Promising clinical trial for innovative heart procedure in Tulsa

Ronald Marsh underwent a clinical trial for a breakthough heart procedure led by Dr. Nicholas Hanna.

When Tulsan Ronald Marsh showed up at church a few days after heart surgery, his friends asked, "Weren’t you supposed to have an operation?"

"I did!" Marsh told them.

For most patients, heart surgery entails intense pain and weeks of recovery. Marsh had no recovery at all — he woke up from the operation with no pain and took no medication. In fact, he walked more than 2 miles a few days after an aortic valve replacement.

This procedure usually requires open-heart surgery. Cutting through the sternum and replacing the aortic valve usually requires 8-10 days of recovery before patients can drive or lift anything over 10 pounds. However, an innovative procedure called the Low Risk Transcatheter Aortic Valve Replacement (TAVR) allows doctors to make a small incision in a patient’s leg, and use a catheter to replace the diseased valve.

Marsh, 75, is a seasoned runner and leads an active, healthy lifestyle. During a routine check-up seven years ago, Marsh’s primary care physician told him he had calcification around his aortic valve. A few years later, after the calcification had intensified, it became clear the valve would need to be replaced.

However, instead of conventional heart surgery, cardiologists said Marsh might qualify for a clinical trial of the Low Risk TAVR. "Mr. Marsh was a great candidate for the clinical trial because he is an overall healthy, vibrant gentleman who essentially was suffering from one major thing (his severe aortic stenosis)," says Dr. Nicholas Hanna, the cardiologist at St. John Medical Center who led Marsh’s operation.

"The first phase of the trial has been completed, and the results are unprecedented," Hanna says. "The Low Risk TAVR trial enrolled 200 patients, and there were zero strokes and zero deaths in the first 30 days. It is the first TAVR trial that has achieved those results."

This procedure drastically reduces the pain and recovery time of the aortic valve replacement, allowing patients to quickly return to daily activities, which suits Marsh. "I don’t do sick very well," he says. "I’d rather be outside working."

Of the seven hospitals participating in the clinical trial nationally, St. John is the only one in the Midwest. "It’s a wonderful thing for the Tulsa community because we are bringing cutting-edge technology to patients who cannot get TAVR because it is not approved for low-risk patients yet," Hanna says. "If we can prove that low-risk patients with severe aortic stenosis do well with TAVR in lieu of surgery, then TAVR will become the default strategy for treatment of this disease. The vast majority of patients will undergo TAVR instead of open-heart surgery." 

 

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