Study finds procedure reduces risk of recurrent stroke compared to medical therapy

University of Texas| Wed Sep 13 16:00:09 EDT 2017
Study finds procedure reduces risk of recurrent stroke compared to medical therapy

 At a track meet in 2011, then 17-year-old Crystal Haynes was warming up for a high jump event when her leg and arm gave out and her world went black. She woke up shortly after and couldn’t speak – she was having a stroke.

By undergoing a procedure to close a hole in her heart – shown in a recently published study to be superior to medical therapy – Haynes, now 24, has significantly reduced her risk of having a recurrent stroke. Haynes is one of an estimated quarter of people born with the condition, called a patent foramen ovale (PFO).

The procedure was performed by Richard Smalling, M.D., Ph.D., an interventional cardiologist from McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth), who was the principal investigator for the Houston site and was a member of the steering committee on the decade-long RESPECT national clinical trial. Results of long term follow-up of the RESPECT trial were published today in the New England Journal of Medicine and revealed that participants who had a PFO closure procedure were 45 percent less likely to have a recurrent stroke than participants who only received medical therapy.

Smalling was part of the team that designed the clinical trial and UTHealth/Memorial Hermann Heart and Vascular Institute – Texas Medical Center was one of the top enrollment sites.

“A PFO, in some patients, allows blood returning from the lower body, potentially containing a blood clot, to slip into the left atrium. From there, it can travel directly to the brain causing a stroke or similarly wreak havoc to other parts of the body as well,” said Smalling, the James D. Woods Distinguished Chair in Cardiovascular Medicine and director of interventional cardiovascular medicine at McGovern Medical School at UTHealth.

Stroke kills nearly 130,000 people a year and is a leading cause of disability, according to the American Stroke Association. Eighty-seven percent of strokes are ischemic, caused when blood clots block the blood vessels to the brain. The cost of a stroke is significant, with more than $34 billion spent in the U.S. each year, according to the Centers for Disease Control and Prevention.

People who are born with a PFO at birth have no symptoms until a stroke strikes. That was the case with Haynes.

“The trainers were speaking to me and I was saying stuff back to them but no voice was coming out,” Haynes remembered about her stroke.

Just the day before, Haynes had competed in a power-lifting meet. The Orange, Texas native was considered a star athlete at her school and was excited to dominate the track that year. Instead, she would spent much of the next semester in the hospital and in physical therapy at TIRR Memorial Hermann.

After years of physical therapy, Haynes learned to run again and enrolled in Lamar University in Beaumont. However, because her PFO remained open, she ran the risk of having a second stroke at any time. During a routine checkup earlier this year, her neurologist mentioned a new PFO closure procedure being performed by Smalling.

In November 2016, the U.S. Food and Drug Administration (FDA) approved the use of a device to close PFOs. Abbott Vascular manufactures the device, called the AMPLATZER PFO Occluder. Since the FDA approval, Smalling has performed dozens of these procedures for patients who are at risk of recurrent stroke. In June, Haynes underwent the procedure at Memorial Hermann Heart and Vascular Institute – Texas Medical Center and put to rest any concerns she had about a recurrent stroke.

“Dr. Smalling and his team are amazing. They treated me like family. And I feel better than I ever have before,” she said after the procedure.

Haynes is now a motivational speaker, sharing her story of overcoming obstacles and keeping a positive outlook on life.

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