TY - JOUR
T1 - Device-related complications in subcutaneous versus transvenous ICD
T2 - a secondary analysis of the PRAETORIAN trial
AU - Knops, Reinoud E.
AU - Pepplinkhuizen, Shari
AU - Delnoy, Peter Paul H. M.
AU - Boersma, Lucas V. A.
AU - Kuschyk, Juergen
AU - el-Chami, Mikhael F.
AU - Bonnemeier, Hendrik
AU - Behr, Elijah R.
AU - Brouwer, Tom F.
AU - Kaab, Stefan
AU - Mittal, Suneet
AU - Quast, Anne-Floor B. E.
AU - van der Stuijt, Willeke
AU - Smeding, Lonneke
AU - de Veld, Jolien A.
AU - Tijssen, Jan G. P.
AU - Bijsterveld, Nick R.
AU - Richter, Sergio
AU - Brouwer, Marc A.
AU - de Groot, Joris R.
AU - Kooiman, Kirsten M.
AU - Lambiase, Pier D.
AU - Neuzil, Petr
AU - Vernooy, Kevin
AU - Alings, Marco
AU - Betts, Timothy R.
AU - Bracke, Frank A. L. E.
AU - Burke, Martin C.
AU - de Jong, Jonas S. S. G.
AU - Wright, David J.
AU - Jansen, Ward P. J.
AU - Whinnett, Zachary I.
AU - Nordbeck, Peter
AU - Knaut, Michael
AU - Philbert, Berit T.
AU - van Opstal, Jurren M.
AU - Chicos, Alexandru B.
AU - Allaart, Cornelis P.
AU - van der Burg, Alida E. Borger
AU - Dizon, Jose M.
AU - Miller, Marc A.
AU - Nemirovsky, Dmitry
AU - Surber, Ralf
AU - Upadhyay, Gaurav A.
AU - Weiss, Raul
AU - de Weger, Anouk
AU - Wilde, Arthur A. M.
AU - Olde Nordkamp, L.R.A.
N1 - © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.
PY - 2022/12/14
Y1 - 2022/12/14
N2 - Background: The subcutaneous implantable cardioverter-defibrillator (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 and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (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. 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 with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.
AB - Background: The subcutaneous implantable cardioverter-defibrillator (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 and results: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (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. 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 with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). Conclusion: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.
KW - Death, Sudden, Cardiac
KW - Defibrillators, Implantable/adverse effects
KW - Humans
KW - Treatment Outcome
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85148361336&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/36030464
U2 - https://doi.org/10.1093/eurheartj/ehac496
DO - https://doi.org/10.1093/eurheartj/ehac496
M3 - Article
C2 - 36030464
SN - 0195-668X
VL - 43
SP - 4872
EP - 4883
JO - European Heart journal
JF - European Heart journal
IS - 47
ER -