The ECOST and the EVATEL studies presented at the ESC Congress, Paris, France, show that remote monitoring (of cardiac rhythm management devices) reduces the number of inappropriate shocks compared with standard follow-up.
The ECOST (Effectiveness and cost of ICD follow-up schedule with telecardiology) study, which was presented in a hotline session at the recent European Society of Cardiology (ESC) Congress (27–31 August 2011, Paris, France), shows that remote monitoring with Biotronik Home Monitoring is at least as safe as standard care (in-office) follow-up reduces inappropriate shocks, reduces the risk of hospitalisation due to inappropriate shocks, and reduces the number of charged shocks with a significant impact on battery longevity.
In the study, 433 patients with an implantable cardiac defibrillator (ICD) were randomised to receive standard care (212) or remote monitoring (221). All patients had mandatory follow-up in-office appointments at one to three months, 15 months, and 27 months (the end of the study) and additional follow-up appointments when triggered by the patient or the physician, but standard care patients also had mandatory follow-up appointments at nine and 21 months. The remote monitoring patients had additional follow-up in-office appointments if triggered by remote monitoring.
According to the results, consistent with the TRUST study (Varma et al, Circulation 2010; 122: 325–32), Biotronik Home Monitoring is non-inferior in terms of safety compared with standard care follow-up. Importantly, in this new study, it was also associated with a significant 52% reduction in the number of patients with inappropriate shocks, a 72% reduction in the risk of hospitalisations due to inappropriate shocks, and a 76% reduction in the risk of charged shocks with a significant impact on battery longevity. Salem Kacet, principal investigator of ECOST, said: “It is of particular note that daily Home Monitoring in the long-term actually saves ICD battery life, as some remote monitoring technologies can substantially drain the device battery. However, Biotronik Home Monitoring enables physicians to adapt the therapy earlier to their patients’ needs. Patients benefit from the reduced risk of inappropriate shocks, which can be a very unpleasant experience, and need ICD replacement less frequently.”
ECOST was not the only study on remote monitoring to be presented at the ESC. The EVATEL (Evaluation telecardiologie) study also showed that remote monitoring (of cardiac rhythm management devices) reduces the number of inappropriate shocks compared with standard follow-up, but its hypothesis that remote monitoring was non inferior to standard follow-up was not validated. This result meant that although the EVATEL investigators did not observe any significant differences between standard care and remote monitoring and found remote monitoring to be clinically safe, they could not conclude remote monitoring was “non inferior” to standard care.
The studies had similar trial designs, inclusion criteria, and endpoints. However, Jean-Claude Daubert, professor of cardiology and vascular diseases at the University of Rennes 1, France, who discussed the results of the ECOST study in the hotline session at the ESC said that there were some differences that might explain the different outcomes. The first of these was that ECOST, which was sponsored by Biotronik, only investigated Biotronik’s Home Monitoring system whereas EVATEL, a non-industry sponsored study, reviewed all of the available remote monitoring systems on the market. “EVATEL can therefore be assessed as being more representative of the real world of remote monitoring.” He added that another difference was that the patient population was much larger in EVATEL (1501 vs. 433) but the follow-up time was twice as long in ECOST (12 months vs. 27 months). “In practice, even if the results are slightly different, the two studies are consistent. As regards to safety, both showed that remote monitoring of ICD patients is clinically safe compared with standard care.” He added that the two studies do not provide evidence that remote monitoring contributes to the prevention of major cardiovascular events.
He also said that he was waiting with much interest for the data on the cost effectiveness of remote monitoring as this information would “constitute the last piece of the validation puzzle” for remote monitoring.