How Well Does Minimally Invasive Transcatheter Valve Implant Work?

A clinical study has shown that the transcatheter surgery can prolong people's lives. The SAPIEN heart valve won approval based on a study of 358 U.S. patients with severe, inoperable aortic stenosis. About half were randomly assigned to have the valve implanted, while the rest received standard care, including medication and valvuloplasty.

After one year, 69 percent of patients in the transcatheter group were still alive, compared with 49 percent of those who received standard care. People who survived with the valve also reported improvements in symptoms such as fatigue and breathing problems, and said they generally felt better physically and mentally.

That's how patients in one study fared over just one year. But some longer-term information has started to come from Europe, where the transcatheter procedure was performed for several years before it became available in the United States. A recent study from Germany, for example, found that 64 percent of patients who had the surgery were still alive two years later.

Another study looking at multiple European hospitals found that the risk of complications from the transcatheter surgery is on par with the risk seen with traditional open-heart surgery—even though people who have the catheter approach are generally older and sicker.

Risks of Transcatheter Valve Implant

In the U.S. study described above, two patients given the SAPIEN heart valve died during the procedure; another three suffered major strokes. And while transcatheter patients had a better survival rate than did standard-therapy patients, they were twice as likely to suffer a stroke within a year—about 8 percent versus 4 percent.

Other risks include "vascular complications," such as blood clots or a tear or hole in the blood vessels that may require another procedure. In the U.S. study, 17 percent of transcatheter patients had such complications within a year, compared with 2 percent of standard-therapy patients.

Most strokes occur when a blood clot blocks a blood vessel supplying the brain. To help cut the risk of clots and stroke after the valve replacement, blood-thinning medication—typically clopidogrel plus aspirin—is usually prescribed for six months, and then aspirin for the rest of the patient's life. Those medications carry their own risks, including bleeding in the digestive tract or brain.

Questions about Transcatheter Valve Implant

Because transcatheter valve replacement is still new, there are some unknowns. It's not established how long the devices last before they may need to be replaced, if ever. To get a clearer long-term picture, researchers are continuing to follow patients who have undergone the procedure.

It's also not known how widely available the procedure will become. A limited number of U.S. medical centers are currently equipped for the procedure. Edwards Lifesciences, which makes the SAPIEN device, is requiring hospitals to undergo screening and training before it will sell them the implant.

That said, the transcatheter surgery offers an option to people who otherwise might have a grim outlook. If you've been told you have aortic stenosis but can't have open-heart surgery, ask your doctor if you might be a candidate for this newer approach.

Publication Review By: Gary Gerstenblith, M.D.; Simeon Margolis, M.D., Ph.D.

Published: 02 Jul 2013

Last Modified: 08 Sep 2015