BERLIN, Germany, August 30, 2011—BIOTRONIK, a leading manufacturer of implantable cardiac devices and the pioneer of wireless remote monitoring technology, announced today the first presentation of results from the ECOST randomized controlled trial.
ECOST provides groundbreaking scientific evidence, demonstrating for the first time that daily remote monitoring with BIOTRONIK Home Monitoring® reduces inappropriate shocks and improves battery longevity in long-term follow-up of patients with an implantable cardioverter-defibrillator (ICD). 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 high-profile Hot Line and prestigious Meet the Trialist sessions.
ECOST is a prospective multi-center clinical trial designed to examine the safety and effectiveness of remote monitoring of ICD patients with BIOTRONIK Home Monitoring® over 27 months. The study analyzed 433 patients who were randomly assigned to Home Monitoring follow-up or standard in-office care. Patients in the Home Monitoring group were scheduled for in-office follow-ups at yearly intervals. In between, device- or patient-related event notifications by the Home Monitoring system could trigger additional in-office follow-ups. Patients in the control group received standard of care with in-office follow-ups every six months.
The ECOST trial results confirm that BIOTRONIK Home Monitoring® is at least as safe as standard in-office follow-up, with no significant difference in the number of patients with one or more major adverse events, which is consistent with previous findings from the landmark TRUST2,3 trial and the COMPAS4 trial.
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 BIOTRONIK 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.
“Most importantly, ECOST is the first trial to demonstrate that Home Monitoring reduces charged and delivered shocks in general, and inappropriate shocks in particular, which has positive effects on battery longevity. This clearly underlines the value of this advanced technology for the surveillance of arrhythmias and early adaptation of ICD therapy”, comments Professor Salem Kacet, principal Investigator of ECOST. “It’s 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.”
“BIOTRONIK is committed to supporting excellent research that will provide valuable clinical evidence for physicians to make the best possible decisions when determining the optimal choice of therapy for their patients,” commented Marlou Janssen, Global Vice President of Marketing and Sales, BIOTRONIK. “ECOST has demonstrated a tremendous outcome in terms of reducing inappropriate shock, an experience which is not only painful but can cause significant anxiety in patients with ICDs.”
“ECOST re-confirms the superior value of the advanced patient management and early detection capabilities of BIOTRONIK Home Monitoring®, and also demonstrates that it enables physicians to optimize device performance and ensure optimal therapy delivery,” continued Janssen.
About BIOTRONIK Home Monitoring®
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 trial.2-3 The system is unique because it allows continuous automatic wireless remote monitoring of patient status and device status with daily updates, all independent from any patient interaction. BIOTRONIK Home Monitoring® has pioneered advances in remote patient management since its first clinical application in the year 2000. Today, BIOTRONIK Home Monitoring® is extensively used in a growing number of patients in more than 3,800 clinics and 55 countries worldwide.
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.
About ESC Congress
The ESC Congress is the world’s premier conference on the science, management and prevention of cardiovascular disease. The prestigious Hot Line sessions are reserved for first-time presentations of the primary endpoints of recently completed trials, and will also be available as webcast on the ESC congress website. The exclusive Meet the Trialist Sessions are reserved for five of the best clinical trials being presented at ESC.
More information: www.biotronik.com.
1 Kacet et al, ESC Congress 2011 Presentation
2 Varma et al., Circulation 2010, 122, 325–332
3 Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436
4 Mabo et al., Heart Rhythm, Vol 8, No 5, Suppl 2011, HRS
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