Scripps Clinic Cardiologists First in County to Implant Newly Approved Devices to Repair Leaky Tricuspid Heart Valve

Minimally invasive procedures avoid open heart surgery

A mature couple jogs in a park, representing how Scripps cardiologists achieved a leaky tricuspid heart valve first.

Minimally invasive procedures avoid open heart surgery

In a major 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 technologies were approved by the Food and Drug Administration (FDA) for commercial use in the United States.

This week, Curtiss Stinis, MD, became the first in San Diego County to implant the EVOQUE tricuspid replacement valve since its FDA approval in February. And 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 the treatment of severe tricuspid regurgitation, which occurs when faulty valve leaflets allow blood to flow backward in the heart. Before now, treatment of a leaky tricuspid valve had been limited to medications that do not always control symptoms and open-heart surgery, which is not an option for many patients who are too sick to undergo such a difficult procedure.

”People with severe tricuspid regurgitation have relatively high mortality when treated with medications alone. These new procedures are providing more hope to many of those patients for a better and longer life.”

Curtiss Stinis, MD

And while minimally invasive procedures to repair or replace other valves of the heart have been revolutionizing cardiology for years, the tricuspid valve had remained the final frontier for such innovation largely because of its complex anatomy and challenging location between the right chambers of the heart.

“These minimally invasive procedures are important new treatments 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.

Minimally invasive intravenous approach

In both recent procedures, the cardiologists used catheters to thread their respective devices through incisions in the patients’ 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, which is made by Edwards Lifesciences, inside the faulty valve of his patient, 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, which are made by Abbott, to bring together the faulty leaflets of a 92-year-old female patient’s valve in a procedure that lasted 2.5 hours. His patient went home the following day.

In both cases, the devices immediately increased the efficiency of the heart and began relieving 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 participating in those clinical trials.

In the randomized study of the EVOQUE device, called TRISCEND II, 392 patients were enrolled from sites across the United States and Germany, with half receiving the valve replacement device and half receiving 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.

In the randomized study of the TriClip device, called TRILUMINATE, 450 participants were enrolled from numerous sites in the U.S., Canada and Europe over a four-year period, with half receiving the clip and the other half receiving conventional medical therapy.

Marked improvement in tricuspid regurgitation was achieved in 90% of the patients who received the TriClip, going from severe or higher levels of regurgitation to moderate or less levels at the 30-day mark after the procedure, and that reduction was sustained for at least a year, according to published trial results. At the same time, 98% of patients receiving the device were free of major adverse events 30 days out, and they 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 most advanced centers dedicated to heart care on the West Coast.

Learn more about Scripps Health, a nonprofit integrated health system in San Diego, Calif.

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Keith Darce

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