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TEVAR using the redesigned TAG device (CTAG) for Traumatic Aortic Transection: A non-randomized multicenter trial
Mark A. Farber, MD1, Joseph Giglia, MD2, Benjamin Starnes, MD3, Scott Stevens, MD4, Jeremiah Holleman, MD5, Rabih Chaer, MD6, Jon Matsumura, MD7.
1University of North Carolina, Chapel Hill, NC, USA, 2University of Cincinnati, Cincinnati, OH, USA, 3University of Washington, Seattle, WA, USA, 4University of Tennessee, Knoxville, TN, USA, 5Carolinas Medical Center, Charlotte, NC, USA, 6University of Pittsburgh, Pittsburgh, PA, USA, 7University of Wisconsin, Madison, WI, USA.
OBJECTIVES:
To evaluate the safety and efficacy of the CTAG device for the endovascular repair of traumatic aortic transections.
METHODS:
A prospective, non-randomized, multicenter trial was conducted at 21 sites. Primary study endpoints included 30 day all cause mortality and major adverse events. The efficacy endpoint was freedom from a major device event (MDE) requiring reintervention through one-month follow-up.
RESULTS:
Fifty-one subjects were enrolled between December 2009 and January 2011 with polytraumatic injuries and a mean injury severity score (ISS) of 32 + 14. The proximal mean intimal aortic diameter measured 24 mm while the mean distal intimal diameter was 22 mm. A total of 56 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 13 days. Adjuvant techniques (lumbar drains and induced hypertension) to prevent paraplegia were used in only 7.8% of patients. No patient developed paraplegia despite 67% having complete or partial left subclavian artery (LSCA) coverage and only 6% receiving LSCA revascularization. In addition there were no device compressions or MDE reported. Overall mortality at 30 days was 7.8% and all were adjudicated by the CEC as not being device or procedure related. Serious adverse events occurred in 35.3% of patients. To date there have been no conversions to open repair. Two site-reported minor endoleaks were detected during the mean follow-up of 4.2 months which did not require reintervention.
CONCLUSIONS:
The CTAG device appears to be a safe and effective treatment modality for traumatic aortic transection based on 30 day outcomes with no device related events.
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