South Florida is a site for major advances in experimental catheter-based heart valve procedures, giving second chances to patients once deemed too sick or frail to withstand the open-heart surgery.
The University of Miami’s International Medicine Institute and Mount Sinai Medical Center both participated in clinical trials for CoreValve, a catheter-based aortic valve replacement technology for the treatment of aortic stenosis, which won FDA approval last month. A rival — the Edwards SAPIEN valve — already exists on the market, though the CoreValve can adapt in size to heart anatomies that the Edwards valve cannot.
The Baptist Cardiac and Vascular Institute was the first medical center in Florida selected to participate in clinical trials for Abbot’s MitraClip, the first catheter-based mitral valve therapy. Mitral regurgitation and prolapse together account for the most common forms of heart valve insufficiency in the United States, with roughly 50,000 people undergoing surgery every year. The FDA approved the MitraClip late last October.
“The take-home message is that medicine continues to progress. We continue to take care of sicker and sicker patients,” says Dr. Niberto Moreno, chief of Cardiothoracic Surgery at Baptist Health South Florida.
Because catheter-based procedures don’t require cracking the chest open — the devices are instead threaded from a patient’s upper thigh or shoulder through an artery to the heart — or putting the patient on a heart-lung machine for hours, intervention is much less traumatic, and recovery time usually dramatically reduced. The surgery typically takes about two hours.
“It’s a major step forward. Patients can have this procedure and at times go home in one or two days. Most of the time they’re out of bed and eating that same evening,” said Dr. Eduardo de Marchena, an interventional cardiologist at the International Medicine Institute, and one of the principal investigators on the CoreValve UM trial.
Approximately 100,000 people in the United States suffer from severe aortic stenosis — a narrowing of the aortic valve that impedes blood from flowing back into the arteries. Its symptoms are typical of heart disease, and include fatigue, chest pains, and breathlessness.
After the onset of symptoms aortic stenosis progresses rapidly, and without valve replacement surgery, the two-year survival rate sits at just 50 percent. But surgery is considered too risky for roughly a third of symptomatic patients — in large part because the disease is itself most commonly caused by the simple process of aging.
“I couldn’t walk three steps without losing my breath,” Arthur Lieberman, 88, said of his state before receiving a CoreValve with UM.
Lieberman took a circuitous route to finally arrive at UM. He was first diagnosed in Boca Raton, where he resides, he was then sent to Palm Beach Gardens for traditional valve replacement surgery. But a surgeon cancelled his surgery the night before, telling him the procedure would be too risky. He was then referred to Holy Cross in Fort Lauderdale, which performs catheter-based aortic valve replacement procedures — in medical parlance: trans-catheter aortic valve replacement (TAVR) — with the SAPIEN valve.
But the SAPIEN valve only comes in three sizes, none of which would fit Lieberman. His surgery, again, was cancelled on its eve.
Lieberman was finally referred to UM where — after a month-long waiting list — he received his valve on July 15. The procedure went off without a hitch, with Lieberman back home in Boca Raton in less than a week.
“A new man! He walked in like a new man, it was unbelievable,” his wife Sylvia said.
In an ironic twist — though perhaps one not so unlikely with a disease this common — Sylvia herself soon developed a symptomatic aortic stenosis. Put on the UM waiting list, she began to deteriorate quickly.
“I was dying. I had written letters to Arthur and to my daughters. I couldn’t breathe,” said Sylvia Lieberman, 91, who was oxygen-dependent and weighed 96 pounds when she underwent the procedure three months after her husband.
Sylvia pulled through — the couple will celebrate her birthday next week — but not without needing a pacemaker and a six-week recovery.
“All I can say is they weren’t ready for me up there. It wasn’t written in the book. My name was not on that page,” she said.
TAVR procedures do carry a heightened risk for several complications — including stroke or need for a pacemaker —compared to conventional surgery, which is still considered the standard of care.
Neither the SAPIEN, MitraClip, or CoreValves are approved for use on patients who haven’t been determined to be either inoperable or at a very high risk of death due in conventional surgery, in large part because the oldest data on the longevity of these devices is itself very young, according to Moreno.
“You have to crimp [the valve] so that it fits inside a catheter. What’s going to happen to the tissue of that valve over a period of time? Is it going to be more easily destroyed? […] We’re neophytes at this point,” he added.