Subcutaneous Versus Transvenous Implantable Defibrillator Therapy: A Systematic Review and Meta‐Analysis of Randomized Trials and Propensity Score–Matched Studies

BACKGROUND: Subcutaneous implantable cardioverter‐defibrillators (S‐ICDs) have been of great interest as an alternative to transvenous implantable cardioverter‐defibrillators (TV‐ICDs). No meta‐analyses synthesizing data from high‐quality studies have yet been published. METHODS AND RESULTS: An electronic literature search was conducted to retrieve randomized controlled trials or propensity score–matched studies comparing S‐ICD against TV‐ICD in patients with an implantable cardioverter‐defibrillator indication. The primary outcomes were device‐related complications and lead‐related complications. Secondary outcomes were inappropriate shocks, appropriate shock, all‐cause mortality, and infection. All outcomes were pooled under random‐effects meta‐analyses and reported as risk ratios (RRs) and 95% CIs. Kaplan–Meier curves of device‐related complications were digitized to retrieve individual patient data and pooled under a 1‐stage meta‐analysis using Cox models to determine hazard ratios (HRs) of patients undergoing S‐ICD versus TV‐ICD. A total of 5 studies (2387 patients) were retrieved. S‐ICD had a similar rate of device‐related complications compared with TV‐ICD (RR, 0.59 [95% CI, 0.33–1.04]; P=0.070), but a significantly lower lead‐related complication rate (RR, 0.14 [95% CI, 0.07–0.29]; P<0.0001). The individual patient data–based 1‐stage stratified Cox model for device‐related complications across 4 studies yielded no significant difference (shared‐frailty HR, 0.82 [95% CI, 0.61–1.09]; P=0.167), but visual inspection of pooled Kaplan–Meier curves suggested a divergence favoring S‐ICD. Secondary outcomes did not differ significantly between both modalities. CONCLUSIONS: S‐ICD is clinically superior to TV‐ICD in terms of lead‐related complications while demonstrating comparable efficacy and safety. For device‐related complications, S‐ICD may be beneficial over TV‐ICD in the long term. These indicate that S‐ICD is likely a suitable substitute for TV‐ICD in patients requiring implantable cardioverter‐defibrillator implantation without a pacing indication.