“Given the large numbers of new pacemaker implantations, there is substantial potential for BIOTRONIK Home Monitoring® to enhance patient care and reduce administrative burden on the health care system”
Abstract
BIOTRONIK has announced the publication of the COMPAS clinical trial results in the European Heart Journal1. COMPAS is the first large-scale, prospective, multi-centre, randomised clinical trial to demonstrate the safety and efficacy of remote monitoring with BIOTRONIK Home Monitoring® in pacemaker patients.
The results further support BIOTRONIK’s claim to have the remote monitoring system with the strongest and most robust clinical evidence in the industry.
Background
BIOTRONIK Home Monitoring® is the first and only remote patient management system with FDA and CE approvals for safe reduction of in-office follow-ups and for early detection of clinically relevant events, leading to earlier intervention, based on results of the TRUST landmark trial5-6.
The implanted device transmits diagnostic, therapeutic, and technical data automatically and silently to a small external patient communicator, the CardioMessenger®, via an integrated antenna – all without any patient interaction.
The external patient device or CardioMessenger® then quickly and efficiently forwards the data automatically to the BIOTRONIK Home Monitoring® Service Center via cellular networks.
The Home Monitoring Service Centre then analyses the data and compiles a continuously updated and consolidated patient status summary or CardioReport. In the event of clinically relevant status changes of the patient‘s condition, the Home Monitoring Service Center generates an immediate event notification, and, depending on the physician’s selection, an additional event alert via email, SMS, or fax is sent to the physicians, letting them know the status of their patients’ condition.
The system uniquely allows continuous automatic wireless remote monitoring of patient and device status with daily updates, all independent from any patient interaction.
The COMPAS trial
COMPAS enrolled a total of 538 patients across 43 centers, randomizing them 1:1 to BIOTRONIK Home Monitoring® or conventional in-clinic care. Follow-up duration was 18 months, at the end of which both groups were scheduled for a protocol-defined in-clinic follow-up. Interim in-office follow-ups occurred in the Home Monitoring group if triggered by a notification from the system, and in the conventional care group based on the clinics’ standard of care.
The publication, “A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial),” by Professor Philippe Mabo et al. provides long-awaited scientific evidence that daily automatic wireless remote monitoring in pacemaker patients is at least as safe and effective as conventional in-clinic care. Importantly, the unique early detection capabilities of BIOTRONIK Home Monitoring® were demonstrated to advance physician intervention for clinically relevant events by almost 4 months versus the control group. Further, COMPAS showed that BIOTRONIK Home Monitoring® significantly decreases the follow-up burden for clinics by virtually halving the need for interim in-clinic visits and at the same time doubling the clinical actionability of these fewer in-clinic visits.
Clinician comments
“Most impressively, the COMPAS trial is the first study to demonstrate a 66% reduction of hospitalizations for atrial arrhythmia and related stroke with Home Monitoring, clearly underlining the value of continuous remote monitoring in pacemaker patients,” commented Professor Philippe Mabo, Principal Investigator of COMPAS and author of the publication, from University Hospital Rennes, France. “The system reliably notified the clinic of medical and technical events, thus enabling us physicians to treat our patients months before a routine in-office follow-up might have been scheduled – and before their clinical condition could deteriorate to the point of a more serious outcome,” added Professor Mabo. “We believe that the reliable early detection of events which enabled us physicians to intervene earlier originates in the uniqueness of the Home Monitoring system. The system works fully automatically and has a track record of high transmission success proven in previous studies2-3 and also observed in COMPAS.”
“Furthermore, COMPAS has shown that it is no longer necessary to continue the old routine of calendar-based follow-ups that often doesn’t result in clinical action but may lead to an inefficient use of scarce resources,” commented Professor Jean-Claude Daubert, one of the co-authors of the publication, University Hospital Rennes, France. “This could reduce the administrative burden of busy clinics by enabling physicians to focus on patients who are more critically in need of medical attention. Patients also benefit through improved overall convenience because they don’t have to travel so frequently to potentially unnecessary in-clinic visits. And, of course, it is reassuring for them to know their device is being monitoring on a daily basis.”
“Given the large numbers of new pacemaker implantations4, there is substantial potential for BIOTRONIK Home Monitoring® to enhance patient care and reduce administrative burden on the health care system”, commented Dr. Werner Braun, Managing Director, BIOTRONIK.
“BIOTRONIK is currently building one of the most substantial portfolios of landmark clinical trials in the industry,” continued Dr. Braun. “Taking into consideration studies such as COMPAS, ECOST, TRUST, EchoCRT, IMPACT, REPLACE, and CASTLE-AF, we intend to continue providing significant evidence upon which paradigm changing clinical decisions and enhancements to therapy guidelines can be made.”
References:
1 Mabo P et al. European Heart Journal 2011; doi: 10.1093/eurheartj/ehr419
2 Varma N et al. Europace 2011;13(3):P1026
3 Varma N et al. Europace Journal (2011);13 (suppl 3):P1026
4 Vardas P et al. The EHRA White Book 2011: The Current Status of Cardiac Electrophysiology in ESC Member Countries. www.escardio.org/EHRA
5 Varma N et al. Circulation 2010;122:325-332
6 Varma N et al. Circulation Arrhythmia and Electrophysiology 2010;3:428-436
Source: BIOTRONIK
published: January 3, 2012 in: Biotronik, Cardio, Clinical Studies/Trials, Telehealth