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

Author:

Botto Giovanni Luca1ORCID,Ziacchi Matteo2ORCID,Nigro Gerardo3ORCID,D’Onofrio Antonio4ORCID,Dello Russo Antonio5ORCID,Francia Pietro6ORCID,Viani Stefano7ORCID,Pisanò Ennio8ORCID,Bisignani Giovanni9,Caravati Fabrizio10ORCID,Migliore Federico11ORCID,De Filippo Paolo12,Ottaviano Luca13ORCID,Rordorf Roberto14ORCID,Manzo Michele15ORCID,Canevese Fabio Lorenzo1ORCID,Lovecchio Mariolina16,Valsecchi Sergio16ORCID,Checchi Luca17ORCID

Affiliation:

1. U.O. Electrophysiology, ASST Rhodense , Viale Carlo Forlanini 95, 20024 Garbagnate Milanese (MI) , Italy

2. Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Policlinico S.Orsola-Malpighi , Bologna , Italy

3. Department of Translational Medical Sciences, University of Campania ‘Luigi Vanvitelli,’ Monaldi Hospital , Naples , Italy

4. ‘Unità Operativa di Elettrofisiologia, Studio e Terapia delle Aritmie’, Monaldi Hospital , Naples , Italy

5. Cardiology and Arrhythmology Clinic, Università Politecnica delle Marche , Ancona , Italy

6. Cardiology, Department of Clinical and Molecular Medicine, Sapienza University, St Andrea Hospital , Rome , Italy

7. Second Cardiology Division, Department of Cardio-Thoracic and Vascular, University Hospital of Pisa , Pisa , Italy

8. Cardiology Division, ‘Vito Fazzi’ Hospital , Lecce , Italy

9. Division of Cardiology, Castrovillari Hospital , Cosenza , Italy

10. Department of Heart and Vessels, Ospedale di Circolo e Fondazione Macchi , Varese , Italy

11. Department of Cardiac, Thoracic Vascular Sciences and Public Health University of Padova , Padua , Italy

12. Cardiac Electrophysiology and Pacing Unit, Papa Giovanni XXIII Hospital , Bergamo , Italy

13. Arrhythmia and Electrophysiology Unit, Cardiothoracic Department, Istituto Clinico Sant'Ambrogio , Milan , Italy

14. Arrhythmia and Electrophysiology and Experimental Cardiology, IRCCS Fondazione Policlinico ‘S. Matteo’ , Pavia , Italy

15. Ospedali Riuniti San Giovanni di Dio e Ruggi d’Aragona , Salerno , Italy

16. Boston Scientific , Milan , Italy

17. University of Florence , Florence , Italy

Abstract

AbstractAimsA 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 resultsWe 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.ConclusionOur data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.Clinical trial registrationClinical Trial Registration: ClinicalTrials.gov; NCT02275637.

Publisher

Oxford University Press (OUP)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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