New Hope on Horizon for Heart Valve Patients

Promising valve replacement procedure now in clinical trial

A cardiologist listens to the heart of a woman patient through a stethoscope - SD Health Magazine

Promising valve replacement procedure now in clinical trial

An 80-year-old man with congestive heart failure was suffering from worsening symptoms.

Medications weren’t helping.

He wasn’t healthy enough to undergo open heart surgery to replace the faulty tricuspid valve that was allowing blood in his heart to flow backward. 

Curtiss Stinis, MD, an interventional cardiologist at Scripps Clinic, says the patient’s prognosis was grim. 

“Open heart surgery for an isolated tricuspid valve is not a great therapy. There’s a high mortality rate, so it’s typically not done,” Dr. Stinis explains. “Medicines don’t fix the valve, though they can help control fluid in the patient’s body. Medicines alone are a Band-Aid at best.” 

New minimally invasive procedure

The patient’s predicament made him a candidate for a new minimally invasive technique that uses catheters to repair or replace faulty heart valves. Dr. Stinis, along with Scripps Clinic cardiologists Matthew Price, MD, and Steven Romero, MD, worked for two hours to thread an investigational device into the patient’s heart through a small incision in his groin. 

The artificial valve — made of cow heart tissue, a metal frame and a fabric skirt — was positioned inside the patient’s faulty tricuspid valve. Anchored in place, it opened like an umbrella and immediately started to work, getting the patient’s blood pumping correctly. 

Called a transcatheter tricuspid valve replacement (TTVR), the July 2022 procedure at Scripps Memorial Hospital La Jolla was the first of its kind in San Diego County. 

The results are encouraging. The patient was well enough to be discharged from the hospital the next day, and follow-up tests show no evidence of further tricuspid regurgitation. 

Global clinical trial

The EVOQUE artificial heart valve could be a game-changer for cardiology patients.

The EVOQUE artificial heart valve could be a game-changer for cardiology patients.

Global clinical trial

The trio of Scripps cardiologists will include their findings in an ongoing international clinical trial. Scripps is the only San Diego health care system participating in the pivotal clinical trial known as TRISCEND II.

Since October, Scripps has screened and enrolled patients in the study, with a goal of 60 patients. The study will ultimately include 800 participants at 51 sites worldwide. Heart patients will either be enrolled in the experimental arm of the study and receive the replacement valve, or in the control group, receiving only drug therapy. 

Enrollment should end in June 2024, with patient outcomes followed over a five-year period. 

If successful, the valve could be considered for commercial clearance by the Food and Drug Administration within a few years. 

“This indicates a trend toward trying to come up with less invasive, less surgical solutions to deal with a problem,” Dr. Stinis says. “Replacing a heart valve 15 years ago without open heart surgery was unheard of. This is where the future is going.”

SD Health Magazine Winter 2023 Cover

This content appeared in San Diego Health, a publication in partnership between Scripps and San Diego Magazine that celebrates the healthy spirit of San Diego.

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