DALLAS, Texas – On Aug. 16, the U.S. Food and Drug Administration (FDA) approved a minimally invasive open-heart surgery alternative for low surgical-risk patients following the successful outcome of the PARTNER 3 and Evolut LR clinical trials.
Baylor Scott & White The Heart Hospital – Plano and Baylor Scott & White Medical Center – Temple participated in the PARTNER 3 trial and Baylor Scott & White Heart and Vascular Hospital – Dallas participated in the Evolut LR trial, following FDA approval of transcatheter aortic valve replacement (TAVR) for inoperable patients in 2012, high-risk patients in 2014 and medium-risk patients in 2017.
"This is a momentous shift to have a disease that's historically been mainly treated by open-heart surgery now treated with a catheter-based approach," said Michael Mack, MD, co-principal Investigator of the PARTNER 3 Trial and medical director of cardiovascular service line for Baylor Scott & White Health. "This approval underscores the importance and value of this research and demonstrates our commitment to improve care options for patients with aortic stenosis."
Baylor Scott & White Health hospitals enrolled the highest number of enrollees in the two trials combined of any health system in the U.S. Baylor Scott & White's 15-year history with TAVR began in 2004 in Leipzig, Germany, with investigators from Baylor Scott & White The Heart Hospital – Plano (then The Heart Hospital Baylor Plano) working with German colleagues. TAVR was performed on humans in early clinical trials less than three years later in the US. Baylor Scott & White is home to Texas' largest TAVR program, having performed more than 3,600 TAVRs and is a top-five provider of TAVR nationally.
An estimated 1.5 million people in the U.S. have aortic stenosis, which is a narrowing of the main heart valve that impedes blood flow from the heart Unlike traditional open-heart surgery, TAVR allows physicians to deliver the new aortic valve via catheter usually through a blood vessel in the leg. This approach has decreased complications and shortened recovery time to one, rather than several, days in the hospital.
Four Baylor Scott & White hospitals offer TAVR:
- Baylor Scott & White The Heart Hospital – Plano
- Baylor Scott & White Heart and Vascular Hospital – Dallas
- Baylor Scott & White All Saints Medical Center – Fort Worth
- Baylor Scott & White Medical Center – Temple
TAVR research at all facilities is led through Baylor Scott & White Research Institute. Learn more about Baylor Scott & White Health's TAVR clinical research on Scrubbing.In.
Learn more about Baylor Scott & White Health's heart valve disease treatment options.
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About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com