Dr. Richard Smalling
Gladys Harvey, 61, had already survived two open heart surgeries. She carried a pacemaker in her chest and was on continuous oxygen. So when it became apparent that she needed a repair for a leaky mitral valve, which was allowing blood to flow dangerously from the heart back into her lungs instead of forward into the body, cardiovascular surgeons advised again open heart surgery.

Instead, she was referred to Dr. Richard Smalling, of The University of Texas Health Science Center at Houston (UTHealth) Medical School, for a procedure that had just been commercially approved by the Food and Drug Administration: the transcatheter MitraClip® procedure.

In the normal heart, blood is pumped forward by the left ventricle – the main pumping chamber of the heart – into the aorta and the rest of the body. The normal mitral valve does not allow backflow into the left atrium and lungs.  In severe mitral regurgitation, the mitral valve leaflets do not work properly and the leaking valve allows blood from the left ventricle to flow back into the left atrium and then into the lungs.

Mitral regurgitation can lead to stroke, heart enlargement and failure, and sudden death. It affects approximately 4 million Americans and symptoms include shortness of breath, irregular heartbeat, lightheadedness, fatigue, and chest pain.

Prior to the MitraClip® procedure, open heart surgery was the only treatment. Smalling, the James D. Woods Distinguished Chair in Cardiovascular Medicine and director of interventional cardiovascular medicine in the Division of Cardiology at UTHealth and the Memorial Hermann Heart & Vascular Institute-Texas Medical Center, was a principal investigator of the EVEREST II trial, which studied the MitraClip® procedure in patients with mitral regurgitation. Results from that study led to approval of the device for use in patients with degenerative mitral regurgitation who are at high risk for open heart surgery.

“It took us nine months to get approval from our insurance company,” said Harvey, who lives in New Mexico. “They said Dr. Smalling was out-of-network and kept asking if there was anyone else who could do it. The answer was ‘no.’ Dr. Smalling was the best and we wanted the best.”

The wait was hard on Harvey, who had to quit her job teaching pre-school kids because of her low oxygen levels.

“I was on oxygen 24-7 and I’m a very active person. My quality of life was minimal, like 40 percent. We couldn’t go camping. We love to do mission trips through our church, and we couldn’t do any of them,” Harvey said.

Harvey was finally scheduled for her procedure in late February at the Memorial Hermann Heart & Vascular Institute-Texas Medical Center. During the procedure, the interventional cardiologist works closely with a cardiologist who specializes in transesophageal echocardiography. A flexible ultrasonic probe is placed into the patient’s esophagus and stomach to capture high resolution images of the heart continuously throughout the procedure. These images allow the interventional cardiologist to position the MitraClip® delivery system precisely between the valve’s two leaflets and clip the valve across the leaking area. Once deployed, the clip still allows blood to be pushed out of the heart, but backward flow is now restricted.

Dr. Catalin Loghin, associate professor of cardiovascular medicine and an interventional echocardiographer specially trained in E-Valve mitral valve repair, helped direct the optimal positioning of the clip placement. Loghin was a co-investigator on the earlier MitraClip® clinical trial.

“We know once the valve is repaired with this technique, the outcome is usually very good,” Smalling said. “The deterioration stops and they get better and the heart function gets better. Over time, the heart actually shrinks.”

Harvey’s procedure took just 35 minutes and a month later, she said her quality of life was up to 75 percent. Two months later, she said she has 95 percent of her quality back and she is looking forward to returning to her classroom in the fall. She uses oxygen only at night and said she will be retested soon to see if she can stop using it altogether.

“I actually sang in the choir on Easter morning for the first time in years,” she said. “I am so excited!”

UTHealth has begun a second trial for the MitraClip®, this one testing its efficacy for functional mitral regurgitation, which is caused by enlargement of the heart due to heart attack or heart failure. The commercially approved MitraClip® is for degenerative mitral regurgitation, caused by damage to the leaflets. For more information, please call 713.500.UTCV.

-Deborah Mann Lake, Office of Public Affairs, Media Relations