Occurrence of Premature Battery Depletion in a Large Multicenter Registry of Subcutaneous Cardioverter-Defibrillator Patients.

AIMS AND BACKGROUND: Subcutaneous implantable cardioverter-defibrillators (S-ICD) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD) which led to an advisory for nearly 40,000 patients. This multicenter study evaluated the incidence of PBD in a large set of S-ICD patients.

METHODS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across 9 centers in Europe and the USA was reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity were analyzed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data was obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on clinicaltrials.gov (NCT05713708).

RESULTS: Of the 1,112 S-ICD devices analyzed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under FDA advisory. The median follow-up time for all patients was 46 (IQR 24-63) months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.

CONCLUSION: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.