Editor's Choice -- Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses

Damir Vakhitov; Jonathan Grandhomme; Salomé Kuntz; Léna Christ; Nicole Neumann; Frédéric Heim; Nabil Chakfé; Anne Lejay; Explants Collaborator Group

doi:10.1016/j.ejvs.2023.09.019

Editor's Choice -- Type IIIb Endoleaks: Fabric Perforations of Explanted New Generation Endoprostheses

Eur J Vasc Endovasc Surg. 2024 Mar;67(3):446-453. doi: 10.1016/j.ejvs.2023.09.019. Epub 2023 Sep 17.

Authors

Damir Vakhitov¹, Jonathan Grandhomme², Salomé Kuntz², Léna Christ³, Nicole Neumann³, Frédéric Heim⁴, Nabil Chakfé², Anne Lejay²; Explants Collaborator Group

Collaborators

Explants Collaborator Group:
Roman Bühlmann⁵, Lucie Cameliere⁶, Stephane Chabert⁷, Bertrand Chavent⁸, Roberto Chiesa⁹, Sébastien Deglise¹⁰, Jean-Pierre Favre¹¹, Michel Ferdani¹², Elena Iborra¹³, Amine Jirari¹⁴, Fabien Koskas¹⁵, Vladimir Makaloski⁵, Jean Piquet¹⁶, Didier Plissonnier¹⁷, Jürg Schmidli⁵, Fabien Thaveau¹⁸

Affiliations

¹ GEPROMED, Strasbourg, France. Electronic address: damir@fimnet.fi.
² GEPROMED, Strasbourg, France; Department of Vascular Surgery and Kidney Transplantation, University Hospital of Strasbourg, Strasbourg, France.
³ GEPROMED, Strasbourg, France.
⁴ GEPROMED, Strasbourg, France; Laboratoire de Physique et Mécanique Textile, Université de Haute-Alsace, Mulhouse, France.
⁵ Department of Cardiovascular Surgery, University Hospital Bern, Bern, Switzerland.
⁶ Department of Vascular and Endovascular Surgery, University Hospital of Caen, Caen, France.
⁷ Clinique Belledonne, Saint-Martin-d'Hères, France.
⁸ Clinique Annecy, Annecy, France.
⁹ Department of Vascular Surgery, San Raffaele Hospital, Milan, Italy.
¹⁰ Department of Vascular Surgery, Centre Universitaire du Vaudois, Lausanne Switzerland.
¹¹ Department of Vascular Surgery, University Hospital of Saint-Etienne, Saint-Etienne, France.
¹² Hôpital Saint Joseph, Marseille, France.
¹³ Department of Angiology and Vascular Surgery, Bellvitge University Hospital, Barcelona, Spain.
¹⁴ Clinique Européenne de Casablanca, Casablanca, Morocco.
¹⁵ Department of Vascular Surgery, La Pitié Salpétrière University Hospital, Paris, France.
¹⁶ Department of Vascular Surgery, University Hospital of Angers, Angers, France.
¹⁷ Department of Vascular Surgery, University Hospital of Rouen, Rouen, France.
¹⁸ Department of Vascular Surgery, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.

PMID: 37717814
DOI: 10.1016/j.ejvs.2023.09.019

Abstract

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.

Keywords: Aortic endoprostheses; Degradation; Expanded polytetrafluoroethylene; Polyester.