EACTS Expert Consensus Document on Robotic Cardiac Surgery Minimum Standards for Programme Implementation, Training and Quality Assurance, developed in collaboration with EACTAIC and EBCP.

Wouter Oosterlinck, Meindert Palmen, Monica Gianoli, Milan Milojevic, Jan Bekaert, Friedhelm Beyersdorf, Filip P A Casselman, Karlien Degezelle, Volkmar Falk, Thierry Folliguet, Ulrich Franke, Pavel Hedvicak, Danny F Hoogma, Jörg Kempfert, Bonnie Kyle, Tom Melvin, Daniel Pereda, Paola Quattroni, Ricard Navarro-Ripoll, Emmanuel Vander Poorten, Johannes O Bonatti, Stepan Cerny
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Abstract

Robotic cardiac surgery is entering a renewed phase of adoption, supported by growing clinical experience, evolving robotic platforms, and rising demand for less invasive procedures and faster recovery. However, implementation remains technically demanding and resource-intensive and can expose patients to avoidable harm when initiated without a structured training programme, clear technical standards, and rigorous outcome monitoring. This expert consensus document summarizes the current state of robotic cardiac surgery and defines requirements for the safe, effective, and sustainable development of robotic cardiac programmes. It addresses the current regulatory environment for surgical robots and accessories and proposes minimum requirements for hardware, software, and instruments for reconstructive intracardiac and coronary cardiac procedures. Furthermore, it outlines prerequisites for starting and developing training centres, including surgeon experience, multidisciplinary team composition, patient selection, and institutional infrastructure and volume considerations. A stepwise, competency-based training pathway is presented that integrates video and live case observation, virtual and simulation-based skills acquisition, wet/dry laboratory training, and proctored clinical implementation, ideally supported by dual-console systems. The document emphasises the need for transparent documentation and outcome benchmarking via a society-driven database to support quality assurance, learning-curve oversight, and continuous improvement. Finally, it highlights priorities for further research, including harmonized reporting standards, long-term and procedure-specific outcome evaluation, and prospective studies assessing training models, cost-effectiveness, and the incremental value of emerging technologies.

EACTS专家共识文件:机器人心脏手术项目实施、培训和质量保证最低标准,与EACTAIC和EBCP合作制定。
在不断增长的临床经验、不断发展的机器人平台以及对微创手术和更快恢复的需求不断增长的支持下,机器人心脏手术正在进入一个新的采用阶段。然而,实施仍然需要技术和资源密集型,如果没有结构化的培训规划、明确的技术标准和严格的结果监测,可能会使患者遭受可避免的伤害。这份专家共识文件总结了机器人心脏手术的现状,并定义了机器人心脏项目安全、有效和可持续发展的要求。它解决了手术机器人和配件的当前监管环境,并提出了重建心内和冠状动脉心脏手术的硬件,软件和仪器的最低要求。此外,它概述了开办和发展培训中心的先决条件,包括外科医生经验、多学科团队组成、患者选择、机构基础设施和数量考虑。提出了一个循序渐进的、基于能力的培训途径,将视频和现场病例观察、基于虚拟和模拟的技能获取、湿/干实验室培训和监督临床实施整合在一起,理想情况下由双控制台系统支持。该文件强调需要通过社会驱动的数据库提供透明的文件和结果基准,以支持质量保证、学习曲线监督和持续改进。最后,它强调了进一步研究的优先事项,包括统一的报告标准、长期和特定程序的结果评估,以及评估培训模式、成本效益和新兴技术的增量价值的前瞻性研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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