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Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study

AIMS: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generato...

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Autores principales: Botto, Giovanni Luca, Ziacchi, Matteo, Nigro, Gerardo, D’Onofrio, Antonio, Dello Russo, Antonio, Francia, Pietro, Viani, Stefano, Pisanò, Ennio, Bisignani, Giovanni, Caravati, Fabrizio, Migliore, Federico, De Filippo, Paolo, Ottaviano, Luca, Rordorf, Roberto, Manzo, Michele, Canevese, Fabio Lorenzo, Lovecchio, Mariolina, Valsecchi, Sergio, Checchi, Luca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10105850/
https://www.ncbi.nlm.nih.gov/pubmed/36794691
http://dx.doi.org/10.1093/europace/euad028
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author Botto, Giovanni Luca
Ziacchi, Matteo
Nigro, Gerardo
D’Onofrio, Antonio
Dello Russo, Antonio
Francia, Pietro
Viani, Stefano
Pisanò, Ennio
Bisignani, Giovanni
Caravati, Fabrizio
Migliore, Federico
De Filippo, Paolo
Ottaviano, Luca
Rordorf, Roberto
Manzo, Michele
Canevese, Fabio Lorenzo
Lovecchio, Mariolina
Valsecchi, Sergio
Checchi, Luca
author_facet Botto, Giovanni Luca
Ziacchi, Matteo
Nigro, Gerardo
D’Onofrio, Antonio
Dello Russo, Antonio
Francia, Pietro
Viani, Stefano
Pisanò, Ennio
Bisignani, Giovanni
Caravati, Fabrizio
Migliore, Federico
De Filippo, Paolo
Ottaviano, Luca
Rordorf, Roberto
Manzo, Michele
Canevese, Fabio Lorenzo
Lovecchio, Mariolina
Valsecchi, Sergio
Checchi, Luca
author_sort Botto, Giovanni Luca
collection PubMed
description AIMS: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. METHODS AND RESULTS: We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17–0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30–0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50–1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. CONCLUSION: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.
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spelling pubmed-101058502023-04-17 Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study Botto, Giovanni Luca Ziacchi, Matteo Nigro, Gerardo D’Onofrio, Antonio Dello Russo, Antonio Francia, Pietro Viani, Stefano Pisanò, Ennio Bisignani, Giovanni Caravati, Fabrizio Migliore, Federico De Filippo, Paolo Ottaviano, Luca Rordorf, Roberto Manzo, Michele Canevese, Fabio Lorenzo Lovecchio, Mariolina Valsecchi, Sergio Checchi, Luca Europace Clinical Research AIMS: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. METHODS AND RESULTS: We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17–0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30–0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50–1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. CONCLUSION: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. CLINICAL TRIAL REGISTRATION: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637. Oxford University Press 2023-02-16 /pmc/articles/PMC10105850/ /pubmed/36794691 http://dx.doi.org/10.1093/europace/euad028 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Clinical Research
Botto, Giovanni Luca
Ziacchi, Matteo
Nigro, Gerardo
D’Onofrio, Antonio
Dello Russo, Antonio
Francia, Pietro
Viani, Stefano
Pisanò, Ennio
Bisignani, Giovanni
Caravati, Fabrizio
Migliore, Federico
De Filippo, Paolo
Ottaviano, Luca
Rordorf, Roberto
Manzo, Michele
Canevese, Fabio Lorenzo
Lovecchio, Mariolina
Valsecchi, Sergio
Checchi, Luca
Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title_full Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title_fullStr Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title_full_unstemmed Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title_short Intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
title_sort intermuscular technique for implantation of the subcutaneous implantable defibrillator: a propensity-matched case–control study
topic Clinical Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10105850/
https://www.ncbi.nlm.nih.gov/pubmed/36794691
http://dx.doi.org/10.1093/europace/euad028
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