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  • Title: Early results of 132 aortic or aorto-iliac arterial reconstructions with the new Stretch ePTFE vascular prosthesis.
    Author: Paaske WP, Laustsen J.
    Journal: Int Angiol; 1994 Dec; 13(4):296-9. PubMed ID: 7790748.
    Abstract:
    OBJECTIVE: The purpose of the present study is to document the short term clinical results after implantation of the new Stretch ePTFE (Gore-Tex) arterial prostheses in patients with aortic or aorto-iliac occlusive atherosclerotic disease or aneurysm. STUDY DESIGN: A descriptive, prospective and non-randomized clinical series with clinical follow-up at three and 12 months. SETTING: The study was performed at an Academic Vascular Surgery Unit. PATIENTS: Within 20 months we consecutively implanted 379 prostheses (tubes or bifurcations): 132 Stretch ePTFE (Gore-Tex) and 247 Dacron (Unigraft, Braun-Melsungen) grafts. RESULTS: There was no intraoperative deaths. Nine of 217 patients (= 4%) with occlusive atherosclerotic disease died < 30 days postoperatively; the mortality rate for asymptomatic aortic aneurysm was 8% (7/91), for symptomatic aneurysm 13% (4/30), and for ruptured aneurysm 22% (8/36). The primary patency of the aortic or aorto-iliac grafts was 99%, secondary patency at three months and one year 100 per cent. One patient with Stretch prosthesis developed a superficial groin infection, and one developed infection of an aortic tube graft. In the Dacron series six patients developed superficial groin infection, and two deep infections occurred. No graft-enteric fistulas or erosions were seen, and by clinical examination no anastomotic aneurysm developed. Five patients had in situ replacement of a pan-infected Dacron bifurcation graft with a Gore-Tex Stretch graft. With an observation time from 50 to 400 days these five patients are well without clinical signs of infection. CONCLUSIONS: These short term results with implantation of aortic or aorto-iliac Stretch ePTFE prostheses are encouraging and will provide the basis for a continuing performance trial with long term follow-up and reporting.
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