Rate and impact on patient outcome and healthcare utilization of complications requiring surgical revision: Subcutaneous versus transvenous implantable defibrillator therapy

• Published in: Journal of cardiovascular electrophysiology 2021-06, Vol.32 (6), p.1712-1723
• Main Authors: Palmisano, Pietro, Ziacchi, Matteo, Ammendola, Ernesto, D'Onofrio, Antonio, Dell'Era, Gabriele, Laffi, Mattia, Biffi, Mauro, Nigro, Gerardo, Bianchi, Walter, Prenna, Eleonora, Angeletti, Andrea, Guido, Alessandro, Stronati, Giulia, Gaggioli, Germano, Dello Russo, Antonio, Accogli, Michele, Guerra, Federico
• Format: Article
• Language: English
• Subjects: Clinical outcomes; complications; Defibrillators; Health services utilization; implantable cardioverter–defibrillator; outcomes; Patients; subcutaneous ICD; transvenous ICD
• ISSN: 1045-3873; 1540-8167
• DOI: 10.1111/jce.15080

Introduction Comparison data on management of device‐related complications and their impact on patient outcome and healthcare utilization between subcutaneous implantable cardioverter–defibrillator (S‐ICD) and transvenous ICD (TV‐ICD) are lacking. We designed this prospective, multicentre, observational registry to compare the rate, nature, and impact of long‐term device‐related complications requiring surgical revision on patient outcome and healthcare utilization between patients undergoing S‐ICD or TV‐ICD implantation. Methods and Results A total of 1099 consecutive patients who underwent S‐ICD or TV‐ICD implantation were enrolled. Propensity matching for baseline characteristics yielded 169 matched pairs. Rate, nature, management, and impact on patient outcome of device‐related complications were analyzed and compared between two groups. During a mean follow‐up of 30 months, device‐related complications requiring surgical revision were observed in 20 patients: 3 in S‐ICD group (1.8%) and 17 in TV‐ICD group (10.1%; p = .002). Compared with TV‐ICD patients, S‐ICD patients showed a significantly lower risk of lead‐related complications (0% vs. 5.9%; p = .002) and a similar risk of pocket‐related complications (0.6 vs. 2.4; p = .215) and device infection (0.6% vs. 1.2%; p = 1.000). Complications observed in S‐ICD patients resulted in a significantly lower number of complications‐related rehospitalizations (median 0 vs. 1; p = .013) and additional hospital treatment days (1.0 ± 1.0 vs. 6.5 ± 4.4 days; p = .048) compared with TV‐ICD patients. Conclusions Compared with TV‐ICD, S‐ICD is associated with a lower risk of complications, mainly due to a lower risk of lead‐related complications. The management of S‐ICD complications requires fewer and shorter rehospitalizations.