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

Study Overview
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Brief Summary
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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.

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

Conditions
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Disparities in Treatment of Aortic Valve Stenosis, Aortic Valve Stenosis

Intervention / Treatment
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* Other: Patient Questionnaire
* Other: Provider Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Severe Aortic Stenosis with Disparities<br>Patients will complete a survey and their aortic stenosis will be clinically followed at 30 days and one year | Other: Patient Questionnaire<br>* Patient Questionnaire<br>|
| Medical Providers with Disparities<br>Referring primary care providers complete a questionnaire on their referral practices for patients with severe aortic stenosis | Other: Provider Questionnaire<br>* Provider Questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Mortality |  | 30 days and 1 year | 
| MACE (Major Adverse Cardiac Event) |  | 30 days and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referring physician- related barriers/biases. | Secondary outcomes (Providers): referring physician-related barriers/biases against routine guideline-driven care for members of disparate groups with severe aortic stenosis. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Disparities