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October 5, 2014

Percutaneous TEVAR With Abbott's Perclose ProGlide Analyzed in Obese Patients

October 6, 2014—An analysis was conducted to describe a single-center experience with percutaneous thoracic endovascular aortic repair (P-TEVAR) using the Perclose ProGlide device (Abbott Vascular), particularly in obese patients in whom use of this technique is thought to be relatively contraindicated. The investigators compared P-TEVAR outcomes in patients with or without obesity. The findings were published by Jason Zakko, et al in the Journal of Vascular Surgery (2014;60:921–928).

According to the investigators, all TEVAR procedures from 2005 to 2011 at a single institution—Shanda Hospital at the University of Florida in Gainesville, Florida—were reviewed, and P-TEVAR patients were stratified by body mass index (obesity ≥ 30 kg/m2). Preoperative CT scans were analyzed for access vessel depth, calcification, and morphology. Technical success was defined as the ability to achieve hemostasis and to maintain limb perfusion without the need for common femoral artery exposure or obligate surgical repair of the vessel within a 30-day postoperative period. Generalized estimating equations and stepwise logistic regression were used to develop prediction models of preclose failure.

As reported in the Journal of Vascular Surgery, the review identified 536 patients, in whom 355 (66%) P-TEVAR procedures were completed (366 arteries; n = 40 [11%] bilateral). Compared with nonobese patients (n = 264), obese patients (n = 91) were typically younger (59 ± 16 years vs 66 ± 16 years; P = .0004) and more likely to have renal insufficiency (28% vs 17%; P = .05) or diabetes mellitus (19% vs 9%; P = .02).

The number of Perclose deployments was similar between groups (P = NS). Mean sheath size (25.4 F vs 25 F; P = .04), access vessel inner diameters (8.5 ± 1.9 mm vs 7.9 ± 2.0 mm; P = .02), and vessel depth (50 ± 20 mm vs 30 ± 13 mm; P < .0001) were greater in obese patients. Adjunctive iliac stents were used in 7% of cases (10 [11%] in obese patients vs 16 [6%] in nonobese patients; P = .2).

Overall technical success was 92% (92% for nonobese patients vs 93% for obese patients; P = .7). Three patients required subsequent operations for access complications (two obese patients [2%] and one nonobese patient [0.4%]; P = .3). Independent predictors of failure were adjunctive iliac stent (odds ratio [OR], 9.5; 95% confidence interval [CI], 3.3–27.8; P < .0001), more than two Perclose devices (OR, 7; 95% CI, 2.3–21; P = .0005), and smaller access vessel diameter to sheath size ratio (OR multiplies by 1.1 for each .01 decrease in ratio; 95% CI, 1.02–1.2; P = .007) (area under the receiver operating characteristic curve = .75).                                                                                         

The investigators concluded that obesity is not a contraindication to P-TEVAR and that P-TEVAR can be performed safely, despite the need for larger-diameter sheaths. However, patients predicted to need adjunctive stenting or possessing smaller access vessel diameter-to-sheath size ratios are at highest risk of preclose failure with the Perclose ProGlide device, and selective use of this technique is recommended, stated the investigators in the Journal of Vascular Surgery.

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October 6, 2014

AnGes Begins Global Phase III Clinical Trial of Collategene for CLI

October 6, 2014

AnGes Begins Global Phase III Clinical Trial of Collategene for CLI


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