Extra-corporeal membrane oxygenation (ECMO) implantation is limited to specialized centres with cardiac surgery facilities. ECMO implantations in centres without on-site cardiovascular surgery facilities have been reported with ECMO system and surgeon dispatched from the referring hospital. We report the circumstances, feasibility, in-hospital complications and outcomes of ECMO implantation by an interventional cardiology team in a local hospital with a high-volume catheterization laboratory but without on-site cardiovascular surgery facilities Study hospital The Hospital Centre of Annecy hosts a catheterization laboratory available 24 hours a day, 7 days a week (24/7), with a team of 12 interventional cardiology nurses and four interventional cardiologists. The hospital catchment area covers a population of 900 000 people. One thousand to1200 percutaneous coronary interventions (PCIs) are performed annually. This local hospital does not have a cardiac surgery department. The nearest cardiac surgical hospital is located 100 km away.

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: Nationwide French Registry including all TOF patients with an ICD initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event endpoint was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (IQR) follow-up of 6.8 (2.5-11.4) years, 78 (47.3%) patients received at least one appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively, p=0.03). Overall, 71 (43.0%) patients presented with at least one ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) primary prevention patients, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with respectively no, one, two, or ≥ three guideline-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (HR 3.47, 95% CI 1.19-10.11), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 (p=0.006). Patients with congestive heart failure and/or reduced LVEF had a higher risk of non-arrhythmic death or heart transplantation (HR=11.01, 95% CI: 2.96-40.95). Conclusions: Patients with TOF and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03837574

BACKGROUND Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators.OBJECTIVE The purpose of this study was to assess IS reduction with the PARAD1 discrimination algorithm in a general population implanted for primary or secondary prevention. METHODS ISIS-ICD (Inappropriate Shock Reduction wIth PARAD1Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD1. IS (shocks not delivered for ventricular tachycardia or fibrillation) were independently adjudicated. The primary endpoint was percentage of IS-free patients at 24 months. Primary and worst-case analyses of annual incidence rates of patients with 1 IS, overall and per defibrillator type, were conducted. RESULTSIn total, 1013 patients (80.7% male; age 67.1 6 11.4 years; 68%/30%/2% primary/secondary/other indication) were enrolled and followed for a median of 552 days (interquartile range 354; 725). Of 993 analyzed patients programmed with PARAD1, 14 had 1 IS, corresponding to a percentage free from IS of 98.1% (95% confidence interval [CI] 96.8%-98.9%). Annual incidence rates (per 100 personyears) of patients with IS were 1.0 (95% CI 0.59-1.69) and 2.1 (95% CI 1.46-3.02) in the primary and worst-case analyses, respectively. In ICD patients, rates were 1.2 (95% CI 0.68-2.23) and 2.3 (95% CI 1.47-3.53), and in CRT-D patients 0.59 (95% CI 0.19-1.83) and 1.8 (95% CI 0.93-3.44) per 100 person-years.CONCLUSION The annual rate of defibrillator patients with IS using the enhanced PARAD1 discrimination algorithm alone ranged from 1.0 to 2.1 per 100 person-years in a general population implanted for primary or secondary prevention.

BACKGROUND Patients with atrial fibrillation (AF) often have sleep apnea (SA), but diagnosis of SA with polysomnography is costly. SA monitoring is a pacemaker feature that measures respiratory disturbance index, the sum of abnormal respiratory events divided by sleep duration. OBJECTIVE The purpose of this study was to evaluate the incidence and severity of SA and its association with AF in an unselected population fitted with pacemakers. METHODS RESPIRE (REgistry of Sleep APnea monItoring and Atrial Fibrillation in pacemakeR patients) was a multicenter, international, observational, open-label study following adult subjects for 18 months after implantation with an SA monitoring-enabled dual-chamber pacemaker. Severe SA was defined as average respiratory disturbance index 20 from implantation to follow-up visit. The first co-primary end point was the difference in significant AF (cumulative AF episodes lasting 24 hours over 2 consecutive days) between subjects with severe and those nonsevere SA at 12 months in the full analysis set (N 5 553). The second co-primary end point was the rate of major serious adverse events at 18 months in the modified intention-to-treat set (N 5 1024). RESULTS Severe SA was detected in 31.1% (172 of 553). A higher incidence of significant AF was reported in patients with severe SA than in patients with nonsevere SA (25.0% vs 13.9%; difference 11.1%; 95% confidence interval 3.7%-18.4%; P 5 .002). Significant AF increased with time in both groups, but at a faster rate in the severe SA group. No intergroup difference in the overall rate of major serious adverse events was observed (P 5 .065). CONCLUSION SA screening over 12 months identified severe SA in almost one-third of unselected patients fitted with pacemakers. Severe SA was associated with a higher incidence of significant AF.

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