Long term complications in patients implanted with subcutaneous implantable defibrillators Real-world data from the Extended ELISIR experience

Background Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 77.6% men; 30.9% ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P = .000), chronic kidney disease (HR 1.960 [1.191–3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P = .001) were protective factors. Conclusion The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.