08:13am Monday 23 October 2017

UHealth Valve Replacement Trial Results Published

The valve replacement procedure is a new option for some older people who suffer from aortic stenosis but would not normally be treatable because they would be unable to withstand open-heart surgery and a long recovery period. The first-of-its-kind study randomized patients to either undergo the transcatheter aortic valve implantation (TAVI) surgery or receive standard therapy, including balloon valvuloplasty.

“Today we have the findings of the first randomized trial which shows that after one year, it is much more likely that the patients who have the valve implanted have better survival rates than those who did not get the valve,” said William O’Neill, M.D., executive dean for clinical affairs at the Miller School, chief medical officer of UHealth – University of Miami Health System, and the study’s principal investigator.

More than two years after becoming one of the first patients at University of Miami Hospital to undergo the revolutionary procedure, Kenneth Horstmyer, 88, is doing spectacularly.

“I feel absolutely no impairment; it has been totally corrected,” said Horstmyer, a retired Burger King executive who lives on Key Biscayne. His aortic stenosis used to make climbing the stairs difficult. “It would take my breath away.”

Aortic stenosis, a narrowing of the valve that restricts blood flow, is most often a function of aging and, if not treatable, has a mortality rate of nearly 90 percent two years after symptoms begin.

The New England Journal of Medicine study covered 358 patients considered not suitable for surgery. They were tracked to measure their progress a year after they underwent the TAVI procedure – using the Edwards SAPIEN heart valve developed by Edwards Lifesciences – or received standard therapy. Patients in the study were drawn from 21 centers, 17 in the United States.

As O’Neill pointed out, “In Mr. Horstmyer, you can see living proof of how wonderful the treatment is.”

Another important finding of the study was that 70 percent of participants who did not have their valve replaced were re-hospitalized within the first year.

“If you don’t treat that problem then people wind up very short of breath, have severe congenital heart failure, and have to go back to the hospital,” said O’Neill, who acknowledged that the surgery can be difficult and has to be performed by a team of experts.

The six-physician team that conducts the TAVI procedures at University of Miami Hospital has served about 60 patients to date, with more and more referrals coming from Palm Beach, Naples and other areas of the state.

O’Neill, who did the first percutaneous valve replacement surgery in the United States, said the study findings will carry a lot of weight in Florida where there is a significant senior population. After age 80, he said, one in three people encounters some kind of aortic valve problem, and some could be eligible for the new procedure as opposed to undergoing open-heart surgery.

“As you heard from Mr. Horstmyer, he was very symptomatic before, he feels dramatically better now, and he hasn’t been back in the hospital for nearly three years,” O’Neill said.

At that, Horstmyer recalled the first days after his valve replacement procedure: “You could have told me I was 19.”


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