Sex Differences in Outcomes of Tetralogy of Fallot Patients With Implantable Cardioverter-Defibrillators.

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

Can permanent His bundle pacing be safely started by operators new to this technique? Data from a multicenter registry.

BACKGROUND: Right ventricular pacing (RVP) induces ventricular asynchrony in patients with normal QRS and increases the risk of heart failure and atrial fibrillation in long term. His bundle pacing (HBP) is a physiological alternative to RVP, and could overcome its drawbacks. Recent studies assessed the feasibility and safety of HBP in expert centers with a vast experience of this technique. These results may not apply to less experienced centers. We aim to evaluate the feasibility and safety of permanent HBP performed by physicians who are new to this technique. METHODS: We included all patients who underwent pacemaker implantation with attempt of HBP in three hospitals between September 2017 and January 2020. Indication for HBP was left to operators' discretion. All the operators were new for HBP. His bundle (HB) electrical parameters were recorded at implant, 3- and 12-month follow-up. RESULTS: HBP was successful in 141 of 170 patients (82.9%); selective HBP was obtained in 96 patients and nonselective HBP in 45. The mean procedure and fluoroscopy durations were 67.0 ± 28.8 min, and 7.3 ± 8.1 min (3.1 ± 4.1 Gy·cm2 ), respectively. The mean HB paced QRS duration was 106 ± 18 ms. The mean HB capture threshold was 1.29 ± 0.77 V and did not increase at 3- and 12-month follow-up. The ventricular lead revision was required in five patients. Our results showed a rapid technical learning allowing a high procedure success rate (89.8%) after 15 procedures. CONCLUSION: HBP performed by operators new to this technique appeared feasible and safe. This should encourage HBP to be performed in patients expected to experience high RVP burden.