Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts Benjamin Ware Starnes,

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Presentation transcript:

Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts Benjamin Ware Starnes, MD, Billi Tatum, RN, CRCC Journal of Vascular Surgery Volume 58, Issue 2, Pages 311-317 (August 2013) DOI: 10.1016/j.jvs.2013.01.029 Copyright © 2013 Society for Vascular Surgery Terms and Conditions

Fig 1 Arc length example. The length measurement is between the superior mesenteric artery (SMA) and the left renal artery. Journal of Vascular Surgery 2013 58, 311-317DOI: (10.1016/j.jvs.2013.01.029) Copyright © 2013 Society for Vascular Surgery Terms and Conditions

Fig 2 Example of centerline adjustment for enhanced measurement precision in angulated anatomy. A, Automatically generated centerline showing length measurement from proximal graft and top of left renal to be 34 mm. B, Actual photograph of physician-modified endovascular graft (PMEG) device for this subject. C, Angiogram demonstrating right renal already stented and left renal fenestration positioned too low for proper alignment. D, Centerline adjustment to mimic path of stiff wire in (C) showing a different length measurement of only 28.3 vs 34 representing a measurement error of 6 mm. Notice the path of the wire in (C) vs the centerline automatically generated in (A). Journal of Vascular Surgery 2013 58, 311-317DOI: (10.1016/j.jvs.2013.01.029) Copyright © 2013 Society for Vascular Surgery Terms and Conditions

Fig 3 Summary and flow chart of subject enrollment to date. Journal of Vascular Surgery 2013 58, 311-317DOI: (10.1016/j.jvs.2013.01.029) Copyright © 2013 Society for Vascular Surgery Terms and Conditions

Fig 4 Subject 003 X-ray at (A) index procedure (July 11, 2011), (B) 1 day postprocedure (July 12, 2011), and (C) 6-month follow-up (December 12, 2011). It is unclear on (C) if there is stent separation. D, Depicts axial computed tomographic angiogram (CTA) image on August 19, 2011 for 30-day follow-up (no stent separation), and (E) depicts axial CTA image on December 12, 2011 clearly demonstrating stent separation and type III endoleak (arrow). Journal of Vascular Surgery 2013 58, 311-317DOI: (10.1016/j.jvs.2013.01.029) Copyright © 2013 Society for Vascular Surgery Terms and Conditions

Fig 5 Subject 003 underwent secondary intervention on February 21, 2012. A, Depicts component separation and type III endoleak (arrow). This subject underwent successful placement of a second covered stent (B) and had resolution of endoleak (C). Journal of Vascular Surgery 2013 58, 311-317DOI: (10.1016/j.jvs.2013.01.029) Copyright © 2013 Society for Vascular Surgery Terms and Conditions