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)
Organizations: School of Biomedical Engineering & Imaging Sciences, Kings College London, London, UK · King’s Technology Evaluation Centre (KiTEC), Kings College London, London, UK · Patient & Public Involvement, Kings College London, London, UK · Department of Interventional Neuroradiology, Rothschild Foundation Hospital, Paris, France ·
Abstract
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.
Figures & tables
| Experimental Factor | in silico | in vitro | ex vivo | in vivo (non-human) |
|---|---|---|---|---|
| Realistic vessel anatomy / Human-like vessel anatomy | 84% ( ) | 95% ( ) | 84% ( ) | 95% ( ) |
| Deformable vessels | 89% ( ) | 84% ( ) | 84% ( ) | 84% ( ) |
| Simulated blood flow | 82% ( ) | 84% ( ) | 86% ( ) | — |
| Simulated pulsatility | 86% ( ) | 95% ( ) | — | — |
| Use of both catheter and guidewire for navigation as opposed to single item | 95% ( ) | 95% ( ) | 89% ( ) | 89% ( ) |
| Diseased vessel containing atherosclerotic plaques | 90% ( ) | 86% ( ) | 80% ( ) | 90% ( ) |
| Effectiveness Measure | in silico | in vitro | ex vivo | in vivo |
| Success rate | 100% ( ) | 100% ( ) | 100% ( ) | — |
| Number of phases or steps [ 28 ] | 84% ( ) | 90% ( ) | 84% ( ) | — |
| Number of failures (e.g., wrong branch catheterization) | 95% ( ) | 89% ( ) | 89% ( ) | — |
| Number of handling errors made [ 28 ] | 84% ( ) | 89% ( ) | 95% ( ) | — |
| Procedure time | 85% ( ) | 89% ( ) | 86% ( ) | — |
| Path following error | 81% ( ) | 81% ( ) | — | — |
| Item | in silico | in vitro | ex vivo | in vivo |
| MT Navigation Phases | (non-human) | |||
| Phase A1 | ✓ | ✓ | ✓ | ✓ |
| Phase A2 | ✓ | ✓ | ✓ | ✓ |
| Phase B | ✓ | ✓ | ✓ | ✓ |
| Phase C | ✓ | ✓ | ✓ | ✓ |
| Phase D | — | — | ✓ | — |
| Domain | Benefit/Risk | Agreement |
|---|---|---|
| Benefit | To decrease patient radiation exposure | 68% ( ) |
| To decrease patient contrast exposure | 41% ( ) | |
| To identify best devices or approach for a particular patient | 68% ( ) | |
| To support training of new operators | 68% ( ) | |
| To standardize procedures | 64% ( ) | |
| To increase instrument dexterity and improve intuitive navigation (reducing the workload of the operator) | 73% ( ) |
| Developmental Stage | Factor | Very Effective/ Somewhat Effective |
| in silico | Simulated respiration | 43% ( ) |
| in vitro | Simulated respiration | 35% ( ) |
| ex vivo | Simulated respiration | 55% ( ) |
| Simulated blood flow | 20% ( ) |
| Developmental Stage | Effectiveness Measure | Very Effective/ Somewhat Effective |
| in silico | Path length | 76% ( ) |
| Instrument tip speed | 76% ( ) | |
| Instrument tip acceleration | 67% ( ) | |
| Volume of contrast agent | 48% ( ) | |
| Number of guidewire tip touches on the vessel wall | 75% ( ) | |
| in vitro | Instrument tip acceleration | 75% ( ) |
| Category | Key Performance Indicators (KPIs) / Milestones |
|---|---|
| Reproducible technical KPIs | Device compatibility: Demonstrated use with standard devices (guide/sheath, aspiration, stent-retrievers) across multiple vendors; rapid tool-change workflow. |
| Operating room integration and interoperability: Compatible with biplane angiography suites; adequate cyber-security (e.g., ISO 27001/NIST), medical IT-network risk management (IEC 80001-1). | |
| Teleoperation performance: Adequate end-to-end latency, jitter, link availability; automatic fail-safe modes and “safe stop/withdraw” on dropouts. | |
| Prospective human data | Showing non-inferior morbidity and mortality outcomes. |
| Faster patient access. | |
| Financial viability | Confirmed commissioned network pilots: funding/reimbursement including training of staff. |
Robotic Endovascular Intervention
Robotic endovascular intervention uses robotic systems to navigate vascular instruments and perform procedures with greater precision, control, or autonomy.
See all 24 papers