Gaps in Access to TAVR and SAVR: ‘Something Needs to Be Done’

A concerted effort is needed to address treatment gaps for aortic valve disease among underserved populations in the United States, authors of a new perspective say. Impediments to care can include socioeconomic issues, distance from quality treatment facilities, diagnostic and treatment referral bias, language and cultural barriers, and a variety of disease-related factors.

In an interview with TCTMD, Wayne Batchelor, MD (Inova Heart & Vascular Institute, Falls Church, VA), lead author of the paper, said he hopes it will spur debate regarding not only issues that underserved patients face but also ideas about who these people are.

“Underserved populations have all sorts of characteristics. We tend to focus on race, sex, and ethnicity, but the elderly can be underserved and rural Americans who live from far distances from TAVR centers and centers of expertise can have access issues,” he observed. In some cases, patients may even choose lower-quality care or forfeit diagnostic testing rather than travel a long distance. Efforts to improve access, Batchelor and colleagues say, may be helped by novel approaches such as miniaturized ultrasound and wireless mobile health technologies that could be used to diagnose aortic valve disease at clinics without traditional echocardiography.

As TAVR has increasingly grown as a treatment option, data show significant underrepresentation of its use among underserved minorities. Of approximately 70,000 TAVR-treated patients in the Society of Thoracic Surgeons/American College of Cardiology TVT Registry between 2011 and 2016, 91% were white, 3.8% black, 3.4% Hispanic, and 1.5% Asian/Native American/Pacific Islander.

“There has not really been any change in the proportion of minorities undergoing this procedure since its inception,” Batchelor noted. “It's not really representative of the demographics of our population and the question is why.”

Despite being less likely to undergo aortic valve replacement, virtually all of the literature indicates that outcomes for both TAVR and SAVR tend to be favorable among minorities, Batchelor and colleagues say. In the paper, published October 28, 2019, in the Journal of the American College of Cardiology, they propose a four-part plan to help close the treatment gap and raise the healthcare community’s awareness of major barriers to care.

Identifying Obstacles and Altering Language

Performance measure-based quality improvement has been shown to be effective and is a key component of the American College of Cardiology's Coalition to Reduce Racial and Ethnic Disparities in Cardiovascular Disease Outcomes, also known as credo. Batchelor and colleagues say identifying the number of underserved minorities with severe symptomatic AS within a practice or health system who are being appropriately referred for intervention, for example, can “identify impediments to care and known or unknown biases.” As with other quality measures, they say the ability of a healthcare system to provide equitable evidence-based care across all patient demographics needs to be more transparent.

Commenting on the paper for TCTMD, Clyde Yancy, MD (Northwestern University Feinberg School of Medicine, Chicago, IL), said he applauds Batchelor and colleagues for starting the conversation and for challenging clinicians to be better informed. He added that quality-improvement initiatives are typically blind to race, ethnicity, sex, and age, making them a great way to anonymize patient characteristics and look at treatment patterns.

“It is such a standard approach to target narrowing gaps in care that is should be deployed without hesitancy,” Yancy said.

Another important part of improving care is altering language and communication strategies, Batchelor and colleagues contend. Specifically, they note that culturally sensitive, clear, and language-concordant communication between the heart team and patients and their families can reduce the risk of inappropriate patient refusal to consent to a AVR procedure. They encourage providers to seek out specific reasons for refusal and address them, when appropriate, adding that all members of the multidisciplinary heart team “need to be made aware of, and sensitive to, the inherent biases that might play into decision-making.”

For Yancy, that statement does not go far enough. Members of the heart team, he said, also need to acknowledge their own biases and how they factor into patient care.

Lastly, Batchelor et al say more emphasis is needed on improving minority representation in clinical research. They also recommend that more trials incorporate investigators who actually work in underserved areas and that underserved populations receive enhanced access to postmarket registries and investigator-initiated studies, as well as earlier commercial access to recently approved valvular heart disease therapies.

“Something needs to be done because as long as you've got major academic medical centers serving as the epicenter for trials, as long as the clinical trial networks remain as they have been configured, it will be increasingly more challenging to recruit diverse populations,” Yancy agreed. “When one considers the very real tendency now to yield to the globalization of clinical trials, a process that incorporates even less of a diverse patient population, and that is relying heavily on European countries to support and to conduct clinical trials, it really does get us into a much more difficult place.”

To TCTMD, Batchelor said impediments to optimal valvular heart disease care for minorities requires close inspection of patient-related, healthcare-system-related, and disease-related factors.

“It's so easy to just look at it and say, ‘Blacks are not offered valve procedures,’ and walk away saying that that's the final summation of all this,” he said. “Well, it's way more complicated than that, because it’s complex interplay between many different factors.”

Natural History, Prevalence, and Disparities in Care

The paper also touches on whether race and ethnicity influence the prevalence of aortic stenosis, noting that the evidence base “more supports than refutes the notion” that African-Americans and other minorities are less likely to have aortic stenosis compared with white individuals. However, “genetic, clinical, and environmental factors that contribute to a lower reported prevalence of aortic stenosis in minorities remain largely unknown,” the researchers note.

Yancy said many questions surround the natural history of aortic stenosis in minority populations that may dovetail with issues of prevalence and care disparities.

“What really needs to be initiated is a search for the truth,” he stressed. “What is the incidence of this condition in underrepresented minorities? How do they present? How do we manage their presenting complaints? How do we navigate? How do we support them as this decision about either surgical or transcatheter intervention is being considered? These are important questions going forward.”

While Batchelor and colleagues say in their paper that bicuspid aortic valve disease and aortic valve sclerosis and calcification appear to be less prevalent in African-Americans based on the published literature, Yancy added that more research is needed before concluding that this statement is accurate. He noted that the limited data may reflect a survival bias against underrepresented minorities who do not live long enough to develop aortic stenosis.

“There are data sets we have not yet perused to identify what the reality of the incidence of calcific trileaflet aortic stenosis is in underrepresented minorities,” he said. “It's important for us to do that.”