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Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design 

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Presentation on theme: "Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design "— Presentation transcript:

1 Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design  Joseph V. Lombardi, MD, Richard P. Cambria, MD, Christoph A. Nienaber, MD, Roberto Chiesa, MD, Omke Teebken, MD, PhD, Anthony Lee, MD, Peter Mossop, MD, Priya Bharadwaj, PhD  Journal of Vascular Surgery  Volume 55, Issue 3, Pages e2 (March 2012) DOI: /j.jvs Copyright © 2012 Society for Vascular Surgery Terms and Conditions

2 Fig 1 Illustration of the Zenith Dissection Endovascular System, comprising the Zenith TX2 thoracic aortic aneurysm Endovascular Graft with Pro-Form and the Zenith Dissection Endovascular Stent. The left panel shows one proximal TX2 endovascular graft and two distal dissection stents deployed in a model of Type B thoracic aortic dissection. The TX2 endovascular graft is available in a variety of standard stock sizes and in tapered (by 4 mm) and nontapered configurations. The right panel shows a closer image of the bare metal dissection stent, which consists of multiple (four, six, or eight) self-expanding stainless steel z-stent segments sewn end-to-end with braided polyester suture. The dissection stent was initially available in one diameter (46 mm) and multiple lengths (82, 123, and 164 mm). A smaller diameter dissection stent (36 mm) was introduced later; however, this 36 mm dissection stent has not been used in patients included in this study. Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

3 Fig 2 Distribution of the primary tear, proximal extent, and distal extent of dissection. CIA, Common iliac artery; EIA, external iliac artery; IIA, internal iliac artery; LRA, left renal artery; LSA, left subclavian artery; RRA, right renal artery; SMA, superior mesenteric artery. Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

4 Fig 3 Device combinations used in this study. TX2 refers to the proximal TX2 stent graft and stent refers to the bare metal dissection stent. Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

5 Fig 4 Adjunctive stent placement during the initial procedure. A, The right renal artery originally perfused by the false lumen (left panel) was treated with a stent inserted from the true lumen through the uncovered dissection stent (right panel). This patient also underwent coil embolization of the distal false lumen and a lumbar artery. B, The dissected right common iliac artery (left panel) was treated with placement of two stents (right panel). Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

6 Fig 5 Kaplan-Meier analysis of all-cause mortality. The vertical bars represent 95% confidence intervals, and the dots represent censored data. Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

7 Fig 6, online only Depiction of entry flow definitions. Entry flow was defined as false lumen flow through the primary entry tear around the proximal or distal end of the stent graft (type I, depicted in blue), via collateral vessels through the primary tear (type II, depicted in red), between joints of the covered components or through defects in the graft material (type III), or due to graft fabric porosity (type IV). The entry flow definitions have been expanded to describe flow from collateral vessels directly into the false lumen as “collateral” (depicted in yellow) and flow from the true lumen into the false lumen through secondary tears as “through secondary tear” (depicted in green). Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

8 Fig 7 Diameter and area measurements (least square means estimated from a general linear model) of true lumen and false lumen along the dissected aorta at preprocedure, postprocedure, and 12-month follow-up. Note that the curves for aorta at the right renal arteries and at the left renal arteries are essentially overlapping. SMA, Superior mesenteric artery. Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

9 Fig 8 Imaging examples of true lumen expansion in the abdominal aorta (A) and aortic remodeling during the course of follow-up (B). Journal of Vascular Surgery  , e2DOI: ( /j.jvs ) Copyright © 2012 Society for Vascular Surgery Terms and Conditions

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