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National Landmark Trial Releases Results

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3/31/2014
Patients from Central PA Participated In Trial. Results from a groundbreaking study performed at PinnacleHealth were revealed  at the American College of Cardiology’s 2014 Scientific Sessions and simultaneously published in The New England Journal Medicine.

"In patients with aortic stenosis, the self-expanding transaortic valve bioprosthesis was associated with a significantly higher rate of survival at one year than surgical aortic valve replacement," states Brijeshwar Maini, MD, FACC, medical director of the PinnacleHealth Heart Valve Clinic.

Patients at PinnacleHealth participated in the study, the Medtronic CoreValve® U.S. Pivotal Trial, which compared transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis to surgical aortic valve replacement in patients with severe aortic stenosis who are at “high risk” for surgery.

This is the first time a prospective, randomized study has shown a transcatheter aortic valve to be superior to surgery. Patients in the trial had narrowed, failing aortic heart valves, called severe aortic stenosis.

In the study, physicians replaced the diseased aortic valves in 747 patients, approximately half of whom were randomized to the minimally invasive CoreValve System, and half of whom were randomized to open-heart surgery. The all-cause mortality rate was only 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgery, a statistically significant finding at one year (the primary endpoint of the trial).

The rate of stroke – one of the complications most concerning to physicians and patients because it increases mortality – was low and not different between the two groups of patients.
Patients also saw significant improvements in their quality of life. Quality of Life scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days, and at one year both patient groups improved significantly with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points (as measured by KCCQ 100-point scale, where five points is considered important, and 20 points is considered a very large improvement).

"The CoreValve System is designed with self-expandable technology to replace a diseased aortic valve. It is placed percutaneously, meaning through the skin, usually through a small opening in the femoral artery, without open heart surgery or removal of the original valve. We then guide it into the heart at the site of the original aortic valve. Once in place, it takes over the original valve’s function and ensures that blood flows out of the heart freely without any obstruction," explains Dr. Maini.

The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk for surgery. The device is not currently approved in the U.S. for use with patients at high risk. PinnacleHealth was actively involved in the extreme risk and high risk trials and continues to participate in further research for those with intermediate risk.

Each year, nearly five million Americans are diagnosed with valve disease. Worldwide, approximately 300,000 people have been diagnosed with severe aortic stenosis and about one-third have been deemed at too high a risk for traditional valve surgery. The CoreValve System is designed to provide a minimally invasive, treatment option for patients with symptomatic, severe aortic stenosis.

"The results of this study are transforming the way we treat aortic stenosis. To participate in this trial and be a part of this revolutionary shift in medicine is exciting, but the true winners are our patients who will benefit from evidence based medicine as we move forward." states Mubashir Mumtaz, MD, FACS, surgical director of the PinnacleHealth Heart Valve Clinic.

Primarily affecting the older population, aortic stenosis is a condition of the aortic valve which keeps the valve from opening and closing properly, thereby restricting healthy blood flow from the aorta to the rest of the body. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood.

Symptoms of the disease can include fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. According to research, without effective treatment, as many as 50 percent of aortic stenosis patients with severe symptoms die within one year.


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 West Shore Hospital will open in Hampden Township in 2014. The five-story hospital will include 108 beds with an emergency department, medical/surgical care, cardiology, orthopedics, chronic disease management, and private patient rooms. PinnacleHealth is part of RiverHealth ACO, an Accountable Care Organization (ACO) in the Medicare Shared Savings Program (MSSP). Medical services, including family practice, imaging, outpatient surgery and oncology are offered at multiple locations throughout the region. For a complete list of services, visit our website at www.pinnaclehealth.org.