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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v21.i4.50
pages 299-319

Detailed Analysis of a Series of Explanted Talent AAA Stent-Grafts: Biofunctionality Assessment

Mark Nutley
Division of Vascular Surgery and Department of Diagnostic Imaging, University of Calgary, Peter Lougheed Health Centre (AB), Calgary, Canada
Robert Guidoin
Department of Surgery, Faculty of Medicine, Laval University, Quebec, QC, Canada; Axe Medecine Regeneratrice, Centre de Recherche du CHU, Quebec, QC, Canada
Tieying Yin
Dept. of Surgery and Radiology, Laval University and Quebec Biomaterials Institute, CHUQ, Canada; Key Laboratory of Biorheological Science and Technology, Bioengineering College, Chongqing University, Chongqing, PR China
Yvan Douville
Departments of Surgery and Radiology, Laval University and Quebec Biomaterials Institute, CHUQ, Quebec
Ze Zhang
Department of Surgery, Faculty of Medicine, Laval University, Quebec, QC, Canada; Axe Medecine Regeneratrice, Centre de Recherche du CHU, Quebec, QC, Canada
Georgi R. Marinov
Department of Anatomy, Histology and Embryology, Medical University of Varna, Varna
Dangheng Wei
The Institute of Cardiovascular Disease, Key Laboratory for Arteriosclerology of Hunan Province, University of South China, Heng Yang, Hunan Province, China; Departments of Surgery and Radiology, Laval University and Quebec Biomaterials Institute, Canada
Jing Lin
Key Laboratory of Textile Science and Technology of Ministry of Education and College of Textiles, Donghua University, Shanghai, PR. China
Benedikt Weber
Clinic for Cardiovascular Surgery, Department of Surgical Research, University Hospital, Zurich, Switzerland
Lu Wang
Key Laboratory of Textile Science and Technology of the Ministry of Education, College of Textile, Donghua University, Shanghai, China
Bin Li
Department of Surgery, Faculty of Medicine, Laval University, Quebec, QC, Canada; Axe Medecine Regeneratrice, Centre de Recherche du CHU, Quebec, QC, Canada; Department of Vasular Surgery Changhai Hospital, Secondary Military Medical University, Shanghai, China
Gregory Samis
Division of Vascular Surgery, University of Calgary, Peter Lougheed Centre, Calgary AB, Canada
Yahye Merhi
Laboratory of Thrombosis and Haemostasis Research Centre, Montreal Heart Institute, Montreal, QC, Canada
Robert McGregor
Imaging Department, Boundary Trails Health Centre Winkler, Manitoba, Canada
Guy Dionne
Departments of Surgery and Radiology, Faculty of Medicine, Laval University, Axe Medecine Regeneratrice, Centre de Recherche, CHU, Quebec, (QC) Canada
Nathalie Gilbert
Departments of Surgery and Radiology, Laval University and Québec Biomaterials Institute, CHUQ, Quebec, QC, Canada

ABSTRACT

Six Talent stent-grafts were harvested at reoperations (N=5) and autopsy (N=1). The explants were observed nondestructively, including gross morphology, X-rays, CT scans and closed pressure system analysis. The Nitinol frames in three devices harvested at reoperations and another harvested at autopsy were intact. One had a stent fracture of the proximal bare stent, and one had a wire fracture of a thin proximal external supporting stent as well as a hole in the fabric just above the bifurcation. For the three devices structurally intact, reoperations were performed for a type 1A endoleak (one patient) and aorto-enteric fistulas (two patients). The healing characteristics were poor or absent. The fabric in the main body of the grafts harvested after aorto-enteric fistula was devoid of biological deposits. Two of the grafts harvested at reoperation demonstrated fabric holes of up to 4 mm 2. The device obtained at autopsy showed an almost continuous internal capsule with variable thickness. The luminal surface was smooth, but the capsule detached easily. The devices explanted at reoperations showed various levels of impaired biofunctionality associated with adverse outcomes. The stent-graft retrieved from autopsy was intact.