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High-risk cardiac study shows promise at HCA Largo Florida Hospital

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LARGO, Fla. — A clinical trial currently underway at HCA Florida Largo Hospital is helping people suffering from tricuspid regurgitation, a heart valve disease.

What You Need To Know

  • HCA Healthcare Research Institute has been chosen to participate in the TRICAV-I clinical study, aimed at enhancing outcomes for patients suffering from severe tricuspid regurgitation

  • Tricuspid valve regurgitation is a heart valve disease, where the valve between the two right heart chambers doesn’t close as it should, according to the Mayo Clinic. It says blood flows backward through the valve into the upper right chamber, creating less blood flow to the lungs. The heart has to work harder then to pump blood

  • Jim Byers was living with swelling in his belly and legs, and had shortness of breath. After the procedure, he felt normal once again


It affects more than 1.6 million people, according to the National Health Institute. 

One of the first patients to participate in the trial was Jim Byers. 

“Back then, well, one of my doctors at the VA said that I’d be dead within six months to a year,” said Byers, describing life before the procedure. 

Just months ago he had fluid in his stomach and legs, and had shortness of breath. It was all a result of tricuspid regurgitation. 

“You worked a miracle,” Byers said to Dr. Saurabh Sanon. 

Sanon is the lead structural cardiologist at HCA Florida Largo Hospital and the regional director for structural heart therapies for the West Florida Division. 

“Mr. Byers’ case is not your run-of-the-mill case. This is actually as complex as it gets,” said Sanon. 

A scan of Byers’ chest showed a lot of past procedures. 

“I have almost died so many times. I quit counting,” said Byers. The Army vet said he has had 13 strokes and heart attacks. 

Because of his history and current health, this meant Byers was out of options. 

“He was not a candidate for open-heart surgery, was not a candidate for commercially available transcatheter tricuspid therapies. And this (new study) seemed to be the best option for him,” said Sanon. 

Sanon had Byers enrolled in the TRICAV-I Clinical Study.

“The TRIC valve consists of two separate valves. There’s one valve that is implanted in the SVC and a second valve that’s implanted in the IVC,” Sanon said.

The TRICAV-I study trial evaluates the TricValve Transcatheter Bicaval Valve System, a bicaval transcatheter tricuspid valve replacement technology. 

For Byers, the minimally invasive surgery changed everything.

“It’s pure quality of life. That’s what he gave me. Pure quality of life,” said Byers. 

The TRICAV-I study is in its early stages. 

HCA Florida Largo Hospital said the trial will follow patients for up to five years to collect long-term safety and efficacy data to advance the future of cardiac intervention. 

Patients should speak to their doctors if they think they would make a good candidate. 

Doctors can email researchinstitute@hcahealthcare.com

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Erin Murray

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