Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up:the PRAETORIAN-XL Trial
| Title: | Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up:the PRAETORIAN-XL Trial |
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| Authors: | Olde Nordkamp, Louise R A; de Veld, Jolien A; Ghani, Abdul; Kuschyk, Jürgen; Bonnemeier, Hendrik; Bode, Kerstin; Boersma, Lucas V A; de Weger, Anouk; de Jong, Jonas S S G; Jansen, Ward P J; Alings, Marco; Bijsterveld, Nick; El-Chami, Mikhael F; Beukema, Rypko Joost; Vernooy, Kevin; Philbert, Berit T; Neuzil, Petr; Nordbeck, Peter; van Opstal, Jurren M; Allaart, Cornelis P; Wright, David J; Knaut, Michael; Betts, Timothy R; Whinnett, Zachary I; Lambiase, Pier D; de Groot, Joris R; Chicos, Alexandru B; Nemirovsky, Dmitry; Kääb, Stefan; Mittal, Suneet; Borger van der Burg, Alida Elisabeth; Dijkshoorn, Leonard Alexander; Pepplinkhuizen, Shari; van der Stuijt, Willeke; Dizon, Jose M; Miller, Marc A; Behr, Elijah R; Burke, Martin C; Kooiman, Kirsten; Quast, Anne-Floor B E; Brouwer, Tom Falk; Wilde, Arthur A M; Smeding, Lonneke; Knops, Reinoud E |
| Source: | Olde Nordkamp, L R A, de Veld, J A, Ghani, A, Kuschyk, J, Bonnemeier, H, Bode, K, Boersma, L V A, de Weger, A, de Jong, J S S G, Jansen, W P J, Alings, M, Bijsterveld, N, El-Chami, M F, Beukema, R J, Vernooy, K, Philbert, B T, Neuzil, P, Nordbeck, P, van Opstal, J M, Allaart, C P, Wright, D J, Knaut, M, Betts, T R, Whinnett, Z I, Lambiase, P D, de Groot, J R, Chicos, A B, Nemirovsky, D, Kääb, S, Mittal, S, Borger van der Burg, A E, Dijkshoorn, L A, Pepplinkhuizen, S, van .... |
| Publication Year: | 2025 |
| Collection: | Maastricht University Research Publications |
| Description: | 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 ... |
| Document Type: | article in journal/newspaper |
| Language: | English |
| ISSN: | 0009-7322; 1524-4539 |
| Relation: | info:eu-repo/semantics/altIdentifier/pissn/0009-7322; info:eu-repo/semantics/altIdentifier/eissn/1524-4539 |
| DOI: | 10.1161/CIRCULATIONAHA.125.074576 |
| Availability: | https://cris.maastrichtuniversity.nl/en/publications/56151585-1b6c-41a6-b095-dd50964f130f; https://doi.org/10.1161/CIRCULATIONAHA.125.074576 |
| Rights: | info:eu-repo/semantics/closedAccess |
| Accession Number: | edsbas.470C1BA7 |
| Database: | BASE |