“A game changer”—that’s what the mainstream media called the recent FDA approval of a nonsurgical alternative to open-heart surgery for replacing a failing aortic valve. For now, though, it changes the game only for people who can’t, or shouldn’t, have open-heart surgery. They are the only ones allowed to undergo the new procedure, though eligibility is likely to expand in the coming years.
The aortic valve is a three-flap structure that sits between the left ventricle, the heart’s main pumping chamber, and the aorta, the main pipeline for blood from the heart to the body. The aortic valve ensures a one-way flow of blood from the left ventricle to the aorta. In some people, aging and an unhealthy lifestyle conspire to encrust the valve with calcium deposits that stiffen and narrow it, restricting blood flow. Once people with this condition—called aortic stenosis—start feeling symptoms such as dizziness, breathlessness, fatigue, and loss of appetite, their quality of life goes inexorably downhill unless the valve is replaced.
It’s understandable why anyone might prefer the nonsurgical procedure, called transcutaneous aortic valve implantation (TAVI). Open-heart surgery involves splitting the breastbone, stopping the heart, and temporarily transferring heart and lung functions to a machine. In contrast, TAVI entails implanting the new valve using a wire, or catheter, that is maneuvered into the heart from a blood vessel in the groin. Both the hospital stay and the recovery are shorter and less painful with TAVI than with open-heart surgery.
The FDA based its approval of TAVI on a clinical trial dubbed PARTNER. In the trial, TAVI improved survival and quality of life at one year. But the procedure came with considerable downsides. TAVI recipients in the PARTNER trial had more than twice the number of strokes and eight times as many serious bleeding complications as those in a standard-care group.
The FDA stipulates that a surgeon must help identify people with aortic stenosis who are poor candidates for traditional valve replacement surgery and who are therefore eligible for TAVI. Such people might have chest tissue that won’t heal well after surgery due to prior radiation treatment, previous artery-bypass surgery that makes valve surgery impractical, or simply a very weak heart. If your choice is between TAVI or no surgery, you’ll have to weigh progressively deteriorating health against a procedure with substantial risks of complications, including a potentially debilitating stroke. Not an easy call.
Everyone with health problems due to aortic stenosis faces difficult decisions about valve replacement. That’s why experts urge people to make such choices with the help of a “heart team” consisting of a general cardiologist, a cardiac surgeon, and a cardiologist whose specialty is catheter-based procedures.