Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial

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).

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Journal
Circulation
Published
2026-04-25
DOI
https://doi.org/10.1161/circulationaha.126.080638
Primary Topic
Cardiac pacing and defibrillation studies
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article
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article

Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial

Roland Richard Tilz, Vincent Probst, Arthur A.M. Wilde, Gregory Golovchiner et al.
Circulation
Cardiac pacing and defibrillation studies
article

Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial

Roland Richard Tilz, Vincent Probst, Arthur A.M. Wilde, Gregory Golovchiner, Hendrik Bonnemeier, Raymond Tukkie, Mikhael F. El‐Chami, Jan Elders, Pier D. Lambiase, Louise R.A. Olde Nordkamp, Jonas S.S.G. de Jong, Léon J. P. M. van Woerkens, Christopher Cassidy, Lonneke Smeding, Kirsten M. Kooiman, Peter Nordbeck, Margriet W. Feenema‐Aardema, Harish Manyam, Anne‐Floor B.E. Quast, Serge Bovéda, Lukas Kaiser, Nick R. Bijsterveld, Michael Glikson, Anouk de Weger, Jolien A. de Veld, Shari Pepplinkhuizen, Leonard A Dijkshoorn, Reinoud E. Knops, Tom F. Brouwer, Martin C. Burke, Duncan C. Field, Frank A.L. E. Bracke, Willeke van der Stuijt, Jürgen Kuschyk, Claire Martin, Christelle Marquié, Nigel Lewis, Anita Arya, P Defaye, E Marijon, A H Maass, L V A Boersma, Abdul Ghani, Tim R Betts, Naushad A. Shaik, Marc A. Miller, Amir Zaidi
article en

Abstract

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).

Circulation
University Medical Center Groningen (NL), Radboud University Nijmegen (NL), University of Liverpool (GB), Orlando Health (US), Heidelberg University (DE), Erlanger Health System (US), AdventHealth Orlando (US), Manchester Academic Health Science Centre (GB), New Cross Hospital (GB), Royal Papworth Hospital (GB), Rabin Medical Center (IL), Centre Hospitalier Universitaire de Grenoble (FR), Emory University Hospital (US), Institut Pasteur de Lille (FR), Blackpool Victoria Hospital (GB), Catharina Ziekenhuis (NL), Shaare Zedek Medical Center (IL), University Hospital Heidelberg (DE), Medisch Centrum Leeuwarden (NL), British Heart Foundation (GB), Christian-Albrechts-Universität zu Kiel (DE), CorVita Science Foundation (US), Albert Schweitzer Ziekenhuis (NL), Mount Sinai Medical Center (US), Spaarne Ziekenhuis (NL), Hôpital Européen Georges-Pompidou (FR), Sheffield Teaching Hospitals NHS Foundation Trust (GB), St. Antonius Ziekenhuis (NL), OLVG (NL), University Hospital Schleswig-Holstein (DE), Essex Cardiothoracic Centre (GB), Canisius-Wilhelmina Ziekenhuis (NL), Institut Génétique Nantes Atlantique (FR), Asklepios Klinik St. Georg (DE), Universitätsklinikum Würzburg (DE), Clinique Pasteur (FR), Oxford University Hospitals NHS Trust (GB), Amsterdam University Medical Centers (NL), University Medical Centre Mannheim (DE), Hôpital Laennec (FR), Spaarne Gasthuis (NL), Bouwcentrum (Netherlands) (NL), University College London (GB), University of Amsterdam (NL), University of Lübeck (DE)
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