When Karine Gasparyan, a 72 year-old Novato, Calif. resident began experiencing COPD-like symptoms, she never imagined an echocardiogram would show severe mitral valve stenosis and regurgitation.

Symptoms including shortness of breath that began in 2022 prompted her to seek diagnosis, revealing the potentially life-threatening heart valve condition where narrowing of the mitral valve, one of the heart’s four chambers, causes blood to flow backward, restricting blood flow to the heart’s main pumping chamber.

As a nurse spending many hours daily on her feet, Gasparyan was struggling to get through the workday without deep fatigue. “Just catching my breath became challenging, never mind feeling enough energy in my free time to walk or garden like I used to,” says Gasparyan.

Surgical Expertise Preps for Clinical Trial Success  

Not wanting the open-heart surgery that was recommended to her, Gasparyan looked further for specialized care. Referred to Dr. David Daniels, an interventional cardiologist practicing in San Francisco with Sutter Health West Bay Medical Group, Gasparyan felt new hope learning of a clinical trial called ENCIRCLE testing a novel, investigational device for patients with symptomatic, severe mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge repair therapy.

The only catch? Gasparyan would first need to undergo a minimally invasive procedure to widen one of the walls of her heart so it could more readily “accept” Edwards Lifesciences SAPIEN M3 device.

Dr. Daniels performed a SESAME (Septal Scoring Along the Midline Endocardium) procedure, carefully placing catheters into Gasparyan’s heart plus a guidewire to safely “split” her heart muscle, precisely making space and clearing the obstruction in her heart.

Now able to receive the SAPIEN M3 device – a minimally-invasive, catheter-based replacement valve – Gasparyan was “a perfect candidate” for ENCIRCLE.

Dr. David Daniels

“The mitral valve is like a one-way door between the left atrium and left ventricle of the heart. When it’s healthy, it opens to let blood flow forward and then closes tightly so blood doesn’t leak backward. In mitral regurgitation, that door doesn’t close properly – blood leaks backward into the left atrium each time the heart squeezes,” says Dr. Daniels. “The  traditional fix is open-heart surgery to repair or replace the valve, but many people are too high-risk for surgery. SAPIEN M3 replaces the faulty mitral valve without opening the chest or stopping the heart.”

On Sept. 25, Dr. Daniels successfully placed the device in Gasparyan’s heart through a sequence of precisely orchestrated steps: inserting a thin tube into one of the veins of her leg, guiding it to the left side of her heart through a tiny puncture in the heart’s wall, placing a flexible metal rink (the “dock”) to support and hold the new valve, and placing the new valve inside the dock to act as a tight, one-way door. The result? Blood began flowing in Gasparyan’s heart forward only, not backward, reducing strain on her heart and significantly reducing her breathlessness and fatigue.

Game-Changing Trial Takes the Stage

On Oct. 27, Dr. Daniels presented one-year results of the ENCIRCLE trial at the annual Transcatheter Cardiovascular Therapeutics Conference in San Francisco, Calif.

The trial tested the Edwards Lifesciences SAPIEN M3 system, a minimally invasive device designed for patients with severe mitral regurgitation who are not candidates for open-heart surgery or other catheter-based treatments. Nearly 300 patients worldwide participated, receiving the investigational mitral valve replacement system. At one year, the device was shown to safely reduce valve leakage, improve heart function and help patients return to daily activities with less fatigue and fewer hospitalizations.

“These findings show that transseptal TMVR significantly reduces regurgitation severity while improving symptoms and quality of life, with a low mortality rate,” said Dr. Daniels. “It provides an alternative for patients who previously had no definitive treatment option.”

Study results were published in The Lancet on behalf of international ENCIRCLE investigators.

Healing the Heart of the Problem

Mitral regurgitation is among the most common and serious heart valve conditions. Left untreated, it can lead to heart failure, arrhythmias, stroke and even death.

“Transcatheter mitral valve replacement is a new option for high-risk patients that minimally invasively and significantly improves heart function with shorter hospital stays, faster recovery and improved quality of life,” says Dr. Daniels. “For patients who have long faced limited or no treatment options, results of ENCIRCLE represent an important step forward. As part of the ENCIRCLE study team, I’m proud that Sutter contributed to this global effort to evaluate a first-of-its-kind technology that could revolutionize care for millions of individuals with severe mitral regurgitation.”

For Gasparyan, mitral valve replacement has transformed her ability to perform at work, enjoy life and look positively toward her future. “With each of the deeper breaths I now take, I count these blessings every day,” she says.

Innovation Close to Home

Sutter Health was the only trial site in Northern California to participate in the ENCIRCLE trial. Through this work, patients like Gasparyan are gaining access to clinical trials that bring world-class therapies directly to their communities.

Sutter Health CEO Warner Thomas

“Dr. Daniels’ leadership on a national stage shows how Sutter is redefining the future of heart and vascular care—building on more than a century of research and innovation to expand lifesaving possibilities for our patients,” says Warner Thomas, president and CEO of Sutter Health. “Through pioneering clinical trials like ENCIRCLE, we are at the forefront of advancing critical, less invasive solutions for heart valve disease, offering new hope to those who previously had few or no treatment options. These breakthroughs reflect our commitment to clinically excellent care powered by cutting-edge science.”

Find heart and vascular care close to home and join clinical trials at Sutter for those eligible.