Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial

Abstract

Background The subcutaneous ICD (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. Methods The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections and the need for invasive interventions. Results Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group 49 complications occurred in 44 patients of which lead-dysfunction was most frequent (HR 0.69; P =0.11). In both groups half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared to the TV-ICD group (P <0.001, P =0.03 respectively). Significantly more complications required invasive interventions in the TV-ICD group compared to the S-ICD group (8.3% vs. 4.3%, HR 0.59; P =0.047). Conclusions This secondary analysis shows that, lead-related complications and systemic infections are more prevalent in the TV-ICD group compared to the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision making in clinical practice.

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

“… 5 Although there was no significant difference between S-ICD and transvenous ICD in overall device-related complications in the PRAETORIAN trial, 5 a recent secondary analysis showed that complications in the transvenous ICD group were more severe as they required significantly more often an invasive intervention. 16 The present analysis revealed a decrease in the rate of complications from 4.6% in the SC group to 1.0% in the IM group, demonstrating an even better safety profile of the S-ICD when new implantation techniques are adopted. The components that seem to have determined this result are a lower need for reinterventions aimed at improving defibrillation efficacy and shock impedance and fewer revisions for pocket infections or patient discomfort, in agreement with preliminary findings on the benefits of the IM technique for implantation of the S-ICD.…”

NL-EVDR: Netherlands—ExtraVascular Device Registry

“…Safety and efficacy at up to 5 years follow-up have been demonstrated in large registries [10,11]. In a previous RCT, the S-ICD was proven non-inferior to the transvenous ICD with respect to all device-related complications over more than 4 years of follow-up, with fewer lead-related complications and systemic infections [5,12]. The LP is a miniaturised pacemaker implanted via the femoral (or jugular) vein that is fully contained within in the heart.…”

Update on Cardiovascular Implantable Electronic Device Infections and Their Prevention, Diagnosis, and Management: A Scientific Statement From the American Heart Association

“…59 In a subanalysis from the PRAETORIAN randomized controlled study (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy), the S-ICD had a lower rate of lead-related complications and systemic infections compared with the transvenous ICD. 60 Likewise, the ATLAS trial (Assessment of Treatment with Lisinopril and Survival) showed a lower rate of lead-related complications, including infections with the S-ICD compared with transvenous ICD. 67 Implantation of a S-ICD may be considered among patients with ICD indications with high risk of infection (ie, previous CIED infection or IE, hemodialysis-dependent kidney disease, immunocompromisation, and congenital heart disease 68 ).…”