Clinical outcomes of Rheocarna therapy in maintenance hemodialysis patients with chronic limb-threatening ischemia: a retrospective case series

Abstract Background Chronic limb-threatening ischemia (CLTI) in patients receiving maintenance hemodialysis is associated with high amputation risk. Rheocarna®, a novel adsorption-type lipoprotein–fibrinogen apheresis, was approved in Japan in 2021 for patients with CLTI who are ineligible for or refractory to revascularization. This study evaluated the efficacy and safety of Rheocarna in hemodialysis patients with CLTI. Methods This retrospective case series included 15 hemodialysis patients treated with Rheocarna at our institution between May 2022 and October 2024. A total of 285 Rheocarna sessions were performed during the treatment course, including 158 sessions at our institution. Wound severity was assessed using the WIfI wound grade. Efficacy was evaluated by wound healing and laboratory changes, and safety by hemodynamic events and circuit clotting. Results The mean age was 73.7 years, and diabetes was the leading cause of end-stage kidney disease. Complete wound healing occurred in five patients (33.3%), partial improvement in two (13.3%), while six (40.0%) remained stable and two (13.3%) showed worsening. Among the five patients who achieved complete wound healing, ulcer recurrence occurred in one patient within the first year and in one additional patient during the second year. The crude 1- and 2-year amputation-free survival (AFS) rates were 60.0% and 33.3%, respectively. Significant reductions in low-density lipoprotein cholesterol, fibrinogen, and C-reactive protein were observed (all p = 0.008). Serum albumin changes did not differ significantly between patients with and without complete wound healing ( p = 0.061). Post-treatment levels ≥ 3.0 g/dL were associated with complete wound healing ( p = 0.007). A ≥ 30 mmHg decrease in systolic blood pressure occurred in 61 of 158 sessions (38.6%), affecting 13 of 15 patients (86.7%). Subjective symptoms occurred in 7 of 158 sessions (4.4%), and no serious treatment-related adverse events were observed. Conclusions Rheocarna therapy was feasible and well tolerated in maintenance hemodialysis patients with CLTI and may be associated with improved wound healing. Although the number of patients available for long-term assessment was limited, ulcer recurrence was observed during follow-up after complete wound healing. These findings highlight the importance of continued long-term surveillance after Rheocarna therapy and require confirmation in larger prospective studies.