Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience / Gasperetti A., Schiavone M., Ziacchi M., Vogler J., Breitenstein A., Laredo M., Palmisano P., Ricciardi D., Mitacchione G., Compagnucci P., Bisignani A., Angeletti A., Casella M., Picarelli F., Fink T., Kaiser L., Hakmi S., Calo L., Pignalberi C., Santini L., et al.. - In: HEART RHYTHM. - ISSN 1547-5271. - STAMPA. - 18:(2021), pp. 2050-2058. [10.1016/j.hrthm.2021.07.008]
Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience
Olivotto I.;
2021
Abstract
Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion. Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort. Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue. Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0–62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8–37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3–3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028–1.100]; P <.001), chronic kidney disease (HR 1.960 [1.191–3.225]; P =.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; P =.043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967–0.994]; P =.007) and procedure performed in high-volume centers (HR 0.463 [0.300–0.715]; P =.001) were protective factors. Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
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