Mission Health Coauthors Global, Multi-center Trifecta Aortic Heart Valve Study

ASHEVILLE, N.C., July 1, 2013 /PRNewswire/ -- After testing a new surgical aortic heart valve for five years, researchers at Mission Hospital have coauthored one of the largest, multi-center, prospective studies ever conducted on a global scale. In the St. Jude Medical Trifecta Heart Valve Study, researchers from Mission Hospital, Mayo Clinic, the University of Pennsylvania, Vanderbilt Medical Center, and the Leipzig (GR) Heart Center reported these successful results:

• Mission Hospital participants' overall survival rates were significantly higher, at 97.2 percent at two years, compared to the study's overall survival rate of 94.5 percent at two years;
• At one year, 94.8 percent of study participants were free from prosthesis-patient mismatch[1], and;
• Outstanding hemodynamic performance (ability to minimize blood flow through the valve) was similar to that of a healthy aortic heart valve.

Mission Hospital is one of six U.S. hospitals asked by the FDA to perform post-market release studies – a result of its exceptionally "clean" data. Mission Hospital is the flagship hospital of Mission Health, rated twice as one of the nation's Top 15 Health Systems.

"Mission Health's Heart Valve Clinic has a reputation for innovation and excellent patient outcomes," Mark A. Groh, MD, Mission Health's leading researcher and a coauthor of the study, said. "We perform more than 400 valve replacement surgeries each year, putting us in the top two percent of valve surgery volume in the nation. The Trifecta aortic heart valve repair surgery is an excellent example of how we align our research involvement and our clinical expertise to deliver the highest possible level of care to our patients."

Mission Hospital is the only hospital in the Southeast to participate in the study. Its data was consistently held among the highest quality of 31 participating national and global trial sites.

The Trifecta valve has been successfully implanted in hundreds of patients at Mission Hospital and thousands globally. Follow-up statistics indicate positive results, including the results below.

• Uniformly low gradients (a reduction in pressure exerted on the heart as blood flows through the valve) indicates exceptional valve function across all sizes for a stented tissue heart valve.
• An extremely low rate of paravalvular leak (blood leakage) and minimal valve regurgitation (a backflow of blood from the aorta into the left ventricle) was reported.
• At two years of clinical follow-up, 83.5 percent of patients had New York Heart Association class I functional status, 14.4 percent had NYHA class II status, and 2.1 percent had NYHA III status. There were no instances of NYHA functional class IV status in follow-up. (A majority of the 1,022 patients had NYHA class II or III symptoms at the start of the study; 55 patients showed class IV symptoms.)

For patients at Mission Health, post-market studies represent five years of complimentary follow-up care. It also means patients in the rural communities of western North Carolina have access to a selection of the most innovative procedures, performed by some of the world's best thoracic surgeons. And these surgeons are directly impacting patient safety on a global scale.

"At Mission Health, we strive to offer our communities, our neighbors, the best cardiac operations available at the most advanced site in the nation. The Trifecta study validates our pursuit of excellence when providing care to patients with complex structural heart disease," Dr. Groh said. "This goal aligns with our BIG(GER) Aim: to get each patient to the desired outcome, first without harm, also without waste and with an exceptional experience for the patient and family."

The Mission Health Heart Valve Clinic is a collaborative effort of cardiologists, cardiovascular surgeons, imaging specialists, physicians, and nurse navigators who diagnose and treat heart valve deterioration and dysfunction. Physicians at Mission Health have performed more than 20,000 cardiac and thoracic surgeries since the Heart Valve Clinic was founded more than 30 years ago.

About Mission Health

Mission Health, based in Asheville, N.C., is the state's sixth-largest health system and the region's only not-for-profit, independent community hospital system governed and managed exclusively in western North Carolina. Mission Health was recognized as one of the nation's Top 15 Health Systems in 2012 and 2013 by Thomson Reuters and Truven Health Analytics, respectively. Mission Health is one of only two medium-sized health systems to receive this recognition in 2012 and 2013, and the only health system in North Carolina to achieve that distinction.

Mission Health, which traces its roots in the region back to 1885, operates five hospitals, numerous outpatient and surgery centers and the region's only dedicated Level II trauma center. Its medical staff consists of more than 1,000 physicians and is certified in more than 50 medical specialties and sub-specialties. Mission Health has seven Centers of Excellence: Cancer, Heart, Mission Children's Hospital, Neurosciences, Orthopedics, Trauma and Women's Health. Mission Hospital, located in Asheville, is the system's flagship hospital and is licensed for 795 beds. It is the regional referral center for tertiary and quaternary care. It also includes Mission Children's Hospital – the region's only children's hospital. Other Mission Health member hospitals include Angel Medical Center in Franklin, Blue Ridge Regional Hospital in Spruce Pine, McDowell Hospital in Marion and Transylvania Regional Hospital in Brevard. With approximately 8,800 employees and 700 volunteers, Mission Health is dedicated to improving the health and wellness of the people of western North Carolina. For more information, please visit mission-health.org.

[1] Prosthesis-patient mismatch occurs when the size of the valve's flow area is too small in relation to the patient's body size.

SOURCE Mission Health