Search

Contains fulltext : 249977.pdf (Publisher’s version ) (Closed access) BACKGROUND: It is important to evaluate whether a new treatment for heart failure with reduced ejection fraction (HFrEF) provides additive benefit to background foundational treatments. As such, we aimed to evaluate the efficacy and safety of empagliflozin in patients with HFrEF in addition to baseline treatment with specific doses and combinations of disease-modifying therapies. METHODS: We performed a post-hoc analysis of the EMPEROR-Reduced randomised, double-blind, parallel-group trial, which took place in 520 centres (hospitals and medical clinics) in 20 countries in Asia, Australia, Europe, North America, and South America. Patients with New York Heart Association (NYHA) classification II-IV with an ejection fraction of 40% or less were randomly assigned (1:1) to receive the addition of either oral empagliflozin 10 mg per day or placebo to background therapy. The primary composite outcome was cardiovascular death and heart failure hospitalisation; the secondary outcome was total heart failure hospital admissions. An extended composite outcome consisted of inpatient and outpatient HFrEF events was also evaluated. Outcomes were analysed according to background use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or angiotensin receptor neprilysin inhibitors (ARNIs), as well as β blockers and mineralocorticoid receptor antagonists (MRAs) at less than 50% or 50% or more of target doses and in various combinations. This study is registered with ClinicalTrials.gov, NCT03057977. FINDINGS: In this post-hoc analysis of 3730 patients (mean age 66·8 years [SD 11·0], 893 [23·9%] women; 1863 [49·9%] in the empagliflozin group, 1867 [50·1%] in the placebo group) assessed between March 6, 2017, and May 28, 2020, empagliflozin reduced the risk of the primary outcome (361 in 1863 participants in the empagliflozin group and 462 of 1867 in the placebo group; HR 0·75 [95% CI 0·65-0·86]) regardless of background therapy or its target doses for ACE inhibitors or ARBs at doses of less than 50% of the target dose (HR 0·85 [0·69-1·06]) and for doses of 50% or more of the target dose (HR 0·67 [0·52-0·88]; p(interaction)=0·18). A similar result was seen for β blockers at doses of less than 50% of the target dose (HR 0·66 [0·54-0·80]) and for doses of 50% or more of the target dose (HR 0·81 [0·66-1·00]; p(interaction)=0·15). Empagliflozin also reduced the risk of the primary outcome irrespective of background use of triple therapy with an ACE inhibitor, ARB, or ARNI plus β blocker plus MRA (given combination HR 0·73 [0·61-0·88]; not given combination HR 0·76 [0·62-0·94]; p(interaction)=0·77). Similar patterns of benefit were observed for the secondary and extended composite outcomes. Empagliflozin was well tolerated and rates of hypotension, symptomatic hypotension, and hyperkalaemia were similar across all subgroups. INTERPRETATION: Empagliflozin reduced serious heart failure outcomes across doses and combinations of disease-modifying therapies for HFrEF. Clinically, these data suggest that empagliflozin might be considered as a foundational therapy in patients with HFrEF regardless of their existing background therapy. FUNDING: Boehringer Ingelheim and Eli Lilly and Company.

Immune thrombocytopenia (ITP) is an acquired bleeding disorder, for which no specific diagnostic test exists. Inherited thrombocytopenia (IT) can mimic ITP and lead to unappropriated management with significant morbidity. Here, in small cohorts of these two disorders, we explored whether platelet sialylation and platelet activation could allow to discriminate the two conditions. We also aimed to confirm the value of immature platelet counts in this discrimination. Platelet sialylation and the expression level of P-selectin were assessed by multiparameter flow cytometry. Immature platelets were estimated on a Sysmex XN 9000 analyzer. No significant difference in platelet sialylation was observed between ITP and IT. Contrarily, platelet activation was significantly higher in ITP patients (p = 0.008). The immature platelet fraction, as previously demonstrated, was significantly lower in the ITP group compared to the IT group (p = 0.014). That statistical significance was achieved in this small pilot study suggests that the two easily available assays of immature platelet count and P-selectin expression could help physicians to reach the proper diagnosis in complex cases of thrombocytopenia.

Aims Cardiac resynchronization therapy with (CRTD) or without (CRTP) defibrillator is recommended in selected patient with systolic chronic heart failure and wide QRS. There is no guideline firmly indicating choice between CRTP and CRTD in primary prevention, particularly in older patients. Methods and results Based on the French administrative hospital-discharge database, information was collected from 2010 to 2017 for all patients implanted with CRTP or CRTD in primary prevention. Outcome analyses were undertaken in the total study population and in propensity-matched samples. During follow-up (913 days, SD 841, median 701, IQR 151–1493), 45 697 patients were analysed (CRTP 19 266 and CRTD 26 431). Incidence rate (%patient/year) of all-cause mortality was higher in CRTP patients (11.6%) than in CRTD patients (6.8%) [hazard ratio (HR) 1.70, 95% confidence interval (CI) 1.63–1.76, P Conclusion In this real-life study, CRTD was associated with a significantly lower all-cause mortality than CRTP in patients with ICM and in patients with NICM under 75 years old. Patients over 75 years old with NICM did not have lower mortality with primary prevention CRTD implantation.

Background and Purpose— Atrial fibrillation (AF) is known to increase risk of ischemic stroke (IS), but the risk of IS in isolated sinus node disease (SND) is unclear. We compared the incidence of IS in patients with SND, patients with AF, and in a control population with other cardiac diseases (disease of the circulatory system using the International Classification of Diseases, Tenth Revision ). Methods— This French longitudinal cohort study was based on the national database covering hospital care for the entire population from 2008 to 2015. Results— Of 1 692 157 patients included in the cohort, 100 366 had isolated SND, 1 564 270 had isolated AF, and 27 521 had AF associated with SND. Incidence of IS during follow-up was higher in isolated patients with AF than in AF associated with SND (yearly rate 2.22% versus 2.06%) and in isolated patients with AF than in isolated patients with SND (yearly rate 2.22% versus 1.59%). The incidence of IS was lower in a control population with other cardiac conditions (n=479 108) compared with SND and patients with AF (0.96%/y, 1.59%/y, and 2.22%/y, respectively). After 1:1 propensity score matching, SND was associated with lower incidence of IS compared to AF (hazard ratio, 0.77 [95% CI, 0.73–0.82]) but higher incidence of IS compared to control population (hazard ratio, 1.27 [95%CI, 1.19–1.35]). Conclusions— Patients with SND had a lower risk of thromboembolic events than patients with AF but a higher risk than a control population with other cardiac diseases. Randomized clinical trial in a selected SND population, with, for example, a high CHA 2 DS 2 -VASc score, would be required to determine the value of IS prevention by anticoagulation.

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.

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.

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: An accurate estimation of the risk of life-threatening (LT) ventricular tachyarrhythmia (VTA) in patients with LMNA mutations is crucial to select candidates for implantable cardioverter-defibrillator implantation. Methods: We included 839 adult patients with LMNA mutations, including 660 from a French nationwide registry in the development sample, and 179 from other countries, referred to 5 tertiary centers for cardiomyopathies, in the validation sample. LTVTA was defined as (1) sudden cardiac death or (2) implantable cardioverter defibrillator–treated or hemodynamically unstable VTA. The prognostic model was derived using the Fine-Gray regression model. The net reclassification was compared with current clinical practice guidelines. The results are presented as means (SD) or medians [interquartile range]. Results: We included 444 patients, 40.6 (14.1) years of age, in the derivation sample and 145 patients, 38.2 (15.0) years, in the validation sample, of whom 86 (19.3%) and 34 (23.4%) experienced LTVTA over 3.6 [1.0–7.2] and 5.1 [2.0–9.3] years of follow-up, respectively. Predictors of LTVTA in the derivation sample were: male sex, nonmissense LMNA mutation, first degree and higher atrioventricular block, nonsustained ventricular tachycardia, and left ventricular ejection fraction (https://lmna-risk-vta.fr). In the derivation sample, C-index (95% CI) of the model was 0.776 (0.711–0.842), and the calibration slope 0.827. In the external validation sample, the C-index was 0.800 (0.642–0.959), and the calibration slope was 1.082 (95% CI, 0.643–1.522). A 5-year estimated risk threshold ≥7% predicted 96.2% of LTVTA and net reclassified 28.8% of patients with LTVTA in comparison with the guidelines-based approach. Conclusions: In comparison with the current standard of care, this risk prediction model for LTVTA in laminopathies significantly facilitated the choice of candidates for implantable cardioverter defibrillators. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03058185.

There are limited data on the relationship of acute dental infections with hospitalisation and new-onset atrial fibrillation (AF). This study aimed to assess the relationship between acute periapical abscess and incident AF. This was a retrospective cohort study from a French national database of patients hospitalized in 2013 (3.4 million patients) with at least five years of follow up. In total, 3,056,291 adults (55.1% female) required hospital admission in French hospitals in 2013 while not having a history of AF. Of 4693 patients classified as having dental periapical abscess, 435 (9.27%) developed AF, compared to 326,241 (10.69%) without dental periapical abscess that developed AF over a mean follow-up of 4.8 ± 1.7 years. Multivariable analysis indicated that dental periapical abscess acted as an independent predictor for new onset AF (p &lt, 0.01). The CHA2DS2VASc score in patients with acute dental periapical abscess had moderate predictive value for development of AF, with Area Under the Curve (AUC) 0.73 (95% CI, 0.71–0.76). An increased risk of new onset AF was identified for individuals hospitalized with dental periapical abscess. Careful follow up of patients with severe, acute dental periapical infections is needed for incident AF, as well as investigations of possible mechanisms linking these conditions.

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.

Funding Acknowledgements Type of funding sources: None. Introduction / Background Subcutaneous implantable cardioverter–defibrillators (S-ICD) was designed to avoid complications of single-chamber transvenous implantable cardioverter-defibrillators (VVI ICD) by using an entirely extra-thoracic placement. Purpose Our objective was to 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. Multivariable analyses for clinical outcomes during the whole follow-up in the groups of interests were performed using a Cox model with all baseline characteristics and reporting hazard ratio. Owing to the non-randomized nature of the study, and considering for significant differences in baseline characteristics, propensity-score matching was also used to control for potential confounders of the treatment outcome relationship. 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 age was 61.2 ± 13.2 years in the VVI ICD group and 52.3 ± 17.5 years in the S-ICD goup. Coronary artery disease was present in 71.6% of patients with a VVI ICD and 48.2% of patients with a S-ICD. Mean follow-up was 28.8 ± 31.8 months. S-ICD patients had a significant 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 sensitivity analysis in patients with coronary artery disease in the matched cohort was performed. Same trends were observed without significant differences in all-cause death and cardiovascular death. 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.

Implantable cardiac defibrillators (ICDs) are recommended to prevent the risk of sudden cardiac death. However, shocks are associated with an increased mortality with a dose response effect, and a strategy of reducing electrical therapy burden improves the prognosis of implanted patients. We review the mechanisms of defibrillation and its consequences, including cell damage, metabolic remodeling, calcium metabolism anomalies, and inflammatory and pro-fibrotic remodeling. Electrical shocks do save lives, but also promote myocardial stunning, heart failure, and pro-arrhythmic effects as seen in electrical storms. Limiting unnecessary implantations and therapies and proposing new methods of defibrillation in the future are recommended.

BACKGROUND A reduced left ventricular ejection fraction (LVEF) ≤35% ≥6 weeks following an acute myocardial infarction (MI) may indicate prophylactic implantation of a cardioverter-defibrillator (ICD). We sought to find predictors of absence of significant left ventricular (LV) remodeling post-MI. METHODS All consecutive patients hospitalized for acute MI with an LVEF ≤35% at discharge in our institution from 2010 were retrospectively included. Patients were assigned to two groups according to the persistence of an LVEF ≤35% (ICD+) or a recovery >35% (ICD-). Logistic regression was performed to build a predictive score, which was then externally validated. RESULTS Among a total of 1533 consecutive MI patients, 150 met inclusion criteria, 53 (35%) in the ICD+ group and 97 in the ICD group. After multivariable analyses, an LVEF ≤25% at discharge (adjusted OR 6.23 [2.47 to 17.0], p 4600 UI/L (adjusted OR 9.99 [4.27 to 25.3], p

International audience

Left ventricular lead placement for cardiac resynchronization therapy may be challenging or even impossible. Left bundle area pacing has emerged as an interesting alternative method in case of failed implantation.

Background The number of patients with atrial fibrillation (AF) and cancer is rapidly increasing in clinical practice. The impact of cancer on clinical outcomes in this patient population is unclear, as is the performance of the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol) and CHA2 DS2 -VASc (Congestive Heart Failure, Hypertension, Age ≥ 75 years, Diabetes Mellitus, Stroke or Transient Ischemic Attack, Vascular Disease, Age 65 to 74 Years, Sex Category) scores. Methods This was an observational, retrospective cohort study including 2,435,541 adults hospitalized with AF. The authors investigated the incidence rates (IRs) of all-cause and cardiovascular mortality, ischemic stroke, major bleeding, and intracranial hemorrhage (ICH) according to the presence of cancer and cancer types. Results Overall, 399,344 (16.4%) had cancer, with the most common cancers being metastatic, prostatic, colorectal, lung, breast, and bladder. During a mean follow-up of 2.0 years, cancer increased all-cause mortality (hazard ratio [HR], 2.00; 95% confidence interval [CI], 1.99-2.01). The IR of ischemic stroke was higher with pancreatic cancer (2.8%/y), uterine cancer (2.6%/y), and breast cancer (2.6%/y), whereas it was lower with liver/lung cancer (1.9%/y) and leukemia/myeloma (2.0%/y), in comparison with noncancer patients (2.4%/y). Cancer increased the risk of major bleeding (HR, 1.27; 95% CI, 1.26-1.28) and ICH (HR, 1.07; 95% CI, 1.05-1.10). Leukemia, liver cancer, myeloma, and metastatic cancers showed the highest IRs for major bleeding/ICH. Major bleeding and ICH rates progressively increased with the HAS-BLED score, which showed generally good predictivity with C indexes > 0.70 for all cancer types. The CHA2 DS2 -VASc score's predictivity was slightly lower in AF patients with cancer. Conclusions Cancer increased all-cause mortality, major bleeding, and ICH risk in AF patients. The association between cancer and ischemic stroke differed among cancer types, and in some types, the risk of bleeding seemed to exceed the thromboembolic risk.

Objective: A systematic review and meta-analysis was performed to evaluate the safety and efficacy of drug-eluting stents (DES) vs bare-metal stents (BMS) in atrial fibrillation (AF) patients. Methods: We systematically searched 5 engines until May 2019 for cohort studies and randomized controlled trials (RCTs). Primary outcomes were major bleeding and major adverse cardiac events (MACE) including cardiac death, myocardial infarction, target vessel revascularization (TVR) or stent thrombosis. Effects of inverse variance random meta-analyses were described with relative risks (RR) and their 95% confidence intervals (CI). We also stratified analyses by type (triple [TAT] vs dual [DAT]) and duration (short-vs long-term) of antithrombotic therapy. Results: Ten studies (3 RCTs; 7 cohorts) including 10,353 patients (DES: 59.6%) were identified. DES did not show higher risk of major bleeding than BMS (5.6% vs 6.9%, RR 1.07; 95%CI, 0.89–1.28, p = 0.47; I2 = 0%) or MACE (12% vs 13.6%; RR 0.96; 95%CI 0.81–1.13, p = 0.60; I2 = 44%). Although, DES almost decreased TVR risk (6.4% vs 8.4%, RR 0.78; 95%CI, 0.61–1.01, p = 0.06; I2 = 15%). Stratified analyses by type and duration of antithrombotic therapy showed no differences in major bleeding or MACE between both types of stents. In DES, long-term TAT showed higher major bleeding risk than long-term DAT (7.7% vs 4.7%, RR 1.48, 95%CI 1.08–2.03, p = 0.01; I2 = 12%). For both types of stents, MACE risk was similar between TAT and DAT. Conclusions: In patients with AF undergoing PCI, DES had similar rate of major bleeding and MACE than BMS. DAT seems to be a safer antithrombotic therapy compared with TAT.

Background Conduction abnormalities leading to permanent pacemaker (PPM) implantation are common complications following transcatheter aortic valve replacement (TAVR). Whether PPM implantation placement is associated with adverse outcomes is unclear. The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of PPI following TAVR. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. Results A total of 49,201 patients with aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using the balloon-expandable (BE) Edwards SAPIEN valve or the self-expanding (SE) Medtronic CoreValve were found in the database. Among them, 10,019 (20.4%) had prior PPM implantation, including 476 (4.8%) treated with cardiac resynchronization therapy (CRT). New PPM implantation was required within 30 days of TAVR in 11,010 patients (22.4%), which varied among those receiving self-expanding valves (24.7%) versus balloon-expanding valves (20.9%). There were 349/10,010 patients (3.1%) treated with cardiac resynchronization therapy (CRT) within 30 days following TAVR. In a multivariable analysis comprising 38 variables (including among others underlying conduction disorders, Euroscore 2, Charlson comorbidity index, frailty score and type of implanted valve), prior PPM implantation was associated with an increased risk of all-cause death (adjusted hazard ratio [HR]: 1.10 95% CI 1.04–1.16). New PPM implantation was associated with even higher risk of mortality (adjusted HR: 1.21 95% CI 1.15–1.28). By contrast, previous CRT was associated with a lower risk of death during follow-up (adjusted HR: 0.78 95% CI 0.63–0.96), while PPM with CRT within 30 days of TAVR was not associated with a different risk of death (adjusted HR: 1.00 95% CI 0.80–1.24). Prior PPM and new PPM implantation were also associated with an increased risk of rehospitalization for heart failure (adjusted HR: 1.26 95% CI 1.19–1.32 and 1.18 95% CI 1.12–1.24, respectively). Previous CRT was associated with a non-significant lower risk of rehospitalization for heart failure (adjusted HR: 0.92 95% CI 0.77–1.09). Conclusions Both previous PPM and early PPM implantation following TAVR are commonly seen in patients treated with TAVR, and they are associated with a higher risk of death and rehospitalisation for heart failure when compared to patients with no PPM. The fact that CRT when implanted before TAVR was associated with a better survival may deserve consideration when elaborating future optimal approaches for management of conduction disturbances in patients treated with TAVR. Funding Acknowledgement Type of funding source: None

Background 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. Purpose 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. To complement the directly genotyped SNPs we performed large-scale imputation based on the Haplotype Reference Consortium European ancestry panel leading to a dataset of 7,5 million of SNPs. 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, biological results, electrocardiographic measures. No locus shows genome-wide significant association (p 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. Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Nantes University Hospital

Background The significance and the management of coronary artery disease (CAD) are disputed in patients treated by transcatheter aortic valve implantation (TAVI). In the presence of a significant CAD eligible for percutaneous coronary intervention (PCI), the issue of the timing of PCI relative to TAVI is unsettled. To answer this question, the present study aimed at comparing the short-term and long-term outcome in patients treated by staged PCI within a 90-day time interval before or after TAVI. Methods Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with TAVI between 2014 and 2018. Patients treated with PCI in the preceding 90 days before the TAVI procedure (pre-TAVI PCI) or subsequent 90 days after the TAVI procedure (post-TAVI PCI) were included. All-cause mortality, cardiovascular mortality, stroke, myocardial infarction and a combined cardiovascular endpoint were assessed at 30 days after the last procedure (short-term) and during the whole follow-up (long-term). Propensity score matching was used for the analysis of outcomes. Results 8613 patients met the inclusion criteria with a vast majority of pre-TAVI PCI patients (N=8324) as opposed to post-TAVI PCI (N=229). After propensity score matching, 2 groups of 227 patients with comparable characteristics were obtained. At 30 days, no significant difference was observed for any of the outcome tested with the exception of myocardial infarction more frequent in post-TAVI PCI (OR 2.43 [1.17–5.07]). After a mean [SD] follow-up of 459 [569] days, all outcomes were identical between subgroups. The figure below illustrates the Kaplan Meier curve for all-cause mortality. Conclusions Our study based on a French nationwide database shows that PCI is performed pre-TAVI in a majority of cases, with no significant impact on outcome. Deferring PCI after TAVI seems safe and may provide an opportunity to make the decision on more objective parameters while the stenosis has been removed (such as FFR or IFR). In any case, the timing of PCI relative to TAVI does not seem to represent a concern and should be decided on an individual basis. Figure 1 Funding Acknowledgement Type of funding source: None

Background When assessing ischemic stroke risk in patients with atrial fibrillation (AF), the CHA2DS2-VASc score is calculated based on the baseline risk factors, and the outcomes are determined after a follow-up period. However, the stroke risk in patients with AF does not remain static, and with time, patients get older and accumulate more comorbidities. This study hypothesized that the “Delta CHA2DS2-VASc score”, which reflects the change in score between baseline and follow-up, may be predictive of ischemic stroke compared with the baseline or follow-up assessments of the CHA2DS2-VASc score. Methods Based on the France nationwide administrative hospital-discharge database, we collected information for all patients treated with AF between 2010 and 2019 in France. Adverse outcomes were investigated during follow-up. A total of 594,169 patients with AF who did not have comorbidities of the CHA2DS2-VASc score except for age and sex, were studied. The Delta CHA2DS2-VASc score was defined as the change/difference between the baseline and follow-up CHA2DS2-VASc scores. During 1,290,721 person-years, 19,492 patients experienced ischemic stroke. The accuracies of baseline, follow-up, and Delta CHA2DS2-VASc scores in predicting ischemic stroke were analysed and compared. Results The mean baseline CHA2DS2-VASc score was 1.69, which increased to 2.33 during the follow-up, with a mean Delta CHA2DS2-VASc score of 0.64. The CHA2DS2-VASc score increased in 39.8% of patients. Among 19,492 patients who experienced ischemic stroke, 66.0% had a Delta CHA2DS2-VASc score ≥1 compared with only 38.9% in patients without ischemic stroke, and 5,811 (29.8%) patients had ≥2 new-onset comorbidity, the most common being hypertension. The follow-up CHA2DS2-VASc score and Delta CHA2DS2-VASc score were significant predictors of ischemic stroke (C-index 0.670 95% CI 0.667–0.674 and 0.637 95% CI 634–641 respectively) that performed better than baseline CHA2DS2-VASc score (C-index 0.613 95% CI 0.609–0.616, p Conclusions In this AF cohort, we found that stroke risk (CHA2DS2-VASc score) was non-static, and that many patients developed ≥1 new stroke risk factor(s) before presentation with ischemic stroke. The follow-up CHA2DS2-VASc score and its change (ie Delta CHA2DS2-VASc, reflecting the change in stroke risk profile between baseline and follow-up) were better predictors of ischemic stroke than relying on the baseline CHA2DS2-VASc score. This emphasises how stroke risk in AF is a dynamic process due to increasing age and incident comorbidities, and regular re-assessment of risk is needed. Funding Acknowledgement Type of funding source: None

Background In patients with acute myocardial infarction (AMI), history of atrial fibrillation (AF) and new onset AF during the early phase may be associated with a worse prognosis. Whether both conditions are associated with a similar risk of stroke and should be similarly managed is a matter of debate. Methods Based on the administrative hospital-discharge database, we collected information for all patients treated with AMI between 2010 and 2019 in France. The adverse outcomes were investigated during follow-up. Results Among 797,212 patients with STEMI or NSTEMI, 146,922 (18.4%) had history of AF, and 11,824 (1.5%) had new AF diagnosed between day 1 and day 30 after AMI. Patients with new AF were older and had more comorbidities than those with no AF but were younger and had less comorbidities than those with history of AF. Both groups with history of AF or new AF had less frequent STEMI and anterior MI, less frequent use of percutaneous coronary intervention but more frequent HF at the acute phase than patients with no AF. During follow-up (mean [SD] 1.8 [2.4] years, median [interquartile range] 0.7 [0.1–3.1] years), 163,845 deaths and 20,168 ischemic strokes were recorded. Using Cox multivariable analysis, compared to patients with no AF, history of AF was associated with a higher risk of death during follow-up (adjusted hazard ratio HR 1.06 95% CI 1.05–1.08) while this was not the case for patients with new AF (adjusted HR 0.98 95% CI 0.95–1.02). By contrast, both history of AF and new AF were associated with a higher risk of ischemic stroke during follow-up compared to patients with no AF: adjusted hazard ratio HR 1.29 95% CI 1.25–1.34 for history of AF, adjusted HR 1.72 95% CI 1.59–1.85 for new AF. New AF was associated with a higher risk of ischemic stroke than history of AF (adjusted HR 1.38 95% CI 1.27–1.49). Conclusion In a large and systematic nationwide analysis, AF first recorded in the first 30 days after AMI was associated with an increased risk of ischemic stroke. Specific management should be considered in order to improve outcomes in these patients after AMI. Funding Acknowledgement Type of funding source: None

International audience; Risk-benefit assessment for transcatheter aortic valve implantation (TAVI) is still a matter of debate. We aimed to identify patients with a bad outcome within 1 year after TAVI, and to develop a Futile TAVI Simple score (FTS). Based on the administrative hospital-discharge database, all consecutive patients treated with percutaneous TAVI in France between 2010 and 2018 were included. A prediction model was derived and validated for 1-year all-cause death after TAVI (considered as futility) by using split-sample validation: 20,443 patients were included in the analysis (mean age 83 +/- 7 years). 7,039 deaths were recorded (yearly incidence rate 15.5%), among which 3,702 (53%) occurred in first year after TAVI procedure. In the derivation cohort (n = 10,221), the final logistic regression model included male sex, history of hospital stay with heart failure, history of pulmonary oedema, atrial fibrillation, previous stroke, vascular disease, renal disease, liver disease, pulmonary disease, anaemia, history of cancer, metastasis, depression and denutrition. The area under the curve (AUC) for the FTS was 0.674 (95%CI 0.660 to 0.687) in the derivation cohort and 0.651 (95%CI 0.637 to 0.665) in the validation cohort (n = 10,222). The Hosmer-Lemeshow test had a p-value of 0.87 suggesting an accurate calibration. The FTS score outperformed EuroSCORE II, Charlson comorbidity index and frailty index for identifying futility. Based on FTS score, 7% of these patients were categorized at high risk with a 1-year mortality at 43%. In conclusion, the FTS score, established from a large nationwide cohort of patients treated with TAVI, may provide a relevant tool for optimizing healthcare decision.

The pathophysiology of jackhammer esophagus is complex and remains unclear. Radiofrequency catheter ablation is indicated for highly symptomatic and drug-refractory atrial fibrillation. This technique can induce esophageal and nerve lesions, due to thermal injury. In this report, we describe a case of hypercontractile esophagus diagnosed by HRM (high-resolution manometry). Esophageal symptoms and HRM normalized immediately after RFCA, and we discuss the pathophysiology of hypercontractile esophagus.

International audience; Background: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. Methods: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. Results: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10–599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P =0.005), cardiovascular death (relative risk, 0.82; corrected P =0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P

Summary Background The recently recommended single lead-based criterion for the diagnosis of Brugada syndrome may lead to overdiagnosis of this disorder and overestimation of the risk of sudden cardiac death. Aim To investigate the value of a single-lead diagnosis in patients with Brugada syndrome and a spontaneous type 1 electrocardiogram. Methods Consecutive patients with Brugada syndrome were included in a multicentre prospective registry; only those with a spontaneous type 1 electrocardiogram were enrolled. Clinical and electrocardiogram data were reviewed by two physicians blinded to the patients’ clinical and genetic status. Results Among 1613 patients, 505 (31%) were enrolled (79% male; mean age 46 ± 15 years). A spontaneous type 1 electrocardiogram pattern was found in one lead in 250 patients (group 1), in two leads in 227 patients (group 2) and in three leads in 27 patients (group 3). Groups were similar except for individuals in group 3, who presented more frequently a fragmented QRS complex, an early repolarization pattern and a prolonged Tpeak–Tend interval. After a mean follow-up of 6.4 ± 4.7 years, ventricular arrhythmia, sudden cardiac death or implantable cardiac defibrillator shock occurred in 46 (9%) patients, without differences between groups. Conclusion The prognosis of Brugada syndrome with a spontaneous type 1 electrocardiogram pattern does not appear to be affected by the number of leads required for the diagnosis.

International audience; Background: According to guidelines, implantable cardioverter defibrillator (ICD) candidates must have a "reasonable expectation of survival with a good functional status >1 year". Identifying risk for early mortality in ICD candidates could be challenging. We aimed to identify factors associated with a =1-year survival among patients implanted with ICDs.Methods: The DAI-PP program was a multicenter, observational French study that included all patients who received a primary prevention ICD in the 2002-2012 period. Characteristics of patients who survived = III), and atrial fibrillation were significantly associatedwith

Background The incidence of conduction abnormalities requiring permanent pacemaker implantation ( PPI ) after transcatheter aortic valve replacement ( TAVR ) with early and later generation prostheses remains debated. Methods and Results Based on the administrative hospital‐discharge database, we collected information for all patients treated with TAVR between 2010 and 2019 in France. We compared the incidence of PPI after TAVR according to the type and generation of valve implanted. A total of 49 201 patients with aortic stenosis treated with TAVR using the balloon‐expandable ( BE ) Edwards SAPIEN valve (early Sapien XT and latest Sapien 3) or the self‐expanding ( SE ) Medtronic CoreValve (early CoreValve and latest Evolut R) were found in the database. Mean ( SD ) follow‐up was 1.2 (1.5 years) (median [interquartile range] 0.6 [0.1–2.0] years). PPI after the procedure was reported in 13 289 patients, among whom 11 010 (22.4%) had implantation during the first 30 days. In multivariable analysis, using early BE TAVR as reference, adjusted odds ratio (95% CI ) for PPI during the first 30 days was 0.88 (0.81–0.95) for latest BE TAVR , 1.40 (1.27–1.55) for early SE TAVR , and 1.17 (1.07–1.27) for latest SE TAVR . Compared with early BE TAVR , the adjusted hazard ratio for PPI during the whole follow‐up was 1.01 (0.95–1.08) for latest BE TAVR , 1.30 (1.21–1.40) for early SE TAVR , and 1.25 (1.18–1.34) for latest SE TAVR . Conclusions In patients with aortic stenosis treated with TAVR , our systematic analysis at a nationwide level found higher rates of PPI than previously reported. BE technology was independently associated with lower incidence rates of PPI both at the acute and chronic phases than SE technology. Recent generations of TAVR were not independently associated with different rates of PPI than early generations during the overall follow‐up.

INTRODUCTION Ablation of premature ventricular contractions (PVCs) has emerged as a safe and effective treatment in patients experiencing a high PVCs burden. Mapping of PVCs origin may sometimes be challenging. We sought to evaluate the accuracy of a new electrophysiological criterion, the distal-to-proximal (DP) delay, at localizing the optimal site for ablation of ventricular ectopic foci. METHODS AND RESULTS Consecutive patients with ablation attempts of symptomatic PVCs were included. Prematurity and DP delay-that is, the time duration between the onset of ablation catheter distal bipolar electrogram and the onset of proximal bipolar electrogram-were measured at successful and unsuccessful ablation sites by three blinded experienced electrophysiologists. Mean DP delay at effective ablation sites (N = 30) was significantly higher than at ineffective sites ( N = 55) (23 ± 9 vs 11 ± 8 milliseconds; P

Background 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 (V3 CRT) may improve clinical status of CRT nonresponders. Objective We assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact. Methods 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 V3 arm (implantation of an additional LV lead; n=43) or control arm (no change; n = 41). Implant success rate, incidence of severe adverse events, CCS, and secondary clinical and echocardiographic end points were evaluated at 12 and 24 months. Results Positioning 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 V3 treatment had no significant influence (P = .27) on the CCS, number of HF hospitalizations, time to first HF hospitalization, New York Heart Association class, and LV ejection fraction at 12 and 24 months. Conclusion Although 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).

Background Patients with kidney disease are more likely to develop atrial fibrillation (AF) than individuals with normal renal function, and more likely to suffer ischemic stroke (IS)/thromboembolism (TE). We investigated the relationship of kidney function evolution to IS/TE, mortality and bleeding in AF patients. Methods In a cohort of 8962 AF patients, 2653 had serum creatinine data, with 10894 patient-years of follow-up. Patients were stratified into quartiles of estimated glomerular filtration rate (eGFR) evolution (in mL/min per 1.73 m2/year). Results Rates of events (IS/TE, bleeding, mortality) increased with worsening eGFR by quartiles. The risk of events was particularly increased when patients in the 4th quartile were compared to others. Renal impairment per se was not an independent predictor of IS/TE but was an independent predictor of bleeding, whilst eGFR worsening was an independent predictor both for IS/TE (Hazard Ratio [HR] 1.573, 95%CI 1.160-2.134 for patients in the last quartile) and for bleeding events (HR 1.543, 95%CI 1.157-2.004). Worsening eGFR did not improve the predictive ability of the CHA2DS2VASc and HAS-BLED scores for identifying a higher risk of IS/TE or bleeding events, respectively. When the benefit of IS reduction was balanced against the increased risk of bleeding events, the net clinical benefit was positive in favor of OAC use (vs non-use) in patients with worsening eGFR. Conclusions Rates of IS/TE, mortality and bleeding increased with worsening eGFR >4.81 mL/min per 1.73 m2. Worsening eGFR was an independent predictor of IS/TE and of bleeding, and a better predictor of IS/TE than renal impairment in AF.

The CHA2DS2-VASc score may identify patients at higher risk of atrial fibrillation (AF) following ischemic stroke (IS) in patients without known AF. We compared gender-related differences in items from CHA2DS2-VASc score and their relation with AF occurrence after IS. This French cohort study was based on the database covering hospital care from 2009 to 2012 for the entire population. Of 336,291 patients with IS, 240,459 (71.5%) had no AF at baseline. Women were older, more frequently had hypertension, heart failure, and had a higher CHA2DS2-VASc score than men (4.63 vs 4.39, p

Summary Background Approximately one-third of patients do not respond favourably to cardiac resynchronization therapy (CRT). A longer distance between ventricular leads may improve response. Aim To study the impact of the true three-dimensional interlead distance (ILD) on outcomes. Methods Consecutive patients undergoing CRT device implantation were included prospectively. Interlead separation was measured from postprocedural anterior-posterior and lateral chest X-rays. The three-dimensional ILD was calculated using the Pythagorean theorem. Response to CRT was defined using a composite clinical score at 6 months. Results Forty-two patients were included (mean age 70 ± 9 years; QRS duration 154 ± 31 ms; left ventricular ejection fraction 26 ± 7%; 50% ischaemic). At 6 months, 71% of patients were considered to be responders. Responders had a significantly longer ILD (108 ± 17 vs. 87 ± 21 mm; P = 0.002). When the ILD was corrected for cardiac size, the optimal cut-off value was ≥ 0.53 for predicting response (sensitivity 83%, specificity 75%, area under the curve 0.84; P = 0.0002). Similar results were obtained in a historical retrospective cohort. The use of proximal electrodes on the left ventricular lead was associated with a longer ILD in 95% of patients, compared with more distal pacing configurations. In the total cohort of 74 patients (median follow-up, 420 days), those with an indexed ILD ≥ 0.53 had a 70% reduction in risk of hospitalization for heart failure (P = 0.004). Conclusion Longer three-dimensional ILD corrected for cardiac size measured on chest radiographs can accurately predict response to CRT and outcomes. This simple variable may be used to identify optimal lead placement and pacing configuration during CRT implantation.

Temporal Trends Over a Decade of Defibrillator TherapyBackground 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. Methods 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). Results 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%, P 30 days after implant) complications significantly increased (4.6 to 7.6%, P = 0.003). Conclusion 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.

Background Charlson comorbidity index (CCI) is a tool to measure comorbid disease status and a strong estimator of mortality. The quantifiable frailty phenotype has also been validated as predictive of mortality and disability. Claims data can be used to classify individuals as frail and non-frail using the Claims-based Frailty Index (CFI). We evaluated whether these tools may help to predict the risk of bleeding in patients with atrial fibrillation (AF). Methods All patients with AF seen in an academic institution were identified and followed up for mortality, stroke and bleeding events. HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT scores, CCI and CFI were calculated for each patient. Hazard ratios were calculated and predictive abilities of the scores were compared using the c-statistic in the whole population and then separately in elderly patients (>75 yo). Results Among 8962 patients with AF, 274 major bleeding events were recorded during a follow-up of 874±1054 days. Bleeding occurred more commonly in patients with higher bleeding risk scores, CCI and CFI. The 4 bleeding risk scores significantly had lower c-statistics than CCI and CFI for predicting major bleeding (table). Results were similar whether patients were treated with OAC or no OAC. In elderly patients, the c-statistics were all lower and were not significantly different for the 4 scores, CCI and CFI scores (0.594, 0,572, 0.595, 0.594, 0.616 and 0.591 for HAS-BLED, HEMORR2HAGES, ATRIA, ORBIT, CCI and CFI, respectively). Predictive values for major bleeding ROC Area 95% Conf. Interval P value vs CCI/CFI HASBLED 0.588 0.555–0.621 0.002/0.003 HEMORR2HAGES 0.564 0.531–0.598 Conclusion Comorbidities and frailty, respectively assessed with CCI and CFI, demonstrated statistically better performances in predicting major bleeding than the 4 established bleeding risk scores in AF, although all c-indexes were broadly similar. The 4 bleeding risk scores, CCI and CFI showed lower performance in predicting bleeding within elderly patients in whom they all performed equally to predict bleeding events. Given their simplicity and similar performances, the user-friendly bleeding risk scores remain attractive tools for the estimation of bleeding risk in elderly patients with AF.

Background The need for ICD back-up may be questionable in candidates for CRT-D device replacement, who no longer meet ICD criteria due to an improved left ventricular ejection fraction (LVEF) and/or an event-free CRT-D service life. Purpose To evaluate the clinical relevance of ICD back-up after CRT-D device replacement in patients with primary prevention ICD indication and to investigate factors predictive of ventricular arrhythmic events (VAE). Methods BioCONTINUE is an observational, multicentre, prospective and international trial. Patients were enrolled after CRT-D replacement and are currently followed up to a minimum of 2 years. We investigated the rate of patients with at least 1 sustained VAE, as defined by ventricular tachycardia >30s and/or ventricular arrhythmic event treated either by ATP or shock. Predictive factors of VAE were evaluated using univariate analyses based on demographics and clinical variables observed at enrolment, followed by a multivariate analysis. These multivariate analyses were adjusted confusion demographic or clinical covariates emerging at a p Results A total of 276 patients are enrolled (70±10 years, 77% men, mean LVEF 40.6±12.6%, 23.6% secondary ICD indication). The mean FU duration at the interim analysis is 19.8±8.7 months, including 98 patients (35.5%) with a 2-year FU. The rate of patients free of VAE, is 91.2%, 88.4% and 85.1% respectively at 1, 2 and 3 years of FU. In patients with persistent ICD indication at enrolment (defined by LVEF Conclusions The interim results of the BioCONTINUE trial show a persistent risk of VAE after CRT-D device replacement, both in patients with and without persistent ICD indication. The risk of VAE is dependent on age, ICD indication and ischemic heart disease. Acknowledgement/Funding Supported by Biotronik

Reliable prediction of atrial fibrillation (AF) progression from paroxysmal to non-paroxysmal form of AF could help in optimizing follow-up and decision-making regarding the rate and rhythm control management. The HATCH score and others have been proposed to identify AF patients likely to progress to sustained forms of AF, but external validation is limited. We aimed at evaluating these scores in a large series of AF patients and to identify possible factors leading to persistent/permanent AF. Methods All patients with AF seen over a period of 10 years were identified in a database and followed up for AF progression and mortality. Predictors of outcomes were identified using Cox regression model. The values of HATCH, CHA2DS2-VASc, ALARMEc, APPLE, MB-LATER scores and CHARLSON comorbidity index were evaluated with C statistics for prediction of AF progression. Results Among 8962 patients (71±14 years), 4991, 476 and 3495 had paroxysmal, persistent AF, and permanent AF, respectively. During a follow-up of 927±1084 days, 404 paroxysmal AF patients progressed to persistent or permanent AF (yearly rate of 3.0%). Progression was associated with a trend toward increased cardiovascular mortality. Independent predictors of AF progression were heart failure (hazard ratio (HR) 2.07; 95% CI 1.50–2.85, p C-statistics for AF progression All patients (n=4,991) p value* HATCH 0.576 (0.562–0.590) Conclusion Most of scores have a modest predictive value to identify the risk of evolution to permanent AF. Among them, the CHARLSON comorbidity index had the best predictive value and outperformed other tools. This suggests that AF progression may actually reflect global aging both at the individual and local atrial level.

Risk-benefit assessment for transcatheter aortic valve replacement (TAVR) is still a matter of debate. A sizeable group of patients do not fully benefit from intervention despite a technically successful procedure. We therefore sought to identify patients with a bad outcome early after the procedure, and to develop a prediction model and calculator for identification of these patients. Methods Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients with aortic stenosis treated with transfemoral TAVR in France between 2008 and 2018. Multivariate logistic regression was used to select the risk factors of early all-cause death in first year after TAVR procedure (considered as futility) for the overall population. Score points were assigned to each risk factor using the β coefficient. Internal validation was performed by a bootstrap method. Calibration was assessed with the Hosmer-Lemeshow goodness of fit test and accuracy with the C-statistic. Results A total of 47,872 patients with transfemoral TAVR were included in the analysis (mean age 83±7 years). Mean follow-up was 1.31±1.61 years and 9,338 deaths were recorded (yearly rate 14.9%), among which 4,562 (49%) occurred in first year after TAVR procedure. The final logistic regression model included older age, male sex, history of hospital stay with heart failure, history of acute pulmonary oedema, atrial fibrillation, previous stroke, vascular disease, diabetes, renal disease, liver disease, pulmonary disease, anemia, history of cancer, metastasis and denutrition,. The area under the curve (AUC) for the score was 0.696 (95% CI 0.688–0.704). This score outperformed frailty index and Charlson comorbidity index for identifying futility. AUC was 0.677 (95% CI 0.669–0.86) for internal validation. The Hosmer–Lemeshow goodness of fit test had a p-value of 0.10 suggesting that the model was accurate. We further divided the model into 4 groups with 5%, 12%, 19% and 30% futility, respectively. The low-risk group consisted of 60% of the patients and the high-risk group consisted of 4% of these patients. Conclusion This futility prediction score established from a large nationwide cohort of patients treated with TAVR may provide a relevant insight for optimizing healthcare decision. It may facilitate identification of patients who, despite an apparently successful procedure, have risk of death that may outweigh the benefit of an anticipated TAVR.

Catheter ablation for atrial fibrillation (AF) is a validated therapy for patients with symptomatic AF to prevent recurrences. The CASTLE AF trial indicated that ablation for AF in patients with heart failure was associated with a lower rate of death from any cause or hospitalization for worsening heart failure than was medical therapy. However, the benefit of AF ablation was not significant in older patients (>65 yo). The purpose of our study was to compare the incidence of these events in patients after AF catheter ablation versus patients not treated with AF ablation at a nationwide level and to analyse whether the possible benefit with AF ablation may differ among patients younger or older than 75 yo. Methods This French longitudinal cohort study was based on the national hospitalization PMSI (Programme de Médicalisation des Systèmes d'Information) database covering hospital care from the entire population. We included all patients, over 18 years old, with AF from January 2010 to December 2015. Results Among the 1,663,284 patients identified with AF, 28,018 patients were treated with AF ablation (28% female, mean age 60±10 yo) and 1,635,266 did not have AF ablation (48% female, mean age 78±11 yo). Among those treated with AF ablation, 1,605/28,018 patients (5.7%) were aged >75 yo. During follow-up (456±546 days), hospitalization with a primary diagnosis of HF and death were recorded. Incidences of hospitalization for HF and death were significantly lower in AF ablation group (respectively 6.09% vs 13.29% person per year, p75 yo for hospitalization for HF; HR 0.21, 95% CI 0.19–0.24, p75 yo for all-cause death. Conclusion In the nationwide analysis of unselected AF patients seen in hospitals, AF ablation was independently associated with a lower risk of hospitalization for HF and death whether patients were aged below or above 75 yo.

Atrial fibrillation (AF) catheter ablation is a validated therapy for patients with symptomatic AF after failure or intolerance to antiarrhythmic drug therapy. Despite improvements in ablation technique, 30 to 50% of the patients may have AF recurrences. The APAF-CRT trial recently demonstrated that atrio-ventricular node ablation (AVNA) and cardiac resynchronization pacing was superior to pharmacological therapy in reducing HF and hospitalization in patients with permanent AF. The purpose of the study was to quantify the use of AVNA after AF catheter ablation and to find independent predictors factors associated with AVNA in this setting. Methods This French longitudinal cohort study was based on the national hospitalization database covering hospital care from the entire population. The data for all patients admitted in France from January 2010 to December 2015 were collected from the national administrative database, the PMSI (Programme de Médicalisation des Systèmes d'Information). We included all patients, over 18 years old, with AF and at least one AF catheter ablation. Routinely collected medical information includes the principal or secondary diagnoses and procedures performed. Items from the baselines characteristics were pooled into a multivariate Cox model to identify predictors of AV node ablation. Results Of 1,663,284 patients identified with AF, 28,018 patients were treated with AF ablation (28% female, mean age 60±10 yo, 22,837 with 1 procedure, 4,576 with 2 procedures and 605 with 3 procedures). Of those 28,018 patients, there were only 369 patients (1.3%) treated with AVNA after a mean follow-up of 374±488 days (median 210, interquartile 15–798). AVNA was less commonly performed than redo AF ablation with 3 procedures, and among these latter patients, only 3.8% were treated with AVNA during follow-up. Most powerful independent predictors of AV node ablation (HR >1.7) were age≥75 yo, heart failure at baseline, abnormal renal function and valve disease. Other independent predictors for AV node ablation (HR 1.2–1.7) were age 65–74 yo, female gender, obesity, coronary artery disease, thyroid disorders, lung disease and hypertension. Conclusion Our findings indicate that AVNA is rarely used after AF ablation failure and is probably an underrated strategy in these patients for now. Considering evidence from the APAF-CRT trial indicating a beneficial effect on mortality of this treatment in symptomatic AF patients, a wider use of AVNA should be more widely proposed in these patients. Its optimal timing during rate and rhythm control management still remains to be established.

Patients undergoing transcatheter aortic valve replacement (TAVR) may have concomitant mitral regurgitation (MR). The impact of MR at baseline or after TAVR on subsequent prognosis remains to be more precisely determined. We analysed the impact of MR before or after TAVR on prognosis in the systematic analysis of patients treated with TAVR at a nationwide level. Methods Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients with aortic stenosis treated with transfemoral TAVR in France between 2008 and 2018. Cox regression was used for the analysis of predictors of events during follow-up. Results A total of 47,872 patients with transfemoral TAVR were included in the analysis (mean age 83±7 years). Moderate/severe MR was present at baseline (MRb) in 9.5% of the patients. Few patients (1.6%) revealed moderate/severe MR post-TAVR (MRpt). Mean follow-up was 1.31±1.61 years. MRb was associated with an increased cardiovascular mortality (Hazard ratio 1.29, 95% CI 1.20–1.39) and total mortality (Hazard ratio 1.15, 95% CI 1.10–1.21). However, MRb was not an independent predictor in multivariable analysis, neither for cardiovascular mortality (adjusted HR 1.06, 95% CI 0.98–1.14) nor for total mortality (adjusted HR 1.01, 95% CI 0.96–1.07). MRpt was not a predictor of cardiovascular or total mortality. Older age, male sex, history of pulmonary edema/cardiogenic shock, atrial fibrillation, myocardial infarction, diabetes, renal failure, liver disease, pulmonary disease, previous cancer and anemia at baseline independently predicted mortality during follow-up. All of them (but history of cancer) were also independent predictor of cardiovascular death. Conclusion Baseline MR was associated with increased cardiovascular and totality mortality following TAVR but was not an independent predictor of any of them. By contrast, several other predictors of cardiovascular and total mortality were identified. This suggests that MR should not be directly considered to establish the strategy for TAVR decision or for avoiding TAVR-related futility.

Atrial fibrillation (AF) may be associated with sinus node disease (SND) presenting as a brady-tachy syndrome (BTS), known to be at risk for embolic ischemic stroke (IS). It remains unclear whether the risk of IS is increased in patients with isolated SND. Methods This French longitudinal cohort study was based on the national database covering hospital care from for the entire population (PMSI) from 2010 to 2015. We compared incidences of IS in patients with a diagnosis of AF or SND to that in a control group of patients with a main diagnosis of cardiac condition (excluding those with AF or SND, history of stroke and mechanical valve or mitral stenosis). Results Of 1,732,412 patients included in the cohort, 1,601,435 (92.44%) had isolated AF, 102,849 (5.94%) had isolated SND and 28,128 (1.62%) had BTS. The control group with cardiac condition included 479,108 patients. Incidence of IS progressively increased when considering patients from the control population, patients with isolated SND, with BTS or with isolated AF (0.67%/yr, 1.95%/yr, 3.03%/yr and 5.48%/yr respectively). These differences were seen in all strata of CHA2DS2VASc score (table). SND patients with a CHA2DS2-VASc score ≥3 had a yearly incidence of IS >2%, comparable to AF population with a CHA2DS2-VASc score ≥1. Incidence (%/year) of ischemic stroke CHA2DS2-VASc AF population SND population “Control” population Women Men Women Men Women Men All scores 6.72% 4.37% 1.93% 1.96% 0.67% 0.68% Score = 0 – 1.960% – 1.211% – 0.217% Score = 1 2.337% 3.046% 0.538% 1.486% 0.166% 0.345% Score = 2 3.917% 4.499% 0.879% 1.541% 0.298% 0.580% Score = 3 7.572% 4.733% 2.207% 2.084% 0.541% 0.907% Score = 4 7.016% 4.820% 2.363% 2.305% 0.930% 1.278% Score = 5 6.725% 5.345% 2.845% 2.849% 1.249% 1.553% Score = 6 7.637% 7.543% 3.319% 4.109% 1.737% 2.031% Score = 7 10.196% 13.927% 4.663% 7.708% 2.346% 4.089% Score = 8 17.654% 12.607% 8.519% 11.904% 2.446% 2.355% Conclusion Patients with isolated SND had a lower risk of IS than patients with AF or BTS. However, SND patients had a non-neglectable risk of IS during follow-up which was higher than in a “control” population. Whether oral anticoagulation may bring a significant clinical benefit might be studied in patients with SND at highest risk of IS.

Atrial fibrillation (AF) is associated with a higher mortality, but modes of death may vary and their respective predictors have been insufficiently defined. Charlson comorbidity index (CCI) is a tool to measure comorbid disease status and a strong estimator of mortality. The quantifiable frailty phenotype is also predictive of mortality and disability and claims data can be used to classify individuals as frail and non-frail using the Claims-based Frailty Index (CFI). We evaluated whether these tools may help to predict mortality and the different modes of death in AF. Methods All patients with AF seen in an academic institution were identified and followed up for mortality. CHA2DS2VASc score, CCI and CFI were calculated for each patient. Predictive abilities of the scores were compared using the c-statistic. Results Among 8962 consecutive patients with AF, 1294 patients died during a follow-up of 929±1082 days (median 456), (yearly rate 5.5%) and 97% of causes of death were identified (54% cardiovascular and 43% non-cardiovascular). Death occurred more often in patients with higher CHA2DS2VASc scores, CCI and CFI. CFI was a better predictor of total mortality than CCI and CHA2DS2VASc score (table). CFI was also a better predictor of cardiovascular mortality than CCI and CHA2DS2VASc score. Finally, CFI was also a better predictor of non-cardiovascular mortality than CCI and CHA2DS2VASc score. The predictive performances of the 3 tools were better for cardiovascular death than for non-cardiovascular death. Prediction of mode of death ROC area (95% C) p vs CHA2DS2VASc/Charlson Total mortality CHA2DS2VASc 0.651 (0.636–0.665) – / 0.0001 CHARLSON (CCI) 0.687 (0.672–0.702) 0.0001 / – Frailty index (CFI) 0.714 (0.700–0.729) Conclusion Frailty assessed with CFI demonstrated better performances in predicting total mortality, cardiovascular mortality and non-cardiovascular mortality than CHA2DS2VASc score and Charlson comorbidity index in AF patients. Identifying the risk of non-cardiovascular death with simple tools remains a more difficult challenge in these patients.

Background Catheter ablation for atrial fibrillation (AF) is a validated therapy for patients with symptomatic AF to prevent recurrences. The CASTLE AF trial indicated that ablation for AF in patients with heart failure (HF) was associated with a lower rate of death from any cause or hospitalization for worsening HF than was medical therapy. The purpose of our study was to compare the incidence of these events in AF patients with HF after AF catheter ablation versus those not treated with AF ablation at a nationwide level in centers possibly less well experienced. Methods This French longitudinal cohort study was based on the national hospitalization PMSI (Programme de Médicalisation des Systèmes d'Information) database covering hospital care from the entire population. We included all patients, over 18 years old, with AF and HF from January 2010 to December 2015. Crude event rates were ascertained and hazard ratios (HR) were estimated using Cox proportional hazards risk model. Propensity-matched Cox regression was also used to compare event rates according to AF ablation usage status. Results Among the 261,449 patients identified with AF and HF, 1,270 patients were treated with AF ablation (24% female, mean age 63±10 yo) and 260,179 did not have AF ablation (45% female, mean age 79±11 yo). During follow-up (417±502 days), there were 56,981 hospitalizations with a primary diagnosis of HF and 81,393 deaths were recorded. Incidence of hospitalization for HF was significantly lower in patients with AF ablation than in those with no ablation (13.74% vs 51.11% person per year respectively, p Conclusion In the nationwide analysis of unselected AF patients with HF seen in hospitals, AF ablation was independently associated with a lower risk of hospitalization for HF and death. This provides “real world” data consistent with those observed in recent trials with lower numbers of highly selected patients

Introduction Brugada syndrome (BrS) is an inherited arrhythmia syndrome with an increased risk of sudden cardiac death (SCD). The recent single lead-based diagnosis of Brugada syndrome recommended criterion may lead to overdiagnosis of Brugada syndrome and overestimation of the risk of SCD. Objective We aim to investigate the value of a single lead diagnosis in spontaneous type 1 ECG Brugada patient and to investigate the association between the number of ECG leads with a spontaneous type 1 ST elevation and the arrhythmic risk. Methods Consecutive patients affected with BrS were recruited in a multicentric prospective registry in France (15 centers) between 1994 and 2016. A total of 1613 patients affected by the Brugada syndrome were enrolled. For this specific study, only patient with a spontaneous type 1 BrS were enrolled (n=505). Data were prospectively collected with an average follow-up of 6.5±4.7 years. ECGs were reviewed by 2 physicians blinded to clinical status. Type 1 ST elevation was defined by ≥2 mm J-point elevation with coved ST segment and negative T wave. Results A total of 505 patients with a spontaneous type 1 BrS (mean age 46±15 years, 398 males, 79%) were enrolled. 117 patients (23%) were symptomatic at baseline (32 (6%) aborted SCD, 85 (17%) syncope). Implantable cardiac defibrillator (ICD) was implanted in 191 patients (38%). Brugada ECG pattern was found in 1 lead in 250 patients (50%, group 1), in 2 leads in 227 patients (45%, group 2) and in 3 leads in 28 patients (5%, group 3). Groups were comparable in term of clinical presentation except for group 3 who presented more frequently an early repolarization pattern (n=19 (8%) in group 1, n=15 in group 2 (6%) and n=7 (25%) in group 3, p=0.02) and more frequently QRS fragmentation (n=6 (2%) in group 1, n=3 in group 2 (1%) and n=3 (11%) in group 3, p=0.03). During follow-up, 46 (9%) patients presented an arrhythmic event: 22 (9%) in group 1 (4 SCD, 14 appropriate ICD therapy, 4 ventricular arrhythmias), 22 (10%) in group 2 (6 SCD, 11 appropriate ICD therapy, 5 ventricular arrhythmias) and 2 (7%) in group 3 (1 SCD, 1 appropriate ICD therapy). Patients with type 1 BrS pattern in 2 or 3 ECG leads had not a significantly higher rate of arrhythmic events than patients with type 1 BrS pattern in only 1 ECG lead (HR: 1.1; 95% CI: 0.6–1.9 for group 2 and HR: 0.7; 95% CI: 0.2–3 for group 2; p=0,087). Conclusion In the largest cohort of BrS patients ever described, the prognosis of Brugada syndrome with a spontaneous ECG pattern does not appear to be affected by the number of leads required for diagnostic.