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Device-related complications in the subcutaneous and transvenous ICD: a secondary analysis of the PRAETORIAN trial

Title: Device-related complications in the subcutaneous and transvenous ICD: a secondary analysis of the PRAETORIAN trial
Authors: Knops, Reinoud E; Pepplinkhuizen, Shari; Delnoy, Peter Paul HM; Boersma, Lucas VA; Kuschyk, Juergen; El-Chami, Mikhael F; Bonnemeier, Hendrik; Behr, Elijah R; Brouwer, Tom F; Kaab, Stefan; Mittal, Suneet; Quast, Anne Floor BE; van der Stuijt, Willeke; Smeding, Lonneke; de Veld, Jolien A; Tijssen, Jan GP; Bijsterveld, Nick R; Richter, Sergio; Brouwer, Marc A; de Groot, Joris R; Kooiman, Kirsten M; Lambiase, Pier D; Neuzil, Petr; Vernooy, Kevin; Alings, Marco; Betts, Timothy R; Bracke, Frank ALE; Burke, Martin C; de Jong, Jonas SSG; Wright, David J; Jansen, Ward PJ; Whinnett, Zachary I; Nordbeck, Peter; Knaut, Michael; Philbert, Berit T; van Opstal, Jurren M; Chicos, Alexandru B; Allaart, Cornelis P; Borger van der Burg, Alida E; Dizon, Jose M; Miller, Marc A; Nemirovsky, Dmitry; Surber, Ralf; Upadhyay, Gaurav A; Weiss, Raul; de Weger, Anouk; Wilde, Arthur AM; Olde Nordkamp, Louise RA
Source: European Heart Journal , 43 (47) pp. 4872-4883. (2022)
Publisher Information: Oxford University Press (OUP)
Publication Year: 2022
Collection: University College London: UCL Discovery
Description: BACKGROUND: The subcutaneous ICD (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS: The PRAETORIAN trial is an international, multicenter, randomised trial in which 849 patients with an indication for ICD therapy were randomised to receive an SICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections and the need for invasive interventions. RESULTS: Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group 49 complications occurred in 44 patients of which lead-dysfunction was most frequent (HR 0.69; P =0.11). In both groups half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared to the TV-ICD group (P
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10155232/1/ehac496.pdf; https://discovery.ucl.ac.uk/id/eprint/10155232/
Availability: https://discovery.ucl.ac.uk/id/eprint/10155232/1/ehac496.pdf; https://discovery.ucl.ac.uk/id/eprint/10155232/
Rights: open
Accession Number: edsbas.AC18FDCD
Database: BASE