Early Haemodynamic Performance and Clinical Outcomes of a Novel Bioprosthetic Mitral Valve

新型生物瓣膜二尖瓣的早期血流动力学性能和临床结果

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Abstract

OBJECTIVES: The MITRIS RESILIA mitral bioprosthesis is a novel pericardial valve developed to improve durability and haemodynamic performance. However, clinical data on its use in mitral valve replacement are limited. This single-center retrospective study aimed to evaluate the early haemodynamic performance and clinical outcomes of the MITRIS RESILIA valve in patients requiring mitral valve replacement. METHODS: We retrospectively reviewed data from 66 patients who underwent mitral valve replacement using MITRIS RESILIA between May 2021 and May 2024. Transthoracic echocardiography was used to assess valve haemodynamic performance at discharge, 1 year, and 2 years postoperatively. The primary end-point was early valve haemodynamics, and the secondary end-points were overall survival and structural valve deterioration. RESULTS: The mean age of the cohort was 75.0 ± 5.8 years, and 48.5% of the patients were male. The mean pressure gradient was 3.9 ± 1.4 mmHg at discharge, 4.0 ± 2.0 mmHg at 1 year, and 3.9 ± 1.3 mmHg at 2 years. The effective orifice area was 1.52 ± 0.50 cm2 after surgery. None of the patients experienced structural valve deterioration or significant paravalvular leak. The rate of freedom from all-cause mortality at 2 years was 93.3%. CONCLUSIONS: MITRIS RESILIA demonstrated stable early haemodynamic performance across all valve sizes, including the 23 mm prosthesis. No cases of structural valve deterioration or paravalvular leak were observed, supporting its feasibility for mitral valve replacement. Further studies with extended follow-up are required to confirm the long-term durability and clinical benefits of the valve.

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