Aortic valve replacement uses small groin puncture in new U.S. study
In a new study researchers will replace aortic heart valves by way of a tiny puncture hole in a patient's groin.
The procedure replaces the need for open heart surgery for those at high risk who otherwise would not be treatable, except with medication.
Surgeons and cardiologists at The Methodist DeBakey Heart & Vascular Center will use the technique in a new study that delivers a new aortic heart valve percutaneously, through a catheter like those used during a cardiac catheterization, without removing the diseased valve.
According to Dr. Neal Kleiman, director of the catheterization labs at the Methodist DeBakey Heart & Vascular Center and cardiology principal investigator for the trial, “This study is the only way individuals have access to this technique in the U.S.” The procedure is available in 34 other countries and has been performed on more than 12,000 patients worldwide.
Traditional aortic valve replacement requires open heart surgery, with 4 to 6 weeks recovery time. Kleiman explains, “Using this new technique in the study, we will be able to replace severely calcified and damaged aortic valves without open heart surgery or removal of the original diseased valve", using a catheter that is inserted through a tiny hole in the groin and then advanced through the femoral artery to the heart.
When the catheter reaches the heart, the new valve is deployed inside the damaged aortic valve. Restoration of blood flow occurs immediately. A fully functional aortic valve is vital for ensuring blood flow to all the organs of the body. With age and disease, heart valves can become narrow, or stenosed, limiting blood flow and oxygen to vital organs. The result causes symptoms that include fatigue, shortness of breath, irregular heart rate and decreased quality of life.
"We routinely perform surgical valve replacement for diseased aortic valves, but many individuals are too high a risk for open-heart surgery due to age or other illness, said Dr. Michael Reardon, cardiac surgeon at Methodist and surgical principal investigator for the trial. "In this trial, we will evaluate whether catheter based aortic valve replacement will help extend the lives of this group of individuals."
Methodist DeBakey Heart & Vascular Center is one of 40 heart centers throughout the US involved in the study that is using the Medtronic CoreValve® System for aortic valve replacement, using the approach, known as percutaneous heart valve replacement. The Medtronic CoreValve U.S. Pivotal Clinical Trial will include more than 1300 patients, with 100 enrollees at Methodist.
Aortic valve replacement used in the study requires a tiny puncture hole in the patient's groin instead of risky open heart surgery, that for many patients is not an option.