Journal of Vascular Surgery
Volume 47, Issue 2 , Pages 247-257.e3 , February 2008

International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results

Presented at the Sixty-first Annual Meeting of the Society for Vascular Surgery, Baltimore, Md, Jun 7-10, 2007.

  • Jon S. Matsumura, MD

      Affiliations

    • Northwestern University Feinberg School of Medicine, Chicago, Ill
    • Corresponding Author InformationReprint requests: Jon S. Matsumura, MD, Department of Surgery, Northwestern University Feinberg School of Medicine, 201 E Huron, Ste 10-105, Chicago, IL 60611.
  • ,
  • Richard P. Cambria, MD

      Affiliations

    • Massachusetts General Hospital, Boston, Mass
  • ,
  • Michael D. Dake, MD

      Affiliations

    • University of Virginia, Charlottesville, Va
  • ,
  • Randy D. Moore, MD

      Affiliations

    • University of Calgary, Calgary, Alberta
  • ,
  • Lars G. Svensson, MD

      Affiliations

    • Cleveland Clinic Foundation, Cleveland, Ohio
  • ,
  • Scott Snyder, PhD

      Affiliations

    • MED Institute, West Lafayette, Ind.
  • ,
  • TX2 Clinical Trial Investigators

Received 8 June 2007 ,Accepted 18 October 2007.

References 

  1. Bickerstaff LK, Pairolero PC, Hollier LH, Melton LJ, Van Peenen HJ, Cherry KJ, et al. Thoracic aortic aneurysms: a population-based study. Surg. 1982;92:1103–1108
  2. Svensson LG, Crawford ES, Hess KR, Coselli JC, Safi HJ. Variables predictive of outcome in 832 patients undergoing repairs of the descending thoracic aorta. Chest. 1993;104:1248–1253
  3. Pressler V, McNamara JJ. Aneurysm of the thoracic aorta. J Thorac Cardiovasc Surg. 1985;89:50–54
  4. Moreno-Cabral CE, Miller DC, Mitchell RS, Stinson EB, Oyer PE, Jamieson SW, et al. Degenerative and atherosclerotic aneurysms of the thoracic aorta. J Thorac Cardiovasc Surg. 1984;88:1020–1032
  5. Coady MA, Rizzo JA, Hammond GL, Mandapati D, Darr U, Kopf GS, et al. What is the appropriate size criterion for resection of thoracic aortic aneurysms?. J Thorac Cardiovasc Surg. 1997;113:476–491
  6. Chiesa R, Melissano G, Moura MR, Civilini E, Tshomba Y, Moura MR, et al. Surgical treatment of thoracic and thoracoabdominal aortic aneurysms: technical notes and the use of left heart bypass. J Vasc Br. 2002;1:207–218
  7. Greenberg RK, O’Neill S, Walker E, Haddad F, Lyden SP, Svensson LG, et al. Endovascular repair of thoracic aortic lesions with the Zenith TX1 and TX2 thoracic grafts: intermediate-term results. J Vasc Surg. 2005;41:589–596
  8. Hassoun HT, Dake MD, Svensson LG, Greenberg RK, Cambria RP, Moore RD, et al. Multi-institutional pivotal trial of the Zenith TX2 thoracic aortic stent-graft for treatment of descending thoracic aortic aneurysms: clinical study design. Perspect Vasc Surg Endovasc Ther. 2005;17:255–264
  9. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35:1048–1060
  10. White GH, May J, Waugh RC, Chaufour X, Yu W. Type III and type IV endoleak: toward a complete definition of blood flow in the sac after endoluminal AAA repair. J Endovasc Surg. 1998;5:305–309
  11. Muhs BE, Balm R, White GH, Verhagen HJM. Anatomic factors associated with acute endograft collapse after Gore TAG treatment of thoracic aortic dissection or traumatic rupture. J Vasc Surg. 2007;45:655-1
  12. Bavaria JE, Appoo JJ, Makaroun MS, Verter J, Yu Z, Mitchell RS. Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial. J Thorac Cardiovasc Surg. 2007;133:369–377
  13. Lawrie GM, Earle N, De Bakey ME. Evolution of surgical techniques for aneurysms of the descending thoracic aorta: twenty-nine years experience with 659 patients. J Card Surg. 1994;9:648–661
  14. Coselli JS, Plestis KA, LaFrancesca S, Cohen S. Results of contemporary surgical treatment of descending thoracic aortic aneurysms: experience in 198 patients. Ann Vasc Surg. 1996;10:131–137
  15. Estrera AL, Miller CC, Chen EP, Meada R, Torres RH, Porat EE, et al. Descending thoracic aortic aneurysm repair: 12-year experience using distal aortic perfusion and cerebrospinal fluid drainage. Ann Thorac Surg. 2005;80:1290–1296
  16. Glade GJ, Vahl AC, Wisselink W, Linsen MAM, Balm R. Mid-term survival and costs of treatment of patients with descending thoracic aortic aneurysms; endovascular vs open repair; a case-control study. Eur J Vasc Endovasc Surg. 2005;29:28–34
  17. Stone DH, Brewster DC, Kwolek CJ, LaMuraglia GM, Conrad MF, Chung TK, et al. Stent-graft versus open-surgical repair of the thoracic aorta: mid-term results. J Vasc Surg. 2006;44:1188–1197
  18. Matsumura JS. Worldwide survey of thoracic endografts: practical clinical application. J Vasc Surg. 2006;43(suppl A):20A–21A
  19. Makaroun MS, Dillavou ED, Kee ST, Sicard G, Chaikof E, Bavaria J, et al. Endovascular treatment of thoracic aortic aneurysms: Results of the phase II multicenter trial of the GORE TAG thoracic endoprosthesis. J Vasc Surg. 2005;41:1–9

 Competition of interest: Dr Matsumura received research funding or consulting fees from Abbott Vascular, Bard, Cook Inc, Cordis, Ev3, W. L. Gore & Associates, and Medtronic. Dr Cambria has research support or consulting from Cook Inc, W. L. Gore & Associates, and Medtronic. Dr Dake has received consulting fees from W. L. Gore & Associates, Abbott Vascular Devices, Medtronic, AngioDynamics, Ev3 Inc, and research grants for clinical trial contracts (no personal remuneration other than expenses as part of conducting trial from Cook, Medtronic and W. L. Gore). Dr Moore received proctor fees from Cook Inc for device training. Dr Svensson received honoraria from Edwards and Medtronic. Dr Snyder is employed by MED Institute Inc, a Cook Group company.

 Additional material for this article may be found online at www.jvascsurg.org.

PII: S0741-5214(07)01693-X

doi: 10.1016/j.jvs.2007.10.032

Journal of Vascular Surgery
Volume 47, Issue 2 , Pages 247-257.e3 , February 2008