More people can now take advantage of a less invasive way to replace the major valve in the heart and avoid open heart surgery.
Transcatheter aortic valve replacement – TAVR for short – involves threading the valve up through an artery in the leg.
“You don't require an incision and dividing the breastbone and stopping the heart,” said Dr. Michael Mack, a surgeon with Baylor Scott and White’s Heart Hospital in Plano. “It doesn't take nearly as long. You can go home the next day, but it's still a serious procedure with serious risks.”
After initially approving its use for patients too old and too frail for open heart surgery, the Food and Drug Administration over time has expanded use of TAVR to include high risk, medium risk and now low risk patients. However, Dr. Mack said some low risk candidates would still fare better with open heart surgery.
INTERVIEW HIGHLIGHTS:
Why the FDA expanded use of TAVR: There have been a series of trials that the FDA has run in the United States looking at who's a candidate for this. And they started 12 years ago with patients who were not candidates for surgery because they were considered prohibitive risk or inoperable, and it's progressively come down to high risk, medium risk and now low risk. Those trials have just been completed.
Low risk? Your chances of surviving open heart surgery are 99 out of 100. There's two basic causes to this disease called aortic stenosis. One is a buildup of calcium on normal valves as you age Some people are born with this condition — but over their first 30, 40, 50 years of life they develop aortic stenosis earlier. Those are patients that are higher risk for the TAVR procedure and have longer to live with the valve. But the majority of patients, with some exceptions over 65 years old, would be seriously considered for this procedure.
How do low-risk patients choose? Go to a hospital that offers both procedures for a balanced set of information regarding the pros and cons of each approach. Second, ask each center how much experience they have in both procedures and then sit down with the physicians. If everything's equal and the risks are equal of both and of course you take the less invasive procedure or TAVR.
Likelihood of a second procedure later: We won't know the answer of the relative need for that until we follow these patients 10 years, which is one of the reasons for doing that. However, whether you get TAVR or surgery, there is an option of putting a TAVR valve inside the first TAVR valve or inside a surgical valve. Theoretically that could potentially double the expectant durability of the valve. So let's just say the valve lasts 10 to 12 years and it wears out, well you could put a second valve inside that first valve and then extend it to 20 or 22 years. Again, that's theoretical at this stage but a very real possibility.
RESOURCES:
FDA Expands TAVR Indication to Low-Risk Patients
TAVR is not the ‘beginning of the end’ for aortic stenosis open heart surgery
