ATLANTA, Ga. - Gail Edwards says open heart surgery to replace her mitral valve back in 2001 was tough, but it bought her almost 15 years of feeling better. Then, last Christmas, things changed.
"I had a lot of shortness of breath,” Edwards says. “And I thought it was stress from losing my parents recently and going through the holidays. I thought things would get better. But they didn't get better."
Instead, the Bartow County mother and grandmother was diagnosed with a leaking tricuspid valve, which was causing the blood to flow backwards into the right atrium of her heart.
Undergoing a second open heart surgery would be very high-risk for Edwards, given her surgical history.
But Piedmont interventional cardiologist Dr. Christopher Meduri and the team at The Marcus Heart Valve Center thought the 59-year old might be a perfect candidate for an investigational new procedure. They wanted to repair her leaking heart valve not with surgery, but by using a hollow tube, or a catheter, threaded from her neck down to her heart.
"It's really just two punctures neck here to try to access the tricuspid,” says Dr. Mediri. “The patient is asleep. But there really is not much of a recovery at all."
But there was a catch.
Piedmont had never performed a percutaneous (or through the skin) transcatheter tricuspid repair. Gail Edwards would be the very first patient in Georgia, and only the 8th in the U.S. to test this procedure as part of an early-stage clinical trial. At first, she said no.
"You're thinking of a place that's never done this surgery,” she says. “A doctor that's never done this surgery."
But, after going home and doing more research, Edwards and her husband reconsidered.
“We looked at it as, if it's a success, not only am I helping myself out, but there's other people out there that could benefit also."
Dr. Meduri says he knows they are asking patients to take a medical leap of faith with this trial.
"But the unique thing, and the reason we felt so good about this procedure, is that it has an extremely good safety profile,” Dr. Meduri says. “Despite there having (been) only 30 done in the world, there has never been a patient who has passed away from the procedure. And, there has really never been any major complication from doing the procedure."
In May, Gail Edwards underwent the minimally-invasive heart valve repair. Her neck was bruised and sore for about 3 weeks. But Edwards says this procedure was not nearly as difficult as the traditional open chest surgery.
"So this is the only place where I had an incision, which you cannot even tell it now,” she says, showing her neck. “And I was only in the hospital one night."
Today, Edwards is back to playing with her high-energy grandson, and planning her next vacation. She says she’s grateful she did her homework and took this gamble.
The SCOUT trial is still enrolling volunteers between the ages of 18 and 85 with moderate to severe tricuspid regurgitation that hasn’t responded to medication. This is a very small trial involving only 15 patients at 5 U.S. sites including Piedmont Atlanta Hospital.
For more information on the study and the requirements, contact Piedmont Atlanta's Marcus Heart Valve Center at 404-605-6517