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新型生物人工二尖瓣的早期血流动力学性能及临床结果

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

作者信息

Wada Yuki, Marui Akira, Nagasawa Atsushi, Tsumaru Shinichi, Hakamada Keisuke, Terazono Kazuya, Kitagata Yuta, Mihara Hironori, Ohno Nobuhisa

机构信息

Department of Cardiovascular Surgery, Kokura Memorial Hospital, Kitakyushu 802-8555, Japan.

出版信息

Interdiscip Cardiovasc Thorac Surg. 2025 Sep 2;40(9). doi: 10.1093/icvts/ivaf186.

DOI:10.1093/icvts/ivaf186
PMID:40795650
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12448282/
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.

摘要

目的

MITRIS RESILIA二尖瓣生物瓣膜是一种新型心包瓣膜,旨在提高耐用性和血流动力学性能。然而,其用于二尖瓣置换术的临床数据有限。这项单中心回顾性研究旨在评估MITRIS RESILIA瓣膜在需要二尖瓣置换术的患者中的早期血流动力学性能和临床结果。

方法

我们回顾性分析了2021年5月至2024年5月期间66例行MITRIS RESILIA二尖瓣置换术患者的数据。采用经胸超声心动图评估出院时、术后1年和2年的瓣膜血流动力学性能。主要终点是早期瓣膜血流动力学,次要终点是总生存率和瓣膜结构退化。

结果

该队列的平均年龄为75.0±5.8岁,48.5%的患者为男性。出院时平均压力阶差为3.9±1.4 mmHg,1年时为4.0±2.0 mmHg,2年时为3.9±1.3 mmHg。术后有效瓣口面积为1.52±0.50 cm²。所有患者均未出现瓣膜结构退化或明显的瓣周漏。2年时全因死亡率的自由率为93.3%。

结论

MITRIS RESILIA在所有瓣膜尺寸(包括23 mm假体)中均表现出稳定的早期血流动力学性能。未观察到瓣膜结构退化或瓣周漏的病例,支持其用于二尖瓣置换术的可行性。需要进一步进行长期随访研究,以确认该瓣膜的长期耐用性和临床益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/32c97dbbce3c/ivaf186f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/4025e0215c7c/ivaf186f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/8d0e74a14e6f/ivaf186f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/15826ea3d45d/ivaf186f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/32c97dbbce3c/ivaf186f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/4025e0215c7c/ivaf186f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/8d0e74a14e6f/ivaf186f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/15826ea3d45d/ivaf186f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8484/12448282/32c97dbbce3c/ivaf186f3.jpg

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本文引用的文献

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Durability of bovine pericardial mitral bioprosthesis based on Heart Valve Collaboratory echocardiographic criteria.基于心脏瓣膜协作组超声心动图标准的牛心包二尖瓣生物假体的耐久性
J Thorac Cardiovasc Surg. 2025 Jan;169(1):92-102.e1. doi: 10.1016/j.jtcvs.2023.11.021. Epub 2023 Nov 21.
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Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue.
COMMENCE试验的中期结果:使用新型组织生物假体进行二尖瓣置换术的研究
JTCVS Open. 2023 Jun 2;15:151-163. doi: 10.1016/j.xjon.2023.05.008. eCollection 2023 Sep.
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Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis.新型组织生物瓣主动脉瓣置换术后 7 年的结果。
J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791. doi: 10.1016/j.jtcvs.2023.09.047. Epub 2023 Sep 29.
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Long-term echocardiographic data, mechanisms of failure, and reintervention outcomes of the Epic valve in mitral position-a large observational cohort.二尖瓣位Epic瓣膜的长期超声心动图数据、失效机制及再次干预结果——一项大型观察性队列研究
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Cardiol Young. 2023 Jun;33(6):998-1000. doi: 10.1017/S1047951122003043. Epub 2022 Sep 28.
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