PMID: 8627888Apr 1, 1996Paper

Transfemoral endovascular repair of abdominal aortic aneurysm: results of the North American EVT phase 1 trial. EVT Investigators

Journal of Vascular Surgery
W S Moore, R B Rutherford

Abstract

This report describes the results of a phase 1 trial of endovascular repair of abdominal aortic aneurysm, conducted under FDA protocol in 13 U.S. medical centers from February 1993 to December 1994. Forty-six patients 54 to 84 years of age underwent endovascular repair of abdominal aortic aneurysm (diameter, 3.8 to 7.1 cm). Fifteen were treated with the original device (EGS-I), and 31 with a revised over-the-wire system (EGS-II). All patients were periodically observed with contrast-enhanced computed tomographic scan, color-flow duplex scan, and plain abdominal films to evaluate the stability of prosthetic location and to detect any vascular communication with or entry of blood into the aneurysm sac or change in aneurysm size. Thirty-nine implants (85%) were successful; average operating time was 194 minutes. Seven attempts were unsuccessful and were converted to open repair without complication (EGS-I, 5 of 15; EGS-II, 2 of 31). Conversions were caused by iliac stenosis in four patients, subintimal deployment in one, proximal displacement in one, and short distal neck in one. No patients died within 30 days of surgery. Complications included myocardial infarction in one patient, iliofemoral arterial injury in eight, wound infe...Continue Reading

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Citations

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