TGH and USF Health first in Florida to use newly developed heart implant

Tampa General Hospital (TGH) and USF Health became the first facilities in Florida and the second in the nation to successfully use a newly developed heart implant last week.

The new implant is designed to replace the tricuspid valve, offering an option to patients who do not meet the criteria for open heart surgery. The procedure, performed by TGH and USF Morsani College of Medicine interventional cardiologists, used TricValve Transcatheter Bicaval Valves — a system of two self-expanding biological valves.

“The TricValve system represents a new transcatheter technology that could offer patients with symptomatic severe tricuspid regurgitation (TR) and heart failure an option for symptom relief and improved function. It is about a one-hour procedure with fast patient recovery and does not involve fully opening the chest cavity,” said Dr. Hiram Grando Bezerra, professor and section chief of interventional cardiology in the USF Health Morsani College of Medicine.

The procedure involves going through a patient’s groin and into a main vein to the heart. TGH is the second hospital in the country to perform the TricValve procedure and the only one to implant two patients. Bezerra and Dr. Fadi Matar, associate professor at the USF Health Morsani College of Medicine and chief of the cardiology department at TGH, performed the procedures on March 15 and 16.

“We’re incredibly excited to help these patients, as there is no other option currently available to treat their severe tricuspid regurgitation,’’ Matar said in a statement. “I think this new device has the potential to improve the quality of life for people with this seriously debilitating condition.”

Although transcatheter therapies have become the main procedures over the last decade to treat aortic and mitral valve disease, until recently there has been no available transcatheter therapy for the tricuspid valve.

Before the procedure, the patients were followed over a period of several months and imaging was analyzed for their potential candidacy to implant the TricValve.

“We have been able to get to know these patients and their families through this journey and our team is honored to be able to offer them this breakthrough technology. We will continue to follow them throughout their recovery, and it will be exciting to see how the valves will impact their lives and hopefully get them back to doing the things they love,” said Jen Bishop, lead nurse practitioner for the TGH Interventional Cardiology Center of Excellence.

TricValve is designated as a breakthrough device by the U.S. Food and Drug Administration (FDA). The FDA’s Breakthrough Devices Program gives patients and health care providers timely access to new medical devices. For the procedures performed at TGH, the FDA granted compassionate-use approval to the academic medical center.

“These milestones, especially the first in human application of the TricValve in a patient with a left ventricular assist device, is symbolic of the (Heart & Vascular Institute)’s ability to innovate and use — before anyone else — disruptive new technologies to benefit patients,” said Dr. Guilherme Oliveira, executive director of TGH Heart & Vascular Institute.

“This represents our commitment to become a destination medical center for cardiovascular care and to continue to define medicine.”

The TricValve is being studied in clinical trials in the U.S and Europe. Patients are not yet being enrolled in the U.S. trial, which is expected to begin in the near future.