For some patients suffering from aortic stenosis, a procedure known as transcatheter aortic valve implantation (TAVI) may soon replace the need for invasive open-heart surgery, according to new research presented during the American College of Cardiology annual meeting in New Orleans on Sunday.

Authors of the PARTNER (Placement of Aortic Transcatheter Valves) study said their research showed TAVI should be considered as the new treatment for patients who are too high risk for open-heart surgery.

Aortic stenosis is a condition that causes the aortic valve to malfunction and decreases blood flow from the heart. Until now, the standard of care for patients with severe cases has been open-heart surgery to replace the valve.
With TAVI, however, an aortic valve device called Sapien produced by Edwards Lifesciences Corp., is threaded into the cardiac chamber by catheter, rather than inserted in an open-heart operation.

During the PARTNER trial, 699 high-risk patients, with an average age of 84 years, were equally randomized to receive either TAVI or aortic valve replacement. The results showed the TAVI group had a lower mortality rate at 30 days than the open-heart surgery group (3.4 percent versus 6.5 percent). The rates at one-year were similar between the two.

Patients who underwent TAVI procedures also had fewer hospitalizations for aortic stenosis at one-year with 22 percent compared with 44 percent for the open surgery group.

"We are enthusiastic that this trial clearly demonstrates the promise of a less-invasive treatment for patients at high risk for surgery," said Edwards' chairman and CEO Michael A. Mussallem in a statement.

"Although this therapy is still relatively new and rapidly evolving, it is impressive that the patient outcomes are similar to the well-established standard of open heart surgery," he said.

The study did find that TAVI carried an increased risk of stroke, with rates of 5.1 percent at one year compared with 2.4 percent for patients having valve replacement by open surgery.

While most results are promising, the Sapien device has not yet gained approval from the Food and Drug Administration and is currently only available in Europe.

If Sapien is cleared for use in the U.S., which could be next year for high-risk surgery patients, it could generate nearly $2.4 billion in sales and account for more than one in three aortic valve repairs by 2015, according to Bloomberg.

Cardiologists are also anticipating a high demand for TAVI from healthier patients who don't want to undergo the pain of surgery, said Michael Crawford, chief of clinical cardiology at the University of California, San Francisco, in the Bloomberg report.

"It's definitely going to change practice in treating this disease," he said.

Irvine, Calif.-based Edwards also reported on a cost-effectiveness study of TAVI that showed that in the 12 months after the procedure, TAVI patients incurred lower hospital costs compared to those receiving open surgery, which was mainly attributed to the reduction of hospitalizations.

The procedure and associated care cost around $80,000, and increase the life expectancy of the mainly elderly patients with inoperable aortic stenosis by about two years, compared with medical therapy, according to reports.

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