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A Journal on Angiology
Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,899
International Angiology 2002 March;21(1):28-35
The ArtAssist® Device in chronic lower limb ischemia. A pilot study
Louridas G., Saadia R., Spelay J., Abdoh A., Weighell W., Arneja A. S.
From the Section of Vascular Surgery, the Department of Surgery and the Department of Rehabilitation Medicine University of Manitoba, St. Boniface Hospital and Health Sciences Centre, Winnipeg, Manitoba, Canada
Background. Patients with chronic critical limb ischemia following a failed bypass graft or with non-reconstructable distal disease diagnosed angiographically, have a very poor prognosis. This is a prospective pilot study to assess the influence of the ArtAssist® Device on pedal blood flow and amputation rate.
Methods. Thirty-three legs in 25 patients were evaluated. Ten legs presented with rest pain, and 23 legs with tissue loss. Nine legs had previously undergone bypass surgery.
Results. At a mean follow-up of 3 months, 14 (42%) legs were amputated, and 19 (58%) were saved. Eleven of the amputated legs were in patients with chronic renal failure, a known risk factor. The amputation rate, excluding this group, was 13.6% (3/22). Toe pressures measured initially and after 3 months on the pump showed a significant improvement (p=0.03). Forty percent of patients presenting with rest pain improved, while 26% of foot ulcers healed on the pump. Mortality rate was 12%.
Conclusions. The results from this prospective study are encouraging but need to be validated in a larger prospective randomized study.