Richard P. Cambria MD1, Alan H. Matsumoto2, Mark F. Fillinger MD3, Alberto Pochettino MD4
1Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, MA; 2 Department of Radiology, University of Virginia School of Medicine, Charlottesville, VA; 3 Vascular Surgery Training Programs, Dartmouth-Hitchcock Medical Center, Lebanon, NH; 4 University of Pennsylvania School of Medicine, Philadelphia, PA.
OBJECTIVES: Prospective single-arm trial of conformable TAG (W.L. Gore) TEVAR endograft (new design since original trial) for treatment of cTBD.
METHODS: cTBD was defined as rupture/malperfusion (MP). The study was powered based on literature/IRAD data such that enrollment was complete when a 25% mortality was ruled out with high probability. Treatment results were compared to SVS outcomes performance criteria (SVS-OPC). (JVS 2011; 53:1082)
RESULTS: 50 pts were enrolled at 26 centers, 1/10-1/12. Mean age was 57 yrs; presentation was within 24 hrs of symptom onset and 98% of pts were treated < 7 days from symptom onset. Indication for Rx was Rupture only 9 (18%), MP only 39 (78%) and both 2 (4%). 90% of MP pts had renal or visceral MP. 30 day SAE for TAG 08-01 vs SVS-OPC are compared in table. 39/40 pts (97.5%) available for CORE LAB analysis had exclusion 1° entry tear (1° efficacy endpoint) and aortic remodeling was progressively favorable out to 1 year (23 pts).
CONCLUSIONS: Albeit qualified by ongoing data analysis, results in the TAG 08-01 trial compare favorably to literature based results in cTBD. Furthermore, they are remarkably consistent with SVSOPC, indicating TEVAR is a valid treatment strategy in cTBD.
AUTHOR DISCLOSURES: R. Cambria MD, Research Grants: W.L. Gore; A. Matsumoto, Research Grants: Medtronic, W.L. Gore, Cook, Endologix; Scientific Advisory Committee: Siemens Medical, Boston Scientific; Consulting Fees or Other Remuneration (Payment): Bolton, Trivascular; M. Fillinger MD, Nothing to Disclose; A. Pochettino MD, Still need Disclosure.
Updated May 2012