Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT 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: 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.
Article Details
Authors (55)
Reinoud E. Knops
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Christelle Marquie
Department of Cardiology, University Hospital of Lille, Lille, France (C.M.).
Peter Nordbeck
Roland R. Tilz
Department of Cardiology, University Heart Center, Lübeck, Germany (R.R. Tilz).
Leonard A. Dijkshoorn
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Anne-Floor B.E. Quast
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Tom F. Brouwer
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Pier D. Lambiase
Christopher J. Cassidy
Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Trust, Blackpool, United Kingdom (C.J.C.).
Lucas V.A. Boersma
Amsterdam University Medical Center, Amsterdam
Martin C. Burke
CorVita Science Foundation, Chicago, IL (M.C.B.).
Timothy R. Betts
Department of Cardiology, Oxford University Hospitals NHS Trust, Oxford, United Kingdom (T.R.B.).
Vincent Probst
Department of Cardiology, L’institut du thorax, CHU de Nantes, Nantes, France (V.P.).
Harish Manyam
Department of Cardiology, Erlanger Health System, University of Tennessee, Chattanooga, TN (H.M.).
Frank A.L.E. Bracke
Department of Electrophysiology, Catharina Hospital Eindhoven, Eindhoven, the Netherlands (F.A.L.E.B.).
Hendrik Bonnemeier
Jürgen Kuschyk
First Department of Medicine, University Medical Center Mannheim, Mannheim, Germany (J.K.).
Gregory Golovchiner
Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel (G.G.).
Anouk de Weger
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Marc A. Miller
Department of Cardiology, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY (M.A.M.).
Jonas S.S.G. de Jong
Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (J.S.S.G.d.J.).
Abdul Ghani
Nigel Lewis
Department of Cardiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom (N.L.).
Eloi Marijon
Cardiology Department, Georges Pompidou European Hospital, Paris
Nick R. Bijsterveld
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Pascal Defaye
Claire A. Martin
Department of Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom (C.A.M.).
Duncan C. Field
Cardiology, Essex Cardiothoracic Centre, Mid and South Essex NHS Foundation Trust, Basildon, United Kingdom (D.C.F.).
Jan Elders
Department of Cardiology, Canisius Wilhelminahospital, Nijmegen, the Netherlands (J.E.).
Naushad A. Shaik
Department of Cardiac Electrophysiology, Advent Health Orlando, Orlando, FL (N.A.S.).
Serge Boveda
Willeke van der Stuijt
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Jolien A. de Veld
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Kirsten M. Kooiman
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Shari Pepplinkhuizen
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Lukas Kaiser
Department of Cardiology and Critical Care Medicine, Asklepios Klinik St. Georg, Hamburg, Germany (L.K.).
Anita Arya
Division of Electrophysiology and Devices, Heart and Lung Centre, New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom (A.A.).
Raymond Tukkie
Department of Cardiology, Spaarne Gasthuis, Haarlem, the Netherlands (R. Tukkie).
Léon J.P.M. van Woerkens
Department of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands (L.J.P.M.v.W.).
Margriet W. Feenema-Aardema
Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands (M.W.F.-A.).
Michael Glikson
Department of Cardiology, Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Jerusalem, Israel (M.G.).
Alexander H. Maass
Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands (A.H.M.).
Amir Zaidi
Manchester Heart Centre, Manchester Academic Health Sciences Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom (A.Z.).
Arthur A.M. Wilde
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Louise R.A. Olde Nordkamp
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Lonneke Smeding
Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure & Arrhythmias, Amsterdam UMC location University of Amsterdam, Amsterdam, the Netherlands (R.E.K., L.A.D., A.-F.B.E.Q., T.F.B., A.d.W., N.R.B., W.v.d.S., J.A.d.V., K.M.K., S.P., A.A.M.W., L.R.A.O.N., L.S., L.V.A.B.).
Mikhael F. El-Chami
Department of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.-C.).
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