Cocchieri Riccardo, van de Wetering Bertus, Baan Jan, Driessen Antoine, Riezebos Robert, van Tuijl Sjoerd, de Mol Bas
OLVG Hospital, Amsterdam, Netherlands.
LifeTec Group BV, Eindhoven, Netherlands.
Front Cardiovasc Med. 2023 Jul 21;10:1101337. doi: 10.3389/fcvm.2023.1101337. eCollection 2023.
This viewpoint report describes how the evolution of transcatheter mitral valve intervention (TMVI) is influenced by lessons learned from three evolutionary tracks: (1) the development of treatment from mitral valve surgery (MVS) to transcutaneous procedures; (2) the evolution of biomedical engineering for research and development resulting in predictable and safe clinical use; (3) the adaptation to local conditions, impact of transcatheter aortic valve replacement (TAVR) experience and creation of infrastructure for skills development and risk management. Thanks to developments in computer science and biostatistics, an increasing number of reports regarding clinical safety and effectiveness is generated. A full toolbox of techniques, devices and support technology is now available, especially in surgery. There is no doubt that the injury associated with a minimally invasive access reduces perioperative risks, but it may affect the effectiveness of the treatment due to incomplete correction. Based on literature, solutions and performance standards are formulated with an emphasis in technology and positive outcome. Despite references to Heart Team decision making, boundary conditions such as hospital infrastructure, caseload, skills training and perioperative risk management remain underexposed. The role of Biomedical Engineering is exclusively defined by the Research and Development (R&D) cycle including the impact of human factor engineering (HFE). Feasibility studies generate estimations of strengths and safety limitations. Usability testing reveals user friendliness and safety margins of clinical use. Apart from a certification requirement, this information should have an impact on the definition of necessary skills levels and consequent required training. Physicians Preference Testing (PPT) and use of a biosimulator are recommended. The example of the interaction between two Amsterdam heart centers describes the evolution of a professional ecosystem that can facilitate innovation. Adaptation to local conditions in terms of infrastructure, referrals and reimbursement, appears essential for the evolution of a complete mitral valve disease management program. Efficacy of institutional risk management performance (IRMP) and sufficient team skills should be embedded in an appropriate infrastructure that enables scale and offers complete and safe solutions for mitral valve disease. The longstanding evolution of mitral valve therapies is the result of working devices embedded in an ecosystem focused on developing skills and effective risk management actions.
本观点报告描述了经导管二尖瓣介入治疗（TMVI）的发展如何受到从三条发展轨迹中汲取的经验教训的影响：（1）从二尖瓣手术（MVS）到经皮手术的治疗发展；（2）生物医学工程研发的演进，从而实现可预测且安全的临床应用；（3）适应当地情况、经导管主动脉瓣置换术（TAVR）经验的影响以及为技能发展和风险管理创建基础设施。得益于计算机科学和生物统计学的发展，关于临床安全性和有效性的报告日益增多。现在有了一整套完整的技术、设备和支持技术，尤其是在外科手术方面。毫无疑问，与微创入路相关的损伤可降低围手术期风险，但由于矫正不完全，可能会影响治疗效果。基于文献，制定了以技术和积极结果为重点的解决方案和性能标准。尽管提到了心脏团队的决策制定，但诸如医院基础设施、病例数量、技能培训和围手术期风险管理等边界条件仍未得到充分探讨。生物医学工程的作用仅由包括人为因素工程（HFE）影响在内的研发周期来界定。可行性研究生成对优势和安全局限性的评估。可用性测试揭示临床使用的用户友好性和安全边际。除认证要求外，这些信息应影响必要技能水平的定义以及随之而来的所需培训。建议进行医生偏好测试（PPT）并使用生物模拟器。两个阿姆斯特丹心脏中心之间相互作用的例子描述了一个有助于创新的专业生态系统的演变。在基础设施、转诊和报销方面适应当地情况，对于完整的二尖瓣疾病管理计划的演变似乎至关重要。机构风险管理绩效（IRMP）的有效性和足够的团队技能应融入适当的基础设施中，该基础设施能够实现规模效益，并为二尖瓣疾病提供完整且安全的解决方案。二尖瓣治疗的长期演变是嵌入专注于技能发展和有效风险管理行动的生态系统中的实用设备的结果。
