13 WTHRLocal surgeons study heart-valve procedure
Anne Marie Tiernon/Eyewitness News
Indianapolis - A local surgeon is performing a new, life-saving heart valve procedure. Two patients, one from Ohio, the other from Chicago, came here for the procedure this week. They are participating in a clinical trial that is part of what the doctor believes is a true "next generation device" for heart patients with valve disease.
Charlie Griewe from Greensburg is in a select group of American patients. He is part of a clinical trial for a revolutionary heart valve called the Shelhigh Aortic replacement valve.
"The valve sounds perfect. You wouldn't know you had your valve replaced," said Dr. Marc Gerdisch, Cardiac Surgery Associates at St. Francis.
"There are only two centers actively implanting right now. Us, and another center in New Jersey," said Dr. Gerdisch.
To date, St. Francis cardiothoracic surgeon Dr. Gerdisch has implanted nearly 60 of the aortic valves.
"This is the aortic valve through which the blood exits the ventricle and goes out in the aorta here," he explained. "We almost always have to replace this valve."
Dr. Gerdisch says metal valves require blood thinning Coumadin for life.
"Coumadin can be life saving for many people because they need it in certain situations but it also carries a significant morbidity and mortality on its own. In other words, taking Coumadin itself is a risk," said Dr. Gerdisch.
Gerdisch says calcifications are common complications of tissue valves and lead to replacements.
"What we really are driving for is have a biologic valve that will last longer," he said.
The investigators believe this part cow, part pig tissue valve will do just that. Doctors like the large opening for blood to pass through and once implanted, the body seems to accept it and incorporate the valve as its own, a process called endothelization.
"There is no other valve on the planet that becomes endothelium," said Dr. Gerdisch.
Results from American patients like Charlie Griewe, 65, will help the FDA consider approval.
"In Europe the valve has been implanted for nearly 11 years and there are over 10,000 of them implanted already in Europe. In that time no one has ever identified a valve that is calcified," said Dr. Gerdisch.
Griewe likes the probability that he won't be on medications long term and in the meantime is helping doctors advance science here.
"I am 65 and hopefully got a lot of years left. If I can help someone else and help make this procedure better for someone else that is what I'm all for," he said.
To participate in this trial you must be 50 years or older. A patient in the hospital right now has a small minimally invasive incision on her chest.
