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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

BackgroundThe literature data on the outcomes of radiofrequency catheter ablation for atrial fibrillation (AF) in women are contradictory.AimTo determine and compare the outcomes and complications of cryoballoon pulmonary vein isolation (cryo-PVI) in men vs. women, and to identify predictors of atrial tachyarrhythmia (ATa) recurrence.MethodsWe included all consecutive patients having undergone cryo-PVI for the treatment of symptomatic AF in our center since 2012. Peri-operative complications were documented. All patients were prospectively monitored for the recurrence of ATa, and predictors were assessed.ResultsA total of 733 patients were included (550 men (75%) and 183 (25%) women). Paroxysmal AF was recorded in 112 (61%) female patients and 252 male patients (46%; p < 0.001). Female patients were older (p < 0.001) and had a greater symptom burden (p = 0.04). Female patients were more likely to experience complications (p = 0.02). After cryo-PVI for paroxysmal AF, 66% of the female patients and 79% of the male patients were free of ATa at 24 months (p = 0.001). Female sex was the only independent predictive factor for ATa recurrence (hazard ratio [95% confidence interval] = 1.87 [1.28; 2.73]; p = 0.001). After cryo-PVI for non-paroxysmal AF, 37% of the male patients and 39% of the female patients were free of ATa at 36 months (p = 0.73). Female patients were less likely than male patients to undergo repeat ablation after an index cryo-PVI for non-paroxysmal AF (p = 0.019).ConclusionA single cryo-PVI procedure for paroxysmal AF was significantly less successful in female patients than in male patients. Overall, the complication rate was higher in women than in men.

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