A recent decision by the Food and Drug Administration opened the door for Sharon Kramer of Atherton, California, to undergo a less-invasive heart valve replacement.
December 13, 2019 - By Tracie White
Sharon Kramer, a 76-year-old businesswoman, has always thrived on hard work and keeping busy. She and her husband run two hofbraus in the San Francisco Bay Area, plus two Italian restaurants and a boutique in Palm Springs, California. Between traveling from their home in Atherton, California, to the businesses, as well as visiting grandchildren, she is constantly on the move. At least until eight months ago, when all that energy disappeared, and she started taking catnaps in her car.
“I’ve always been high energy, so when I was starting to get unusually tired, I just thought, ‘Well, getting older is finally catching up with me,” she said. “I’d get up in the morning and be good for a couple of hours, but if I did too much, I would have to go back to bed. When I did go out, sometimes I’d park my car in a shady place and take a nap.”
Eventually, disturbed by this unusual fatigue along with some shortness of breath and a fainting episode in a department store, she went to see her Stanford doctors. She discovered that she wasn’t just getting older: She needed heart surgery. Medical tests showed that she had severe aortic valve stenosis, a narrowing of the aortic valve, which is life threatening. She needed a new heart valve.
“At that point, I was facing open heart surgery,” she said. “But I didn’t want to do that. I understood that they had to split my chest open and that recovery could be quite painful and take four to six weeks. There was just no way I could lie around recuperating that long.”
Fortunately for Kramer, her doctors were able to offer her a less-invasive option: transcatheter aortic valve replacement. TAVR reduces the patient’s hospital stay and recuperation period because it eliminates the need to cut open the chest. Instead, physicians insert an expandable biological heart valve via a catheter and thread it, usually through a needle puncture in the groin, into an artery in the leg up through the aorta and down into the heart to replace the diseased valve.
“It can be wonderful for patients,” said William Fearon, MD, professor of cardiovascular medicine, who, along with other Stanford researchers, has been involved with several of the clinical trials used to study TAVR over the past decade. “TAVR is a less-invasive way for repairing defective heart valves, with a better quality of life.”
Previously, TAVR had been reserved for patients at high risk of not surviving open heart surgery. But positive results from two recent clinical trials resulted in its approval for use in a broader, healthier segment of the patient population who need new aortic valves.
“The doctors said I was fortunate,” said Kramer, who compared the pros and cons of both procedures and ultimately chose TAVR. “They said I was in the right place at the right time.”
Aortic stenosis occurs in more than 5% of the American population older than 75, according to the American Heart Association. As the valve opening narrows, it restricts blood flow to the aorta, the body’s main artery, forcing the heart to work harder to pump blood throughout the body. In severe cases, it can cause fainting, chest pain, heart failure, irregular heart rhythms and cardiac arrest — and even lead to death.
The standard treatment has been to open the chest cavity and replace the aortic valve with a mechanical or bioprosthetic valve to improve blood flow. But TAVR started to change that in 2012, when it was approved for high-risk patients by the Food and Drug Administration. Last summer, after two randomized clinical trials revealed the procedure to be as good or even better for low-risk patients, the FDA approved use of the device for such patients.
“This new approval significantly expands the number of patients who can be treated with this less-invasive procedure for aortic valve replacement,” said Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in an Aug. 16 statement. It “follows a thorough review of data demonstrating these devices are safe and effective for this larger population.”
‘Well-studied in patients’
What the FDA approved was two artificial valves the two clinical trials found to be safe for use in the procedure. Stanford was a participant in one of the trials, and the Palo Alto Veterans Affairs Health Care System participated in the other.
“This procedure has been well studied in patients,” Fearon said. “At Stanford, our approach has really evolved over the past decade. We’ve done more than 2,000 — about six a week.” With all the practice and advances in equipment over the years, the outcomes have continued to improve, he said. Fearon added that the trial results alleviated earlier concerns that TAVR showed a higher stroke risk than open heart procedures.
“The one remaining unknown is the valve’s long-term durability,” Fearon said. As part of its approval, the FDA required the valve manufacturers to follow up with patients enrolled in the randomized studies for at least a decade to help determine durability.
The official FDA approval came on Aug. 16, but Kramer was able to have her surgery at Stanford on July 23 because Stanford, as one of the trial sites, had received FDA approval to continue to treat low-risk patients with TAVR.
“She was a perfect example of this extension of TAVR into low-risk cases,” said Claire Watkins, MD, assistant professor of cardiothoracic surgery. Watkins performed the procedure together with Fearon, an interventional cardiologist. “It went really well. She’s back to working and traveling. I think she spent two days in the hospital instead of the four to seven days required for open surgery and what would have been at least a month away from work.”
Kramer said she was thrilled with the outcome. She said she’s able to travel and work with the same amount of energy she had prior to getting sick.
“There was hardly any pain involved,” she said. “When I got home within a day or two, I was walking up and down stairs. I think I stayed in bed the first morning, but within two days, we were out to dinner, and I had a margarita in front of me. It was that quick.”
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