As Market Forces Drive TAVI Access, Rural Patients Left Behind

Since the approval of TAVI for the treatment of symptomatic severe aortic stenosis more than a decade ago, the overwhelming number of new TAVI programs have been launched in metropolitan areas, according to a new study presented today. Moreover, more than half of these programs were launched in cities where TAVI was already available at another nearby center.

The findings, said lead investigator Ashwin Nathan, MD (Hospital of the University of Pennsylvania, Philadelphia), highlight the disparities in access to new advances in cardiovascular medicine.

“The increased number of TAVR programs over the last 10 years has not necessarily translated to increased access,” said Nathan. “TAVR sites are predominantly located in metropolitan areas, and the majority of TAVR sites, when they open, open in areas with a preexisting program. This increase numerically does not necessarily translate into increased geographic access.”

Presenting the results of their study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions, Nathan said they also observed significant socioeconomic disparities in TAVI access, noting that hospitals adopting programs tended to be located in areas with more-affluent patients. “As a result, wealthy, and more privileged patients have more access to TAVR just by the virtue of the hospitals that serve them,” he said in a press conference.

Senior author Jay Giri, MD (Hospital of the University of Pennsylvania), who spoke after Nathan’s presentation, told the session’s audience that their results show “market forces overwhelmingly seemed to drive the development of new TAVR programs over access to care considerations.”

Treatment gaps based on access to TAVI have been documented previously, with studies showing that minority groups are underrepresented compared with white patients. Others have shown that in addition to race and ethnicity, people living in rural areas face challenges accessing hospitals with TAVI programs.

In 2019, when the Centers for Medicare & Medicaid Services (CMS) drafted their national coverage determination for TAVI reimbursement, the agency had to walk a fine line between maintaining quality and ensuring equitable access to patients in smaller, rural communities. In fact, some interventionalists were critical of the volume requirements, because they feared it might limit the development of new programs.

Just 11 Newcomers Outside Big Cities

In this study, the researchers performed a cross-sectional analysis of Medicare claims between 2012 and 2018. During that time, 554 hospitals developed new TAVI programs. Of those, 98% were in metropolitan areas, which was defined as a geographic area with more than 50,000 residents. Slightly more than half of new programs (53%) were started in metropolitan areas with a preexisting TAVI program. Just 11 programs were started in nonmetropolitan areas.  

When compared with hospitals that did not start a program, those that did were based in areas with significantly higher median household incomes (difference $1,305; P = 0.03). Additionally, hospitals without a TAVI program cared for more patients “dual eligible” for Medicare and Medicaid, which is a marker of socioeconomic vulnerability, and more patients from economically disadvantaged zip codes as measured by the distressed community index.   

Finally, the researchers looked at TAVI rates using markers of socioeconomic status and the number of procedures per 100,000 Medicare beneficiaries. Overall, there were lower rates of TAVI in areas with more Medicare and Medicaid dual-eligible patients, lower average median household incomes, and more economic distress. 

Highlighting the inequitable access to TAVI, session moderator David Cox, MD (Cardiovascular Associates/Brookwood Baptist Hospital, Birmingham, AL), pointed to the CMS volume requirements and wondered if another model might be needed for smaller, rural communities. Larger academic medical centers in urban areas might work cooperatively, rather than competitively, to mentor and proctor physicians at smaller, rural hospitals to ensure high-quality care, he suggested.

Nathan acknowledged there is a “tension” between upholding quality standards while also expanding programs to serve smaller communities.      

For the researchers, next steps involve understanding what role race and ethnicity play in inequitable access to TAVI. For example, they plan to delve into the 25 largest urban areas to determine if there are disparities in access to care based on socioeconomic status and race. Additionally, they would like to identify some of the system- and patient-level barriers to TAVI access.

“There are barriers to access, both physically [and] geographically, in accessing a procedure, as well as in navigating the [healthcare] system,” said Nathan. “Things like community health workers and patient ‘navigators’ may help patients navigate the complex aortic valve replacement pathway. In other fields it’s been shown that community health workers and patient navigators can really help, especially in oncology.”

Moving through the healthcare system, specifically from the time of symptom onset to a diagnosis of aortic stenosis and finally to a multidisciplinary evaluation by the heart team, can be daunting, agreed Giri. “Obviously, folks with increased health literacy and more means are more likely to make it through that gauntlet, but from a public health perspective, I would argue that the onus is more on the medical community at large to figure out how to roll these programs out more widespread,” he said.  

Megan Coylewright, MD (Erlanger Health System, Chattanooga, TN), one of the session discussants, suggested that individual physicians also have a responsibility. “We all tend to aggregate together, those of us who have had structural heart training or that have trained at certain institutions,” she said. “It’s certainly on us to continue to spread out and go to the communities in need to ensure access.”