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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.
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.