Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses

Vakhitov, Damir; Grandhomme, Jonathan; Kuntz, Salomé; Christ, Léna; Neumann, Nicole; Heim, Frédéric; Chakfé, Nabil; Lejay, Anne (2024). Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses. European journal of vascular and endovascular surgery EJVES, 67(3), pp. 446-453. Elsevier 10.1016/j.ejvs.2023.09.019

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Objective: To analyse explanted endografts (EGs) and describe fabric degradation responsible for type IIIb endoleaks.

Methods: As part of the European collaborative retrieval programme, 32 EGs with fabric defects on macroscopic evaluation were selected. The explanted EGs were processed and studied based on the ISO 9001 certified standard protocol. It includes instructions on the collection, transportation, cleaning, and examination of explanted material. The precise analysis was performed with a digital microscope of 20 - 200 times magnification. Possible perforation mechanisms were assessed in stress tests.

Results: The median time to explantation of the 32 EGs was 54 months. The explants included 65 separate EG modules, with 46 (70.8%) having a combined 388 fabric perforations. Each EG had a median of 4.79 mm2 (interquartile range [IQR] 9.86 mm2) of cumulated hole area (an average of 0.13% of an EG's area). There were 239 (61.6%) expanded polytetrafluoroethylene (ePTFE; 11 EGs) and 149 (38.4%) polyethylene terephthalate (PET; 21 EGs) fabric ruptures, with no difference in hole distribution between these types of material. Overall, 126 (32.5%) stent related and 262 (67.5%) non-stent related fabric perforations were identified. Perforations caused by fabric fatigue in ePTFE (151, 63.2%) and material kinking in PET (41, 27.5%) were the most common. The stent related perforations were larger in size (0.80 mm2) than non-stent related perforations (0.19 mm2); p < .001. Wider interstent spaces and prolonged implantation duration were associated with an increased risk of stent related perforation development; p < .001 and p = .004, respectively. Large stent related perforations were also detected in the short term, suggesting mechanical issues as underlying causes.

Conclusion: The fabric of EGs may degrade and lead to the development of perforations. The largest perforations are stent related. Their occurrence and size depend on the implantation time and the EG shape affected by arterial tortuosity. The conclusions are limited to the samples from a select explant group.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Heart Surgery

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1078-5884

Publisher:

Elsevier

Language:

English

Submitter:

Felix Loeper

Date Deposited:

13 Dec 2023 11:28

Last Modified:

14 Mar 2024 00:13

Publisher DOI:

10.1016/j.ejvs.2023.09.019

PubMed ID:

37717814

Additional Information:

Roman Bühlmann, Vladimir Makaloski, and Jürg Schmidli are members of the Explants Collaborator Group.

BORIS DOI:

10.48350/190162

URI:

https://boris.unibe.ch/id/eprint/190162

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