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Introduction Ventricular arrhythmic events are responsible for 50% of death in heart failure but no reliable predictive marker is known to discriminate patients at risk of fatal arrhythmia. Interestingly, familial predisposition has been reported suggesting a role of genetic factors. Objective Identify genetic markers increasing the arrhythmic risk in heart failure population. Method We prospectively included heart failure patients with left ventricular ejection fraction (LVEF) under 35% and a cardioverter defibrillator in primary prevention in 22 French centres between 2009 and 2017. Patients were followed for 72 months and divided into two groups: cases with an arrhythmic event during follow-up and controls. A Genome Wide Association Study (GWAS) was done. Single Nucleotide Polymorphisms (SNPs) genotyping was performed on Affymetrix Axiom Precision Medicine Research Array plates. Results 332 cases and 567 controls were included (86% men, mean age at implantation 52 ± 11 years). 78% of patients had ischaemic cardiopathy, 20% had dilated cardiomyopathy. Mean LVEF was 27 ± 5%. No statistical difference was found between cases and controls on clinical parameters or electrocardiographic measures. No locus shows genome-wide significant association (P Fig. 1 ). Conclusion No locus raises genome-wide significance, but several signals with a nominal p-value point to relevant genes and pathways. Replication of the GWAS is ongoing on a cohort of 156 new patients with a less severe cardiopathy implanted with a cardioverter defibrillator in secondary prevention.

Background Cardiotoxicity of some medical anti-cancer treatment and radiotherapy (RT) is well known for breast cancer (BC) patients. However, heart rhythm disorders are almost absent of research in this area, while many studies have reported cases of syncope, atrioventricular block or atrial fibrillation occurring several years after cancer treatment. Purpose To evaluate whether BC treatment, in particular RT, is associated with an increased risk of cardiac arrhythmias and conduction disorders (ACD) characterized by implantation of a pacemaker or defibrillator or hospitalization for rhythm disorders possibly associated with interventional procedures (EP Study and/or ablation). Methods Our study is based on the Echantillon Generaliste de Beneficiaires (EGB), the 1/97 random sample of Systeme National des Donnees de Sante, the French nationwide health database. Within the EGB we will identify patients treated for BC between 2008 and 2012 after excluding cases of prevalent cancer, arrhythmia or conduction disorders and identify incident cases of ACD arising post BC and until December 2017. The ACD incidence rates in the population of BC according to the BC treatment (surgery ± chemotherapy ± RT) will be estimated and compared to the national incidence rates estimated from the whole EGB population by age and calendar year standardization. Results With an initial cohort of approximately 260 000 women in the EGB, we plan to identify nearly 3 000 patients treated for BC between 2008 and 2012. Based on the estimation of PM or DEF implantations or AF cases in France, we should observe approximately 5 000 incident cases of ACD in the general population and 60 incident cases in the BC subgroup if the BC treatment has no effect. The observation of at least 85 cases instead of 60 (RR = 1.4) will have a statistical power of 80%. Conclusion The study is ongoing. It will allow quantifying the excess risk of ACD suspected for BC treatment, in particular mediastinal RT.

The frequency, characteristics and outcomes of primary prevention implantable cardioverter defibrillator (ICD) recipients who eventually undergo heart transplantation (HT) during follow-up have not been well described.In a cohort of patients with heart failure implanted with an ICD for primary prevention of sudden cardiac death, to identify those at high risk of subsequent HT and evaluate ICD usefulness.Between 2002 and 2012, 5539 patients received a primary prevention ICD across 12 centers, and were enrolled in the DAI-PP programme, including 5427 with full HT information available.During a median follow-up of 1024 days (interquartile range 484-1702 days), 176 (3.2%) patients underwent HT. Median duration between ICD implantation and HT was 484 days (IQR 169-1117 days). Among those aged≤65 years (theoretical age limit for HT registration in France), the overall incidence per 1000 person-years was 18.03 (95% confidence interval [CI]: 15.32-20.74). Left ventricular ejection fraction25% (hazard ratio [HR]: 3.43, 95% CI: 2.34-5.04; P0.0001), younger age (HR: 0.95, 95% CI: 0.93-0.96; P0.0001), New York Heart Association (NYHA) class III-IV (HR: 2.67, 95% CI: 1.79-4.00; P0.0001) and no cardiac resynchronization therapy (HR: 2.09, 95% CI: 1.39-3.14; P=0.0004) were independently associated with HT. Patients with these three characteristics (excluding age) had a 1-year HT rate of 15.2%. Incidence of appropriate ICD therapies was 92.7 per 1000 person-years for patients who underwent HT versus 76.1 for those who did not (P=0.64).The overall incidence of HT in this primary prevention population was relatively high, especially among young patients with a very low ejection fraction, an advanced NYHA class and were unsuitable for cardiac resynchronization therapy (up to 15% annually). Patients awaiting HT experienced a significant rate of appropriate ICD therapies, reinforcing the importance of specific cardiac rhythm management in these patients.

Aims The very long-term outcome of patients who survive the first few years after receiving cardiac resynchronization therapy (CRT) has not been well described thus far. We aimed to provide long-term outcomes, especially with regard to the occurrence of sudden cardiac death (SCD), in CRT patients without (CRT-P) and with defibrillator (CRT-D). Methods and results A total of 1775 patients, with ischaemic or non-ischaemic dilated cardiomyopathy, who were alive 5 years after CRT implantation, were enrolled in this multicentre European observational cohort study. Overall long-term mortality rates and specific causes of death were assessed, with a focus on late SCD. Over a mean follow-up of 30 months (interquartile range 10–42 months) beyond the first 5 years, we observed 473 deaths. The annual age-standardized mortality rates of CRT-D and CRT-P patients were 40.4 [95% confidence interval (CI) 35.3–45.5] and 97.2 (95% CI 85.5–109.9) per 1000 patient-years, respectively. The adjusted hazard ratio (HR) for all-cause mortality was 0.99 (95% CI 0.79–1.22). Twenty-nine patients in total died of late SCD (14 with CRT-P, 15 with CRT-D), corresponding to 6.1% of all causes of death in both device groups. Specific annual SCD rates were 8.5 and 5.8 per 1000 patient-years in CRT-P and CRT-D patients, respectively, with no significant difference between groups (adjusted HR 1.0, 95% CI 0.45–2.44). Death due to progressive heart failure represented the principal cause of death (42.8% in CRT-P patients and 52.6% among CRT-D recipients), whereas approximately one-third of deaths in both device groups were due to non-cardiovascular death. Conclusion In this first description of very long-term outcomes among CRT recipients, progressive heart failure death still represented the most frequent cause of death in patients surviving the first 5 years after CRT implant. In contrast, SCD represents a very low proportion of late mortality irrespective of the presence of a defibrillator.

The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)-only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients.Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF.The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia ≥30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame ≥14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee.A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p 0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge.Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731).

International audience; Background Post-procedural recovery following sub-cutaneous ICD (S-ICD) implantation is feared to be more painful and to require more prolonged hospital admission. The purpose of this study was to compare peri-procedural and short clinical outcomes of the S-ICD vs. the Transvenous ICD (TV-ICD). Methods We conducted a single-center cross-sectional study including all consecutive patients who underwent S-ICD implantation by the same operator since January 2016 and a gender and age-matched control group with all single chamber TV-ICD implanted patients over a contemporary time period. Results Thirty-one patients (sex ratio 1/5; mean age 58.7 ± 13.2 years) with S-ICD were compared to 31 matched TV-ICD patients. Duration of the implant procedure was significantly longer for the S-ICD (58.0 ± 24.4 min vs 41.7 ± 20.8 min TV-ICD, p < 0.01). Mean fluoroscopy time for the TV-ICD was 3.5 ± 3.6 min vs 0.1 ± 0.01 min for all S-ICD patients (p < 0.01). Requirement of on-demand analgesia administration, and duration of hospitalization (1.5 days for both groups; p = NS) were similar in the two groups. No peri-procedural events were reported, and after a mean follow-up of 6 months, the only complication was a pocket infection requiring reintervention in the TV-ICD group. Conclusions The S-ICD appears to be as effective and safe as the conventional single chamber TV-ICD. Duration of hospital admission and need of on-demand analgesia are also comparable for S-ICD patients. © 2017 Elsevier Ireland Ltd

Objectives This study evaluated a new algorithm relying on maximal pre-excitation. Background Prior knowledge of accessory pathway (AP) location facilitates an individual ablation strategy. Delta-wave analysis on a 12-lead electrocardiogram is recognized as crucial for predicting ablation site, but can be ambiguous at basal state. Methods An algorithm based on maximal pre-excitation, as induced by atrial pacing during an electrophysiological study, was initially developed in 132 patients with a single manifest AP. The maximally pre-excited QRS features included the global polarity in lead V1 (step 1), inferior leads (step 2), and leads V3 or I (step 3), as well as the morphology in lead II (step 4). Three investigators prospectively tested the new algorithm in 207 consecutive patients by comparing its efficacy to a control algorithm relying on basal pre-excitation. Results The accuracy, defined as the percent of patients with an exact prediction of AP location, was significantly greater with the new algorithm (90% vs. 63%; p 0.75; p Conclusions An algorithm based on maximal pre-excitation allows accurate and reproducible localization of manifest APs. When ablation is indicated, the analysis of maximal pre-excitation is a sensible approach for giving a head start in endocardial mapping.

The purpose of this patient survey was to analyse the knowledge, experiences, and attitudes regarding cardiac implantable electronic devices (CIED) in patients with pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization devices. Of the 1644 patients with CIEDs from seven European countries, 88% were over 50 years of age. Most patients (90%) knew what device they were implanted with and felt sufficiently informed about the indications for therapy. As many as 42% of patients needed additional information on the battery replacement and limitations in physical activity. The self-reported incidence of complications was 9%, and among these, a quarter of the respondents felt insufficiently informed about the possibility of complications and their management. The majority of patients (83%) were followed by face-to-face visits, which was the most commonly preferred follow-up strategy by the patients. Nearly 75% of the patients reported improved quality of life after device implantation, but about 40% had worries about their device. Less than 20% had discussed with their physician or thought about device handling in the end-of-life circumstances or end-stage disease. Notably, almost 20% of the ICD patients did not wish to answer the question regarding what they wanted to be done with their ICD in case of end-stage disease, indicating the challenges in approaching these issues. acceptedVersion

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE.

International audience; The prevalence of atrial fibrillation (AF) is increased in hyperthyroidism. The degree to which thyroid hormones affect the outcomes of left atrial (LA) ablation is still unclear. From September 2010 to September 2013, 1,095 patients who underwent LA ablation (59.7% paroxysmal AF, 32.3% persistent AF, and 8.0% LA tachycardia) had their serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) levels measured in the 48 hours before the procedure. Patients were followed until they presented the first AF relapse after a blanking period of 3 months. TSH and FT4 were assessed as predictors of arrhythmia relapse and were adjusted for possible confounders. During a mean follow-up of 12.5 ± 7.9 months, 28.9% of patients presented an atrial arrhythmia relapse. TSH was not a predictor of relapse. In contrast, after adjustment, FT4 (median = 11.8 ng/L and interquartile range 10.6 to 14.6 ng/L) remained a predictor of relapse with 15% increase per quartile (hazard ratio 1.15, 95% confidence interval 1.03 to 1.29, p = 0.014). In conclusion, FT4 levels influence the success rate of LA ablation procedures, even when in the normal range.

Pulmonary vein isolation is the cornerstone of paroxysmal atrial fibrillation ablation. Radiofrequency (RF) ablation is currently the most widespread technique. Recently, cryoballoon ablation has emerged as an alternative to RF ablation for paroxysmal atrial fibrillation. Until now there are no data from randomized trial comparing these two techniques. The purpose of this report was to review the pulmonary vein isolation acute success, the efficiency at follow-up and the safety of these two ablation strategies. Additionally, some considerations are made concerning the contact-force sensing RF catheters and the second-generation cryoballoon.

Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF), but is limited by a substantial proportion of nonresponders. We hypothesized that adding a second left ventricular (LV) lead to deliver a triple-site CRT (VWe assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact.Eighty-four recipients of a CRT system and considered as nonresponders as per clinical composite score (CCS) were enrolled in this multicenter study. They were randomized to the VPositioning of a second LV lead was successful at first (40 of 44 - 90.9%) or second (4 of 44 - 9.09%) attempt. The perioperative complication rate (infection, system explant, pneumothorax, and hematoma) was high (procedures or system-related complications for 9 patients- 20.4%). After 24 months, 35 systems (79.5%) were working properly. The multinomial logistic regression model showed that VAlthough addition of a second LV lead in CRT nonresponders is feasible with a high success rate, this approach is associated with a significant rate of severe adverse events and does not provide significant long-term clinical benefits (ClinicalTrials.gov Identifier No. NCT01059175).

Women traditionally have been and are still underrepresented in research in many important areas of cardiology, and guideline recommendations which also encompass women are mostly based on research conducted predominantly in men. However, there is plausible cause to believe that sex may have a potential influence on the benefit derived from the implantable cardioverter-defibrillators (ICD), alone or in association with cardiac resynchronization therapy. We assessed the possible relationship between sex and outcome with ICD implantation in the setting of primary prevention, by pooling the results of MUSTT, MADIT-II, DEFINITE, COMPANION, SCD-HeFT and DANISH trials in a meta-analysis. We pooled results for female and male patients separately. The results suggest that women as a group do not seem to obtain a significant survival benefit from the primary prevention ICD, contrary to men. This in turn may also have contributed to a relative underestimation of the ICD benefit among males when looking at the results in total. It is time for the medical and research communities to actively question the presumed overarching benefit of ICDs irrespective of sex and engage in systematic scientific efforts to definitively evaluate the value of this intervention in women.

ObjectiveIn patients indicated for cardiac resynchronisation therapy (CRT), the choice between a CRT-pacemaker (CRT-P) versus defibrillator (CRT-D) remains controversial and indications in this setting have not been well delineated. Apart from inappropriate therapies, which are inherent to the presence of a defibrillator, whether adding defibrillator to CRT in the primary prevention setting impacts risk of other acute and late device-related complications has not been well studied and may bear relevance for device selection.MethodsObservational multicentre European cohort study of 3008 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias, undergoing CRT implantation with (CRT-D, n=1785) or without (CRT-P, n=1223) defibrillator. Using propensity score and competing risk analyses, we assessed the risk of significant device-related complications requiring surgical reintervention. Inappropriate shocks were not considered except those due to lead malfunction requiring lead revision.ResultsAcute complications occurred in 148 patients (4.9%), without significant difference between groups, even after considering potential confounders (OR=1.20, 95% CI 0.72 to 2.00, p=0.47). During a mean follow-up of 41.4±29 months, late complications occurred in 475 patients, giving an annual incidence rate of 26 (95% CI 9 to 43) and 15 (95% CI 6 to 24) per 1000 patient-years in CRT-D and CRT-P patients, respectively. CRT-D was independently associated with increased occurrence of late complications (HR=1.68, 95% CI 1.27 to 2.23, p=0.001). In particular, when compared with CRT-P, CRT-D was associated with an increased risk of device-related infection (HR 2.10, 95% CI 1.18 to 3.45, p=0.004). Acute complications did not predict overall late complications, but predicted device-related infection (HR 2.85, 95% CI 1.71 to 4.56, pConclusionsCompared with CRT-P, CRT-D is associated with a similar risk of periprocedural complications but increased risk of long-term complications, mainly infection. This needs to be considered in the decision of implanting CRT with or without a defibrillator.

International audience; In the setting of primary prevention of sudden cardiac death, international guidelines (1) recommend an implantable cardioverter-defibrillator (ICD) for symptomatic patients (New York Heart Association [NYHA] functional class II or III) with altered left ventricular ejection fraction (LVEF) (#35%). Our objective was to compare outcomes among patients implanted with a primary prevention ICD according to whether the implantations were guideline-based or not. The DAI-PP (Primary Prevention ICD French Registry) (NCT01992458) enrolled all consecutive patients with ischemic or dilated cardiomyopathy implanted with a primary prevention ICD in 12 French centers between 2002 and 2012 (2). On-guideline patients met both basic criteria, namely, LVEF #35% and NYHA functional class II to III. Off-guideline patients did not meet at least 1 of the 2 criteria. We focused on candidates without an indication for cardiac resynchronization therapy. Vital status and causes of death were ascertained by review of hospital medical files or by communication with primary care physicians, and were corroborated with the French vital status database of the National Institute of Economic Statistics and the French Center on Medical Causes of Death. ICD programming was nonstandardized, although there was a broad consensus between centers (all except 1) concerning the use of high ventricular rates and usually 2 zones (typically ventricular tachycardia >180 beats/min, ventricular fibrillation >220 beats/ min). All data were analyzed using the SAS program version 9.4 (SAS Institute, Cary, North Carolina). Of a total of 5,539 patients enrolled in DAI-PP study, 2,538 were implanted with a single-or double-chamber ICD. Mean age was 60.2 AE 11.7 years, 1,694 (87.4%) were men, 1,379 (71.9%) had ischemic car-diomyopathy, mean LVEF was 28.2 AE 8.6%, and 853 (59.3%) had a QRS width

International audience; AIMS: Implantable cardioverter defibrillators (ICDs) are an effective primary prevention of sudden cardiac death. We examined whether dual-chamber (DC) ICDs confer a greater benefit than single-chamber (SC) ICDs, and compared the long-term outcomes of recipients of each type of device implanted for primary prevention.AbstractAIMS:Implantable cardioverter defibrillators (ICDs) are an effective primary prevention of sudden cardiac death. We examined whether dual-chamber (DC) ICDs confer a greater benefit than single-chamber (SC) ICDs, and compared the long-term outcomes of recipients of each type of device implanted for primary prevention.METHODS AND RESULTS:Between 2002 and 2012, the DAI-PP registry consecutively enrolled 1258 SC- and 1280 DC-ICD recipients at 12 French medical centres. The devices were interrogated at 4- to 6-month intervals during outpatient visits, with a focus on the therapies delivered. The study endpoints were incidence of appropriate therapies, ICD-related morbidity, and deaths from all and from specific causes. The mean age of the SC- and DC-ICD recipients was 59 ± 12 and 62 ± 11 years, respectively (P< 0.0001). The distribution of genders, New York Heart Association functional classes and glomerular filtration rates, and the rates of ischaemic vs. dilated cardiomyopathies and of defibrillation tests at implant, were similar in both study groups. The rates of periprocedural complications were 12.1% in the DC- vs. 8.8% in the SC-ICD groups (P= 0.008). Over a mean follow-up of 3.1 ± 2.2 years, pulse generators were replaced in 21.9% of the DC- vs. 13.6% of the SC-ICD group (P< 0.0001). The proportions of patients treated with ≥1 appropriate therapies (24.7 vs. 23.8%) and ≥1 inappropriate shocks (8.4 vs. 7.8%), and all-cause mortality (12.4 vs. 13.2%) were similar in both groups.CONCLUSION:In this large registry of ICD implanted for primary prevention, DC-ICDs were associated with higher rates of peri-implant complications and generator replacements, whereas the survival and rates of inappropriate shocks were similar in both groups.CLINICAL TRIAL NUMBER:NCT#01992458.Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions please email: journals.permissions@oup.com.

International audience; 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.

Aim The magnitude of benefit related to implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden cardiac death (SCD) in non-ischaemic cardiomyopathy (NICM) and ischaemic cardiomyopathy (ICM) has not been evaluated extensively in clinical practice. Methods and results Of the 5539 consecutive patients enrolled in the multicentre Defibrillateur Automatique Implantable-Prevention Primaire (DAI-PP) study (2002-12), 5485 patients (with information on underlying heart disease) were included in the present analysis: 2181 (39.8%) had NICM and 3304 (60.2%) had ICM. ICM patients were older (63.7 ±10.3 vs. 60.6 ± 12.2 years, P

AIMS: Previous studies evaluating the ability of novel oral anticoagulants (NOAC) to prevent thromboembolism in patients with non-valvular atrial fibrillation (AF) have identified differences between the efficacy and safety of the drugs tested. Whether these differences reflect differences in direct thrombin or Xa inhibition, different dosing regimens or specific aspects of each agent or trial has not yet been explored.METHODS: A search was performed on MEDLINE, EMBASE and COCHRANE, and ongoing studies were tracked on clinicaltrials.gov. Phase III randomized controlled trials of direct thrombin inhibitors (DTI) and factor Xa inhibitors (FXaI) vs. warfarin in patients with AF were eligible. Data were pooled using random-effects, according to the Mantel-Haenszel model. Sensitivity analyses were performed on DTI, FXaI, once-daily and twice-daily regimens.RESULTS: Seven studies were pooled, including a total of 80,290 patients. Both DTI and FXaI outperformed warfarin regarding stroke or systemic embolism, intracranial bleeding, total and cardiovascular mortality. No significant differences were found between DTI and FXaI or between once-daily and twice-daily regimens. Some drugs performed worse than warfarin regarding some secondary endpoints, including: edoxaban 30mg bid on ischaemic stroke, dabigatran on acute myocardial infarction, dabigatran 150mg bid and rivaroxaban 20mgod on gastrointestinal bleeding.CONCLUSION: Our pooled data do not support the hypothesis of a significant class-effect of DTI or FXaI, nor the benefit of once-daily vs. twice-daily dosing in the setting of AF, reinforcing that the choice of NOAC should be adapted to the specific patient and focused on the agent itself, rather than the pharmacological class or dosing regimen.

Aim Real-time assessment of pulmonary vein (PV) disconnection is possible using an inner circular mapping catheter during cryoablation of atrial fibrillation (AF). However, it has been recently demonstrated that such continuous monitoring may only be possible in

Real-Time Contact Force Sensing for Pulmonary Vein IsolationIntroduction The additional benefit of contact force (CF) technology during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) to improve mid-term clinical outcome is unclear. Methods and Results Eligible patients with symptomatic paroxysmal AF were enrolled in this prospective trial, comparing circular antral catheter ablation (guided by Carto 3 System, Biosense Webster) using either a new open-irrigated CF catheter (SmartTouch Thermocool, Biosense Webster) (CF group) or a non-CF open-irrigated catheter (EZ Steer Thermocool, Biosense Webster) (control group). Overall, 30 patients were enrolled in each group, with a standardized 12-month follow-up, free of antiarrhythmic therapy. Demographic, cardiovascular and anatomic characteristics were similar in both groups. Though complete PVI was eventually achieved in all cases in both groups, success using an exclusive anatomic approach was 80.0% in CF group versus 36.7% in control group (P < 0.0001). CF use was associated with significant reductions in fluoroscopy exposure (P < 0.01) and radiofrequency time (P = 0.01). The incidence rates of AF recurrence were 10.5% (95% CI, 1.38–22.4) in the CF group, and 35.9% (95% CI, 12.4–59.4) in the control group (log rank test, P = 0.04). After adjustment on potential confounders, the use of CF catheter was found to be associated with a lower AF recurrence (OR 0.18, 95% CI 0.04–0.94, P = 0.04). Conclusion Our findings suggest a potential benefit of real-time CF sensing technology, in reducing AF recurrence during the first year after PVI.

Background— Implantable cardioverter-defibrillator indications in Brugada syndrome remain controversial, especially in asymptomatic patients. Previous outcome data are limited by relatively small numbers of patients or short follow-up durations. We report the outcome of patients with Brugada syndrome implanted with an implantable cardioverter-defibrillator in a large multicenter registry. Methods and Results— A total of 378 patients (310 male; age, 46±13 years) with a type 1 Brugada ECG pattern implanted with an implantable cardioverter-defibrillator (31 for aborted sudden cardiac arrest, 181 for syncope, and 166 asymptomatic) were included. Fifteen patients (4%) were lost to follow-up. During a mean follow-up of 77±42 months, 7 patients (2%) died (1 as a result of an inappropriate shock), and 46 patients (12%) had appropriate device therapy (5±5 shocks per patient). Appropriate device therapy rates at 10 years were 48% for patients whose implantable cardioverter-defibrillator indication was aborted sudden cardiac arrest, 19% for those whose indication was syncope, and 12% for the patients who were asymptomatic at implantation. At 10 years, rates of inappropriate shock and lead failure were 37% and 29%, respectively. Inappropriate shock occurred in 91 patients (24%; 4±4 shocks per patient) because of lead failure (n=38), supraventricular tachycardia (n=20), T-wave oversensing (n=14), or sinus tachycardia (n=12). Importantly, introduction of remote monitoring, programming a high single ventricular fibrillation zone (>210–220 bpm), and a long detection time were associated with a reduced risk of inappropriate shock. Conclusions— Appropriate therapies are more prevalent in symptomatic Brugada syndrome patients but are not insignificant in asymptomatic patients (1%/y). Optimal implantable cardioverter-defibrillator programming and follow-up dramatically reduce inappropriate shock. However, lead failure remains a major problem in this population.

Background Dabigatran etexilate, a new thrombin inhibitor, has been shown to be comparable to warfarin in patients with atrial fibrillation (AF). However, there is a limited body of evidence on the efficacy and safety of using dabigatran among patients undergoing AF catheter ablation. Objective A random effects meta-analysis was performed of controlled trials comparing dabigatran and warfarin in paroxysmal/persistent AF patients undergoing catheter ablation. Methods Data sources included Medline, Embase, and Cochrane (from inception to April 2013). Three independent reviewers selected studies comparing warfarin to dabigatran. Descriptive and quantitative information was extracted from each selected study, regarding periprocedural all cause mortality, thromboembolic events and major bleeding, as well as modalities of periprocedural anticoagulation bridging. Results After a detailed screening of 228 search results, 14 studies were identified enrolling a total of 4782 patients (1823 treated with dabigatran and 2959 with warfarin). No deaths were reported. No significant differences were found between patients treated with dabigatran and warfarin as regards thromboembolic events (0.55% dabigatran vs 0.17% warfarin; risk ratios (RR)=1.78, 95% CI 0.66 to 4.80; p=0.26) and major bleeding (1.48% dabigatran vs 1.35% warfarin; RR=1.07, 95% CI 0.51 to 2.26; p=0.86). No difference was found between the 110 mg twice daily and 150 mg twice daily dabigatran dosages concerning major bleeding (0% vs 1.62%, respectively; RR=0.19, 95% CI 0.01 to 3.18; p=0.25) and thromboembolism (0% vs 0.40%, respectively; RR=0.72, 95% CI 0.04 to 12.98; p=0.82). Conclusions In the specific setting of AF catheter ablation, this first pooled analysis suggests that patients treated with dabigatran have a similar incidence of thromboembolic events and major bleeding compared to warfarin, with low event rates overall.

We have read with interest the letter by Canpolat and would like to thank him to his important remarks.1 We suggested in our study that cryoballoon ablation displayed comparable results to radiofrequency, irrespectively of pulmonary vein anatomy, assessed as number of veins on each side.2 Indeed, some previous studies have shown some discrepant results according with the pulmonary veins anatomy and the energy source. Such data with detailed anatomical evaluation like PV orientation, PV ostium …

International audience; We aimed to assess if the outcome of primary prevention implantable cardioverter defibrillators (ICDs) without cardiac resynchronization therapy is dependent on New York Heart Association (NYHA) class. Among the participants of Defibrillateur Automatique Implantable-Prevention Primaire (DAI-PP; NCT01992458) multicenter cohort study, 155 patients in NYHA class I, 504 in NYHA class II, and 188 in NYHA class III had a QRS width

Objective Among primary prevention patients with heart failure receiving cardiac resynchronisation therapy (CRT), the impact of additional implantable cardioverter defibrillator (ICD) treatment on outcomes and its interaction with sex remains uncertain. We aim to assess whether the addition of the ICD functionality to CRT devices offers a more pronounced survival benefit in men compared with women, as previous research has suggested. Methods Observational multicentre cohort study of 5307 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias having CRT implantation with (cardiac resynchronisation therapy defibrillator (CRT-D), n=4037) or without (cardiac resynchronisation therapy pacemaker (CRT-P), n=1270) defibrillator functionality. Using propensity score (PS) matching and weighting and cause-of-death data, we assessed and compared the outcome of patients with CRT-D versus CRT-P. This analysis was stratified according to sex. Results After a median follow-up of 34 months (interquartile range 22–60 months) no survival advantage, of CRT-D versus CRT-P was observed in both men and women after PS matching (HR=0.95, 95% CI 0.77 to 1.16, p=0.61, and HR=1.30, 95% CI 0.83 to 2.04, p=0.25, respectively). With inverse-probability weighting, a benefit of CRT-D was seen in male patients (HR 0.78, 95% CI 0.65 to 0.94, p=0.012) but not in women (HR 0.87, 95% CI 0.63 to 1.19, p=0.43). The excess unadjusted mortality of patients with CRT-P compared with CRT-D was related to sudden cardiac death in 7.4% of cases in men but only 2.2% in women. Conclusions In primary prevention patients with CRT indication, the addition of a defibrillator might convey additional benefit only in well-selected male patients.

Technology and clinical practice surrounding the use of the primary prevention implantable cardioverter defibrillator (ICD) are in a state of constant evolution. The purpose of the study was to test the hypothesis of significant temporal trends in characteristics and outcomes over a decade of ICD therapy.Between 2002 and 2012, 5,539 consecutive patients (age 62.5 ± 11 years, 84.9% male), with ischemic or nonischemic cardiomyopathy, implanted with a primary prevention ICD from 12 centers in France were included. Information on characteristics and outcomes (including causes of death) were evaluated over a median follow-up of 994 days (466-1,667).In addition to a shift in the type of devices implanted with a significant increase in cardiac resynchronization therapy-defibrillator (CRT-D) over time (43.6 to 60.4%, P = 0.0001), an increase in mean age (from 61.5 ± 11.6 to 63.2 ± 10.9 years, P = 0.0016), proportion of nonischemic cardiomyopathy (31.0 to 44.7%, P0.0001) and women recipients (11.4 to 15.8%, P = 0.004) was observed. A total of 1,181 patients (22.3%) received ≥1 appropriate therapy, inappropriate therapies occurred in 355 patients (6.7%) and 826 patients (15.2%) died, mainly from cardiovascular causes (49.3%). Annual mortality incidence (5.4% to 4.3%, P = 0.05), as well as incidence of appropriate therapy (10.4% to 7.1%, P = 0.0004), significantly decreased over the decade. By contrast, incidence of ICD-related late (30 days after implant) complications significantly increased (4.6 to 7.6%, P = 0.003).Our findings demonstrate significant changes in patterns of use and outcomes in primary prevention ICD over the last decade with reductions in mortality and appropriate therapies, counterbalanced by an increase in complications.

Aims The purpose of this European Heart Rhythm Association (EHRA) survey is to provide an overview of the current use of subcutaneous cardioverter defibrillators (S-ICDs) across a broad range of European centres. Methods and results A questionnaire was sent via the internet to centres participating in the EHRA electrophysiology research network. Questions included standards of care and policies used for patient management, indications, and techniques of implantation of the S-ICDs. In total, 52 centres replied to the questionnaire. More than one-fourth of the responding centres does not implant the S-ICD ( n = 14, 27%). The majority reported to have implanted

International audience; 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 +/- 10.3 years, 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 < 60 ml/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 +/- 2.1 years, 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. (C) 2016 Elsevier Ireland Ltd. All rights reserved.

Aims This ANSWER (Evalu A tio N of the S afeR mode in patients W ith a dual chamb ER pacemaker indication) sub-study assesses safety and effectiveness of SafeR™ and the impact of ventricular pacing (VP) prevention on anticipated device longevity and replacement rate. Methods and results Patients implanted for atrioventricular block (AVB, n = 310) or sinus node dysfunction (SND, n = 336) were randomly assigned to SafeR ( n = 314) or DDD ( n = 318) and followed for 36 months. Safety, median VP, estimated device longevity (mean difference, 95% confidence interval \[CI]), and anticipated replacement rates were analysed by pacing mode and implant indication. No difference in mortality, syncope, or mode intolerance was observed between randomization groups regardless of the indication. Ventricular pacing on SafeR vs. DDD was 11.5 vs. 93.6% in the overall population ( P < 0.001), 89.2 vs. 83.8% in permanent AVB ( P = 0.944), 53.5 vs. 98.2% in intermittent AVB ( P < 0.001), and 2.2 vs. 84.7% in SND ( P < 0.001). Anticipated median device longevity increased on SafeR by 14 [Q1 10; Q3 17] months [10; 17\] ( P < 0.001) in the overall population, 9 months \[−5; 22\] ( P = 0.193) in permanent AVB, 14 months \[8; 19\] ( P < 0.001) in intermittent AVB, and 14 months \[9; 19\] ( P < 0.001) in SND. In intermittent AVB and SND, prolonged estimated battery longevity translated into the prevention of one anticipated replacement in at least 23% of patients. Conclusion SafeR was effective in reducing VP in intermittent AVB and in SND. No effect was observed in permanent AVB. No safety issue was observed. Ventricular pacing reduction by SafeR translated into relevant estimated prolongation of device longevity and anticipated reduction of required replacements.

International audience; 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.

International audience; Despite the increasingly high rate of implantation of pacemakers (PM) and cardioverter-defibrillators (ICD) in elderly patients, data supporting their clinical and cost-effectiveness in this age stratum are ambiguous and contradictory. We reviewed the data regarding the applicability, safety, and effectiveness of the conventional pacing, ICD and cardiac resynchronization therapy (CRT) in elderly patients. Although peri-procedural risk may be slightly higher in the elderly, the procedure of implantation of PMs and ICDs is still relatively safe in this age group. In older patients with sinus node disease, a general consensus is that dual chamber pacing, along with the programming of an algorithm to minimise ventricular pacing is preferred. In very old patients presenting with intermittent or suspected AV block, VVI pacing may be appropriate. In terms of correcting potentially life-threatening arrhythmias, the effectiveness of ICD therapy is comparable in older and younger individuals. However, the assumption of persistent ICD benefit in the elderly population is questionable, as any advantage of the device on arrhythmic death may be attenuated by a higher total non-arrhythmic mortality. While septuagenarians and octogenarians have higher annual all-cause mortality rates, ICD therapy may remain effective in selected patients at high risk of arrhythmic death and with minimum comorbidities despite advanced age. ICD implantation among the elderly, as a group, may not be cost-effective, but the procedure may reach cost-effectiveness in those expected to live >5-7 years after implantation. The elderly patients usually experience a significant functional improvement after CRT, similar to that observed in middle-aged patients. Management of CRT non responders remains globally the same, while considering a less aggressive approach in terms of re interventions (revision of LV lead placement, addition of a RV or LV lead, LV endocardial pacing configuration). Overall, age, comorbidities and comprehensive geriatric assessment should be the decisive factor in making a decision on device implantation selection for survival and well-being benefit in elderly patients.

We read with great interest the study by Zeitler et al. [(1)][1] of patients enrolled in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy), in which the authors demonstrated that in patients with left bundle branch block, the relative

a Centre cardiologique du Nord, 32—36, rue des Moulins-Gemeaux, 93207 St. Denis, France b University Hospital, 76031 Rouen, France c Clinique Pasteur, 31076 Toulouse, France d Hopital de Hautepierre, 67000 Strasbourg, France e University Hospital, 35033 Rennes, France f University Hospital, 38043 Grenoble, France g La Timone University Hospital, 13385 Marseille, France h Nouvelles cliniques nantaises, 44277 Nantes, France i University Hospital, 80054 Amiens, France j University Hospital, 59037 Lille, France k Lariboisiere University Hospita

Background Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is limited by a high proportion of nonresponders. Attempts have been made, in small studies, to increase the number of stimulation sites to optimize the resynchronization therapy. V 3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second LV lead in nonresponders after at least 6 months of standard biventricular stimulation. Methods and Results A total of 84 patients will be enrolled in 11 French medical centers. Patients will be randomly assigned to receive either an additional LV lead (test group) or to keep their current stimulation system unchanged (control group). Enrollment is planned to begin in March 2010 and is expected to end within 1 year. The primary study end point will be the HF clinical composite score evaluated at 1 year follow-up. Secondary end points include degree of echocardiographic reverse remodeling and changes in clinical measurements. Conclusions The V 3 trial will examine the clinical benefit conferred by the addition of a second LV lead in nonresponders to standard CRT.

Decreased autonomic function is known to be predictive of death, especially in chronic heart failure (CHF) patients. We sought to report mid-term heart rate and heart rate variability (HRV) changes after cardiac resynchronization therapy (CRT), using a continuous device-based measurement, which should facilitate daily management of CHF patients. Stored data were retrieved for 92 CHF patients who were enrolled in a prospective multicentre study and received a CRT pacemaker capable of continuous assessment of HRV. This parameter was recorded daily as a footprint plot, a graphic visualization of the distribution of HRV. Decreases in mean heart rate (from 75.4±11.7 to 71.4±8.4 bpm) and increases in HRV as attested by footprint area (from 33.5±13.5% to 40.7±14.5%) were statistically significant after 12 months follow-up ( p p

RESUME Malgre les progres therapeutiques actuels la mortalite est elevee dans l’insuffisance cardiaque atteignant pour les formes les plus graves, 20 % par an. Plus de 60 % des deces dans les dysfonctions ventriculaires gauches sont subits dus a une tachycardie ou fibrillation ventriculaire, 15 a 20 % a une bradyarythmie, 18 % environ a une defaillance irreversible de la pompe ventriculaire. Une dysfonction ventriculaire gauche severe, avec une fraction d’ejection egale ou inferieure a 35 % comporte de nombreuses modifications structurales et fonctionnelles, substrats arythmogenes qui sont des facteurs de rentrees, d’automatismes anormaux. L’activation neuro hormonale deletere facilite les arythmies et predispose a la mort subite. Les defibrillateurs automatiques (DAI) implantes en prevention secondaire ou primaire ont fait la preuve de leur efficacite reduisant la mortalite subite de plus de 50 %. Il est important d’evaluer chez un patient presentant une alteration majeure de la fonction ventriculaire le risque arythmique et de selectionner les patients qui tireront le plus grand benefice de ces dispositifs. Cette etude fondee sur notre experience et l’analyse de la litterature fait le point sur la recherche de marqueurs de risque basee sur l’etude du systeme nerveux autonome (variabilite sinusale, sensibilite du baroreflexe) la dynamique de la repolarisation, la dispersion ventriculaire (alternance de T et dispersion de l’espace QT, turbulence de la frequence cardiaque, les potentiels tardifs ventriculaires) de la stimulation ventriculaire programmee. La combinaison de ces marqueurs et des donnees etiologiques et cliniques peut permettre de definir les indications electives d’implantation de DAI et de stimulateurs qui associes au traitement medical optimal, ont reduit la mortalite globale et subite dans des etudes multicentriques randomisees.