A Scripps Clinic interventional cardiologist this week became the first in California to repair a tricuspid heart valve using a tiny experimental clip that is placed inside the heart using a minimally invasive procedure rather than open heart surgery.
Matthew Price, MD, used a catheter to implant three TriClips in an 82-year-old San Diego man who has suffered from heart failure for several years as a result of the leaky valve that separates the two chambers on the right side of his heart.
The three-hour procedure was performed in the cardiac catheterization laboratory in the John R. Anderson V Medical Pavilion located on campus of Scripps Memorial Hospital La Jolla.
Scripps La Jolla is the only hospital in the San Diego region participating in the pivotal TRILUMINATE Trial, an international clinical study evaluating the safety and efficacy of the TriClip for treating tricuspid valve regurgitation. The prospective randomized trial, which is sponsored by the device’s maker, Abbott, will enroll up to 700 subjects over three years, with half receiving the clip and the other half receiving conventional medical therapy.
“The TriClip procedure represents the final frontier in transcatheter heart valve procedures,” said Dr. Price. “Until now, it has been very challenging to successfully treat a leaky tricuspid valve. This minimally-invasive procedure and innovative device have the potential to improve symptoms and quality of life without the risks and complications of more invasive approaches.”
Tricuspid regurgitation occurs when the three leaflets of the heart valve that regulate the flow of blood between the right atrium and right ventricle no longer seal tightly, allowing blood to flow backward in the heart. Symptoms include fatigue, shortness of breath, swelling in the abdomen or legs due to fluid buildup, and a decrease in physical endurance. More severe cases can lead to heart failure and death if left untreated.
On Wednesday, a team of physicians, nurses and technicians led by Dr. Price used a specially designed catheter device to thread the clip through a small incision in the patient’s leg and into an artery leading to his heart. The clips were positioned, while the heart was still beating, inside the right ventricle and deployed in a way that brought together the leaflets of the valve at the site of major leakage.
The patient was able to leave the hospital the following day.
While heart surgery to repair or replace the tricuspid valve is an option, most patients are too sick or frail to undergo the difficult operation, and mortality following more intensive surgery is high at around 10 percent. Medications are available to treat some of the symptoms of tricuspid regurgitation, but those drugs do nothing to correct the leaking valve.
Currently, there are no non-surgical, minimally invasive treatments approved by the Food and Drug Administration for treating severe tricuspid regurgitation, which affects about one in 30 people over the age of 65 in the United States.
In an earlier feasibility study of the TriClip, a large majority of patients who received the device saw significant reduction of tricuspid regurgitation and experienced improvements in their heart failure symptoms and quality of life.
The TriClip is essentially a modified version of the MitraClip, an FDA-approved device also made by Abbott that is used to repair a leaking mitral valve that divides the chambers on the left side of the heart.
Dr. Price has treated nearly 300 patients with the MitraClip since 2013 when that device became available on the U.S. market, more than any other physician in the San Diego area. Before FDA approval, Dr. Price participated in several clinical trials that validated the MitraClip’s safety and efficacy.
Participation in the TRILUMINATE trial is the latest example of Scripps’ leadership and innovation in cardiovascular care.
Ranked No. 1 for heart care in San Diego County by U.S. News and World Report, Scripps Health treats more than 100,000 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.
For more information about the TRILUMINATE clinical trial, call (858) 824-5269.