ArtAssist Sequential Compression Biomechanical Device as a Cost-Dominant Limb-Salvage Strategy for No-Option Chronic Limb-Threatening Ischaemia: A Decade and Half, Single-Centre Cohort Study with Health Economic and Q-TWiST Analysis.

Abstract

Background: Major lower limb amputation for no-option chronic limb-threatening ischaemia (CLTI) costs the Irish Health Service Executive (HSE) a median €88,820 per patient; long-term health economic and quality-adjusted survival evidence for ArtAssist SCBD is lacking.

Methods: Longitudinal cohort analysis of 428 patients with non-reconstructible CLTI managed with ArtAssist SCBD at a single tertiary centre (January 2008-June 2025). Primary endpoints were limb salvage, cost-effectiveness versus primary amputation, and Q-TWiST. Kaplan-Meier analysis of limb salvage, multivariable Cox regression for major amputation, competing-risks analysis, and health economic modelling using contemporaneous cost data were performed.

Findings: Overall crude limb salvage, defined as freedom from major amputation, was achieved in 85% (294/347 patients). At last follow-up, 48% of patients were alive without major amputation. Kaplan-Meier estimated 5-year limb salvage at 95%. The cumulative incidence of major amputation at 5 years was 8% when accounting for death as a competing event, confirming durable limb preservation despite substantial long-term mortality in this elderly, comorbid population. Male sex, hypertension, and ischaemic heart disease independently predicted major amputation or limb-salvage failure (HRs 1·70, 1·80, 1·71; all P ≤ ·012). Comorbidity burden showed a dose-response relationship (P = ·008). 90-day rental (€1,373/patient) reduced total expenditure six-fold versus primary amputation (€5·3M vs €30·8M), saving €76,500/patient. Q-TWiST yielded a gain of 3·37 QALYs per patient; ICER €21,900/QALY confirms a dominant strategy.

Interpretation: ArtAssist SCBD achieves a six-fold reduction in costs versus primary amputation, +3·37 QALYs/patient, and an ICER of €21,900/QALY a dominant strategy supported by durable limb preservation, with 85% overall crude limb salvage and an estimated 5-year limb salvage of approximately 95% in the largest single-centre cohort reported. These findings support universal commissioning of ArtAssist SCBD for non-reconstructible CLTI.