Non-operative active management of Critical Limb Ischaemia (CLI): Initial experience using a Sequential Compression Biomechanical Device (SCBD) for Limb Salvage.

Objectives: We aim to evaluate non-operative management using a SCBD in amputation-bound non-reconstructible CLI patients.
Composite-primary endpoints were limb-salvage, rest-pain resolution, toe pressure change and 90-day mortality. Second endpoints were popliteal artery bloodflow velocity(PABV) variation, ulcer healing and cost-effectiveness.
Methods: 35 patients (39 limbs: rest pain=12, tissue loss=27) presented over 24-months. 30 had non-reconstructible arterial outflow vessels. 5 were non-operable due to severe co-morbidity (ASA IV). 74% males. Mean age 74.3years. All were Rutherford classification IV/V with multiple level disease.
All underwent a 12-week treatment protocol and best medical treatment. Follow-up was 4-weekly with duplex scan, ankle-brachial pressure index and digital pressures.
Results: Mean follow-up was 10months(+/-SD 6months). One-year Cumulative Limb-salvage rate was 88%(+/-SE 7.62%). Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 61.9mmHg(95%CI -33.19-14.19). Analgesia requirements decreased from the 1^st week (p< 0.0001).
PABV increased from 43.8 to 45.5cm/s²(95%CI (18.56-8.089). Mean hospital stay was 15days.
In a matched cohort of CLI patients in the preceding 24 months, 45 primary amputations were performed with mean hospital stay of 25days and one-year mortality rate of 84.4%(+/-SE 5.41%). This compares to one-year mortality of 84.5%(+/-SE 8.00%) in the SCBD cohort (p=0.93, hazard ratio=0.95, 95%CI[0.30 to 2.98]). Estimated median Inpatient/Total cost of managing a primary-amputation patient is €15,000/€29,815 compared to €9000/€13,900 for SCBD.
Conclusions: SCBD enhanced limb salvage, reduced length of hospital stay and provided rapid relief of rest pain without surgical intervention in patients with limited life expectancy with non-reconstructible lower limb arterial tree in a cost effective manner.