Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
Québec Heart and Lung Institute, Laval University, Quebec, Quebec, Canada.
Ann Thorac Surg. 2021 Jan;111(1):314-326. doi: 10.1016/j.athoracsur.2020.05.060. Epub 2020 Oct 6.
Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.
全面了解外科心脏瓣膜(SHV)的特性对于优化瓣膜选择至关重要。此类信息对于评估瓣膜置换后的 SHV 功能也很重要。尽管存在 SHV 尺寸和标签的现有监管框架,但以统一的方式获取各种 SHV 的此类信息具有挑战性。为了确保临床医生得到充分告知,欧洲心胸外科学会(EACTS)、胸外科医师学会(STS)和美国胸外科学会(AATS)成立了一个由心脏外科医生、心脏病学家、工程师、监管机构、国际标准化组织代表和主要瓣膜制造商组成的工作组。此前,EACTS-STS-AATS 瓣膜标签工作组确定了围绕 SHV 尺寸和标签的最重要问题。本专家共识文件制定了以透明、统一的方式提供 SHV 物理尺寸、预期植入位置和血液动力学性能的建议。此外,工作组主张引入和使用标准化图表来评估假体与患者不匹配的概率,并呼吁瓣膜制造商在标准化瓣膜图表上提供选择 SHV 所需的基本信息,适用于所有 SHV 型号。