FDA approval gives patients okay for alternative to open-heart surgery

It’s a new era for heart patients.

The U.S. Food and Drug Administration recently approved the Evoluttranscatheter aortic valve replacement (TAVR) system to treat symptomatic severe aortic stenosis (ssAS) patients who are at low risk of surgical mortality after research findings indicated positive outcomes and that the procedure typically reduced patients’ hospital stays, allowing them to get back to enjoying their lives sooner. This is big news, as low-risk patients are often slightly younger and more active than their higher-risk counterparts, and often want to resume daily life activities soon after surgery.Previously, these patients would’ve only been indicated to receive the more invasive surgical valve replacement given their risk score assessment.The low risk patient population is the final surgical risk category to be approved for TAVR, meaning the therapy is now a treatment option for all patients with symptomatic severe aortic stenosis.

Houston Methodist DeBakey Heart & Vascular Center cardiothoracic surgeon and medical researcher Dr. Michael Reardon, who is also the principal investigator leading the trial that led to this approval, said this year, they expect 85,000 TAVRR procedures. With FDA approval, they expect more than 100,000 TAVRR procedures.

"Up to recently, the only option was for me to open your chest, stop your heart, cut the old valve out and put a new one in. This new procedure, transcatheter valve replacement, allows us to go up through your leg and do this without opening your chest and without stopping your heart," said Reardon.

He said it means less chance of risks after the procedure and quicker recovery.

"You come in now and I use a TAVR to replace your aortic valve, I don't even have to put you to sleep. I can do this under local anesthesia. You don't go to an ICU, you go to recovery, so that afternoon, you're with your family. You're usually home in one to two days and by one week, you're back to normal activity," said Reardon.

Reardon performed the first successful heart auto transplantation for a cancerous heart tumor in 1998.

His career includes accomplishments as an attending physician and medical school professor in Houston. He joined the staff of the Houston Methodist Hospital in 1985 following his cardiac fellowship. He became a faculty member of Baylor College of Medicine in 1993. He was appointed as Chief of Cardiac Surgery and Professor of Cardiothoracic Surgery of Weill Cornell Medical College and Houston Methodist Hospital in 1995. He currently holds the position of Clinical Professor of Cardiothoracic Surgery at MD Anderson Cancer Center and created the multi-institution, multidisciplinary cardiac tumor team with Houston Methodist Hospital and MD Anderson Cancer Center.

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