The small metal mesh ring is a little more than an inch in diameter but when Alexander Yankowsky heard it was finally coming to University Hospital, he broke down and cried.
“I’m going to cry now, I think,” he said, choking up as he sat in his room at University’s Heart & Vascular Institute.
Yankowsky, 69, was the first commercial patient in Georgia and South Carolina to receive the new 29-millimeter Edwards Sapien XT aortic valve replacement, a device he waited 10 months for the Food and Drug Administration to approve. Some patients at Emory University and Medical University of South Carolina received it as part of the clinical trials but University was the first hospital to implant the devices in those two states after it was approved last week, said Dr. Les Walters, an interventional cardiologist with University.
“That was huge for us,” he said. “We’ve been waiting a year to get this.”
The valve replacement is delivered by a method known as transcatheter aortic valve replacement or TAVR, where a catheter is threaded up through an artery in the groin into the heart to deliver a new valve that fits in place over the diseased one and takes over its function, in this case controlling the flow of blood from the left ventricle to the aorta. Two heart surgeons have to sign off that the patient is unfit or high-risk for the traditional open heart valve replacement first before the patient can be considered for the procedure, Walters said.
The company had approval on two smaller valve sizes but many patients, including Yankowsky, needed a larger device, he said. They became known as the “29 Club” because they were all waiting on that 29-millimeter device to get approval, Walter said.
“That lets us do people who are larger,” Walters said. “Most of these people who are waiting are men.”
The delivery system is also smaller, almost a third the size of the previous one, he said.
“That’s a huge difference in size,” Walters said. “That means there are a lot more people we can get into with a lot less chance of vascular complications.”
After learning he needed the larger valve, the wait for the approval dragged on, Yankowsky said.
“A week went by and then a month went by.” he said. “And then another month went by. And another month went by.”
The wait became “quite frightening at times, I’ll say that,” Yankowsky said, as he worried it wouldn’t get approved in time for him.
Sitting in a chair in his room, Yankowsky said he was feeling much better after his procedure Tuesday and he is looking forward to golfing again.
“I love to play golf,” he said. “It’s been a while, it’s been over a year.”
He also hopes the procedure will give him the energy to keep up with his young grandsons. Yankowsky said he is part of a new group now.
“I’m Team 29 now,” he said. “And I am captain of that team. I’m the first one.”
Yankowsky is also grateful to the Structural Heart Clinic team that performed the procedure.
“I’m alive, I’m here because of their diligence,” he said.