制定AI辅助机器人取栓的评估标准,提升卒中救治效率
A Position Statement on Endovascular Models and Effectiveness Metrics for Mechanical Thrombectomy Navigation, on behalf of the Stakeholder Taskforce for AI-assisted Robotic Thrombectomy (START)
- 构建四类测试环境,从仿真到活体分阶段验证技术
- 区分不同阶段的评估指标,技术导航与临床结果分开衡量
- 强调患者安全,推动体外数据与体内并发症关联研究
尽管我们在对抗传染病和癌症方面取得进展,21世纪中期的重大医疗挑战之一将是卒中的日益普遍。大血管闭塞尤其致残,但有效治疗(需在数小时内完成以获得最佳效果)仍受限于地理因素。一种改善地理分散人群及时获取机械取栓治疗的方法是部署机器人手术系统。人工智能(AI)辅助可帮助操作者提升技能,适应这一新兴疗法。我们的目标是建立开发与验证AI辅助取栓机器人的共识框架。具体包括标准化有效性指标,并在仿真、体外、离体和活体环境中定义参考测试平台。为此,我们召集了神经介入、机器人、数据科学、健康经济学、政策、统计学及患者倡导领域的专家。通过孵化日、德尔菲法和最终立场声明达成共识。我们确认四种核心测试环境各有其独特验证角色:简易测试平台需包含适用于导丝和导管使用的现实血管解剖;标准测试平台应包含可变形血管;更高级测试平台应包含血流、搏动性和疾病特征。有效性指标分为两类:一类用于仿真、体外和离体阶段,聚焦技术导航性能;另一类用于活体阶段,关注临床结局。患者安全是该技术发展的核心。当前迫切需要的一项任务是将体外测量结果与体内并发症相关联。
原文摘要 · Abstract (English)
While we are making progress in overcoming infectious diseases and cancer; one of the major medical challenges of the mid-21st century will be the rising prevalence of stroke. Large vessels occlusions are especially debilitating, yet effective treatment (needed within hours to achieve best outcomes) remains limited due to geography. One solution for improving timely access to mechanical thrombectomy in geographically diverse populations is the deployment of robotic surgical systems. Artificial intelligence (AI) assistance may enable the upskilling of operators in this emerging therapeutic delivery approach. Our aim was to establish consensus frameworks for developing and validating AI-assisted robots for thrombectomy. Objectives included standardizing effectiveness metrics and defining reference testbeds across in silico, in vitro, ex vivo, and in vivo environments. To achieve this, we convened experts in neurointervention, robotics, data science, health economics, policy, statistics, and patient advocacy. Consensus was built through an incubator day, a Delphi process, and a final Position Statement. We identified that the four essential testbed environments each had distinct validation roles. Realism requirements vary: simpler testbeds should include realistic vessel anatomy compatible with guidewire and catheter use, while standard testbeds should incorporate deformable vessels. More advanced testbeds should include blood flow, pulsatility, and disease features. There are two macro-classes of effectiveness metrics: one for in silico, in vitro, and ex vivo stages focusing on technical navigation, and another for in vivo stages, focused on clinical outcomes. Patient safety is central to this technology's development. One requisite patient safety task needed now is to correlate in vitro measurements to in vivo complications.
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