- Question
- Is the subcutaneous implantable cardioverter defibrillator (S-ICD) superior to the transvenous ICD (TV-ICD) with respect to device-related complications during long-term (8-year) follow-up?
- Design
- Long-term extension of the PRAETORIAN trial: randomized, open-label, with 426 patients assigned to S-ICD and 423 to TV-ICD across 39 centers in the United States and Europe. Median follow-up was 87.5 months.
- Population
- Patients with a class I or IIa indication for ICD therapy and no need for pacing. Median age at implantation was 63 years in the S-ICD group and 64 years in the TV-ICD group.
- Intervention
- Implantation of a subcutaneous ICD (S-ICD).
- Control
- Implantation of a transvenous ICD (TV-ICD).
- Primary outcome
- Composite of all device-related complications, lead-related or not and minor or major (major being those requiring an invasive intervention), analyzed by modified intention-to-treat using a Fine-Gray subdistribution hazards model.
- Results
- There was no significant difference in all device-related complications combined (subdistribution HR 0.73; 95% CI, 0.48-1.12; P=0.15). TV-ICD patients had more major complications (P=0.03) and more lead-related complications (P<0.001). In the as-treated analysis, the TV-ICD was associated with more complications (HR 0.64; 95% CI, 0.41-0.99; P=0.047).
- Safety
- The TV-ICD carried a higher risk of major and lead-related complications than the S-ICD.
- Conclusion
- There was no significant difference in overall device-related complications over long-term follow-up, but the TV-ICD was associated with more major and lead-related complications.
- Why it matters
- Supports considering the S-ICD as an option for patients without a pacing indication who are being evaluated for an ICD, particularly given the lower burden of lead-related complications.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026