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Background: Electrocardiographic screening before subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is unsuccessful in around 10% of cases. A personalized screening method, by slightly moving the electrodes, to obtain a better R/T ratio has been described to overcome traditional screening failure., Objective: The objectives of the SIS study were to assess to what extent a personalized screening method improves eligibility for S-ICD implantation and to evaluate the inappropriate shock rate after such screening success., Methods: All consecutive patients eligible for an S-ICD implantation were prospectively recruited across 20 French centers between December 2019 and January 2022. In case of traditional screening failure, patients received a second personalized screening. If at least 1 vector was positive, the personalized screening was considered successful, and the patient was eligible for implantation., Results: The study included 474 patients (mean age, 50.4 ± 14.1 years; 77.4% men). Traditional screening was successful in 456 (96.2%) cases. This figure rose to 98.3% (n = 466; P = .002) when personalized screening was performed. All patients implanted after successful personalized screening had correct signal detection on initial device interrogation. Nevertheless, after 1-year follow-up, 3 of the 7 patients (43%) implanted with personalized screening experienced inappropriate shock vs 18 of the 427 patients (4.2%) with traditional screening and S-ICD implantation (P = .003)., Conclusion: Traditional S-ICD screening was successful in our study in a high proportion of patients. Considering the small improvement in success of screening and a higher rate of inappropriate shock, a strategy of personalized screening cannot be routinely recommended., Clinicaltrials: gov identifier: NCT04101253., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: To assess long-term effectiveness and safety of edoxaban in Europe., Methods and Results: ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHA 2 DS 2 -VASc and HAS-BLED scores were 3.0 (2.0-4.0) and 2.0 (1.0-2.0), respectively. Follow-up duration was 3.98 (3.21-4.05) years. Patients on edoxaban 30 mg (n = 3042) at baseline were older (80.0 vs 73.0 years), more likely assessed as frail by investigators (27.0% vs 6.6%) and had more comorbidities than those on edoxaban 60 mg (n = 9617; missing dosing information for n = 505). Annualised event rates of all-cause and cardiovascular death in the overall population, edoxaban 60 mg and edoxaban 30 mg groups were 4.1%, 2.8% and 8.4%, and 1.0%, 0.7% and 2.0%, respectively. Annualised rates of stroke were relatively constant throughout the follow-up, transient ischaemic attack and systemic embolism were < 1% in the overall population. Rates of any major and major gastrointestinal bleeding were low, with slightly higher rates for edoxaban 30 vs 60 mg group. Intracranial haemorrhage was uncommon (0.2%)., Conclusions: In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics., Competing Interests: Declaration of competing interest P.K. receives research support for basic, translational, and clinical research projects from European Union Big- Data@Heart (grant agreement EU IMI 116074) CATCH ME (grant agreement ID: 633196) AFFECT-EU (grant agreement ID: 847770); Leducq foundation, Medical Research Council (UK); German Centre for Cardiovascular Research supported by the German Ministry of Education and Research; from several drug and device companies active in atrial fibrillation and has received honoraria from several such companies in the past, but not in the last three years. P.K. is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). P.K. is employed as Director of the Department of Cardiology, University Heart and Vascular Centre UKE Hamburg and Professor of Cardiovascular Medicine (part-time), University of Birmingham, UK. He is Speaker of the board of AFNET, Germany, and Board member of the ESC. A.B. is founder and clinical trial design advisor of Amore Health Ltd., reports support from Daiichi Sankyo for attending meetings and advisory boards; receives honorarium from Daiichi Sankyo, Pfizer, BMS, Bayer, Novartis, Roche, Napp, Boehringer Ingelheim for lecturing and scientific advice outside the submitted work. C.d.A. has received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Atricure, Biosense Webster, Boston Scientific, Acutus Medical and research grants on behalf of the centre from Biotronik, Medtronic Abbott, Microport, Boston Scientific, Biosense Webster, Acutus Medical. J.R.d.G. reports personal fees from Daiichi Sankyo during the conduct of the study; grants from Abbott, Atricure, Bayer, Boston Scientific, Daiichi Sankyo, Johnson & Johnson and Medtronic; personal fees from Atricure, Bayer, Berlin Chemie, Daiichi Sankyo, Johnson & Johnson, Menarini, Medtronic, Novartis, and Servier; and other from RhythmCARE outside the submitted work. J.C.D. has received honoraria for lectures from Bayer, Boehringer Ingelheim, and Bristol Myers Squibb. J.C.D. has also received research grants from Boston Scientific, Sorin Group, Biotronik, and Abbott. P.K. has received speaker's and committee membership from Daiichi Sankyo, and received consulting fee (<€5000) from Alexion and Novo Nordisk. He is the Lead Investigator of the HRB Stroke Clinical Trials Network Ireland, which has received grant funding from the Irish government, Irish Heart Foundation, Daiichi Sankyo, Bayer, Boehringer Ingelheim, Pfizer, Bristol Myers Squibb, Amgen, and A Menarini. E.L.-d.-S. reports personal fees from Daiichi Sankyo; grants and personal fees from Servier, ZOLL Medical, and Becton Dickinson; grants from AstraZeneca, MedImmune LLC and Novartis, during the conduct of the study. P.M. is an ETNA-AF investigator and has received lecture and research fees from Daiichi Sankyo, Bayer, Boehringer Ingelheim, and Pfizer/BMS. E.-M.F., M.L., P.L., and R.S. are employees of Daiichi Sankyo Europe GmbH, Munich, Germany. J.S. has received consultant and/or speaker fees from Abbott, Alexion, Astra-Zeneca, Bayer, Berlin-Chemie, Biosense Webster, Biotronik, Boehringer-Ingelheim, Boston Scientific, BMS, Daiichi Sankyo, Medscape, Medtronic, Menarini, Merck/MSD, Organon, Pfizer, Saja, Servier, and WebMD. He reports ownership of Swiss EP and CorXL. J.W. reports personal fees and non-financial support from Biotronik, Boehringer Ingelheim, and Daiichi Sankyo; personal fees from Akzea, Bayer Vital, MSD, Berlin-Chemie and Siemens Healthineers, outside the submitted work. T.W.W. has received fees, honoraria and research funding from AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb/Pfizer, Daiichi Sankyo, Medtronic, Menarini Pharma, Novartis, and Sanofi Aventis. R.D.C. reports grants, personal fees and non-financial support from Daiichi Sankyo, during the conduct of the study; and reports consulting fees, honoraria and other financial or non-financial interests: Amgen, Boehringer Ingelheim, Bayer, BMS/Pfizer, Daiichi Sankyo, Janssen, Milestone, Novartis, Sanofi, Menarini, Guidotti, and Roche, outside the submitted work. Consultancy fees from Daiichi Sankyo Europe for the Chairing of the ETNA-AF Europe registry., (Copyright © 2023. Published by Elsevier B.V.)

Syncopal events in patients with hypertrophic cardiomyopathy (HCM) are of concern as they are a vital consideration in algorithms for risk stratification for sudden cardiac death (SCD) and ICD implantation. However, the cause of syncope is often under-investigated and/or unexplained. Current syncope guidelines do not provide a detailed definition of unexplained syncope. To address this important gap, an international panel of experts in the field of both syncope and HCM wrote a consensus document with the aim of providing practical guidance for the diagnosis and management of syncope in patients with HCM., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Syncope in patients with an early repolarization (ER) pattern presents a challenge for clinicians as it has been identified as an indicator of a higher risk of life-threatening ventricular arrhythmias (VAs)., Objectives: This study aimed to analyze the outcome of patients with an ER pattern and syncope and to evaluate the factors predictive of VAs., Methods: Over a period of 5 years, we enrolled 143 patients with an ER pattern and syncope in a multicenter prospective registry., Results: After the initial examinations, 97 patients (67.8%) were implanted with a device allowing electrocardiogram monitoring, including 84 (58.7%) with an implantable loop recorder. During a mean follow-up period of 68 ± 34 months, we documented 16 arrhythmias presumably responsible for syncope (5 VAs, 10 bradycardias, and 1 supraventricular tachycardia). Additionally, recurrent syncope not associated with electrocardiogram documentation occurred in 16 patients (11.2%). The cause of syncope was identified in 23 of 97 patients with a monitoring device (23.8%). The 5-year incidence of VAs and arrhythmic events presumably responsible for syncope was 4.9% and 11.0%, respectively. Patients who developed VAs showed no prodromes or specific triggers at the time of syncope. Neither the presence of a family history of sudden cardiac death nor the previously reported high-risk electrocardiographic parameters differed between patients with and without VAs., Conclusion: VAs occurred in 4.9% of patients with an ER pattern and syncope. Device implantation based on detailed history taking seems to be a reasonable strategy. Previously reported high-risk electrocardiographic patterns did not identify patients with VAs., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Transvenous lead extraction (TLE) remains a high-risk procedure., Objective: The purpose of this study was to develop a machine learning (ML)-based risk stratification system to predict the risk of major adverse events (MAEs) after TLE. A MAE was defined as procedure-related major complication and procedure-related death., Methods: We designed and evaluated an ML-based risk stratification system trained using the European Lead Extraction ConTRolled (ELECTRa) registry to predict the risk of MAEs in 3555 patients undergoing TLE and tested this on an independent registry of 1171 patients. ML models were developed, including a self-normalizing neural network (SNN), stepwise logistic regression model ("stepwise model"), support vector machines, and random forest model. These were compared with the ELECTRa Registry Outcome Score (EROS) for MAEs., Results: There were 53 MAEs (1.7%) in the training cohort and 24 (2.4%) in the test cohort. Thirty-two clinically important features were used to train the models. ML techniques were similar to EROS by balanced accuracy (stepwise model: 0.74 vs EROS: 0.70) and superior by area under the curve (support vector machines: 0.764 vs EROS: 0.677). The SNN provided a finite risk for MAE and accurately identified MAE in 14 of 169 "high (>80%) risk" patients (8.3%) and no MAEs in all 198 "low (<20%) risk" patients (100%)., Conclusion: ML models incrementally improved risk prediction for identifying those at risk of MAEs. The SNN has the additional advantage of providing a personalized finite risk assessment for patients. This may aid patient decision making and allow better preoperative risk assessment and resource allocation., (Copyright © 2022 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The aim is to report healthcare costs in a nationwide cohort of patients with an implantable cardioverter defibrillator (ICD)., Methods: This real-life longitudinal retrospective cohort study was based on the French National Health Data System and enrolled all adult patients from the general health insurance scheme implanted with an ICD between 2008 and 2011, and followed them until 2018., Results: Overall, 19,408 patients were included (mean age 63.8, SD 12.4 years, 81.6% males), with cardiac resynchronization therapy (CRTD), single-chamber, and dual-chamber ICD in 42.5%, 29.8%, 27.7% of patients, respectively. After a mean follow-up of 6.6 SD 3.3 years, 9514 patients (49.0%) died, and 8678 patients (44.7%) had their ICD replaced. The total healthcare cost (all diseases and injuries combined) was €15,893/patient-year, of which 32% were estimated to be ICD-related. These ICD-related costs were: the implantation hospital stay (representing 59% of the ICD-related costs), ICD replacement (22%), complications' management (11%), and follow-up (9%). Some health events (e.g., a complication during ICD replacement) were counted in two categories, hence the sum of the proportions is >100%. Being under 55 vs. above 75 years old, being treated for hypertension vs. not treated, and receiving a CRT-D vs. a single-chamber ICD each increased the mean total ICD-related cost per patient by approximately 20%; ICD replacement vs. no replacement increased it by 71%., Conclusions: Almost two thirds of the total ICD patients' healthcare costs remained not ICD-related. Advancing the understanding of direct and indirect costs may help improving cost-effectiveness of patients' care pathway., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: QTc interval monitoring, for the prevention of drug-induced arrhythmias is necessary, especially in the context of coronavirus disease 2019 (COVID-19). For the provision of widespread use, surrogates for 12‑lead ECG QTc assessment may be useful. This prospective observational study compared QTc duration assessed by artificial intelligence (AI-QTc) (Cardiologs®, Paris, France) on smartwatch single‑lead electrocardiograms (SW-ECGs) with those measured on 12‑lead ECGs, in patients with early stage COVID-19 treated with a hydroxychloroquine-azithromycin regimen., Methods: Consecutive patients with COVID-19 who needed hydroxychloroquine-azithromycin therapy, received a smartwatch (Withings Move ECG®, Withings, France). At baseline, day-6 and day-10, a 12‑lead ECG was recorded, and a SW-ECG was transmitted thereafter. Throughout the drug regimen, a SW-ECG was transmitted every morning at rest. Agreement between manual QTc measurement on a 12‑lead ECG and AI-QTc on the corresponding SW-ECG was assessed by the Bland-Altman method., Results: 85 patients (30 men, mean age 38.3 ± 12.2 years) were included in the study. Fair agreement between manual and AI-QTc values was observed, particularly at day-10, where the delay between the 12‑lead ECG and the SW-ECG was the shortest (-2.6 ± 64.7 min): 407 ± 26 ms on the 12‑lead ECG vs 407 ± 22 ms on SW-ECG, bias -1 ms, limits of agreement -46 ms to +45 ms; the difference between the two measures was <50 ms in 98.2% of patients., Conclusion: In real-world epidemic conditions, AI-QTc duration measured by SW-ECG is in fair agreement with manual measurements on 12‑lead ECGs. Following further validation, AI-assisted SW-ECGs may be suitable for QTc interval monitoring., Registration: ClinicalTrial.govNCT04371744., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Biventricular endocardial pacing (BiV ENDO) is a therapy for heart failure patients who cannot receive transvenous epicardial cardiac resynchronization therapy (CRT) or have not responded adequately to CRT. BiV ENDO CRT can be delivered by a new wireless LV ENDO pacing system (WiSE-CRT system; EBR Systems, Sunnyvale, CA), without the requirement for lifelong anticoagulation., Objective: The purpose of this study was to assess the safety and efficacy of the WiSE-CRT system during real-world clinical use in an international registry., Methods: Data were prospectively collected from 14 centers implanting the WiSE-CRT system as part of the WiCS-LV Post Market Surveillance Registry. (ClinicalTrials.gov Identifier: NCT02610673)., Results: Ninety patients from 14 European centers underwent implantation with the WiSE-CRT system. Patients were predominantly male, age 68.2 ± 10.5 years, left ventricular ejection fraction 30.6% ± 8.9%, mean QRS duration 180.7 ± 27.0 ms, and 40% with ischemic etiology. Successful implantation and delivery of BiV ENDO pacing was achieved in 94.4% of patients. Acute (<24 hours), 1- to 30-day, and 1- to 6-month complications rates were 4.4%, 18.8%, and 6.7%, respectively. Five deaths (5.6%) occurred within 6 months (3 procedure related). Seventy percent of patients had improvement in heart failure symptoms., Conclusion: BiV ENDO pacing with the WiSE-CRT system seems to be technically feasible, with a high success rate. Three procedural deaths occurred during the study. Procedural complications mandate adequate operator training and implantation at centers with immediately available cardiothoracic and vascular surgical support., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: According to guidelines, implantable cardioverter defibrillator (ICD) candidates must have a "reasonable expectation of survival with a good functional status >1 year". Identifying risk for early mortality in ICD candidates could be challenging. We aimed to identify factors associated with a ≤1-year survival among patients implanted with ICDs., Methods: The DAI-PP program was a multicenter, observational French study that included all patients who received a primary prevention ICD in the 2002-2012 period. Characteristics of patients who survived ≤1 year following the implantation were compared with those who survived >1 year, and predictors of early death determined., Results: Out of the 5539 enrolled patients, survival status at 1 year was known for a total of 5,457, and overall 230 (4.2%) survived ≤1 year. Causes of death were similar in the two groups. Patients with ≤1-year survival had lower rates of appropriate (14 vs. 23%; P = 0.004) and inappropriate ICD therapies (2 vs. 7%; P = 0.009) than patients who lived >1 year after ICD implantation. In multivariate analysis, older age, higher NYHA class (≥III), and atrial fibrillation were significantly associated with ≤1-year survival. Presence of all 3 risk factors was associated with a cumulative 22.63% risk of death within 1 year after implantation., Conclusions: This is the largest study determining the factors predicting early mortality after ICD implantation. Patients dying within the first year had low ICD therapy rates. A combination of clinical factors could potentially identify patients at risk for early mortality to help improve selection of ICD candidates., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations., Objective: The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) ≤35% (primary prevention ≤35%)., Methods: Primary prevention ≤35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression., Results: In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at ≤65 J). Higher BMI was predictive of failing DFT at ≤65 J. The rate of 30-day freedom from complications was 95.8%. Most complications involved postoperative healing (45%) or interventions after DFT or impedance check (19%)., Conclusion: The procedural outcome data of UNTOUCHED reinforce that S-ICD therapy has low perioperative complication rates and high conversion efficacy of induced ventricular fibrillation, even in a higher-risk cohort with low LVEF and more comorbidities than previous S-ICD studies. Higher BMI warrants more careful attention to implant technique., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Patients affected by syncope without or with very short (≤5 s) prodrome with normal heart and normal ECG have been seen to present low plasma adenosine levels. We investigated whether chronic treatment of these patients with theophylline, a non-selective adenosine receptor antagonist, results in clinical benefit., Methods: In a consecutive case-series of 16 patients (mean age 47 ± 25 years, 9 females) who had ECG documentation of asystolic syncope, we compared the incidence of syncopal recurrence during a period without and a period with tailored theophylline therapy., Results: During a median of 60 months before ECG documentation of the index episode, the patients had a median of 2 syncopes per year. During the 6 months of the study phase without therapy, the patients had a median of 2.6 syncopes per year, p = 0.63. During the 23 months of the study phase with theophylline, the patients had a median of 0.4 syncopes per year, p = 0.005 vs history and p = 0.005 vs no therapy. In the 13 patients who had an implantable loop recorder during both study phases, the incidence of asystolic episodes > 3 s decreased from 9.6 per year to 1.1 per year, p = 0.0007. During theophylline treatment, syncope recurred in 1/5 (20%) patients who had an idiopathic atrioventricular block as the index event versus 9/11 (81%) patients who had a sinus arrest, p = 0.005., Conclusion: Theophylline is effective in reducing syncopal burden in patients with syncope without prodromes with normal heart and normal ECG. Its efficacy is greater in those with idiopathic atrioventricular block., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Almost 1/3 of heart failure patients fail to respond to cardiac resynchronization therapy (CRT). A simple clinical score to predict who these patients are at the moment of referral or at time of implant may be of importance for early optimization of their management., Methods: Observational study. A risk score was derived from factors associated to CRT response. The derivation cohort was composed of 1301 patients implanted with a CRT defibrillator in a multi-center French cohort-study. External validation of this score and assessment of its association with CRT response and all-cause mortality and/or heart transplant was performed in 1959 CRT patients implanted in 4 high-volume European centers., Results: Independent predictors of CRT response in the derivation cohort were: female gender (OR = 2.08, 95% CI 1.26-3.45), NYHA class ≤ III (OR = 2.71, 95% CI 1.63-4.52), left ventricular ejection fraction ≥ 25% (OR = 1.75, 95% CI 1.27-2.41), QRS duration ≥ 150 ms (OR = 1.70, 95% CI 1.25-2.30) and estimated glomerular filtration rate ≥ 60 mL/min (OR = 2.01, 95% CI 1.48-2.72). Each was assigned 1 point. External validation showed good calibration (Hosmer-Lemeshow test-P = 0.95), accuracy (Brier score = 0.19) and discrimination (c-statistic = 0.67), with CRT response increasing progressively from 37.5% in patients with a score of 0 to 91.9% among those with score of 5 (Gamma for trend = 0.44, P < 0.001). Similar results were observed regarding all-cause mortality or heart transplant., Conclusion: The ScREEN score (Sex category, Renal function, ECG/QRS width, Ejection fraction and NYHA class) is composed of widely validated, easy to obtain predictors of CRT response, and predicts CRT response and overall mortality. It should be helpful in facilitating early consideration of alternative therapies for predicted non-responders to CRT therapy., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: Although the implantable cardioverter-defibrillator (ICD) remains the main therapy for Brugada syndrome (BrS), it does not reduce life-threatening ventricular arrhythmia. Based on pathophysiologic mechanisms, hydroquinidine (HQ) has been suggested for effective prevention of arrhythmia., Objective: The purpose of this study was to provide evidence-based data supporting HQ use to prevent life-threatening ventricular arrhythmia in high-risk patients with BrS., Methods: We performed a prospective multicenter randomized (HQ vs placebo) double-blind study with two 18-month crossover phases in patients with BrS and implanted with an ICD., Results: Among the 50 patients enrolled (mean age 47.0 ± 11.4 years, 42 [84%] male), 26 (52%) fully completed both phases. Thirty-four (68%) presented HQ-related side effects, mainly gastrointestinal, which led to discontinuation of the therapy in 13 (26%). HQ lengthened the QTc interval (409 ± 32 ms vs 433 ± 37 ms; P = .027) and increased repolarization dispersion as evaluated by Tpe max in precordial leads (89 ± 15 ms vs 108 ± 27 ms; P <.0001) with no significant changes in J-point elevation. During the 36-month follow-up, 1 appropriate ICD shock (0.97% event per year), 1 self-terminating ventricular fibrillation, and 1 inappropriate ICD shock occurred under placebo therapy. No arrhythmic events were reported under HQ therapy., Conclusion: Although HQ seems to be effective in preventing life-threatening ventricular arrhythmia, it could not be an alternative for ICD implantation. Its frequent side effects greatly reduce its probable compliance and therefore do not reveal a significant effect. HQ increases repolarization dispersal with no changes in BrS pattern, which could indicate a more complex action of HQ than its I to blocking effect alone., (Copyright © 2017 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Programming implantable cardioverter-defibrillators (ICDs) with a high-rate therapy strategy has proven to be effective in reducing shocks and is associated with a reduced mortality., Objective: We sought to determine the impact of a very high rate cutoff programming strategy on outcomes in patients with a primary indication for an ICD due to reduced left ventricular ejection fraction., Methods: Using data from the multicenter French DAI-PP registry, this cohort-controlled study compared outcomes in 500 patients programmed with a very high rate cutoff (VH-RATE group: monitor zone 170-219 beats/min; ventricular fibrillation zone ≥220 beats/min with 13 ± 4 detection intervals) with 1500 matched control patients programmed with 1 or 2 therapy zone. All ICDs were implanted for primary prevention in patients with systolic dysfunction. Risks of events were compared after propensity score matching of sex, age, ejection fraction, New York Heart Association class, cardiomyopathy, atrial fibrillation, and type of device., Results: After a mean follow-up of 3.6 ± 2.3 years, VH-RATE programming was associated with a reduction of appropriate therapy risk (hazard ratio [HR] 0.40; 95% confidence interval [CI] 0.31-0.51; P < .0001) and inappropriate shock (HR 0.42; 95% CI 0.27-0.63; P < .0001). It was also associated with a decreased risk of sudden cardiac death (HR 0.43; 95% CI 0.17-0.99; P = .04) as compared with patients programmed with 2 therapy zones. There was no significant difference in overall survival between the groups., Conclusion: In patients implanted with an ICD in primary prevention with left ventricular dysfunction, very high rate cutoff programming (single therapy zone ≥220 beats/min) was associated with a 60% reduction of appropriate therapies as well as inappropriate shocks, without affecting mortality., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Little data address the usefulness of defibrillation testing in patients with prolonged QRS duration, known for more advanced myocardial disease. We aimed to compare baseline characteristics and outcomes between patients who underwent defibrillation testing (DT+) and those who did not (DT-), immediately after the implantation of a cardiac resynchronization therapy with defibrillator (CRT-D)., Methods: Data from all patients with ischemic or non-ischemic cardiomyopathy implanted in primary prevention with a CRT-D in 12 French centers were considered for analysis (2002-2012)., Results: Out of the 1516 patients with DT information available, DT was performed in 958(63%) patients. Compared to DT- patients, DT+ patients presented no significant differences in terms of age (65.1±10.8 vs 64.7±10.3years, p=0.45), LVEF (25%[20.0-30.0] vs 25%[20.5-30.0], p=0.30), or etiologies of heart failure (ischemic: 49.6% vs 46.9%, p=0.32). By contrast, DT+ patients were less likely to present atrial fibrillation (25.3% vs 33.4%, p=0.001), renal insufficiency (eGFR<60ml/min in 45.3% vs 51.7%, p=0.04) and NYHA functional class≥III (68.9% vs 77.4%, p=0.0006). All of the three perioperative deaths occurred in the DT+ group and were related to DT itself. After a mean follow-up of 3.1±2.1years, the adjusted incidence of overall mortality was lower among DT+ patients (adjusted HR 0.6, 95%CI 0.4-0.7, p<0.0001). However, ICD-unresponsive sudden deaths remained very rare and no more frequently observed among DT- patients (p=0.41)., Conclusions: In our cohort, the higher (up to 40%) mortality at midterm among DT- patients is mainly reflecting their more severe cardiac disease, rather than a higher rate of ICD-unresponsive sudden death., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The lifesaving benefit of implantable cardioverter-defibrillators (ICDs) has been demonstrated. Their use has increased considerably in the past decade, but related complications have become a major concern., Objective: The purpose of this study was to assess the incidence and effect on outcomes of early (≤30 days) complications after ICD implantation for primary prevention in a large French population., Methods: We analyzed data from 5539 patients from the multicenter French DAI-PP (Défibrillateur Automatique Implantable-Prévention Primaire) registry (2002-2012) who had coronary artery disease or dilated cardiomyopathy and were implanted with an ICD for primary prevention., Results: Overall, early complications occurred in 707 patients (13.5%), mainly related to lead dislodgment or hematoma (57%). Independent factors associated with occurrence of early complications were severe renal impairment (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.17-2.37, P = .02), age ≥75 years (OR 1.01, 95% CI 1.00-1.02, P = .03), cardiac resynchronization therapy (OR 1.58, 95% CI 1.16-2.17, P = .01), and anticoagulant therapy (OR 1.28, 95% CI 1.02-1.61, P = .03). During a mean ± SD follow-up of 3.1 ± 2.3 years, 824 (15.8%) patients experienced ≥1 late complication (>30 days), and 782 (14.9%) patients died. After adjustment, early complications remained associated with occurrence of late complications (OR 2.15, 95% CI 1.73-2.66, P < .0001) and mortality (OR 1.70, 95% CI 1.34-2.17, P = .003)., Conclusion: Early complications are common after ICD implantation for primary prevention, occurring in 1 in 7 patients, and are associated with an increased risk of late complications and overall mortality. Further studies are needed to investigate the underlying mechanisms of such associations., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The nonresponder rate to cardiac resynchronization therapy (CRT) may be due to incomplete resynchronization, with dyssynchrony persisting in approximately 30% of patients. We hypothesized that CRT with triple-site ventricular stimulation (TRIV) may improve resynchronization and its outcomes., Objective: The purpose of this study was to assess the feasibility and safety of TRIV and collected data on clinical outcomes to dimension future studies., Methods: Our pilot randomized trial was designed to assess the safety and feasibility of TRIV with 2 right ventricular leads and 1 left ventricular leads compared to conventional CRT. The primary end-point was the rate of severe adverse events at 6 months. Secondary end-points included functional improvement parameters, quality-of-life (QOL) score, and changes of echocardiographic indices at 6 and 12 months in a subset of patients., Results: Seventy-six patients were enrolled at 11 centers and randomized to control or TRIV arm. All implant procedures but one were successful. At 6 months, there was no statistical difference between proportions of patients with at least 1 severe adverse event in both groups (34.1% vs 25.7%, P = .425). There also was no difference between functional improvement parameters, 6-minute walking distances (P = .40), QOL scores (P = .27), and echographic indices. At 12 months, the proportions of patients with a left ventricular ejection fraction gain of more than 5%, 10%, or 15% were significantly superior with TRIV., Conclusion: TRIV pacing is an effective and safe technique and may provide a greater benefit in ventricular remodeling than conventional CRT. Further studies are needed to assess its long-term benefit., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Syncope due to idiopathic AV block is characterized by: 1) ECG documentation (usually by means of prolonged ECG monitoring) of paroxysmal complete AV block with one or multiple consecutive pauses, without P-P cycle lengthening or PR interval prolongation, not triggered by atrial or ventricular premature beats nor by rate variations; 2) long history of recurrent syncope without prodromes; 3) absence of cardiac and ECG abnormalities; 4) absence of progression to persistent forms of AV block; 5) efficacy of cardiac pacing therapy. The patients affected by idiopathic AV block have low baseline adenosine plasma level values and show an increased susceptibility to exogenous adenosine. The APL value of the patients with idiopathic AV block is much lower than patients affected by vasovagal syncope who have high adenosine values., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D) is a genetic disease predominantly caused by desmosomal gene mutations that account for only ~50% of cases. Ryanodine receptor 2 (RYR2) gene mutations usually cause catecholaminergic polymorphic ventricular tachycardia but have been associated with a peculiar phenotype named ARVC2., Objective: We aimed to determine the prevalence and phenotype associated with RYR2 mutations in a large ARVC/D population., Methods: We analyzed the whole RYR2 coding sequence by Sanger sequencing in 64 ARVC/D probands without desmosomal gene mutations., Results: We have identified 6 rare missense variants: p.P1583S, p.A2213S, p.G2367R, p.Y2932H, p.V3219M, and p.L4670V. It corresponds to a 9% prevalence of rare RYR2 variants in the ARVC/D population (6 of 64 probands), which is significantly higher than the estimated frequency of rare RYR2 variants in controls (Fisher exact test, P = .03). Phenotypes associated with RYR2 variants were similar to desmosome-related ARVC/D, associating typical electrocardiographic abnormalities at rest, frequent monomorphic ventricular tachycardia, right ventricular dilatation, wall motion abnormalities, and fibrofatty replacement when histopathological examination was available., Conclusion: In this first systematic screening of the whole coding region of the RYR2 gene in a large ARVC/D cohort without mutation in desmosomal genes, we show that putative RYR2 mutations are frequent (9% of ARVC/D probands) and are associated with a conventional phenotype of ARVC/D, which is in contrast with previous findings. The results support the role of the RYR2 gene in conventional ARVC/D., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Although risks and life-threatening complications associated with lead extraction are well characterized, practice patterns vary regarding whether procedures are performed in an operating room (OR) or electrophysiology (EP) laboratory with cardiothoracic surgical backup., Objective: Our objective was to compare procedural outcomes and complications associated with lead extraction in the OR vs. EP laboratory., Methods: Prospectively acquired data were pooled from 2 referral centers. Lead extraction procedures were performed between 2000 and 2010, encompassing a transition phase from the OR to EP laboratory. Analyses were conducted using generalized estimating equations., Results: A total of 1,364 leads (533 OR; 831 EP laboratory) were targeted in 684 consecutive procedures, 41.2% of which were in the OR. Laser sheaths and snares were used for 699 (51.2%) and 101 (7.4%) leads, respectively. Overall, 775 (93.1%) vs. 487 (91.4%) leads were completely extracted in the EP laboratory vs. OR [odds ratio 1.3, 95% confidence interval 0.9 to 2.1]. Complications occurred in 2.24% vs. 2.84%, respectively (P = .431). Two patients died because of superior vena caval lacerations (0.29%), 1 in each group. Rapid surgical intervention was helpful in 6 (0.9%) patients [4 OR (2 subclavian vein lacerations, 1 tricuspid valve laceration, 1 tamponade); 2 EP laboratory (tamponades)], with subsequently favorable outcomes. The only independent predictor of complications was older lead age [odds ratio 1.11 per year, 95% confidence interval 1.02 to 1.20]., Conclusion: Lead extraction in the EP laboratory with surgical backup is associated with a similarly low rate of complications and mortality as procedures performed in the OR., (Copyright © 2011 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to determine the incidence, diagnostic value, and outcome of intracardiac masses observed by echocardiography after device removal. We hypothesized that these "ghosts" of leads could be associated with the diagnosis of cardiac device-related infective endocarditis (CDRIE)., Background: The echocardiographic appearance of residual floating masses in the right atrium after removal of permanent pacemakers and implantable cardioverter-defibrillators was recently described. However, the significance of these ghosts and their relationship with CDRIE are unknown., Methods: The pre-operative clinical, microbiological, and echocardiographic conditions; the indication; and the removal technique were analyzed in a retrospective cohort including all consecutive patients who underwent percutaneous lead removal. Three groups were formed according to the final diagnosis: CDRIE, local device infection, and noninfectious indications. The incidence of ghosts was compared among the 3 groups. All clinical, infectious, and extraction-related factors were studied for their association with ghosts. All patients with ghosts were followed after hospitalization., Results: Two hundred twelve patients underwent lead removal. Ghosts were observed in 17 patients (8% incidence), including 14 (16%) of 88 patients with CDRIE and 3 (5%) of 59 patients with local device infection. Ghosts were never observed among the remaining 65 noninfected patients. A significant association was found between CDRIE and the presence of a ghost (odds ratio: 7.63, 95% confidence interval: 2.12 to 27.45, p = 0.001). At 3 months, 2 patients with ghosts died suddenly, 2 underwent surgery, and 1 had a pulmonary embolism., Conclusions: Ghosts are observed in 8% of patients after percutaneous device extraction. Their presence is suggestive of device infection and seems to be associated with the diagnosis of CDRIE. The prognostic significance of such findings needs further investigation., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)