Lennart Karstensen

Harry Robertshaw, Anna Barnes, Phil Blakelock et al.

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.

Harry Robertshaw, Benjamin Jackson, Jiaheng Wang et al.

Purpose: Autonomous systems in mechanical thrombectomy (MT) hold promise for reducing procedure times, minimizing radiation exposure, and enhancing patient safety. However, current reinforcement learning (RL) methods only reach the carotid arteries, are not generalizable to other patient vasculatures, and do not consider safety. We propose a safe dual-device RL algorithm that can navigate beyond the carotid arteries to cerebral vessels. Methods: We used the Simulation Open Framework Architecture to represent the intricacies of cerebral vessels, and a modified Soft Actor-Critic RL algorithm to learn, for the first time, the navigation of micro-catheters and micro-guidewires. We incorporate patient safety metrics into our reward function by integrating guidewire tip forces. Inverse RL is used with demonstrator data on 12 patient-specific vascular cases. Results: Our simulation demonstrates successful autonomous navigation within unseen cerebral vessels, achieving a 96% success rate, 7.0s procedure time, and 0.24 N mean forces, well below the proposed 1.5 N vessel rupture threshold. Conclusion: To the best of our knowledge, our proposed autonomous system for MT two-device navigation reaches cerebral vessels, considers safety, and is generalizable to unseen patient-specific cases for the first time. We envisage future work will extend the validation to vasculatures of different complexity and on in vitro models. While our contributions pave the way towards deploying agents in clinical settings, safety and trustworthiness will be crucial elements to consider when proposing new methodology.

Harry Robertshaw, Lennart Karstensen, Benjamin Jackson et al.

Purpose: Autonomous navigation of catheters and guidewires can enhance endovascular surgery safety and efficacy, reducing procedure times and operator radiation exposure. Integrating tele-operated robotics could widen access to time-sensitive emergency procedures like mechanical thrombectomy (MT). Reinforcement learning (RL) shows potential in endovascular navigation, yet its application encounters challenges without a reward signal. This study explores the viability of autonomous navigation in MT vasculature using inverse RL (IRL) to leverage expert demonstrations. Methods: This study established a simulation-based training and evaluation environment for MT navigation. We used IRL to infer reward functions from expert behaviour when navigating a guidewire and catheter. We utilized soft actor-critic to train models with various reward functions and compared their performance in silico. Results: We demonstrated feasibility of navigation using IRL. When evaluating single versus dual device (i.e. guidewire versus catheter and guidewire) tracking, both methods achieved high success rates of 95% and 96%, respectively. Dual-tracking, however, utilized both devices mimicking an expert. A success rate of 100% and procedure time of 22.6 s were obtained when training with a reward function obtained through reward shaping. This outperformed a dense reward function (96%, 24.9 s) and an IRL-derived reward function (48%, 59.2 s). Conclusions: We have contributed to the advancement of autonomous endovascular intervention navigation, particularly MT, by employing IRL. The results underscore the potential of using reward shaping to train models, offering a promising avenue for enhancing the accessibility and precision of MT. We envisage that future research can extend our methodology to diverse anatomical structures to enhance generalizability.

Harry Robertshaw, Lennart Karstensen, Benjamin Jackson et al.

Purpose: Autonomous navigation of devices in endovascular interventions can decrease operation times, improve decision-making during surgery, and reduce operator radiation exposure while increasing access to treatment. This systematic review explores recent literature to assess the impact, challenges, and opportunities artificial intelligence (AI) has for the autonomous endovascular intervention navigation. Methods: PubMed and IEEEXplore databases were queried. Eligibility criteria included studies investigating the use of AI in enabling the autonomous navigation of catheters/guidewires in endovascular interventions. Following PRISMA, articles were assessed using QUADAS-2. PROSPERO: CRD42023392259. Results: Among 462 studies, fourteen met inclusion criteria. Reinforcement learning (9/14, 64%) and learning from demonstration (7/14, 50%) were used as data-driven models for autonomous navigation. Studies predominantly utilised physical phantoms (10/14, 71%) and in silico (4/14, 29%) models. Experiments within or around the blood vessels of the heart were reported by the majority of studies (10/14, 71%), while simple non-anatomical vessel platforms were used in three studies (3/14, 21%), and the porcine liver venous system in one study. We observed that risk of bias and poor generalisability were present across studies. No procedures were performed on patients in any of the studies reviewed. Studies lacked patient selection criteria, reference standards, and reproducibility, resulting in low clinical evidence levels. Conclusions: AI's potential in autonomous endovascular navigation is promising, but in an experimental proof-of-concept stage, with a technology readiness level of 3. We highlight that reference standards with well-identified performance metrics are crucial to allow for comparisons of data-driven algorithms proposed in the years to come.