An in-vitro method for comparative analysis of aspiration catheter tracking performance.

ABSTRACT

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MT) for acute ischemic stroke (AIS) relies on efficient tracking of aspiration catheters through complex vascular anatomies. Differences in catheter design lead to variation in tracking performance which may only become apparent after use in patients. We developed an in-vitro methodology for evaluating aspiration catheter performance under a variety of pre-defined circumstances, that can be used during catheter development for design optimization. METHODS: Validation of the in-vitro methodology involved testing four large bore aspiration catheters on recreated challenging vascular access routes derived from patient angiograms. Two experienced neurointerventionalists conducted the tests under controlled physiological and procedural conditions. Each catheter design was evaluated across 30 unique anatomy-procedural set-up combinations. A fifth, prototype large bore catheter was evaluated by trained engineers to assess the applicability of the in-vitro test. RESULTS: Results from statistical analysis using a general linear model demonstrated the methodology's effectiveness in detecting significant tracking differences among catheter designs (p < 0.01). Minimal inter-operator variability was observed (p = 0.304), while procedural techniques significantly influenced tracking performance (p < 0.01). The tortuosity of the arterial access route notably impacted catheter performance (p < 0.01), with anatomical features revealing varying degrees of influence on desirable and undesirable catheter design aspects. CONCLUSION: We successfully developed a test methodology for evaluating the trackability of large bore aspiration catheters intended for treating acute ischemic stroke with large vessel occlusions. This methodology offers a robust approach to pre-clinical design assessment, utilizing anatomical models that simulate real-world vascular challenges to enhance catheter optimization.