- Question
- Is omitting defibrillation testing after subcutaneous ICD (S-ICD) implantation, guided by the PRAETORIAN score, noninferior with respect to first-shock efficacy?
- Design
- Multinational, randomized, open-label noninferiority trial in 37 centers, including 965 patients (483 without defibrillation testing and 482 with testing), with a median follow-up of 41 months.
- Population
- Patients undergoing de novo S-ICD implantation because of risk of sudden cardiac death.
- Intervention
- S-ICD implantation without induction of ventricular fibrillation or post-implant defibrillation testing; device position was assessed with the chest X-ray-based PRAETORIAN score before discharge.
- Control
- S-ICD implantation with induction of ventricular fibrillation and post-implant defibrillation testing.
- Primary outcome
- Failed first shock for spontaneous ventricular arrhythmias, as a surrogate for defibrillation success, tested for noninferiority with a 3% absolute risk margin.
- Results
- First shock failed in 1.7% of the no-testing group versus 2.3% of the testing group (difference -0.6%; 95% CI -2.6 to 1.4; P<0.001 for noninferiority). There were no significant differences in all-cause mortality (HR 0.9; 95% CI 0.6-1.4) or arrhythmic death (HR 0.4; 95% CI 0.04-3.4).
- Safety
- Potential complications related to defibrillation testing occurred in 1.7% of the testing group. Postoperative device revisions for inadequate positioning were identical between groups (2 in each).
- Conclusion
- PRAETORIAN score-guided omission of defibrillation testing did not increase the risk of failed first shocks and reduced procedural risk without more device revisions.
- Why it matters
- Supports a simpler and safer S-ICD implantation strategy that relies on radiographic assessment of device position rather than routine induction of ventricular fibrillation.
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