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Number 45

Non-operative Active Management of Critical Limb Ischaemia (CLI): Initial Experience Using a Sequential Compression Biomechanical Device (SCBD) for Acute Limb Salvage in CLI

Esan, O.; Mahendran, B.; Fahy, A.; Hynes, N.; Tawfik, S.; Zalatel, E.; Sultan, S.
Western Vascular Institute, University College Hospital Galway, Ireland. 2006.

Presented at the Society for Clinical Vascular Surgery, Orlando, FL. March 2007 and at the European Society for Vascular Surgery, Prague, September 2006.

Introduction: CLI patients are at risk of primary amputation in the absence of reconstructible outflow vessels and prohibitive cardiovascular risk factors. SCBD epiomises a worthwhile non-operative prospect in threatened limbs. Composite primary endpoints were limb salvage, resolution of rest pain, increase in toe pressures and 90-day mortality. Secondary endpoints were popliteal flow velocity, healing of ulcers or gangrene and cost effectiveness over primary amputation.

Materials and Methods : 35 consecutive patients with 39 critically ischaemic limbs (rest pain=12, tissue loss=13, rest pain and tissue loss=14) presented over a 24-month period. All but 9 were males. Mean age was 74.3 years. All were Rutherford classification IV/V. Patients underwent a 12-week treatment protocol with SCBD and given best medical treatment. Follow-up was done at 4-weekly intervals with duplex scan, laser Doppler and digital pressures.

Results: One-year Cumulative Limb salvage rate was 88% ( +/- SE 7.62%). Mean follow-up 10 months (+/- SD 6 months). There were 4 amputations. Ninety-day mortality was zero. Toe pressures (p<0.0001) increased while analgesia requirements decreased from the 1st week. Mean toe pressures increased from 38.2 to 61.9 mm Hg (95% CI (33.19-14.19). Popliteal flow velocity increased from 43.8 to 45.5 cm/s2 (95% CI (18.56-8.089. Mean hospital stay was 15 days.

In comparison to matched cohorts of CLI patients in the preceding 24 months, 45 primary amputation were performed with one-year mortality rate of 84.4% (+/- SE 5.41%) in comparison to one-year mortality rate of 84.5% (+/- SE 8.00%) in the SCBD study cohort (p=0.93, hazard ratio=0.95, 95%CI [0.30 to 2.98]). The estimated median cost of managing a primary amputation patient due to critical ischaemia is ?14,815 compared to ?4900 for the SCBD.

Conclusion: SCBD enhanced limb salvage, reduced length of hospital stay and imparted prompt relief of rest pain without surgical intervention in patients at the end of their live in a cost effective manner.