New TRUST trial data confirms clinical benefits of home cardiac monitoring
5 September 2009
Biotronik SE & Co. KG has announced that new data from the TRUST trial [1] presented at the European Society of Cardiology Congress 2009 demonstrates the benefits of the Biotronik Home Monitoring system in the early detection of patient clinical events as well as the safe reduction of in-office follow-up visits.
Biotronik Home Monitoring is a wireless, mobile remote monitoring system for patients with implantable cardiac devices. The new data from the TRUST trial reported that Biotronik Home Monitoring can safely and effectively replace conventional in-office device follow-up visits. Patients can be monitored safely through the Biotronik Home Monitoring wireless system with only one annual in-office visit [2].
The TRUST trial also concluded that Biotronik Home Monitoring with automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling earlier physician intervention.
Patients were evaluated earlier by their physician when significant changes occurred in their implanted devices or clinical condition. Remote monitoring event notifications were evaluated in a median of 3 days compared to more than 30 days with conventional care [3].
Moreover, the trial showed that the event notifications generated from the Biotronik Home Monitoring system provided accurate information, even for silent clinical events (eg asymptomatic atrial fibrillation) of which the patients were unaware [3]. At the same time, despite daily remote monitoring, the event notifications were triggered infrequently and do not overburden physicians’ or clinic resources with unnecessary or distracting information.
“There has been a call from the medical community for remote monitoring of patients with implantable cardiac devices. TRUST is the first prospective large scale (1,443 patients) clinical trial to test this technology. TRUST demonstrated that Biotronik Home Monitoring, which is an advanced automatic remote monitoring system, can streamline hospital visits and enhance surveillance for important device- or patient-related clinical data. These results have important implications for improved patient safety,” said Niraj Varma, MD, PhD, TRUST Principal Investigator, Cleveland Clinic, Cleveland, Ohio, USA.
About the TRUST Trial
Developed by a steering committee of electrophysiologists and cardiologists, with 1,443 patients enrolled from 105 North American sites, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and rapid detection of symptomatic and asymptomatic cardiac events in a prospective, randomized trial. The study used BIOTRONIK Home Monitoring, an automatic, fully wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation.
References
1. N. Varma et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial. Circulation 2008;118;2309-2317, Abstract 4078.
2. N. Varma et al. Efficiency of calendar based ICD checks: conventional follow-up compared to remote monitoring in the TRUST trial. ESC Congress, Barcelona, Spain, August 30, 2009, Abstract 86114.
3. N. Varma et al. Event notification by remote monitoring systems performing automatic daily checks: load, characteristics and clinical utility. ESC Congress, Barcelona, Spain, August 31, 2009, Abstract 87438.
Bookmark this page