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 / Ricciardi D.; Ziacchi M.; Gasperetti A.; Schiavone M.; Picarelli F.; Diemberger I.; Bontempi L.; Di Belardino N.; Bisignani G.; De Bonis S.; Mitacchione G.; Calabrese V.; Lavalle C.; Piro A.; Pignalberi C.; Santini L.; Grigioni F.; Tondo C.; Biffi M.; Forleo G.B.. - In: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. - ISSN 1045-3873. - STAMPA. - 32:2(2021), pp. 468-476. [10.1111/jce.14833]
Clinical impact of defibrillation testing in a real-world S-ICD population: Data from the ELISIR registry
Ziacchi M.;Diemberger I.;
2021
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
