TCT-448: Scanning Electron Microscopic Observation of Coating Irregularities and Their Precursors in Unexpanded Durable Polymer-Based Drug-Eluting Stents

Mounir W.Z. Basalus, Kenneth Tandjung, Hanim Sen, Thea van Westen, Dirk W. Grijpma, Aart A. van Apeldoorn, Clemens von Birgelen

Research output: Contribution to journalMeeting AbstractAcademic

Abstract

Background: Previous scanning electron microscopy (SEM) studies in expanded DES revealed differences in the frequency and size of coating irregularities between DES types and specific distribution patterns, however, the origin of these irregularities is unclear.The current study quantifies coating irregularities on unexpanded and expanded durable polymer-based drug-eluting stents (DES) to gain insights into the potential origin of coating irregularities.

Methods:We assessed at bench side a total of 1200 SEM images obtained in 30 DES samples (15 expanded and 15 unexpanded) of Cypher Select, Taxus Liberté, Endeavor, Xience V, and Resolute.

Results: For most types of coating irregularities seen on expanded DES (72%; 23/32), a matching irregularity (n=18/24) and/or its precursor (n=11/24) was observed in unexpanded corresponding DES. Only a few individual coating irregularities (13%; 4/32) could not be accessed in unexpanded samples, as these irregularities were located on the (invisible) luminal side. Unexpanded Cypher Select showed (small) crater lesions and cracks together with precursors of ‘peeling of polymer’. On unexpanded Taxus Liberté, thinning of polymer, small bare metal areas, wrinkles and one type of precursor was found. Unexpanded phosphorylcholine-based Endeavor stents showed cracks, small bare metal areas, and crater lesions as well as precursors of the latter. Unexpanded Xience V and Endeavor Resolute mainly revealed crater lesions and their precursors.

Conclusion: SEM assessment demonstrated the presence of various coating irregularities and/or their precursors on unexpanded durable polymer-based DES. These findings provide evidence that coating irregularities arise during both DES manufacturing and stent expansion.
Original languageEnglish
Pages (from-to)B122-B122
Number of pages1
JournalJournal of the American College of Cardiology
Volume58
Issue number20, Suppl.
DOIs
Publication statusPublished - 8 Nov 2011
Event23rd Annual Scientific Symposium of Transcatheter Cardiovascular Therapeutics, TCT 2011 - San Francisco, United States
Duration: 7 Nov 201111 Nov 2011
Conference number: 23

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Drug-Eluting Stents
Polymers
Electrons
Electron Scanning Microscopy
Taxus
Stents
Metals
Phosphorylcholine

Keywords

  • METIS-282971

Cite this

@article{0e2e57d06c3e475da1dccedc564497c7,
title = "TCT-448: Scanning Electron Microscopic Observation of Coating Irregularities and Their Precursors in Unexpanded Durable Polymer-Based Drug-Eluting Stents",
abstract = "Background: Previous scanning electron microscopy (SEM) studies in expanded DES revealed differences in the frequency and size of coating irregularities between DES types and specific distribution patterns, however, the origin of these irregularities is unclear.The current study quantifies coating irregularities on unexpanded and expanded durable polymer-based drug-eluting stents (DES) to gain insights into the potential origin of coating irregularities.Methods:We assessed at bench side a total of 1200 SEM images obtained in 30 DES samples (15 expanded and 15 unexpanded) of Cypher Select, Taxus Libert{\'e}, Endeavor, Xience V, and Resolute.Results: For most types of coating irregularities seen on expanded DES (72{\%}; 23/32), a matching irregularity (n=18/24) and/or its precursor (n=11/24) was observed in unexpanded corresponding DES. Only a few individual coating irregularities (13{\%}; 4/32) could not be accessed in unexpanded samples, as these irregularities were located on the (invisible) luminal side. Unexpanded Cypher Select showed (small) crater lesions and cracks together with precursors of ‘peeling of polymer’. On unexpanded Taxus Libert{\'e}, thinning of polymer, small bare metal areas, wrinkles and one type of precursor was found. Unexpanded phosphorylcholine-based Endeavor stents showed cracks, small bare metal areas, and crater lesions as well as precursors of the latter. Unexpanded Xience V and Endeavor Resolute mainly revealed crater lesions and their precursors.Conclusion: SEM assessment demonstrated the presence of various coating irregularities and/or their precursors on unexpanded durable polymer-based DES. These findings provide evidence that coating irregularities arise during both DES manufacturing and stent expansion.",
keywords = "METIS-282971",
author = "Basalus, {Mounir W.Z.} and Kenneth Tandjung and Hanim Sen and {van Westen}, Thea and Grijpma, {Dirk W.} and {van Apeldoorn}, {Aart A.} and {von Birgelen}, Clemens",
year = "2011",
month = "11",
day = "8",
doi = "10.1016/j.jacc.2011.10.458",
language = "English",
volume = "58",
pages = "B122--B122",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier",
number = "20, Suppl.",

}

TCT-448: Scanning Electron Microscopic Observation of Coating Irregularities and Their Precursors in Unexpanded Durable Polymer-Based Drug-Eluting Stents. / Basalus, Mounir W.Z.; Tandjung, Kenneth; Sen, Hanim; van Westen, Thea; Grijpma, Dirk W.; van Apeldoorn, Aart A.; von Birgelen, Clemens.

In: Journal of the American College of Cardiology, Vol. 58, No. 20, Suppl., 08.11.2011, p. B122-B122.

Research output: Contribution to journalMeeting AbstractAcademic

TY - JOUR

T1 - TCT-448: Scanning Electron Microscopic Observation of Coating Irregularities and Their Precursors in Unexpanded Durable Polymer-Based Drug-Eluting Stents

AU - Basalus, Mounir W.Z.

AU - Tandjung, Kenneth

AU - Sen, Hanim

AU - van Westen, Thea

AU - Grijpma, Dirk W.

AU - van Apeldoorn, Aart A.

AU - von Birgelen, Clemens

PY - 2011/11/8

Y1 - 2011/11/8

N2 - Background: Previous scanning electron microscopy (SEM) studies in expanded DES revealed differences in the frequency and size of coating irregularities between DES types and specific distribution patterns, however, the origin of these irregularities is unclear.The current study quantifies coating irregularities on unexpanded and expanded durable polymer-based drug-eluting stents (DES) to gain insights into the potential origin of coating irregularities.Methods:We assessed at bench side a total of 1200 SEM images obtained in 30 DES samples (15 expanded and 15 unexpanded) of Cypher Select, Taxus Liberté, Endeavor, Xience V, and Resolute.Results: For most types of coating irregularities seen on expanded DES (72%; 23/32), a matching irregularity (n=18/24) and/or its precursor (n=11/24) was observed in unexpanded corresponding DES. Only a few individual coating irregularities (13%; 4/32) could not be accessed in unexpanded samples, as these irregularities were located on the (invisible) luminal side. Unexpanded Cypher Select showed (small) crater lesions and cracks together with precursors of ‘peeling of polymer’. On unexpanded Taxus Liberté, thinning of polymer, small bare metal areas, wrinkles and one type of precursor was found. Unexpanded phosphorylcholine-based Endeavor stents showed cracks, small bare metal areas, and crater lesions as well as precursors of the latter. Unexpanded Xience V and Endeavor Resolute mainly revealed crater lesions and their precursors.Conclusion: SEM assessment demonstrated the presence of various coating irregularities and/or their precursors on unexpanded durable polymer-based DES. These findings provide evidence that coating irregularities arise during both DES manufacturing and stent expansion.

AB - Background: Previous scanning electron microscopy (SEM) studies in expanded DES revealed differences in the frequency and size of coating irregularities between DES types and specific distribution patterns, however, the origin of these irregularities is unclear.The current study quantifies coating irregularities on unexpanded and expanded durable polymer-based drug-eluting stents (DES) to gain insights into the potential origin of coating irregularities.Methods:We assessed at bench side a total of 1200 SEM images obtained in 30 DES samples (15 expanded and 15 unexpanded) of Cypher Select, Taxus Liberté, Endeavor, Xience V, and Resolute.Results: For most types of coating irregularities seen on expanded DES (72%; 23/32), a matching irregularity (n=18/24) and/or its precursor (n=11/24) was observed in unexpanded corresponding DES. Only a few individual coating irregularities (13%; 4/32) could not be accessed in unexpanded samples, as these irregularities were located on the (invisible) luminal side. Unexpanded Cypher Select showed (small) crater lesions and cracks together with precursors of ‘peeling of polymer’. On unexpanded Taxus Liberté, thinning of polymer, small bare metal areas, wrinkles and one type of precursor was found. Unexpanded phosphorylcholine-based Endeavor stents showed cracks, small bare metal areas, and crater lesions as well as precursors of the latter. Unexpanded Xience V and Endeavor Resolute mainly revealed crater lesions and their precursors.Conclusion: SEM assessment demonstrated the presence of various coating irregularities and/or their precursors on unexpanded durable polymer-based DES. These findings provide evidence that coating irregularities arise during both DES manufacturing and stent expansion.

KW - METIS-282971

U2 - 10.1016/j.jacc.2011.10.458

DO - 10.1016/j.jacc.2011.10.458

M3 - Meeting Abstract

VL - 58

SP - B122-B122

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 20, Suppl.

ER -