Boston Scientific's new line of Resonate implantable defibrillators will include a new suite of sensors designed to predict heart failure events before they happen.Boston Scientific Corp.
A suite of sensors designed to make implantable defibrillators smarter received a boost of support this week in the form of a late-breaking clinical trial presentation at the Heart Failure Society of America's annual scientific meeting in Dallas. New data confirmed that Boston Scientific's HeartLogic Diagnostic, which is slated for commercial release later this year as part of a new line of implantable heart devices, accurately enhanced the ability to classify patients at high or low risk of a future heart failure event.
The Multisensor Chronic Evaluation in Ambulatory Heart Failure Patients (MultiSENSE) trial showed that the HeartLogic Diagnostic significantly expanded the ability of a baseline blood test to identify when patients were at an elevated risk of a heart failure event. The combination of the HeartLogic Diagnostic with a baseline NT-proBNP measurement accurately identified when patients within varying risk groups were at 23 to 50 times increased risk of a heart failure event.
Boston Scientific said the new tool provides continuous measurement of a patient's heart failure by combining data from sensors evaluating heart sounds, respiration rate and volume, thoracic impedance, heart rate and activity. Current clinical guidelines recommend the use of a blood test to measure natriuretic peptides BNP or NT-proBNP in order to diagnose heart failure or determine disease severity. However, the company said the blood test can only reflect a snapshot assessment at the time of a blood draw, which loses relevance as a patient's condition changes.
"Through the utilization of the HeartLogic Diagnostic, physicians can more accurately triage appropriate care to this vulnerable patient population in a timely manner, particularly when using the alert in combination with an intermittent measure of NT-proBNP," said John Boehmer, MD, principal investigator of the study, director of the heart failure program at Penn State Health Milton S. Hershey Medical Center, and a professor of medicine at Penn State College of Medicine.
The study included 900 patients who had enhanced sensor data collection enabled in their cardiac resynchronization therapy defibrillator (CRT-D) systems and were followed for up to one year. Previously published study data demonstrated that the HeartLogic Diagnostic had an observed sensitivity of 70% as well as the ability to provide weeks of advance notice and low burden for detecting indications of worsening heart failure.
The company received CE mark and FDA approval of the HeartLogic Diagnostic within its Resonate family of implantable cardioverter defibrillator and CRT-D systems earlier this year.