The Ohio State University Medical Center Testing New Approach for Aortic Valve Stenosis

April 6, 2011

A new approach to aortic valve replacement holds promise for better outcomes and more treatment options for patients who are considered inoperable today.

The cardiothoracic surgery and interventional cardiology teams at The Ohio State University Medical Center are participating in a randomized clinical trial comparing the safety and efficacy of a catheter-based delivery system to traditional open heart surgery for the treatment of patients with aortic valve stenosis. The procedure, performed at Ohio State’s Richard M. Ross Heart Hospital, is only available for patients considered a “very high risk” or “extreme risk/inoperable” for conventional surgery requiring cardiopulmonary bypass.

“Surgical aortic valve replacement currently is the only effective treatment for patients with severe aortic valve stenosis,” says Dr. Juan Crestanello, a cardiothoracic surgeon at Ohio State’s Medical Center and the local principal investigator with Dr. John P. Cheatham, director of interventional cardiology at Nationwide Children’s Hospital and a professor of pediatrics and internal medicine, cardiology, at The Ohio State University College of Medicine. “Some patients are poor candidates for surgery due to age, frailty or some other complicating medical condition. This new approach provides another option for those patients,” adds Crestanello.

The new approach, in which pig tissue is formed into a valve, allows a catheter to be inserted into the leg or arm artery through which the new valve is implanted – without the use of cardiopulmonary bypass.

Enrollment of patients in the transcatheter group is expected to be completed within 18 months, with all trial patients being followed for five years. Screening studies include echocardiograms, CT angiograms of the thoracic and abdominal aorta and a cardiac catheterization to rule out significant coronary artery disease.

Patients locally are evaluated at the Ross Heart Hospital’s Heart Valve Clinic. According to Crestanello and Cheatham, this is beneficial since it provides comprehensive evaluation of patients with valvular heart disease in a single setting to achieve maximum efficiency and create a convenient patient experience. The clinic also offers multidisciplinary evaluation by physicians specialized in advanced imaging technologies, cardiac hemodynamic and coronary interventions, and anesthesia.

Aortic valve stenosis occurs when the aortic valve narrows, preventing blood from flowing properly into the aorta and the rest of the body. The heart’s left ventricle must work harder than normal to pump blood, which can lead to symptoms such as fatigue, fainting with exertion, difficulty catching your breath, abnormal heartbeats and chest pain. Problems with valves can be a cause of heart failure.

Among the causes of stenosis are changes due to aging with calcification of the leaflets, congenital abnormality of the valve, and infections in the heart such as rheumatic fever and endocarditis. Aortic stenosis is common among elderly patients and leads to significant deterioration of functional status and ultimately limits survival.

This multi-center CoreValve U.S. Pivotal Trial is sponsored by Medtronic, Inc., Minneapolis, MN.  Ohio State is one of 40 sites in the United States participating in this study.

About Nationwide Children's Hospital

Named to the Top 10 Honor Roll on U.S. News & World Report ‘s 2018-19 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.4 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.