Cardiac implantable electronic devices (CIEDs) with remote monitoring capabilities can provide a wealth of information to help manage patients with debilitating and potentially life-threatening rhythm disturbances. Yet some physicians and hospitals choose not to use this resource, and those that do may not be able to use it to its full potential.

Reimbursed yet rebuffed 

The United States and Germany are among the few, and perhaps the only two, countries that fully reimburse services performed remotely using CIEDs. In the United States, victory for electrophysiologists and cardiologists came in late 2008, when the Centers for Medicare & Medicaid Services (CMS) approved revised codes that acknowledged the value that CIED remote monitoring brought to patient care. Earlier that same year, an expert consensus statement by leading U.S. and European cardiology societies listed remote monitoring’s potential benefits (Heart Rhythm 2008;5[6]:907-925).

“There is a fair amount of data saying that using [remote monitoring], outcomes are improved,” says Bruce L. Wilkoff, MD, lead author of the consensus paper and director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic. “Efficiency is improved, patients live longer, have fewer shocks, have faster time to diagnosis—really clinically important endpoints.”

The authors proposed that lack of reimbursement might create a disincentive for the adoption of these technologies, a view supported by a European Heart Rhythm Association survey published in 2015. In that study, European physicians considered the lack of reimbursement as the biggest barrier to remote monitoring’s implementation (Europace 2015;17:814-818).

Yet uptake in the United States has been lackluster, despite reimbursement. One analysis of 269,471 patients treated with automatic remote monitoring-capable CIEDs between 2008 and 2011 found that 53 percent never used remote monitoring (J Am Coll Cardiol 2015;65[24]:2601-2610). Only about a quarter of the patients remotely sent weekly data 75 percent of the time or more. That group had the highest survival rate, but even patients who were less adherent had a lower mortality than patients who didn’t use remote monitoring at all.

“The lack of consistent use of remote monitoring among patients who have received devices with this capability represents a waste of a valuable resource, which can provide significant benefits to patients and healthcare facilities alike,” says Niraj Varma, MD, PhD, the study’s lead author and an electrophysiologist at the Cleveland Clinic. “We are trying to find a reason for that.”

The 2015 updated consensus statement on remote interrogation and monitoring of CIEDs, which Varma co-chaired, made remote monitoring with CIEDs a Class 1A recommendation, the highest level (Heart Rhythm 2015;12[7]:e69–e100). The authors recommended at least one in-person visit a year as well, and recommended that all patients with CIEDs be offered remote monitoring as a management strategy.

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Making the most of data

Even with reimbursement, remote monitoring may impose costs and other burdens that become an impediment to use. Remote monitoring is not a substitute for patient care: It requires hospitals to invest in and maintain infrastructure, staffing and adjusted workflows to monitor the data and provide timely follow-up when alerts are transmitted. These more technically advanced devices may be more expensive than models without the capability, too. Some practices worry about liability implications as well.

Providers and physicians also need to find a way to let patients who are monitored remotely know that they are being cared for, even if it isn’t apparent, Wilkoff adds. The Cleveland Clinic, for instance, communicates with patients about remote monitoring transmissions and gives them the option to get more information if they are interested.

“The patient touch part of this has to be maintained as well,” he emphasizes. “You have to work that into the paradigm.”

Wilkoff likens CIEDs with activated automatic remote monitoring to “implanted friendly spies. They monitor the patient continuously.” That produces reams of data transmitted to servers owned and managed by device manufacturers and then passed on to providers. The system bypasses tedious manual data entry and provides “a boatload of data that tells us about quality,” Wilkoff says. “We can measure the time of an event to when they are seen. We can see how they are doing later on.”

That raises several problems, though. Large amounts of data can overload a hospital’s electronic medical record (EMR), they say, especially hospitals that already struggle to meet federal Meaningful Use regulations. Middleware technologies may help to discern what data are relevant and upload them into the EMR, but who pays for this technology? Then there is the challenge standardizing a vendor-neutral interface for linking CIED data with EMR data such as comorbidities, history of hospitalizations and medication use, which could be used to improve care and underscore the technology’s value.

“The major barrier is medical interoperability,” Wilkoff says. “A lot of the cost of trying to get outcomes comes with these interfaces. … If we use a standard interface, then we don’t have to reinvent the wheel every time.”

Industry may be compelled to standardize interface protocols, Wilkoff says. “You either have to provide for the interface or you have to go to one single provider. The answer is either the companies have to say this is in our best interest to do so, or they are going be encouraged strongly by legislation.”

Opening the doors to big-data analyses using remote CIED monitoring and EMRs might change the field from treatment to prevention. “Generally, we react to a critical event when the patient is sick,” Varma says. “Remote monitoring promises us and is pointing us in that direction of preemptive care so we act before the patient is sick and has to come to the hospital.”

That shift from treating patients in sickness to strategically managing patients in health will change how electrophysiologists and cardiologists practice medicine, he predicts. That is, if more hospitals, physicians and patients would be willing to use this resource.

“One thing we have to address is the total lack of operation of remote monitoring among 50 percent of patients receiving capable devices,” Varma says, referring to his study. “It is very striking. There is a huge inertia that we have to overcome. … We hope that the recommendations will resolve some of those barriers.”