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BackgroundRisk-benefit for cardiac resynchronisation therapy (CRT) defibrillator (CRT-D) over CRT pacemaker remains a matter of debate. We aimed to identify patients with a poor outcome within 1 year of CRT-D implantation, and to develop a CRT-D Futility score.MethodsBased on an administrative hospital-discharge database, all consecutive patients treated with prophylactic CRT-D implantation in France (2010–2019) were included. A prediction model was derived and validated for 1-year all-cause death after CRT-D implantation (considered as futility) by using split-sample validation.ResultsAmong 23 029 patients (mean age 68±10 years; 4873 (21.2%) women), 7016 deaths were recorded (yearly incidence rate 7.2%), of which 1604 (22.8%) occurred within 1 year of CRT-D implantation. In the derivation cohort (n=11 514), the final logistic regression model included—as main predictors of futility—older age, diabetes, mitral regurgitation, aortic stenosis, history of hospitalisation with heart failure, history of pulmonary oedema, atrial fibrillation, renal disease, liver disease, undernutrition and anaemia. Area under the curve for the CRT-D Futility score was 0.716 (95% CI: 0.698 to 0.734) in the derivation cohort and 0.692 (0.673 to 0.710) in the validation cohort. The Hosmer-Lemeshow test had a p-value of 0.57 suggesting accurate calibration. The CRT-D Futility score outperformed the Goldenberg and EAARN scores for identifying futility. Based on the CRT-D Futility score, 15.9% of these patients were categorised at high risk (predicted futility of 16.6%).ConclusionsThe CRT-D Futility score, established from a large nationwide cohort of patients treated with CRT-D, may be a relevant tool for optimising healthcare decision-making.

Aims Cardiac resynchronization therapy (CRT) is highly effective in dilated cardiomyopathy (DCM) patients with impaired left ventricular ejection fraction (LVEF) and left bundle block branch. In cardiac amyloidosis (CA) patients, left ventricular dysfunction and conduction defects are common, but the potential of CRT to improve cardiac remodelling and survival in this particular setting remains undefined. We investigated cardiovascular outcomes in CA patients after CRT implantation in terms of CRT echocardiographic response and major cardiovascular events (MACEs). Methods and results Our retrospective study included 47 CA patients implanted with CRT devices from January 2012 to February 2020, in nine French university hospitals (77 ± 6 years old, baseline LVEF 30 ± 8%) compared with propensity‐matched (1:1 for age, LVEF at implantation, and CRT indication) DCM patients with a CRT device. CA patients had lower rates of CRT response (absolute delta LVEF ≥ 10%) compared with DCM patients (36% vs. 70%, P = 0.002). After multivariate Cox analysis, CA was independently associated with MACE (hospitalization for heart failure/cardiovascular death) [hazard ratio (HR) 3.73, 95% confidence interval (CI) 1.85–7.54, P

Catheter ablation (CA) is a well-established treatment of atrial fibrillation (AF). Data-driven cluster analysis is able to better distinguish prognostically-relevant phenotype clusters among patients with AF. We performed a hierarchical cluster analysis in a cohort of AF patients undergoing a first CA and evaluate associations between identified clusters and recurrences of arrhythmia following ablation. The study included 209 AF patients treated with CA. A total of 3 clusters with distinct characteristics were identified. Recurrences at 1 year occurred in 27.2% in Cluster 1, 43.2% in Cluster 2 and 60.9% in Cluster 3 (P < 0.0001). Cluster classification was independently associated with arrhythmia recurrences (HR 1.58, 95% CI 1.01-2.49, P = 0.046) after adjustment for age, CHA2DS2-VASc score, left atrial volume, type of atrial fibrillation and ejection fraction. To concluded, cluster analysis identified 3 statistically-driven groups among AF patients treated with CA with different risks for arrhythmia recurrences. Catheter ablation (CA) is a well-established treatment of atrial fibrillation (AF). Data-driven cluster analysis is able to better distinguish prognostically-relevant phenotype clusters among patients with AF. We performed a hierarchical cluster analysis in a cohort of AF patients undergoing a first CA and evaluate associations between identified clusters and recurrences of arrhythmia following ablation. The study included 209 AF patients treated with CA. A total of 3 clusters with distinct characteristics were identified. Recurrences at 1 year occurred in 27.2% in Cluster 1, 43.2% in Cluster 2 and 60.9% in Cluster 3 (P < 0.0001). Cluster classification was independently associated with arrhythmia recurrences (HR 1.58, 95% CI 1.01-2.49, P = 0.046) after adjustment for age, CHA2DS2-VASc score, left atrial volume, type of atrial fibrillation and ejection fraction. To concluded, cluster analysis identified 3 statistically-driven groups among AF patients treated with CA with different risks for arrhythmia recurrences.

Leadless pacing has emerged as an alternative to conventional transvenous pacemakers to mitigate the risks of pocket- and lead-related complications but its use remains controversial in young adults mostly because experience in this patient population is limited. We sought to examine the feasibility and safety of implanting leadless single chamber pacemakers in young adults.This multicenter, retrospective, observational study sought to evaluate the safety, efficacy, and electrical performance of the Micra VR Transcatheter Pacemaker System (Medtronic) in patients between 18 and 40 years who underwent implantation of a leadless pacemaker for any indication at the university medical centers of Bordeaux, Clermont-Ferrand, Toulouse, and Tours (France), between 2015 and 2021. The primary safety endpoint was freedom from system-related or procedure-related major complications at 6 months. The primary efficacy endpoint was the combination of a low (≤2 V) and stable (increase within 1.5 V) pacing capture threshold at 6 months.Leadless pacemaker implantation was successful in all 35 patients. At six months, safety endpoint was met for 35 (100%) and efficacy endpoint for 34 (97%) patients. During a follow-up of 26±15 months (range: 6-60 months), Safety endpoint remained 100% and efficacy endpoint was 94%. Leadless pacemaker retrieval was not required in any patient. Approximately one third of patients (n=13, 37%) had40% ventricular pacing burdens at one year, including all 10 patients with a complete AV block but also 3 patients with normal AV conduction during implantation. One patient reported symptoms of pacemaker syndrome which was confirmed using Holter recording and successfully treated using reprogramming.In this observational study, leadless pacemakers demonstrated favorable short- and intermediate-term safety and effectiveness in young adults. This article is protected by copyright. All rights reserved.

Aims Several reports suggest that illicit drug use may be a major cause of acute myocardial infarction (AMI) independently of smoking habits and associated with a poorer prognosis. The aim of our study was to evaluate the impact of illicit drug use on (i) the risk of AMI and (ii) its prognosis. Methods and results This French longitudinal cohort study was based on the administrative hospital-discharge database from the entire population. First, we collected data for all patients admitted in hospital in 2013 with at least 5 years of follow-up to identify potential predictors of AMI. In a second phase, we collected data for all patients admitted with AMI from January 2010 to December 2018. We identified patients with a history of illicit drug use (cannabis, cocaine, or opioid). These patients were matched with patients without illicit drug use to assess their prognosis. In 2013, 3 381 472 patients were hospitalized with a mean follow-up of 4.7 ± 1.8 years. In multivariable analysis, among all drugs under evaluation, only cannabis use was significantly associated with a higher risk of AMI [HR 1.32 (95% CI 1.09–1.59), P = 0.004]. Between January 2010 and December 2018, we then identified 738 899 AMI patients. Among these patients, 3827 (0.5%) had a known history of illicit drug use. These patients were younger, most often male and had less comorbidities. After 1:1 propensity score matching, during a mean follow-up of 1.9 ± 2.3 years, there was no significant difference between patients without illicit drug use and patients with illicit drug use regarding all-cause death, cardiovascular death, stroke, or heart failure. Conclusion In a large and systematic nationwide analysis, cannabis use was an independent risk factor for the incidence of AMI. However, the prognosis of illicit drug users presenting with AMI was similar to patients without illicit drug use.

We report a case report of a 68-year-old man with chemotherapy-induced cardiomyopathy and uncontrolled permanent atrial fibrillation. Cardiac resynchronization therapy implantation and atrioventricular junction ablation were planned. DF-1 single chamber defibrillator was connected to lead's defibrillation and a lead destinated to left bundle branch area pacing. This system leads to reduce costs by one-third, improve battery longevity, and provide a more physiological pacing.

Left bundle branch area pacing (LBBAP) has emerged as a promising technique to deliver cardiac resynchronization therapy (CRT). However, safety and efficacy of ventricular arrhythmia sensing via the left bundle in implantable cardioverter-defibrillator (ICD) recipients remain unclear. We sought to evaluate the feasibility of a single LBBAP lead connected to a dual-chamber ICD in patients indicated with a CRT-D implantation.The CROSS-LEFT pilot study prospectively included 10 consecutive patients with a reduced ejection fraction and a complete left bundle branch block, indicated with a prophylactic CRT-D. A DF-1 lead was implanted at the right ventricular (RV) apex, and an LBBAP lead through the interventricular septum. Ventricular fibrillation was induced at implantation in both conventional (RV) and left bundle branch area sensing configurations. The latter was the final sensing configuration, and patients were implanted with a dual-chamber DF-1 ICD connected to the atrial lead (RA port), the LBBAP lead (RV IS-1 port), and the defibrillation lead (RV DF-1 port), the IS-1 pin being capped. Atrioventricular delay was optimized to ensure fusion between LBBAP and native conduction from the right bundle. Patients were followed during 6 months.No difference between both configurations was observed regarding R-wave sensing in sinus rhythm (p = 0.22), ventricular fibrillation median interval detection (p = 1.00), or total induced episode duration (p = 0.78). LBBAP resulted in a significant reduction of median QRS width from 164 to 126 ms (p = 0.002). Median ventricular sensing significantly improved from 9.7 at implantation to 18.8 mV at 6 months (p = 0.01). Median LVEF also significantly improved from 29 to 44% at 6 months (p = 0.002).Ventricular arrhythmia sensing and defibrillation can be performed via a single LBBAP lead connected to a dual-chamber ICD, and is associated with significant electromechanical reverse remodeling.NCT05102227 In patients presenting with left bundle branch block and left ventricular systolic dysfunction, a left bundle branch area pacing lead connected to a DF-1 dual-chamber implantable cardioverter-defibrillator provides safe ventricular arrhythmia sensing and efficient electro-mechanical resynchronization.

Aims FRench Attitude reGistry in case of ICD LEad replacement (FRAGILE) registry was set-up to describe the attitude in different French institutions in case of implantable cardioverter-defibrillator (ICD) lead replacement, extraction, or abandonment and to compare outcomes in both groups. Methods and results Prospective observational study comparing two attitudes in case of ICD lead replacement, extraction, or abandonment. Primary endpoint describes the attitude in different French centres, collect parameters that may influence the decision. Secondary endpoint compares early and mid-term (2 years) complications in both groups. Between April 2013 and April 2017, 552 patients were included in 32 centres. 434 (78.6%) were male, mean patient’s age was 60.3 ± 14.4 years. In 56.9% of the cases, the decision was to explant the lead. Patients in the extraction group were younger than in the abandonment group (56.7 ± 14.5 vs. 65 ± 12.7 P Conclusion In this registry, the strategy in case of non-infected ICD lead replacement was mainly influenced by patient’s age and comorbidities and lead dwelling time. No difference was observed in outcomes in both strategies.

Aims Risk stratification of sudden cardiac arrest (SCA) in Brugada syndrome (Brs) remains the main challenge for physicians. Several scores have been suggested to improve risk stratification but never replicated. We aim to investigate the accuracy of the Brs risk scores. Methods and results A total of 1613 patients [mean age 45 ± 15 years, 69% male, 323 (20%) symptomatic] were prospectively enrolled from 1993 to 2016 in a multicentric database. All data described in the risk score were double reviewed for the study. Among them, all patients were evaluated with Shanghai score and 461 (29%) with Sieira score. After a mean follow-up of 6.5 ± 4.7 years, an arrhythmic event occurred in 75 (5%) patients including 16 SCA, 11 symptomatic ventricular arrhythmia, and 48 appropriate therapies. Predictive capacity of the Shanghai score (n = 1613) and the Sieira (n = 461) score was, respectively, estimated by an area under the curve of 0.73 (0.67–0.79) and 0.71 (0.61–0.81). Considering Sieira score, the event rate at 10 years was significantly higher with a score of 5 (26.4%) than with a score of 0 (0.9%) or 1 (1.1%) (P Conclusions In the largest cohort of Brs patient ever described, risk scores do not allow stratifying the risk of arrhythmic event in intermediate-risk patient.

International audience; Background: Women with congenital heart disease at high risk for sudden cardiac death have been poorly studied thus far.Objectives: The aim of this study was to assess sex-related differences in patients with tetralogy of Fallot (TOF) and implantable cardioverter-defibrillators (ICDs).Methods: Data were analyzed from the DAI-T4F (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator) cohort study, which has prospectively enrolled all patients with TOF with ICDs in France since 2010. Clinical events were centrally adjudicated by a blinded committee.Results: A total of 165 patients (mean age 42.2 ± 13.3 years) were enrolled from 40 centers, including 49 women (29.7%). Among the 9,692 patients with TOF recorded in the national database, the proportion of women with ICDs was estimated to be 1.1% (95% CI: 0.8%-1.5%) vs 2.2% (95% CI: 1.8%-2.6%) in men (P < 0.001). The clinical profiles of patients at implantation, including the number of risk factors for ventricular arrhythmias, were similar between women and men. During a median follow-up period of 6.8 years (IQR: 2.5-11.4 years), 78 patients (47.3%) received at least 1 appropriate ICD therapy, without significant difference in annual incidences between women (12.1%) and men (9.9%) (HR: 1.22; 95% CI: 0.76-1.97; P = 0.40). The risk for overall ICD-related complications was similar in women and men (HR: 1.33; 95% CI: 0.81-2.19; P = 0.30), with 24 women (49.0%) experiencing at least 1 complication.Conclusions: Our findings suggest that women with TOF at high risk for sudden cardiac death have similar benefit/risk balance from ICD therapy compared with men. Whether ICD therapy is equally offered to at-risk women vs men warrants further evaluation in TOF as well as in other congenital heart disease populations. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574)

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).This study aimed to analyze the outcome of patients with an ER pattern and syncope and to evaluate the factors predictive of VAs.Over a period of 5 years, we enrolled 143 patients with an ER pattern and syncope in a multicenter prospective registry.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.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.

Background and Purpose: Patients with hypertrophic cardiomyopathy (HCM) have high risk of ischemic stroke (IS), especially if atrial fibrillation (AF) is present. Improvements in risk stratification are needed to help identify those patients with HCM at higher risk of stroke, whether AF is present or not. Methods: This French longitudinal cohort study from the database covering hospital care from 2010 to 2019 analyzed adults hospitalized with isolated HCM. A logistic regression model was used to construct a French HCM score, which was compared with the HCM Risk-CVA and CHA 2 DS 2 -VASc scores using c-indexes and calibration analysis. Results: In 32 206 patients with isolated HCM, 12 498 (38.8%) had AF, and 2489 (7.7%) sustained an IS during follow-up. AF in patients with HCM was independently associated with a higher risk for death (hazard ratio, 1.129 [95% CI, 1.088–1.172]), cardiovascular death (hazard ratio, 1.254 [95% CI, 1.177–1.337]), IS (hazard ratio, 1.210 [95% CI, 1.111–1.317]), and other major cardiovascular events. Independent predictors of IS in HCM were older age, heart failure, AF, prior IS, smoking and poor nutrition (all P 2 DS 2 -VASc score and a French HCM score, all c-indexes were 0.65 to 0.70, with good calibration. Among patients with AF, the CHA 2 DS 2 -VASc score had marginal improvement over the HCM Risk-CVA score but was less predictive compared with the French HCM score ( P =0.001). In patients without AF, both HCM Risk-CVA score and the French HCM score had significantly better prediction compared with CHA 2 DS 2 -VASc (both P Conclusions: Patients with HCM have a high prevalence of AF and a significant risk of IS, and the presence of AF in patients with HCM was independently associated with worse outcomes. A simple French HCM score shows good prediction of IS in patients with HCM and clinical usefulness, with good calibration.

BACKGROUND Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated. OBJECTIVE The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant. METHODS We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR. RESULTS Among 1795 patients with AC status available, 585 were not on AC, 795 had AC interrupted, and 415 had AC continued during Micra implant. Non-AC patients tended to be younger, with less history of atrial fibrillation and chronic obstructive pulmonary disease, and more history of dialysis than interrupted and continued patients. The implant success rate was similar for all groups (99.1%-99.8%). Through 30 days postimplant, the overall major complication rate was 3.1% for the non-AC group, 2.6% for the interrupted group, and 1.5% for the continued group. The combined rate for any vascular or pericardial effusion adverse event did not differ significantly among AC strategies (6.5%, 4.8%, and 3.6%, respectively). CONCLUSION Implant of Micra seems to be safe and feasible regardless of an interrupted or continued periprocedural oral AC strategy, with no increased risk of perforation or vascular complications.

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; P =0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19–10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 ( P =0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96–40.95]). Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03837574.

Despite a strong genetic background, Brugada syndrome (BrS) mainly affects middle-age patients. Data are scarce in the youngest and oldest age groups.The purpose of this study was to describe the clinical characteristics and variations in rhythmic risk in BrS patients according to age.Consecutive BrS patients diagnosed in 15 French tertiary centers in France were enrolled from 1993 to 2016 and followed up prospectively. All of the clinical and ECG data were double reviewed.Among the 1613 patients enrolled (age 45 ± 15 years; 69% male), 3 groups were defined according to age (52 patients17 years; 1285 between 17 and 59 years; and 27660 years). In the youngest patients, we identified more female gender (42%), diagnosis by familial screening (63%), previous sudden cardiac death (15%), SCN5A mutation (62%) sinus dysfunction (8%) and aVR sign (37%) (P.001). The oldest patients had the same clinical characteristics except for gender (40% women; P.001). During median follow-up of 5.5 [2.1, 10.0] years, 91 patients experienced an arrhythmic event, including 7 (13%) in the youngest patients, 80 (6%) in middle-age patients, and 4 (1%) in the oldest patients. Annual event rates were 2.1%, 1%, and 0.3%, respectively (P.01).Age on diagnosis changes the clinical presentation of BrS. Although children are identified more during familial screening, they present the highest risk of sudden cardiac death, which is an argument for early and extensive familial screening. The oldest patients present the lowest risk of SCD.

International audience; BACKGROUND Conduction abnormalities following transcatheter aortic valve replacement (TAVR) often may require permanent pacemaker implantation (PPM).OBJECTIVE The purpose of this study was to evaluate outcomes associated with PPM after a TAVR procedure in a large, nationwide-level population.METHODS Based on the administrative hospital discharge database, the incidence of all-cause death, cardiovascular death, and hospitalization for heart failure (HF) were retrospectively collected, based on the presence or absence of PPM, in the first 30 days following all TAVRs in France from 2010 to 2019.RESULTS Among 520,662 patients hospitalized for aortic stenosis, 49,201 were treated with TAVR. A total of 29,422 patients had follow-up >= 6 months (median 1.7 years), 22% already had PPM at baseline, and 22% underwent PPM within the first 30 days post-TAVR. Adjusted hazard ratios for the combined risk of all-cause death and hospitalization for HF, during the whole follow-up, were higher in both patients with a previous PPM and in those implanted within 30 days (hazard ratio [95% confidence interval] 1.12 [1.07-1.17] and 1.11 [1.06-1.16], respectively).CONCLUSION PPM at baseline and within 30 days post-TAVR are independently associated with higher mortality and HF hospitalization during follow-up.

Introduction/Background By using an entirely extra-thoracic lead placement, subcutaneous implantable cardioverter–defibrillators (S-ICD) were designed to avoid lead-related complications of single-chamber transvenous implantable cardioverter-defibrillators (VVI ICD). Purpose Our objective was to assess and compare outcomes following first VVI ICD or S-ICD implantation in an exhaustive nationwide matched cohort. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2010 to September 1, 2020, who underwent a VVI ICD or S-ICD implantation were included. Patients with a previous pacemaker or ICD or with a history of infective endocarditis were excluded. Results 21,667 patients were included in the cohort, 19,493 patients had a transvenous VVI ICD and 2,174 had a subcutaneous ICD. Mean follow-up was 28.8±31.8 months. S-ICD patients was associated with higher rate of all-cause death (HR: 1.684, 95% CI: 1.309–2.165, p Using propensity score, 1,582 patients with VVI ICD were matched 1:1 with S-ICD patients. Mean follow-up was 4.5±7.2 months. In the matched analysis, there were no significant differences in all-cause death (HR: 1.090, 95% CI: 0.728–1.633, p=0.68) and cardiovascular death (HR: 1.167, 95% CI: 0.603–2.260, p=0.65) between the two groups. A trend toward a lower risk of infective endocarditis in the S-ICD group was also observed without reaching significance (HR: 0.219, 95% CI: 0.047–1.017, p=0.053). A sensitivty analysis in patients with coronary artery disease in the matched cohort was performed. 1,024 patients had a VVI ICD and 977 had a S-ICD. Same trends were observed without significant differences in all-cause death (HR: 0.966, 95% CI: 0.605–1.543, p=0.88) and cardiovascular death (HR: 1.307, 95% CI: 0.610–2.799, p=0.49). Conclusion Our nationwide study highlighted a higher risk of all-cause death in patients treated with subcutaneous which however was not statistically significant after propensity score matching. No differences regarding cardiovascular mortality was found. An interesting trend toward diminution of infective endocarditis was also observed without reaching significancy. Funding Acknowledgement Type of funding sources: None. Baseline characteristicsCardiovascular death

Introduction/Background Leadless ventricular permanent pacemakers (leadless VVI, LPM) were designed to reduce lead-related complications of conventional VVI pacemakers (CPM). Purpose The aim of our study was to assess and compare real-life clinical outcomes within the first 30 days and during a mid-term follow-up with the two techniques at a nationwide level. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from for the entire population. All adults (age ≥18 years) hospitalized in French hospitals From January 1, 2017 to September 1, 2020, who underwent a first LPM or CPM implantation were included. Importantly, patients with dual chamber pacemaker were not included in our study. Results Of 42,315 patients included in the cohort, 40,828 patients (96%) had a CPM and 1,487 had a LPM. Using propensity score, 1,344 patients with CPM were adequately matched in a 1:1 fashion with LPM patients. Clinical outcomes at day 30 In the unmatched population, within the 30 days after implantation, patients with LPM had a lower rate of all-cause mortality (OR: 0.635, 95% CI: 0.527–0.765, p In the matched population, LPM implantation was still significantly associated with a lower rate of all-cause death (OR: 0.583, 95% CI: 0.456–0.744, p Clinical outcomes during mid-term follow-up In the unmatched patients, mean follow-up was 8.6±10.5 months. Annual incidence of all-cause death was high in both groups, and significantly higher in the LPM group than in CPM group (31%/year vs. 20%/year, p In the matched patients, mean follow-up was 6.2±8.7 months. All-cause death, cardiovascular death and infective endocarditis were not significantly different between groups. Conclusion Mortality is high among unselected patients implanted with ventricular permanent pacemakers, whether leadless or conventional pacemaker are used. Implantation of leadless pacemakers seems to be a safe procedure in this high-risk population, with better outcomes at 1 month. Mid-term outcomes appear relatively similar in LPM and CPM patients. Funding Acknowledgement Type of funding sources: None. Central illustration

Background The Micra pre-market study showed that the Micra transcatheter pacing system could be safely implanted in patients with pacing indications. Patients with pre-existing cardiac implantable electronic devices (CIED) were excluded from this clinical trial; however, this group of patients might benefit from a leadless pacemaker especially when a lead fails or after incidence of system-related infections. Objective To determine the outcome of patients with a pre-existing CIED or lead that remains in situ at the time of Micra implant attempt. Methods Patients who had a pre-existing CIED and/or lead at the time of Micra implantation attempt were identified from the Micra Post-Approval Registry and Micra Acute Performance studies. Baseline characteristics were summarized, and a Fine-Gray competing risk model was used to compare risk for major complication through 24 months for patients with and without a pre-existing CIED. Results Of the 2323 patients included in the analysis, 111 patients had a pre-existing CIED or lead at the time of Micra implantation attempt that remained in situ. Types of pre-existing devices included 81 pacemakers (45 single chamber, 32 dual chamber, 4 of unknown type), 10 ICDs (2 single chamber, 2 dual chamber, 6 unknown type), 10 CRT devices (6 CRT-P, 4 CRT-D), 3 generators of unknown type, and 7 patients had only leads remaining. Patients with pre-existing devices were younger and less likely to have a pacing indication of bradyarrhythmia with atrial fibrillation compared to patients without pre-existing devices (p99% for both cohorts. Mean follow-up duration was 21.2±14.3 months (range 0–56) for pre-existing devices patients and 23.3±15.8 months (range 0–62) for other patients. The rate of major complications through 24 months was 1.8% for patients with and 3.8% for patients without prior devices (p=0.36). There were no major complications related to device malfunction or device-device interaction. There were 6 system revisions in 4 patients with preexisting devices and 52 revisions in 51 patients without preexisting devices. Pacing thresholds for patients with and without prior devices were similar at implant (0.72 and 0.63, respectively; p=0.31) and remained stable through 12 months. Conclusion Micra can be safely and successfully implanted in patients with a pre-existing CIED remaining in situ. It should be considered a treatment option for patients in whom CIED extraction may be deemed high risk. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic, Inc. Risk of major complications

Background There is little evidence to support selection of heart rate control therapy in patients with permanent atrial fibrillation (AF), in particular those with coexisting heart failure. In the recent RATE-AF trial that included patients with permanent AF and symptoms of heart failure, treatment with low-dose digoxin or bisoprolol did not result in statistically significant difference in quality of life at 6 months. The purpose of the study was to analyse whether the clinical outcomes may differ among unselected patients with permanent AF treated with digoxin or beta-blocker seen in daily practice. Methods All patients with atrial fibrillation (AF) seen in an academic institution were identified in a database. We examined the clinical course of 8962 consecutive patients with AF seen over a 10-year period. The adverse outcomes were investigated during follow-up and we identified the causes of death. Among them 1,787 patients had the RATE-AF criteria of inclusion (permanent AF, age ≥60 and NYHA ≥2), of whom 512 patients (29%) were treated with beta-blocker alone, 425 (24%) were treated with digoxin alone and 237 (13%) were treated with both a beta-blocker and digoxin. Outcomes in patients treated with beta-blocker alone or digoxin alone were compared after 1:1 propensity-score matching. Results After propensity score matching, 270 patients treated with beta-blocker were matched 1:1 with 270 patients treated with digoxin. In these patients (age 79±8 years, CHA2DS2VASc score 4.0±1.3), 125 deaths were recorded during a follow-up of 2.2±2.7 years (median 1.1, interquartile 0.1–3.5 years, yearly rate of death 10.4%) including 72 cardiovascular deaths (yearly rate 6.0%). Major clinical events (all-cause death, myocardial infarction, ischemic stroke or major bleeding) were recorded in 192 patients (yearly rate 19.1%). In this matched analysis, risk was not statistically significant in the 2 groups for all-cause death (HR 0.95, 95% CI 0.67–1.35 for beta-blocker use vs digoxin use), cardiovascular death (HR 1.23, 95% CI 0.77–1.96 for beta-blocker use vs digoxin use) or major clinical events (HR 0.98, 95% CI 0.74–1.31 for beta-blocker use vs digoxin use). Conclusion Our analysis included more patients and had a longer follow-up than in the RATE-AF trial, resulting in a 10-fold higher number of clinical events. We found that among patients with permanent AF and symptoms of HF, there was no statistically significant difference in the risk of all-cause death, cardiovascular mortality and major clinical events between those treated with digoxin or beta-blocker. Concerns regarding the use of digoxin, such as the narrow therapeutic window and drug interactions, were not issues resulting in worse clinically relevant cardiovascular outcomes with the approach used in the current study. Funding Acknowledgement Type of funding sources: None.

Background Patients with hypertrophic cardiomyopathy (HCM) have high risk of death related to cardiovascular (CV) death. Improvements in risk stratification are needed to help identify those HCM patients at higher risk of all-cause death and cardiovascular death. Methods This French longitudinal cohort study from the database covering hospital care from 2010 to 2019 analyzed adultshospitalized with isolated HCM. The overall sample of 52,091 patients was randomly partitioned into derivation (n=26,067) and validation (n=26,024) populations. A logistic regression model was used to construct HCM death and CV-death scores in the derivation sample, which were compared to the Charlson index, Frailty index and CHA2DS2VASc scores using c-indexes and calibration analysis. Results In 52,091 patients with isolated HCM, 12,676 (24.0%) died during follow-up of 3.0±2.8 years (median 2.3, interquartile range 0.4–5.0). Rate of all-cause death was 8.10%/year (7.96–8.24) and was 2.76%/year (2.68–2.84) for CV death.Independent predictors of CV death in HCM were older age, diabetes mellitus, heart failure, history of pulmonary edema, atrial fibrillation, ventricular tachycardia or fibrillation, ischemic stroke, while smoking and poor nutrition were associated with better survival (all p Conclusion HCM patients have a high risk of all-cause and CV mortality. Independent predictors of CV-mortality in HCM were used to derive and validate a simple risk prediction model (French HCM CV-mortality score) which performed better than clinical scores, Charlson Index and Frailty Index; showing the best clinical usefulness, with good calibration. Funding Acknowledgement Type of funding sources: None.

Introduction Evidence from randomized trials suggests that, in patients with sinus-node dysfunction (SND), physiologic pacing (dual-chamber, DDD) may be superior to single-chamber (ventricular, VVI) pacing because it is associated with lower risks of atrial fibrillation and stroke, better exercise capacity and lower risk of pacemaker syndrome. However, benefits on mortality and risk of heart failure have not been demonstrated and these issues have not been fully evaluated in large “real life” analyses. The aim of our study was to assess and compare clinical outcomes within the first 30 days and during a longer-term follow-up with the two types of pacing at a nationwide level for patients with SND. Methods Using the administrative hospital database in France 2010–2020, 52,974 patients with SND were included in the analysis: 4,069 patients had VVI pacing and 48,905 had DDD pacing. Patients with leadless VVI pacemakers were excluded of the analysis. After propensity score matching 2,213 patients with VVI pacemaker were matched 1:1 with 2,213 patients treated with DDD pacemaker. Results In the matched analysis, patients with DDD pacemakers had a lower rate of all-cause (hazard ratio HR 0.711, 95% CI 0.61–0.828) and cardiovascular death (HR 0.628, 95% CI 0.48–0.818) within the 30 days after implantation. There were no significant differences for incidence of tamponade (HR 0.666, 95% CI 0.11–3.992), pneumothorax (HR 1.000, 95% CI 0.32–3.105), hemothorax (HR 0.800, 95% CI 0.21–2.982), major bleeding (HR 0.824, 95% CI 0.68–1.005) and transfusion (HR 1.016, 95% CI 0.83–1.243). During subsequent follow-up (mean: 3.0±2.8 years), risk of all-cause death in the matched population was significantly lower in the DDD group than in the VVI pacemaker group (HR 0.683, 95% CI 0.60–0.784). Patients with SND treated DDD pacemakers also had a lower risk of cardiovascular death (HR 0.569, 95% CI 0.44–0.732), new-onset atrial fibrillation (HR 0.638, 95% CI 0.58–0.706), ischemic stroke (HR 0.685, 95% CI 0.53–0.887) and hospitalization for heart failure (HR 0.758, 95% CI 0.68–0.850) than those treated VVI pacemakers, whilst risk of endocarditis was not significantly different (HR 0.986, 95% CI 0.50–1.951). Conclusion Patients with SND treated with DDD pacemakers had better clinical outcomes compared to those treated with VVI pacemakers. DDD pacing was associated with lower risks of death, cardiovascular death, new-onset atrial fibrillation, ischemic stroke, hospitalization for heart failure. DDD pacing was neither associated with a higher risk of complication on the short-term nor of endocarditis on the longer-term. Funding Acknowledgement Type of funding sources: None.

Background Catheter ablation of atrial fibrillation (AF) has become a therapy of choice to treat symptomatic AF in current practice. As an alternative, atrioventricular node (AVN) ablation is an older but efficient procedure to control ventricular rate. Purpose To assess long-term clinical outcomes of AF ablation and AVN ablation in large cohort of patients with AF and to compare these two procedures. Methods This French multicentric retrospective study enrolled all patients hospitalized with a primary or secondary diagnosis of AF from 1st January 2010 to 31st December 2019, using an administrative hospital-discharge database. Clinical outcomes were analyzed in overall population and in propensity-matched samples. Results During follow-up (mean [SD] 2.0 [2.2], median [IQR] 1.0 [0.1–3.3] years), 2,438,015 patients were analysed (No ablation 2,360,833, AF ablation 62,490 and AVN ablation 14,692). Compared to patients treated without ablation, incidence of all-cause death was lower in patients treated with AF ablation (hazard ratio (HR) 0.272, 95% confidence interval (CI) 0.259–0.287, p Conclusion AF ablation and AVN ablation may be associated with better survival compared to non-invasive strategy. Compared to AVN ablation, AF ablation is associated with lower risk of all-cause death, cardiovascular death and hospitalization for HF, but higher incidence of ischemic stroke. Funding Acknowledgement Type of funding sources: None. Baseline characteristics matched cohortMain results

Background Temporary transvenous pacing in critically ill patients requiring prolonged cardiac pacing is associated with a high risk of complications. We sought to evaluate the safety and efficacy of self-contained intracardiac leadless pacemaker (LPM) implantation in this population. Methods and results Consecutive patients implanted with a Micra LPM during the hospitalization in an intensive care unit were retrospectively included. Inclusion criteria were: ≥1 supracaval central venous, or a ventilation tube, or intravenous antibiotic therapy for ongoing sepsis or bacteremia. Patients with a history of previous implantation of a pacemaker were excluded. Out of 1,016 patients implanted with an LPM, 99 met the inclusion criteria. Mean age was 75 years and Charlson comorbidity index 7. LPM implantation was successfully performed in 98% of cases, with a peri-operative complication rate of 5%, mainly cardiac injuries. In-hospital mortality rate was 6%. No late (>30 days) device-related complication occurred, especially no infection. Conclusions LPM appears as an acceptable alternative to conventional temporary transvenous pacing in selected critically ill patients requiring prolonged cardiac pacing, especially regarding the risk of infection. This article is protected by copyright. All rights reserved.

Aims Sports practice, especially in competition, is usually restrained in patients diagnosed with long QT syndrome (LQTS). Although data are scarce, a low incidence of cardiac arrhythmic events (CAEs) during sports practice is reported. We aim to evaluate the incidence of CAE during sports practice in LQTS patients. Methods and results All consecutive patients above 18 years of age diagnosed with LQTS and prospectively followed at the referral centre for inherited arrhythmia syndrome received a survey to retrospectively assess their sports practice prior to and after the diagnosis of LQTS. Two hundred and forty-six patients were included (57% females). The median age was 43 years, and the median QTc was 457 ms (428; 482). Patients reported a total of 4092 years [1376 (34%) after diagnosis] of sports practice: 2905 (77%) [1138 (39%) after diagnosis] years of leisure practice and 1187 (23%) [238 (20%) after diagnosis] years of competitive practice. One hundred and eighty (73%) patients practiced sport prior to the diagnosis of LQTS and 170 (69%) after. Prior to the diagnosis, four (2%) patients presented a CAE during leisure sports practice and one during competition. After diagnosis, only one patient presented a CAE, appropriately treated by an implantable cardioverter defibrillator discharge, in the context of beta-blocker non-compliance. The CAE event rate was 0.0007 events/year in the 1376 years of total sports practice after the diagnosis of LQTS. Conclusion After the diagnosis of LQTS, the occurrence of CAE is very low during sports practice, even in competitive practice. There was no CAE in patients properly treated with beta-blocker therapy with good compliance.

Background Although less common, typical atrial flutter shares similar pathophysiological roots with atrial fibrillation. Following successful cavo‐tricuspid isthmus ablation using radiofrequency, many patients, however, develop atrial fibrillation in the mid‐to‐long‐term. This study sought to assess whether pulmonary vein isolation conducted at the same time as cavo‐tricuspid isthmus ablation would significantly modify the atrial fibrillation burden upon follow‐up in patients suffering from typical atrial flutter. Methods This was a multicenter randomized controlled study involving typical atrial flutter patients with history of non‐predominant atrial fibrillation (1 atrial fibrillation episode only, in 67% of population) who were scheduled for cavo‐tricuspid isthmus radiofrequency ablation. Patients were randomly assigned to either undergo cavo‐tricuspid isthmus ablation alone or cavo‐tricuspid isthmus plus pulmonary vein isolation (CTI+). Pulmonary vein isolation was performed using cryoballoon technology. An outpatient consultation with ECG and 1‐week Holter monitoring was performed at 3, 6 months, 1 year, and 2 years postprocedure. The primary endpoint was atrial fibrillation recurrences lasting more than 30 s at 2 years postablation. Results Of the patients enrolled, 36 were included in each group. At 2‐year follow‐up, the atrial fibrillation recurrence rate was significantly higher in the CTI vs CTI+group (25/36, 69% vs. 12/36, 33% respectively; P, Atrial flutter (AFl) patients with prior occasionally recorded atrial fibrillation (AF) were randomly assigned to undergo cavo‐tricuspid isthmus (CTI) ablation or CTI plus pulmonary vein isolation (combined atrial flutter ablation). AF was neither the predominant (67% of the population with only one recorded AF episode) nor the targeted arrhythmia. At 2‐year FU, AF recurrences were significantly higher in atrial flutter ablation group vs combined atrial flutter group with similar AFL recurrences.

Funding Acknowledgements Type of funding sources: None. Introduction.Evidence from randomized trials suggests that, in patients with sinus-node dysfunction (SND), physiologic pacing (dual-chamber, DDD) may be superior to single-chamber (ventricular, VVI) pacing because it is associated with lower risks of atrial fibrillation and stroke, better exercise capacity and lower risk of pacemaker syndrome. However, benefits on mortality and risk of heart failure have not been demonstrated and these issues have not been fully evaluated in large "real life" analyses. Objective.The aim of our study was to assess and compare clinical outcomes within the first 30 days and during a longer-term follow-up with the two types of pacing at a nationwide level for patients with SND. Methods and results.Using the administrative hospital database in France 2010-2020, 52,974 patients with SND were included in the analysis: 4,069 patients had VVI pacing and 48,905 had DDD pacing. Patients with leadless VVI pacemakers were excluded of the analysis. After propensity score matching 2,213 patients with VVI pacemaker were matched 1:1 with 2,213 patients treated with DDD pacemaker. In the matched analysis, patients with DDD pacemakers had a lower rate of all-cause (hazard ratio HR 0.711, 95%CI 0.61-0.828) and cardiovascular death (HR 0.628, 95%CI 0.48-0.818) within the 30 days after implantation. There were no significant differences for incidence of tamponade (HR 0.666, 95%CI 0.11-3.992), pneumothorax (HR 1.000, 95%CI 0.32-3.105), hemothorax (HR 0.800, 95%CI 0.21-2.982), major bleeding (HR 0.824, 95%CI 0.68-1.005) and transfusion (HR 1.016, 95%CI 0.83-1.243). During subsequent follow-up (mean: 3.0 ± 2.8 years), risk of all-cause death in the matched population was significantly lower in the DDD group than in the VVI pacemaker group (HR 0.683, 95%CI 0.60-0.784). Patients with SND treated DDD pacemakers also had a lower risk of cardiovascular death (HR 0.569, 95%CI 0.44-0.732), new-onset atrial fibrillation (HR 0.638, 95%CI 0.58-0.706), ischemic stroke (HR 0.685, 95%CI 0.53-0.887) and hospitalization for heart failure (HR 0.758, 95%CI 0.68-0.850) than those treated VVI pacemakers, whilst risk of endocarditis was not significantly different (HR 0.986, 95%CI 0.50-1.951). Conclusion.Patients with SND treated with DDD pacemakers had better clinical outcomes compared to those treated with VVI pacemakers. DDD pacing was associated with lower risks of death, cardiovascular death, new-onset atrial fibrillation, ischemic stroke, hospitalization for heart failure. DDD pacing was neither associated with a higher risk of complication on the short-term nor of endocarditis on the longer-term.