In a significant advance in treating structural heart disease, Scripps Clinic interventional cardiologists recently performed separate minimally invasive procedures to implant two different devices that repair leaky tricuspid heart valves for the first time since the Food and Drug Administration (FDA) approved the technologies for commercial use in the United States.
Last week, Curtiss Stinis, MD, became the first in San Diego County to implant the EVOQUE tricuspid replacement valve since its FDA approval in February. On May 1, Matthew Price, MD, became the first cardiologist in the county to repair a patient’s faulty tricuspid valve with the new TriClip, which received a green light from regulators in early April.
Both procedures marked a milestone in treating severe tricuspid regurgitation, which occurs when faulty valve leaflets allow blood to flow backward in the heart. Before now, treatment options for a leaky tricuspid valve included medications, which do not always control symptoms, and open-heart surgery, which many patients are too sick to undergo.
While minimally invasive procedures to repair or replace other heart valves have revolutionized cardiology for years, the tricuspid valve has remained the final frontier for such innovation primarily because of its complex anatomy and challenging location between the heart’s right chambers.
“These minimally invasive procedures are important new treatment options, and we are fortunate to be able to offer them to our patients in the San Diego area,” Dr. Price said.
“Unfortunately, people with severe tricuspid regurgitation have relatively high mortality when treated with medications alone,” Dr. Stinis said. “These new procedures are providing more hope to many of those patients for a better and longer life.”
While about 1.6 million people in the United States are affected by tricuspid regurgitation, women are four times more likely to have the condition than men, according to published research. The condition is often debilitating, causing shortness of breath, fatigue, and fluid buildup in the abdomen and legs. If left untreated, it can lead to an irregular heartbeat, heart failure, or even death.
In both recent procedures, the cardiologists used catheters to thread their respective devices through incisions in the patient’s groins, up the femoral vein, and into the heart as it continued to beat normally. The procedures were performed in cardiac catheterization laboratories in the John R. Anderson V Medical Pavilion on the campus of Scripps Memorial Hospital La Jolla.
Dr. Stinis positioned the EVOQUE replacement valve, made by Edwards Lifesciences, inside his patient’s faulty valve, opened it like an umbrella, and anchored it in place. His patient, an 88-year-old female from La Mesa, went home the following day.
In the other procedure, Dr. Price used two clips made by Abbott to connect the faulty leaflets of a 92-year-old female patient’s valve. The procedure lasted 2.5 hours, and his patient went home the following day.
In both cases, the devices immediately increased the heart’s efficiency and relieved some of the symptoms of tricuspid regurgitation.
Both cardiologists had previously served as lead local investigators in clinical trials sponsored by the device makers that validated the new treatments and paved the way for the recent FDA approvals. Scripps La Jolla was the only hospital in San Diego County that participated in those clinical trials.
The EVOQUE device TRISCEND II randomized study enrolled 392 patients from sites across the United States and Germany. Half of the patients received the valve replacement device, while the other half received optimal medical therapy.
According to published and presented results from that trial, patients receiving the EVOQUE replacement valve experienced significant reduction or elimination of tricuspid regurgitation, significant and sustained quality of life improvement, improvement in the function of the right side of the heart, and a trend towards improved mortality while demonstrating a favorable balance between risk and benefit.
The TRILUMINATE randomized study of the TriClip device enrolled 450 participants from numerous sites in the U.S., Canada, and Europe over four years. Half of the participants received the clip, while the other half received conventional medical therapy.
According to published trial results, 90% of the patients who received the TriClip experienced marked improvement in tricuspid regurgitation, going from severe or higher levels to moderate or lower at the 30-day mark after the procedure. The reduction persisted for at least a year. At the same time, 98% of patients who received the device remained free of major adverse events 30 days later and experienced a significant improvement in quality of life.
Both devices previously had been approved for commercial use in the European market.
Scripps Health treats more than 212,000 cardiovascular patients every year. Its Prebys Cardiovascular Institute brings together leading researchers, physicians, staff, and technologies in one of the West Coast’s most advanced centers dedicated to heart care.