Tampa General Hospital Is the First and Only in the Southeast to Complete Transcatheter Mitral Valve Replacement (TMVR) with AltaValve Technology

Tampa General is one of just five health care institutions in the nation to offer AltaValve as an alternative to open-heart surgery.

TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter. The patient suffered from severe mitral regurgitation (MR), a common heart disease that generally requires open heart surgery. The patient underwent the minimally invasive procedure in December at Tampa General's main campus on Davis Islands in downtown Tampa and was safely discharged after just two days.

"At Tampa General, we're pioneering new technologies that can save lives, especially for the patients with the highest risk," said John Couris, president and CEO of Tampa General Hospital. "The transcatheter mitral valve replacement was made possible by a multidisciplinary team of best-in-class professionals who don't just meet standards of care; they establish them. With new technologies, groundbreaking innovations and unparalleled talent, the team at Tampa General is working to transform health care."

Tampa General Hospital is one of just five health care systems across the nation approved by the Food and Drug Administration (FDA) to participate in a feasibility study using the AltaValve technology for TMVR. As an academic health system, Tampa General and USF Health combine clinical care, academics and research to deliver the best possible patient outcomes. This robust research enterprise enables providers to use cutting-edge technologies, resources and therapies to address some of the most complex health conditions.

"The successful outcome of this innovative procedure is a great example of the way patients benefit from the expertise of faculty physicians in academic health systems," said Dr. Charles J. Lockwood, MHCM, executive vice president of USF Health and dean of the USF Health Morsani College of Medicine. "Academic health systems are able to provide multidisciplinary, life-saving and cutting-edge care in the most complex cases – often with procedures and techniques that patients simply can't get elsewhere. It's because we can provide this level of care that patients have better outcomes and are more likely to survive when they receive treatment at an academic medical center."

Lockwood also is executive vice president and chief academic officer at Tampa General.

The multidisciplinary team that contributed to the success of the procedure is comprised of interventional cardiology, cardiothoracic surgery, cardiac imaging and heart failure specialists. This multidisciplinary team allows for an unbiased approach, with the consideration of all options for each patient, ranging from conventional open chest surgery, minimally invasive surgery and transcatheter therapies.

"It's exciting to have a new, alternative, minimally invasive procedure to treat mitral valve disease with such exceptional results and fast recovery. Patients across the Southeast can turn to Tampa General for solutions to complex and high-risk cases," said Dr. Hiram Bezerra, director of the Interventional Cardiology Center of Excellence at TGH and professor in the Division of Cardiovascular Sciences at the USF Health Morsani College of Medicine. "This patient is well on the road to recovery thanks to a talented team of doctors, surgeons, nurses and researchers who are pioneers of the health care industry."

The success of the procedure is the first step toward full FDA approval of the AltaValve device, according to Dr. Lucian Lozonschi, who serves as co-director of the Minimally Invasive Valve Program at TGH with Bezerra.

"Unlike transcatheter aortic valve replacement (TAVR), which is now the standard of care and has mainly displaced conventional open-chest surgery, the TMVR field remains challenging, as evidenced by the absence of an FDA-approved TMVR valve despite years of dedicated research," said Lozonschi, director of Cardiothoracic Surgery Center of Excellence at TGH and a professor in the Department of Surgery in the USF Health Morsani College of Medicine. "AltaValve is a new player in this field, extending hope to those with heavily diseased mitral valves and at high risk for the conventional surgical approach."

The AltaValve is a prosthetic valve created by a 3D printer that is implanted in the left atrium during a minimally invasive procedure. Its unique design is customized to the patient's physical measurements and ensures critical cardiac structures are retained within the left ventricle. It is a self-expanding device that is fully functional seconds after deployment, ensuring the patient's hemodynamic stability.

"For patients who have exhausted medical therapy and found traditional transcatheter or surgical options inadequate, the AltaValve offers a new ray of hope," said Dr. Konstantinos Marmagkiolis, a member of the TGH Interventional Cardiology Center who served as co-principal investigator of the AltaValve study.

In preliminary clinical trials of the AltaValve, patients experienced significant improvement in heart function and a reduction in symptoms of mitral valve regurgitation.

ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1,040-bed, not-for-profit, academic health system, 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 and World Report's 2023-24 Best Hospitals, with six specialties ranking among the top 50 best hospital programs in the United States. Tampa General Hospital has been designated as a model of excellence by the 2022 Fortune/Merative 100 Top Hospitals list. The academic health system's commitment to growing and developing its team members is recognized by two prestigious Forbes magazine rankings – in the top 100 nationally in the 2023 America's Best Employers for Women and top 25 in Florida in the 2023 America's Best Employers by State. Tampa General is the safety net hospital for the region, caring for everyone regardless of their ability to pay, and in fiscal year 2021, provided a net community benefit worth more than $224.5 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 six 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 neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes TGH North which is comprised of three hospitals and several outpatient locations in Citrus and Hernando counties, 17 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Outpatient Center, TGH Virtual Health, and 21 TGH Imaging outpatient radiology centers throughout Hillsborough, Pasco, Pinellas and Palm Beach counties. Tampa Bay area residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics. To see a medical care professional live anytime, anywhere on a smartphone, tablet or computer, visit Virtual Health | Tampa General Hospital (tgh.org). As one of the largest hospitals in the country, Tampa General Hospital is the first in Florida to partner with GE Healthcare and open a clinical command center that provides real-time situational awareness 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, a high-impact research university dedicated to student success and committed to community engagement, generates an annual economic impact of more than $6 billion. Through hundreds of millions of dollars in research activity each year, USF is a leader in solving global problems and improving lives. For more information, visit health.usf.edu.

Media Contact: Amanda Bevis
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