Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Incidence of Premature Battery Depletion in Subcutaneous Cardioverter-Defibrillator Patients. Insights from a Multicenter Registry
J. Lüker1, M. Strik2, A. Raymond-Paquin3, M. H. ElRefai4, P. Roberts4, Ó. Cano Pérez5, J. Kron3, J. Koneru3, H. Franqui-Rivera6, A. Sultan1, A. Pott7, C. G. Veltmann8, J. Schmitt9, N. T. Srinivasan10, J. Collinson10, A. M. W. van Stipdonk11, D. Linz11, N. Fluschnik12, T. Tönnis13, A. Haeberlin14, S. Ploux2, D. Steven1
1Elektrophysiologie, Herzzentrum der Universität zu Köln, Köln; 2Cardio-Thoracic Unit, Bordeaux University Hospital (CHU), Pessac-Bordeaux, FR; 3Pauley Heart Center, Virginia Commonwealth University, Virginia, US; 4Division of Cardiology, University Hospital Southampton - NHS, Southampton, UK; 5Unidad de Arritmias, Servicio de Cardiología, Hospital Universitario y Politécnico La Fe, Valencia, ES; 6Department of Medicine, Cardiovascular Disease Division, University of Puerto Rico, San Juan - Puerto Rico, US; 7Klinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm; 8Kardiologie und Angiologie, Medizinische Hochschule Hannover, Hannover; 9Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 10Essex Cardiothoracic Centre, Basildon University Hospital, Basildon, UK; 11Department of Cardiology, Maastricht UMC+Heart+Vascular Center, Maastricht, NL; 12Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 13Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 14Department of Cardiology, Inselspital Bern, Bern, CH;

Introduction

A subset of more than 35,000 S-ICD is under a FDA advisory, warning of the potential of premature battery depletion (PBD) caused by a faulty low-voltage capacitor. Based on internal data, the manufacturer projects the incidence at 3.7% after 5 years. Data independent from the manufacturer is sparse. 

 

Methods

This study was a multicenter effort of 14 centers in Europe, the US, and Canada. Consecutive patients who received a S-ICD at the participating centers were included in this retrospective analysis. Patients with the 1010 S-ICD generator model, and those without available follow-up information were excluded. Data was collected and managed using REDCap electronic data capture tools hosted at the University Hospital Cologne. 

 

The primary endpoint was defended as device explantation, generator replacement, or generator failure. Reasons for explantation, replacement, or failure were collected. Device longevity was defined as the time from device insertion to the time of replacement, explantation, or failure, where applicable. Premature battery depletion was defined as the occurrence of battery depletion requiring generator replacement less than 60 months. 


Whether devices are under the PBD advisory was identified with the Boston Scientific serial number lookup tool.  

The study complies with the Declaration of Helsinki. Ethics committee approval was obtained. This study is registered with Clinicaltrials.gov (identifier NCT04767516).

Results

Data of n=1102 S-ICD devices were analyzed. The registry comprised of S-ICD generators implanted between 03/2015 and 09/2021 (43.4% A209 model and 56.6% A219 model). Of these, 611 devices (55.4%) were under advisory. The mean follow-up duration was 2.43±1.66 years.

 

During follow-up, 110 devices (10%) were explanted after 2.9±1.7 years. Battery depletion was the indication in n=52. The endpoint of PBD (battery depletion after less than 5 years) was met in 37 devices (6% of the devices under advisory), after 4.1±0.6 years. Device explantation for PBD occurred exclusively in devices affected by the PBD advisory.

 

In 58 cases, the S-ICD was explanted for reasons other than battery depletion. Infection (16), system upgrade (20), heart transplant or LVAD therapy (7), and inappropriate shocks or inappropriate sensing (7) were the most common indications.

 

Discussion

This registry provides a systematic and manufacturer independent analysis of premature battery depletion in S-ICD patients. In the affected devices, the incidence of PBD was 6%. This is higher than what is projected by the manufacturer. The rate of PBD increases notably around the 4-year mark. 

 

Conclusion

S-ICD generators suffer from PBD in the context of low-voltage capacitor failure at a higher incidence than previously reported. Patients equipped with these devices should be closely monitored, especially when approaching four years after implantation.
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