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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.v17.i3.70
pages 237-262

Characterization of an Endovascular Prosthesis Using the 3Bs Rule (Biocompatibility, Biofunctionality and Biodurability): A Recommended Protocol to Investigate a Device Harvested at Necropsy

Zaipin Xu
Department of Veterinary Medicine, College of Zoology, Guizhou University, Guiyang, PR China
Yubo Fan
Department of Bioengineering, Beihang University, Beijing, PR China
Robert M. Geelkerken
Department of Surgery, Medisch Spectrum Twente, Enschéde, The Netherlands
Xiaoyan Deng
College of Biomedical Engineering, Chongqing University, Chongqing; Department of Bioengineering, Beihang University, Beijing, PR China
Martin King
College of Textiles, North Carolina State University, Raleigh, NC
Amidou Traore
STIM, INRA-Theix, St-Genès-Champanelle, France
Nilesh Ingle
College of Textiles, North Carolina State University, Raleigh, NC, USA
Stephane Turgeon
Departments of Surgery and Radiology, Laval University and Quebec Biomaterials Institute, CHUQ, Quebec
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
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
Andre-Pierre Legrand
Laboratoire de Physique Quantique, ESPCI, Paris, France
Randolph Guzman
Vascular Surgery, St. Boniface General Hospital and Department of Surgery, University of Manitoba, Winnipeg, Manitoba, Canada
Hongbo Zhang
Departments of Surgery and Radiology, Laval University and Quebec Biomaterials Institute, CHUQ, Quebec, Canada; Department of Biological Engineering, Chongqing University, Chongqing, PR China
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
Mark Nutley
Division of Vascular Surgery and Department of Diagnostic Imaging, University of Calgary, Peter Lougheed Health Centre (AB), Calgary, Canada
Jean-Pierre Renou
STIM, INRA-Theix, St-Genès-Champanelle, France
Robert Guidoin
Department of Surgery, Faculty of Medicine, Laval University, Quebec, QC, Canada; Axe Medecine Regeneratrice, Centre de Recherche du CHU, Quebec, QC, Canada

ABSTRACT

Numerous endovascular stent grafts to treat intrarenal aortic aneurysms are now commercially available, and many new concepts are currently in development worldwide. In order to objectively quantify their outcomes, we propose a detailed protocol to examine a reference device that was harvested from a patient who died a few hours after endovascular stent-graft deployment for an abdominal aortic aneurysm according to the 3Bs rule (biocompatibility, biofunctionality, and biodurability). Relevant patient history of this 63-year-old man included radiotherapy treatment for lung cancer. Following the patient's death, the device was harvested en bloc together with the aneu -rysmal sac. The analysis of the device was conducted using nondestructive testing (X-rays, CT scan, magnetic resonance imaging [MRI], and endoscopy) and destructive testing (dissection, histology, and fabric and wire component analyses). Results from the gross examination demonstrated that the outer layer of the aneurysm sac was white, stiff, and continuous without any disruption. The X-ray analysis, CT scan, and MRI confirmed that the device together with its modular segments was properly deployed at implantation. Endoscopy showed that the device was deployed securely immediately distal to the renal arteries. As anticipated, thin scattered mural thrombi at the blood/foreign material interface were observed on the blood tight flow surface. There were no tears in the fabric, and the dimensions and textile structure were well preserved. The metallic wires were intact. This fatality had no association with the stent graft as the patient's death was caused by the rupture of the pulmonary artery following intensive radiotherapy. In conclusion, autopsy, nondestructive testing, and destructive testing are therefore the necessary steps to validate any explanted endovascular stent graft in terms of biocompatibility, biofunctionality, and biodurability. In this specific case, the endovascular device fulfills the 3Bs rule. The authors recommend this protocol to investigate explanted endovascular devices.