| Report on the results of thoracic endovascular aortic repair for acute, complicated, type B aortic dissection at 30 days and 1 year from a multidisciplinary subcommittee of the Society for Vascular Surgery Outcomes Committee. | |
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MedLine Citation:
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PMID: 21334174 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: This study analyzed 1-year outcome after thoracic endovascular aortic repair (TEVAR) in patients with complicated type B aortic dissection (cTBAoD) who had rupture or malperfusion and symptom onset ≤14 days (acute), 15 to 30 days (subacute), and 31 to 90 days (chronic) until required intervention. The main focus of this report is primarily on the acute cohort. METHODS: Clinical data were systematically collected from five physician-sponsored investigational device exemption (IDE) clinical trials between 2000 and 2008 using standardized definitions and forms. Adverse events were reported early (≤30 days) and late (>30 days) by body system. Major adverse events included death, stroke, myocardial infarction, renal failure, respiratory failure, paralysis, and bowel ischemia. RESULTS: There were 99 cTBAoD patients: 85 were acute, 11 were subacute, and 3 were chronic. Among the acute patients, 31.8% had rupture and 71.8% had malperfusion, including 55.7% lower extremity, 36.1% renal, 19.7% visceral, 8.2% other, and 3.3% spinal cord (patients may have more than one source). Rupture and malperfusion were both reported for three acute patients. Additional findings for the acute cohort included pain (76.5%), hypertension (43.5%), and bleeding (8.2%); comorbidities included hypertension (83.5%), current/past smoking history (69.8%), and diabetes (12.9%). The main focus of this analysis was the acute cohort (n = 85). Age averaged 59 years (72.9% male). Early adverse events included pulmonary (36.5%), vascular (28.2%), renal (25.9%), and neurologic (23.5%). Early major adverse events occurred in 37.6% of patients, including death (10.6%), stroke (9.4%), renal failure (9.4%), and paralysis (9.4%); late adverse events included vascular (15.8%), cardiac (10.5%), gastrointestinal (6.6%), and hemorrhage (5.3%). The point-estimate mortality rate was 10.8 (95% confidence interval [CI], 4.1-17.5) at 30 days and 29.4 (95% CI, 18.4-40.4) at 1 year, when 34 patients remained at risk. CONCLUSIONS: Emergency TEVAR for patients with cTBAoD (malperfusion or rupture) provided acceptable mortality and morbidity results out to 1 year. Manufacturers can use this 30-day mortality point-estimate of 10.8 (95% CI, 4.1-17.5) for the acute cohort to establish a performance goal for use in single-arm commercial IDE trials if the Food and Drug Administration and other regulatory bodies concur. |
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Authors:
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Rodney A White; D Craig Miller; Frank J Criado; Michael D Dake; Edward B Diethrich; Roy K Greenberg; Rebecca S Piccolo; Flora Sandra Siami; |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2011-02-18 |
Journal Detail:
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Title: Journal of vascular surgery Volume: 53 ISSN: 1097-6809 ISO Abbreviation: J. Vasc. Surg. Publication Date: 2011 Apr |
Date Detail:
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Created Date: 2011-03-28 Completed Date: 2011-05-27 Revised Date: 2012-10-03 |
Medline Journal Info:
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Nlm Unique ID: 8407742 Medline TA: J Vasc Surg Country: United States |
Other Details:
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Languages: eng Pagination: 1082-90 Citation Subset: IM |
Copyright Information:
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Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved. |
Affiliation:
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Harbor UCLA Medical Center, Torrance, Calif., USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acute Disease Adult Aged Aged, 80 and over Aneurysm, Dissecting / complications, mortality, surgery* Aortic Aneurysm, Thoracic / complications, mortality, surgery* Blood Vessel Prosthesis Blood Vessel Prosthesis Implantation* / adverse effects, instrumentation, mortality Chi-Square Distribution Clinical Trials as Topic Endovascular Procedures* / adverse effects, instrumentation, mortality Evidence-Based Medicine Female Humans Kaplan-Meier Estimate Male Middle Aged Prosthesis Design Risk Assessment Risk Factors Societies, Medical Stents Time Factors Treatment Outcome United States |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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