Open heart surgery is often done to patients suffering from coronary heart disease. The procedure is also done to repair or replace heart valves which are responsible for allowing the blood to flow through the heart.
While the operation may be crucial and even life-saving for many patients, it comes with it potentially life-threatening risks including infection, bleeding, damage to organs, stroke and even death. Patients who are very sick prior to the operation or are suffering from other medical conditions such as diabetes, and peripheral arterial disease are also more vulnerable to complications.
Transcatheter aortic valve replacement (TAVR), which allows doctors to insert synthetic heart valves using a catheter, may soon spare thousands of Americans from the pains, discomforts and risks associated with traditional open heart surgery
The old method of replacing damaged aortic valve, which involves making a lengthy slice in the chest, is a far cry to Medtronic's CoreValve system which only requires a one-inch cut to replace abnormal heart valves. The new procedure is also safer than open heart surgery as proven by a new study.
In the "Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis" presented Saturday at the 63rd Annual Scientific Session of the American College of Cardiology (ACC) in Washington and published simultaneously in the New England Journal of Medicine, researchers involved patients with severe aortic stenosis who have extreme risks for surgery.
They found that only about 14 percent of the patients who underwent treatment with CoreValve died within a year after the procedure. Nineteen percent of the patients who underwent open-heart surgery, on the other hand, died within the same time period reflecting an increased survival rate of five percent in patients who had the CoreValve treatment.
"In patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at one year than surgical aortic-valve replacement," the researchers reported.
CoreValve received its approval from the U.S. Food and Drug Administration (FDA) in January for extreme-risk patients. The result of the trial involving less ill high-risk patients, however, will likely help medical device company Medtronic gain approval for treating a larger group of patients.
"Upon reviewing the CoreValve Trial's results for high risk patients, the FDA has determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel," Medtronic said in a statement.
