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Tens of thousands of heart patients may not need open-heart surgery
[NEW YORK] The operation is a daring one: To replace a failing heart valve, cardiologists insert a replacement through a patient's groin and thread it all the way to the heart, maneuvering it into the site of the old valve.
The procedure, called transcatheter aortic valve replacement (TAVR), has been reserved mostly for patients so old and sick they might not survive open-heart surgery. Now, two large clinical trials show that TAVR is just as useful in younger, healthier patients.
It might even be better, offering lower risks of disabling strokes and death, compared to open-heart surgery. Cardiologists say it will likely change the standard of care for most patients with failing aortic valves.
In open-heart surgery, a patient's ribs are cracked apart 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 awake through the procedure, and recovery takes just days, not months, as is often the case following the usual surgery.
The results "shift our thinking from asking who should get TAVR to why should anyone get surgery," said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania.
The studies are to be published in the New England Journal of Medicine and presented Sunday at the American College of Cardiology's annual meeting.
The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 intermediate- and high-risk patients who get the operation now.
"This is a clear win for TAVR," said Dr. Michael J. Mack, a heart surgeon at Baylor Scott and White The Heart Hospital-Plano, in Texas. From now on, "we will be very selective" about who gets open-heart surgery, said Mack, a principal investigator in one of the trials.
Some healthier patients will still need the traditional surgery — for example, those born with two flaps to the aortic valve instead of the usual three.
The trials were sponsored by makers of TAVR valves, Edwards Lifesciences of Irvine, California, and Medtronic, headquartered in Dublin.