Comparison of scanning electron microscopy and optical coherence tomography for imaging of coronary bifurcation stents

Silva, Guilherme V.; Gahremanpour, Amir; Attizzani, Guilherme F.; Zeng, Yi; Wang, Wei; Yamamoto, Hiroaki; Kanaya, Tomoaki; Rippy, Marian K.; Bezerra, Hiram G.; Costa, Marco A.; Perin, Emerson C.

doi:10.1002/ccd.25612

Cited by 2 publications

(1 citation statement)

References 31 publications

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“…As such, SEM is commonly used in medical device pathology in assessment of cellular response to device surfaces. SEM is particularly useful for evaluating neoendothelial formation versus fibrin deposition in stents (Silva et al 2009(Silva et al , 2015, grafts, aneurysm occlusion devices (Rodriguez et al 2014), and pressure sensors (Trainor et al 2013), as well as to evaluate the mesothelial cell reaction to barrier devices used in surgery (Brochhausen et al 2012). TEM allows for ultrastructural analysis and can be used to identify specific cell types based on morphology, but this method is destructive to the tissue and will be expensive.…”

Section: Postexplant Imaging-electron Microscopy Analysismentioning

confidence: 99%

Introduction to Currently Applied Device Pathology

et al. 2019

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Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities' assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory's experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment.

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Section: Postexplant Imaging-electron Microscopy Analysismentioning

confidence: 99%

Introduction to Currently Applied Device Pathology

et al. 2019

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Effect of strut distribution on neointimal coverage of everolimus-eluting bioresorbable scaffolds: an optical coherence tomography study

Sato

Jose

Allai

et al. 2017

J Thromb Thrombolysis

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The thick struts of bioresorbable vascular scaffolds (BRS) are associated with changes in wall shear stress and contribute to neointimal proliferation. We aimed to evaluate the relationship between the BRS strut distribution and the neointimal proliferation. 50 lesions underwent optical coherence tomography, 12 months after BRS implantation. Scaffold area and neointimal thickness were evaluated in each cross-sectional area (CSA). Scaffold eccentricity was defined as follows: (maximum diameter - minimum diameter) × 100/maximum diameter. CSAs of BRS were divided into four quadrants. The maximal neointimal thickness (Maximal-NIT), Minimal-NIT and the number of struts in each quadrant were measured. The number of struts were classified as 1, 2, 3 and ≥ 4. Furthermore, the mean-NIT acquired in each quadrant was divided by the average-NIT of all struts in the same CSA, which was defined as the unevenness score. In addition, Maximal-NIT minus Minimal-NIT was divided by the average-NIT of all struts in the same CSA, which was defined as heterogenicity of neointimal proliferation. There was a significant difference in the association between the number of struts and not only the unevenness score (no. of strut = 1 (N = 440), unevenness score 1.04 ± 0.34; 2 (N = 696), 0.98 ± 0.27; 3 (N = 994), 0.96 ± 0.23; ≥4 (N = 1202), 1.04 ± 0.22, P < 0.01) but also Maximal-NIT and Minimal-NIT. Furthermore, a significant correlation was observed between scaffold eccentricity in each CSA and the heterogeneity of neointimal proliferation in the same CSA (N = 892, R = 0.38, p = 0.01). Crowding of struts is associated with increased neointimal proliferation after BRS implantation. The scaffold eccentricity causes heterogeneity of neointimal proliferation.

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Comparison of scanning electron microscopy and optical coherence tomography for imaging of coronary bifurcation stents

Abstract: In a non-atherosclerotic pig model, we showed strong agreement between OCT and SEM in imaging coverage of stent struts bridging side-branch ostia.

Cited by 2 publications

References 31 publications

Introduction to Currently Applied Device Pathology

Introduction to Currently Applied Device Pathology

Effect of strut distribution on neointimal coverage of everolimus-eluting bioresorbable scaffolds: an optical coherence tomography study

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