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Longitudinal deformation bench testing using a coronary artery model: a new standard?

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|December 12, 2017
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Summary

Stent susceptibility to longitudinal stent deformation (LSD) varies with malapposed length. Promus Premier showed reduced strength at longer lengths, while Biomatrix remained the strongest, highlighting design impacts on stent stability.

Keywords:
coronary artery diseaselongitudinal stent deformationpercutaneous coronary intervention

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Area of Science:

  • Cardiovascular device engineering
  • Biomaterials science
  • Medical device testing

Background:

  • Longitudinal stent deformation (LSD) is a concern, with recent modifications to the Promus Element (now Promus Premier) potentially reducing susceptibility.
  • Previous studies have not evaluated LSD susceptibility at long malapposed lengths.
  • The underlying mechanisms contributing to LSD remain incompletely understood.

Purpose of the Study:

  • To compare the susceptibility of five different stent platforms to longitudinal stent deformation (LSD).
  • To utilize a clinically relevant bench testing model simulating both short and long malapposed lengths.
  • To investigate how malapposed segment length influences stent deformation.

Main Methods:

  • Five stent platforms (Omega, Integrity, Multilink 8, Biomatrix, Promus Premier) were tested, using non-drug-eluting versions where applicable.
  • A stepped tube model was used to deploy 3.5 mm stents, with the proximal section exposed to varying lengths.
  • Stents were compressed by a fixed distance under symmetrical and point loading to measure the force required, comparing performance at short (4 mm) and long (12 mm) exposed lengths.

Main Results:

  • Promus Premier exhibited comparable longitudinal strength to Multilink and Integrity at short exposed lengths (4 mm).
  • At longer exposed lengths (12 mm), Promus Premier became weaker, falling between Omega and other platforms.
  • Omega (Promus Element) was significantly weaker than other tested stents, while Biomatrix demonstrated the highest strength.

Conclusions:

  • Stent susceptibility to LSD is significantly influenced by the length of the malapposed segment.
  • The study suggests multifactorial mechanisms contribute to LSD, potentially involving connector number, strut thickness, connector alignment, and ring orientation.
  • Further research is needed to fully elucidate the mechanisms driving stent susceptibility to longitudinal deformation.