Imminent Decision on Medicare Coverage of TAVR; New Research Shows Patients Benefit in Recovery

WASHINGTON, June 21, 2019 /PRNewswire/ -- Heart Valve Voice US (HVV), the leading patient advocate group for people living with heart valve disease, says new research on the benefits of transaortic valve replacement (TAVR) should be a major consideration for the Centers for Medicare and Medicaid Services as they determine how they will cover TAVR. CMS will make their decision by June 24th.

A new analysis of the SURTAVI trial shows that two years after treatment, valve disease patients treated with TAVR (transcatheter aortic valve replacement) had significant improvement in a 6-minute walk test compared to patients who were treated surgically. TAVR patients also had better functional status at the 30-day mark as well. Dr. Mark Tuttle of the Beth Israel Deaconess Medical Center in Boston suggested in his presentation at TVT that the trauma from surgery, including the sternotomy, has lingering effects. Surgery patients, "take a hit, and they don't completely recover," he said.

In addition to superior recovery, with the use of current generation TAVR devices, there is no longer a detectable learning curve or demonstrable volume-outcomes relationship, according to a review published in the Journal of the American College of Cardiology, February 2019.

"Patients with aortic stenosis should have access to all FDA approved therapies no matter where they live or who they are," said Lisa M. Tate, Interim Executive Director for the nonprofit patient advocacy organization, Heart Valve Voice US.

Currently, Medicare coverage determines which hospitals may provide TAVR, based on the number of surgical and interventional cardiac procedures they do each year. This has limited TAVR access primarily to the largest hospitals, even though the data over seven years points to little difference in outcomes in larger volume hospitals vs. smaller volume hospitals.

Rural communities face access barriers with greater than 90% of TAVR procedures in the U.S. performed in urban, teaching hospitals. Seventy-eight percent of patients served by those hospitals are in higher income zip codes. These barriers also limit access for African Americans and Hispanics, who represent 17% of the older adult Medicare population, but only 7.2% of TAVR patients.

"The benefits of recovery with TAVR, combined with the disparities in who has access to the procedure currently, clearly points to a need to expand the availability of TAVR to more hospitals," said Tate.

About Heart Valve Voice US
Heart Valve Voice US is a nonprofit patient advocacy organization that provides a voice to those living with heart valve disease and educates patients and the public about heart valve disease.

SOURCE Heart Valve Voice US