Aug. 29, 2011 ECOST, a French prospective, multicenter, randomized clinical trial concludes that cardiac device management using a home monitoring system with daily telemetry in patients with an implantable cardioverter-defibrillator (ICD) is safe, reduces the number of inappropriate shocks, and improves battery longevity.
The results were presented during the ESC Congress 2011 on August 29, 2011, in Paris, France, by Professor Salem Kacet, CHRU Lille, France, in the Hot Line II and Meet the Trialist III sessions.
To prevent sudden cardiac death 600 ICDs per million population are implanted yearly in the United States and 189 per million in Europe. Information and Communication technology (ICT) applications for health, referred to as "e-health," will significantly enhance the world healthcare systems during the ongoing decade in order to deliver high-quality patient care. The new device is a telemedicine technology which allows remote monitoring of patients with ICDs and pacemakers.
ECOST was designed to investigate whether daily remote monitoring follow-up is safe and effective compared to in clinic follow-up for ICD recipients.
A total of 433 patients were followed for 27 months in 43 centres after having been randomized to remote monitoring (active group) or in-clinic follow-up (control group). A first in-clinic ICD follow-up within 1 to 3 months after implantation was scheduled for all patients. Then, in the active group, patients were seen in the ambulatory department only once a year, unless an anomalous ICD function or an event of clinical concern was reported by remote monitoring and required an additional in-clinic visit. In the control group, the patients were followed in the ambulatory department at 6-month intervals.
Importantly, the ECOST trial is the first trial to show a 52% reduction of the number of patients with inappropriate shocks and a 72% reduction in the risk of hospitalizations related to inappropriate shocks, clearly underlining the effectiveness of home monitoring in ICD recipients. In addition, ECOST shows a 76% reduction in the number of charged shocks with a significant impact on ICD battery longevity.
ECOST has clinically proven with a non inferiority hypothesis that remote ICD monitoring is a safe alternative to conventional follow-up in terms of all cardiac and device related major adverse events and all cause deaths. These results are consistent with, and extend, previous findings by clearly demonstrating the safety of long-term remote ICD monitoring
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