Explant analysis of AneuRx stent grafts: relationship between structural findings and clinical outcome Christopher K Zarins, MD, Frank R Arko, MD, Tami.

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Presentation transcript:

Explant analysis of AneuRx stent grafts: relationship between structural findings and clinical outcome Christopher K Zarins, MD, Frank R Arko, MD, Tami Crabtree, MS, Daniel A Bloch, PhD, Kenneth Ouriel, MD, Robert C Allen, MD, Rodney A White, MD Journal of Vascular Surgery Volume 40, Issue 1, Pages 1-11 (July 2004) DOI: 10.1016/j.jvs.2004.03.008

Fig 1 Nitinol exoskeleton is composed of individual 1-cm long stent rings (top) joined end-to-end and attached to the graft fabric with sutures. Each stent diamond has four struts. The early prototype “stiff” bifurcation module (bottom left) had a single 5-cm long bifurcation stent. The flexible segmented design (bottom right) was used in most clinical trial patients, and is the design used in the commercially marketed stent graft. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)

Fig 2 A, Explanted device demonstrates a broken suture between aortic stent rings 3 and 4, and a stent strut fracture in stent ring 4. B, Scanning electron microscopy image confirms that this stent strut fracture is a fatigue fracture, by the fault lines visible on the fracture surface. C, Reduced porosity material (RPM) fabric used in most patients in the clinical trial and in the commercially marketed stent graft. D, PreRPM fabric used in the initial devices had a less dense fabric weave. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)

Fig 3 Number of stent strut fatigue fractures per explanted device. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)

Fig 4 Number of fabric holes (>0.2 mm2) per explanted device. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)

Fig 5 Fractures and holes as a function of number of months the device was implanted. Number of explants at each time point is indicated on the x-axis. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)

Fig 6 Explant case example. A, A 24 × 14 × 16.5-cm-long bifurcation module was implanted through the right femoral artery to treat a 5.5-cm abdominal aortic aneurysm. A 14 × 8.5-cm-long left iliac limb was used and positioned below the bifurcation junction gate (see markers). The left iliac limb was too short, and barely reached the left iliac artery. The aneurysm was successfully excluded from the circulation, with no evidence of endoleak (see inserts). However, insecure fixation both proximally and distally of the left iliac limb was apparent on the x-ray film. B, Bowing of the left iliac limb and slight angulation of the bifurcation module was apparent on x-ray film at 12 months. There continued to be no endoleak, and no change in aneurysm size. C, Aneurysm ruptured at 21 months as a result of separation of the iliac limb from the bifurcation module. The AneuRx stent graft was explanted during successful surgical conversion. D, Explant analysis revealed fatigue fractures in ring 3 of the bifurcation module (top arrows), and fabric holes in the angulated right iliac limb at rings 14 to 16, remote from the aneurysm sac (bottom arrows). There were no abnormalities in the left iliac limb. Journal of Vascular Surgery 2004 40, 1-11DOI: (10.1016/j.jvs.2004.03.008)