Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
FS/20/11/34750
British Heart Foundation - United Kingdom
- Klíčová slova
- defibrillators, implantable, electrophysiology, tachycardia,
- MeSH
- defibrilátory implantabilní normy MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři MeSH
- srdeční arytmie diagnóza terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. 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 MC 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
Division of Cardiology Northwestern Memorial Hospital Northwestern University Chicago IL
Division of Cardiology Section of Electrophysiology Emory University Atlanta GA
Division of Cardiovascular Medicine College of Medicine The Ohio State University Columbus
European Reference Network for Rare Low Prevalence and Complex Diseases of the Heart ERN GUARD 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 Sinai Hospital New York
Liverpool Heart and Chest Hospital United Kingdom
Medical Spectrum Twente Enschede The Netherlands
Medisch Centrum Leeuwarden 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
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01296022
