At first, the symptoms — dizziness, shortness of breath, fatigue — weren't so bad. But 15 years after he was diagnosed with a narrowing heart valve that was restricting his blood supply, Dr. Richard Meriwether knew he couldn't go on much longer. • He'd long since given up tennis. Now he no longer could manage the 27 steps between his condo and the beach.
Yet, at 87, he wasn't strong enough for the usual remedy for aortic stenosis: cracking his breast bone and spreading his ribs open to install a new valve. Until recently, his physicians would have told the retired pediatrician to go home with his wife, Norma, and wait for the end.
Instead, on Feb. 2 Meriwether became the first patient at a Tampa Bay-area hospital to receive a new kind of valve, inserted through a one-inch incision in his leg, then snaked up to his heart through an artery.
Morton Plant Hospital in Clearwater is the first in the area to offer the Edwards Sapien valve, just approved by the FDA in November for patients who can't have open heart surgery. The agency now is considering it for other high-risk patients; more local hospitals plan to offer it soon.
"This is a radical change from standard open heart surgery," said Morton Plant thoracic surgeon John Ofenloch, who has performed several hundred open chest valve replacements in his 10-year career. "With all the post (operative) pain and complications and the long recovery (of traditional surgery), implanting the valve through the groin is a remarkable advance."
The procedure requires high tech imaging equipment and a combination catheterization lab and operating room, plus a large team of specialists. Morton Plant, which spent $3 million and 18 months preparing, expects to treat 40 to 50 patients a year.
Doctors made the incision in Meriwether's leg and passed a catheter through the femoral artery to his heart. The new valve, made of cow tissue supported by a stainless-steel mesh frame and wrapped in polyester, was collapsed to about the size of a pencil and threaded through the catheter on a guidewire with a balloon. Once inside the diseased valve, the balloon — similar to but larger than those used to place stents in the heart — was opened, deploying the new valve.
"There are no hooks, there's no sewing. The balloon pushes it into the tissue of the old valve with so much force that it stays in place," said interventional cardiologist Douglas Spriggs, who, along with Ofenloch, was part of the 15-member team involved in Meriwether's procedure. "It begins working immediately."
The cost of treatment is about $79,000, with the valve alone coming in at $30,000.
In a clinical trial, 70 out of 100 patients were alive a year after getting the new valve, compared with 49 out of 100 comparable patients who didn't have valve replacement.
But it comes with the risk of complications, according to the FDA. Patients who received it had three times more strokes than those who did not, and they had more problems with the arteries leading to their legs. Those who can't use blood-thinning drugs can't get the device.
Morton Plant estimates that perhaps two or three out of 10 who seek it will qualify.
"This is not for the otherwise healthy patient who wants to avoid a chest incision," said Ofenloch. "This is reserved for the sickest of the sick.
"But we think there are many people out there who, maybe six months ago, were told they were not surgical candidates and went home to die. They don't know this might be an option."
Meriwether already is looking forward to being able to "hit the tennis ball again."
In fact, he felt so good after surgery he presented himself to Morton Plant's cardiac rehabilitation unit last week, before his physicians even had cleared him to exercise. He was sent home and told to take it easy for a little longer.
Contact Irene Maher at firstname.lastname@example.org