Document Detail


A multicenter clinical trial of endovascular stent graft repair of acute catastrophes of the descending thoracic aorta.
MedLine Citation:
PMID:  19958982     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 <or= 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.
Authors:
Richard P Cambria; Robert S Crawford; Jae-Sung Cho; Joseph Bavaria; Mark Farber; W Anthony Lee; Venkatesh Ramaiah; Christopher J Kwolek;
Publication Detail:
Type:  Controlled Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  50     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-04     Completed Date:  2009-12-21     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1255-64.e1-4     Citation Subset:  IM    
Affiliation:
Division of Vascular and Endovascular Surgery, Massachusetts General Hospital and Harvard Medical School, Boston, Mass, USA. rcambria@partners.org
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Adult
Age Factors
Aged
Aged, 80 and over
Aneurysm, Dissecting / etiology,  mortality,  surgery*
Aortic Aneurysm, Thoracic / complications,  mortality,  surgery*
Aortic Rupture / etiology,  mortality,  surgery*
Blood Vessel Prosthesis*
Blood Vessel Prosthesis Implantation / adverse effects,  instrumentation*,  mortality
Catastrophic Illness
Female
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Odds Ratio
Paraplegia / etiology
Prospective Studies
Prosthesis Failure
Pulmonary Disease, Chronic Obstructive / complications,  mortality
Reoperation
Risk Assessment
Risk Factors
Stents
Time Factors
Treatment Outcome
United States

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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