Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms
Presented at the Society for Vascular Surgery Annual Meeting, Baltimore, Md, Jun 7-10, 2007.
Received 28 August 2007; accepted 3 December 2007. published online 20 March 2008.
Objectives
Report the results of a phase II multicenter, prospective trial comparing endovascular treatment of descending thoracic aneurysm (TEVAR) with the TAG device to surgical controls after 5 years of follow-up.
Methods
The Gore TAG trial compared the TAG endograft patients (n = 140) with standard open surgical controls (n = 94) with enrollment from September of 1999 to May of 2001. An additional 51 patients were enrolled in 2003 after revision of the endograft. Follow-up consisted of patient visits, computed tomography (CT) scans and x-rays at 1, 6, and 12 months and yearly. Significant sac size change was defined as ≥5 mm increase or decrease from the 1 month baseline measurement. Migration was defined as ≥10 mm cranial or caudal movement of the device inside the aorta. Significance was determined as P ≤ .05.
Results
At 5 years, aneurysm-related mortality was lower for TAG patients at 2.8% compared with open controls at 11.7% (P = .008). No differences in all-cause mortality were noted, with 68% of TAG patients and 67% of open controls surviving to 5 years (P = .43). Major adverse events at 5 years were significantly reduced in the TAG group; 57.9% vs 78.7% (P = .001). Endoleaks in the TAG group decreased from 8.1% at 1 month to 4.3% at 5 years. Five TAG patients have undergone major aneurysm-related re-interventions at 5 years (3.6%), including one arch aneurysm repair for type 1 endoleak and migration, one open conversion and five endovascular procedures for endoleaks in three patients. There were fewer secondary procedures not directly related to aneurysm repair in the TAG vs the open repair group at 5 years, 15.0% vs 31.9%, (P = .01). For TAG patients, sac size at 60 months decreased in 50% and increased in 19% compared with the 1-month baseline. Comparison with the modified low-porosity device at 24 months showed sac increase in 12.9% of original vs 2.9% in modified grafts (P = .11). At 5 years, there have been no ruptures, one migration, no collapse, and 20 instances of fracture in 19 patients, all before the revision of the TAG graft.
Conclusions
In anatomically suitable patients, TAG treatment of thoracic aneurysms is superior to surgical repair at 5 years. Although sac enlargement is concerning, early modified device results indicate this issue may be resolved.
aDivision of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa
bDivision of Cardiovascular Surgery, Arizona Heart Institute, Phoenix, Ariz
cDivision of Vascular Surgery, Massachusetts General Hospital, Boston, Mass.
Correspondence: Ellen D. Dillavou, MD, Division of Vascular Surgery, University of Pittsburgh Medical Center Suite A-1011, PUH, 200 Lothrop St, Pittsburgh, PA 15213.
Competition of interest: Dr Cambria has been paid consulting fees and has received research support from W. L. Gore, Medtronic, and Cook Inc. Dr Wheatley is a scientific advisory board member of W. L. Gore & Associates. Dr Makaroun has been paid consulting fees and has received research support from W. L. Gore & Associates.
ABSTRACT