Anne-Floor B E Quast1, Sarah W E Baalman2, Tim R Betts3, Lucas V A Boersma4, Hendrik Bonnemeier5, Serge Boveda6, Tom F Brouwer2, Martin C Burke7, Peter Paul H M Delnoy8, Mikhael El-Chami9, Juergen Kuschyk10, Pier Lambiase11, Christelle Marquie12, Marc A Miller13, Lonneke Smeding2, Arthur A M Wilde2, Reinoud E Knops2. 1. Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands. Electronic address: a.f.quast@amc.uva.nl. 2. Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands. 3. Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom. 4. Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands; Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands. 5. Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany. 6. Clinique Pasteur, Cardiology Department, 31076, Toulouse, France. 7. Amsterdam UMC, University of Amsterdam, Heart Center; department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands; CorVita Science Foundation, Chicago, IL, United States. 8. Department of Cardiology, Isala Heart Centre, Zwolle, The Netherlands. 9. Division of Cardiology Section of Electrophysiology, Emory University, Atlanta, GA, United States. 10. University Medical Centre Mannheim, I. Medical Department, Mannheim, Germany. 11. UCL & Barts Heart Centre Director of Clinical Electrophysiology Research Lead for Inherited Arrhythmia Specialist Services. 12. Institut Coeur Poumon, Lille, France. 13. Icahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, NY, New York, United States.
Abstract
In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. STUDY DESIGN: The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. CONCLUSION: The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.
RCT Entities:
In transvenous implantable cardioverter-defibrillator (TV-ICD) implants, routine defibrillation testing (DFT) does not improve shock efficacy or reduce arrhythmic death but patients are exposed to the risk of complications related to DFT. The conversion rate of DFT in subcutaneous ICD (S-ICD) is high and first shock efficacy is similar to TV-ICD efficacy rates. STUDY DESIGN: The PRAETORIAN-DFT trial is an investigator-initiated, randomized, controlled, multicenter, prospective two-arm trial designed to demonstrate non-inferiority of omitting DFT in patients undergoing S-ICD implantation in which the S-ICD system components are optimally positioned. Positioning of the S-ICD will be assessed with the PRAETORIAN score. The PRAETORIAN score is developed to systematically evaluate implant position of the S-ICD system components which determine the defibrillation threshold on post-operative chest X-ray. A total of 965 patients, scheduled to undergo a de novo S-ICD implantation without contra-indications for either DFT strategy, will be randomized to either standard of care S-ICD implantation with DFT, or S-ICD implantation without DFT but with evaluation of the implant position using the PRAETORIAN score. The study is powered to claim non-inferiority of S-ICD implantation without DFT in de novo S-ICD patients in respect to the primary endpoint of first shock efficacy in spontaneous arrhythmia episodes. Patients with a high PRAETORIAN score (≥90) in the interventional arm of this study will undergo DFT according to the same DFT protocol as in the control arm. CONCLUSION: The PRAETORIAN-DFT trial is a randomized trial that aims to gain scientific evidence to safely omit a routine DFT after S-ICD implantation in patients with correct device positioning.
Authors: Szymon Budrejko; Maciej Kempa; Wojciech Krupa; Tomasz Królak; Tomasz Fabiszak; Grzegorz Raczak Journal: Int J Environ Res Public Health Date: 2022-08-06 Impact factor: 4.614