Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02180-w
Subcutaneous Implantable Cardioverter-Defibrillator Generator Removal: a Multicenter Analysis
J. Lüker1, M. Strik2, J. Andrade3, A. Raymond Paquin4, M. H. Elrefai5, P. R. Roberts5, Ó. Cano Pérez6, J. Kron7, J. Koneru7, H. Franqui Rivera8, A. Sultan1, A. Ernst9, J. Schmitt10, A. Pott11, C. G. Veltmann12, N. T. Srinivasan13, J. Collinson13, A. M. W. van Stipdonk14, D. Linz15, N. Fluschnik16, T. Tönnis17, A. Haeberlin18, S. Ploux2, D. Steven1
1Elektrophysiologie, Herzzentrum der Universität zu Köln, Köln; 2Cardio-Thoracic Unit, Bordeaux University Hospital (CHU), Pessac-Bordeaux, FR; 3Center for Cardiovascular Innovation, University of British Columbia, Vancouver, CA; 4Montreal Heart Institute, Université de Montréal, Quebec; 5Division of Cardiology, University Hospital Southampton NHS Foundation Hospital Trust, Southampton, UK; 6Unidad de Arritmias, Área de Enfermedades Cardiovasculares, Hospital Universitari i Politècnic La Fe Valencia, Valencia, ES; 7Pauley Heart Center, Virginia Commonwealth University, Richmond, US; 8Department of Medicine, Cardiovascular Disease Division,, University of Puerto Rico, San Juan, Puerto Rico, US; 9Institute of Medical Statistics and Computational Biology (IMSB), University Hospital Cologne / University of Cologne, Köln; 10Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 11Klinik für Innere Medizin II, Universitätsklinikum Ulm, Ulm; 12Elektrophysiologie Bremen, Bremen; 13Department of Cardiac Electrophysiology, Essex Cardiothoracic Centre, Basildon, UK; 14Cardiovascular Research Institute, Maastricht University, Maastricht, NL; 15Department of Cardiology, Maastricht UMC+Heart+Vascular Center, Maastricht, NL; 16Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 17Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg; 18Universitätsklinik für Kardiologie, Inselspital - Universitätsspital Bern, Bern, CH;

Introduction

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was a significant recent advance in sudden cardiac death prevention. Device-related complications, including infection or lead fracture sometimes necessitate device removal. Real-world multicenter data on S-ICD removal are sparse. This multicenter analysis sought to assess the incidence and indications for S-ICD generator removal at 14 centers in the US, Canada, and Europe.

 

Methods

Retrospective data and the most recent follow-up data on S-ICD devices implanted at the participating centers, and information on subsequent device removal was submitted to an online database. Limited baseline patient information and the incidence of and reasons for S-ICD generator removal or failure were reported.  Premature device removal was defined as explantation within 5 years.

Results

Data from 1106 devices was analyzed. Devices were implanted between 10/2009 and 04/2021 at the participating centers. The first-generation model 1010 generator was implanted in 55 (5%), the newer models A209 or A219 were implanted in 457 (41.3%) and 594 (53.7%) respectively.

Patients were aged 46.7±16.1 years and the indication for ICD therapy was primary prevention in 616 (55.7%) and secondary prevention in 484 (43.8%). During the follow-up period, 37 (3%) patients deceased, and 96 patients were excluded from the analysis due to lack of follow-up (<4 weeks).

 

Premature device removal was performed in 103 (9.3%) during the follow-up period of 31.3±19.5 months. The most common reasons for premature explantation was premature battery depletion (57%), upgrade to transvenous ICD (17%) and infection (11%). Other indications explantation included heart transplantation (4.3%) or ventricular assist device implantation (1.4%),  noise detection or inappropriate shocks (6.5%), and patient discomfort (0.7%). (Fig.1)

 

Regular battery depletion occurred in 34 devices after a mean±std of 69.2±5.3 months. There was no difference in device longevity between the different generator models (1010, A209, and A219).

 

Conclusions

In this real-world retrospective multicenter analysis, premature generator removal occurred in 9.3% of patients. The need for pacing, infections, abnormal sensing, and premature battery depletion were the most common indications for early S-ICD generator removal.
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