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Harvard Medical School: No-surgery option of aortic stenosis not for everyone

Posted: March 11, 2012 at 12:34 pm

QUESTION: My cardiologist says I have aortic stenosis and need a new aortic valve. Apparently 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 it is not for everyone. Can you walk me through the pros and cons of these two approaches?

ANSWER: Ask your doctors. This is 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% of the patients undergoing TAVI were alive after a year, compared with 50% 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% 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 trial had more than twice the number of strokes and many more serious bleeding complications than patients in the other group.

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Harvard Medical School: No-surgery option of aortic stenosis not for everyone

Recommendation and review posted by G. Smith