Clinical Trial Helps Restore a Healthy Heart for NorCal Resident

At age 85, former flight attendant Rosemarie Widdicombe has seen the advent of technologies from online travel scheduling to virtual reality-aided flying.

This spring, thanks to a clinical trial offered at Sutter Health testing a new heart device technology, her birthday was especially significant. The Sacramento-area resident celebrated a healthy life free from a heart condition caused by a leaky heart valve.

Widdicombe sought medical advice in March 2021 when swelling and occasional bleeding in her legs became severe. An echocardiogram performed by her cardiologist revealed a diagnosis of severe tricuspid valve regurgitation — a leaky tricuspid valve.

The tricuspid valve is one of the heart’s four valves, each whose opening and closing is critical to the normal functioning of one’s heart.

Research, Innovation Usher in New Treatment

When the swelling in her legs became acute and resulted in admittance to the intensive care unit at Sutter Medical Center, Sacramento, Widdicombe was referred to Pei-Hsiu Huang, M.D., a Sutter interventional cardiologist. Reviewing her case and the available options to treat tricuspid regurgitation, Dr. Huang told Widdicombe about a clinical trial being offered at Sutter for certain individuals with severe tricuspid valve regurgitation.

“I willingly joined the clinical trial because today’s science becomes tomorrow’s new and better medicines,” says Widdicombe, hails from Lincoln, a town north of Sacramento. “I thought to myself, ‘If there’s a novel approach that’s showing promise in significantly helping people with tricuspid regurgitation return to full health, I’m keen to participate in the research.’”

Called TRILUMINATE Pivotal Trial, the study is the first randomized controlled trial to evaluate the safety and effectiveness of the TriClip™ transcatheter edge-to-edge repair system, also called TEER. It’s a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation that is manufactured by Abbott and approved in April by the U.S. Food and Drug Administration.

Results of the TRILUMINATE Pivotal Trial were published last year in The New England Journal of Medicine by TRILUMINATE investigators including Dr. Huang and other interventional cardiologists who helped conduct the study at Sutter, including Christian Spies, M.D. and Chad Rammohan, M.D. Sutter Health was one of only a limited number of hospital systems in California offering patients enrollment to the study.

Closing Gap on Serious Heart Condition

Tricuspid valve regurgitation is a type of heart valve disease that occurs when the valve’s flaps improperly close. The tricuspid valve controls the flow of blood from the heart’s right atrium – the top chamber — to the right ventricle, or the bottom chamber.

More than 1.6 million people in the U.S. are affected by tricuspid regurgitation, which can severely impact quality of life. When left untreated, the condition can lead to atrial fibrillation, heart failure and even death.

“The tricuspid valve has been referred to as the ‘forgotten valve.’ But with a better understanding of the disease process, severe tricuspid valve regurgitation is now recognized as a potential cause of congestive heart failure,” says Dr. Huang. “Abbott’s TriClip System offers patients a safe, minimally invasive treatment alternative to surgery for severe tricuspid valve regurgitation, which is frequently a higher risk procedure than surgery performed on other heart valves.”

Delivered through a vein in the leg, the TriClip system works by clipping together a portion of the leaflets — or flaps of tissue — to repair the tricuspid valve and help blood flow in the proper direction without the need for open-heart surgery. Most individuals who receive the TriClip system spend one night in the hospital and can return home the following day.

“Through research and clinical trials at Sutter Health, we are proud to offer patients with damaged or diseased heart valves access to novel treatments like TriClip system through the TRILUMINATE Pivotal Trial. And we thank individuals like Rosemarie who proudly contribute to studies that advance the science underlying new and improved technologies and treatments,” says Dr. Huang.

Durable Fix for ‘Leaky’ Heart Valve

Widdicombe received the TriClip therapy in November 2021. After a three-hour minimally invasive procedure and one night in the hospital at Sutter Medical Center to recover, she went home without complications and rested in anticipation of a Thanksgiving dinner with her family the next day.

“When I left the hospital, I felt like a different person,” says Widdicombe. “My daughter thought I wouldn’t make it to the end of the year. And now I’m restored to the health and vitality that frees me to enjoy time with my grandchildren, regular swims and visits to see extended family in Germany. The doctors and researchers at Sutter saved my life and I’m so grateful for the compassionate, expert care I received."