LITTLE ROCK — Arkansas Heart Hospital and Interventional Cardiologists Dr. David Mego and Dr. William Rollefson became the first in this region of the United States to implant the SAPIEN transcatheter aortic heart valve as an FDA-approved standard of care, officials said Dec. 23.

LITTLE ROCK — Arkansas Heart Hospital and Interventional Cardiologists Dr. David Mego and Dr. William Rollefson became the first in this region of the United States to implant the SAPIEN transcatheter aortic heart valve as an FDA-approved standard of care, officials said Dec. 23.

The implants on Dec. 20 were the fifth and sixth in the nation since FDA approval. Device approval was based on results from the PARTNER trial, which showed that transcatheter aortic valve implantation improved survival and quality of life compared with standard therapy in non-operative patients with severely diseased aortic valves, spokesmen said.

The Partner study demonstrated dramatic mortality benefits at 1 and 2 years versus medical therapy.

“Approval of the SAPIEN transcatheter aortic heart valve is a monumental event on par with FDA approval of the bare metal stent in 1994. For patients too sick for open-heart surgery, this new treatment is the difference between life and death,” said Dr. Bruce Murphy, president and CEO of Arkansas Heart Hospital. “It is a huge honor for our team to perform the first two procedures in this region of the United States as an FDA-approved preferred treatment.”

Mego’s and Rollefson’s patients were turned down for traditional open heart surgery and had no other viable treatment options. Both patients were discharged from the hospital two days after their procedure.

This new way to perform heart valve replacement enables the placement of a collapsible aortic

heart valve into the body via a catheter that is inserted through the leg, and threaded up to the

heart. Transcatheter aortic valve replacement is approved at this time for people with life

threatening aortic valve disease who are not surgical candidates, according to Mego.

“TAVR represents a major advance for inoperable patients,” Mego adds. “Patients who would

have otherwise had no surgical options now have a way to cure their valve disease.”

Aortic valves, which regulate blood flow from the heart into the aorta, are susceptible to stenosis

(failure to open) and insufficiency (blood to flow in the wrong direction, back into the heart).

Critical aortic stenosis results in a death rate of approximately 50 percent in the first two to three

years after diagnosis without surgical intervention. Approximately 300,000 Americans suffer

from severe aortic stenosis. At least 30 percent of these patients do not undergo surgery for

replacement of the aortic valve because of advanced age, heart failure, or the presence of

multiple coexisting conditions.