Outside-the-box thinking is needed to close gaps in care: hospitals, trialists, industry, and regulators all have a role to play.
CHICAGO, IL—The pervasive inequities in access to medical care in the United States are well documented, but one expert believes the racial, ethnic, and socioeconomic disparities currently observed in structural heart disease can be corrected if patient groups, hospitals and physicians, industry, and regulatory agencies work together to address the problem.
During a keynote lecture last week at TVT 2022, Ashwin Nathan, MD (University of Pennsylvania Perelman School of Medicine, Philadelphia), an interventional cardiologist whose research has addressed inequities in care, detailed the unequal access to medical devices for structural heart interventions, whether that’s TAVI, left atrial appendage occlusion (LAAO), or transcatheter edge-to-edge repair (TEER) for mitral regurgitation. These procedures, some of which have been shown to be lifesaving, are not equally distributed to everybody in United States, he said.
“It’s not that we don’t want to put patients on our table,” Nathan said. “I don’t think there’s a single interventional cardiologist or surgeon who would see a patient who is a racial/ethnic minority, or socioeconomically disadvantaged, and wouldn’t offer them a procedure. I don’t think that’s explicitly happening. What I think is happening is that there is a problem in the entire diagnostic and treatment-referral pathway. This is a long and complex pathway.”
To undergo aortic valve replacement, for example, patients are referred from their primary care physician to the cardiologist, who in turn sends patients onto the interventional cardiologist or cardiac surgeon. During this process, which takes weeks or months and requires multiple appointments, there are patient-specific hurdles such as inadequate social support, challenges with transportation, and language barriers, among others. Some patients may simply not be referred to a cardiologist and those who are might not trust the healthcare system.
Race, ethnicity, and socioeconomic status all impact these different barriers, said Nathan.
He highlighted research his group published in 2021 showing that even in metropolitan areas where geographic access to TAVI shouldn’t pose a problem, there are large racial/ethnic and socioeconomic discrepancies in who is getting treated. In fact, during a separate late-breaking clinical trial session, Nathan presented data showing that hospitals involved in clinical trials for transcatheter mitral or tricuspid therapies take care of a more socioeconomically advantaged patient population compared hospitals not involved in those trials.
We struggle to get the patients in our immediate surroundings into the clinics and onto our tables for TAVR procedures that are necessary. Ashwin Nathan
For example, the city of Philadelphia has the largest percentage of patients with dual eligibility for Medicaid, which is a marker of poverty, as well as the highest proportion of Black or Hispanic patients within the broader Philadelphia-Camden-Wilmington metropolitan area. The city, home to Penn Medicine, one the largest TAVI programs in the United States, has the lowest age-adjusted rates of TAVI in the broader metropolitan region.
“We struggle to get the patients in our immediate surroundings into the clinics and onto our tables for TAVR procedures that are necessary,” said Nathan.
The same phenomenon exists for left atrial appendage occlusion for the treatment of atrial fibrillation. As with TAVI, the city of Philadelphia has some of the lowest age-adjusted rates of LAAO with Watchman (Boston Scientific) in the Philadelphia-Camden-Wilmington region, he said.
Wayne Batchelor, MD (Inova Heart and Vascular Institute, Fairfax, VA), one of the session moderators, agreed that a lot of patients with aortic stenosis and other structural conditions remain untreated.
“I think it’s an upstream problem,” he said. “We still don’t understand the difference in prevalence of aortic stenosis between races and ethnicities. It’s poorly understood, and we can’t get the information from the databases. . . . To me, it’s the patients we’re not seeing. We need to swim further upstream to get our hands around those patients who are dying unnecessarily within a year or two of having aortic stenosis and are not being properly evaluated.”
Roxana Mehran, MD (Icahn School of Medicine at Mount Sinai, New York, NY), one of the session’s discussants, also emphasized the need to identify patients early and to think outside the box when it comes to screening underserved groups. Taking CVD screening programs directly into the communities might be one way to help identify patients, she said.
Alignment of Interests
During his keynote, Nathan emphasized that the lack of access among certain racial, ethnic, and socioeconomic groups doesn’t need to be this way, pointing out that providing lifesaving, evidence-backed care is a win for patients, hospitals/healthcare systems, and industry. The community as a whole, he said, needs to take advantage of the aligned interests in order to improve access to these interventions.
We need to swim further upstream to get our hands around those patients who dying unnecessarily. Wayne Batchelor
“I think industry has a really important role in how to address inequities in structural heart disease,” he said. “For the trials that are upcoming, I think it’s important to set racial, ethnic, and socioeconomic-stratified recruitment targets for industry-sponsored structural heart disease trials. And honestly, nonsponsored trials as well. This will ensure that we will provide access to these therapies, not only for issues of generalizability, but also because often these are lifesaving therapies and because without enrollment in trials patients might not be offered a therapy.”
Hospitals and physicians should also consider investing in community engagement efforts, said Nathan. By way of example, he noted that Penn Medicine recently purchased the Mercy Catholic Medical Center, which is located in West Philadelphia and provides care to a predominantly Black population on Medicaid. Access to services there has been largely streamlined to make it easier for patients, he noted. Finally, he said hospitals should retain a diverse workforce of physicians and providers who work with minority communities. That can be a challenge, he conceded, because it requires time and investment, with no tangible metric to measure success.
Howard Herrmann, MD (University of Pennsylvania Perelman School of Medicine), said that one of the hurdles in structural heart disease is that many marginalized patients simply aren’t exposed to clinical trials where they can gain access to investigational therapies. For example, even after acquiring Mercy Catholic Medical Center, these patients still don’t get enrolled into studies.
“Part of that reason is that we’re really disincentivized to do it,” said Herrmann. “It’s not really money, but time more than anything else. . . . All of these devices that we now think of as lifesaving—TAVR, Watchman—started as clinical investigations, as trial devices. That’s where it really begins at these hospitals, but we don’t have the finances to put a study coordinator in these hospitals. We don’t have the time for the principal investigators to have a clinic out there that’s only a mile away.”
One way to help address that problem would be to start the clinical trials at some of these smaller hospitals, said Herrmann. Batchelor noted that there is a need for industry- and investigator-initiated clinical trials to be done quickly with good efficacy and safety data, which explains why trials tend to enlist those that have done studies in the past, assuming that these will lead to expedited enrollment and solid outcomes.
All of these devices that we now think of as lifesaving—TAVR, Watchman—started as clinical investigations, as trial devices. Howard Herrmann
“I think we have to challenge that assumption,” said Batchelor. Otherwise clinical sites participating in trials will maintain their entrenched advantage, he added, since this ultimately affects patient access later on.
“If you’re selected as a site participating in the protocol for a new device, you’re going to get the device first [if/when approved],” continued Batchelor. “You’re going to have a competitive advantage over your surrounding hospitals. You’re going to be seen as an expert site. . . . And that is all with certain demographic pockets of the United States. We have to come up with clever ways to include more sites within more ethnically diverse communities.”
Mayra Guerrero, MD (Mayo Clinic, Rochester, MN), who participated in the panel discussion, said that she’s come up against some of these ingrained ways of doing things when trying to enroll patients into clinical trials. For example, she recently had a patient who was a good candidate for an investigational therapy, but that patient was initially blocked by the research team because the patient didn’t speak English.
“Those types of barriers are things we need to identify,” she said.
Role for Regulatory Agencies
During his keynote, Nathan also highlighted the role for groups like as the Food and Drug Administration, National Cardiovascular Data Registry, and Centers for Medicare & Medicaid Services. While these entities do a good job measuring outcomes in those who receive therapies, less attention is paid to the outcomes of those not treated. Tracking the “denominator” of untreated patients can help the community prioritize the care of historically disadvantaged patients.
If you want to do something, you really need to fix your healthcare system. If you don’t do that, it will remain a problem. Ran Kornowski
Bram Zuckerman, MD (Food and Drug Administration, Silver Spring, MD), director of the agency’s office of cardiovascular devices, said the agency is committed to improving the availability of healthcare data with respect to race, ethnicity, and gender. He noted that previous efforts to do so haven’t been as successful as they would have liked, but they are interested in working with different stakeholders to do better. He also said industry has recognized the problem and is committed to addressing the problems.
Ran Kornowski, MD (Rabin Medical Center/Beilinson Hospital, Petach Tikva, Israel), as the lone non-US physician on the panel, said his perspective differs slightly from his American colleagues. In his opinion, the racial, ethnic, and socioeconomic disparities in access to structural heart interventions really are just the tip of the iceberg.
“It’s a surrogate of a much larger problem,” he said. “You can’t isolate the topic from other healthcare measures that are much broader and no less problematic. . . . You can’t detach the problem in structural heart disease and isolate it from the healthcare problem without tackling the wider problem of healthcare in America. If you want to do something, you really need to fix your healthcare system. If you don’t do that, it will remain a problem.”