Endovascular grafting of abdominal aortic aneurysms

A preliminary study

W. H. Edwards, T. C. Naslund, W. H. Edwards, J. M. Jenkins, K. McPherson, J. M. Seeger, J. R. Wheeler, Mitchell Goldman

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Objective: The authors report the experience of a single investigational center involving two Phase I and a Phase II clinical trials approved by the Food and Drug Administration (FDA) for the transfemoral implantation of woven Dacron grafts for abdominal aortic aneurysms. Summary Background Data: In 1993, EndoVascular Technologies, Inc. ([EVT]; Menlo Park, CA), began an FDA- approved clinical trial of repair of abdominal aortic aneurysms by transfemoral placement of a tube endograft. Subsequently, a bifurcated endograft trial was started. This is the first single institution report using the EVT endograft for both tube and bifurcated aortic replacement. Methods: Seventeen patients were enrolled in two Phase I and one Phase II clinical trials. The Phase I tube graft trial and the Phase I bifurcated graft trial were nonrandomized studies. The Phase II tube graft trial consisted of a randomized prospective control trial of open endoaneurysmorrhaphy versus transfemoral placement of an endograft. Results: Seventeen patients were enrolled in the trial. The graft was placed successfully in all but one patient. Five patients randomized to open procedure and one declined to participate. Eleven patients with endografts are available for follow-up. One graft has been explanted for attachment system migration. One patient is a late failure because of persistent filling of the aneurysm sac. Conclusion: Transfemoral placement of an endovascular graft is a viable and effective treatment of abdominal aortic aneurysms in the short term. Use of a bifurcated endograft will open the procedure to more patients. The ideal attachment system and graft material await long-term implantation follow-up.

Original languageEnglish (US)
Pages (from-to)568-575
Number of pages8
JournalAnnals of Surgery
Volume223
Issue number5
DOIs
StatePublished - May 21 1996

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Abdominal Aortic Aneurysm
Transplants
Phase II Clinical Trials
United States Food and Drug Administration
Technology
Polyethylene Terephthalates
Aneurysm
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

Edwards, W. H., Naslund, T. C., Edwards, W. H., Jenkins, J. M., McPherson, K., Seeger, J. M., ... Goldman, M. (1996). Endovascular grafting of abdominal aortic aneurysms: A preliminary study. Annals of Surgery, 223(5), 568-575. https://doi.org/10.1097/00000658-199605000-00012

Endovascular grafting of abdominal aortic aneurysms : A preliminary study. / Edwards, W. H.; Naslund, T. C.; Edwards, W. H.; Jenkins, J. M.; McPherson, K.; Seeger, J. M.; Wheeler, J. R.; Goldman, Mitchell.

In: Annals of Surgery, Vol. 223, No. 5, 21.05.1996, p. 568-575.

Research output: Contribution to journalArticle

Edwards, WH, Naslund, TC, Edwards, WH, Jenkins, JM, McPherson, K, Seeger, JM, Wheeler, JR & Goldman, M 1996, 'Endovascular grafting of abdominal aortic aneurysms: A preliminary study', Annals of Surgery, vol. 223, no. 5, pp. 568-575. https://doi.org/10.1097/00000658-199605000-00012
Edwards WH, Naslund TC, Edwards WH, Jenkins JM, McPherson K, Seeger JM et al. Endovascular grafting of abdominal aortic aneurysms: A preliminary study. Annals of Surgery. 1996 May 21;223(5):568-575. https://doi.org/10.1097/00000658-199605000-00012
Edwards, W. H. ; Naslund, T. C. ; Edwards, W. H. ; Jenkins, J. M. ; McPherson, K. ; Seeger, J. M. ; Wheeler, J. R. ; Goldman, Mitchell. / Endovascular grafting of abdominal aortic aneurysms : A preliminary study. In: Annals of Surgery. 1996 ; Vol. 223, No. 5. pp. 568-575.
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