Endovascular Repair of Descending Thoracic Aneurysms: Results With "On-Label" Application in the Post Food and Drug Administration Approval Era

G. Chad Hughes, Sean Lee, Mani A. Daneshmand, Syamal D. Bhattacharya, Judson B. Williams, Sonny W. Tucker, Richard L. McCann

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background: Most studies of thoracic endovascular aortic repair (TEVAR) published since the technology gained US Food and Drug Administration (FDA) approval in March 2005 have included multiple applications including dissection, trauma, and "hybrid" approaches, all of which are currently "off-label." However, little post-approval data exist for the only FDA-approved application, namely descending thoracic aneurysm (DTA). The purpose of this study was to examine our experience with TEVAR for aneurysms limited to the descending thoracic aorta. Methods: Between March 23, 2005 (date of initial FDA approval) and April 6, 2009, 210 TEVAR procedures were performed at our institution. Of these, 79 (38%) were for saccular (n = 31) or fusiform (n = 48) DTA and form the basis of this report. Patients requiring "hybrid" approaches other than carotid-subclavian bypass were excluded. Devices utilized were Gore TAG (W. L. Gore Associates, Flagstaff, AZ) (n = 67; 85%), Zenith TX2 (Cook Medical Incorporated, Bloomington, IN) (n = 10; 13%), and Medtronic Talent (Medtronic, Inc, Santa Rosa, CA) (n = 5; 6%); 3 (4%) patients received more than one type of device. Results: Median patient age was 73 ± 4 years; 35 (44%) were female. Mean aortic diameter was 5.8 ± 1.8 cm. Twenty-four (30%) procedures were urgent-emergent. Thirty-day in-hospital rates of death, stroke, and permanent paraplegia-paresis were 5.1% (n = 4; 1.9% elective mortality), 2.5% (n = 2), and 1.3% (n = 1), respectively. The median postoperative length of stay was 3.0 days (25th and 75th percentiles = 2 and 6, respectively). At a mean follow-up of 23 ± 17 months (range, 6 to 55), there were 2 (2.5%) late aortic deaths from graft infection (n = 1) and aneurysm rupture (n = 1). Overall actuarial midterm survival is 73% at 55 months, with an aorta-specific actuarial survival of 86% during this same time interval. Five patients (6.3%) required late (>30 days) secondary endovascular re-intervention for type I (n = 4) or type II (n = 1) endoleak; re-intervention was successful in 4 of 5. Conclusions: Despite the advanced age, comorbid conditions, and significant incidence of urgent-emergent status of patients presenting with DTA, on-label application of TEVAR yields excellent 30-day and midterm outcomes, especially when compared with historic rates of morbidity and mortality with open repair. However, "on-label" applications represent a minority of current TEVAR use, likely due to the relative scarcity of DTA. These data appear to support the increasing utilization of TEVAR as a treatment strategy for this pathology.

Original languageEnglish (US)
Pages (from-to)83-89
Number of pages7
JournalAnnals of Thoracic Surgery
Volume90
Issue number1
DOIs
StatePublished - Jul 1 2010

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Drug Approval
United States Food and Drug Administration
Aneurysm
Thorax
Thoracic Aorta
Mortality
Endoleak
Equipment and Supplies
Aptitude
Survival
Aortic Aneurysm
Paraplegia
Paresis
Aorta
Dissection
Rupture
Length of Stay
Stroke
Pathology
Technology

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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Endovascular Repair of Descending Thoracic Aneurysms : Results With "On-Label" Application in the Post Food and Drug Administration Approval Era. / Hughes, G. Chad; Lee, Sean; Daneshmand, Mani A.; Bhattacharya, Syamal D.; Williams, Judson B.; Tucker, Sonny W.; McCann, Richard L.

In: Annals of Thoracic Surgery, Vol. 90, No. 1, 01.07.2010, p. 83-89.

Research output: Contribution to journalArticle

Hughes, G. Chad ; Lee, Sean ; Daneshmand, Mani A. ; Bhattacharya, Syamal D. ; Williams, Judson B. ; Tucker, Sonny W. ; McCann, Richard L. / Endovascular Repair of Descending Thoracic Aneurysms : Results With "On-Label" Application in the Post Food and Drug Administration Approval Era. In: Annals of Thoracic Surgery. 2010 ; Vol. 90, No. 1. pp. 83-89.
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title = "Endovascular Repair of Descending Thoracic Aneurysms: Results With {"}On-Label{"} Application in the Post Food and Drug Administration Approval Era",
abstract = "Background: Most studies of thoracic endovascular aortic repair (TEVAR) published since the technology gained US Food and Drug Administration (FDA) approval in March 2005 have included multiple applications including dissection, trauma, and {"}hybrid{"} approaches, all of which are currently {"}off-label.{"} However, little post-approval data exist for the only FDA-approved application, namely descending thoracic aneurysm (DTA). The purpose of this study was to examine our experience with TEVAR for aneurysms limited to the descending thoracic aorta. Methods: Between March 23, 2005 (date of initial FDA approval) and April 6, 2009, 210 TEVAR procedures were performed at our institution. Of these, 79 (38{\%}) were for saccular (n = 31) or fusiform (n = 48) DTA and form the basis of this report. Patients requiring {"}hybrid{"} approaches other than carotid-subclavian bypass were excluded. Devices utilized were Gore TAG (W. L. Gore Associates, Flagstaff, AZ) (n = 67; 85{\%}), Zenith TX2 (Cook Medical Incorporated, Bloomington, IN) (n = 10; 13{\%}), and Medtronic Talent (Medtronic, Inc, Santa Rosa, CA) (n = 5; 6{\%}); 3 (4{\%}) patients received more than one type of device. Results: Median patient age was 73 ± 4 years; 35 (44{\%}) were female. Mean aortic diameter was 5.8 ± 1.8 cm. Twenty-four (30{\%}) procedures were urgent-emergent. Thirty-day in-hospital rates of death, stroke, and permanent paraplegia-paresis were 5.1{\%} (n = 4; 1.9{\%} elective mortality), 2.5{\%} (n = 2), and 1.3{\%} (n = 1), respectively. The median postoperative length of stay was 3.0 days (25th and 75th percentiles = 2 and 6, respectively). At a mean follow-up of 23 ± 17 months (range, 6 to 55), there were 2 (2.5{\%}) late aortic deaths from graft infection (n = 1) and aneurysm rupture (n = 1). Overall actuarial midterm survival is 73{\%} at 55 months, with an aorta-specific actuarial survival of 86{\%} during this same time interval. Five patients (6.3{\%}) required late (>30 days) secondary endovascular re-intervention for type I (n = 4) or type II (n = 1) endoleak; re-intervention was successful in 4 of 5. Conclusions: Despite the advanced age, comorbid conditions, and significant incidence of urgent-emergent status of patients presenting with DTA, on-label application of TEVAR yields excellent 30-day and midterm outcomes, especially when compared with historic rates of morbidity and mortality with open repair. However, {"}on-label{"} applications represent a minority of current TEVAR use, likely due to the relative scarcity of DTA. These data appear to support the increasing utilization of TEVAR as a treatment strategy for this pathology.",
author = "Hughes, {G. Chad} and Sean Lee and Daneshmand, {Mani A.} and Bhattacharya, {Syamal D.} and Williams, {Judson B.} and Tucker, {Sonny W.} and McCann, {Richard L.}",
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TY - JOUR

T1 - Endovascular Repair of Descending Thoracic Aneurysms

T2 - Results With "On-Label" Application in the Post Food and Drug Administration Approval Era

AU - Hughes, G. Chad

AU - Lee, Sean

AU - Daneshmand, Mani A.

AU - Bhattacharya, Syamal D.

AU - Williams, Judson B.

AU - Tucker, Sonny W.

AU - McCann, Richard L.

PY - 2010/7/1

Y1 - 2010/7/1

N2 - Background: Most studies of thoracic endovascular aortic repair (TEVAR) published since the technology gained US Food and Drug Administration (FDA) approval in March 2005 have included multiple applications including dissection, trauma, and "hybrid" approaches, all of which are currently "off-label." However, little post-approval data exist for the only FDA-approved application, namely descending thoracic aneurysm (DTA). The purpose of this study was to examine our experience with TEVAR for aneurysms limited to the descending thoracic aorta. Methods: Between March 23, 2005 (date of initial FDA approval) and April 6, 2009, 210 TEVAR procedures were performed at our institution. Of these, 79 (38%) were for saccular (n = 31) or fusiform (n = 48) DTA and form the basis of this report. Patients requiring "hybrid" approaches other than carotid-subclavian bypass were excluded. Devices utilized were Gore TAG (W. L. Gore Associates, Flagstaff, AZ) (n = 67; 85%), Zenith TX2 (Cook Medical Incorporated, Bloomington, IN) (n = 10; 13%), and Medtronic Talent (Medtronic, Inc, Santa Rosa, CA) (n = 5; 6%); 3 (4%) patients received more than one type of device. Results: Median patient age was 73 ± 4 years; 35 (44%) were female. Mean aortic diameter was 5.8 ± 1.8 cm. Twenty-four (30%) procedures were urgent-emergent. Thirty-day in-hospital rates of death, stroke, and permanent paraplegia-paresis were 5.1% (n = 4; 1.9% elective mortality), 2.5% (n = 2), and 1.3% (n = 1), respectively. The median postoperative length of stay was 3.0 days (25th and 75th percentiles = 2 and 6, respectively). At a mean follow-up of 23 ± 17 months (range, 6 to 55), there were 2 (2.5%) late aortic deaths from graft infection (n = 1) and aneurysm rupture (n = 1). Overall actuarial midterm survival is 73% at 55 months, with an aorta-specific actuarial survival of 86% during this same time interval. Five patients (6.3%) required late (>30 days) secondary endovascular re-intervention for type I (n = 4) or type II (n = 1) endoleak; re-intervention was successful in 4 of 5. Conclusions: Despite the advanced age, comorbid conditions, and significant incidence of urgent-emergent status of patients presenting with DTA, on-label application of TEVAR yields excellent 30-day and midterm outcomes, especially when compared with historic rates of morbidity and mortality with open repair. However, "on-label" applications represent a minority of current TEVAR use, likely due to the relative scarcity of DTA. These data appear to support the increasing utilization of TEVAR as a treatment strategy for this pathology.

AB - Background: Most studies of thoracic endovascular aortic repair (TEVAR) published since the technology gained US Food and Drug Administration (FDA) approval in March 2005 have included multiple applications including dissection, trauma, and "hybrid" approaches, all of which are currently "off-label." However, little post-approval data exist for the only FDA-approved application, namely descending thoracic aneurysm (DTA). The purpose of this study was to examine our experience with TEVAR for aneurysms limited to the descending thoracic aorta. Methods: Between March 23, 2005 (date of initial FDA approval) and April 6, 2009, 210 TEVAR procedures were performed at our institution. Of these, 79 (38%) were for saccular (n = 31) or fusiform (n = 48) DTA and form the basis of this report. Patients requiring "hybrid" approaches other than carotid-subclavian bypass were excluded. Devices utilized were Gore TAG (W. L. Gore Associates, Flagstaff, AZ) (n = 67; 85%), Zenith TX2 (Cook Medical Incorporated, Bloomington, IN) (n = 10; 13%), and Medtronic Talent (Medtronic, Inc, Santa Rosa, CA) (n = 5; 6%); 3 (4%) patients received more than one type of device. Results: Median patient age was 73 ± 4 years; 35 (44%) were female. Mean aortic diameter was 5.8 ± 1.8 cm. Twenty-four (30%) procedures were urgent-emergent. Thirty-day in-hospital rates of death, stroke, and permanent paraplegia-paresis were 5.1% (n = 4; 1.9% elective mortality), 2.5% (n = 2), and 1.3% (n = 1), respectively. The median postoperative length of stay was 3.0 days (25th and 75th percentiles = 2 and 6, respectively). At a mean follow-up of 23 ± 17 months (range, 6 to 55), there were 2 (2.5%) late aortic deaths from graft infection (n = 1) and aneurysm rupture (n = 1). Overall actuarial midterm survival is 73% at 55 months, with an aorta-specific actuarial survival of 86% during this same time interval. Five patients (6.3%) required late (>30 days) secondary endovascular re-intervention for type I (n = 4) or type II (n = 1) endoleak; re-intervention was successful in 4 of 5. Conclusions: Despite the advanced age, comorbid conditions, and significant incidence of urgent-emergent status of patients presenting with DTA, on-label application of TEVAR yields excellent 30-day and midterm outcomes, especially when compared with historic rates of morbidity and mortality with open repair. However, "on-label" applications represent a minority of current TEVAR use, likely due to the relative scarcity of DTA. These data appear to support the increasing utilization of TEVAR as a treatment strategy for this pathology.

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