麻豆传媒

SAN FRANCISCO -- The sturm und drang over Apple Watch ECG, wearable heart rate monitoring, and patient access to implantable cardiac device data is a cultural shift that electrophysiologists should not only get on board with but lead.

That was the message from a "call to action" white paper by the Heart Rhythm Society (HRS) in its HeartRhythm journal and released at a day-long at its annual conference here.

"Because many of the early digital health initiatives have taken place in the arrhythmia world, the specialty of cardiac electrophysiology is poised to lead the charge by establishing high foundational standards of excellence in this new arena," HRS president Thomas Deering, MD, and colleagues said in an accompanying editorial.

Open Access to Data

"I call this the new symptom in cardiology -- a high heart rate on a wearable device," said Nassir Marrouche, MD, of the University of Utah Health Sciences Center in Salt Lake City, and chair of the Digital Health Working Group that helped create the document.

Practices are seeing such patients once or twice a week coming in concerned because of something they saw on their wearable. Most are just artifacts, but clinicians have to respond, Marrouche noted.

He related an experience with one patient who, after the fact, told Marrouche he felt bad, found afib with his ECG device at home, and took a pill to convert the arrhythmia and felt better. "Patients are doing this. They are in control of things" that used to require admission to the hospital.

Lead author David Slotwiner, MD, of NewYork-Presbyterian Medical Group Queens in New York City, called it a cultural change to know the expectation from patients that they should be in charge of their data.

However, when more open access for patient data was brought up for discussion, they didn't realize how controversial this would be, Slotwiner said. Physicians expressed concern that patients might interpret the information incorrectly and worried about being inundated with a deluge of data and related tasks with unestablished reimbursement.

And, importantly, while clinicians see the value to patients of consumer wearables, the document noted they "have concerns that important and fundamental components of how the data are communicated and stored remain unresolved."

Regardless, "it's clearly the future. It's obvious to us that this train has left the station and we can either try to catch up or we can lead," Slotwiner said at the session, concluding, "It's our strong belief we must lead."

Lead or Be Led

John Mandrola, MD, of Louisville Cardiology in Kentucky, who has been a vocal skeptic on ECG wearables in particular, argued for the societies to produce a consensus statement on what the expectations are and how to weigh a finding of 2 hours or 6 hours of afib.

Marrouche agreed but warned against just pointing to the hurdles and calling for regulation. "Apple, Samsung, and Google, they're moving ... We need to take the next step, otherwise it's moving without us."

FitBit, Medtronic, and Boston Scientific representatives at the session asked for guidance from the HRS on what information to give the patient.

"We want to do this in responsible way," the FitBit employee said from the audience. "We invite you onto the train."

Mintu Turakhia, MD, of Stanford University, argued that patients shouldn't be given only actionable data but that instead the paradigm of being a gatekeeper for medical information has to change. "If we don't change it, patients are just going to buy software as a service. They're going to buy remote monitoring options, pay $10 a month, and not see us because they're getting the data."

The Recommendations

For cardiac implanted electronic devices (CIEDs), the majority of patients want some data but are happy to receive it after being reviewed by the care team, Slotwiner noted. He worked with physicians, allied professionals, patients and advocates, as well as industry on the HRS document.

"For medical-grade cardiac monitors, data should be accessible to patients in a high-level summary as well as full disclosure, similar to CIED data," the document recommended.

For consumer devices, such as FitBit heart rate readings and ECG strips from AliveCor or Apple Watch 4, the impressions from stakeholders were less clear. The strong recommendation from Slotwiner's group centered on consistency and communication.

"Medical team members should discuss at the outset expectations for patients who wish to share data from their consumer wearable device with the team," they wrote. "This discussion should include the method by which the data will be communicated, expected frequency, the type of data, and expected response time from a team member."

Solutions and Hurdles

Leslie Saxon, MD, of the University of Southern California Center for Body Computing in Los Angeles, presented her group's solution, a patient-facing, manufacturer-agnostic app called CORA.

It presents simple dashboard-style information about the patient's device, such as remaining battery life, any administered shocks, and pacing rate trends. Saxon said she envisioned it as a non-profit, non-proprietary platform that could be managed as a clinical community with a uniform standard that all companies would conform to.

"We're ready to roll with it, it's ready," she told 麻豆传媒. While her group is in discussions with industry and the FDA, CORA needs more vetting and collaboration and hasn't been submitted for FDA clearance yet, she acknowledged, while expressing optimism that they could have something out there within months.

CORA is just one of a number of such tools being developed and there are significant hurdles ahead, session panelist Rodolphe Katra, MBA, PhD, of Medtronic, cautioned in an interview with 麻豆传媒.

"From a technology standpoint, it is not a tough challenge. The challenge is the privacy, the security, the FDA, the business environment, HIPAA. It's not the tangibles of the technology ... we can solve that easily. We just need leadership from the HRS, from the medical associations, we need direction and tone set by [the] FDA to allow us to play in that space just like the consumer companies do."

That will take time, he acknowledged. Legislation, reimbursement, and professional societies aren't known for moving quickly.

Saxon urged the EP community to push ahead and not wait for someone to do it for them. Electronic medical records (EMRs) are the cautionary example she raised at the session: "the absolute worst example of how to knit a patient's care together."

Some audience members and panelists at the session testified about the difficulty of trying to get the EMR to work with data submitted by patients, others pointed to their institutions' electronic patient portals as the best solution for now despite its inefficiency.

Slotwiner's group agreed on EMR patient portals but said such interim steps "should not be considered acceptable end points."

"Anything less than full and transparent access to digital health data will not be acceptable to patients or the public, and it will limit the potential for these tools to reduce inefficiencies, improve access, reduce costs, and make medicine more personalized for patients," the white paper concluded.

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