Remotely monitored pacemaker patients devices may get a major leg up over patients without the extra surveillance, researchers reported today during Heart Rhythm 2014, the Heart Rhythm Society’s 35th Annual Scientific Sessions in San Francisco.
Patients who were highly engaged with their remote monitoring regimens saw the highest mortality benefit, with survival rates double that of non-monitored patients, researchers said. Even minimally engaged RM patients fared better than the non-RM group, regardless of socioeconomic factors.
The mega-study marks an important milestone for RM technology, with researchers reporting positive data from more than 260,000 patients across the U.S., but it’s not clear how or why RM patients are doing better than their isolated peers.
There are 3 main possibilities underlying the survival benefit, lead author Dr. Suneet Mittal told MassDevice.com ahead of the presentation.
The 1st possibility is that patients with RM pacemakers, especially those that are highly engaged with the surveillance regimen, may be more engaged with their health in general. On the other hand, patients engaged with RM regimens may simply have better doctors that are offering more effective care. Third, patients may be benefiting from the remote monitoring itself, which transmits alerts about abnormal rhythms and delivered shocks to give healthcare providers a chance to intervene.
Whatever the mechanism, Mittal maintained that patients stand only to gain from RM devices. The patients in the study received St. Jude Medical (NYSE:STJ) implants and were monitored through the company’s Merlin.net system, but rival device makers also have their fingers in RM technology.
Medtech giant Medtronic (NYSE:MDT) in August 2012 launched its CareLink network, a connectivity system for its pacemakers and defibrillators. Boston Scientific (NYSE:BSX) in June 2012 touted the European launch of its Latitude NXT patient monitoring system, which combines data from implanted devices as well as blood pressure readers and weight scales.
In a separate poster study presented yesterday, Mittal reported that the RM benefit may extend to a range of cardiac devices. That analysis combined surveillance data on single chamber ICDs, dual chamber ICDs and CRT-Ds, finding a similar benefit compared to patients without monitoring.
"The primary takeaway from this is that patients who are being implanted with a defibrillator should be encouraged to be enrolled in remote monitoring," he told us.
"It appears that patients with an implantable defibrillator who are being remotely monitored have a 50% reduction in mortality during the follow-up," he said. "The mechanism for what’s accounting for that mortality reduction is unclear, but this now confirms the findings of earlier studies which showed a similar amount of mortality reduction. This suggests that the signal is a real signal."
Teasing out the exact mechanism of the survival benefit through a randomized study may be a challenge, Mittal noted. Patients receiving new pacemakers and defibrillators aren’t likely to agree to a device without RM when the technology is available and, from the patient perspective, free of charge.
"There’s no charge from the vendor for using remote monitoring and CMS has a reimbursement policy which provides reimbursement to the physician for the work entailed in remote monitoring," Mittal said. "From the patient standpoint – given the convenience of having their devices checked from home, given the assurance of knowing that there are no alerts that are going to be missed and knowing that there’s coverage for this service – it really seems like it’s close to a free lunch."
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.