“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.
Fortunate News from the Doctor
“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.
Now Approved for High-risk 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.”