Efficacy of Rheocarna®, a Novel Apheresis Device, in Patients With No- or Poor-Option Chronic Limb-Threatening Ischemia

Abstract

Background: Although revascularization is first-line therapy for chronic limb-threatening ischemia (CLTI), there are no established treatments for patients in whom revascularization is not (or is a poor) option, including CLTI that has responded poorly to revascularization. This study verified the efficacy of the Rheocarna®, a novel apheresis device, for no-option CLTI or poor-response CLTI after revascularization. Methods and Results: This multicenter retrospective observational study analyzed 221 patients (221 limbs) with no- or poor-option CLTI (mean [±SD] age 71±10 years; males, 70.1%; diabetes, 76.5%; dialysis, 87.8%; Rutherford category 6, 26.4%) undergoing apheresis with the Rheocarna between March 2021 and March 2022. The primary endpoint was the 1-year wound-healing rate. After apheresis with the Rheocarna, C-reactive protein, fibrinogen, and low-density lipoprotein cholesterol (LDL-C) levels decreased significantly, and the ankle-brachial index (ABI) and skin perfusion pressure (SPP) increased significantly (all P<0.05). At 1 year, the wound-healing rate was 60.7%, and rates of limb salvage, freedom from reintervention, overall survival, and amputation-free survival were 83.4%, 69.2%, 70.2% and 61.3%, respectively. At baseline, non-ambulatory status, lower ejection fraction, and lower blood albumin levels were independently associated with a lower wound-healing rate. Conclusions: Apheresis with the Rheocarna in patients with no- or poor-option CLTI reduced LDL-C and fibrinogen levels and improved ABI and SPP, achieving a 1-year wound healing rate of 60.7%. This novel approach could provide additional treatment options for conventional CLTI.