Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial
Abstract
BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) investigated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) compared with a transvenous ICD (TV-ICD) and showed noninferiority of the S-ICD with regard to the composite end point of device-related complications and inappropriate shocks after 49.1 months. Complications associated with transvenous leads are expected to occur after longer follow-up. The PRAETORIAN-XL trial aims to investigate whether the S-ICD is superior to the TV-ICD with respect to device-related complications at 8-year follow-up. METHODS: The PRAETORIAN trial randomized patients with a class I or IIa indication for ICD therapy without the need for pacing to either S-ICD or TV-ICD among 39 centers in the United States and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months by an additional 4 years for the PRAETORIAN-XL trial. The primary end point was the composite of all device-related complications. Complications could be related or unrelated to the lead and minor or major, with major complications being those requiring an invasive intervention. End points were analyzed according to the modified intention-to-treat principle using a Fine-Gray subdistribution hazards model to account for competing risks. An as-treated analysis was performed using a Cox proportional hazards model with device type as time-dependent variable. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). Twenty-one percent of the S-ICD group versus 18% of the TV-ICD group were women. The median age at implantation was 63 (interquartile range, 54–69) years for the S-ICD and 64 (interquartile range, 56–69) years for the TV-ICD. After a median follow-up of 87.5 months, all device-related complications (major and minor combined) were not significantly different in the modified intention-to-treat analysis (subdistribution hazard ratio, 0.73 [95% CI, 0.48–1.12]); P =0.15). However, TV-ICD patients more often had a major complication or lead-related complication ( P =0.03 and P <0.001, respectively). Moreover, the as-treated analysis showed significantly more complications in patients with a TV-ICD compared with an S-ICD (hazard ratio, 0.64 [95% CI, 0.41–0.99]; P =0.047). CONCLUSIONS: The PRAETORIAN-XL trial demonstrated that there was no significant difference between the S-ICD and TV-ICD in all device-related complications during long-term follow-up. However, the TV-ICD carries a higher risk of major and lead-related complications compared with S-ICD therapy. The S-ICD should therefore be considered for all patients without a pacing indication who are evaluated for ICD therapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01296022.
Article Details
Authors (51)
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.).
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.).
Abdul Ghani
Jürgen Kuschyk
First Department of Medicine, University Medical Center Mannheim, Mannheim, Germany (J.K.).
Hendrik Bonnemeier
Kerstin Bode
Lucas V.A. Boersma
Amsterdam University Medical Center, Amsterdam
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.).
Jonas S.S.G. de Jong
Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (J.S.S.G.d.J.).
Ward P.J. Jansen
Department of Cardiology, Tergooi MC, Blaricum, the Netherlands (W.P.J.J.).
Marco Alings
Department of Cardiology, Amphia Hospital, Breda, the Netherlands (M.A.).
Nick Bijsterveld
Department of Cardiology, Flevoziekenhuis, Almere, the Netherlands (N.B.).
Mikhael F. El-Chami
Department of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.-C.).
Rypko J. Beukema
Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (R.J.B.).
Kevin Vernooy
Maastricht UMC, Maastricht, Netherlands
Berit T. Philbert
Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (B.T.P.).
Petr Neuzil
Peter Nordbeck
Jurren M. van Opstal
Medical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.).
Cornelis P. Allaart
Department of Cardiology, Amsterdam UMC, Amsterdam, The Netherlands (L.H.G.A.H., M.J.W.G., M.F.K., M.J.S., P.G.P., S.A.J.C., C.P.A., M.J.B.K.).
David J. Wright
Liverpool Heart and Chest Hospital, Liverpool, United Kingdom (D.J.W.).
Michael Knaut
Heart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Dresden, Germany (M.K.).
Timothy R. Betts
Department of Cardiology, Oxford University Hospitals NHS Trust, Oxford, United Kingdom (T.R.B.).
Zachary I. Whinnett
National Heart and Lung Institute, Imperial College London, London, United Kingdom (Z.I.W.).
Pier D. Lambiase
Joris R. de Groot
Department of Cardiology, University of Amsterdam, Amsterdam, the Netherlands (L.R.A.O.N., J.A.d.V., L.V.A.B., A.d.W., J.R.d.G., L.A.D., S.P., W.v.d.S., K.M.K., A.B.E.Q., T.F.B., A.A.M.W., L.S., R.E.K.).
Alexandru B. Chicos
Division of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.).
Dimitry Nemirovksy
Department of Medicine, Englewood Hospital and Medical Center, Englewood, NJ (D.N.).
Stefan Kääb
Suneet Mittal
Valley Health System, New York, New York, United States
Alida E. Borger van der Burg
Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands (A.E.B.v.d.B.).
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.).
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.).
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.).
Jose M. Dizon
Marc A. Miller
Department of Cardiology, Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, New York, NY (M.A.M.).
Elijah R. Behr
Martin C. Burke
CorVita Science Foundation, Chicago, IL (M.C.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.).
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.).
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.).
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.).
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.).
F.A.L.E. Bracke
J.G.P. Tijssen
T. Demming
F.J. Oosterwerff
F. Leyva
T. Germans
J. Perdeck