Early results of 132 aortic or aorto-iliac arterial reconstructions with the new Stretch ePTFE vascular prosthesis.

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.