Characterization of an endovascular prosthesis using the 3Bs rule (biocompatibility, biofunctionality and biodurability): a recommended protocol to investigate a device harvested at necropsy.
Résumé
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 aneurysmal 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 Xray 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.