Archie “Ace” Dalton, at 90, is among a select group of patients worldwide to have a mitral heart-valve replacement in a trailblazing clinical trial that his doctors believe will add years to his life.
Within a few days of receiving the implant earlier this month, he was smiling and joking with the physicians and nurses gathered in his room at St. Francis Hospital in Flower Hill. He told them he was eager to return to his home nearby in Plandome, where he has lived since 1962.
Until recently, heart specialists shied away from complex valve procedures in very old patients, because open-heart surgery was their primary option and those operations are far too risky in people of advanced age.
Now, the emergence of minimally invasive techniques is removing age as a barrier and changing how doctors view certain forms of heart disease in elderly patients.
“It was not at all as tough as I thought it would be, and the benefits have been so remarkable,” said Dalton, who noticed immediately after the procedure that he no longer was short of breath.
He is able to breathe with such ease now that he plans to take long walks around Plandome, the retired pharmaceutical sales manager said.
Dalton is not the first nonagenarian to benefit from a heart-valve clinical trial at St. Francis.
Anthony Leto, of West Hempstead, who had a different type of heart-valve disease, received a replacement valve just before he turned 93. He recently celebrated his 100th birthday. St. Francis doctors credited the patient’s new lease on life to his valve implant.
Dalton was diagnosed with severe mitral valve regurgitation, a condition in which the diseased valve causes blood to flow backward and pool in a heart chamber. A leaky valve is a dangerous situation, and if left untreated, the regurgitation can result in congestive heart failure or death.
Heart valve disorders of all kinds, involving the mitral, aortic or tricuspid valves, are considered “mystery killers” by the Heart Valve Society of America. All develop imperceptibly.
More than 5 million people in the United States have moderate to severe valve disease. Among those 70 and older, more than half have heart valve dysfunction, the society’s statisticians have estimated.
Dalton’s problems with mitral valve regurgitation mounted slowly. His primary care doctor had noticed a heart murmur long before the diagnosis of valve disease. Dalton said his doctor asked him about shortness of breath, and he responded that he didn’t have that problem.
Over the course of a year, however, symptoms gradually began to emerge — swollen ankles, extreme fatigue and the hallmark sign, shortness of breath.
“I said, ‘Doc, I may not have had it before, but I sure do have it now,’ ” Dalton said of not being able to catch his breath.
At St. Francis, Dr. George Petrossian and Dr. Newell Robinson — co-directors of The John Brancaccio Heart Valve Center — confirmed severe mitral valve disease.
They thought Dalton might benefit from the Global Apollo clinical trial, in which a diseased mitral valve is replaced with a new bovine-derived valve in a minimally invasive procedure. All told, 1,200 patients are expected to be part of the research worldwide.
Petrossian, Robinson and other doctors in the study are using the Intrepid Transcatheter Mitral Valve Replacement system. The experimental system is a product of Medtronic Inc., a Minneapolis-based medical device-maker.
Dalton is the first patient on Long Island to receive it.
St. Francis is one of two participants in the clinical trial on Long Island and the only one to perform the procedure; Northwell Health’s Sandra Atlas Bass Heart Hospital in Manhasset also is a participant.
“Somebody like Mr. Dalton was on the fringe for conventional open-heart surgery. But he would have been high-risk, no question about it. We felt this [system] would be much lower risk for him,” said Petrossian, director of interventional cardiology at St. Francis. Interventional cardiology specializes in guiding catheters through arteries to deploy devices that treat serious heart disorders.
With the Intrepid system, the bovine valve is compressed inside a hollow delivery catheter and inserted between the ribs to enter the part of the heart called “the apex,” which is formed by the left ventricle and is directed downward.
“The apex is the bottom end, or the tip end of the heart, where you put your hand over your heart and you can feel the thump of the heart. It’s just below the fifth rib,” said Robinson, chairman of cardiothoracic and vascular surgery.
The new replacement valve is expanded directly into the malfunctioning one, Robinson added, and the new implant conforms to the native valve without the need for sutures.
The replacement valve is one in a growing array of cardiac valve replacements. About a half-dozen other mitral valve implants are being developed by other medical device companies.
Petrossian and Robinson were investigators seven years ago in a clinical trial of a system designed to replace a faulty aortic valve. That system, called CoreValve, also developed by Medtronic, was approved by the U.S. Food and Drug Administration in 2014.
Their first CoreValve patient, Leto, a retired butcher from West Hempstead, now writes his age in triple digits. If CoreValve hadn’t existed, Leto might have died because open-heart surgery would have been too risky for him in 2011, when he was nearly 93.
Leto’s replacement valve is working splendidly, his doctors said.
Dalton, meanwhile, said he made many friends at the hospital and didn’t expect to meet someone from his home state. Both he and Robinson are originally from Mississippi, although from opposite sides of the state.
“It’s a very small world,” Dalton said. “I’ve always said you never know who you’ll meet. Just be prepared for surprises.”
A previous version of this story did not mention that Northwell Health’s Sandra Atlas Bass Heart Hospital in Manhasset also is a participant in the Apollo clinical trial.
Step-by-step: Mitral valve replacement
The mitral valve, when healthy, regulates blood flow into the left ventricle, the heart’s main pumping chamber. The valve closes to keep blood from leaking backward when the ventricle contracts. When diseased, the valve does not properly close, causing blood to pool in the chamber.
A minimally invasive procedure, in which a new valve is implanted without open-heart surgery, is being tested in a global clinical trial.
Here’s how it is done:
- A tiny incision is made just below the fifth rib, allowing a slim catheter loaded with the implant to enter the body.
- The loaded catheter enters through a vessel in the heart’s apex, the bottom of the organ.
- The catheter is guided into place, upward to the mitral valve, while viewed by way of live-motion X-rays.
- When the mitral valve is reached, the new valve is deployed and the catheter is removed.
- The valve is made up of an outer, latticelike framework and an inner, circular one.
- The outer meshwork expands to fit snugly over the diseased valve, fully covering it.
- The inner circle of the device contains the new bovine-tissue valve, which begins functioning as soon as the device is in place.
- The entire procedure takes about 90 minutes.
Sources: Dr. George Petrossian and Dr. Newell Robinson, St. Francis Hospital; Medtronic Inc.; Mount Sinai Hospital, Manhattan