Scripps Clinic cardiologists recently became the first in San Diego County to replace a tricuspid heart valve in a patient using a minimally invasive procedure that threads the device into the heart through a small incision in the groin.
The heart team led by interventional cardiologist Curtiss Stinis, MD, along with Matthew Price, MD, and Steven Romero, MD, performed the 2-hour procedure, known as a transcatheter tricuspid valve replacement or TTVR, July 7 at Scripps Memorial Hospital La Jolla on an 80-year-old man who suffered from worsening symptoms of congestive heart failure and fluid retention. This was due to a faulty tricuspid valve that allowed blood to flow backward within his heart.
Scripps is the only healthcare system in San Diego participating in the ongoing international clinical trial testing the investigational device.
"This procedure, if validated through this study, could offer new hope to these patients for a better and longer life.”Curtiss Stinis, MD, Scripps Clinic cardiologist
Medications were no longer controlling the patient’s symptoms, and he wasn’t healthy enough to undergo a more conventional and invasive open-heart surgery to replace the valve.
“Patients with isolated severe tricuspid regurgitation unfortunately have a relatively high mortality when treated with medications alone,” Dr. Stinis said. “Open heart surgery for these patients is high risk and has typically been associated with poor outcomes, and thus is typically avoided. This procedure, if validated through this study, could offer new hope to these patients for a better and longer life.”
The study is the latest effort to repair or replace faulty parts of the heart with catheter-based procedures that are far less invasive than surgery and have much shorter recovery times. Scripps has participated in many of the pivotal clinical trials that validated earlier procedures involving the other three valves of the heart, including transcatheter aortic valve replacement or TAVR. The tricuspid valve is one of the final frontiers in this medical technology revolution largely because of its challenging anatomy.
For the procedure, Dr. Stinis inserted a catheter topped with the EVOQUE replacement valve made by Edwards Lifesciences through a small incision in the patient’s groin and threaded the device through a vein up to the heart, where it was positioned inside the faulty tricuspid valve, opened like an umbrella and anchored in place. The artificial valve, which is made of cow heart tissue, a metal frame and a fabric skirt, started working immediately.
The patient was discharged from the hospital the morning after the procedure, and follow-up testing showed no further evidence of tricuspid regurgitation. Dr. Stinis said he expects the patient’s symptoms to quickly improve over the coming weeks, resulting in a significant improvement in the overall quality of his life.
The pivotal clinical trial, known as TRISCEND II, is a prospective, multi-center, randomized controlled study evaluating the safety and effectiveness of the EVOQUE system. Investigators at 51 study locations will recruit more than 800 participants, enrolling them in either the experimental arm to receive the replacement valve or the control arm for drug therapy. Patients are being followed for five years, and enrollment is expected to end in June 2024.
Positive results could lead to clearance by the Food and Drug Administration for commercial availability in the United States.
Scripps is one of four study sites in California, along with Cedars-Sinai Medical Center in Los Angeles, Stanford University and Kaiser Permanente San Francisco.
Dr. Stinis hopes to enroll up to 60 Scripps patients in the study. Those wishing to explore eligibility can call Misty Daniel at 858-824-5249.
Learn more about Scripps Health, an integrated health care system in San Diego, Calif.