Document Detail

Transfemoral endovascular repair of abdominal aortic aneurysm: results of the North American EVT phase 1 trial. EVT Investigators.
MedLine Citation:
PMID:  8627888     Owner:  NLM     Status:  MEDLINE    
PURPOSE: 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.
METHODS: 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.
RESULTS: 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 infection in seven, required transfusion in eight, transient unexplained fever in nine, and minor emboli with foot petechiae in two. There were no amputations, major emboli, or episodes of mesenteric ischemia. Contrast enhancement outside the graft but within the aneurysm sac was detected initially in 17 grafts (44%), of which nine (53%) resolved spontaneously. Of eight persistent leaks into the aneurysm sac, one was controlled with transluminal balloon angioplasty and one required surgical explanation because of aneurysm enlargement. Six patients continued to have contrast enhancement, but had no evidence of aneurysm enlargement from 6 to 27 months after surgery. Hospital stay averaged 3.8 days (range, 1 to 13 days). Follow-up extends to 27 months, with one non-device related death of respiratory failure at 6 months. Metallic attachment system fracture, a device-related malfunction, was identified in nine implants (23%), which led to one removal; the remaining eight functioned normally with no untoward sequelae. The program was suspended while the defect was corrected. Preparations are complete for the phase 2 portion of the trial.
CONCLUSIONS: Endovascular repair of abdominal aortic aneurysm appears to be safe and efficacious. Long-term results and late consequences of attachment system fracture have yet to be determined. The long-term results of perigraft leak into the aneurysm sac are unknown but worrisome in view of adverse outcomes reported by other investigators.
W S Moore; R B Rutherford
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase I; Controlled Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of vascular surgery     Volume:  23     ISSN:  0741-5214     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  1996 Apr 
Date Detail:
Created Date:  1996-06-24     Completed Date:  1996-06-24     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  543-53     Citation Subset:  IM    
Section of Vascular Surgery, UCLA Center for the Health Sciences, 90095-6904, USA.
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MeSH Terms
Aged, 80 and over
Aortic Aneurysm, Abdominal / radiography,  surgery*,  ultrasonography
Blood Transfusion
Blood Vessel Prosthesis* / adverse effects
Contrast Media
Embolism / etiology
Femoral Artery / injuries
Fever / etiology
Follow-Up Studies
Iliac Artery / injuries
Middle Aged
Myocardial Infarction / etiology
Prosthesis Design
Prosthesis Failure
Radiographic Image Enhancement
Surgical Wound Infection / etiology
Tomography, X-Ray Computed
Ultrasonography, Doppler, Color
Ultrasonography, Doppler, Duplex
United States
United States Food and Drug Administration
Vascular Patency
Reg. No./Substance:
0/Contrast Media

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