IEGM-online based evaluation of implantable cardioverter defibrillator therapy appropriateness
Appropriate and inappropriate therapies of implantable cardioverter defibrillators have a major impact on morbidity and quality of life in ICD recipients. Intracardiac electrograms (IEGMs) stored in the ICD have been shown to be essential for differentiating appropriate and inappropriate ICD therapies. The recently introduced third generation of ICD Home Monitoring offers remotely transmitted IEGMs (IEGM-online). Hence, the appropriateness of ICD therapies might be remotely assessed. Validation of these electrograms is currently being performed in the RIONI study. A total of 210 episodes will be collected by about 40 European clinical centers. The study primarily investigates whether the IEGM-online based evaluation of the appropriateness of the ICD’s therapeutic decision following a tachyarrythmia episode detection is equivalent to the evaluation based on the complete ICD episode holter. The evaluation is independently performed by an expert board of three experienced ICD investigators. The equivalence of the two methods is accepted if the conclusions deviate for less than 10% of all evaluated IEGMs. Secondary endpoints investigate the IEGM-online usefulness in more detail. The conclusion of the study is expected by mid of 2007. RIONI has successfully been started for proving the reliability of IEGM-online. The expected results will significantly influence the efficacy of Home Monitoring based patient management.