John P. Vavalle, MD, MHS, FACC, and Matthew A. Cavender, MD, MPH, FACC, interventional cardiologists and their collaborative team in the Structural Heart Disease Program at UNC, have performed their first transcatheter tricuspid valve replacement in the clinical setting, a revolutionary treatment for patients living with a common type of heart valve disease.
CHAPEL HILL, N.C. For the first time in the state of North Carolina,thestructural heart teamatUNC Hospitalshasperformedatranscatheter tricuspid valve replacementin the clinical setting.Theimplant, whichwas only the 12th in the UnitedStates,is arevolutionarytreatmentfor patientslivingwithtricuspid valve regurgitation (TR), acommontype of heartvalve disease.
We now have apercutaneous,minimally invasive way to fix tricuspid valve regurgitation and offer valve replacement withoutthe need foropen heart surgery, saidJohn Vavalle, MD, MHS, FACC, medical director of theStructural Heart Disease Program at UNC Hospitals and associate professor of medicine at the UNC School of Medicine. Its only at a place like UNC, where there is this spirit of collaboration and this desire to push the technology forward, that you can do this kind of work.
About 5 in 1,000 people in the United States have severe tricuspid valve regurgitation.The condition occurs when thetricuspid valve,the valve that separates the right atrium and the right ventricleof the heart, does not close properly. As a result, blood cannot be ejected to the lungs to be oxygenated and instead flows back into the body.
Without treatment,the condition can become life threatening.It can cause fluid buildup in the abdomen and legs and weakening of theheart muscle, resulting infatigue, low energy, breathlessness, andevenkidney failure.Medicines like diuretics can help improve swelling from the fluid buildup, but fixing a leaky valve previously required open heart surgery.
Many of these patients are too sickto have major open-heart surgery, including our very first patient, said Vavalle. This procedure is much more minimally invasive.Its done through catheters and over wires inserted through the blood vessels in the groin,allowingus to implantanewtricuspidvalve in place of the old one.
The EVOQUE tricuspid valve replacement system, created by the Edwards Lifesciences Corporation, is the first transcatheter therapy to receive U.S. Food and Drug Administration (FDA) approval for the treatment of tricuspid regurgitation.
The EVOQUE system is indicated for the improvement of health status in patients with symptomatic severe TRdespite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.
TheUNC Heart Valve Clinic, which is an American College of Cardiology certified Transcatheter ValveCenter of Excellence, was one of20centers in the United Statesselected for implanting thevalvebecause of UNCshigh level of expertise.It is the only center in the state of North Carolina currently performing this procedure.
The same team, led by Vavalle and Thomas Caranasos, MD, as co-principal investigatorsparticipated intheTRISCEND II clinical trialthat determined the safety and effectiveness of the EVOQUE valve,eventually leadingto FDA approval.
The surgery requires a diverse team of cardiologists, cardiac surgeons, cardiac anesthesiologists, and advanced imagers. John Vavalle worked with fellow interventional cardiologistMatthew Cavender, MD, MPH, chief of cardiac surgeryJohnIkonomidis, MD, PhD, anesthesiologistEmily Teeter, MD, FASE, and imaging specialistThelsa Thomas Weickert, MD, on the case.
Media contact:Kendall Daniels, Communications Specialist, UNC Health | UNC School of Medicine
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