FDA approves heart surgery technique; FAHC at forefront of study - WCAX.COM Local Vermont News, Weather and Sports-

FDA approves heart surgery technique; FAHC at forefront of study

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Carol Boone was the perfect candidate for Transcatheter Aortic Valve Replacement -- also known as TAVI.  Channel 3 first visited her nearly two years ago, not long after she'd become Vermont's first TAVI patient.  She'd been weak and she struggled to breathe because of aortic stenosis -- a severe narrowing in the aortic valve.

"It was very restricting. I had trouble getting around the house -- walking from A to B," Boone said.

But traditional open heart surgery was not an option. She was considered extremely high risk.  Boone had a 50-percent chance of dying within a year -- until doctors at Fletcher Allen asked her if she'd like to participate in the nationwide TAVI trial. Here's how it works. A small incision is placed in the groin and a catheter -- with the new valve attached -- is fed through the artery to the heart.  Once stabilized, the metal is deployed.  It then springs open and the new valve operates inside the old one.

Now, two years later, the study results are in. "We would expect 50-percent to die at a year and we've been able to do TAVI on them with a 20-percent mortality rate at one year," said FAHC's Dr. Harry Dauerman. "So we've cut the mortality rate in half and we are seeing dramatic improvements in the quality of life in these patients after getting the valve implanted."

And based on those clinical trial results, the Food and Drug Administration has just given the Medtronics technology final approval.  450 TAVIs have been done nationwide -- 71 of them at Fletcher Allen Health Care. They are older, high risk patients who would have died without it.  "It's a life saving treatment to fix aortic valve disease, and aortic valve disease is not metastatic cancer -- it's a one up. You fix it and it's fixed. So for patients who have this, if they're 85 and it is something that if they are otherwise good and have a functional life, it's worthwhile pursuing the treatment," Dr. Dauerman said.

Traditional open heart surgery is still considered the treatment of choice for younger patients, but for people like Carol Boone, participating in the TAVI trial saved her life.

Fletcher Allen and other sites nationwide are now testing TAVI on patients deemed a little less risky --- those in their 70's.  Dr. Dauerman expects FDA approval for those patients by the end of the year.

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