The Gore Excluder US multi-center trial: analysis of adverse events at 2 years.
Although open surgical repair of abdominal aortic aneurysms remains the standard of care, endovascular repair is becoming an attractive alternative as more long-term outcome data become available to show its safety and efficacy. The authors review data on the 2-year outcome of the pivotal US multicenter, prospective Gore Excluder Trial. Patients treated with the Excluder endograft (W.L. Gore, Flaggstaff, AZ) had less blood loss (310 +/- 19 v 1,590 +/- 124 mL; P <.0001), required fewer homologous transfusions (6% v 32%; P <.0001), and had faster inpatient recovery (2.0 +/- 0.1 v 9.8 +/- 1.4 days; P <.0001) compared with those treated with open repair. Early major adverse events were reduced significantly in the patients treated with the endograft (14% v 57% in control; P <.0001), and this persisted at 2 years. There was no difference in overall survival rate (P =.13). There were no deployment failures, early conversions, or aneurysm ruptures. At the 2-year time-point, trunk migration occurred in 1%, limb migration in 1%, limb narrowing in 1%, endoleak in 20%, and aneurysm growth in 14%. There was a 7% annual reintervention rate in the endograft group in the first 2 years. The Excluder endograft is a safe and effective treatment compared with open surgical repair for infrarenal abdominal aortic aneurysms with appropriate anatomy.
Kibbe
Melina R
MR
Division of Vascular Surgery, Northwestern University Medical School, 201 E. Huron, Chicago, IL 60611, USA.
Matsumura
Jon S
JS
D000368:Aged; D017130:Angioplasty / Q000009:adverse effects*; D017544:Aortic Aneurysm, Abdominal / Q000601:surgery*; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D018795:Device Approval; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011475:Prosthesis Failure; D016896:Treatment Outcome; D014481:United States