UAB doctors' successful alternative to open-heart surgery still awaiting FDA approval

Surgeons at University of Alabama at Birmingham successfully used an alternative to open heart surgery. The noninvasive procedure is used for high risk patients. It is already being done in hospitals in Europe and Canada but has yet to gain FDA approval. However, a clinical trial is underway in the United States.

It's called a Valve in Valve Transcatheter Aortic Valve Replacement. It's a way to replace heart valves without opening up the patient. What's new is that doctors are using the replacement technique for patients who have already had tissue valve replacements.

"I'm feeling great," said Randall Warren, the first patient to have the procedure in Alabama. "I'm feeling like I've just started a new life."

Warren had no trouble breathing during our interview Tuesday- something that would have been challenging just a month ago.

"I'd lay down and I might as well cover my mouth cause I couldn't breathe," said Warren. "Even on my left side, I couldn't breathe. I could breathe a little bit if I laid on my right side. But, it was one of the most miserable times in my life."

Warren had an aortic valve replacement about three years ago, but it deteriorated quickly.

Doctors were left with few options.

"We looked at him and we talked about it," said Dr. James Davies, a Cardiothoracic Surgeon at UAB. "But, given his age, the redo status and his other comorbidities, we really felt he was way too high risk for open surgery."

Davies and his colleague Dr. Seun Alli conducted Alabama's first Valve in Valve Transcatheter Aortic Valve Replacement.

"Basically where we go through the groin or from another access site to replace the valve without taking the other valve out and without using the heart lung machine," explained Davies. "So, basically we don't stop the heart and we put a new valve in."

"Immediately, it was just great," described Warren. "I woke up and I was breathing- laying down on my back breathing."

The procedure is not yet FDA approved, but Davies and Alli felt comfortable performing it.

"There's a lot of data in it but still not approved by the FDA so its sort of an off the label use of the device," explained Alli.

Warren says he had no hesitation, "I would think of having to sit there in that chair and breath or lay down and breath. I was ready to try, I would have tried anything that was reasonable sensible."

Warren's surgery was about a month ago. He says he feels great today and would do it again.

Davies hope to do this procedure every one to two weeks going forward. He explains patients are getting older and outliving their replacement heart valves. So, he believes this technique will be very useful for patients who are high risk for open heart surgery.