AHA 2016: Investigational device notifies clinicians of worsening heart failure
After one year, the HeartLogic heart failure diagnostic service helped alert healthcare professionals of worsening heart failure in patients with cardiac resynchronization therapy defibrillator (CRT-D) systems, according to a multicenter, nonrandomized trial.
Lead researcher John P. Boehmer, MD, of the Pennsylvania State University College of Medicine, presented the results Nov. 16 in a late-breaking clinical trials session at the American Heart Association Scientific Sessions in New Orleans.
Boston Scientific, which manufactures the HeartLogic, funded the study
The FDA has not approved the HeartLogic, but Boston Scientific said it had submitted a premarket approval application with the FDA. The company also plans on conducting post-approval studies.
The HeartLogic contains an algorithm and sensors that measure heart sounds, respiration, thoracic impedance, heart rate and activity.
“They act much like a clinician measuring a number of aspects of a patient’s clinical condition through signs and symptoms and then combining them to understand the heart patient’s status,” Boehmer said during a news conference.
In this trial, known as MultiSENSE, the researchers enrolled 900 patients who had investigational software downloaded into their CRT-D systems for 12 months. After a year, their device was converted to its original form. Boehmer said that treating clinicians, researchers and clinical event committee members were blinded to the sensor data.
He added that the data were allocated into a development set to develop the composite index and alert algorithm and a test set to independently validate the algorithm’s performance.
The development group included 500 patients. After a median follow-up period of 324 days, 12.8 percent of patients had heart failure events. Boehmer said the researchers analyzed the data, balanced sensitivity and specificity and chose an alert threshold of 16 for the test data set.
The HeartLogic alert had an observed sensitivity of 70 percent, which was significantly higher than the pre-specified 70 percent endpoint. The unexplained alert rate was 1.47 alerts not followed by a heart failure event per year.
The median time from the alert on the HeartLogic to a heart failure event was 34 days, which Boehmer said was a long time period to treat patients and prevent a heart failure event.
“Further understanding of this alert is going to require clinical trials where this is used to manage heart failure patients,” Boehmer said.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.