Smits Jonas, Schegg Pierre, Wauters Loic, Perard Luc, Languepin Corentin, Recchia Davide, Damerjian Pieters Vera, Lopez Stéphane, Tchetche Didier, Grubb Kendra, Hansen Jorgen, Sejor Eric, Berthet-Rayne Pierre
Caranx Medical, Nice, France.
Department of Cardiac Surgery, Heart Institute Arnault Tzanck, Saint Laurent du Var, France.
Front Robot AI. 2025 Oct 21;12:1650228. doi: 10.3389/frobt.2025.1650228. eCollection 2025.
Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive procedure in which a transcatheter heart valve (THV) is implanted within the patient's diseased native aortic valve. The procedure is increasingly chosen even for intermediate-risk and younger patients, as it combines complication rates comparable to open-heart surgery with the advantage of being far less invasive. Despite its benefits, challenges remain in achieving accurate and repeatable valve positioning, with inaccuracies potentially leading to complications such as THV migration, coronary obstruction, and conduction disturbances (CD). The latter often requires a permanent pacemaker implantation as a costly and life-changing mitigation. Robotic assistance may offer solutions, enhancing precision, standardization, and reducing radiation exposure for clinicians. This article introduces a novel solution for robot-assisted TAVI, addressing the growing need for skilled clinicians and improving procedural outcomes. We present an animal demonstration of robotic-assisted TAVI, showing feasibility of tele-operative instrument control and THV deployment. This, done at safer distances from radiation sources by a single operator. Furthermore, THV positioning and deployment under supervised autonomy is demonstrated on phantom, and shown to be feasible using both camera- and fluoroscopy-based imaging feedback and AI. Finally, an initial operator study probes performance and potential added value of various technology augmentations with respect to a manual expert operator, indicating equivalent to superior accuracy and repeatability using robotic assistance. It is concluded that robot-assisted TAVI is technically feasible , and presents a strong case for a clinically meaningful application of level-3 autonomy. These findings support the potential of surgical robotic technology to enhance TAVI accuracy and repeatability, ultimately improving patient outcomes and expanding procedural accessibility.
经导管主动脉瓣植入术（TAVI）是一种微创手术，通过该手术将经导管心脏瓣膜（THV）植入患者病变的天然主动脉瓣内。即使是中度风险和年轻患者，也越来越多地选择该手术，因为它将与心脏直视手术相当的并发症发生率与侵入性小得多的优势结合在一起。尽管有这些好处，但在实现准确且可重复的瓣膜定位方面仍存在挑战，定位不准确可能会导致诸如THV移位、冠状动脉阻塞和传导障碍（CD）等并发症。后者通常需要植入永久性起搏器作为一种代价高昂且改变生活的缓解措施。机器人辅助可能会提供解决方案，提高精度、标准化程度，并减少临床医生的辐射暴露。本文介绍了一种用于机器人辅助TAVI的新颖解决方案，满足了对熟练临床医生日益增长的需求并改善了手术结果。我们展示了机器人辅助TAVI的动物实验，证明了远程操作器械控制和THV部署的可行性。这由一名操作员在离辐射源更远的安全距离处完成。此外，在模型上展示了在监督自主模式下的THV定位和部署，并证明使用基于摄像头和荧光透视的成像反馈以及人工智能是可行的。最后，一项初步的操作员研究探究了各种技术增强相对于手动专家操作员的性能和潜在附加值，表明使用机器人辅助时精度和可重复性相当或更优。得出的结论是，机器人辅助TAVI在技术上是可行的，并且为三级自主的临床有意义应用提供了有力依据。这些发现支持了手术机器人技术提高TAVI准确性和可重复性的潜力，最终改善患者预后并扩大手术可及性。
