Last updateWed, 18 Oct 2017 10am

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Heart health: New El Camino Hospital clinical trial benefits seniors

Photo Courtesy Of El Camino Hospital An El Camino Hospital team that includes Dr. James Joye, Dr. Vincent Gaudiani and radiology technician Baumshik Eom oversees a Medtronic CoreValve procedure.

After suffering from heart problems for years, Ruth Neapolitan, who will turn 84 in May, said she feels better than ever – “fantastic,” in fact.

Neapolitan attributes her good health to a revolutionary procedure that could prolong lives for many elderly, frail patients with severe aortic stenosis, an arterial narrowing that prevents the heart from pumping blood efficiently through the body.

If doctors can keep that valve open, they can increase the quality and length of life for such patients, according to Dr. James Joye, director of research and education at El Camino Hospital’s Heart and Vascular Institute. And significantly, it could provide an alternative to open-heart surgery.

At a heart forum in Mountain View last month, Joye’s presentation, lightheartedly dubbed “Invite Me to Your 100th Birthday,” drew an audience of doctors and heart patients.

Joye, a doctor of osteopathy who specializes in interventional cardiology, leads a team of surgeons researching heart health, including Drs. Vincent Gaudiani and Conrad Vial.


The heart of the matter

Aortic stenosis causes sufferers to weaken and develop shortness of breath, fatigue, tightness in their chests and dizziness during activity.

“Untreated, it causes certain death,” said Joye, who with colleagues at El Camino developed Cryoplasty and percutaneous bypass, pioneering endovascular techniques that target peripheral vascular disease.

The three treatment options for aortic stenosis are medical management of symptoms, open-heart valve replacement and the new Medtronic CoreValve Transcatheter Aortic-Valve Implantation (TAVI).

Doctors are evaluating the safety and effectiveness of the minimally invasive, experimental procedure, the Medtronic Core-Valve System, in a U.S. Food and Drug Administration clinical trial launched at El Camino Hospital last December. Joye praised the “generous gift” of $4 million from philanthropists Ed and Pamela Taft of Los Altos Hills, a grant that enabled the research. The Tafts donated funds to underwrite the Taft Center for Clinical Research, headquartered at the Fogarty Institute for Innovation on El Camino’s Mountain View campus.

Neapolitan is one of three

patients El Camino doctors have treated with the new procedure. While not commercially available in the United States, TAVI received European approval in 2007. Since then, 15,000 Europeans have had the CoreValve successfully implanted, and 35 countries worldwide use the procedure. A New England Journal of Medicine article documents a 50 percent reduction in overall mortality compared to conventional aortic replacement in high-risk patients.


Less expensive and less invasive

If the FDA approves the artificial valve system, it could be a win-win situation for patients, doctors and insurers, who lose money on traditional treatments for heart patients due to long hospital stays.

For example, open-heart surgery involves removing and replacing the aortic valve during a grueling two- to five-hour procedure performed under general anesthesia. Doctors make a 5- to 7-inch cut, connect the patient to a heart-lung machine and split the sternum in half. Patients must stay in the hospital up to two weeks to recover.

Neapolitan knew the risks of open-heart surgery – two brothers underwent the procedure.

“I know how painful that could be, and I knew I couldn’t tolerate that,” she said.

Just a month after undergoing the CoreValve implantation, she said she felt great.

When doctors chose Neapolitan to participate in the CoreValve trial, she rejoiced. She said her quality of life has improved greatly since the procedure.

“Before this operation, I couldn’t walk 50 feet without having to sit down,” she said. “I know for a fact that it has helped me. I feel fantastic.”

Forty hospitals and 1,200 patients are scheduled to participate in the trial across the country. Joye said doctors will consider patients who are both high risk, those in their 80s and older, and extreme-risk, those considered to be inoperable. Although there is no stated age limit, most participants are 75 or older.

Aortic stenosis, Joye said, is a very common and “relentless disease.” Caused by aging, or normal degeneration, the narrowed aortic valve’s leaflets stick to each other and become calcified.

The prosthetic heart valve, made of tissue from a pig’s heart, has thermal memory.

“It always goes back to the same dimensions,” Joye said.

The device costs approximately $35,000, but Joye compared it to the enormous cost of treating heart failure – “one of the loss leaders” for insurance companies, because hospitals have to readmit patients many times.

Before loading the valve into a catheter through the groin, doctors plunge the device into an ice bath so its leaflets will close up like an umbrella.

They then make a 2- to 3-inch incision in the groin area and wind the new valve through the femoral artery via a hollow tube, or catheter. Once placed in the real valve, the artificial one opens up like a flower, due to its thermal memory.

The system will particularly help inoperable heart patients who would otherwise seek hospice care, according to Dr. Dominick Curatola, El Camino’s medical director.

“In addition to weakened heart muscles, the kidney and other organs don’t do well, and (aortic stenosis) sets off a vicious cycle of failure,” Joye said.

Because doctors may decide that elderly patients should not undergo open-heart surgery, aortic stenosis often goes untreated. Joye said that offering experimental surgery is more ethical than doing nothing.

Neapolitan, who underwent the procedure in early March, would agree. As she prepared for release from Portola Valley’s The Sequoias assisted-living center last week, the octogenarian said she was “doing great.” She had suffered from aortic stenosis for two years and already had a stent in her heart.

Until the CoreValve procedure, doctors used only morphine to treat her symptoms.

“I am blessed,” she said.

For more information, visit www.elcaminoinnovates.org.

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