| Source: |
Knops, R E, Pepplinkhuizen, S, Delnoy, P P H M, Boersma, L V A, Kuschyk, J, El-Chami, M F, Bonnemeier, H, Behr, E R, Brouwer, T F, Kaab, S, Mittal, S, Quast, A-F B E, van der Stuijt, W, Smeding, L, de Veld, J A, Tijssen, J G P, Bijsterveld, N R, Richter, S, Brouwer, M A, de Groot, J R, Kooiman, K M, Lambiase, P D, Neuzil, P, Vernooy, K, Alings, M, Betts, T R, Bracke, F A L E, Burke, M C, de Jong, J S S G, Wright, D J, Jansen, W P J, Whinnett, Z .... |
| Description: |
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. |