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.