In Vitro Evaluation of Mechanical Properties of Segmented Esophageal Self-Expandable Metal Stents: Innovative Test Methods Are Needed.

ABSTRACT

Background: Self-expanding metal stents (SEMSs) in different geometric shapes are well established treatment options in diseases of the esophagus. Mechanical properties and stent design may have an impact on patient comfort, migration rate, and removability. In this in vitro study, we evaluated mechanical properties of three segmented SEMSs (segSEMSs) for the esophagus with regard to distinct stent sections. Materials and Methods: Radial forces were measured using a testing method distinguishing between circumferential radial and local radial force. The center parts of the segSEMSs were measured for circumferential radial forces without being affected by the flared ends. Axial forces were measured at 20° bending. Results: Circumferential radial force measurements over the full stent length showed substantial differences against measurements of the center parts of the stents as the flared ends falsify test results by up to 53%. Although circumferential radial forces of the center parts were about the same (<10% variances) for all segSEMSs, local radial forces showed considerable differences of up to 26%. One segSEMS showed high axial forces, whereas the other two only needed half of the force (up to 53%) to be bent to 20°. Conclusion: Flared ends of segSEMSs have a substantial impact on radial force measurements and therefore alter test results, confirmed by our separated center part test of segSEMSs. Our innovative setup whereby we compressed the stent in an asymmetric manner (local radial force) and evaluated sections of stents separately, indeed revealed differences to circumferential measurements, leading to a more in-depth knowledge of stent characteristics.