Elsevier

Journal of Vascular Surgery

Volume 50, Issue 6, December 2009, Pages 1255-1264.e4
Journal of Vascular Surgery

Clinical research study
From the Society for Vascular Surgery
A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta

Presented in part at the Tenth Annual Meeting of the Society for Vascular Surgery, Baltimore, MD, June 7-10, 2007.
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Objective

Thoracic endovascular aortic repair (TEVAR) is applicable to a spectrum of thoracic aortic pathology with half of the procedures performed world-wide for indications other than degenerative aneurysm of the descending thoracic aorta (DTA). This multicenter, prospective study queried perioperative and one-year results of TEVAR using the commercially available GORE TAG device, in the treatment of acute complicated Type B dissection (cTBD), traumatic aortic tear (TT), and ruptured degenerative aneurysm (RDA) of the DTA.

Methods

This prospective, non-randomized, literature controlled study included 59 patients; cTBD, n = 19; RDA, n = 20; TT, n = 20. The primary end-point was the composite of death and total paraplegia in subjects at ≤ 30 days post-treatment compared with a cohort from current literature. Secondary end-points included adverse events related to device, procedural and systemic complications, and one-year survival.

Results

All 59 patients had successful endoprosthesis deployment. Fifteen of 19 (79%) patients in the cTBD group had either rupture or malperfusion syndromes at presentation. Combined 30-day mortality/paraplegia rate was 13.6% (8/59), with seven (11.9%) deaths (cTBD [3], RDA [3] and TT [1]) and 1 (TT, 1.7%) case of paraplegia. The primary end-point for the TEVAR cohort was significantly lower (P = .008) when compared with a composite literature control of 800 patients (combined 30-day mortality/paraplegia of 29.6%). Thirty-day complications of any nature occurred in 48 (81%) patients; 11 (18.6%) were device related, and 43 (73%) experienced one or more systemic adverse events. Six (10%) patients required additional TEVAR implantations and 3 (5%) patients (one in each pathology group) required conversion to open surgery. Seventeen (29%) patients had endoleaks of any kind or degree through 30 days; cTBD (7), TT (2), RDA (8). Nine patients (15.3%) had perioperative strokes with two resultant deaths. During mean follow-up time of 409 ± 309 days, an additional 12 patients died, one patient required open conversion (cTBD), and two patients had major device related events. Actuarial survival at one year was 66% (range, 52%-77%) for the entire cohort; (cTBD) 79% (range, 53%-92%), (TT) 79% (range, 53%-92%) and (RDA) 37% (range, 16%-59%). On regression analysis, age at treatment (1.05 [range, 1.01-1.09]; P = .008) and chronic obstructive pulmonary disease (COPD) (4.3 [range, 1.3-14.4]; P = .02) were predictive of death at one year.

Conclusion

This study confirmed treatment advantages for TEVAR for thoracic aortic catastrophes when compared with literature-based results of open repair. One-year treatment results indicate a low incidence of graft-related complications. TEVAR is the preferred initial treatment for the DTA catastrophes studied herein.

Cited by (0)

Competition of interest: Joseph Bavaria is a primary investigator for WL Gore and is on their speaker's bureau. Richard Cambria has received research support to conduct this trial, and as principle investigator has received intermittent consulting fees. The study was funded by W.L. Gore Company. Mark Farber has been paid a consulting fee by Medtronic, WL Gore, Book, and Bolton Medical. Christopher Kwolek is a consultant for Medtronic and is on the speaker's bureau for Cook Medical.

Additional material for this article may be found online at www.jvascsurg.org.

The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.