Dr. David Daniels, an interventional cardiologist with Sutter West Bay Medical Group and chief of the structural heart section at Sutter’s Advanced Heart & Vascular Service Line, presented the results of the ENCIRCLE Clinical Trial at the Transcatheter Cardiovascular Therapeutics conference in San Francisco. The findings were also published in The Lancet.
“On behalf of ENCIRCLE investigators, I’m proud to share the results of our study which will transform care for mitral regurgitation: for patients with severe mitral regurgitation who previously had no viable surgical or transcatheter option, the SAPIEN M3 system not only significantly reduced regurgitation severity but also improved heart failure symptoms and quality of life. This is a groundbreaking step in heart and vascular medicine —giving hope and a new therapeutic option for high‑risk patients who until now were left without a definitive treatment option,” said Dr. Daniels.
The ENCIRCLE trial was a multicenter pivotal study that evaluated Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement system. The study found that this system effectively reduced mitral regurgitation while maintaining low rates of complications and mortality. Researchers screened 1,171 patients across 56 sites in the United States, Canada, Europe, Israel, and Australia. Of those screened, 35 percent were excluded due to anatomical criteria. In total, 299 patients with significant mitral regurgitation (MR ≥3+) and NYHA Class II or higher who could not undergo surgery or other available transcatheter treatments were included; 287 received the SAPIEN M3 valve.
The primary outcome measured was a combination of all-cause mortality and rehospitalization for heart failure at one year compared to a pre-set goal of 45 percent. After one year, this rate was 25.2 percent (95% CI: 20.6-30.6; p <0.0001). Rates for all-cause death and heart failure hospitalization were reported as 13.9 percent and 16.7 percent respectively.
Patients experienced improvements in daily functioning and quality of life after receiving treatment with the SAPIEN M3 system. More than 95 percent had little-to-no valve leakage at both 30 days and one year post-procedure; nearly three-quarters showed better heart function after one year; almost nine out of ten reported fewer symptoms during daily activities.
Adverse event rates at one year included stroke (9.3%), clinically significant leaflet thrombosis (6.7%), and hemolysis (7.1%).
“Percutaneous transseptal TMVR had a low mortality rate while providing a significant reduction in mitral regurgitation severity and meaningful and durable improvements in functional status and quality of life,” said Dr. Daniels. “These findings will help guide clinical practice by providing an alternative treatment option for patients who are unsuitable for conventional surgery or transcatheter edge-to-edge repair procedures.”
Sutter Health is recognized as having one of the largest heart and vascular clinical trials programs on the U.S. West Coast, supporting research that aims to expand treatment options for conditions like mitral regurgitation through minimally invasive techniques such as robotic-assisted valve repair.
Warner Thomas, president and CEO of Sutter Health, commented on Dr. Daniels’ role: “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,” he said. “Through pioneering clinical trials like ENCIRCLE, we are at the forefront of advancing critical, minimally invasive solutions for valvular heart disease, offering new hope to those who had few or no treatment options. These breakthroughs reflect our commitment to clinical excellence powered by cutting-edge science.”
