Critical limb ischemia (CLI) is a clinical syndrome of ischemic pain at rest or tissue loss, such as non-healing ulcers or gangrene, related to Peripheral Artery Disease (PAD). CLI has a high short-term risk of limb amputation.Mortality after amputation is extremely high and is increased in diabetic patients. An Endovascular first approach is recommended based on a lower procedural risk.

AIM: To determine whether the use of the Orbital Atherectomy System (OAS) in calcified infrapopliteal lesions for CLI patients can be a cost saving technology for regional health institutions compared to the currently used treatment: Balloon Angioplasty (BA) alone. In particular, the study is presented in the context of the Maria Cecilia Hospital (Italy) which is a reference center in the treatment of CLI patients.

METHOD: Budget Impact Model was developed with clinical and healthcare utilization data from CALCIUM 360 trial (2) and current cost data at Maria Cecilia Hospital. Existing OAS modelling analysis determined cost-effectiveness of OAS+BA vs current treatment for infrapopliteal calcified lesions in the US (1), but never before in Europe. By considering the resource usage per CLI patient at Maria Cecilia Hospital, and the consumable unit costs, the BIA was prepared to demonstrate cost savings for the hospital.

RESULTS: The analysis suggests that the strategy OAS+BA is associated with 12-month cost savings up to 460,500€ for every 100 procedures to the hospital. The economic value of OAS+BA is related to a reduced need for major amputation, TLR/TVR and the cost of end-of-life care despite higher upfront costs. Results were consistent compared to the current US literature where it has been demonstrated the superiority in incremental QALYs and incremental free-of-amputation years of life.(1) (2)

CONCLUSIONS: Orbital Atherectomy System prior to Balloon Angioplasty was associated with significant cost savings to the Maria Cecilia Hospital.