When patients need a new heart valve, they can get an artificial one—if they’re healthy enough for the conventional method, open-heart surgery.
But a new artificial valve, inserted via catheter, doesn’t require major surgery at all, and a group of heart experts is meeting Wednesday to weigh in on the device’s safety.
The artificial Sapien heart valve system, from Edwards Lifesciences, will be reviewed by an advisory panel to the FDA, which doesn’t have to follow the panel’s advice but usually does.
Replacement valves are needed when a valve in the aorta, the main artery that carries blood away from the heart, becomes narrowed and prevents blood from flowing normally. The Sapien valve can be threaded through a leg artery to the aorta. In a clinical trial among patients deemed too sick for surgery, those who had the Sapien valve had better survival after a year than those who got other care, including using a balloon catheter to expand the valve.
But the same trial also found a higher rate of side effects, such as stroke, among those with the replacement valve.
Yet the FDA appears warm toward the valve system. A briefing document on the agency’s website concludes:
“While TAVR [transcatheter aortic valve replacement] is associated with an increased risk for stroke and procedure-related adverse events (e.g., bleeding and vascular complications), the benefit from TAVR in inoperable patients with severe aortic stenosis is substantially greater than the risk.”