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Doctors expand valve-within-valve procedure to low-risk patients

Anthi Mavlios of Glen Head, left, kisses her

Anthi Mavlios of Glen Head, left, kisses her father, Ioannis Mavlios of Astoria, at St. Francis Hospital in Port Washington Wednesday, Sept. 7, 2016. Ioannis was one of the first "low-risk" patients to undergo a procedure called transcatheter aortic valve replacement, or TAVR, at St. Francis last month. Credit: Barry Sloan

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It started getting really tough for Ioannis Mavlios to walk a short distance or climb a few stairs about a year ago. With either effort, the Astoria, Queens, man could barely breathe.

“We thought it was his lungs,” said his daughter Anthi Mavlios, of Glen Head, who translates for her father, 81, who speaks Greek. Ioannis Mavlios said he was winded — so fatigued. “Things that once were easy, weren’t very simple any more,” the daughter said, noting her father had to sit up most of the time because the shortness of breath became especially pronounced while lying down.

It took until this year for a definitive diagnosis — and treatment.

Doctors at St. Francis Hospital in Roslyn concluded it was the retired auto mechanic’s heart — not his lungs — that was giving him problems. He had a major heart-valve problem, a disorder called aortic stenosis. The condition is marked by excessive calcium deposits in the valve, which limited the flow of oxygenated blood throughout Mavlios’s body. Aortic stenosis is a major killer when left untreated.

Normally, open-heart surgery accompanied by weeks of recuperation is the standard of care, said Dr. George Petrossian, co-director of the hospital’s Heart Valve Center. During that invasive procedure, a pigs or cow’s valve is implanted to restore healthy blood flow.

But he and Dr. Newell Robinson, the center’s other director, had just begun an arm of a new clinical trial for so-called low risk patients. The aim was to determine how these patients fared in a minimally invasive procedure that shaved weeks off the time needed to recuperate.

The technique, the doctors said, leaves the diseased valve in place, with the new one implanted overlapping the old one.

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“We considered him low risk based on an algorithm,” Petrossian said of a Society of Thoracic Surgeons’ risk-calculator. The metric help doctors determine whether a patient’s probability of surviving open-heart surgery is high, moderate or low. The low score Mavlios received suggested he could weather the surgery without problems. Now, the good score would help him be part of a scientific investigation.

“They told my dad he’s still young,” Anthi Mavlios said, marveling. “Yep, 81, and still young.”

Robinson said Mavlios is a classic low-risk patient despite aortic stenosis because he was not encumbered by other vagaries of age.

The clinical trial of a valve-within-a-valve is an expansion of one begun five years ago known as transcatheter aortic valve replacement, or simply TAVR, the doctors said.

It borrows from a technique used to implant stents in clogged coronary arteries — threading a catheter bearing the new valve within a mesh scaffold through a small incision in the groin. The catheter and its cargo are guided within the femoral artery in the thigh upward to the heart.

Petrossian said the new valve fits permanently inside the patient’s damaged one and starts functioning immediately. The catheter and scaffold are removed. The implantation device is called the CoreValve Evolut-R System.

Treating aortic stenosis this way has been approved by the U.S. Food and Drug Administration, but for patients at dramatically higher risk than Mavlios.

“These are patients at such extreme risk they would not be considered for surgery under any circumstance,” Robinson said.

When medical scientists research the effectiveness of devices for serious disorders they generally begin testing in people who are in greatest need and highest risk, Robinson said. He added that it would be unethical to begin testing in patients who could be easily helped with the standard of care.

Now that clinical research has demonstrated the procedure extends the lives of high-risk patients (the doctors’ first high-risk patient came back in February for his five-year checkup at age 97) the time has come to determine whether low-risk patients can benefit as well.

Aortic stenosis is the most common and serious form of heart valve disease in the United States, where it is a major public health concern, according to the American Heart Association. The group estimates that one in eight patients over age 75 has moderate to severe aortic stenosis.

Over time, calcium builds up in the valve’s “leaflets,” three tiny flaps that open wide to let blood pass into the aorta and clamp tight to prevent blood from flowing backward. Once stenosis occurs, the faulty valve can obstruct the flow of blood from the heart into the aorta and the rest of the body, leading to the characteristic shortness of breath.

“I am feeling very, very good,” Mavlios said in English, but added in Greek, that he feels strong enough to go fishing again.

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