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Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study

Lambiase, Pier D; Theuns, Dominic A; Murgatroyd, Francis; Barr, Craig; Eckardt, Lars; Neuzil, Petr; Scholten, Marcoen; ... Boersma, Lucas VA; + view all (2022) Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study. European Heart Journal 10.1093/eurheartj/ehab921. (In press). Green open access

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Abstract

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. KEY QUESTION: Is subcutaneous implantable cardioverter-defibrillator (S-ICD) shock efficacy maintained over time? KEY FINDING: Subcutaneous implantable cardioverter-defibrillator shock efficacy remains high for discrete and storm episodes. For discrete episodes first and final shock efficacy do not change over time or by rhythm type. TAKE-HOME MESSAGE: The EFFORTLESS study 5-year results provide the longest follow up of a large patient cohort implanted with the S-ICD. For 984 patients with a median follow-up of 5.1 years, the S-ICD maintains a high level of shock efficacy of 98%.

Type: Article
Title: Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/eurheartj/ehab921
Publisher version: https://doi.org/10.1093/eurheartj/ehab921
Language: English
Additional information: © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/).
Keywords: Implantable cardioverter-defibrillator, Primary prevention, Secondary prevention, Subcutaneous ICD, Sudden death
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science > Clinical Science
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
URI: https://discovery.ucl.ac.uk/id/eprint/10143543
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