Search

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.

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.

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 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

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 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. 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 Conclusion Patients treated with leadless VVI pacemakers had better clinical outcomes in the first month compared to the patients treated with conventional VVI pacing. During a mid-term follow-up, risk of all-cause death, cardiovascular death and endocarditis in patients treated with leadless VVI pacemaker was not statistically different after propensity score matching.

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.

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic, Inc. OnBehalf Micra Acute Performance EMEA Investigators Background The first in-man implant of the Micra leadless pacemaker occurred in December 2013. While prior trials demonstrated a high implant success rate and favorable safety and efficacy results; whether the patient population and outcomes have changed over time is not well studied. Purpose To characterize the evolution of patient profile and outcomes for patients receiving a leadless pacemaker through the pre-market and post-market environment. Methods Patients undergoing a Micra leadless pacemaker implant attempt from the initial Micra Investigational Device Exemption [IDE] and current Micra studies (Micra post-approval registry [PAR], Micra acute performance [MAP] study) were analyzed. Patient characteristics and pericardial effusions regardless of severity were summarized. Results The 3466 patients included in the analysis underwent a Micra implant attempt and were enrolled during consecutive timeframes: patients from the Micra IDE study (n = 726) underwent a Micra implant attempt from 2013-2015, patients from the PAR (n = 1814) from 2015-2018, and patients from Micra MAP cohort (n = 926) from 2018 – 2020. Implant success was >99.0% in all 3 studies. Median age ranged from 78 – 79 years among the 3 studies without significant difference. There were more patients requiring dialysis in the MAP cohort compared to the PAR or IDE cohorts (10.3%, 7.9%, and 3.9%, respectively; P Conclusion Despite patient differences over time, the Micra leadless pacemaker was implanted with a high success rate and a low perforation rate, in-line with prior reports. Abstract Figure. Pericardial effusion rate by study

Background Sympathetic overactivity is implicated in the initiation and maintenance of electrical storm (ES). Deep sedation has empirically been considered as an efficient therapeutic option to blunt sympathetic tone and control ES. Purpose The aim of this multicenter study was to determine the efficacy of deep sedation in patients presenting intractable ES refractory to anti-arrhythmic drugs. Methods Patients requiring deep sedation for refractory ES from January 1st 2007 to July 31st 2018 were retrospectively included in 13 centers. The primary endpoint was the rate of acute response to sedation, defined as ES termination within 15 minutes after deep sedation. Results Among the 116 patients, 55 (47.4%) had ES termination within 15 minutes and were considered “acute responders” to deep sedation. Clinical signs of congestive heart failure before deep sedation (OR=3.31, 95% CI:1.001–10.97, p=0.049) was the only independent predictor of non-acute response. Twenty-one non-acute responders (34.4%) had an extracorporeal membrane oxygenation (ECMO) implanted. Non-acute responders had a significantly lower in-hospital survival (Log-rank, p=0.010). ECMO implantation did not influence survival in non-acute responders to sedation. Acute response to deep sedation was an independent protector of in-hospital mortality, decreasing by 73% the risk of death (OR 0.27; 95% CI:0.10–0.70, p=0.008). Conclusion To the best of our knowledge, this multicenter study is the first analysis of the efficacy of deep sedation in patients with intractable ES refractory to anti-arrhythmic drugs, and demonstrating the positive impact of “acute response” on in-hospital survival. 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

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 Frailty and multimorbidity are common in patients with atrial fibrillation (AF). The quantifiable frailty phenotype has been validated as predictive of mortality and disability, and patients can be categorised as frail and non-frail using the Claims-based Frailty Index (CFI). The Charlson comorbidity index (CCI) is a tool to quantify multimorbidity and also a strong estimator of mortality. We evaluated whether frailty and multimorbidity are associated with the risk of major bleeding in patients with AF. Methods Based on the administrative hospital-discharge database, we collected information for all patients with AF between 2010 and 2019 in France. CCI and CFI were calculated for each patient, and their associated risks of bleeding compared to 4 bleeding risk scores (HAS-BLED, HEMORR2HAGES, ATRIA and ORBIT). The analysis focused on patients with events or with at least one year of follow-up. Predictive abilities of the scores were compared in the whole population, and then separately in the subgroup of elderly patients (>75 yo). Results Among 1,372,567 patients with AF, 131,535 major bleeding events were recorded during a follow-up of 3.5±2.1 years (median 3.1, IQR 1.8–4.9) (yearly rate 2.7%). Bleeding occurred more commonly in patients with higher HAS-BLED, ATRIA, CCI and CFI scores. Those with high frailty and multimorbidity had markedly higher yearly incidences of bleeding events of 13.0% and 14.7%, respectively (vs low frailty and multimorbidity: 4.3%% and 4.1%, respectively; p Conclusion Multimorbidity 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. Funding Acknowledgement Type of funding source: None

Aims This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs. Methods and results A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Medicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were €20 623 and €23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients. Conclusion Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.

Aims Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P

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.

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.

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.

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

Aims Implantable cardioverter defibrillators (ICDs) are efficient in reducing mortality in patients with left ventricular systolic dysfunction. High-rate cut-off programming may be effective in reducing appropriate and inappropriate therapies, but as the long-term consequences on morbidity and mortality remain unclear, it is underutilized. Methods and results We prospectively studied 365 consecutive patients (mean age 60 ± 10 years), with ischaemic (63%) or non-ischaemic cardiomyopathy and left ventricular dysfunction (mean ejection fraction 25 ± 7%), who were implanted with an ICD in primary prevention of sudden cardiac death (41% single chamber, 31% dual chamber, and 28% biventricular). All devices were programmed with a shock-only zone over 220 beats per minute (b.p.m.) and a monitoring zone between 170 and 220 b.p.m. During a median follow-up of 40 months, 41 patients received appropriate shocks (11.2%) and 24 inappropriate shocks (6.6%). Then, 306 patients never experienced any ICD shock (84%). Inappropriate discharges were related to supraventricular tachyarrhythmia in 10 patients, and noise/oversensing in 14 patients. Ventricular tachycardia episodes, sustained or not, were recorded in the monitoring zone in 43 patients (11.8%). Seven of these patients were symptomatic (1.9%), without lethal consequence. Sixty-two patients (17%) died: 35 from end-stage heart failure, 1 from unexplained sudden death, and 26 from a documented non-cardiac cause. Conclusion High-rate cut-off (220 b.p.m.) shock-only ICD programming, in primary prevention patients with reduced left ventricular ejection fraction, appeared to be safe during a long-term follow-up. It also resulted in a very low rate of discharges, which are known to be deleterious in this population.

A 57-year-old woman with a previous history of mechanical mitral prosthesis surgery was referred for congestive heart failure complicating permanent atrial …