Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: To improve survival of patients at risk of sudden cardiac death, subcutaneous implantable cardioverter defibrillators (S-ICDs) require optimal implant positioning for effective shocks. Defibrillation (DF) testing is recommended but carries serious risks. The PRAETORIAN score predicts defibrillation outcomes on the basis of chest X-ray. The PRAETORIAN-DFT (Prospective Randomized Comparative Trial of Subcutaneous Implantable Cardioverter Defibrillator Implantation With and Without Defibrillation Testing) trial evaluated whether omission of DF testing guided by the PRAETORIAN score is noninferior 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 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: <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.
Source: Circulation
Authors: Reinoud E. Knops, Christelle Marquie, Peter Nordbeck, Roland R. Tilz, Leonard A. Dijkshoorn, Anne-Floor B.E. Quast, Tom F. Brouwer, Pier D. Lambiase, Christopher J. Cassidy, Lucas V.A. Boersma, Martin C. Burke, Timothy R. Betts, Vincent Probst, Harish Manyam, Frank A.L.E. Bracke, Hendrik Bonnemeier, Jürgen Kuschyk, Gregory Golovchiner, Anouk de Weger, Marc A. Miller, Jonas S.S.G. de Jong, Abdul Ghani, Nigel Lewis, Eloi Marijon, Nick R. Bijsterveld, Pascal Defaye, Claire A. Martin, Duncan C. Field, Jan Elders, Naushad A. Shaik, Serge Boveda, Willeke van der Stuijt, Jolien A. de Veld, Kirsten M. Kooiman, Shari Pepplinkhuizen, Lukas Kaiser, Anita Arya, Raymond Tukkie, Léon J.P.M. van Woerkens, Margriet W. Feenema-Aardema, Michael Glikson, Alexander H. Maass, Amir Zaidi, Arthur A.M. Wilde, Louise R.A. Olde Nordkamp, Lonneke Smeding, Mikhael F. El-Chami, J. Vogler, M. van Gent, H. Al Hashimi, F.J. Oosterwerff, DJ. Van Doorn, A.E. Borger van der burg, D. Nemirovsky, P.P.H.M. Delnoy
Institutions: Amsterdam UMC Location University of Amsterdam, Amsterdam Cardiovascular Sciences, Université de Lille, Centre Hospitalier Universitaire de Lille, Universitätsklinikum Würzburg, University of Lübeck, University College London, Blackpool Teaching Hospitals NHS Foundation Trust, St. Antonius Ziekenhuis, CorVita Science Foundation, Oxford University Hospitals NHS Trust, Centre Hospitalier Universitaire de Nantes, Institut du Thorax, University of Tennessee at Chattanooga, Erlanger Health System, Catharina Ziekenhuis, Christian-Albrechts-Universität zu Kiel, German Centre for Cardiovascular Research, University Medical Centre Mannheim, Rabin Medical Center, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, OLVG, Isala, Sheffield Teaching Hospitals NHS Foundation Trust, Hôpital Européen Georges-Pompidou, Centre Hospitalier Universitaire de Grenoble, Royal Papworth Hospital, Essex Cardiothoracic Centre, Canisius-Wilhelmina Ziekenhuis, AdventHealth Orlando, Clinique Pasteur, Asklepios Klinik St. Georg, Asklepios Kliniken Hamburg, New Cross Hospital, The Royal Wolverhampton NHS Trust, Spaarne Gasthuis, Albert Schweitzer Ziekenhuis, Medisch Centrum Leeuwarden, Shaare Zedek Medical Center, Bikur Cholim Hospital, University Medical Center Groningen, Manchester Academic Health Science Centre, Emory University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7155603769