Tampa General Hospital and USF Health First in Florida Second in Nation to Use TricValve Implants

The TricValve® Transcatheter Bicaval Valves System can provide patients who are not eligible for traditional heart surgery a treatment option where none existed before.

Tampa, FL (March 18, 2022) – Tampa General Hospital (TGH) and USF Health Morsani College of Medicine Interventional Cardiologists reached multiple milestones this week in being the first in Florida and second in the nation to use a newly developed heart implant designed to replace the tricuspid valve and offer an option to patients who do not meet the criteria for open heart surgery. The complex population treated by USF Health physicians and Tampa General Hospital also led to one case being the first in the world to implant the TricValve system in a patient with a left ventricular assist device (LVAD).

"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 and director of the Interventional Cardiology Center of Excellence within the TGH Heart & Vascular Institute. 

Tampa General is the second hospital in the country to perform the TricValve procedure and the only one to implant two patients. These procedures were performed on March 15 and 16 by Bezerra and Dr. Fadi Matar, associate professor in the USF Health Morsani College of Medicine and chief of the cardiology department at Tampa General.

“We’re incredibly excited to help these patients, as there is no other option currently available to treat their severe tricuspid regurgitation,’’ Matar said. “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 standard of care procedures over the last decade with aortic and mitral valve therapies, until recently there has been no available transcatheter therapy for the tricuspid valve.

The TricValve Transcatheter Bicaval Valves is a system of two self-expanding biological valves. Specifically, the transcatheter procedure involves going through a patient’s groin and into a main vein to the heart. The two self-expanding valves are deployed at the end of a probe and implanted percutaneously into the inferior and superior vena cava which then replaces the function of the tricuspid valve.

The patients were followed over a period of several months and imaging was analyzed for their potential candidacy to implant the TricValve. Jen Bishop, DNP, APRN lead nurse practitioner for the TGH Interventional Cardiology Center of Excellence commented “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.”

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 Tampa General, the FDA granted a 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 HVI’s ability to innovate and use – before anyone else –disruptive new technologies to benefit patients,” said Dr. Guilherme Oliveira, professor and chief, division of cardiovascular sciences, USF Health Morsani College of Medicine and executive director, TGH Heart & Vascular Institute. “This represents our commitment to become a destination medical center for cardiovascular care and to continue to define medicine.”

Designed and manufactured by P+F Products + Features headquartered in Vienna, Austria, 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.

ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1,041-bed non-profit academic medical center, is one of the largest hospitals in America and delivers world-class care as the region’s only center for Level l trauma and comprehensive burn care. Tampa General Hospital is the highest-ranked hospital in the market in U.S. News & World Report's 2021-22 Best Hospitals, and one of the top 4 hospitals in Florida, with five specialties ranking among the best programs in the United States. The academic medical center’s commitment to growing and developing its team members is recognized by two prestigious 2021 Forbes magazine rankings – America’s Best Employers by State, third out of 100 Florida companies and first among health care and social organizations and 13^th nationally in America’s Best Employers for Women. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal 2020 provided a net community benefit worth more than $182.5 million in the form of health care for underinsured patients, community education and financial support to community health organizations in Tampa Bay. It is one of the nation’s busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center and its 32-bed Neuroscience Intensive Care Unit is the largest on the West Coast of Florida. It also is home to the Jennifer Leigh Muma 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital’s footprint includes 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Health and 19 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track.  As one of the largest hospitals in the country, Tampa General Hospital is first in Florida to partner with GE Healthcare and open a clinical command center that uses artificial intelligence and predictive analytics to improve and better coordinate patient care at a lower cost.  For more information, go to www.tgh.org.

ABOUT USF HEALTH
USF Health's mission is to envision and implement the future of health. It is the partnership of the USF Health Morsani College of Medicine, the College of Nursing, the College of Public Health, the Taneja College of Pharmacy, the School of Physical Therapy and Rehabilitation Sciences, the Biomedical Sciences Graduate and Postdoctoral Programs, and USF Health’s multispecialty physicians’ group. The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News & World Report’s national university rankings than USF. For more information, visit health.usf.edu.