(RxWiki News) For some high-risk patients with blocked aortic valves, open heart surgery poses too much risk. Hoping to remedy that, doctors at John Hopkins University are testing a new device that replaces blocked heart valves.
Often times open heart surgery is too dangerous for the elderly, people who are frail and those with serious medical problems. Johns Hopkins' physicians are evaluating a new device called CoreValve, a self-expanding system designed to replace diseased aortic valves.
"Talk to your cardiologist about options for severely blocked aortic valves."
Dr. Jon Resar, M.D., an interventional cardiologist of the adult cardiac catheterization lab at Johns Hopkins University School of Medicine and study co-leader, noted that those who can most benefit are often bedridden and weak because of severely narrowed aortic valves. He said that in many cases the device is the only hope for such patients.
The new device is inserted into a patient's damaged valve via a catheter that is threaded through a leg artery to the aorta, the heart's main blood vessel. After the device is in place, a protective covering over the valve is removed through the catheter.
This enables the leaflets to open and close so that blood flow can be directed to the brain and the rest of the body. The process takes about two hours.
Currently, the CoreValve has only been approved for use in Europe. Tests in Europe showed that patients experienced twice the blood flow as before the procedure. Ejection fractions, a measure of the blood pumped, improved from 20 percent to up to 60 percent in those patients.
The minimally invasive procedure is known as transcatheter aortic valve implantation. The device can be risky, but most patients have no other options. About 30 percent of patients die within a year of the procedure from complications in the kidneys, liver or lungs. For patients whose only management option is medication, about half die within one year.
European patients are living more than five years with the device, and implantation itself is less risky than traditional surgery.
In the U.S., about 1,200 participants will be enrolled in the two-year study. Those selected will have severe aortic valve narrowing and be at high risk for open heart surgery. Patients will receive either medication or implantation of the device.
Johns Hopkins University is one of 40 medical centers participating in the U.S. Medtronic CoreValve Pivotal trial. Medtronic, which manufactures the device, is also funding the study.