A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta

• Published in: Journal of vascular surgery Vol. 50; no. 6; pp. 1255 - 1264.e4
• Main Authors: Cambria, Richard P., Crawford, Robert S., Cho, Jae-Sung, Bavaria, Joseph, Farber, Mark, Lee, W. Anthony, Ramaiah, Venkatesh, Kwolek, Christopher J.
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.12.2009
• Subjects: Acute Disease; Adult; Age Factors; Aged; Aged, 80 and over; Aneurysm, Dissecting - etiology; Aneurysm, Dissecting - mortality; Aneurysm, Dissecting - surgery; Aortic Aneurysm, Thoracic - complications; Aortic Aneurysm, Thoracic - mortality; Aortic Aneurysm, Thoracic - surgery; Aortic Rupture - etiology; Aortic Rupture - mortality; Aortic Rupture - surgery; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Blood Vessel Prosthesis Implantation - mortality; Catastrophic Illness; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Odds Ratio; Paraplegia - etiology; Prospective Studies; Prosthesis Failure; Pulmonary Disease, Chronic Obstructive - complications; Pulmonary Disease, Chronic Obstructive - mortality; Reoperation; Risk Assessment; Risk Factors; Stents; Surgery; Time Factors; Treatment Outcome; United States; United States
• ISSN: 0741-5214; 1097-6809; 1097-6809
• DOI: 10.1016/j.jvs.2009.07.104

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. 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. 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. 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.