New Medical Devices & Partnerships Could Break Barriers & Lead to Better Heart Failure Care

Despite societal emphasis on health and wellness, the number of patients with heart failure in the U.S. is expected to rise substantially through the end of the decade, from about 6.7 million people to 8.5 million by 2030.

Costs associated with their care are expected to be in the multi-billion category. The Heart Failure Society of America estimates direct medical expenses for 8 million people with heart failure will entail direct costs of $53 billion, indirect costs of $70 billion.  The organization estimates that total cardiovascular care direct costs will be $160 billion as measured in 2010 dollars.

The burdens of heart failure also strike different demographics inequitably. Data from the National Inpatient Sample from 2002 to 2013 showed that Black women and men had the highest rates of hospitalizations for heart failure compared with other races, and the rate of hospitalizations for Black women and men was almost two-and-a-half times higher than for Caucasian patients.

A new cadre of medical technologists and clinicians intends to bend that curve back – or at least to catch heart failure earlier and to manage it in a far more convenient mode than the typical case that is diagnosed in the emergency department and managed through multiple ongoing office visits. Through a combination of new devices that fit easily into a patient's daily routine, and additional clinical partnerships that make management of cases more efficient, these pioneers of remote heart failure care hope to demonstrate a new way to keep patients healthier.

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“Cases are going up and I am of the opinion we haven’t gotten a lot better at treating heart failure just yet,” Chris Darland, CEO and president of New York-based Peerbridge Health, said. “Heart failure has the highest readmission rate of any health issue; there’s over a 1-in-3 chance you’ll come back to the hospital after discharge. So, we haven’t cracked the code yet, and we definitely haven’t gotten better at identifying it earlier.”

Darland and his colleagues hope their wireless patch electrocardiogram technology, trademarked Cor, helps to change those dynamics. The technology recently emerged from a small 37-patient feasibility study with an accuracy rate of nearly 96% in identifying heart failure in patients utilizing ECG as the only input. The patients wore the three-lead, two-channel wireless ambulatory ECG patch at home anywhere from three to seven days. Leveraging five-minute windows of electrocardiogram signals, the Peerbridge platform was able to determine whether an individual patient had heart failure, through either reduced or preserved ejection fraction, with 95.7% accuracy.

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Darland said the company’s three-lead technology improves on both spectral and spacial fidelity of signals received from the more common single-lead portable ECG technology, and AI-enabled tools in its stack leverage advanced signal processing techniques.

“Our approach was actually founded on interesting research done in the 1960s and ’70s, but the tools didn’t exist to prove they were right,” Darland said, “and they were probably closer than they thought. So, we start there and then layer on some of our proprietary work on top.”

Peerbridge is now configuring a full trial slated to start this autumn. Darland said he expects FDA to ask for between 500 and 800 enrolled patients, and that other aspects of the trial are still being worked out.

“Heart failure is a little trickier from the trial perspective because there is no gold standard for diagnosing it,” he said. “Some doctors may use echo, some may use cardiac MRI, so we are trying to figure out what makes FDA comfortable so we can broadly use this as a screening tool. But ejection fraction we are starting right away.”

One upgrade the Cor patch will get very soon is built-in LTE cellular communication. The existing version must be mailed into a testing lab; while Peerbridge considered the idea of making the new version communicate through a smartphone app, Darland said cardiologists told the company some of their patients didn’t have phones or would be unable to set up networking connections if they did.

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“We need to make this as simple as humanly possible, so the LTE chip was the way we went,” he said.

Remote Heart Failure care at, and with, scale

San Francisco-based Bodyport also opted to use cellular technology rather than short-range and WiFi spectrum for its technology – but, rather than an ECG patch that technology is a body weight scale that includes hemodynamic sensors that can report fluid concentrations, and signal heart failure, more accurately than the existing weight-only paradigm.

“The way we use bioimpendance is unique from other systems and allows us to differentiate between different types of accumulation,” Corey Centen, Bodyport co-founder, president, and CTO, said. “You will have fluids’ fluctuation due to consuming things like sodium on a daily basis, but they do look different from a biomarker standpoint from what we see in a heart failure exacerbation.”

As the investigators in the company’s SCALE HF-1 study explained, the impedance signal is captured at multiple frequencies to enable the measurement of both extracellular and intracellular fluid. The peripheral fluid status, they surmised, could be an important clinical correlate for heart failure patients not captured by traditional weight measurements. Data from a preliminary analysis of 329 enrolled subjects on the device, which is already FDA-approved and in commercial use, showed the Bodyport scale detected twice as many heart failure events as compared to the weight-only based standard of care, while minimizing false alerts for care teams, generating nearly 40% fewer overall alerts.

Centen said Bodyport is promoting the scale as an alternative to the patch approach because patients will find virtually no disruption to a routine they have already been doing. 

“Patches with adhesives are great for the first couple weeks after discharge, but there’s the possibility of irritability, of sensitivity, and you have to keep applying patches,” he said, “but the scale you can use for years – a 20-second measurement every day you can do for years.”

For ChristianaCare, convenience and consistency

Just as the new technologies from Peerbridge and Bodyport are designed for at-home convenience, Wilmington, DE-based ChristianaCare has gone all-in on remote heart failure care. The system has been partnering with Story Health; the Cupertino, CA-based company blends a digital platform and health coaches to make sure patients stay on track with medication adherence and clinical monitoring. Kirk Garratt, MD, medical director of ChristianaCare’s Center for Heart & Vascular Health, said the partnership has been very effective in maximizing the capacity for the system’s 10 clinicians to serve 2,000 patients discharged with heart failure every year.

“In brief, they have developed algorithms for patients to accelerate their medication therapies until they get to their optimal dosing, then they help support them in staying at that dosing,” Garratt said, “while also assessing how the patient is doing. That is done both through remote monitoring devices such as electronic scales and the like, but also, very importantly, having a dialog with the patient.”

Garratt said the Story Health coaches enable patients to reach their maximally tolerated dose of medications very quickly – “In our old care model patients would come into the office newly diagnosed and come back in three weeks, and that would be first step up. With Story Health we can have you already up to your maximally tolerated dose in that period. And if you have just come out of the hospital we are really on the hook for readmissions. In terms of costs, our ability to deflect  readmissions in a relatively short period of time has a big payback to the organization.”

Garratt also lauded the partnership in addressing social disparities in treatment; the system’s Black heart failure patients more than doubled their medication adherence after the partnership began.

For Peerbridge’s Darland, the drive to deliver better and more convenient remote care is a great motivation.

“How do we treat those millions of people who are – I hate to say falling between the cracks – but also are not necessarily going out of their way to get help?” he said. “And I think we can fix this. The tools to diagnose heart failure quickly exist today, but they all sit in the hospital and they are all pretty expensive. Cardiologists would love to be able to catch patients a little earlier and save them from an ER visit.”