Coronary Stent Fracture: Clinical Evidence Vs. the Testing Paradigm

Research output: Contribution to journalArticle

Abstract

Purpose
The United States’ Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis.

Methods
This paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards.

Results
The scale of stent fracture is evident from the clinical data reviewed. In terms of model setups, either physical or computational the loadings, in particular, dictate the durability response.

Conclusions
The full scale of stent fracture is most likely under-reported and its assessment is dependent on detection time and detection resolution. Within the event of SF it is not necessarily consequential; further research is warranted to distinguish when the event negatively impacts the patient.
Original languageEnglish
Pages (from-to)752–760
JournalCardiovascular Engineering and Technology
Volume9
Issue number4
DOIs
Publication statusPublished - 19 Oct 2018

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Stents
United States Food and Drug Administration
Equipment and Supplies
Fatigue
Thrombosis
Incidence
Research

Cite this

Conway, Claire. / Coronary Stent Fracture: Clinical Evidence Vs. the Testing Paradigm. In: Cardiovascular Engineering and Technology. 2018 ; Vol. 9, No. 4. pp. 752–760.
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abstract = "PurposeThe United States’ Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis.MethodsThis paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards.ResultsThe scale of stent fracture is evident from the clinical data reviewed. In terms of model setups, either physical or computational the loadings, in particular, dictate the durability response.ConclusionsThe full scale of stent fracture is most likely under-reported and its assessment is dependent on detection time and detection resolution. Within the event of SF it is not necessarily consequential; further research is warranted to distinguish when the event negatively impacts the patient.",
author = "Claire Conway",
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Conway, C 2018, 'Coronary Stent Fracture: Clinical Evidence Vs. the Testing Paradigm', Cardiovascular Engineering and Technology, vol. 9, no. 4, pp. 752–760. https://doi.org/10.1007/s13239-018-00384-0

Coronary Stent Fracture: Clinical Evidence Vs. the Testing Paradigm. / Conway, Claire.

In: Cardiovascular Engineering and Technology, Vol. 9, No. 4, 19.10.2018, p. 752–760.

Research output: Contribution to journalArticle

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AU - Conway, Claire

PY - 2018/10/19

Y1 - 2018/10/19

N2 - PurposeThe United States’ Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis.MethodsThis paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards.ResultsThe scale of stent fracture is evident from the clinical data reviewed. In terms of model setups, either physical or computational the loadings, in particular, dictate the durability response.ConclusionsThe full scale of stent fracture is most likely under-reported and its assessment is dependent on detection time and detection resolution. Within the event of SF it is not necessarily consequential; further research is warranted to distinguish when the event negatively impacts the patient.

AB - PurposeThe United States’ Food and Drug Administration (FDA) recommends that device manufacturers demonstrate 10 years of equivalent life duration for endovascular stents. Yet since the early 2000s clinical evidence of stent strut fracture defies the recommendations for these FDA approved devices. Stent strut fracture has been correlated with a higher incidence of adverse clinical events, such as in-stent thrombosis and in-stent restenosis.MethodsThis paper reviews the current clinical evidence, computational modelling relating to fatigue lifetimes, experimental testing of coronary stents, and the related regulatory guidance and standards.ResultsThe scale of stent fracture is evident from the clinical data reviewed. In terms of model setups, either physical or computational the loadings, in particular, dictate the durability response.ConclusionsThe full scale of stent fracture is most likely under-reported and its assessment is dependent on detection time and detection resolution. Within the event of SF it is not necessarily consequential; further research is warranted to distinguish when the event negatively impacts the patient.

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