August 29th, 2011
Not Shocking: French Studies Evaluate Remote Monitoring of ICDs
Remote monitoring of ICDs can reduce inappropriate shocks, but the overall clinical benefit and cost-effectiveness of the technology has not yet been demonstrated, according to two new studies presented at the ESC meeting in Paris.
Salem Kacet presented the ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) study in which 433 ICD patients were randomized to follow-up with remote monitoring or in-office visits in 43 French centers. The trial found that daily remote monitoring was noninferior to in-office visits for the primary endpoint of cumulative survival free of major adverse events (HR 0.91, CI 0.68-1.23, p<0.05).
Kacet emphasized the secondary effectiveness endpoint, which found a 52% reduction in the number of patients who had inappropriate shocks:
- Eleven (5%) patients in the remote monitoring group had inappropriate shocks versus 22 (10.4%) in the control group (p=0.03).
- Three patients in the remote monitoring group were hospitalized for a cause related to their inappropriate shocks, versus 11 in the control group (p=0.02).
Kacet also noted that the reduction in inappropriate shocks would have a significant impact on battery longevity. He did not present the cost-effectiveness component of the study.
The results of the EVATEL (EVAluation of TELe follow-up) study, presented by Philippe Mabo, were less positive. Some 1501 patients were randomized to the remote follow-up group, consisting of a transmission to the implant center every 3 months, or to the control group, consisting of an in-office follow-up at the implant center every 3 months. No significant difference in the incidence of the first major cardiovascular event was observed (28.5% in the control group vs. 30.2% in the remote monitoring group, p=ns). However, the trial failed to meet the primary noninferiority endpoint, either in the intent-to-treat analysis (p=0.0268) or in the per-protcol analysis (p=0.0862).
Commenting on the studies, AHA spokesperson Mariell Jessup said in an interview that remote monitoring may improve outcomes and reduce inappropriate shocks, but that it can not be recommended until its benefits are proven and it has been shown to be cost-effective.