First Patients Treated in Trial for Low-Risk Aortic Stenosis

HARRISBURG, Pa., April 1, 2016 /PRNewswire/ -- PinnacleHealth CardioVascular Institute enrolled the first two patients in the United States in a randomized trial studying a heart valve to treat aortic valve disorders. Sponsored by Medtronic, the new study compares this catheter-based approach, called transcatheter aortic valve replacement (TAVR), to open surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis who are considered low-risk (less than 3 percent risk of mortality) for surgery. Harrisburg Hospital is one of up to 80 study sites across the country. With 1,200 enrolled patients, this is the first clinical trial to examine the effectiveness of catheter-based treatment in the low-surgical-risk population.

This catheter-based valve, called CoreValve® Evolut® R System, is FDA approved for patients with severe aortic stenosis who are at increased surgical risk. PinnacleHealth's chief of cardiothoracic surgery, Mubashir Mumtaz, MD, FACS, FACC, was one of the authors in the published landmark study comparing TAVR to SAVR for high risk patients. ¹ Since 2011, PinnacleHealth has been offering TAVR to patients in central Pennsylvania.

According to an article published in the Journal of the American College of Cardiology, aortic stenosis (AS) is the most common valvular heart disease in developed countries with prevalence estimated between 3 and 23 percent.² Aortic stenosis mainly affects older people, due to scarring and calcium buildup in the valve cusp. With a growing elderly population, aortic stenosis is anticipated to become a major public health concern.

"Our team of cardiologists and cardiovascular surgeons is pleased to be involved in this next phase of clinical investigation," said Dr. Mumtaz. "Continued involvement in this trial and others allows us to bring new therapies to the region before they are widely available."

At PinnacleHealth, there is a team approach to TAVR procedures. These procedures involve direct care by both a cardiothoracic surgeon and interventional cardiologist in a specially equipped operating room.

"Cardiovascular medicine is transforming right here in Harrisburg at PinnacleHealth," said Hemal Gada, MD, MBA, medical director of structural heart at PinnacleHealth. "It is invigorating to be on the national forefront of care and to be able to locally provide these treatments to our patients."

1. http://www.ncbi.nlm.nih.gov/pubmed/24678937  
2. http://content.onlinejacc.org/article.aspx?articleid=1695808  

About PinnacleHealth System

PinnacleHealth is a pioneer not-for-profit healthcare system dedicated to improving the health and quality of life for the people of Central Pennsylvania since 1873. A proven leader in medical innovation, PinnacleHealth offers a wide range of services from primary care to the most complex surgeries and Magnet recognition for nursing excellence. The healthcare network includes four campuses (Community, West Shore, Harrisburg and Polyclinic). The new five-story West Shore Hospital includes 108 beds with an emergency department, medical/surgical care, cardiology, orthopedics, chronic disease management, and private patient rooms. PinnacleHealth's network includes family practice, imaging, outpatient surgery and oncology, which are offered at multiple locations throughout the region. For a complete list of services, visit our website at www.pinnaclehealth.org

Media Contact: Kelly McCall, 717-231-8104, [email protected]

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SOURCE PinnacleHealth System