The procedure takes less than an hour, and patients leave the hospital after a day or two, he said. Open-heart surgery, on the other hand, can last four to six hours, and recovery may take three months, he noted.
After a year, patients who underwent TAVI had a significantly lower rate of death from any cause compared with patients who got standard therapy (30.7 percent vs. 50.7 percent).
TAVI patients also had a reduced rate of death or re-hospitalization compared with those receiving standard care (42.5 percent versus 71.6 percent respectively), the researchers report.
TAVI patients reported greater reduction in symptoms than the other group, and no valve deterioration was noted during the year after the procedure.
"It's not just the fact they are living longer, they are feeling dramatically better," Leon said.
However, more patients who underwent TAVI had a major stroke (5 percent) in the 30 days after the procedure than those in the standard therapy group (1.1 percent), the researchers note.
Efforts are under way to reduce complications, Leon said.
Another trial is assessing the procedure in high-risk patients who could undergo surgery. "In the future we will be looking at lower-risk patients as well," he said.
Previously, no effective treatments were available for patients with severe aortic stenosis who were not candidates for aortic valve surgery, said Dr. Gregg Fonarow, an American Heart Association spokesman and a cardiology professor at the University of California, Los Angeles. These patients "faced a very high risk of mortality," he added.
"As a result of this impressive new trial and pending FDA approval, transcatheter aortic-valve implantation represents an important therapeutic advance and a new standard of care for this important patient population," Fonarow said.
Dr. William O'Neill, executive dean for clinical affairs at the University of Miami Miller School o
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