ST. PETERSBURG—When Joshua Rovin, MD, first relocated to Florida's West Coast, surgeons were not yet performing complex endovascular aortic procedures.

 

Rovin, who had developed expertise in valve repair, thoracic aortic surgery, valve sparing aortic root reconstruction, and endovascular thoracic aortic repair during his cardiothoracic surgery residency at the University of Virginia, connected with Eugene Murphy, MD, a general/vascular surgeon with special expertise in vascular surgery. Together, they began performing increasingly complex vascular/aortic procedures.

 

On Oct. 21, the expert team made history at Bayfront Medical Center in St. Petersburg as the first surgeons in the world to use a revolutionary product that promises to enhance outcomes for patients with thoracic aortic aneurysms.

 

In the first FDA clinical device trial in the United States, Rovin and Murphy implanted a stent graft—the Conformable Gore TAG—crafted from a novel material that provides more durability and better conformability. Its ability to conform and wide range of sizes makes the stent graft unique, providing more options for a wide range of people, especially younger patients.

 

On this particular autumn day, two patients in the winter of their lives—one male, the other female—who suffered from thoracic aortic aneurysms were on the operating room table in the James Heart Center to participate in an FDA 30-day trial focused on outcomes with shorter recovery time and lower rates of complications.

 

Bayfront surgeons were chosen as the first team for their academic reputation, clinical outcomes and clinical experience. Bayfront, a 502-bed, not-for-profit teaching hospital in St. Petersburg, was chosen as the site for the trial because of its high-tech endovascular labs and reputation for clinical excellence.

 

"I happened to have two patients in the pipeline—both in their eighties—when the FDA approved the device for this investigational trial," said Rovin. "They had to qualify as candidates for open surgery to participate in the trial."

 

In the minimally invasive endovascular surgical procedure, the doctors deployed the stent graft by entering the patient's femoral artery, located in the thigh, to get to the appropriate location in the aorta.

 

"At the end of 30 days, their grafts looked perfect," reported Rovin. "That was wonderful news, and the research team from GORE have been pleased with the results."

 

Since the landmark procedure, about 20 other hospitals have signed on to participate in the trial.

 

"This signals the wave of the future," said Rovin. "There are so many techniques and procedures that we can do now with wires and catheters that didn't seem feasible even five years ago because technology has advanced."

 

Rovin is a partner with Florida-based Cardiac Surgical Associates (CSA), the largest practice of its kind in the United States providing cardiovascular surgery, thoracic surgery and cardiac transplantation.

 

Murphy, originally from Ireland, works with Suncoast Medical Clinic, South Pinellas County's largest physician alliance.  

 

The century-plus old hospital is one of 29 sites in North America, and the only one in Florida, to have approved use of the Conformable Gore TAG for aneurysmal disease.