AIMS: To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices. METHODS AND RESULTS: Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS. CONCLUSION: In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.

Cardiology Angiology Hemostaseology and Internal Intensive Care Medicine Faculty of Medicine Mannheim University of Heidelberg Heidelberg Germany

Department of Cardiology 2 University Hospital Muenster Germany

Department of Cardiology Amsterdam University Medical Centers Amsterdam The Netherlands

Department of Cardiology Auckland City Hospital Auckland New Zealand

Department of Cardiology Erasmus Medical Center Rotterdam The Netherlands

Department of Cardiology King's College Hospital London UK

Department of Cardiology Na Homolce Hospital Prague Czechia

Department of Cardiology Russells Hall Hospital Dudley UK

Heart Center St Antonius Hospital Nieuwegein The Netherlands

Institute of Cardiovascular Science University College of London and Barts Heart Centre West Smithfield London EC1A 7BE UK

Rhythm Management Division Boston Scientific St Paul MN USA

Thorax Center Medical Spectrum Twente Enschede The Netherlands

Eur Heart J. 2022 Jun 1;43(21):2051-2053. doi: 10.1093/eurheartj/ehac137. PubMed

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