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 leukemia. Despite this poor natural history, the vast majority of patients with significant VHD do not receive appropriate, guideline recommended, lifesaving surgical therapy. 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 risk.
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 barriers. 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 populations.
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.