Patients with symptomatic mitral regurgitation (MR) who underwent full percutaneous transseptal transcatheter mitral valve replacement (TMVR) with the SAPIEN M3 system continued to see durable near MR elimination and sustained improvements in functional and health status outcomes at two years, based on new results from the ENCIRCLE trial presented at TCT 2026 and simultaneously published in JACC.

Researchers assessed two-year outcomes data available for 202 of the 299 patients treated in the main ENCIRCLE cohort. According to John G. Webb, MD, FACC, et al., the two-year composite rate of all-cause mortality or hospitalization for heart failure (HF) was 35.6%. Broken down by event, freedom from mortality and HF hospitalization were about 75% and 77%, respectively

In other findings, researchers noted fewer cases of disabling stroke, clinically significant valve thrombosis, and hemolysis requiring intervention over two years, with rates at 6.6%, 7.1% and 7.6%, respectively. Additionally, sustained improvements in functional and health status outcomes were observed and no instances of clinically significant left ventricular outflow obstruction were reported.

"This two-year report confirms and extends the observed on-year outcomes after transseptal TMVR with the SAPIEN M3 system," said Webb and colleagues. "These findings support transseptal TMVR as a therapeutic option for carefully selected patients with symptomatic MR."

In a related editorial comment, Amit N Vora, MD, MPH, FACC, and Gilbert Hin-Lung Tang, MD, MSc, MBA, FACC, write: "The ENCIRCLE 2-year data demonstrate that a transfemoral transseptal percutaneous mitral valve can eliminate MR durably through two years, and that most device-related risks recede after the first year." However, they also caution that whether TMVR outperforms mitral transcatheter edge-to-edge repair or surgery in eligible patients remains to be seen and they highlight the importance of longer-term data and randomized evidence in "closing the circle."

A separate TCT 2026 study simultaneously published in JACC sheds early light on TAVR using the Trilogy transcatheter heart valve for left ventricular assist device (LVAD)-associated aortic regurgitation. Researchers involved with the JENA-VAD study shared early outcomes showing that TAVR using the dedicated system in LVAD patients "was feasible with high technical and device success and without early death, stroke or moderate or severe residual AR." Ravi K. Ramana, DO, FACC, and colleagues noted that follow-up is ongoing to inform longer-term safety and effectiveness.

Explore more simultaneously published research through JACC Journals' TCT 2026 Coverage, and visit ACC's TCT Meeting Coverage for additional studies, clinical insights and news from the meeting.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Transcatheter Aortic Valve Replacement, Aortic Valve Insufficiency, Mitral Valve, Ventricular Outflow Obstruction, Heart Failure, Thrombosis, Stroke