Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment.

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Presentation transcript:

Midterm results from a physician-sponsored investigational device exemption clinical trial evaluating physician-modified endovascular grafts for the treatment of juxtarenal aortic aneurysms Benjamin W. Starnes, MD, Rachel E. Heneghan, MD, Billi Tatum, RN Journal of Vascular Surgery Volume 65, Issue 2, Pages 294-302 (February 2017) DOI: 10.1016/j.jvs.2016.07.123 Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 1 Intraoperative imaging depicting deployment of a polytetrafluoroethylene-covered stent into the right renal artery (left panel) and completion imaging for a standard three-vessel physician-modified endovascular graft (PMEG) procedure (right panel). Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 2 Endoleaks by type and number throughout the study period (50 months). Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 3 Physician-modified endovascular graft (PMEG) subject 009 at 2 years demonstrating a typical appearance of dramatic sac regression from preoperatively (left) to follow-up (right). Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 4 Kaplan-Meier survival curves for physician-modified endovascular graft (PMEG). Freedom from all-cause mortality (blue) and aneurysm-related mortality (ARM; red) to 4 years. ∗One patient died of rupture 1 day before being treated. Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 5 Freedom from reintervention. Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 6 Seal zone length in standard endovascular aneurysm repair (EVAR; left) compared with physician-modified endovascular graft (PMEG; right). Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions

Fig 7 A typical example of a physician-modified endovascular graft (PMEG) device that cannot be manufactured or sold within the United States as a ZFEN device but is easily available under our investigational device exemption (IDE) clinical trial. A, Intraoperative photograph of the actual graft created for a patient with a solitary right kidney and a superior mesenteric artery (SMA) origin that is close to the origin of the right renal artery. B, Preoperative computed tomography angiography axial image. C, Intraoperative angiogram showing successful implantation. D, Axial image at 1 year demonstrating a widely patent SMA and right renal artery. Journal of Vascular Surgery 2017 65, 294-302DOI: (10.1016/j.jvs.2016.07.123) Copyright © 2016 Society for Vascular Surgery Terms and Conditions