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Comparative Study
. 2011 May;91(5):1314-22; discussion 1322.
doi: 10.1016/j.athoracsur.2011.01.037. Epub 2011 Mar 24.

Have thoracic endografting outcomes improved since US Food and Drug Administration approval?

Castigliano M Bhamidipati  1 , Damien J LaPar, Gaurav S Mehta, John A Kern, Irving L Kron, Gilbert R Upchurch Jr, Gorav Ailawadi
Affiliations
Comparative Study

Have thoracic endografting outcomes improved since US Food and Drug Administration approval?

Castigliano M Bhamidipati et al. Ann Thorac Surg. 2011 May.

Abstract

Background: Thoracic endovascular aneurysm repair (TEVAR) is gaining acceptance since Food and Drug Administration approval in 2005. We hypothesize that, compared with open repair (OPEN), mortality and complication rate after TEVAR have continued to improve.

Methods: All patients who underwent thoracic and (or) thoracoabdominal aneurysm repair from 2005 to 2007 in the Nationwide Inpatient Sample were examined. Patients were stratified by TEVAR or OPEN. Demographics, hospital characteristics, and outcomes were analyzed. Multivariable logistic regression models for complications and in-hospital mortality were developed.

Results: A weighted total of 7,644 had TEVAR, while 32,948 patients underwent OPEN. The TEVAR utilization increased from 5.5% (2005) to 24.1% (2007). Mortality for all patients undergoing thoracic aneurysm repair decreased yearly (p<0.001). Mortality (TEVAR: 7.3%, OPEN: 9.8%, p<0.001) and complication rate (TEVAR: 24.3%, OPEN: 42.1%, p<0.001) were superior with TEVAR. The unadjusted annual mortality (7%) and complication rate (24%) after TEVAR did not improve each year; however, after risk adjustment, mortality after TEVAR steadily decreased annually. Moreover, risk-adjusted mortality for OPEN has improved since 2005. Multivariate analysis revealed age and ruptured aneurysm were highly predictive of death (p<0.001, respectively), while TEVAR lowered the adjusted odds of death by 18% (p<0.05).

Conclusions: Mortality in patients undergoing repair of thoracic aneurysms has decreased in the United States since Food and Drug Administration approval of stent grafts in 2005. This is due to wider adoption of TEVAR and improved mortality in patients undergoing TEVAR or open repair.

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Figures

Figure 1
Figure 1. Distribution of thoracic endografting and open repair in aneurysm cases by year
Thoracic Aneurysm Repair Trends Over time. TEVAR and OPEN treated aneurysm cases are shown by year.
Figure 2
Figure 2. In-hospital mortality trends of thoracic endografting and open repair over 3 years
Thoracic Aneurysm Mortality Trend Over Time. Postoperative TEVAR and OPEN in-hospital mortality trends are shown by year.
See this image and copyright information in PMC

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