Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial.
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Knops Reinoud E, Marquie Christelle, Nordbeck Peter, Tilz Roland R, Dijkshoorn Leonard A, Quast Anne-Floor B E, Brouwer Tom F, Lambiase Pier D, Cassidy Christopher J, Boersma Lucas V A, Burke Martin C, Betts Timothy R, Probst Vincent, Manyam Harish, Bracke Frank A L E, Bonnemeier Hendrik, Kuschyk Jürgen, Golovchiner Gregory, de Weger Anouk, Miller Marc A, de Jong Jonas S S G, Ghani Abdul, Lewis Nigel, Marijon Eloi, Bijsterveld Nick R, Defaye Pascal, Martin Claire A, Field Duncan C, Elders Jan, Shaik Naushad A, Boveda Serge, van der Stuijt Willeke, de Veld Jolien A, Kooiman Kirsten M, Pepplinkhuizen Shari, Kaiser Lukas, Arya Anita, Tukkie Raymond, van Woerkens Léon J P M, Feenema-Aardema Margriet W, Glikson Michael, Maass Alexander H, Zaidi Amir, Wilde Arthur A M, Olde Nordkamp Louise R A, Smeding Lonneke, El-Chami Mikhael F, PRAETORIAN-DFT Investigators
Аннотация
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 end point was failed first shock for spontaneous ventricular arrhythmias, as a surrogate for defibrillation success, tested for noninferiority with a 3% absolute risk margin. Secondary end points 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 (hazard ratio [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.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03495297.