- Question
- Is the subcutaneous implantable cardioverter-defibrillator (ICD) noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks?
- Design
- Randomized, open-label, noninferiority trial analyzing 849 patients (426 with a subcutaneous ICD and 423 with a transvenous ICD), with a median follow-up of 49.1 months.
- Population
- Patients with an ICD indication (class I or IIa) and no indication for cardiac pacing.
- Intervention
- Implantation of a subcutaneous ICD, placed entirely extrathoracically.
- Control
- Implantation of a conventional transvenous ICD.
- Primary outcome
- Composite of device-related complications and inappropriate shocks, with a noninferiority margin of 1.45 for the upper boundary of the 95% CI of the hazard ratio.
- Results
- A primary end-point event occurred in 68 patients in each group (48-month cumulative incidence 15.1% vs. 15.7%; HR 0.99; 95% CI 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Appropriate shocks were more frequent with the subcutaneous ICD (HR 1.52; 95% CI 1.08 to 2.12).
- Safety
- Device-related complications occurred in 31 patients with the subcutaneous ICD and 44 with the transvenous ICD (HR 0.69; 95% CI 0.44 to 1.09), and inappropriate shocks in 41 and 29 patients, respectively (HR 1.43; 95% CI 0.89 to 2.30). Death occurred in 83 and 68 patients (HR 1.23; 95% CI 0.89 to 1.70).
- Conclusion
- In patients with an ICD indication and no need for pacing, the subcutaneous ICD was noninferior to the transvenous ICD for device-related complications and inappropriate shocks.
- Why it matters
- It provided randomized evidence, previously based mainly on observational studies, supporting the subcutaneous ICD as an alternative to the transvenous ICD in patients without a pacing indication.
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 18, 2026