RheoNet registry analysis of rheopheresis for microcirculatory disorders with a focus on age-related macular degeneration.
The purpose of establishing the RheoNet registry was to evaluate the safety and efficacy of rheopheresis, a specific method of therapeutic apheresis used to treat microcirculatory disorders. Apheresis centers providing rheopheresis therapy and physicians caring for the underlying disease were asked to participate in the registry, and the registry data were analyzed for safety and tolerability. Age-related macular degeneration (AMD) was selected as a model disease to evaluate efficacy. The RheoNet registry was successfully established recording 7722 rheopheresis treatments of 1110 patients, including 833 AMD patients. The mean age of patients was 72 years. Adverse events (AE) were reported in 5.67% of treatments, but termination of the treatment session was only required in 0.48%. Transient hypotension was the most frequently reported AE. No age-related increase in AE was observed. Ophthalmological data of 428 eyes (of 279 treated patients) with dry AMD could be analyzed; 85 eyes of 55 untreated AMD patients served as the control. At 6.75 +/- 5.25 months post-baseline, 42% of the treated eyes had improved visual acuity. The proportion of eyes with a decline in visual acuity was 17%, compared to 40% in the untreated controls (P < 0.01). The RheoNet registry has been successfully established and data analysis revealed that rheopheresis is a safe outpatient treatment for microcirculatory disorders. Moreover, RheoNet currently provides the largest evaluation of the efficacy of rheopheresis for dry AMD. Registry analysis contributes to a safe and appropriate use of rheopheresis in clinical practice.
Klingel
Reinhard
R
Apheresis Research Institute, University of Mainz, Mainz, Germany. afi@apheresis-research.org
Fassbender
Cordula
C
Heibges
Andreas
A
Koch
Frank
F
Nasemann
Joachim
J
Engelmann
Katrin
K
Carl
Thomas
T
Meinke
Michael
M
Erdtracht
Bernard
B
D000368:Aged; D000369:Aged, 80 and over; D001781:Blood Component Removal / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007022:Hypotension / Q000453:epidemiology; D008268:Macular Degeneration / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D012042:Registries; D016896:Treatment Outcome; D014792:Visual Acuity