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Randomized Controlled Trial
. 2025 Jul 22;152(3):172-182.
doi: 10.1161/CIRCULATIONAHA.125.074576. Epub 2025 Apr 25.

Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial

Louise R A Olde Nordkamp #  1 , Jolien A de Veld #  1 , Abdul Ghani  2 , Jürgen Kuschyk  3   4 , Hendrik Bonnemeier  5 , Kerstin Bode  6 , Lucas V A Boersma  1   7 , Anouk de Weger  1 , Jonas S S G de Jong  8 , Ward P J Jansen  9 , Marco Alings  10   11 , Nick Bijsterveld  12 , Mikhael F El-Chami  13 , Rypko J Beukema  14 , Kevin Vernooy  15 , Berit T Philbert  16 , Petr Neuzil  17 , Peter Nordbeck  18 , Jurren M van Opstal  19 , Cornelis P Allaart  20 , David J Wright  21 , Michael Knaut  22 , Timothy R Betts  23 , Zachary I Whinnett  24 , Pier D Lambiase  25 , Joris R de Groot  1 , Alexandru B Chicos  26 , Dimitry Nemirovksy  27 , Stefan Kääb  28   29 , Suneet Mittal  30 , Alida E Borger van der Burg  31 , Leonard A Dijkshoorn  1 , Shari Pepplinkhuizen  1 , Willeke van der Stuijt  1 , Jose M Dizon  32 , Marc A Miller  33 , Elijah R Behr  34   35 , Martin C Burke  36 , Kirsten M Kooiman  1 , Anne-Floor B E Quast  1 , Tom F Brouwer  1 , Arthur A M Wilde  1   37 , Lonneke Smeding  1 , Reinoud E Knops  1 ; PRAETORIAN-XL Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial

Louise R A Olde Nordkamp et al. Circulation. .

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.

Keywords: complications; defibrillators, implantable; electrophysiology.

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Conflict of interest statement

R.E.K. reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. M.F.E. reports consultancy fees from Boston Scientific and Medtronic. S.M. reports consultancy fees from Boston Scientific and Medtronic. K.M.K. reports consultancy fees from Boston Scientific. P.D.L. reports educational and research grants from and is on the research board of Boston Scientific and reports research grants from Abbott. K.V. reports consultancy fees from Medtronic and Abbott. M.C.B. is a consultant for and receives honoraria as well as research grants from Boston Scientific and has equity in and is chief medical officer for AtaCor Medical, Inc. D.J.W. has consultancy arrangements with Boston Scientific, Medtronic, and iRhythm and a research grant from Boston Scientific. P.N. reports modest speaker honoraria from Biotronik, Boston Scientific, and Medtronic. M.A.M. reports consultancy fees from Boston Scientific. Z.I.W. is an advisor for Boston Scientific and is on the advisory board for Medtronic and Abbot, and reports speaker fees from Medtronic.

Figures

Figure 1.
Figure 1.
Flowchart for composition of the study cohort. S-ICD indicates subcutaneous implantable cardioverter defibrillator; and TV-ICD, transvenous implantable cardioverter defibrillator.
Figure 2.
Figure 2.
Eight-year estimated cumulative incidences of device-related complications Shown are the results of the following analyses. A, Modified intention-to-treat of all complications. In the subcutaneous implantable cardioverter defibrillator group, an increase in cumulative incidence was reported after 5 years of follow-up. In this group, 16 of 37 patients with a complication experienced their first complication after 5 years. In these patients, 10 of 16 (63%) complications emerged as a result of: (1) complication of generator replacement, (2) defibrillation test failure during generator replacement, (3) re-evaluation and subsequent repositioning of device position during generator replacement, and (4) re-evaluation of the device type at the time of generator replacement, followed by a subsequent complication. B, modified intention-to-treat of major complications. C, Modified intention-to-treat of lead-related complications. D, As-treated of all complications. HR indicates hazard ratio; sHR, subdistribution hazard ratio; S-ICD, subcutaneous implantable cardioverter defibrillator; and TV-ICD, transvenous implantable cardioverter defibrillator.
Figure 3.
Figure 3.
Complications stratified by device in which it occurred. The number of complications in the transvenous implantable cardioverter defibrillator was nearly twice as high compared with the S-ICD. This was mainly because of major complications, leading to an invasive intervention. S-ICD indicates subcutaneous implantable cardioverter defibrillator; and TV-ICD, transvenous implantable cardioverter defibrillator
Figure 4.
Figure 4.
Eight-year estimated cumulative incidence of all-cause mortality. sHR indicates subdistribution hazard ratio; S-ICD, subcutaneous implantable cardioverter defibrillator; and TV-ICD, transvenous implantable cardioverter defibrillator.
See this image and copyright information in PMC

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