Device-related complications in subcutaneous versus transvenous ICD : a secondary analysis of the PRAETORIAN trial
© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology..
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.
| Errataetall: | |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
European heart journal - 43(2022), 47 vom: 14. Dez., Seite 4872-4883 |
| Sprache: |
Englisch |
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| Links: |
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| Anmerkungen: |
Date Completed 15.12.2022 Date Revised 11.01.2023 published: Print CommentIn: Eur Heart J. 2022 Nov 16;:. - PMID 36380686 Citation Status MEDLINE |
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| doi: |
10.1093/eurheartj/ehac496 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Knops, Reinoud E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Device-related complications in subcutaneous versus transvenous ICD |b a secondary analysis of the PRAETORIAN trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 15.12.2022 | ||
| 500 | |a Date Revised 11.01.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a CommentIn: Eur Heart J. 2022 Nov 16;:. - PMID 36380686 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Complications | |
| 650 | 4 | |a Infections | |
| 650 | 4 | |a Invasive interventions | |
| 650 | 4 | |a Lead-related complications | |
| 650 | 4 | |a Subcutaneous ICD | |
| 650 | 4 | |a Transvenous ICD | |
| 700 | 1 | |a Pepplinkhuizen, Shari |e verfasserin |4 aut | |
| 700 | 1 | |a Delnoy, Peter Paul H M |e verfasserin |4 aut | |
| 700 | 1 | |a Boersma, Lucas V A |e verfasserin |4 aut | |
| 700 | 1 | |a Kuschyk, Juergen |e verfasserin |4 aut | |
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| 700 | 1 | |a van der Stuijt, Willeke |e verfasserin |4 aut | |
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