First Patient in Hampton Roads Receives TricValve Implant in FDA Breakthrough Device Trial for Severe Tricuspid Regurgitation
核心洞察
Karen Bellemare became the first patient in Hampton Roads to receive the TricValve system (搜索) at Sentara Heart Hospital (搜索) as part of a national FDA-designated early feasibility breakthrough device trial.
The innovative procedure places valves in blood vessels leading to the heart rather than replacing the heart valve itself, offering a new treatment option for patients with severe tricuspid regurgitation (搜索).
Bellemare experienced immediate improvement in symptoms including reduced swelling and increased energy levels after suffering from severe fatigue that limited her daily activities.
Karen Bellemare, a Virginia Beach woman diagnosed with severe tricuspid regurgitation (搜索) in late 2024, has become the first patient in Hampton Roads to receive the TricValve system (搜索) at Sentara Heart Hospital (搜索). The procedure is part of an FDA-designated early feasibility breakthrough device trial that offers new hope for patients with advanced heart valve disease who have limited treatment options.
Revolutionary Approach to Tricuspid Valve Disease
The TricValve system (搜索) represents a paradigm shift in treating tricuspid regurgitation (搜索), a condition where the tricuspid valve (搜索) fails to close properly. "Instead of putting valves in the heart to replace the heart valve problem, we put those valves in the big blood vessels that lead back to the heart," explained Dr. Matthew Summers, interventional cardiologist and program director of Sentara's Structural Heart Center.
When the tricuspid valve (搜索) is leaky, "a significant amount-- 50, 60, 70 percent-- of that blood regurgitates, or leaks, backwards through an open door instead of going to the lungs," Dr. Summers said. This backward flow causes swelling in the legs and abdomen, liver and kidney congestion, fatigue and, if untreated, right heart failure (搜索).
Addressing an Unmet Medical Need
Moderate to severe tricuspid regurgitation (搜索) affects approximately 4 percent of people over 75, according to Dr. Summers. "For decades, we've had people with this problem that we didn't have answers for," he noted. Traditional treatment typically involved managing fluid buildup with medications rather than addressing the valve dysfunction directly.
"It's very difficult to just continue to try to decongest them with diuretics, knowing that the problem is still congesting their kidneys and liver," Dr. Summers explained.
Clinical Trial Details and Patient Experience
The trial began at Sentara in July 2025, with only 36 sites nationwide participating in the study. Patients must meet strict study criteria and undergo close monitoring for at least one year, with data collection extending up to five years.
Before receiving the TricValve system (搜索) in October 2025, Bellemare's condition severely impacted her quality of life. "I couldn't do normal things around the house," she said. "I'd, like, throw in a little laundry, and I would have to go down and sleep for, like, two or three hours because I was that exhausted."
Doctors initially attempted a minimally invasive repair using clips, which worked temporarily before her symptoms returned. Open-heart surgery was not considered safe for her case, leaving the TricValve procedure as a promising alternative.
Immediate Clinical Benefits
The improvement following the TricValve procedure was rapid and dramatic. "The swelling was going away, the energy level was coming back up," Bellemare reported. "It was like winning the lottery."
The TricValve system (搜索) provides "the same benefits-- decongestion, not allowing blood to pool in the extremities, the kidney, the liver, the intestines-- and it dramatically reduces symptoms," according to Dr. Summers.
Implications for Patient Care
The availability of this advanced treatment option at Sentara Heart Hospital (搜索) provides patients in Hampton Roads access to specialized care without requiring long-distance travel. The breakthrough device designation from the FDA reflects the significant unmet medical need and the potential for this technology to transform treatment outcomes for patients with severe tricuspid regurgitation (搜索).
Health officials recommend that patients experiencing persistent swelling, unexplained fatigue, or shortness of breath consult with their physicians, as these symptoms may indicate underlying heart valve problems that could benefit from emerging treatment options.