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Europace Advance Access published online on March 16, 2006
Europace, doi:10.1093/europace/eul009
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© The European Society of Cardiology 2006. All rights reserved
Received August 30, 2005
Accepted January 22, 2006

Article

The RIONI study rationale and design: validation of the first stored electrograms transmitted via home monitoring in patients with implantable defibrillators

C. Perings 1 *, G. Klein 2, E. Toft 3, C. Moro 4, D. Klug 5, D. Böcker 6, H. J. Trappe 1, T. Korte 2, and on behalf of the RIONI Investigators

1 Department of Cardiology, University of Bochum, Bochum, Germany
2 Department of Cardiology and Angiology, Medical School Hannover, Carl-Neuberg-Street 1, D-30625 Hannover, Germany
3 Institute of Health Science and Technology, Aalborg University, Aalborg, Denmark; Department of Cardiology, Aalborg Sygehus, Århus Universitu Hospitals Aalborg, Denmark
4 Department of Cardiology, Hospital Ramón y Cajal, Madrid, Spain
5 Department of Cardiology, Centre Hospitalier Régional Universitaire Lille, Lille, France
6 Department of Cardiology, Medizinische Klinik und Poliklinik C, Univ.-Klinikum Münster, Münster, Germany

* To whom correspondence should be addressed.
C. Perings, E-mail: christian.perings{at}marienhospital-herne.de


  Abstract

Appropriate and inappropriate therapies of implantable cardioverter defibrillators (ICDs) have a major impact on morbidity and quality of life in ICD recipients. The recently introduced home monitoring of ICD devices is a promising new technique which remotely offers information about the status of the system. Stored intracardiac electrograms (IEGMs), which are essential for correct classification of appropriate and inappropriate ICD discharges, have until now not been available with ICD home monitoring on a day-by-day basis because of limitations of transferable data. We demonstrate the first compressed IEGMs daily transferable via home monitoring (IEGM-online). Validation of these electrograms will be performed in the Reliability of IEGM-Online Interpretation (RIONI) study. A total of 210 episodes of stored IEGMs will be collected by at least 12 European centres. The primary endpoint of this study is to investigate whether the IEGM-online based evaluation of the appropriateness of the ICDs therapeutic decision following episode detection is equivalent to the evaluation based on the complete ICD episode Holter extracted from the IEGM stored. The evaluation is independently done by an expert board of three experienced ICD investigators. The equivalence of the two methods is accepted if the evaluations yield a different conclusion for <10% of all evaluated IEGMs. The conclusion of the study is expected at the beginning of 2007. If RIONI successfully validates IEGMs transmitted via home monitoring, a strong basis for the use of this promising technique will be established.

Keywords: Implantable defibrillator; Home monitoring; Stored intracardiac electrogram.
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