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Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial
RE. Knops, S. Pepplinkhuizen, PPHM. Delnoy, LVA. Boersma, J. Kuschyk, MF. El-Chami, H. Bonnemeier, ER. Behr, TF. Brouwer, S. Kaab, S. Mittal, ABE. Quast, W. van der Stuijt, L. Smeding, JA. de Veld, JGP. Tijssen, NR. Bijsterveld, S. Richter, MA....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu randomizované kontrolované studie, multicentrická studie, časopisecké články, práce podpořená grantem
NLK
Free Medical Journals
od 1996 do Před 1 rokem
Open Access Digital Library
od 1996-01-01
- MeSH
- defibrilátory implantabilní * škodlivé účinky MeSH
- lidé MeSH
- náhlá srdeční smrt * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
1st Department of Medicine University Medical Center Mannheim Mannheim Germany
CorVita Science Foundation Chicago IL United States
Department of Cardiology Amphia Hospital Breda the Netherlands
Department of Cardiology Flevoziekenhuis Almere the Netherlands
Department of Cardiology Homolka Hospital Prague Czech Republic
Department of Cardiology Isala Heart Centre Zwolle The Netherlands
Department of Cardiology OLVG Amsterdam Netherlands
Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands
Department of Cardiology St Antonius Hospital Nieuwegein The Netherlands
Department of Cardiology Tergooi MC Blaricum The Netherlands
Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Copenhagen Denmark
Department of Electrophysiology Catharina Hospital Eindhoven Eindhoven the Netherlands
Department of Electrophysiology Heart Center at University of Leipzig Leipzig Germany
Department of Internal Medicine 1 Jena University Hospital Jena Germany
Department of Medicine 1 Ludwig Maximillians University Hospital München Germany
Division of Cardiology Section of Electrophysiology Emory University Atlanta GA United States
European Reference Network for rare low prevalence and complex diseases of the heart ERN GUARD Heart
German Center for Cardiovascular Research Munich Heart Alliance Munich Germany
German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany
Icahn School of Medicine at Mount Sinai Mount Sinaï Hospital New York NY United States
Liverpool Heart and Chest Hospital Liverpool United Kingdom
Medical Spectrum Twente Enschede the Netherlands
Medisch Centrum Leeuwarden Leeuwarden The Netherlands
National Heart and Lung Institute Imperial College London London United Kingdom
Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust Oxford United Kingdom
St George's University hospitals NHS Foundation Trust London United Kingdom
St George's University of London London United Kingdom
The Valley Health System Ridgewood NJ United States
University and University Hospital Würzburg Würzburg Germany
Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands
Citace poskytuje Crossref.org
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