DETROIT (April 12, 2023) – Henry Ford Hospital structural heart interventional cardiologists Pedro Villablanca, M.D., and Brian O’Neill, M.D., are the first in the U.S. to successfully implant the new transcatheter tricuspid valve replacement device LuX-Valve Plus™ for the treatment of patients with symptomatic tricuspid valve disease for whom traditional open-heart surgery is too high of a risk.
“These are patients with severe tricuspid regurgitation who have no other options available to them in the U.S., based on the anatomy of their native valve and medical complexities,” said Dr. Villablanca.
Pioneering this novel valve replacement approach, Dr. Villablanca and Dr. O’Neill successfully performed the first U.S. procedure for Norma O’Connor, an 80-year-old Detroit-area woman with severe tricuspid regurgitation, when it became evident that no other means would work. Traditional valve replacement was not medically viable for the patient, who is currently thriving after surgery.
In this minimally invasive procedure, Drs. Villablanca and O’Neill insert a new valve through a catheter via a small incision in the patient’s neck without removing the old, damaged valve. Then, under the guidance of advanced real-time intraprocedural 3D imaging and 4D modeling, the new valve is placed inside the old valve, replacing the function of the diseased valve.
“It is incredible to see the new valve functioning immediately upon positioning in the heart, the right side of the heart’s function started improving withing minutes of successful implant,” said Dee Dee Wang, M.D., Henry Ford Health Structural Heart imaging cardiologist.
The tricuspid valve controls blood flow between the two right-sided chambers of the heart. When the tricuspid valve starts to fail, blood can leak backwards into the top chamber of the heart, causing it to pump harder to move blood through the valve. In severe cases, this condition can cause pressure to rise in the top and bottom right-sided chambers of the heart, causing the chambers to expand and weaken over time, which leads to heart failure.
Tricuspid regurgitation is fairly common in the U.S. Traces of it can be found in about 50-60% of young adults while mild cases can occur in about 15% of adults. About 1.6 million people in the U.S. have moderate or severe cases and some 70 million people have some form of the condition worldwide.
Common symptoms associated with this condition include fatigue, swelling of the legs, abdominal bloating and shortness of breath. People who have been admitted for heart failure may also be candidates for the procedure.
“This is a condition that commonly occurs with aging. As people age, the valve naturally deteriorates,” said Dr. Villablanca. He added that often, in people with pacemakers, the device’s wires implanted across the heart can also pinch the tricuspid valve and cause leaking.
Drs. O’Neill, Villablanca and William O’Neill developed the minimally invasive implant procedure, leading the effort to make the novel valve system available to patients across the country.
“We’re hoping to leverage our experience with very sick patients who are out of options to help lead a clinical trial which can better evaluate the safety and efficacy of this novel valve in all patients,” said Dr. Brian O’Neill. “Patients come to Henry Ford Health’s Center for Structural Heart Disease with complex heart conditions, and we do whatever we can to help them find a solution.”
He added that for patients who have symptoms associated with a leaky tricuspid valve and have been told there’s nothing that can be done, or who want to find an alternative to surgery, they should contact the Henry Ford Structural Heart team to explore options that may be available to them.
Without the requirement of open-heart surgery, this minimally invasive tricuspid valve replacement procedure can be performed with a shorter procedural time, allowing for faster recovery, and the ability for patients to return home in a matter of days.
To learn more about Henry Ford Health’s Center for Structural Heart Disease, visit henryford.com/services/structural-heart.
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MEDIA ONLY MAY CONTACT: Sal Giacona / sgiacon1@hfhs.org / 313-421-9108
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