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Dr. Angelo Auricchio,
Dr. Philippe Mabo
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Presenter | see Discussant report
Philippe Mabo (France)
List of Authors: Philippe Mabo CHU Rennes Inserm U 642, Pascal Defaye CHU Grenoble, Nicolas Sadoul CHU Nancy, Jean-Marc Davy Chu Montpellier, Jean-Claude Deharo CHU Marseille , Salem Kacet CHU Lille, Eric Bellissant CHU Rennes CIC, Jean-Claude Daubert CHU Rennes Inserm U 642
Background: according to manufactor guidelines, a telemetric control of implanted ICD has to be performed every 3 months. Now, device follow-up (FU) may be performed either during in-office visit or by analysing remote data transmitted to implant centre. Aim of the study: to evaluate safety and efficiency of ICD remote FU as compared to conventional in-office FU. Study design: EVATEL is a prospective, randomized, non-inferiority trial, with 2 parallel groups (“control group” with in-office FU and “remote group” with remote FU, conducted in patients (pts) with a first single or dual chamber ICD implantation. All commercially available devices with remote features may be implanted. A device FU was performed every 3 months either during in-office visit or remotely according to the randomization arm during an overall 1 year period. The primary endpoint was a composite endpoint: death - cardiovascular hospitalization - inappropriate or ineffective device therapy. A cost-effectiveness evaluation was also planned as a secondary end-point. Results: 1501 pts were included in 30 French centres from January 2008 to January 2010, the last FU being performed in January 2011. The mean age of pts was 59 + 13 years with a majority of males (84.9%). The indication for ICD implant was predominantly primary prevention (971 pts - 64.7%). An underlying cardiomyopathy was observed in 1380 pts (92.2%), of ischemic origin in 67.5%. The NYHA class was I or II in 85.7% of pts. All the baseline characteristics were comparable between the 2 groups excepted for history of atrial fibrillation (23.8% vs 18.9%, p=0.020) and heart failure hospitalisation within the year before inclusion (23.8% vs 18.9%, p=0.018) more frequently observed in the remote group. Switch from remote to control group before validation of the primary endpoint was observed in 46 pts mainly due to non compatible phone connexion. On per protocol analysis, the primary endpoint was validated in 210 pts (28.5%; 95% CI 25.2 – 31.7) in the control group (n= 738) and in 214 pts (30.2%; 95% CI 26.8 – 33.6) in the remote group (n=696). As the 95% CI of the difference of the event rate was from -3.0 to 6.4% the non inferiority hypothesis with a safety margin of 5% between the 2 groups is not validated. Nevertheless a difference between groups on the primary endpoint has not been demonstrated. The time to occurrence of the first primary endpoint (p=0.71) and the actuarial survival rate between the 2 groups (p=0.31) did not show any significant difference. The number of inappropriate therapies was lower in the remote group (n=33; 4.7%) as compared to the control group (n=55; 7.5%) (p=0.03). Conclusion: Even if the non inferiority hypothesis with a strict safety margin of 5% was not validated, remote FU may be proposed as an alternative for ICD FU as no significant differences were observed between the 2 groups on the primary composite endpoint and on overall mortality. In addition less inappropriate therapies were delivered in the remote group. The cost/effectiveness analysis is still ongoing. Discussant | see Presenter abstract
Angelo Auricchio (Switzerland)
707001 - 707002
Hot Line II - Frontiers in interventional and device treatments
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