Hemolysis a Growing Concern With Newer Sapien TAVR Device

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Source: MedPage Today

Original: https://www.medpagetoday.com/cardiology/interventionalcardiology/119477...

Published: Fri, 16 Jan 2026 15:33:29 -0500

Hemolysis is a growing problem with the newer Sapien 3 Ultra Resilia device in transcatheter aortic valve replacement (TAVR).[1] In a single-center retrospective study from Japan from the OCEAN-TAVI registry, 1070 patients who underwent TAVR with this device from the end of March to November 2023 were included.[1] Hemolytic anemia developed in 18 patients (1.7%).[1] The definition included a drop in hemoglobin of more than 2.0 g/dL within 3 months after the procedure and a diagnosis of mechanical hemolysis based on two of the criteria: lactate dehydrogenase >220 IU/L, haptoglobin <0.5 g/L, or reticulocytes ≥2%.[1] These patients had significantly lower excess sizes of the prosthesis relative to the native annulus (-3.7% vs 7.5%, p<0.001) and a higher prevalence of paravalvular regurgitation (PVL) ≥mild (mild PVL 61.1% vs 12.4%; moderate to severe PVL 16.7% vs 0.2%, p<0.001).[1] PVL ≥mild was associated with a higher incidence of hemolytic anemia, especially with excess size <-5% (33.3% vs 1.3%, p<0.001) and with -5% to <10% (8.3% vs 0.7%, p<0.001).[1]