P2279First clinical evaluation of subcutaneous implantable cardiac defibrillator in Brugada patients

• Published in: European heart journal Vol. 40; no. Supplement_1
• Main Authors: Probst, V, Clerici, G, Babuty, D, Badenco, N, Marquie, C, Leenhardt, A, Maury, P, Blangy, H, Deharo, J C, Tfelt-Hansen, J, Rudic, B, Behar, N, Mansourati, J, Sacher, F, Gourraud, J B
• Format: Journal Article
• Language: English
• Published: Oxford University Press 01-10-2019
• Subjects: Implantable Cardioverter / Defibrillator
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehz748.0756

Abstract
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 specific 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 112 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 95 (85%) males. Implantation was performed in 91 (83%) patients for primary prevention and in 18 (16%) patients for secondary prevention. There is an indication of ICD replacement for 16 patients (14%): 13 lead defect (81%), 1 infection (6%) and 2 ICD end of life (13%). In this cohort, 57 patients (51%) had spontaneous type I BrS, 60 patients (55%) were symptomatic: 10 resuscitated SCD (17%) and 48 (83%) syncope.
Implantation was performed under general anesthesia in 79 patients (71%). The mean operation time was 56±19 min. The lead was placed at the left side of the sternum in 102 patients (92%) and at the right side in 9 (8%). Sensing configuration was the primary vector for 46 patients (41%), secondary vector for 57 (51%) and alternative vector for 9 (8%). No complications occurred during implantation.
During a mean follow-up of 15.6 months (0–39 months), 6 patients (5%) had at least one appropriate shock (n=9). The rate of appropriate shock was 4.5%/y. All the VF episodes were successfully treated with the first shock. One patient had VF ablation for recurrent VF. Among the 6 patients who received an appropriate shock, 3 (50%) were implanted for secondary prevention and 3 (50%) were implanted for primary prevention including 2 patients with a history of syncope and one asymptomatic patient.
Twelve patients (11%) had at least one inappropriate shock (n=22) 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 2 years. The rate of inappropriate shock was 9%/y. One patient died of myocardial infarction.
Five patients (4%) were hospitalized for complications (4 pocket or scar infections and 1 electrode failure).
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 9%/y. In view of these results, S-ICD implantation seems to be efficient to protect BrS patients against SCD.
Acknowledgement/Funding
Investigator-Sponsored Research program, Boston Scientific