PRAETORIAN score-guided omission of defibrillation testing was non-inferior to testing for failed first shocks (1.7% vs 2.3%; absolute difference -0.6%, 95% CI -2.6 to 1.4; p<0.001).
RCT (n=965)
Yes
Does PRAETORIAN score-guided omission of defibrillation testing prevent failed first shocks for spontaneous ventricular arrhythmias compared to routine defibrillation testing in patients undergoing S-ICD implantation?
Omission of defibrillation testing guided by the PRAETORIAN score is non-inferior to routine testing for first-shock efficacy in S-ICD patients, while avoiding testing-related complications.
Effect estimate: Absolute difference -0.6% (95% CI -2.6 to 1.4)
Absolute Event Rate: 1.7% vs 2.3%
p-value: p=<0.001
Background: To improve survival in patients at risk of sudden cardiac death, subcutaneous ICDs (S-ICDs) require optimal implant positioning for effective shocks. Defibrillation (DF) testing is recommended but carries serious risks. The PRAETORIAN score predicts defibrillation outcomes based on chest X-rays. The PRAETORIAN-DFT trial evaluated whether omission of DF testing guided by the PRAETORIAN score is non-inferior for first-shock efficacy. Methods: In this multinational trial, S-ICD patients from 37 centers were randomized to DF testing or no DF testing. In the No-DF testing group, the PRAETORIAN score was evaluated before discharge. The primary endpoint was failed first shock for spontaneous ventricular arrhythmias, as a surrogate for defibrillation success, tested for non-inferiority with a 3% absolute risk margin. Secondary endpoints included mortality, potential DF testing-related complications, and S-ICD revisions. Results: The included 965 patients (No-DF testing, n=483;DF testing, n=482) were followed for a median of 41 months. Failed first shock for spontaneous ventricular arrhythmia occurred in 1.7% of the No-DF testing group versus 2.3% of the DF testing group (–0.6%, 95% CI –2.6 to 1.4; p<0.001). 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). Potential DF testing-related complications occurred in 1.7% in the DF testing group. Postoperative S-ICD revisions due to inadequate positioning were identical between groups (n=2 each). Conclusions: PRAETORIAN score–guided omission of DF testing- after S-ICD implantation did not increase the risk of failed first shocks for spontaneous ventricular arrhythmias and reduced procedural risk without increasing S-ICD revisions. (Funded by Boston Scientific; PRAETORIAN-DFT).
“The risk-benefit ratio of routinely performing DT seems to favor not doing routine testing.”
Late-breaking at HRS 2026 with simultaneous publication; rapid uptake in electrophysiology community with 40+ expert posts on X and podcast discussions; addresses long-standing debate on DFT necessity; 10+ news summaries in cardiology outlets.
Knops et al. (Sat,) conducted a rct in S-ICD patients at risk of sudden cardiac death (n=965). No defibrillation (DF) testing guided by the PRAETORIAN score vs. Defibrillation (DF) testing was evaluated on failed first shock for spontaneous ventricular arrhythmias (Absolute difference -0.6%, 95% CI -2.6 to 1.4, p=<0.001). PRAETORIAN score-guided omission of defibrillation testing was non-inferior to testing for failed first shocks (1.7% vs 2.3%; absolute difference -0.6%, 95% CI -2.6 to 1.4; p<0.001).