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Europace Advance Access originally published online on April 7, 2008
Europace 2008 10(5):528-535; doi:10.1093/europace/eun072
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions©oxfordjournals.org.

ICDs

Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial

Jesus Almendral1,*, Fernando Arribas2, Christian Wolpert3, Renato Ricci4, Pedro Adragao5, Erik Cobo6, Xavier Navarro7, Aurelio Quesada the DATAS Steering Committee and Writing Committee on behalf of the DATAS Investigators8

1 Cardiology Department, Hospital General Universitario Gregorio Maranon, Madrid, Spain; 2 Cardiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain; 3 Cardiology Department, University Hospital of Mannheim, Mannheim, Germany; 4 Heart Diseases Department, Hospital San Filippo Neri, Roma, Italy; 5 Cardiology Department, Hospital Santa Cruz, Carnaxide, Portugal; 6 Estadistica e Investigacion Operativa, Universitat Politecnica de Catalunya, Barcelona, Spain; 7 Scientific and Clinical Department, Medtronic Iberica, Barcelona, Spain; 8 Cardiology Department, Hospital General Universitario de Valencia, Valencia, Spain

Aims: This randomized trial evaluated clinically significant adverse events (CSAEs), in patients implanted with dual-chamber (DC) vs. single-chamber (SC) implantable cardioverter defibrillator (ICD). DC-ICD had atrial tachyarrhythmia (AT) therapy capabilities. Strict programming recommendations were reinforced.

Methods and results: Patients with conventional SC-ICD indication were randomized to DC-ICD, SC-ICD, or a DC-ICD programmed as an SC-ICD (SC-simulated) and followed for 16 months. Patients in the DC and SC-simulated groups crossed over after 8 months. The primary endpoint was a composite of CSAE: all-cause mortality; invasive intervention; hospitalization (>24 h) for cardiovascular causes; inappropriate shocks (two or more episodes); and sustained symptomatic AT lasting >48 h. The outcome variable was a pre-specified score that corrected for clinical severity and follow-up duration. Three hundred and thirty-four patients were analysed (DC-ICD, n = 112; SC-ICD, n = 111; SC-simulated, n = 111). The mean left ventricular ejection fraction was 0.36 ± 0.13, 69% were in functional class ≥II. CSAE occurred in 65 DC-ICD, 82 SC-ICD, and 84 SC-simulated patients. The outcome variable was 33% lower in the DC-ICD group (OR 0.31; 95% CI 0.14–0.67; P = 0.0028). Mortality was 4% in DC, 9% in SC, and 10% in SC-simulated.

Conclusion: In patients with a standard SC-ICD indication, DC-ICD was associated with less CSAE when compared with SC-ICD.

Key Words: Defibrillation, Tachyarrhythmias, Pacing

* Corresponding author: Servicio de Cardiologia (Planta 5), Hospital Gregorio Marañon, Doctor Esquerdo, 46, 28007 Madrid, Spain. Tel: +34 915868281; fax: +34 915868018.E-mail address: almendral{at}secardiologia.es

Manuscript submitted 8 December 2007. Accepted after revision 22 February 2008.


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