Monitoring TAVR Patients for Improved Outcomes
By Matt Phillion
For patients with severe symptomatic aortic stenosis, a transcatheter aortic valve replacement (TAVR) procedure is often performed as a minimally invasive alternative to open-heart surgery. This helps shorten a patient’s hospital stay and increases their chances of being discharged home. As TAVR procedures become more common, hospitals are now leveraging cardiac monitoring devices to monitor for significant arrhythmias post-discharge.
According to a recent study shared by Philips, remote monitoring is reshaping the standard of care in a cost-effective way for patients undergoing TAVR and other procedures. Philips offers a mobile cardiac outpatient telemetry (MCOT) clinical service for TAVR patients.
“The question is always ‘How can technology make sure patients are getting the right care at the right time in the right setting?’ Especially now, between COVID and staff burnout, with less resources,” says Jennifer Lavelle, head of global business marketing, ambulatory, monitoring, and diagnostics at Philips.
The MCOT TAVR home monitoring pathway came about in part because of the number of TAVR patients who had a fatal arrhythmia called a full heart block. “You don’t know you have this arrhythmia if you’re not monitored,” says Lavelle. The arrhythmia is detected through near-real-time cardiac ambulatory monitoring, and can show up anywhere between three and 24 days after the surgery. As many as 10% of patients have this arrhythmia, according to a study by the University of Colorado.
According to that study, patients who developed a fatal arrhythmia post-TAVR were otherwise perfectly healthy, were at low risk, and were not being rushed out of the hospital after their procedure. “It was one of those occurrences that, as a result of these procedures, you can have an arrhythmia, and the one we’re looking for—full heart block—can have dire consequences,” requiring a pacemaker to resolve, Lavelle says.
So, what clinical protocol could best help the healthcare system keep patients safe without overburdening the system elsewhere? To examine the cost in terms of both effort and money, Philips looked at over 4,000 Medicare patients who had this procedure; of that group, 280 patients were discharged with MCOT devices that provided near-real-time notifications about their ongoing condition.
“We looked at this and found that there was no impact that caused an increased cost to the system. It actually helped bring up profitability,” says Lavelle. “We saw improved outcomes without additional costs.”
The device helped systems triage patients more effectively, but it also helped keep patients in the system where they originally received care. If the patient needed further medical attention, they could go back to where they initially received their care rather than being rushed to an emergency department or to another health system entirely. “It allows the patient to stay tethered to the system and also have better clinical outcomes, lower mortality rates, and improved length of stay,” says Lavelle.
A new kind of monitoring
The American College of Cardiology’s 2020 guidelines recommend that a TAVR patient should be monitored within 48 hours of discharge if the patient does not have a clear pacemaker indication but is at risk for full heart block. From a risk perspective, it’s up to the clinicians to determine when the patient can be discharged and how to conduct monitoring.
Historically, monitoring devices such as Holter monitors have not been patient friendly or real time. “There’s lots of lead wires, they’re clunky, they operate for a short duration,” says Lavelle. “When you think about a patient wearing a short-term or long-term Holter monitor, they can go up to 14 days being recorded. Then there’s a period of time when the patient sends that recorder back to the physician; there’s time before that report is uploaded, interpreted, and sent to the physician for evaluation so they can look at the findings, sign off on them, and determine the next course of action for care.”
Connected monitors like Philips’ MCOT allow for faster diagnosis and earlier clinical decision-making. Compared to Holter monitoring, the surveillance is 24/7, which works better for higher-risk cases where timely intervention impacts clinical outcomes. “For TAVR patients, knowing the types of arrythmia associated with it, they need that near-real-time detection and notification,” says Lavelle.
The experience for the patient is improved as well. “You’re going from those lead wires, where you had octopus arms coming out of you and a big block or fanny pack to carry around, to a patch technology,” says Lavelle, who notes the patch is a rectangle only a couple of inches in size. The patch is paired with an accompanying smartphone and can be worn up to 30 days, so the patient is able to live their normal life and just needs to keep the phone and sensor charged. “It’s designed to be super simple,” she says.
The MCOT unobtrusively relies on a cellular connection and sends its data into the cloud. An AI algorithm flags data for review by a team of certified cardiac technologists, who will determine whether the patient has an arrythmia, such as a pause. Based on the severity and how the physician has set up notifications, the monitoring team will connect with the physician, clinic, or hospital that ordered the monitor.
“If it’s an urgent event, we follow the physician’s protocol to follow up on that notification,” says Lavelle. “The report is uploaded into the portal, and we offer EMR integration to help with workflow.” The intent is for the data to end up where the care team needs it, when they need it. Daily reports and an end-of-service summary are also made available so that the team has data-rich, actionable insights throughout the patient’s journey.
“From the clinician perspective, we’re building our reports so they are actionable and accurate, eliminating false positives,” says Lavelle. “We’re looking at ways to combine humans and technology to make sure we’re not over-alerting the physicians. This is where technology and people come together. We put people between the technology and the report.”
In the future, AI will be part of a continuous learning loop—the more data that comes in, the smarter it gets. “It’s a deep learning network, looking at how we ingest more data,” says Lavelle. “How is the AI processing the data? Think about how much data comes off these devices: If that algorithm can make it faster and more reproducible, that speed and efficiency is a win-win for patients and physicians. That’s where we’re continuing to evolve.”
As consumer wearables get more sophisticated, vendors like Philips must continue to wrangle the data deluge. “That deluge coming from these devices is only going to continue,” says Lavelle. Getting more disease-specific data and marrying data points together to help physicians interpret faster and more efficiently is the end goal.
“When we think about the future, it’s how do we make this process more actionable, usable, and also eliminate the fatigue from this mountain of data?” says Lavelle. “How do we help physicians look at types of data sets and also look at the patient holistically? With access to blood pressure, EKGs, diabetic information, what does that data ecosystem look like? And how do we bring it all together in a format that is easy to access, fast to use, and helps physicians work at the top of their license to have better interactions with patients?”
All of this combined can drive better costs of care, Lavelle notes.
“It’s a touchy thing in terms of cost and adding an additional step to patient care. When we look at the study, we’re showing better outcomes with no added cost with our MCOT by enabling pacemaker implants to happen as needed because of timely notifications,” she says. “It’s having a positive impact on the overall system, and that’s what we want: better outcomes for the patient, ease of use for the physicians, and peace of mind that the patient is being watched. And if there is an intervention, the patient is coming back into the system at the right time for the right procedure to avoid patient leakage.”
Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at matthew.phillion@gmail.com.