Background: Brugada syndrome (BrS) is an inherited arrhythmia syndrome with an increased risk of SCD. While Subcutaneous ICD (S-ICD) is a seductive approach to treat these patients, questions raised on the risk of inappropriate shock in this population.
Objective: The aim of this study was to evaluate the safety and the effectiveness of the S-ICD in BrS patients.
Methods: We prospectively enrolled 130 BrS patients implanted with S-ICD in 17 European centers. During the screening at least 2 vectors must be suitable but it was not necessary to check for the suitability of the ECG during sodium channel blocker or exercise test. S-ICD indications follow the current guidelines.
Results: Mean age of patients was 45 ± 13 years, with 110 (85%) males. Implantation was performed in 107 (82%) patients for primary prevention and in 22 (17%) for secondary prevention. In this cohort, 66 patients (51%) had spontaneous type I BrS, 69 (53%) were symptomatic: 12 resuscitated SCD (17%) and 57 syncope (83%). Implantation was performed under general anesthesia in 92 patients (71%). Sensing configuration was the primary vector for 55 patients (43%), secondary vector for 64 (50%) and alternative vector for 10 (8%). No complications occurred during implantation. During a median follow-up of 23.8 months (0.2-55 months), 7 patients (5.4%) had at least one appropriate shock (n=10). The mean rate of appropriate shock was 2.8%/y. All the VF episodes were successfully treated with the first shock. One patient had VF ablation for recurrent VF. 17 patients (13%) had at least one inappropriate shock (n=27) including 2 patients with respectively 8 and 4 inappropriate shocks due to T-wave oversensing. With the SMART pass system the first patient had no more inappropriate shock for now 3 years. The mean rate of inappropriate shock was 6.9%/y. Five patients (3.8%) presented infection and one (0.8%) electrode failure. Seven patients were explanted (infection (n=3, 2.3%), inappropriate shock (n=4, 3.1%)). One patient died of myocardial infarction.
Conclusion: Our initial experience showed that S-ICD is efficient to treat VF episode in BrS patients. In this population, the rate of inappropriate shock was 7%/y. In view of these results, S-ICD implantation seems to be efficient to protect BrS patients against SCD.