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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Disparities in Treatment of Aortic Valve Stenosis
• Intervention / Treatment: Other: Patient Questionnaire; Other: Provider Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sarah Schwager, RN, BSN; Phone Number: 612-863-6257; Email: Sarah.Schwager@allina.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Contact: Mario Goessl, MD, PhD; Phone Number: 612-863-3833; Email: mario.goessl@allina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients:

- Over 18 years of age with echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score who have a disparate condition

Providers:

- Referring primary care providers, cardiologists and cardiovascular surgeons at the study sites.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Investigators: Principal Investigator: Mario Goessl, MD, PhD, Minneapolis Heart Institute Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Disparities
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic; Aortic Valve Disease
• Other Study ID Numbers: Racial Disparities

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No