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Two large clinical trials now show that TAVR is equally useful in younger, healthier patients.
It could even be better, offering less risk of disabling strokes and deaths, compared to open heart surgery. Cardiologists say this will likely alter the standard treatment for most patients with aortic valve failures.
In open-heart surgery, a patient's ribs are fractured and the heart is stopped to insert the new aortic valve.
With TAVR, the only incision is a small hole in the groin where the catheter is inserted. Most patients are sedated, but stay awake throughout the procedure and recovery only takes a few days, not months, as is often the case after the usual surgery.
The findings "make us think about who should get a PVR rather than knowing why a person should undergo surgery," said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania.
The studies will be published in the New England Journal of Medicine and presented Sunday at the annual meeting of the American College of Cardiology.
The Food and Drug Administration should approve the procedure for low-risk patients. Not less than 20,000 patients a year would be eligible for the AVAL, in addition to the nearly 60,000 patients at intermediate and high risk who are currently undergoing surgery.
"This is an obvious victory for TAVR," said Dr. Michael J. Mack, cardiologist surgeon at Baylor Scott and White The Heart Hospital in Plano, Texas. From now on, "we will be very selective" about open heart surgery, said Mack, principal investigator in one of the trials.
Some healthier patients will still need traditional surgery – for example, those who are born with two flaps to the aortic valve instead of the usual three.
The trials were sponsored by valve manufacturers TAVR, Edwards Lifesciences of Irvine, California, and Medtronic, headquartered in Dublin.
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