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

Area of Science:

• Biomedical Engineering
• Medical Device Development
• Interventional Neurology

Background:

• Mechanical thrombectomy (MT) for acute ischemic stroke (AIS) requires precise catheter navigation.
• Existing catheter designs show performance variability in complex vascular anatomies.
• Pre-clinical evaluation methods are needed for aspiration catheter design optimization.

Purpose of the Study:

• To develop and validate an in-vitro methodology for assessing aspiration catheter trackability.
• To enable design optimization of catheters used in mechanical thrombectomy for AIS.
• To evaluate catheter performance under simulated challenging vascular conditions.

Main Methods:

• Developed an in-vitro testing methodology using patient-derived angiograms for vascular models.
• Tested four large bore aspiration catheters across 30 unique anatomy-procedural setups.
• Assessed inter-operator variability and the impact of procedural techniques and arterial tortuosity.

Main Results:

• The methodology effectively identified significant differences in catheter tracking performance (p < 0.01).
• Inter-operator variability was minimal (p = 0.304), while procedural techniques and arterial tortuosity significantly impacted performance (p < 0.01).
• The study revealed how anatomical features influence desirable and undesirable catheter design aspects.

Conclusions:

• A robust in-vitro methodology for evaluating large bore aspiration catheter trackability was successfully developed.
• This approach provides a valuable pre-clinical assessment tool for optimizing catheter designs for AIS treatment.
• The methodology simulates real-world vascular challenges, enhancing the development of improved interventional devices.