| Title: |
Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up: the PRAETORIAN-XL Trial. |
| Authors: |
Olde Nordkamp, LRA; de Veld, JA; Ghani, A; Kuschyk, J; Bonnemeier, H; Bode, K; Boersma, LVA; de Weger, A; de Jong, JSSG; Jansen, WPJ; Alings, M; Bijsterveld, N; El-Chami, MF; Beukema, RJ; Vernooy, K; Philbert, BT; Neuzil, P; Nordbeck, P; van Opstal, JM; Allaart, CP; Wright, DJ; Knaut, M; Betts, TR; Whinnett, ZI; Lambiase, PD; de Groot, JR; Chicos, AB; Nemirovsky, D; Kääb, S; Mittal, S; Borger van der Burg, AE; Dijkshoorn, LA; Pepplinkhuizen, S; van der Stuijt, W; Dizon, JM; Miller, MA; Behr, ER; Burke, MC; Kooiman, K; Quast, A-FBE; Brouwer, TF; Wilde, AAM; Smeding, L; Knops, RE; PRAETORIAN-XL Investigators |
| Publisher Information: |
Ovid Technologies (Wolters Kluwer Health) |
| Publication Year: |
2025 |
| Collection: |
St George's University of London: Repository |
| Description: |
Background The PRAETORIAN trial investigated the efficacy and safety of the subcutaneous implantable cardioverter-defibrillator (S-ICD) compared with transvenous ICD (TV-ICD) and showed non-inferiority of the S-ICD with regard to the composite endpoint of device-related complications and inappropriate shocks (IAS) 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 US and Europe between March 2011 and January 2017. The follow-up was extended after 49.1 months with an additional four years, for the PRAETORIAN-XL trial. The primary endpoint 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. Endpoints 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 was female. The median age at implantation was 63 (IQR 54-69) years for the S-ICD and 64 (IQR 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 (sHR 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 |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| ISSN: |
0009-7322 |
| Relation: |
https://openaccess.sgul.ac.uk/id/eprint/117463/5/olde-nordkamp-et-al-device-related-complications-in-transvenous-versus-subcutaneous-defibrillator-therapy-during-long.pdf; https://openaccess.sgul.ac.uk/id/eprint/117463/3/circ-2025-074576-s01.pdf; https://openaccess.sgul.ac.uk/id/eprint/117463/4/circ-2025-074576-s02.pdf; https://openaccess.sgul.ac.uk/id/eprint/117463/1/olde-nordkamp-et-al-device-related-complications-in-transvenous-versus-subcutaneous-defibrillator-therapy-during-long.pdf; Olde Nordkamp, LRA; de Veld, JA; Ghani, A; Kuschyk, J; Bonnemeier, H; Bode, K; Boersma, LVA; de Weger, A; de Jong, JSSG; Jansen, WPJ; et al. Olde Nordkamp, LRA; de Veld, JA; Ghani, A; Kuschyk, J; Bonnemeier, H; Bode, K; Boersma, LVA; de Weger, A; de Jong, JSSG; Jansen, WPJ; Alings, M; Bijsterveld, N; El-Chami, MF; Beukema, RJ; Vernooy, K; Philbert, BT; Neuzil, P; Nordbeck, P; van Opstal, JM; Allaart, CP; Wright, DJ; Knaut, M; Betts, TR; Whinnett, ZI; Lambiase, PD; de Groot, JR; Chicos, AB; Nemirovsky, D; Kääb, S; Mittal, S; Borger van der Burg, AE; Dijkshoorn, LA; Pepplinkhuizen, S; van der Stuijt, W; Dizon, JM; Miller, MA; Behr, ER; Burke, MC; Kooiman, K; Quast, A-FBE; Brouwer, TF; Wilde, AAM; Smeding, L; Knops, RE; PRAETORIAN-XL Investigators (2025) Device-related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-term Follow-up: the PRAETORIAN-XL Trial. Circulation, 152 (3). pp. 172-182. ISSN 0009-7322 https://doi.org/10.1161/circulationaha.125.074576 SGUL Authors: Behr, Elijah Raphael |
| DOI: |
10.1161/circulationaha.125.074576 |
| Availability: |
https://openaccess.sgul.ac.uk/id/eprint/117463/; https://doi.org/10.1161/circulationaha.125.074576 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.88A94F3A |
| Database: |
BASE |