Wound-Directed Perfusion in a Vascular Surgery Registry of Rheocarna Apheresis for Treatment-Refractory Chronic Limb-Threatening Ischemia: Visualized Flow to the Wound Bed and Sustained Pedal Inflow as Determinants of Healing and Recurrence.

BACKGROUND

Rheocarna® is a selective low-density lipoprotein and fibrinogen apheresis device introduced in Japan as an adjunctive option for chronic limb-threatening ischemia (CLTI). Real-world data in treatment-refractory limbs managed within a vascular-surgery pathway are scarce. We assembled a two-center registry to describe its use and examine which wound-directed perfusion parameters track with healing and recurrence.

METHODS

We retrospectively analyzed all 53 CLTI limbs receiving Rheocarna at two vascular-surgery-led centers (2021-2025). This descriptive, single-arm registry had no comparator; all limbs received comprehensive limb-salvage care. Perfusion was characterized using wound-oriented angiography, including visualized flow to the wound bed (VFW) and sustained pedal inflow (SPI). Common femoral endarterectomy was regarded as inflow reconstruction; limbs treated by endarterectomy plus superficial femoral artery treatment were classified as endovascular therapy. Infrainguinal revascularization comprised open bypass (n = 13) and endovascular therapy (n = 21); 19 limbs were unsuitable for revascularization. Outcomes were estimated by Kaplan-Meier analysis, with VFW and SPI explored using penalized Cox models.

RESULTS

Complete wound healing occurred in 40 limbs (75.5%), with cumulative estimates of 81% and 86% at 6 and 12 months. Limb salvage at 12 months was 85.9%. VFW was associated with higher healing and fewer additional minor amputations; SPI with greater recurrence-free wound stability. Fibrinogen fell during therapy while albumin and C-reactive protein were stable.

CONCLUSION

Within this pathway, wound-directed perfusion, VFW for initial healing, and SPI for recurrence-free durability were the dominant correlates of outcome and may refine candidate selection for Rheocarna. Prospective comparative studies are required to establish efficacy.