Assessment of distal access catheter performance during neuroendovascular procedures: measuring force in three-dimensional patient specific phantoms.

BACKGROUND: The amount of force applied on a device is an important measure to evaluate the endovascular and surgical device manipulations. The measure has not been evaluated for neuroenodvascular procedures. PURPOSE: We aimed to study the use of force measure as a novel approach to test distal access catheter (DAC) performance during catheterization of cervical and intracranial vessels using patient specific 3-dimentional (3D) phantoms. METHODS: Using patient specific 3D phantoms of the cervical and intracranial circulation, we recorded measure of force required to deliver three types of DACs beyond the ophthalmic segment of the internal carotid artery. Six different combinations of DAC-microcatheter-guidewire were tested. We intentionally included what we considered suboptimal combinations of DACs, microcatheters, and guidewires during our experiments to test the feasibility of measuring force under different conditions. A six axis force sensor was secured to the DAC with an adjustable torque used to track axially directed push and pull forces required to navigate the DAC to the target site. RESULTS: In a total of 55 experiments, we found a significant difference in the amount of force used between different DACs (mean force for DAC A, 1.887±0.531N; for DAC B, 2.153±1.280 N; and for DAC C, 1.194±0.521 N, P=0.007). There was also a significant difference in force measures among the six different catheter systems (P=0.035). CONCLUSIONS: Significant difference in the amount of force used between different DACs and catheter systems were recorded. Use of force measure in neuroendovascular procedures on 3D printed phantoms is feasible.

3D Printed Cardiovascular Patient Specific Phantoms Used for Clinical Validation of a CT-derived FFR Diagnostic Software.

PURPOSE: 3D printed patient specific vascular models provide the ability to perform precise and repeatable benchtop experiments with simulated physiological blood flow conditions. This approach can be applied to CT-derived patient geometries to determine coronary flow related parameters such as Fractional Flow Reserve (FFR). To demonstrate the utility of this approach we compared bench-top results with non-invasive CT-derived FFR software based on a computational fluid dynamics algorithm and catheter based FFR measurements. MATERIALS AND METHODS: Twelve patients for whom catheter angiography was clinically indicated signed written informed consent to CT Angiography (CTA) before their standard care that included coronary angiography (ICA) and conventional FFR (Angio-FFR). The research CTA was used first to determine CT-derived FFR (Vital Images) and second to generate patient specific 3D printed models of the aortic root and three main coronary arteries that were connected to a programmable pulsatile pump. Benchtop FFR was derived from pressures measured proximal and distal to coronary stenosis using pressure transducers. RESULTS: All 12 patients completed the clinical study without any complication, and the three FFR techniques (Angio-FFR, CT-FFR, and Benchtop FFR) are reported for one or two main coronary arteries. The Pearson correlation among Benchtop FFR/Angio-FFR, CT-FFR/ Benchtop FFR, and CT-FFR/ Angio-FFR are 0.871, 0.877, and 0.927 respectively. CONCLUSIONS: 3D printed patient specific cardiovascular models successfully simulated hyperemic blood flow conditions, matching invasive Angio-FFR measurements. This benchtop flow system could be used to validate CT-derived FFR diagnostic software, alleviating both cost and risk during invasive procedures.