Anchoring fins of fully covered self-expandable metal stents affect pull-out force and stent migration

Franz Brinkmann; Kai Uhlig; Anna Sambale; Markus Stommel; Marco Berning; Jana Babatz; Stefan Sulk; Susanne Krasz; Renate Schmelz; Stefan Brückner; Jochen Hampe; Sebastian Zeissig

doi:10.1016/j.gie.2023.10.036

Anchoring fins of fully covered self-expandable metal stents affect pull-out force and stent migration

Gastrointest Endosc. 2024 Mar;99(3):377-386.e3. doi: 10.1016/j.gie.2023.10.036. Epub 2023 Oct 18.

Authors

Affiliations

¹ Department of Medicine I, University Hospital Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany; Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden (TU Dresden), Dresden, Germany.
² Department Materials Engineering, Leibniz Institute of Polymer Materials, Dresden, Germany.
³ Department Materials Engineering, Leibniz Institute of Polymer Materials, Dresden, Germany; Institute for Materials Science, Technische Universität Dresden (TU Dresden), Dresden, Germany.
⁴ Department of Medicine I, University Hospital Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany.
⁵ Department of Medicine I, University Hospital Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany; Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden (TU Dresden), Dresden, Germany; Center for Regenerative Therapies Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany.
⁶ Department of Medicine I, University Hospital Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany; Center for Regenerative Therapies Dresden, Technische Universität Dresden (TU Dresden), Dresden, Germany.

PMID: 37863243
DOI: 10.1016/j.gie.2023.10.036

Abstract

Background and aims: Stent migration and subsequent adverse events are frequently observed in the use of fully covered self-expandable metal stents (FCSEMSs) for distal biliary stenosis. In this study, we identified predictors for stent migration based on biomechanical stent characteristics and associated these findings with clinical outcomes.

Methods: The migration resistance of FCSEMSs was quantified by measuring the pull-out force. We analyzed a single-center retrospective cohort of 178 FCSEMSs for treatment success and adverse events occurring during 180 days of follow-up.

Results: Biomechanical measurements revealed a 4-fold higher migration resistance of FCSEMSs with anchoring fins (AF-FCSEMSs; F_max = 14.2 ± .1 N) compared with FCSEMSs with flared ends (FE-FCSEMSs; F_max = 3.8 ± 1.0 N; P < .0001). Clinically, AF-FCSEMSs showed lower rates of migration compared with FE-FCSEMSs (5% vs 34%, P < .0001). Unscheduled ERCP procedures because of stent dysfunction were less frequent in the AF group compared with the FE group (15% vs 29%, P = .046). Cholangitis because of stent dysfunction was observed in 5% of the AF group compared with 19% in the FE group (P = .02). Stent patency rates at 1, 3, and 6 months were higher in the AF group (96%, 90%, and 80%, respectively) compared with the FE group (90%, 74%, and 66%; log-rank test: P = .03).

Conclusions: The pull-out force as a biomechanical stent property predicts the migration resistance of FCSEMSs in distal biliary stenosis and may thus be used to classify stents for this application. AF-FCSEMSs showed a significantly lower rate of migration and adverse events compared with FE-FCSEMSs.

MeSH terms

Cholestasis* / etiology
Cholestasis* / surgery
Constriction, Pathologic / etiology
Humans
Retrospective Studies
Self Expandable Metallic Stents* / adverse effects
Stents / adverse effects
Treatment Outcome