Scripps MD First in County to Fix Leaky Aortic Valve With New Device

Minimally invasive procedures have revolutionized the treatment of heart valve diseases over the last decade, extending the lives of patients and greatly improving their quality of life. But one group has been left out of this great medical leap forward —those with a certain type of leaky aortic valve who are too sick to undergo open-heart surgery. 

Now, those patients have a new life-saving option following the recent approval of the first transcatheter aortic valve replacement (TAVR) implant to treat severe aortic regurgitation (AR) by the Food and Drug Administration (FDA). 

Scripps Clinic cardiologists and 22 of their patients participated in the pivotal clinical trial that validated the Trilogy device made by JenaValve based in Irvine. 

And on April 21, Scripps Clinic interventional cardiologist Curtiss Stinis, MD, became the first doctor in San Diego County to implant the valve in a patient following its clearance for commercial use in the United States. 

During a one-hour catheterization laboratory procedure at the Scripps Clinic John R. Anderson V Medical Pavilion on the Scripps Memorial Hospital La Jolla campus, Dr. Stinis used a catheter to thread the replacement valve through a small incision in the patient’s groin, up the femoral artery and into the heart as it continued to beat normally, where the new valve was opened and anchored in place. The patient went home the following morning. 

“The Trilogy valve has the potential to change the lives of patients who haven’t had any other options for reversing this life-threatening disease,” said Stinis, who served as the lead investigator at Scripps. “Through the clinical trial and now with the first procedures following FDA approval, Scripps continues its longstanding commitment to providing our patients with the latest innovations available in medicine.” 

 AR is the third most common heart valve disease, according to a study published in 2022 by the peer-reviewed medical journal Open Heart, and its prevalence has increased as the U.S. population has become older. 

AR occurs when the valve between the lower left heart chamber and the body’s main artery doesn’t close tightly, causing some of the blood to leak backwards into the left ventricle. By making the heart work harder, aortic regurgitation can cause a range of symptoms such as shortness of breath, fatigue, chest pain, lightheadedness, swelling in the ankles and feet, and an irregular heartbeat. Eventually, the problem can lead to heart failure and even death.

Previous TAVR devices have been designed to treat valves that are narrowed due to calcium buildup (a condition known as aortic stenosis) and rely upon those calcium deposits to anchor and remain in place. Use of these TAVR valves for patients with AR isn’t a good option since the lack of calcium deposits can lead to the valve migrating or leaking.  

The Trilogy device, which is covered by Medicare and most private insurance plans, is the first approved TAVR implant that anchors to heart valve tissue even when no calcium is present. 

“This advance is a game changer for this subgroup of patients whose more severe disease has significantly impacted their quality of life and in many cases threatens their survival,” Dr. Stinis said. 

For John Rufo of Escondido, the Trilogy valve has proven to be a life saver. 

The 65-year-old engineer/business developer was diagnosed with AR in late 2023 after undergoing a routine echocardiogram. Before long, symptoms began to worsen and his overworked heart started growing, a sign of heart failure. “It became a struggle just to walk up the stairs to my bedroom,” he said. 

A device that had been implanted 12 years earlier during open-heart surgery for an unrelated heart problem made another surgery to replace the valve too risky.

Instead, Dr. Stinis enrolled Rufo in the Trilogy clinical trial and implanted the device in his heart in May of 2024 during an out-patient procedure. Rufo immediately felt better, and his heart soon returned to its normal size. 

“Without a doubt, the TAVR device saved my life,” he said. 

His experience reflects the broader positive results of the study, which were published in the medical journal The Lancet in November. While almost all 700 participants came into the trial with moderate-to-severe AR, only three ended up with any significant residual valve leakage following their procedures. Stroke rates and mortality also were significantly lower in study participants after one month of treatment than would have been expected had they undergone open-heart surgery. 

Additionally, researchers found that the minimally invasive procedure resulted in “large and durable” improvements in patient function and quality of life for up to two years following treatment. 

With nearly 200 affiliated cardiovascular physicians and a network of clinics and hospitals throughout San Diego County, Scripps Health offers a comprehensive range of heart screening tests, diagnostic exams and treatment options. For the last 20 years, the cardiovascular program has been ranked as one of the best in the nation by U.S. News & World Report. All four Scripps hospital emergency departments are certified by the American Heart Association for receiving STEMI patients experiencing life-threatening heart attacks. Scripps cardiologists are involved in clinical research that brings the latest technologies and treatments to their patients. The Cardiovascular Disease Fellowship Program at Scripps Clinic provides training to the next generation of leading heart doctors. And the Prebys Cardiovascular Institute on the Scripps La Jolla campus provides advanced heart care services in a patient-centered environment. 

For more information about aortic regurgitation and other heart valve diseases, visit the Scripps Health structural heart disease webpage. 

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