November 11, 2008
BIOTRONIK Announces Positive Clinical Trial Results at American Heart Association Scientific Sessions
BIOTRONIK, the pioneer in wireless remote monitoring technology for patients with cardiac devices, announced today that data presented at the New Trials in Electrophysiology and Pacing Session of the American Heart Association (AHA) 2008 Scientific Sessions shows remote monitoring of its implantable cardioverter defibrillators (ICD) is a safe and effective alternative to conventional in-office follow-up care, which helps reduce the burden on capacity-constrained cardiac centers.
Developed by a steering committee of U.S. electrophysiologists and enrolling 1,443 patients in 105 North American sites three months ahead of schedule, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and fewer scheduled office visits in a prospective, randomized trial. The study used BIOTRONIK Home Monitoring(R), an automatic, wireless system (i.e. does not require patient activation) that performs daily telemetric surveillance of the patient and the technical status of the implanted device. BIOTRONIK was the first cardiac device company to develop remote monitoring technology.
"The data demonstrates that the BIOTRONIK Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events," said Dr. Niraj Varma, TRUST principal investigator, Cleveland Clinic. "Based on the results from this large-scale clinical trial, I believe remote monitoring may improve the way physicians care for patients with implanted cardiac devices."
In comparison with the control group of patients enrolled in conventional in-office follow up, clinical trial data from TRUST show that remote monitoring:
-- Reduces the number of in-office follow-up visits, while maintaining patient safety. The remote monitoring group had approximately half the total number of office visits as compared to the conventional follow-up group while achieving the same patient outcomes.
-- Leads to earlier detection of arrhythmic events. In the remote monitoring group, the time from onset of the arrhythmic event to evaluation was reduced by 21-35 days compared to the control group, depending on the type of arrhythmia detected.
-- Drives efficient use of clinic time. Eighty-nine percent of remote monitoring alerts were managed remotely and required no follow-up office visit. About 30 percent of unscheduled office visits among patients in both the control and study groups required physician interaction and were considered "actionable." However, unscheduled office visits that were triggered by the remote monitoring system nearly doubled the rate of treatment; more than 51 percent led to some action by the clinician, making better use of clinic time.
"The study results show that remote monitoring facilitates follow-up care and, very importantly, enhances patient safety, which can provide patients with additional security," said Dr. Andrew Epstein, TRUST principal investigator and professor of medicine in the division of cardiovascular disease at the University of Alabama at Birmingham.
"Decreasing the number of non-actionable, scheduled and unscheduled office visits through remote monitoring will ease the pressure of overloaded follow-up cardiac clinics. This will permit physicians to focus on patients who actually require intervention," said Dr. Charles Love, TRUST principal investigator and director of arrhythmia device services and associate investigator, Dorothy M. Davis Heart & Lung Research Institute at The Ohio State University Medical Center.
The TRUST clinical study tested the hypothesis that remote monitoring was safe and effective for ICD follow up for more than one year in a prospective, randomized controlled clinical trial. The multi-center trial involved 1,443 enrolled patients at 105 sites in the United States and Canada who were randomized 2:1 to remote monitoring or conventional groups. Patients participating in the TRUST trial had either a single chamber or dual chamber ICD.
About BIOTRONIK Home Monitoring
Over seven years ago, BIOTRONIK was first to develop and introduce a remote monitoring system using the GSM telephone network. Today, more than 150,000 BIOTRONIK Home Monitoring devices have been implanted, helping to optimize patient care in over 3,000 clinics in more than 50 countries worldwide.
About Implantable Cardioverter Defibrillators (ICD)
An ICD is used in patients at risk for recurrent, sustained ventricular tachycardia or fibrillation. The device is connected to leads positioned inside the heart or on its surface, which are used to deliver electrical shocks, sense the cardiac rhythm and pace the heart as needed. The various leads are tunneled to a pulse generator, which is implanted in a pouch beneath the skin of the chest or abdomen. These generators have electronics that automatically monitor and treat heart rhythms recognized as abnormal.
As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4,000 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.