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