Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Minneapolis Heart Institute Foundation

Status: Unknown

Conditions: Aortic Valve Stenosis; Disparities in Treatment of Aortic Valve Stenosis

Treatments: Other: Provider Questionnaire; Other: Patient Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04525937

Racial Disparities

Details and patient eligibility

About

Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that >94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education))
• Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR)
• Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score

Exclusion criteria

• Age < 18
• Patients who do not allow their records to be used for research

Trial design

200 participants in 2 patient groups

Patients with Severe Aortic Stenosis with Disparities

Description:

Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year

Treatment:

Other: Patient Questionnaire

Medical Providers with Disparities

Description:

Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis

Treatment:

Other: Provider Questionnaire