Sonoma County heart patients set to benefit from heart-valve replacement breakthrough

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Last October, Peter Gennet was told he had a failing aortic valve, a crucial gateway in his heart that for seven decades faithfully opened and closed roughly 2.5 billion times, regulating the flow of oxygen-rich blood to the rest of his body, organs, muscles, skin and brain.

The 72-year-old Napa resident, who exercises regularly and eats relatively well, was told he had severe aortic stenosis, a heart valve disease that for “low-risk” surgery patients like him requires open-heart surgery.

“Replacement is the only option,” Gennet said. “They told me basically that, if I didn’t treat it, I’d be dead in a year.”

Open-heart surgery would have meant splitting his ribs apart, rerouting his blood flow with a heart-lung bypass machine and temporarily stopping his heart to replace the valve.

Fortunately, Gennet said he was given a different option, a nonsurgical procedure called transcatheter aortic-valve replacement, or TAVR. It’s essentially a marriage between modern coronary stent technology and traditional valve replacement. In the procedure, the replacement valve is run along a guidewire through the femoral artery, through the groin all the way to the aorta and aortic valve in the heart. The collapsed valve is placed directly over the obstructed aortic valve and expanded, similar to a coronary stent.

Now, the procedure is medically approved for patients who are at high- and intermediate-risk of complications from open-heart surgery. Two recent clinical trials involving the use of separate TAVR devices yielded favorable results for low-risk patients like Gennet. The studies were recently published recently in the New England Journal of Medicine.

In a milestone for the heart procedure breakthrough, the U.S. Food and Drug Administration is expected to approve the procedure for low-risk patients. In advance of that approval, local health care giants Sutter Health, Kaiser Permanente and St. Joseph Health are gearing up for the flood of new patients.

Dr. David Daniels, a Sutter Health interventional cardiologist who participated in one of the two trials — the Partner 3 trial — said data from the trial showed that in cases when a patient with severe aortic stenosis is receiving a tissue-based, nonmechanical valve replacement, and undergoing no other cardiac procedures, TAVR is now the “gold standard.”

“The risk of dying or having a stroke — what we consider to be two of the most important complications with this operation — was three times lower with TAVR compared to surgery,” Daniels said of the trial results.

Sutter has been approved to continue offering the heart valve procedure to low-risk patients, while the FDA reviews the clinical trials. Sutter’s patients in the North Bay who are good candidates for it are sent to one of three hospitals: California Pacific Medical Center in San Francisco, Alta Bates Summit Medical Center in Oakland, and Mills-Peninsula Medical Center in Burlingame.

Daniels said Sutter does about 450 to 500 of the procedures a year at those three health centers. He said once the FDA approves TAVR for low-risk heart patients, who make up about 80% of people with severe aortic stenosis, the volume of noninvasive procedures could increase by 50%.

The Partner 3 trial involved the use of a third-generation, balloon-expandable TAVR device made by Edwards Lifesciences headquartered in Irvine. A separate clinical trial involved a Medtronic device called Evolut, which is made of self-expanding nitinol.

Once in place, the compressed Edwards valve is expanded using a catheter balloon. The Evolut, which is compressed when cooled, is fed through the blood vessel, warms and then expands when its sheath is withdrawn.

Aortic stenosis and severe aortic stenosis affects thousands of Sonoma County residents, though it’s unclear exactly how many.

A 2013 study in the Journal of American College of Cardiology estimated the prevalence of aortic stenosis and severe aortic stenosis in people 75 and older in Europe and the U.S. was 12.4% and 3.4%, respectively, of the total population of people in that age group. Applying this to Sonoma County’s 36,732 residents 75 and older means that roughly 4,554 local residents suffer from aortic stenosis and 1,248 from severe aortic stenosis.

Dr. Patrick Coleman, director of interventional cardiology and the cardiac catheter labs at Santa Rosa Memorial Hospital, said up to 1.5 million people in the United States have aortic stenosis, and up to 750,000 have severe cases. But Coleman, who is also co-director of Memorial’s structural heart program, said not all cases of severe aortic stenosis will require medical intervention.

Memorial hospital, the only local health care institution where TAVR procedures are performed, currently only performs the noninvasive procedure on high-risk and intermediate-risk heart patients, as well those who can’t undergo surgery at all. Low-risk patients are usually referred to another provider, such as Sutter, Coleman said.

Coleman said that once aortic stenosis becomes “symptomatic,” treatment becomes imperative. Symptoms include shortness of breath, chest pain, heart palpitations, fainting, among others.

“We know that once people get symptomatic, their 2-year survival rate is 50%,” the heart doctor said.

He said that surgical aortic-valve replacement, which usually requires more than a week in the hospital for the patient, a lengthy stay in the intensive-care unit and a long rehabilitation. TAVR, however, is a “game changer” for heart patients, Coleman said, requiring only a one or two days in the hospital.

“Since January the vast majority of our patients have gone home the next day,” he said. “We’re dealing with the elderly population — they don’t do well when they go down for any reason for seven days.”

Coleman said a recent patient here who was roughly 90 years old was walking within 24 hours of his aortic valve replacement via transcatheter.

“If he had had surgical aortic- valve replacement, he would still be in the ICU with all sorts of monitoring lines, chest tubes, all sorts of things — but he went home later that afternoon,” he said.

Still, Coleman and other local cardiac experts on the noninvasive heart valve procedure said it’s not for everyone. Examples would be when patients need surgery to repair or replace an aneurysm close to the aortic valve or when medical intervention also is required for one of the other heart valves, such as the mitral valve.

Also, cardiac experts say for younger, healthier patients who likely have decades of life ahead of them, surgical valve replacement may be optimal, since it is unclear how long TAVR devices will last compared with traditional surgical valve replacements.

Dr. Jacob Mishell, an interventional cardiologist and medical director of structural heart disease for Kaiser Permantente in Northern California, said the health care provider is working on expanding its capacity to treat more patients with the new aortic-valve device. Kaiser does about 400 TAVR procedures a year at its medical centers in San Francisco, he said.

“In the North Bay, (TAVR) patients have the option being treated by Kaiser Permanente physicians but Kaiser uses Mercy Hospital in Sacramento,” he said, adding that next month Kaiser will start doing the procedure in Santa Clara.

Coleman said the results of the recent trials fall into the category of a “paradigm shift.” But, he said, those results are only short term and it will be some years before sufficient data is accumulated to evaluate the impact of the noninvasive heart valve replacement on low-risk heart patients.

“If you’re looking at a young healthy patient, it’s worth considering the trade-offs of having a less invasive procedure with easy recovery versus a more invasive one that we know a lot about,” he said.

Sutter’s Dr. Daniels, who lives in Petaluma, performs the TAVR procedure at Sutter’s California Pacific Medical Center in San Francisco and Mills-Peninsula Medical Center in Burlingame. Beginning in June, Daniels will start working every Tuesday at Sutter Santa Rosa Regional Hospital, placing stents, treating emergency cardiac patients and working with the local “heart team” on patients getting the noninvasive valve replacement.

Daniels tells patients with severe aortic stenosis that their illness is as aggressive as colon cancer and that it will eventually kill them. And he tells many of them there’s now a proven alternative to open-heart surgery.

“I tell them we got a cure, it’s a 100%, would you like to take it or not?” he said of the noninvasive heart treatment.

You can reach Staff Writer Martin Espinoza at 707-521-5213 or martin.espinoza@pressdemocrat.com. On Twitter @pressreno.

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