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Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial
LRA. Olde Nordkamp, S. Pepplinkhuizen, A. Ghani, LVA. Boersma, J. Kuschyk, MF. El-Chami, ER. Behr, TF. Brouwer, S. Kääb, S. Mittal, ABE. Quast, W. van der Stuijt, L. Smeding, JA. de Veld, JGP. Tijssen, NR. Bijsterveld, S. Richter, MA. Brouwer,...
Language English Country United States
Document type Journal Article, Multicenter Study, Randomized Controlled Trial, Comparative Study
NLK
Free Medical Journals
from 2008 to 1 year ago
Open Access Digital Library
from 2008-04-01
- MeSH
- Time Factors MeSH
- Defibrillators, Implantable * MeSH
- Electric Countershock * instrumentation adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Treatment Outcome 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: Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial. METHODS: This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population. RESULTS: In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; P=0.97). There was no significant difference in patients experiencing IAS between both groups (P=0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; P=0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; P=0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; P=0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; P=0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (P=0.046). CONCLUSIONS: There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
1st Department of Medicine University Medical Center Mannheim Germany
CorVita Science Foundation Chicago IL
Department of Cardiology Amphia Hospital 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 NY
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
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
St George's University Hospitals National Health Service 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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- $a Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial / $c LRA. Olde Nordkamp, S. Pepplinkhuizen, A. Ghani, LVA. Boersma, J. Kuschyk, MF. El-Chami, ER. Behr, TF. Brouwer, S. Kääb, S. Mittal, ABE. Quast, W. van der Stuijt, L. Smeding, JA. de Veld, JGP. Tijssen, NR. Bijsterveld, S. Richter, MA. Brouwer, JR. de Groot, KM. Kooiman, PD. Lambiase, P. Neuzil, K. Vernooy, M. Alings, TR. Betts, FALE. Bracke, MC. Burke, JSSG. de Jong, DJ. Wright, WPJ. Jansen, ZI. Whinnett, P. Nordbeck, M. Knaut, BT. Philbert, JM. van Opstal, AB. Chicos, CP. Allaart, AE. Borger van der Burg, JM. Dizon, MA. Miller, D. Nemirovsky, R. Surber, GA. Upadhyay, R. Weiss, A. de Weger, AAM. Wilde, RE. Knops, PRAETORIAN Investigators
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