Minneapolis Heart Institute Foundation Enrolls First Patient in Racial and Ethnic Disparities Study for Valvular Heart Disease

Minneapolis, MN – September 13, 2018 – Researchers at the Minneapolis Heart Institute Foundation® (MHIF) enrolled their first patient in the TVINCITIES study (aorTic Valve dIsease aNd raCIal dispariTIES). This study is an example of physician-initiated research conducted at MHIF and is inspired and led by Mario Gössl, MD, PhD, co-chair, MHIF Valve Science Center, and MHIF researcher.

“There is a tremendous disparity in the treatment of severe aortic stenosis in the United States. This is reflected by the Trans Catheter Valve Therapy (TVT) registry in which greater than ninety percent of treated patients are white,” said Dr. Gössl. “In a unique collaboration with Edwards Lifesciences, we are exploring various potential biases and factors that may be responsible for this disparity in order to address them and improve access to life saving therapies like transcatheter aortic valve replacement (TAVR) for all patients in the United States.”

More than 3.2 million Americans have been diagnosed with valvular heart disease. Most of these patients have options to treat the disease and research has led to less invasive, advanced valve treatments. Yet, many patients receive only conservative therapy or undergo watchful waiting. In a collaboration with Hennepin County Medical Center, Minneapolis, MN and Edwards Lifesciences, Dr. Gössl established the TVINCITIES study to determine the impact of referral biases and patient factors on disparities in care for those requiring surgical or transcatheter therapies. Patients as well as referring providers will be asked to complete a standardized questionnaire that addresses these questions.

Patients who have been diagnosed with severe or symptomatic valvular heart disease (VHD) have survival rates that are comparable or worse than many advanced malignancies, including breast cancer, colon adenocarcinoma, and leukemia1, 2. Despite this poor natural history, the vast majority of patients with significant VHD do not receive appropriate, guideline recommended, lifesaving surgical therapy3-5. This is especially troublesome given the advent of minimally invasive and catheter-based therapies, which, along with surgery, has enabled the treatment of all patients with aortic stenosis, regardless of surgical risk6,7.

Common barriers to receiving appropriate guideline-driven care for patients with VHD include referral biases by primary care providers (lack of education), comorbidities (degree of fragility), psychosocial issues and cultural barriers6,8,9. Additionally, race, ethnicity and socioeconomic status (SES) are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between the various ethnic patient populations6,9,10.

The study will also compare the clinical outcomes (death, stroke, quality of life, etc.) between disparity groups (race/ethnicity, language barriers/education and/or low SES) and whites (age/gender matched group of white/non-diverse patients treated with the Sapien S3 Valve at Minneapolis Heart Institute® and/or patients from the PARTNER trial(s)) following transcatheter therapy.

About the Minneapolis Heart Institute Foundation® Valve Science Center

Established in 2016, the mission of the MHIF Valve Science Center is to eliminate the morbidity and mortality of valvular heart disease. Through its commitment to leading research and education, in partnership with physicians at the Minneapolis Heart Institute®, the Center is addressing the root causes of currently poor outcomes by studying barriers to care, advancing public education and disease state awareness, accelerating innovation in medical technology, and introducing novel patient care pathways to improve outcomes. MHIF actively participates in major clinical trials and conducts many investigator-initiated research studies focused on disease mechanisms, clinical care effectiveness and applying new treatment, diagnosis or monitoring methods. MHIF’s valve team has authored hundreds of papers and presents frequently at national conferences, such as American Heart Association, Transcatheter Cardiovascular Therapeutics and American College of Cardiology. More information can be found at http://www.mplsheart.org/valvesciencecenter

 

About the Minneapolis Heart Institute Foundation®

The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.

  • Scientific Innovation and Research — MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 175 peer-reviewed abstracts. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
  • Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.

The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital.  Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin. More information can be found at http://www.mplsheart.org

 

REFERENCES

1. Lung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J 2003;24:123143.

2. Mirabel M, Iung B, Baron G, et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J 2007;28:135865.

3. Varadarajan P, Kapoor N, Bansal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis. Ann Thorac Surg 2006;82:21115.

4. Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD, Jr., Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes 2009;2:5339.

5. Freed BH, Sugeng L, Furlong K, et al. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol 2010;105:133942.

6. Hassapoyannes CA, Giurgiutiu DV, Eaves G, Movahed MR. Apparent racial disparity in the utilization of invasive testing for risk assessment of cardiac patients undergoing noncardiac surgery. Cardiovasc Revasc Med 2006;7:649.

7. Minha S, Barbash IM, Magalhaes MA, et al. Outcome comparison of African American and Caucasian patients with severe aortic stenosis subjected to transcatheter aortic valve replacement: a single center experience. Catheter Cardiovasc Interv 2015;85:6407.

8. Williams DR, Priest N, Anderson NB. Understanding associations among race, socioeconomic status, and health: Patterns and prospects. Health Psychol 2016;35:40711.

9. Ahmed A, Sorajja P, Pai A, Plimpton N, Bae R, Pedersen WA, Tindell L, Farivar RS, Harris K. and Gössl M,. Prospective Evaluation of the Eyeball Test for Assessing Frailty in Patients With Valvular Heart Disease. J Am Coll Cardiol 2016; 68:25.

10. Gillum RF, Gillum BS, Francis CK. Coronary revascularization and cardiac catheterization in the United States: Trends in racial differences. J Am Coll Cardiol 1997;29:155762.