By AMERICAN HEART ASSOCIATION NEWS

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For heart failure patients, they symbolized a way their medical providers could monitor their cardiovascular health, unobtrusively and from afar. But new research shows that remote monitoring of implantable electronic devices may not add any benefit or value for patients who have them.

Regular remote monitoring did not help heart failure patients live longer or reduce hospitalizations when compared to patients who received conventional care, according to a study released at the European Society of Cardiology Congress held this week in Rome.

American heart specialists don’t expect the findings to prompt any immediate changes in treatment.

“I don’t think anything major will happen,” said University of Pennsylvania cardiologist and professor Mariell Jessup, M.D., who moderated the ESC session where two studies on remote monitoring were released.

Both trials reported that use of remote monitoring failed to change outcomes and “confirmed my suspicion that we do not yet understand how to effectively follow patients with heart failure to prevent their worsening,” Jessup said.

Advanced heart failure and transplant cardiologist Eldrin Lewis, M.D., said the findings probably won’t have a significant impact on people already fitted with remote monitoring capabilities for one simple reason.

“For many patients, they’re not turned on,” said Lewis, a Harvard Medical School associate professor who was not involved in the studies. “So even though the devices have this capability, they haven’t been turned on because there’s no one to monitor it.”

Even when the devices are switched on, remotely collected data doesn’t help many patients who already have several factors going for them, Lewis said.

“If you have a patient who has very good self-efficacy skills and the quality of your healthcare delivery system is already excellent, then having remote monitoring is not going to change the natural history,” he said.

Researchers in the Remote Management of Heart Failure Using Implantable Electronic Devices, or REM-HF, study led by co-principal investigator Martin Cowie, M.D., looked at patients who had one of three implantable devices equipped for remote monitoring: a cardiac resynchronization therapy device with a pacemaker, a CRT device with a defibrillator function, or an implantable cardioverter defibrillator.

“In the modern era of digital health, we could find no evidence of additional benefit from weekly remote monitoring of these devices,” Cowie said during a presentation Sunday of his findings before the ESC 2016 Congress.

He noted the devices of the patients being monitored provided abundant amounts of data but very little of it resulted in meaningful changes in patient care.

In another similar trial presented by lead investigator Giuseppe Boriani, M.D., Ph.D., at the same ESC session, researchers found that remote monitoring of heart failure patients with biventricular defibrillators did not fare better than patients monitored during regular office visits. The study, dubbed MORE-CARE, was simultaneously published in the European Journal of Heart Failure.

However, Boriani said patients in the study made fewer trips to their doctor’s office and hospital emergency rooms. That resulted in significant healthcare savings that roughly totaled $3,200 per 100 patients over a two-year period. The remote monitoring also helped cut travel costs for patients by about $160 over the same time span.

“The 41 percent reduction in office visits and associated monetary savings are not trivial, particularly in a time when health resources are increasingly constrained,” said Duke University Medical Center professor Jonathan Piccini, M.D., who was not involved in the study.

The implementation of a remote monitoring system varies widely, depending on the healthcare practices and the nation, Piccini said.

He noted Boriani’s study focused on atrial arrhythmia and heart failure-related alerts, “but remote monitoring does a lot more.”

“The study is very informative, but I don’t think they change our current approach or recommendations for remote monitoring of implanted cardiac devices,” Piccini said.

Jessup said it’s unclear what either trial will mean for manufacturers of remote monitoring systems.

“Many clinicians still find them useful to follow their patients,” she said, especially in monitoring the patient’s respiration rate.

Lewis said that his ideal study would examine the effectiveness of remote monitoring in heart failure patients more in need of such a system – perhaps because they live in rural areas and are hours away from the nearest clinic, or because they lack the self-discipline necessary to take care of their disease.

“These are people who don’t know how to recognize symptoms. They don’t call when they get into trouble, or when their weight changes or when they’re cheating with their diet or food intake,” Lewis said. “If you find that patient population, I would be surprised if you don’t see a benefit from remote monitoring.”

But he didn’t disqualify the two new trials.

“I think these two studies are very important because they say, with this technology and in this patient population there is no benefit,” he said. “What we need to understand is if there’s any population that would benefit. And we need to figure out if the failure to show a benefit was due to the patient population, due to the quality of the technology in the remote monitoring, or due to the design of the study.”

Niraj Varma, M.D., Ph.D., a Cleveland Clinic cardiac electrophysiologist, agreed, describing both studies as “good randomized trials.”

“The new data did not take away from the huge benefits shown for remote monitoring to preserve patient connection,” and to help reduce the patient’s frequency in return office and hospital visits, he said.

There remains a need to find better data sets that can help predict heart failure decompensation, the sudden worsening of heart failure signs and symptoms. Still, Varma said he believes “remote monitoring remains standard of care for managing patients with implanted devices.”