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Stent Graft Repair (TEVAR) Of Complex Thoracic Aortic Pathology: A Multicenter, Prospective Trial

Richard P. Cambria¹, Christopher J. Kwolek¹, Venkatesh Ramaiah², Joseph Bavaria³, Alan Lumsden⁴, W. Anthony Lee⁵, Mark Farber⁶, Jae Cho.^7
1Massachusetts General Hospital, Boston, Mass.; ²Arizona Heart Institute, Phoenix, Ariz.; ³University of Pennsylvania Health System, Philadelphia, Pa.; ⁴Baylor College of Medicine, Houston, Texas; ⁵University of Florida, Gainesville, Fla.; ⁶University of North Carolina Chapel Hill, Chapel Hill, N.C.; ⁷University of Pittsburgh, Pittsburgh, Pa.

OBJECTIVES: This prospective study assessed the utility of stent graft repair with the GORE TAG® Thoracic Endoprosthesis for Thoracic aortic rupture (TAR), acute complicated Type B dissections (AD) and Traumatic Aortic Tear (TAT) at 14 academic medical centers.

METHODS: During the interval 8/05-2/07, 59 patients (20 TAR/19AD/20 TAT) were enrolled in the trial; 30 day outcomes were available.

RESULTS: Demographic/clinical data included: 80% male, median age 66 years but differing widely as function of pathology (80 yrs for TAR but 53 yrs for AD/TAT). Mean ISS in TAT patients was 36, and mean SVS risk score was highest (7.6±5.6) in TAR pts.  There were no arterial access nor deployment failures. 30-day composite death/paraplegia occurred in 8/59 (13.6%) of patients with a single paraplegia event (1.7% overall) in a TAT patient; six (10.2%) patients experienced reversible paraparesis. Of the 6, 3 died without known recovery from paraparesis, 2 recovered and 1 was ongoing although this patient had no motor function assessment pre-tx. 30 day mortality was 5% for TAT, but in the 15% range for both TAR/AD. ASA class was the sole independent predictor of mortality/paraplegia (OR 4.0, 95% CI: 1.3-18.0). Procedural deployment-related adverse events occurred in seven (11.9%) patients and included two instances of extension of AD. Device-related adverse events through 30 day follow-up occurred in 11(18.6%) pts: [rupture in 2AD, graft infection (presented w/ infection, but not confirmed until after tx) in 1 TAR, graft collapse 2 TAT and major endoleak in 6 patients]; 3 (5% overall) of these underwent explant/open conversion. Four reinterventions with TEVAR were performed; 3 for endoleak and 1 for persistent aortic dissection.

CONCLUSIONS: These preliminary data suggest the utility of TEVAR for life threatening complex thoracic aortic pathology wherein conventional surgical treatment has traditionally been accompanied by excess mortality and/or paraplegia. Further analysis and presentation to the FDA are anticipated later this year.