PinnacleHealth CardioVascular Institute
recently became the first hospital in the country to implant via direct aortic access the Trans Catheter CoreValve ® after the U.S. Food and Drug Administration (FDA) approval. Dr. Brijeshwar Maini
and Dr. Mubashir Mumtaz
, co-directors of the Heart Valve Clinic at PinnacleHealth, were also the first in Pennsylvania to use the CoreValve® System commercially to treat patients with severe aortic stenosis who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. These patients have a 50 percent risk of death at one year unless they are treated.
Most commonly, the CoreValve ® System is inserted into a patient via an artery in the leg, and the physician then guides 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.
“In this case, the patient’s leg arteries weren’t accessible, so the CoreValve System was inserted through an opening in the chest while his heart remained beating,” states Dr. Mumtaz. “The FDA approval of this system allows us to provide a lifesaving option to patients who are too sick to withstand surgery and the opportunity for an improved quality of life.”
The patient is recovering in the new Cardiothoracic Intensive Care Unit (CTICU) at Harrisburg Hospital. This unit offers increased privacy for patients, better amenities for families and innovative workflow design for more efficient patient care.
The FDA recently approved the CoreValve System due to its positive clinical performance in a U.S. clinical study. It had low rates of common complications – such as stroke and valve leakage –which have a dramatic impact on patients’ quality of life.
With age, a heart valve can become stenotic, or narrowed, preventing it from properly opening and closing, which diminishes blood flow between the heart and the rest of the body. This causes the heart to weaken and function poorly; this condition is called aortic stenosis. Symptoms include fatigue, dizziness, chest pain/pressure, shortness of breath during activity, heart palpitations and fainting. Approximately one-third of patients who suffer from severe aortic stenosis are not eligible for open-heart surgery because they are deemed at too high risk.
PinnacleHealth was one of 45 U.S. sites involved in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which led to the FDA approval of the CoreValve System.
“PinnacleHealth was among the top enrollers in the U.S. in the Extreme Risk Study. Participation in clinical trials can lead to improved care and innovations, particularly for our complex cardiac patients,” states Dr. Maini.
“PinnacleHealth CardioVascular Institute surgeons perform more coronary artery bypass and valve surgeries than any other hospital in the region and is in the top five acute care hospitals in Pennsylvania. While maintaining this high volume, important quality indicators such as mortality and readmission rates remain low,” states Michael A. Young, president & CEO for PinnacleHealth. “This milestone in cardiac treatment can reassure the community that nationally recognized heart care is available close to home.”
The advanced design of the new device was developed to address the needs of the transcatheter aortic valve replacement (TAVR) patient population, serving a broad spectrum of severe aortic stenosis patients. The CoreValve System is suitable for patients with native valves of nearly all sizes, and it is delivered via a small delivery system, making it possible to treat patients with vascular systems that are small or difficult to navigate. Additionally, the CoreValve System enables physicians to deliver the device to the diseased valve in a controlled manner, allowing for accurate placement.
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
About the CoreValve U.S. Pivotal Trial (Illiofemoral Access)
The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent. Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the Continued Access Study, an extension of the U.S. pivotal Trial, demonstrated even better survival and stroke performance.