A trial is underway at Mercy Medical Center in Des Moines on a heart valve replacement procedure that does not require opening up the patient’s chest. Cardiologist, Atul Chawla, says they are doing the procedure on patients with severe aortic stenosis, or failure of the aortic valve.
Chawla says a metalic cage that has pig tissue made into a valve on it is mounted on a catheter and the catheter is sent through a leg artery into the heart. Dr. Chawla says the new cage valve is then installed right into the diseased valve. He says they go in with a balloon and dilate the old valve and then place the cage, which is self-expanding, and it opens up and pushes the old valve out of the way.
Chawla says they are looking for up to 1,800 patients who are interested in taking part in the trial. Chawla says the trial is comparing this procedure with the standard procedure to see if it is the equivalent without having to open up the chest. The second part of the trial is examining whether this non-surgival procedure is better for patients who cannot have the one-heart operations.
Chawla says the first couple of procedures have had great results. He says the patients were discharged much earlier and much healthier than those who undergo the surgical procedure because there is not recovery from the surgery. Chawla says his first patient was sitting up and talking and having dinner three hours after the procedure.
Chawla says they kept the first patient’s in the hospital for three days as a precaution, but someone could normally go home 48 hours after this procedure. The trial will continue into early spring or summer of next year, and then the F.D.A. will evaluate the procedure and determine if it can be used.
Chawla says it usually takes the F.D.A. six months to one year to analyze the data from a trial, as they like to have at least one year of follow up data. An F.D.A. panel would then approve the procedure. The approval is usually given first for patients who can’t undergo the open-heart operation, and then later approved for all patients.
Chawla says another non-surgical procedure that uses a totally different type of valve recently won F.D.A. approval and should be available at the end of this year. The valve Chawla uses is called the Medtronic CoreValve, and you can find out more about participating in the trial at: www.aorticstenosistrial.com or by calling 515-802-4057.