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The Sapien M3 transcatheter mitral valve replacement device continues to show durable results at 2 years, with 97% of patients achieving near-elimination of mitral regurgitation, per new ENCIRCLE trial data. The composite endpoint of death or heart failure hospitalization sat at 35.6% — still below the 1-year performance goal of 45%. However, experts remain divided on the optimal long-term anticoagulation strategy for these high-risk patients.
Two-year data from the ENCIRCLE trial, presented at TCT 2026, show that transcatheter mitral valve replacement (TMVR) with the Sapien M3 device (Edwards Lifesciences) continues to deliver meaningful benefits for patients with symptomatic mitral regurgitation (MR) who aren't candidates for surgery or transcatheter edge-to-edge repair (TEER). Nearly all patients (97%) achieved MR grade 1+ or below at 2 years, and 87% reported improved functional symptoms (NYHA class I/II).
Still, the results come with caveats. One in four patients had died by 2 years, and rates of stroke, bleeding, and valve thrombosis continued to climb after year one. Experts emphasized that this is a very high-risk, "end of the line" population — making the outcomes more impressive in context, but also raising hard questions about patient selection and long-term management.
Key Takeaways:
Why it matters: The Sapien M3 is FDA-approved for patients who have no other options, and these 2-year results support its continued use. But the lack of a standardized anticoagulation protocol — and the real bleeding and clotting risks that come with it — means clinicians need clearer guidance before this therapy can be more broadly and safely deployed.
