Background: Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S-ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real-world data show a growing trend in avoidance of DT after S-ICD implantation. Methods: All patients undergoing S-ICD implant at nine associated Italian centers joining in the ELISIR registry (ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long-term follow-up events were recorded and compared to report the long-term efficacy and safety of S-ICD implantations without DT in a real-world setting. Results: A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT- group). Over a median follow-up of 19 (11-31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S-ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). Conclusion: Implanting an S-ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.

Clinical impact of defibrillation testing in a real-world S-ICD population : Data from the ELISIR registry / D. Ricciardi, M. Ziacchi, A. Gasperetti, M. Schiavone, F. Picarelli, I. Diemberger, L. Bontempi, N. Di Belardino, G. Bisignani, S. De Bonis, G. Mitacchione, V. Calabrese, C. Lavalle, A. Piro, C. Pignalberi, L. Santini, F. Grigioni, C. Tondo, M. Biffi, G.B. Forleo. - In: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. - ISSN 1045-3873. - (2020 Dec 09). [Epub ahead of print] [10.1111/jce.14833]

Clinical impact of defibrillation testing in a real-world S-ICD population : Data from the ELISIR registry

A. Gasperetti
;
M. Schiavone;C. Tondo;
2020

Abstract

Background: Current guidelines recommend defibrillation testing (DT) performance in patients with a subcutaneous implantable cardioverter defibrillator (S-ICD), theoretically to reduce the amount of ineffective shocks. DT, however, has been proven unnecessary in transvenous ICD and real-world data show a growing trend in avoidance of DT after S-ICD implantation. Methods: All patients undergoing S-ICD implant at nine associated Italian centers joining in the ELISIR registry (ClinicalTrials.gov Identifier: NCT04373876) were enrolled and classified upon DT performance. Long-term follow-up events were recorded and compared to report the long-term efficacy and safety of S-ICD implantations without DT in a real-world setting. Results: A total of 420 patients (54.0 ± 15.5 years, 80.0% male) were enrolled in the study. A DT was performed in 254 (60.5%) patients (DT+ group), while in 166 (39.5%) was avoided (DT- group). Over a median follow-up of 19 (11-31) months, a very low rate (0.7%) of ineffective shocks was observed, and no significant differences in the primary combined arrhythmic outcome were observed between the two groups (p = .656). At regression analysis, the only clinical predictor associated with the primary combined outcome was S-ICD placement for primary prevention (odds ratio: 0.42; p = .013); DT performance instead was not associated with a reduction in primary outcome (p = .375). Conclusion: Implanting an S-ICD without DT does not appear to impact the safety of defibrillation therapy and overall patients' survival.
DFT; defibrillation testing; subcutaneous device; subcutaneous implantable cardioverter defibrillator
Settore MED/11 - Malattie dell'Apparato Cardiovascolare
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/807148
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