Cocchieri Riccardo, van de Wetering Bertus, Stijnen Marco, Riezebos Robert, de Mol Bastian
Heart Center, OLVG Hospital, 1091 AC Amsterdam, The Netherlands.
Department of Biomedical Engineering, Eindhoven University of Technology, 5600 MB Eindhoven, The Netherlands.
J Clin Med. 2021 Aug 28;10(17):3877. doi: 10.3390/jcm10173877.
(1) We describe the boundary conditions for minimally invasive cardiac surgery (MICS) with the aim to reduce procedure-related patient injury and discomfort. (2) The analysis of the MICS work process and its demand for improved tools and devices is followed by a description of the relevant sub-specialties of bio-medical engineering: electronics, biomechanics, and materials sciences. (3) Innovations can represent a desired adaptation of an existing work process or a radical redesign of procedure and devices such as in transcutaneous procedures. Focused interaction between engineers, industry, and surgeons is always mandatory (i.e., a therapeutic alliance for addressing 'unmet patient or professional needs'. (4) Novel techniques in MICS lean heavily on usability and safe and effective use in dedicated hands. Therefore, the use of training and simulation models should enable skills selection, a safe learning curve, and maintenance of proficiency. (5) The critical technical steps and cost-benefit trade-offs during the journey from invention to application will be explained. Business considerations such as time-to-market and returns on investment do shape the cost-benefit room for commercial use of technology. Proof of clinical safety and effectiveness by physicians remains important, but establishing the technical reliability of MICS tools and warranting appropriate surgical skills come first.
(1) 我们描述了微创心脏手术（MICS）的边界条件，旨在减少与手术相关的患者损伤和不适。(2) 在对MICS工作流程及其对改进工具和设备的需求进行分析之后，接着描述了生物医学工程的相关子专业：电子学、生物力学和材料科学。(3) 创新可以是对现有工作流程的理想调整，也可以是对手术和设备的彻底重新设计，比如经皮手术。工程师、行业和外科医生之间的密切互动始终是必不可少的（即，为满足“未满足的患者或专业需求”而结成的治疗联盟）。(4) MICS中的新技术在很大程度上依赖于可用性以及在专业人员手中的安全有效使用。因此，使用培训和模拟模型应有助于技能筛选、安全的学习曲线以及熟练程度的维持。(5) 将解释从发明到应用过程中的关键技术步骤以及成本效益权衡。诸如上市时间和投资回报等商业考量确实会影响技术商业应用的成本效益空间。医生证明临床安全性和有效性仍然很重要，但首先要确立MICS工具的技术可靠性并确保具备适当的手术技能。
