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An experimental assessment of catheter trackability forces with tortuosity parameters along patient-specific coronary
1Galway Medical Technologies Centre (GMedTech), Department of Mechanical and Industrial Engineering, Galway-Mayo Institute of Technology, Galway, Ireland.
Insights
This study found that a new parameter, tracking curvature, strongly correlates with the forces needed to deliver coronary stents in patient-specific vessels. This could help predict and improve stent delivery success in complex cases.
Area of Science:
- Cardiovascular Medicine and Medical Device Engineering
- Biomechanical analysis of medical devices
Background:
- Coronary artery disease is a leading cause of death, with 70% of revascularization procedures using endovascular stents.
- Successful stent delivery is critical, but challenging in tortuous vessels, potentially causing injury and complications.
- Existing tortuosity parameters inadequately predict stent delivery forces.
Purpose of the Study:
- To assess the correlation between coronary stent system trackability forces and geometrical parameters in patient-specific vessel models.
- To evaluate the predictive capability of various tortuosity parameters for stent delivery forces.
Main Methods:
- A motorized delivery system was used to deliver a coronary stent in three phantom patient-specific coronary vessels.
- Trackability forces were monitored, alongside measurements of vessel curvature and torsion.
- A novel parameter, 'tracking curvature,' incorporating lumen radius and centerline curvature, was analyzed.
Main Results:
- Trackability forces varied significantly across different vessel geometries (p < 0.002).
- Traditional tortuosity parameters did not show significant differences between vessels (p > 0.05).
- Tracking curvature was significantly different for all vessels (p < 0.002) and strongly correlated with trackability forces.
Conclusions:
- Tracking curvature is a significant predictor of stent delivery forces in tortuous coronary vessels.
- This new parameter offers a potential clinical tool to aid in planning and improving stent delivery success.
- Further development of stent delivery systems can benefit from incorporating tracking curvature analysis.
Abstract:
Coronary artery disease is one of the leading causes of cardiovascular deaths worldwide. Approximately 70% of patients requiring coronary revascularisation receive endovascular stents. The endovascular procedure is the preferred option due to its minimally invasive nature when compared to open heart surgery. Stent delivery is paramount for the success of the endovascular procedure. Catheter delivery forces within tortuous blood vessels can produce vasoconstriction and injury, resulting in reactive intimal proliferation or distal embolisation associated with end-organ ischaemia and infarction. Trackability is evaluated by most medical device companies for further development of their delivery systems. Relevant device design attributes must be tested in settings which simulate aspects of the intended use conditions, such as vessel geometry and compliance. Various tortuosity parameters are used to facilitate endovascular intervention planning. This study assessed the significance and correlation between the trackability forces for a coronary stent system with various geometrical parameters based on patient-specific geometries. A motorised delivery system delivered a commercially available coronary stent system and monitored the trackability forces along three phantom patient-specific thin-walled, compliant coronary vessels supported by a cardiac phantom model. The maximum trackability forces, curvature and torsion values ranged from 0.31 to 0.87 N, 0.06 to 0.22 mm(-1) and -11.1 to 5.8 mm(-1), respectively. The trackability forces were significantly different between all vessels (p < 0.002), while the tortuosity parameters were not significantly different (p > 0.05). A new tortuosity parameter-coined tracking curvature which considers the lumen radius as well as the curvature along the centreline was statistically different (p < 0.002) for all vessels and correlated with the trackability forces. There was a strong correlation between the cumulative trackability force and the cumulative tracking curvature. Tracking curvature could be used as a predictive clinical tool to aid stent delivery to the vicinity of the lesion.
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