Newswise — PLANO, TX, November 14, 2013 – The Heart Hospital Baylor Plano became the first in the nation to treat a patient with the catheter-based SAPIEN 3 heart valve using the transapical approach (through the ribs). This new phase of a clinical trial, also known as Partner II, may offer older patients with inoperable heart valve conditions a second chance at life.
Edwards Lifesciences Corp. created the transcatheter aortic valve replacement (TAVR) treatment option, which can give patients the opportunity to have their valves replaced without open-heart surgery. While a version of this product is approved by the U.S. Food and Drug Administration (FDA), it is the only one approved at this time. Additionally, there is no drug therapy for this type of valve condition.
Prior to the availability of TAVR, patients with high risk heart valve conditions , or determined to be inoperable, often went untreated. At the Heart Hospital Baylor Plano the heart team takes a comprehensive approach to evaluate these high-risk patients to determine the best treatment options. The team offers patients access to early stage TAVR clinical trials, the latest heart valve devices and a physician heart team with more than 10 years’ experience in transcatheter valve therapy.
“The Heart Hospital’s mission is to offer the latest, cutting-edge treatments to patients and achieve the highest quality outcomes. We’re thrilled to be among 25 sites to be awarded an investigational treatment that offers patients a variety of options to replace their heart valve via a catheter-based approach. This Transcatheter Aortic Valve Replacement not only helps to extend a patient’s life but, more importantly, it enhances their quality of life. We’re excited that Edwards Lifesciences Corp. continues to provide new innovations that allow surgical teams across the globe to expand offerings to high-risk, inoperable patients,” said David L. Brown, MD, Director of Interventional Cardiology and Transcatheter Valve Therapy.
Edwards Lifesciences Corp. received conditional approval from the FDA in August to initiate a clinical trial of the SAPIEN 3 device. The trial is evaluating the safety and effectiveness of the valve for the treatment of high-risk and inoperable patients with severe, symptomatic, aortic stenosis. The trial will enroll up to 500 patients to be treated with one of three delivery techniques: the transfemoral approach through an incision in the leg, the transapical route using a small incision on the side, and the transaortic approach through a small incision in the chest and aorta.
If you are a patient, or are a family member of a patient suffering from severe aortic stenosis and are interested in learning more about transcatheter aortic valve replacement, please contact The Heart Valve Center of Texas at 1.855.4CV.CARE (1-855-428-2273).
About The Heart Hospital Baylor PlanoThe Heart Hospital Baylor Plano, located in Plano, Texas, is a 116-bed, for-profit hospital affiliated with Baylor Health Care System. Recognized as the No. 1 Cardiovascular Specialty Hospital* in the country based on cardiac surgery volume, the hospital is the first and only freestanding, full-service hospital in North Texas dedicated solely to heart and vascular health care. The hospital is ranked in the top 10 in the nation for both cardiothoracic surgery and valve surgery volumes and in 2012-2013 was awarded the highest rating—three-stars from the Society of Thoracic Surgeons. In addition, the hospital is a seven-time Press Ganey® Summit Award® recipient for patient satisfaction. For more information visit: www.TheHeartHospitalBaylor.com
About Baylor Scott & White HealthBaylor Scott & White Health is a not-for-profit health care system with total assets of $8.3 billion*** and the vision and resources to offer its patients continued quality care while creating a model system for a dramatically changing health care environment. The new system includes 43 hospitals, more than 500 patient care sites, more than 6,000 active physicians, 34,000 employees and the Scott & White Health Plan. For more information visit: www.BaylorScottandWhite.com
* TRG Health Care Solutions website: www.trghcsolutions.com**The Society of Thoracic Surgeons developed a comprehensive rating system for the quality of cardiac surgery among hospitals across the country. Approximately 6% of hospitals received the “3 star” rating, which denotes the highest category of quality. In the current analysis of national data covering the period from July 2009 through June 2012, the cardiac surgery performance of the hospital is established in the highest quality tier, thereby receiving an STS three star rating. The STS National Cardiac Database measures outcomes on over 95% of the 1,100 cardiac surgery programs in the U.S.***based on unaudited fiscal year 2013 financial statements
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