1161/CIRCEP.114.001796.
  
  Roque Carla, Trevisi Nicola, Silberbauer John, Oloriz Teresa, Mizuno Hiroya, Baratto Francesca, Bisceglia Caterina, Sora Nicoleta, Marzi Alessandra, Radinovic Andrea, Guarracini Fabrizio, Vergara Pasquale, Sala Simone, Paglino Gabriele, Gulletta Simone, Mazzone Patrizio, Cireddu Manuela, Maccabelli Giuseppe, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  The mechanism of cardiac resynchronization therapy (CRT)-induced proarrhythmia remains unknown. We postulated that pacing from a left ventricular (LV) lead positioned on epicardial scar can facilitate re-entrant ventricular tachycardia. The aim of this study was to investigate the relationship between CRT-induced proarrhythmia and LV lead location within scar.
  
  METHODS AND RESULTS:
  Twenty-eight epicardial and 63 endocardial maps, obtained from 64 CRT patients undergoing ventricular tachycardia ablation, were analyzed. A positive LV lead/scar relationship, defined as a lead tip positioned on scar/border zone, was determined by overlaying fluoroscopic projections with LV electroanatomical maps. CRT-induced proarrhythmia occurred in 8 patients (12.5%). They all presented early with electrical storm (100% versus 39% of patients with no proarrhythmia; P
  CONCLUSIONS:
  CRT-induced proarrhythmia presented early with electrical storm and was associated with an LV lead positioning within epicardial scar. Catheter ablation allowed for resumption of biventricular stimulation in all patients.
  
  © 2014 American Heart Association, Inc.
  
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• Atrial fibrillation and chronic kidney disease in hypertension: a common and dangerous triad.
  Curr Vasc Pharmacol

  2015 ;13(1):111-20.
  
  Tsiachris Dimitris, Tsioufis Costas, Mazzone Patrizio, Katsiki Niki, Stefanadis Christodoulos
  
  Abstract
  
  Hypertension (HTN) and chronic kidney disease (CKD) often coexist sharing common pathophysiological factors that both in combination and separately induce fibrotic changes in the heart provoking atrial fibrillation (AF). AF, per se, is associated with a 4- to 5-fold increased risk of stroke and a 2-fold increased risk of all-cause death. The co-existence of AF with HTN and renal dysfunction considerably increases morbidity and mortality. Management of AF in hypertensive patients with CKD is complex and multidisciplinary, since these patients have both a prothrombotic state and a coagulopathy with an increased tendency for bleeding. Novel oral anticoagulants such as dabigatran, rivaroxaban and apixaban offer better efficacy and safety especially in patients without optimal treatment with vitamin K antagonists.
  
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• Noninducibility and late potential abolition: a novel combined prognostic procedural end point for catheter ablation of postinfarction ventricular tachycardia.
  Circ Arrhythm Electrophysiol

  2014 Jun;7(3):424-35. doi: 10.1161/CIRCEP.113.001239.
  
  Silberbauer John, Oloriz Teresa, Maccabelli Giuseppe, Tsiachris Dimitris, Baratto Francesca, Vergara Pasquale, Mizuno Hiroya, Bisceglia Caterina, Marzi Alessandra, Sora Nicoleta, Guarracini Fabrizio, Radinovic Andrea, Cireddu Manuela, Sala Simone, Gulletta Simone, Paglino Gabriele, Mazzone Patrizio, Trevisi Nicola, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Successful late potential (LP) abolition and postprocedural ventricular tachycardia (VT) noninducibility constitute significant end points after catheter ablation for VT. We investigated the prognostic impact of a combined procedural end point of VT noninducibility and LP abolition in a large series of post-myocardial infarction patients with VT.
  
  METHODS AND RESULTS:
  A total of 160 (154 men, 94% with implantable cardioverter defibrillators) consecutive post-myocardial infarction patients undergoing first-time ablation procedures from 2010 to 2012 were included. Of the 159 patients surviving the procedure, 137 (86%) were either inducible or in VT at baseline and 103 (65%) had baseline LP presence, of which 79 (77%) underwent successful LP abolition. The combined end point was assessable in 155 (97%) patients. There were 50 (32%) patients with VT recurrences and 17 (11%) cardiac deaths during follow-up. Patients who fulfilled the combined end point of VT noninducibility and LP abolition compared with inducible patients exhibited a significantly lower incidence of VT recurrence (16.4% versus 47.4%; log-rank P
  CONCLUSIONS:
  Achieving a combined catheter ablation procedural end point of VT noninducibility and LP abolition reduces VT recurrence rates to low levels (16%). The overall strategy was associated with a significant impact on cardiac survival.
  
  © 2014 American Heart Association, Inc.
  
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• Catheter ablation of ventricular arrhythmia in nonischemic cardiomyopathy: anteroseptal versus inferolateral scar sub-types.
  Circ Arrhythm Electrophysiol

  2014 Jun;7(3):414-23. doi: 10.1161/CIRCEP.114.001568.
  
  Oloriz Teresa, Silberbauer John, Maccabelli Giuseppe, Mizuno Hiroya, Baratto Francesca, Kirubakaran Senthil, Vergara Pasquale, Bisceglia Caterina, Santagostino Giulia, Marzi Alessandra, Sora Nicoleta, Roque Carla, Guarracini Fabrizio, Tsiachris Dimitris, Radinovic Andrea, Cireddu Manuela, Sala Simone, Gulletta Simone, Paglino Gabriele, Mazzone Patrizio, Trevisi Nicola, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  The aim was to relate distinct scar distributions found in nonischemic cardiomyopathy with ventricular tachycardia (VT) morphology, late potential distribution, ablation strategy, and outcome.
  
  METHODS AND RESULTS:
  Eighty-seven patients underwent catheter ablation for drug-refractory VT. Based on endocardial unipolar voltage, 44 were classified as predominantly anteroseptal and 43 as inferolateral. Anteroseptal patients more frequently fulfilled diagnostic criteria for dilated cardiomyopathy (64% versus 36%), associated with more extensive endocardial unipolar scar (41 [22-83] versus 9 [1-29] cm(2); P
  CONCLUSIONS:
  Unipolar low-voltage distribution in nonischemic cardiomyopathy allows categorization of scar pattern as inferolateral, often requiring epicardial ablation mainly based on late potentials, and anteroseptal, which frequently involves an intramural septal substrate, leading to a higher VT recurrence.
  
  © 2014 American Heart Association, Inc.
  
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• Substrate mapping strategies for successful ablation of ventricular tachycardia: a review.
  Arch Cardiol Mex

  2013 ;83(2):104-11. doi: 10.1016/j.acmx.2013.02.001.
  
  Vergara Pasquale, Roque Carla, Oloriz Teresa, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  Catheter ablation of ventricular tachycardia (VT) currently has an important role in the treatment of incessant ventricular tachycardia and reduction of the number of episodes of recurrent ventricular tachycardia. Conventional mapping techniques require ongoing tachycardia and haemodynamic stability during the procedure. However, in many patients with scar-related ventricular tachycardia, non-inducibility of clinical tachycardia, poor induction reproducibility, haemodynamic instability, and multiple ventricular tachycardias with frequent spontaneous changes of morphology, preclude tachycardia mapping. To overcome these limitations, new strategies for mapping and ablation in sinus rhythm (SR) - substrate mapping strategies - have been developed and are currently used by many centres. This review summarizes the progresses recently achieved in the ablative treatment of ventricular tachycardia using a substrate mapping approach in patients with structural heart disease.
  
  Copyright © 2012 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.
  
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• Multidisciplinary treatment of subclavian artery injury after catheterization for atrial fibrillation ablation.
  J Cardiovasc Med (Hagerstown)

  2015 Jan;16 Suppl 1():S18-9. doi: 10.2459/JCM.0b013e32836204a5.
  
  Tsiachris Dimitris, Negri Giampiero, Marone Maria Enrico, Muriana Piergiorgio, Ciriaco Paola, Mazzone Patrizio
  
  Abstract
  
  Subclavian vein cannulation is frequently performed in patients undergoing electrophysiologic procedures in order to facilitate catheterization of the coronary sinus. We present a rare case of massive haemothorax, secondary to subclavian artery injury, during an ablation of atrial fibrillation. Following the procedure, a chest radiograph revealed a massive left haemothorax and the angiographic phase of a computed tomography scan indicated the presence of active bleeding due to left subclavian artery injury. Active bleeding was initially managed through embolization of the subclavian artery branches and the patient was subsequently treated with combined endovascular stenting and video-assisted thoracic surgery.
  
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• Advanced techniques for chronic lead extraction: heading from the laser towards the evolution system.
  Europace

  2013 Dec;15(12):1771-6. doi: 10.1093/europace/eut126.
  
  Mazzone Patrizio, Tsiachris Dimitris, Marzi Alessandra, Ciconte Giuseppe, Paglino Gabriele, Sora Nicoleta, Gulletta Simone, Vergara Pasquale, Della Bella Paolo
  
  Abstract
  
  AIM:
  The evolution mechanical dilator sheath has been reported to be an effective tool for chronic lead extraction (LE). We examined safety and efficacy of evolution system as compared with laser system.
  
  METHODS AND RESULTS:
  From 2005 to 2009, all extractions requiring the use of a powered sheath were performed using the excimer laser system (n = 73). Since 2009, laser system was no longer available and the evolution system was introduced as the first-line method for powered extraction (n = 48). All procedures were performed by a single first operator. Success and complications were defined according to the current guidelines. Patients of the evolution group compared with those of the laser group had a greater number of extracted leads per patient (2.77 vs. 2.4, P = 0.049) and a longer implant duration (101.1 vs. 62.4 months, P = 0.001). Additional use of snare was required in 27.1% of the evolution group and 8.2% of the laser group (P = 0.005). Complete procedural success was achieved in 91.7% of the evolution group and 97.3% of the laser group (P = 0.16). There was also no difference between evolution and laser groups in clinical success (97.9 vs. 98.6%, P = 0.76), as well as regarding major (4.2 vs. 2.7%, P = 0.66) or minor complications (4.2 vs. 5.5%, P = 0.76).
  
  CONCLUSION:
  Use of the recently introduced evolution system for LE exhibit acceptably high levels of safety, as well as of procedural and clinical success, although additional use of snare was required more frequently in the evolution compared with the laser group.
  
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• Predictors of advanced lead extraction based on a systematic stepwise approach: results from a high volume center.
  Pacing Clin Electrophysiol

  2013 Jul;36(7):837-44. doi: 10.1111/pace.12119.
  
  Mazzone Patrizio, Tsiachris Dimitris, Marzi Alessandra, Ciconte Giuseppe, Paglino Gabriele, Sora Nicoleta, Sala Simone, Vergara Pasquale, Gulletta Simone, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Lead extraction (LE) techniques have evolved from simple traction to extraction with dilators and powered sheaths with very high success rates. On the basis of the systematic implementation of a stepwise approach, we aimed to identify those characteristics that can predict the need for advanced LE techniques.
  
  METHODS:
  Between April 2005 and March 2012, 208 consecutive LE procedures were performed and 456 leads were extracted using an initial superior approach. Advanced techniques for LE (step 4 according to our stepwise approach) were used in 122 patients (58.7%).
  
  RESULTS:
  Younger patient age (odds ratio [OR] = 0.963, P = 0.002), longer duration of the initial implantation (OR = 1.013, P = 0.002), the number of extracted leads (OR = 2.184, P 37 months, extraction of at least two leads, one of them being a defibrillator lead). The absence of all the four characteristics was accompanied by 0% positive predictive value for the requirement of step 4 for LE, whereas the coexistence of all four risk factors is characterized by 87% requirement of advanced LE.
  
  CONCLUSION:
  In most of the patients with indication for LE, use of a powered sheath extraction is necessary in order to obtain clinical success. We have identified four patient and lead characteristics that may help the operator plan the means of extraction.
  
  ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.
  
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• Contact force monitoring for cardiac mapping in patients with ventricular tachycardia.
  J Cardiovasc Electrophysiol

  2013 May;24(5):519-24. doi: 10.1111/jce.12080.
  
  Mizuno Hiroya, Vergara Pasquale, Maccabelli Giuseppe, Trevisi Nicola, Eng Sebastiano Colombo, Brombin Chiara, Mazzone Patrizio, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Although the importance of contact force monitoring during mapping and ablation procedures is widely recognized, only indirect measurements have been validated.
  
  METHODS:
  Real-time force values were measured using the force-sensing catheter and electroanatomical mapping system from 27 chambers (13 LVs, 6 RVs, and 8 epicardial space) in 17 patients affected by ventricular tachycardia. Left ventricular mapping was performed by the transaortic approach in all patients and in 5 patients also by a transseptal approach with the aid of a deflectable sheath. All points were divided into 2 groups according to the presence of positive contact force during diastole: good and poor contact. The frequency of good contact and its impact on electrophysiological parameters such as signal amplitude, local impedance, and frequency of late potentials was evaluated. The best cut-off value to discriminate the 2 groups was calculated by a generalized linear mixed-effects model.
  
  RESULTS:
  Among all 5,926 points, 1,566 (26%) points were taken with poor contact. In healthy tissue, categorical increase of contact force caused the increase of unipolar and bipolar signal potential amplitude followed by plateau. The frequency of late potentials in the poor contact group was significantly lower when compared to the good contact group (11.9 vs 23.2%; P
  CONCLUSIONS:
  A combined transaortic and transseptal approach allows better endocardial contact during left ventricular mapping. Ventricular mapping with sufficient contact force produces better substrate characterization within pathological areas.
  
  © 2012 Wiley Periodicals, Inc.
  
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• Safety and efficacy of open irrigated-tip catheter ablation of Wolff-Parkinson-White syndrome in children and adolescents.
  Pacing Clin Electrophysiol

  2013 Apr;36(4):486-90. doi: 10.1111/pace.12086.
  
  Gulletta Simone, Tsiachris Dimitris, Radinovic Andrea, Bisceglia Caterina, Mazzone Patrizio, Trevisi Nicola, Paglino Gabriele, Bellini Barbara, Sala Simone, Della Bella Paolo
  
  Abstract
  
  BACKGROUND:
  Irrigated-tip catheter technology has been used for the elimination of resistant accessory pathways (AP) in adults with Wolff-Parkinson-White (WPW) syndrome. However, there are persistent concerns regarding the safety of irrigated catheters in the pediatric population. In this report we present our experience, in terms of effectiveness and safety, of irrigated catheter technology in children and adolescents who underwent ablation of WPW.
  
  METHODS:
  We prospectively followed up all patients less than 18 years old (n = 41, mean age of 12.8 years old) who were referred to our center for radiofrequency (RF) catheter ablation of WPW between January 2010 and July 2011. Catheter ablation was performed in all patients using an open irrigated-tip catheter (Celsius Thermocool 3.5 mm, 7F, B-type, Biosense Webster, Diamond Bar, CA, USA). Power was started from 15 W up to 30 W in right-sided AP; RF pulses in left-sided APs were delivered at 40 W while 20 W was delivered inside the coronary sinus.
  
  RESULTS:
  Mean procedure time was 26.4 minutes and mean fluoroscopy time was 12.2 minutes. Overall procedural success was obtained in 39/41 (95.1%) patients after the first procedure. No complications were observed after the procedure. All patients attended their scheduled follow-up visit at 3, 6, and 12 months and no recurrences were observed based on 12-lead electrocardiogram and 24-hour Holter monitoring.
  
  CONCLUSIONS:
  RF ablation of APs using open irrigated-tip catheters can be performed in children and adolescents with a high acute and long-term success rate, very short procedure times, and acceptable fluoroscopy times.
  
  ©2013, The Authors. Journal compilation ©2013 Wiley Periodicals, Inc.
  
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• Indication to cardioverter-defibrillator therapy and outcome in real world primary prevention. Data from the IRIDE [Italian registry of prophylactic implantation of defibrillators] study.
  Int J Cardiol

  2013 Sep;168(2):1416-21. doi: 10.1016/j.ijcard.2012.12.042.
  
  Proclemer Alessandro, Muser Daniele, Campana Andrea, Zoni-Berisso Massimo, Zecchin Massimo, Locatelli Alessandro, Brieda Marco, Gramegna Lorena, Santarone Mauro, Chiodi Leandro, Mazzone Patrizio, Rebellato Luca, Facchin Domenico
  
  Abstract
  
  AIMS:
  Several trials demonstrated the life saving role of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD). The aim was to evaluate the clinical characteristics and 4-year outcome of consecutive patients treated in clinical practice by prophylactic ICD implantation on the basis of class I recommendations and up-to-date ICD programming.
  
  METHODS AND RESULTS:
  IRIDE multi-center, prospective and observational study enrolled 604 consecutive patients (mean age: 66 ± 10 years) treated by ICD between 01/01/2006 and 30/06/2010. Main characteristics were similarly distributed among the inclusion criteria of MADIT II (24%), SCD-HeFT (24%), COMPANION (26%) and MADIT-CRT (18%) trials, while a small number of patients met the MUSTT and MADIT (7%) inclusion criteria. Single-chamber ICDs were implanted in 168 (28%) patients, dual-chamber in 167 (28%) and biventricular in 269 (43%) patients. ATP programming was activated in 546 (90%) patients. Overall survival and rate of appropriate ICD intervention by ATP and/or shock at 12-24-36-48 months of follow-up were 94%, 89%, 80%, 75% and 16%, 28%, 37% and 50%, respectively. No difference in mortality rate between the groups who received or did not receive appropriate ICD interventions was demonstrated (p=ns).
  
  CONCLUSIONS:
  The IRIDE study confirms the effectiveness in real world practice of ICD implantation in patients at risk of SCD. The life saving role of ICD therapy increases as the duration of follow-up is prolonged and the survival benefit is similar in patients who received or did not receive appropriate device treatment, thus suggesting a beneficial effect of up-to-date device programming.
  
  Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
  
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• Epicardial management of myocarditis-related ventricular tachycardia.
  Eur Heart J

  2013 Jan;34(3):244. doi: 10.1093/eurheartj/ehs316.
  
  Mazzone Patrizio, Tsiachris Dimitris, Della Bella Paolo
  
  
  
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• [Current integrated approaches for the treatment of focal atrial tachycardia].
  Recenti Prog Med

  2012 Mar;103(3):92-7. doi: 10.1701/1046.11398.
  
  Pozzoli Alberto, Benussi Stefano, Mazzone Patrizio, Taramasso Maurizio, Vergara Pasquale, Alfieri Ottavio, Della Bella Paolo
  
  Abstract
  
  Focal atrial tachyardia constitutes more than 10% of the supraventricular tachycardias and it could be responsible for the initiation of other atrial arrhythmias, like atrial fibrillation and atrial flutter. Frequently, the focal atrial tachycardia does not respond to the medical treatment, while a definitive cure is often obtained with radiofrequency transcatheter ablations and integrated minimally-invasive approaches (atrial appendage clip). This paper describes physiopathological mechanisms underlying the focal atrial tachycardia, its anatomical localizations, the clinical patterns and the fundamentals of the diagnosis. Finally, the more recent treatment strategies will be illustrated and discussed.
  
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• Thoracoscopic appendage exclusion with an atriclip device as a solo treatment for focal atrial tachycardia.
  Circulation

  2011 Apr;123(14):1575-8. doi: 10.1161/CIRCULATIONAHA.110.005652.
  
  Benussi Stefano, Mazzone Patrizio, Maccabelli Giuseppe, Vergara Pasquale, Grimaldi Antonio, Pozzoli Alberto, Spagnolo Pietro, Alfieri Ottavio, Della Bella Paolo
  
  
  
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• Pulmonary vein isolation after circumferential pulmonary vein ablation: comparison between Lasso and three-dimensional electroanatomical assessment of complete electrical disconnection.
  Heart Rhythm

  2009 Dec;6(12):1706-13. doi: 10.1016/j.hrthm.2009.09.008.
  
  Augello Giuseppe, Vicedomini Gabriele, Saviano Massimo, Crisa Simonetta, Mazzone Patrizio, Ornago Ombretta, Zuffada Francesca, Santinelli Vincenzo, Pappone Carlo
  
  Abstract
  
  BACKGROUND:
  Pulmonary vein isolation (PVI) is one of the common endpoints of all atrial fibrillation (AF) ablation procedures and is most often validated using a preshaped circular catheter. However, three-dimensional (3D) electroanatomical systems used for anatomy reconstruction and to guide coalescent delivery of ablation lesions avoid the use of multiple transeptal punctures and multiple catheters in the left atrium.
  
  OBJECTIVE:
  To assess correspondence in PVI validation between a 3D electroanatomical system and a Lasso catheter.
  
  METHODS:
  Twenty-five patients affected by nonpermanent AF were enrolled after giving informed consent. After ablation of all four pulmonary vein (PV) ostia, encircled areas were extensively mapped (15 +/- 5 points acquired for each PV ostium) to assess the absence of any electrical activity conducted from the left atrium to the PV. At the end of the procedure, the physician performing the ablation procedure judged the complete versus incomplete PVI according to Carto/ablation catheter mapping during coronary sinus pacing. Thereafter, a second operator blinded to the result of the ablation procedure positioned a preshaped Lasso catheter in each PV ostium and annotated complete/incomplete PVI during pacing from the coronary sinus.
  
  RESULTS:
  PVI as assessed with CARTO was 100% concordant with Lasso evaluation of PVI. Fluoroscopic times were 2.5 +/- 0.9 minutes to complete circumferential PV ablation and 5.5 +/- 1.9 minutes to properly position the Lasso catheter. No acute complications were reported in this series of patients.
  
  CONCLUSIONS:
  PVI assessment using a 3D electroanatomical system is as accurate as Lasso evaluation, with excellent concordance.
  
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• The natural history of asymptomatic ventricular pre-excitation a long-term prospective follow-up study of 184 asymptomatic children.
  J Am Coll Cardiol

  2009 Jan;53(3):275-80. doi: 10.1016/j.jacc.2008.09.037.
  
  Santinelli Vincenzo, Radinovic Andrea, Manguso Francesco, Vicedomini Gabriele, Gulletta Simone, Paglino Gabriele, Mazzone Patrizio, Ciconte Giuseppe, Sacchi Stefania, Sala Simone, Pappone Carlo
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to describe the natural history of asymptomatic ventricular pre-excitation in children and to determine predictors of potentially life-threatening arrhythmic events.
  
  BACKGROUND:
  Sudden death can be the first clinical manifestation in asymptomatic children with ventricular pre-excitation, but reduction of its incidence by prophylactic ablation requires the identification of subjects at high risk.
  
  METHODS:
  Between 1995 and 2005 we prospectively collected clinical and electrophysiologic data from 184 children (66% male; median age 10 years; range 8 to 12 years) with asymptomatic ventricular pre-excitation on the electrocardiogram. After electrophysiologic testing, subjects were followed as outpatients taking no medications. The primary end point of the study was the occurrence of arrhythmic events. Predictors of potentially life-threatening arrhythmias were analyzed.
  
  RESULTS:
  Over a median follow-up of 57 months (min/max 32/90 months) after electrophysiologic testing, 133 children (mean age 10 years; range 8 to 12 years) did not experience arrhythmic events, remaining totally asymptomatic, while 51 children had within 20 months (min/max 8/60 months) a first arrhythmic event, which was potentially life-threatening in 19 of them (mean age 10 years; range 10 to 14 years). Life-threatening tachyarrhythmias resulted in cardiac arrest (3 patients), syncope (3 patients), atypical symptoms (8 patients), or minimal symptoms (5 patients). Univariate analysis identified tachyarrhythmia inducibility (p
  CONCLUSIONS:
  These findings are potentially relevant in terms of early identification of high-risk asymptomatic children with ventricular pre-excitation. Subjects with short APERPs and multiple pathways are at higher risk of developing life-threatening arrhythmic events and are the best candidates for prophylactic ablation.
  
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• Atrial fibrillation progression and management: a 5-year prospective follow-up study.
  Heart Rhythm

  2008 Nov;5(11):1501-7. doi: 10.1016/j.hrthm.2008.08.011.
  
  Pappone Carlo, Radinovic Andrea, Manguso Francesco, Vicedomini Gabriele, Ciconte Giuseppe, Sacchi Stefania, Mazzone Patrizio, Paglino Gabriele, Gulletta Simone, Sala Simone, Santinelli Vincenzo
  
  Abstract
  
  BACKGROUND:
  Few data on atrial fibrillation (AF) progression from the first paroxysmal episode are available.
  
  OBJECTIVE:
  The purpose of this study was to assess the progression of AF not due to potentially reversible causes in patients treated according to current guidelines recommendations that also include catheter ablation.
  
  METHODS:
  Among 402 screened patients with first AF, 106 patients (mean age 57.5 years) were selected and followed for 5 years. Of these patients, 54 had lone AF and 52 had comorbidities.
  
  RESULTS:
  Fifty patients (61.1% with lone AF) had no further recurrence after 5 years. The remaining 56 patients within 19 months after the first episode developed recurrent paroxysmal AF requiring long-term antiarrhythmic drug therapy, which was continued in 45 patients and was stopped because of intolerance/failure in 11 patients who underwent catheter ablation. AF became persistent in 24 of the 45 patients on antiarrhythmic drug therapy and then permanent in 16, of whom 6 had refused catheter ablation at the time of persistence. No AF recurrences or AF progression occurred after ablation. Kaplan-Meier curves demonstrated that patients with comorbidities were more likely to progress than were those with lone AF (P <.001 and that patients who underwent catheter ablation were at lower risk for progression to permanent af than those on antiarrhythmic drug therapy .029 age diabetes heart failure predict final af.>
  CONCLUSION:
  Patients with first AF and comorbidities are at higher risk for rapid progression to permanent AF, and age, diabetes, and heart failure are independent predictors. Catheter ablation rather than antiarrhythmic drug therapy is beneficial in eliminating recurrences delaying arrhythmia progression.
  
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• A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study.
  J Am Coll Cardiol

  2006 Dec;48(11):2340-7.
  
  Pappone Carlo, Augello Giuseppe, Sala Simone, Gugliotta Filippo, Vicedomini Gabriele, Gulletta Simone, Paglino Gabriele, Mazzone Patrizio, Sora Nicoleta, Greiss Isabelle, Santagostino Andreina, LiVolsi Laura, Pappone Nicola, Radinovic Andrea, Manguso Francesco, Santinelli Vincenzo
  
  Abstract
  
  OBJECTIVES:
  We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF).
  
  BACKGROUND:
  Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge.
  
  METHODS:
  One hundred ninety-eight patients (age, 56 +/- 10 years) with PAF of 6 +/- 5 years' duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT.
  
  RESULTS:
  By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p
  CONCLUSIONS:
  Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show; NCT00340314).
  
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• Robotic magnetic navigation for atrial fibrillation ablation.
  J Am Coll Cardiol

  2006 Apr;47(7):1390-400.
  
  Pappone Carlo, Vicedomini Gabriele, Manguso Francesco, Gugliotta Filippo, Mazzone Patrizio, Gulletta Simone, Sora Nicoleta, Sala Simone, Marzi Alessandra, Augello Giuseppe, Livolsi Laura, Santagostino Andreina, Santinelli Vincenzo
  
  Abstract
  
  OBJECTIVES:
  We assessed feasibility of magnetic catheter guidance in patients with atrial fibrillation (AF) undergoing circumferential pulmonary vein ablation (CPVA).
  
  BACKGROUND:
  No data are available on feasibility of remote navigation for AF ablation.
  
  METHODS:
  Forty patients underwent CPVA for symptomatic AF using the NIOBE II remote magnetic system (Stereotaxis Inc., St. Louis, Missouri). Ablation was performed with a 4-mm tip, magnetic catheter (65 degrees C, maximum 50 W, 15 s). The catheter tip was guided by a uniform magnetic field (0.08-T), and a motor drive (Cardiodrive unit, Stereotaxis Inc.). Left atrium maps were created using an integrated CARTO RMT system (Stereotaxis Inc.). End point of ablation was voltage abatement >90% of bipolar electrogram amplitude.
  
  RESULTS:
  Remote ablation was successful in 38 of 40 patients without complications. The median mapping and ablation time was 152.5 min (range, 90 to 380 min) but was much longer in the first 12 patients (192.5 min vs. 148 min; p = 0.012). Median ablation time was 49.5 min (range, 17 to 154 min), but it was much shorter in the last 28 patients than in the first 12 patients (49 min vs. 70 min; p = 0.021). Patients receiving remote ablation had longer procedure times than control patients (p
  CONCLUSIONS:
  Remote magnetic navigation for AF ablation is safe and feasible with a short learning curve. Although all procedures were performed by a highly experienced operator, remote AF ablation can be performed even by less experienced operators.
  
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• Endocardial impedance mapping during circumferential pulmonary vein ablation of atrial fibrillation differentiates between atrial and venous tissue.
  Heart Rhythm

  2006 Feb;3(2):171-8.
  
  Lang Christopher C E, Gugliotta Filippo, Santinelli Vincenzo, Mesas Cézar, Tomita Takeshi, Vicedomini Gabriele, Augello Giuseppe, Gulletta Simone, Mazzone Patrizio, De Cobelli Francesco, Del Maschio Alessandro, Pappone Carlo
  
  Abstract
  
  BACKGROUND:
  Circumferential pulmonary vein ablation (CPVA) is an effective treatment for atrial fibrillation (AF). Accurate left atrial (LA) mapping is essential for creating lesions at the LA-pulmonary vein (PV) junction, avoiding PV stenosis.
  
  OBJECTIVES:
  The purpose of this study was to establish whether endocardial impedance varies within the LA and PVs and whether it is a useful tool for mapping and ablation.
  
  METHODS:
  Pilot Phase: Three-dimensional LA maps were created using CARTO. Impedance (Z) was measured using a radiofrequency generator at multiple points in the LA, PV ostia (PVO), and deep PVs in 79 patients undergoing their first AF ablation (group 1) and 29 patients undergoing repeat CPVA (group 2). Prospective Phase: In an additional 20 patients, using pilot phase data, one operator defined catheter tip location as either LA or PVO based on CARTO and fluoroscopy. A second operator blinded to CARTO simultaneously did the same based on impedance at 15 +/- 4 points per patient.
  
  RESULTS:
  Group 1: Z(LA) was 99.4 +/- 9.0 omega. Z(PVO) was higher (109.2 +/- 8.5 omega), rising further as the catheter advanced into deep PV (137 omega +/- 18). Z(PVO) differed from Z(LA) by 9 +/- 4 omega. Group 2 had a lower Z(LA) and Z(PVO) compared with group 1 (P <.05 impedance monitoring differentiated between la and pvo with specificity sensitivity positive predictive value negative value. at follow-up no patients had evidence of pv stenosis on magnetic resonance imaging.>
  CONCLUSION:
  Impedance mapping reliably identifies the LA-PV transitional zone, facilitating AF ablation, and its use is associated with a low incidence of PV stenosis.
  
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• Transcatheter radiofrequency ablation of atrial fibrillation in patients with mitral valve prostheses and enlarged atria: safety, feasibility, and efficacy.
  J Am Coll Cardiol

  2005 Mar;45(6):868-72.
  
  Lang Christopher C, Santinelli Vincenzo, Augello Giuseppe, Ferro Amedeo, Gugliotta Filippo, Gulletta Simone, Vicedomini Gabriele, Mesas Cézar, Paglino Gabriele, Sala Simone, Sora Nicoleta, Mazzone Patrizio, Manguso Francesco, Pappone Carlo
  
  Abstract
  
  OBJECTIVES:
  Few data have been published on transcatheter ablation of atrial fibrillation (AF) in patients with mitral valve prostheses. Thus, we sought to report our experience.
  
  BACKGROUND:
  Ablation is an effective treatment for AF. Patients with prosthetic mitral valves represent a special group because of an increased risk from the ablation procedure due to the possibility of damage to the prosthetic valve.
  
  METHODS:
  Between July 2001 and July 2003, 26 patients with mitral valve prostheses (MVP) underwent circumferential pulmonary vein ablation for AF. A matched group of 52 ablated patients without MVP acted as control subjects. After a blanking period of three months, a follow-up of 12 months was considered for MVP patients and controls. Holter recordings were performed in all subjects at 3, 6, and 12 months.
  
  RESULTS:
  Radiation exposure was higher in the MVP group, with fluoroscopy times of 35.3 +/- 21 min versus 20.9 +/- 15 min in controls. At the end of follow-up, 73% of MVP patients were in sinus rhythm, compared with 75% of controls. Atrial tachycardia occurred in six (23%) MVP patients, requiring repeat ablation in three, and one (2%) control subject, which settled without treatment. One transient ischemic attack and one femoral pseudoaneurysm occurred in the MVP group. No complications occurred in the control group.
  
  CONCLUSIONS:
  Ablation of AF in patients with MVP is feasible, with outcomes similar to those of standard patients. Complications were higher among MVP patients with a greater radiation exposure and a higher incidence of post-ablation atrial tachycardia.
  
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• Radiofrequency ablation in children with asymptomatic Wolff-Parkinson-White syndrome.
  N Engl J Med

  2004 Sep;351(12):1197-205.
  
  Pappone Carlo, Manguso Francesco, Santinelli Raffaele, Vicedomini Gabriele, Sala Simone, Paglino Gabriele, Mazzone Patrizio, Lang Christopher C, Gulletta Simone, Augello Giuseppe, Santinelli Ornella, Santinelli Vincenzo
  
  Abstract
  
  BACKGROUND:
  Ventricular fibrillation can be the presenting arrhythmia in children with asymptomatic Wolff-Parkinson-White syndrome. Deaths due to this arrhythmia are potentially preventable.
  
  METHODS:
  We performed a randomized study in which prophylactic radiofrequency catheter ablation of accessory pathways was compared with no ablation in asymptomatic children (age range, 5 to 12 years) with the Wolff-Parkinson-White syndrome who were at high risk for arrhythmias. The primary end point was the occurrence of arrhythmic events during follow-up.
  
  RESULTS:
  Of the 165 eligible children, 60 were determined to be at high risk for arrhythmias. After randomization, but before any ablation had been performed, the parents withdrew 13 children from the study. Of the remaining children, 20 underwent prophylactic ablation and 27 had no treatment. The characteristics of the two groups were similar. There were three ablation-related complications, one of which led to hospitalization. During follow-up, 1 child in the ablation group (5 percent) and 12 in the control group (44 percent) had arrhythmic events. Two children in the control group had ventricular fibrillation, and one died suddenly. The cumulative rate of arrhythmic events was lower among children at high risk who underwent ablation than among those at high risk who did not. The reduction in risk associated with ablation remained significant after adjustment in a Cox regression analysis. In both the ablation and the control groups, the independent predictors of arrhythmic events were the absence of prophylactic ablation and the presence of multiple accessory pathways.
  
  CONCLUSIONS:
  In asymptomatic, high-risk children with the Wolff-Parkinson-White syndrome, prophylactic catheter ablation performed by an experienced operator reduces the risk of life-threatening arrhythmias.
  
  Copyright 2004 Massachusetts Medical Society
  
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• Cardiac contractility modulation by non-excitatory electrical currents. The new frontier for electrical therapy of heart failure.
  Ital Heart J

  2004 Jun;5 Suppl 6():68S-75S.
  
  Augello Giuseppe, Santinelli Vincenzo, Vicedomini Gabriele, Mazzone Patrizio, Gulletta Simone, Maggi Francesco, Mika Yuval, Chierchia GianBattista, Pappone Carlo
  
  Abstract
  
  Heart failure (HF) may complicate ischemic heart disease in both its acute and chronic manifestations, representing a prevalent health problem throughout the world. Development of therapies to improve heart function, relieve symptoms, reduce hospitalizations and improve survival is a high priority in cardiovascular medicine. The available pharmacological strategies, including angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, beta-blockers, and aldosterone receptor antagonists have recently been complemented by new electrical therapy, including implantable cardioverter-defibrillators for "MADIT II" patients and cardiac resynchronization for the 30% of HF patients with concomitant intraventricular conduction delay. The wide variety of available HF medications provides ample evidence that we have not yet succeeded in this effort. Safe and effective inotropic electrical therapy could be a useful addition to our therapeutic armamentarium in an attempt to correct Ca2+ fluxes abnormalities during the cardiac action potential. Cardiac contractility modulation (CCM) by means of non-excitatory electrical currents delivered during the action potential plateau has been shown to acutely enhance systolic function in humans with HF. Herewith, we report on our preliminary experience with CCM therapy for patients with HF, providing fundamental notions to characterize the rationale of this novel form of therapy. Briefly, CCM therapy appears to be safe and feasible. Proarrhythmic effects of this novel therapy seem unlikely. Preliminary data indicate that CCM gradually and significantly improves systolic performance, symptoms and functional status. The technique would appear to be attractive as an additive treatment for severe HF. Controlled randomized studies are needed to validate this novel concept.
  
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• Pulmonary vein denervation enhances long-term benefit after circumferential ablation for paroxysmal atrial fibrillation.
  Circulation

  2004 Jan;109(3):327-34.
  
  Pappone Carlo, Santinelli Vincenzo, Manguso Francesco, Vicedomini Gabriele, Gugliotta Filippo, Augello Giuseppe, Mazzone Patrizio, Tortoriello Valter, Landoni Giovanni, Zangrillo Alberto, Lang Christopher, Tomita Takeshi, Mesas Cézar, Mastella Elio, Alfieri Ottavio
  
  Abstract
  
  BACKGROUND:
  There are no data to evaluate the relationship between autonomic nerve function modification and recurrent atrial fibrillation (AF) after circumferential pulmonary vein ablation (CPVA). This study assesses the incremental benefit of vagal denervation by radiofrequency in preventing recurrent AF in a large series of patients undergoing CPVA for paroxysmal AF.
  
  METHODS AND RESULTS:
  Data were collected on 297 patients undergoing CPVA for paroxysmal AF. Abolition of all evoked vagal reflexes around all pulmonary vein ostia was defined as complete vagal denervation (CVD) and was obtained in 34.3% of patients. Follow-up ended at 12 months. Heart rate variability attenuation, consistent with vagal withdrawal, was detectable for up to 3 months after CPVA, particularly in patients with reflexes and CVD, who were less likely to have recurrent AF than those without reflexes (P=0.0002, log-rank test). Only the percentage area of left atrial isolation and CVD were predictors of AF recurrence after CPVA (P
  CONCLUSIONS:
  This study suggests that adjunctive CVD during CPVA significantly reduces recurrence of AF at 12 months.
  
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• A randomized study of prophylactic catheter ablation in asymptomatic patients with the Wolff-Parkinson-White syndrome.
  N Engl J Med

  2003 Nov;349(19):1803-11.
  
  Pappone Carlo, Santinelli Vincenzo, Manguso Francesco, Augello Giuseppe, Santinelli Ornella, Vicedomini Gabriele, Gulletta Simone, Mazzone Patrizio, Tortoriello Valter, Pappone Alessia, Dicandia Cosimo, Rosanio Salvatore
  
  Abstract
  
  BACKGROUND:
  Young age and inducibility of atrioventricular reciprocating tachycardia or atrial fibrillation during invasive electrophysiological testing identify asymptomatic patients with a Wolff-Parkinson-White pattern on the electrocardiogram as being at high risk for arrhythmic events. We tested the hypothesis that prophylactic catheter ablation of accessory pathways would provide meaningful and durable benefits as compared with no treatment in such patients.
  
  METHODS:
  From 1997 to 2002, among 224 eligible asymptomatic patients with the Wolff-Parkinson-White syndrome, patients at high risk for arrhythmias were randomly assigned to radio-frequency catheter ablation of accessory pathways (37 patients) or no treatment (35 patients). The end point was the occurrence of arrhythmic events over a five-year follow-up period.
  
  RESULTS:
  Patients assigned to ablation had base-line characteristics that were similar to those of the controls. Two patients in the ablation group (5 percent) and 21 in the control group (60 percent) had arrhythmic events. One control patient had ventricular fibrillation as the presenting arrhythmia. The five-year Kaplan-Meier estimates of the incidence of arrhythmic events were 7 percent among patients who underwent ablation and 77 percent among the controls (P
  CONCLUSIONS:
  Prophylactic accessory-pathway ablation markedly reduces the frequency of arrhythmic events in asymptomatic patients with the Wolff-Parkinson-White syndrome who are at high risk for such events.
  
  Copyright 2003 Massachusetts Medical Society
  
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• Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study.
  J Am Coll Cardiol

  2003 Jul;42(2):185-97.
  
  Pappone Carlo, Rosanio Salvatore, Augello Giuseppe, Gallus Giuseppe, Vicedomini Gabriele, Mazzone Patrizio, Gulletta Simone, Gugliotta Filippo, Pappone Alessia, Santinelli Vincenzo, Tortoriello Valter, Sala Simone, Zangrillo Alberto, Crescenzi Giuseppe, Benussi Stefano, Alfieri Ottavio
  
  Abstract
  
  OBJECTIVES:
  This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL).
  
  BACKGROUND:
  Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy.
  
  METHODS:
  We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey.
  
  RESULTS:
  Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p
  CONCLUSIONS:
  Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.
  
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• Combining electrical therapies for advanced heart failure: the Milan experience with biventricular pacing-defibrillation backup combination for primary prevention of sudden cardiac death.
  Am J Cardiol

  2003 May;91(9A):74F-80F.
  
  Pappone Carlo, Vicedomini Gabriele, Augello Giuseppe, Mazzone Patrizio, Nardi Stefano, Rosanio Salvatore
  
  Abstract
  
  Biventricular pacing (BVP) improves hemodynamics and symptoms in patients with heart failure with bundle branch block. Patients with a left ventricular ejection fraction
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• Usefulness of invasive electrophysiologic testing to stratify the risk of arrhythmic events in asymptomatic patients with Wolff-Parkinson-White pattern: results from a large prospective long-term follow-up study.
  J Am Coll Cardiol

  2003 Jan;41(2):239-44.
  
  Pappone Carlo, Santinelli Vincenzo, Rosanio Salvatore, Vicedomini Gabriele, Nardi Stefano, Pappone Alessia, Tortoriello Valter, Manguso Francesco, Mazzone Patrizio, Gulletta Simone, Oreto Giuseppe, Alfieri Ottavio
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to assess in a large cohort of asymptomatic subjects with Wolff-Parkinson-White (WPW) pattern the usefulness of invasive electrophysiologic testing (EPT) in predicting the occurrence of arrhythmic events over a five-year follow-up.
  
  BACKGROUND:
  Sudden death may be the first clinical manifestation of the WPW syndrome in previously asymptomatic patients. Serial EPTs have been proposed to identify patients at risk.
  
  METHODS:
  A total of 212 consecutive asymptomatic WPW patients were enrolled after a baseline EPT; patients were followed for five years, and 162 patients (115 noninducible and 47 inducible) patients underwent a second EPT.
  
  RESULTS:
  After a mean follow-up of 37.7 months, 33 patients became symptomatic. Of the 115 noninducible patients, 18.2% lost anterograde accessory pathway (AP) conduction, 30% retrograde AP conduction, and only 4 (3.4%) developed symptomatic supraventricular tachycardia (SVT). Of the 47 inducible patients, 25 with sustained atrioventricular reciprocating tachycardia (AVRT) and atrial fibrillation (AF), and 4 with nonsustained AVRT and AF became symptomatic for SVT (n = 21) and AF (n = 8). They were younger, had shorter AP anterograde refractory periods, and multiple APs compared to patients who remained asymptomatic (for all comparisons, p
  CONCLUSIONS:
  In asymptomatic WPW subjects, EPT may be a valuable tool to stratify the risk of symptomatic and fatal arrhythmic events.
  
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• Lung resection for cancer in patients with coronary arterial disease: analysis of short-term results.
  Eur J Cardiothorac Surg

  2002 Jul;22(1):35-40.
  
  Ciriaco Paola, Carretta Angelo, Calori Giliola, Mazzone Patrizio, Zannini Piero
  
  Abstract
  
  OBJECTIVE:
  Patients with lung cancer may present concomitant coronary arterial disease. Feasibility of lung resection is dependent on the severity of the cardiac impairment since it can increase operative morbidity and mortality. The aim of this study was to analyze the results of lung resection in patients with coronary arterial disease in terms of operative complications and hospital stay.
  
  METHODS:
  Between January 1993 and March 2001, 50 patients with coronary arterial disease underwent lung resection for cancer at our department. Nineteen patients with a curable left-main or multiple-vessel disease first underwent surgical (six patients) or transluminal (13 patients) myocardial revascularization. Twenty-two of the 31 patients who did not require myocardial revascularization presented a medium-high cardiac risk. Univariate analysis determined the impact of coronary disease on operative complications and hospital stay.
  
  RESULTS:
  Surgery consisted in 40 lobectomies, three pneumonectomies and seven wedge resections. The overall mortality and morbidity rates were 4% and 28%, respectively. Ten patients (22%) experienced postoperative cardiac complications such as arrhythmia and there was one intraoperative death, three suffered secretion retention and one patient died as a consequence of a stroke. Occurrence of postoperative complications was influenced by age (P=0.02) and the presence of medium-high cardiac risk (P=0.03). Hospital stay was longer for patients who did not have prior myocardial revascularization (11.7+/-4 vs. 8.1+/-3 days) and underwent more extensive pulmonary resection (10.6+/-5 vs. 7.4+/-2 days).
  
  CONCLUSIONS:
  Lung resection in patients with coronary arterial disease is justified in selected cases. Previous myocardial revascularization and limited resections can decrease operative complications and hospital stay. Careful preoperative evaluation can identify patients who might benefit from myocardial revascularization prior to surgery.
  
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