Man get a small incision in his left chest, guided the four or five inches to his heart by a tubelike catheter.
MIAMI — As recently as 2005, U.S. Air Force retiree Merle Hargis, then 78, would routinely ride his motorcycle to the airport so he could fly one of the ultralight airplanes he had built. More recently, though, he’s been too tired, too weak. The problem: age-related aortic stenosis, a condition in which calcium made his aortic heart valve too stiff to properly pump blood.
He needed a new valve.
“But he was too fragile for open-heart surgery,” the usual way of getting a valve, says Dr. William O’Neill, a top cardiologist at the University of Miami Medical School. So on Nov. 22, Hargis got the needed valve without the rib-cracking open-heart surgery. Instead, he got it through a small incision in his left chest, guided the four or five inches to his heart by a tubelike catheter.
He was one of the first two patients to get the procedure since it was approved by the U.S. Food and Drug Administration on Nov. 2. The operation took place in the University of Miami Hospital’s first-of-its-kind Elaine and Sydney Sussman Cardiac Catheterization Lab. Friday was the ribbon-cutting for the new lab, which was built with a $2.5 million donation from Sydney Sussman, the steel, solar power, real estate and parking magnate of North Palm Beach, Fla., and Princeton, N.J.
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“O’Neil called me the other day, and he was crying,” Sussman said. “He said, ‘We just saved two people we would have lost without that lab.”‘
Hargis’ new valve is called the SAPIEN transcatheter aortic heart valve, by Edwards Lifesciences Corp., of Irvine, Calif. It’s designed specifically for patients who are elderly and too weak for open-heart surgery.
The device has been in testing since 2002, and the University of Miami Med School did more than 100 experimental procedures with it during years of clinical testing leading up to FDA approval.
For several years, doctors have been doing mitral valve repair via catheter, but this is the first time a heart valve has been replaced that way. It can be done through the chest, as with Hargis, or through a small slit in the groin, with the new valve pushed by catheter up the femoral artery to the heart.
Also last week, Josefina Perez of Miami, who is 85, received a new aortic valve in a similar operation through her left chest, also avoiding open-heart surgery. She has had some breathing difficulties since, but is expected to go home in a few days, O’Neill said.
At the ribbon-cutting, O’Neill was upbeat: “This is the final culmination of all the trials. It shows the valve works really well and can save many lives.”
The valve is only for those 70 and older.
“Younger patients tend to have a different valve disease; it’s likely this valve wouldn’t work for them. Other valves are being studied for them.”
The cutting-edge operating room/cath lab is designed specifically for this and other complex heart procedures. It has a doctor’s station on each side of the patient. In Perez’s operation, Dr. Don Williams, a cardiac surgeon, made the incision in the chest and a hole in the heart wall; O’Neill then put the valve in place, using X-rays and CT scans to guide him.
As he worked, a massive robotic arm from the new machine swiftly and smoothly moved the CT scan machine over the patient, tracking progress.
The valve, made of cow material and polyester, was compressed and placed inside a stainless steel mesh stent crimped around a balloon at the end of a catheter tube. O’Neill guided it into place and inflated the pencil-sized balloon, expanding the valve into place. The old, diseased valve was simply pushed aside.
The operation is not without risk, especially in sick, elderly patients. In the clinical trials, compared to patients not undergoing valve replacement, patients who got the new valves suffered 2 ½ times more strokes and eight times as many vascular and bleeding complications, O’Neill said. Still, 69 percent of those who got the valve were still alive a year later compared to 50 percent of those untreated.
Patients diagnosed with aortic stenosis usually die within two years, he said. Patients who have had the new procedure have lived for at least five years. “And they’re still going.”
With the FDA approval, all qualified U.S. hospitals will be permitted to use the new procedure. UM will become a center for training doctors from other hospitals.
Seated in a wheelchair in the new cath lab, Hargis was pale but smiling, saying little.
How does he feel now? “Fine.”
How did he feel before the procedure? “Tired.”
“It’s been hard for the past three or four years,” said his wife, Pilar. “We’re hoping he can lead a more comfortable life now.”