The ArtAssist  Device in chronic lower limb ischemia. A pilot study.
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.
Louridas
G
G
Section of Vascular Surgery, the Department of Surgery, University of Manitoba, St. Boniface Hospital and Health Sciences Centre, Winnipeg, Manitoba, Canada.
Saadia
R
R
Spelay
J
J
Abdoh
A
A
Weighell
W
W
Arneja
A S
AS
Tanner
J
J
Guzman
R
R
D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D002908:Chronic Disease; D023381:Endpoint Determination; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000453:epidemiology / Q000628:therapy*; D007866:Leg / Q000098:blood supply* / Q000601:surgery; D023821:Limb Salvage / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome