Apr 29, 2012 4 min read

(EDITOR’S NOTE: The following information was prepared by the Harvard Medical School Adviser at www.health.harvard.edu/adviser. Submit questions to

Q: My cardiologist says I have aortic stenosis and need a new aortic valve. He also mentioned that the FDA has approved a new procedure that replaces the aortic valve without open-heart surgery. This option sounds safer to me, but my doctor says this new option is not for everyone. Can you walk me through the pros and cons of these two approaches?

A: The short answer may seem facetious: Ask your doctors. In fact, it’s a complicated decision that requires an individualized answer depending on your health, your preferences and — above all — the experience and skill of your cardiac care team. With that said, let’s discuss some general considerations.

The aortic valve is a three-flapped structure that ensures the one-way flow of blood from the heart’s main pumping chamber to the rest of the body. In some people, the aortic valve becomes encrusted with calcium deposits that stiffen and narrow it, restricting blood flow.

When people with aortic stenosis start feeling symptoms such as light-headedness or fainting, breathlessness, fatigue and loss of appetite, quality of life goes downhill quickly until the valve is replaced.

Until recently, replacing the aortic valve required open-heart surgery.

Now that the FDA has approved a no-surgery technique for replacing a failed aortic valve, many people with aortic stenosis are asking, “Can I get this procedure?”

The answer is “Maybe.” That’s because the FDA has currently restricted its use to people who are not good candidates for open-heart surgery.

As you point out, it’s easy to see why people might prefer the new approach, called transcatheter aortic valve implantation, or TAVI.

The new valve is placed using a wire, or catheter, that is maneuvered into the heart from a blood vessel in the groin. Both the hospital stay and recovery are shorter and less painful than with open-heart surgery.

The FDA based its approval on a clinical trial dubbed PARTNER. In this trial, 69 percent of the patients undergoing TAVI were alive after a year, compared with 50 percent of a group that received standard therapy, which included balloon valvuloplasty, an attempt to increase the valve opening with a balloon-tipped catheter.

PARTNER data presented at a scientific meeting in late 2011 showed that more than two-thirds of the people in the standard-care group had died after two years, compared with 43 percent in the TAVI group.

Another analysis found that quality-of-life scores after one year among the TAVI group improved by 32 points on a 100-point scale, while scores among the standard-care group improved by only 4 points.

But although it prolongs life and is less invasive than open-heart surgery, TAVI has its drawbacks. TAVI recipients in the PARTNER trial had more than twice the number of strokes and many more serious bleeding complications than patients in the other group. The bleeding problems were mostly related to the wide catheter that’s used during TAVI.

So it’s important to look at the benefits and drawbacks of TAVI on an individual basis, taking into account your specific health status.

That’s where your heart team can be very useful in advising you. People who are treated with TAVI may live longer than patients who undergo standard therapy, but the procedure does have limitations that need to be considered, too.

The FDA stipulates that a surgeon must help determine which people with aortic stenosis are eligible for TAVI.

Patients may be eligible because they have an unhealthy aorta (the main pipeline for blood from the heart to the body), chest tissue that won’t heal well due to past radiation treatment, previous artery-bypass surgery that makes another surgery impractical or simply a very weak heart.

The TAVI procedure is an prime example of astounding medical innovation. But it still takes old-fashioned experience and judgment to decide when to use this new technology.