Rheopheresis in Patients with Critical Limb Ischemia––Results of an Open Label Prospective Pilot Trial

Abstract

Rheopheresis is a specifically designed application of double filtration plasmapheresis, for extracorporeal treatment of microcirculatory disorders. Safety and efficacy of Rheopheresis for wound healing and skin oxygenation were investigated in patients with critical limb ischemia. Twelve patients of Fontaine stage III-IV were treated with a series of 10 Rheopheresis sessions over 17 weeks. Transcutaneous oxygen pressure (tcpO(2)) and ankle-brachial index (ABI) were repeatedly determined to monitor the effects of the Rheopheresis treatment series on microcirculation and skin blood flow. Laboratory parameters of blood rheology were measured in addition to safety parameters and course of the pain syndrome was documented. In four patients (baseline Fontaine stage III) Rheopheresis was associated with an improvement of Fontaine stage, a pronounced increase in tcpO(2) and complete regression of the rest pain. As an adjunct therapeutic option, Rheopheresis may preserve a functional lower extremity, delay amputation or reduce the extent of amputation.

Prospective, randomized, controlled clinical study evaluating the efficacy of Rheopheresis for dry age-related macular degeneration

“…In the treatment group, the mean reduction rates achieved were: for LDL 64.9% (s=0.09), for alpha-2-macroglobulin 52.5% (s=0.15) and for fibrinogen 59.6% (s=0.12), demonstrating an efficient reduction of hemorheological parameters which is in accord to already published data [10,11].…”

“…A systematic decrease in choroidal circulatory parameters was observed in combination with an increase in the severity of AMD features associated with risk for the development of choroidal neovascularisations (CNV), supporting the role of ischemia in the development of CNV [26]. Rheopheresis has been demonstrated to increase oxygen concentration in ischemic tissues [10,11]. Improvement of the pulsatile ocular blood flow and shortening of the arteriovenous passage time in patients with AMD after Rheopheresis treatment demonstrated a positive effect of Rheopheresis on the microcirculation directly in the eye [27,28].…”

“…Results from prospective clinical trials with patients suffering from AMD and microcirculatory disorders of other tissue beds (e.g. ischemic diabetic foot, critical limb ischemia, diabetic retinopathy, and sudden sensorineural hearing loss) can be mentioned as proof of principle [10][11][12][13]. The primary objective of Rheopheresis is to preserve and potentially restore functional vision in AMD patients.…”

Fibrinogen Apheresis in the Treatment of Peripheral Arterial Disease

“…Moreover, ABI is more relevant in studies of medium caliber vessels than of the microcirculation, which is theoretically more sensitive to variations of plasma viscosity. In other studies conducted with other apheretic methods (rheopheresis), ABI showed no significant improvements either [31] .…”

“…In fact, a reduction in fibrinogen using nonselective methods for this substance such as LDL apheresis [30] or rheopheresis [31] resulted in increased muscle oxygen tension and transcutaneous oxygen pressure, improving the symptoms in both cases. Our study confirms these findings, emphasizing the value of fibrinogen reduction in rapidly improving the clinical symptoms, likely induced by correction of the rheological properties of blood.…”