y Mary Jo Feldstein, St. Louis Post-Dispatch, July 11, 2007

Open-heart surgery, without the open? Physicians at Barnes-Jewish Hospital will soon replace the heart valves of high-risk patients through a minimally invasive procedure.

The procedure is designed to treat patients with severe aortic valve stenosis, a narrowing of the heart valve that restricts blood flow. The new procedure is in its early stages and only being tested on patients who are considered high-risk for a traditional valve replacement.

Historically, the only way to fix this ailment was to replace the valve through open-heart surgery.

That procedure requires cracking open the chest, stopping the heart and using a heart-lung machine to keep the body going during the operation. This surgery can be quite risky, particularly for patients who are older or have other illnesses. The risk is so high for some patients that they are not able to have the surgery.

In the new procedure, the valve can be inserted through the groin or a small incision between two ribs. Barnes-Jewish is part of a study to determine whether the device will be approved by the Food and Drug Administration for use outside the trial setting.

Because of the new nature of the device, it''s currently being tested only on high-risk patients, some of whom would not even qualify for the traditional surgery. Barnes-Jewish has yet to perform the procedure but hopes to treat its first patient soon.

The study, taking place at only a few sites around the country, has two arms. The surgical arm of the study will enroll about 350 patients who are high-risk but still candidates for open-heart surgery. Patients will be randomized either to receive the transcatheter heart valve or undergo the traditional surgery.

The medical management arm of the trial will include 250 patients who are considered too high-risk for traditional surgery. Patients will be randomized to receive either the new procedure or medication that will help make them comfortable, but not cure the underlying problem.

The average age of patients in both arms of the trial is 80. The oldest patient to participate was 100 at the time of the surgery. The average hospital payment for the procedure is $40,000 plus additional costs for extended hospital stays that can arise from complications.

Larry Wood, vice president for transcatheter valve replacement at Edwards Life Sciences, the device maker, said that despite the cost and risk, he doesn''t think the procedure should be limited to younger patients.

"We''ve found when you correct their aortic stenosis, (older patients) really can have a good quality of life," Wood said. "I don''t know if it''s our position to judge if a person is too old or too sick. I think that''s up to the patient and the doctor."

Eventually, physicians hope this minimally invasive procedure will bring the same benefits as laparoscopic appendectomies and gallbladder removals - after surgeries and easier and faster recoveries.

"We''re working out strategies that allow people to recover faster," said Dr. John Lasala, medical director at the cardiac catheterization laboratory at Barnes-Jewish.

To help facilitate the new procedure, Barnes-Jewish has built a new room that incorporates features of traditional operating rooms and catheterization laboratories.

"We''re reaching an area where we''d like to be able to combine the ability of an operating room...with the excellent imaging that you have in a catheterization laboratory," said Dr. Ralph Damiano, chief of cardiac surgery at Barnes-Jewish.

"I think this is going to be a huge trend in health care and in surgery, particularly cardiac surgery, over the next five or 10 years."