|Biotronik's Lumax device--Courtesy of Biotronik|
Patients implanted with heart rhythm devices that automatically send information about cardiac abnormalities to a telemonitoring center showed improved outcomes in heart failures and fewer deaths than those without the remote monitoring leads, a new study published in The Lancet said.
According to researchers, 18.9% of patients with the monitoring devices automatically showed deterioration in heart function compared with 27.2% of similar control patients. Additionally, there were 10 deaths in the group being telemonitored versus 27 deaths in the control group.
The IN-TIME study was funded by the German pacemaker manufacturer Biotronik and enrolled 716 patients, of which 664 were randomly assigned to two groups, one with the daily monitoring protocol and one as the control group getting standard care treatment. The patients--located in Europe, Australia and Israel--were implanted with either a Lumax dual-chamber implantable cardioverter-defibrillator or a cardiac resynchronization defibrillator equipped with a Biotronik Home Monitoring function.
"Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure," Gerhard Hindricks, who is director of electrophysiology at Leipzig University Herzzentrum in Germany and headed the study, said in a statement. "Such telemonitoring is feasible and should be used in clinical practice."
Despite the benefits of such telemonitoring shown in the IN-TIME study, some questions remain.
"Was the benefit due to the device coupled with enhanced surveillance triggered by the device, or would enhanced surveillance such as direct contact more frequently by clinicians produce similar outcomes," Dr. Robert Bonow, a professor of cardiology at Northwestern University in Chicago and a spokesperson for the American Heart Association, told Medpage Today.
Bonow also said reimbursement by insurers in the U.S. for the extra services would likely be a problem.
In May, Biotronik received FDA approval for its next-generation, MRI-safe pacemaker system. The Entovis pacemaker system includes both single-chamber (SR-T) and dual-chamber (DR-T) devices implanted with Setrox pacing leads, making Biotronik the first company in the U.S. to offer both single- and dual-chamber pacemakers approved for use in an MRI environment. Biotronik competes in a crowded cardiac implant market with Medtronic ($MDT), Boston Scientific ($BSX) and St. Jude ($STJ).