Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection

Mark A. Farber, Joseph S. Giglia, Benjamin W. Starnes, Scott Stevens, Jeremiah Holleman, Rabih Chaer, Jon S. Matsumura

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 ± 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100% with an operative mortality of 0%. Femoral access was utilized in 96% of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 63% having complete or partial left subclavian artery coverage and only 9% of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8%, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2% of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events.

Original languageEnglish (US)
Pages (from-to)651-658
Number of pages8
JournalJournal of Vascular Surgery
Volume58
Issue number3
DOIs
StatePublished - Sep 1 2013

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Thorax
Equipment and Supplies
Tunica Intima
Subclavian Artery
Paraplegia
Mortality
Endoleak
Safety
Injury Severity Score
Thigh
Multicenter Studies
Intensive Care Units
Length of Stay
Hypertension
Wounds and Injuries

All Science Journal Classification (ASJC) codes

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection. / Farber, Mark A.; Giglia, Joseph S.; Starnes, Benjamin W.; Stevens, Scott; Holleman, Jeremiah; Chaer, Rabih; Matsumura, Jon S.

In: Journal of Vascular Surgery, Vol. 58, No. 3, 01.09.2013, p. 651-658.

Research output: Contribution to journalArticle

Farber, Mark A. ; Giglia, Joseph S. ; Starnes, Benjamin W. ; Stevens, Scott ; Holleman, Jeremiah ; Chaer, Rabih ; Matsumura, Jon S. / Evaluation of the redesigned conformable GORE TAG thoracic endoprosthesis for traumatic aortic transection. In: Journal of Vascular Surgery. 2013 ; Vol. 58, No. 3. pp. 651-658.
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abstract = "Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 ± 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100{\%} with an operative mortality of 0{\%}. Femoral access was utilized in 96{\%} of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8{\%} of patients. No patient developed paraplegia despite 63{\%} having complete or partial left subclavian artery coverage and only 9{\%} of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8{\%}, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2{\%} of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events.",
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AU - Farber, Mark A.

AU - Giglia, Joseph S.

AU - Starnes, Benjamin W.

AU - Stevens, Scott

AU - Holleman, Jeremiah

AU - Chaer, Rabih

AU - Matsumura, Jon S.

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N2 - Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 ± 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100% with an operative mortality of 0%. Femoral access was utilized in 96% of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 63% having complete or partial left subclavian artery coverage and only 9% of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8%, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2% of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events.

AB - Objective: To evaluate the safety and effectiveness of the conformable GORE TAG thoracic endoprosthesis (CTAG) device (W. L. Gore and Associates, Flagstaff, Ariz) for the endovascular repair of traumatic aortic transections. Methods: A prospective, nonrandomized, multicenter trial was conducted at 21 sites. Primary safety end points included 30-day all-cause mortality. The effectiveness end point was freedom from a major device event requiring reintervention through 1-month follow-up. Results: Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean Injury Severity Score of 32 ± 14. The proximal mean intimal aortic diameter measured 24 mm, while the mean distal intimal diameter was 22 mm. A total of 57 CTAG devices were implanted (mean, 1.1/subject; range, 1-2) with a mean patient age of 44 years (range, 21-87) and a male-to-female ratio of 2:1. Technical success was 100% with an operative mortality of 0%. Femoral access was utilized in 96% of patients. The mean procedure time and blood loss was 105 minutes and 148 mL, respectively. All subjects required admission to an intensive care unit with a mean hospital stay of 14.6 days. Adjuvant techniques (ie, lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 63% having complete or partial left subclavian artery coverage and only 9% of those receiving left subclavian artery revascularization. In addition, there were no device compressions or major device events reported. Overall mortality at 30 days was 7.8%, and all were adjudicated by the clinical events committee as not being device or procedure related. Serious adverse events occurred in 39.2% of patients through 30 days. To date, there have been no conversions to open repair. Two site-reported endoleaks were detected during the mean follow-up of 4.2 months, which did not require reintervention. Conclusions: The CTAG device was demonstrated to be a safe and effective treatment for traumatic aortic transection based on 30-day outcomes. There were no device-related serious adverse events.

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