CLEVELAND-- A nonsurgical heart valve replacement that avoids open heart surgery has been federally approved for low-risk patients.
On Friday, the Food and Drug Administration announced its approval of Transcatheter Aortic Valve Replacement (TAVR) for treatment of aortic stenosis in low-risk patients.
Aortic stenosis is a condition where the heart’s aortic valve, which leads blood from the heart to the rest of the body, hardens. It can cause chest pain and shortness of breath in patients, and the condition can lead to heart failure.
“I was doing less and less and less, and it was because I was breathless, but I didn't realize it,” said Arlene Bryant, of Twinsburg.
The 74-year-old said she began experiencing shortness of breath while walking, climbing stairs and doing other simple tasks. Her cardiologist recommended replacement of her aortic valve.
Bryant, who was considered low-risk, underwent TAVR in April at University Hospitals, which took part in a trial of the procedure among low-risk patients. She said her recovery lasted days, much faster than recovery from open heart surgery.
“I just feel like I have a new lease on life,” Bryant, who now walks more than 2 miles five times per week. “I just can't believe how good I feel and how much energy I have.”
With TAVR, a catheter is threaded into a blood vessel through the groin, then guided into the patient’s heart to replace the aortic valve.
Dr. Marco Costa, president of the Harrington Heart and Vascular Institute at University Hospitals, said most patients at UH don’t need to undergo general anesthesia.
“It's a paradigm shift in terms of how we see replacement of a very important piece of the heart, the aortic valve,” Costa said. “It's really transformational in terms of how we're going to approach our patients from now on.”
Ninety-five percent of TAVRs at University Hospitals are performed under conscious sedation in a cath lab, and more than half of patients go home the next day, according to a University Hospitals spokesperson.
Previously, the only alternative procedure for low-risk patients was open heart surgery, which is invasive and requires months of recovery.
“We have a choice to offer patients the lowest risk and minimally invasive approach,” Costa said. “To me, it's a game changer.”
The hospital system has performed more than 1,250 TAVR procedures since trials began in the U.S., and it was the first teaching site in the U.S. for the procedure, teaching the technique to physicians around the world, according to the hospital spokesperson.
Bryant said she is grateful she was a candidate for the procedure, which is now available to others in her situation.
“It's going to be such a help for people, it really is,” she said. “I'm really happy that this is going to make a difference in a lot of other peoples' lives.”