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.
N1 - Funding Information:
Conflict of interest: R.E.K reports consultancy fees and research grants from Abbott, Boston Scientific, Medtronic, and Cairdac and has stock options from AtaCor Medical Inc. S.M. reports consultancy fees from Boston Scientific. K.V. reports consultancy fees from Medtronic and Abbott. M.C.B. is a consultant 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 and Medtronic 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 on the advisory board for Medtronic and Abbot and reports speaker fees from Medtronic. The other authors report no conflicts.
Funding Information:
The PRAETORIAN trial was funded by Boston Scientific, which had no role in the design of the trial, analysis of the data, or the drafting and submission of the manuscript (grant number ISROTH20076).
Publisher Copyright:
© 2022 The Author(s). 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 - Complications
KW - Infections
KW - Invasive interventions
KW - Lead-related complications
KW - Subcutaneous ICD
KW - Transvenous ICD
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U2 - 10.1093/eurheartj/ehac496
DO - 10.1093/eurheartj/ehac496
M3 - Article
C2 - 36030464
AN - SCOPUS:85148361336
SN - 0195-668X
VL - 43
SP - 4872
EP - 4883
JO - European heart journal
JF - European heart journal
IS - 47
ER -