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FDA approves transcatheter aortic valve replacement for low-risk patients

By Staff | Oct 23, 2019

Dr. Brian Hummel

Following extensive clinical trials, the Food and Drug Administration has approved transcatheter aortic valve replacement (TAVR) surgery for low-risk patients. TAVR is a minimally-invasive alternative to open heart surgery for patients with aortic stenosis, and was vaulted to widespread attention when Rolling Stones frontman Mick Jagger underwent the procedure earlier this year.

Aortic stenosis is a narrowing of the aortic valve, leading to a restriction of blood flow. TAVR had only been available to patients who were at a high or intermediate risk of complication from open heart surgery, and the FDA decision makes the procedure widely-available to a larger group of patients.

In 2011, Lee Health was the second health system in the country to perform TAVR procedures, and was selected to participate in the FDA trials for low-risk patients. The team led by Dr. Brian Hummel, cardiothoracic surgeon with Lee Health, recently performed its 1,000th procedure and the positive results shown during the trial helped open the door to FDA approval for low-risk patients nationwide.

TAVR is performed by crimping the new valve down to the diameter of a pencil and placing it on a catheter. From there, the catheter is fed to the heart through a small incision in an artery. The valve, which will begin working immediately, is then securely placed inside of the diseased valve.

“We are thrilled that more patients will be able to opt for this great alternative to open heart surgery,” Hummel said. “Patients undergoing a TAVR procedure are often ready to go home the next day and return to their day-to-day lives in days rather than weeks. The research shows that TAVR greatly reduces the risk of complications compared to traditional surgery, and this FDA decision is great news for patients.”

About half of TAVR patients are able to go home the day after their surgery and can expect to return to their normal lifestyle in five to six days. Patients having a heart valve replaced via traditional open heart surgery typically experience up to eight weeks of recovery. TAVR also has shown an equal or lower risk for complications such as heart attack or stroke in connection with valve replacement.

For a visual demonstration of the surgery, visit www.leehealth.org/cardiaccare/treat/tavr.asp