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Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study
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...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9156377/ https://www.ncbi.nlm.nih.gov/pubmed/35090007 http://dx.doi.org/10.1093/eurheartj/ehab921 |
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author | Lambiase, Pier D Theuns, Dominic A Murgatroyd, Francis Barr, Craig Eckardt, Lars Neuzil, Petr Scholten, Marcoen Hood, Margaret Kuschyk, Jȕrgen Brisben, Amy J Carter, Nathan Stivland, Timothy M Knops, Reinoud Boersma, Lucas V A |
author_facet | Lambiase, Pier D Theuns, Dominic A Murgatroyd, Francis Barr, Craig Eckardt, Lars Neuzil, Petr Scholten, Marcoen Hood, Margaret Kuschyk, Jȕrgen Brisben, Amy J Carter, Nathan Stivland, Timothy M Knops, Reinoud Boersma, Lucas V A |
author_sort | Lambiase, Pier D |
collection | PubMed |
description | 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/m(2), 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. |
format | Online Article Text |
id | pubmed-9156377 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-91563772022-06-04 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 Hood, Margaret Kuschyk, Jȕrgen Brisben, Amy J Carter, Nathan Stivland, Timothy M Knops, Reinoud Boersma, Lucas V A Eur Heart J Clinical Research 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/m(2), 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. Oxford University Press 2022-01-28 /pmc/articles/PMC9156377/ /pubmed/35090007 http://dx.doi.org/10.1093/eurheartj/ehab921 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Clinical Research Lambiase, Pier D Theuns, Dominic A Murgatroyd, Francis Barr, Craig Eckardt, Lars Neuzil, Petr Scholten, Marcoen Hood, Margaret Kuschyk, Jȕrgen Brisben, Amy J Carter, Nathan Stivland, Timothy M Knops, Reinoud Boersma, Lucas V A Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title | Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title_full | Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title_fullStr | Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title_full_unstemmed | Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title_short | Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study |
title_sort | subcutaneous implantable cardioverter-defibrillators: long-term results of the effortless study |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9156377/ https://www.ncbi.nlm.nih.gov/pubmed/35090007 http://dx.doi.org/10.1093/eurheartj/ehab921 |
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