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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....

. 2024 ; 17 (11) : e010822. [pub] 20241119

Language English Country United States

Document type Journal Article, Randomized Controlled Trial, Comparative Study, Multicenter Study

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

Center for Arrhythmia Care Heart and Vascular Institute University of Chicago Pritzker School of Medicine IL

CorVita Science Foundation Chicago IL

Department of Cardiology Amphia Hospital Breda the Netherlands

Department of Cardiology Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias Amsterdam University Medical Centers Location University of Amsterdam Heart Center the Netherlands

Department of Cardiology and Amsterdam Cardiovascular Sciences Amsterdam University Medical Centers Location VUMC the Netherlands

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Center 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

Heart Surgery Heart Center Dresden Carl Gustav Carus Medical Faculty Dresden University of Technology Germany

Icahn School of Medicine at Mount Sinai Mount Sinaï Hospital New York NY

Klinik für Innere Medizin 3 Schwerpunkt Kardiologie und Angiologie Universitätsklinikum Schleswig Holstein Campus Kiel Germany

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

Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services University College London and Barts Heart Centre 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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