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Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial
RE. Knops, JA. de Veld, A. Ghani, LVA. Boersma, J. Kuschyk, MF. El Chami, H. Bonnemeier, ER. Behr, TF. Brouwer, S. Kääb, S. Mittal, S. Pepplinkhuizen, ABE. Quast, L. Smeding, W. van der Stuijt, A. de Weger, NR. Bijsterveld, S. Richter, MA....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Comparative Study, Multicenter Study
NLK
Free Medical Journals
from 2008 to 1 year ago
Open Access Digital Library
from 2008-09-01
- MeSH
- Time Factors MeSH
- Defibrillators, Implantable * MeSH
- Mental Health * MeSH
- Electric Countershock * instrumentation adverse effects MeSH
- Functional Status MeSH
- Quality of Life * MeSH
- Middle Aged MeSH
- Humans MeSH
- Death, Sudden, Cardiac prevention & control MeSH
- Prospective Studies MeSH
- Prosthesis Design MeSH
- Surveys and Questionnaires MeSH
- Risk Factors MeSH
- Aged MeSH
- Arrhythmias, Cardiac therapy diagnosis physiopathology MeSH
- Treatment Outcome MeSH
- Health Status MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
1st Department of Medicine University Medical Center Mannheim Germany
Cardiac Electrophysiology Division Department of Medicine Englewood Hospital and Medical Center NJ
CorVita Science Foundation Chicago IL
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 the Netherlands
Department of Cardiology Radboud University Medical Center Nijmegen the Netherlands
Department of Cardiology St Antonius Hospital Nieuwegein the Netherlands
Department of Cardiology Tergooi Medisch Centrum Blaricum the Netherlands
Department of Cardiology The Heart Centre Rigshospitalet University of Copenhagen Denmark
Department of Electrophysiology Catharina Hospital Eindhoven the Netherlands
Department of Electrophysiology Heart Center at University of Leipzig Germany
Department of Internal Medicine 1 Jena University Hospital Germany
Department of Medicine 1 Ludwig Maximillians University Hospital München Germany
Department of Medicine Cardiology Columbia University Irving Medical Center New York NY
Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL
Division of Cardiology Section of Electrophysiology Emory University Atlanta GA
European Reference Network for Rare Low Prevalence and Complex Diseases of the Heart
German Center for Cardiovascular Research Munich Heart Alliance Germany
German Center for Cardiovascular Research Partner Site Heidelberg Mannheim Germany
Icahn School of Medicine at Mount Sinai Mount Sinaï Hospital New York NY
Liverpool Heart and Chest Hospital United Kingdom
Medical Spectrum Twente Enschede the Netherlands
Medisch Centrum Leeuwarden the Netherlands
National Heart and Lung Institute Imperial College London United Kingdom
Oxford Biomedical Research Centre Oxford University Hospitals NHS Trust United Kingdom
St George's University Hospitals NHS Foundation Trust London United Kingdom
St George's University of London United Kingdom
The Valley Health System Ridgewood NJ
University and University Hospital Würzburg Germany
Werkgroep Cardiologische Centra Nederland Utrecht the Netherlands
References provided by Crossref.org
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