by T. Nishimoto, M.D., Medical Director of Clinical Apheresis Services, Carter BloodCare
The American Society for Apheresis (ASFA) released the Seventh Edition of the Guidelines on the Use of Therapeutic Apheresis in Clinical Practice in the Journal of Clinical Apheresis (JCA) in June 2016. The JCA Seventh Edition still contains the ASFA categories and grading system definitions in the 87 fact sheets (14 new fact sheets since Sixth Edition) for therapeutic apheresis diseases, with 179 indications, which are separately categorized and graded within the fact sheets.
The article describes the ten ASFA members’ methodology of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system and ASFA categories in assessing the quality of published literature. Most clinicians find the ASFA categories most useful when determining if therapeutic apheresis is an appropriate treatment for their patient.
The first ASFA guideline was published in 1986 (1) and subsequent guidelines were reviewed and revised every seven years until 2007 (Fourth Edition) (2-4). In 2007, JCA Special Issue Writing Committee decided to revise the guidelines every three years and began incorporating a systematic review process, along with evidence-based medicine in the grading, categorization of apheresis indications – which created the concept of the fact sheets that were also introduced in 2007 (Fourth Edition). Fact sheets provide the practitioner a user-friendly, concise summary of the evidence for the use of therapeutic apheresis for their patient(s).
The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was first introduced in 2010 (Fifth Edition) to validate the recommendations and enhance the ASFA categories in the fact sheets. The subsequent ASFA Guidelines (2013) continued to utilize GRADE system and category rating.
|Category I||Disorders for which apheresis is accepted as first-line therapy either as primary stand-alone treatment or in conjunction with other modes of treatment (e.g. Myasthenia gravis, acute sickle cell disease, TTP)|
|Category II||Disorders for which apheresis is accepted as second-line therapy, either as a stand-alone treatment or in conjunction with other modes of treatment (e.g. myeloma cast nephropathy, acute chest syndrome in acute sickle cell disease)|
|Category III||Optimum role of apheresis therapy is not established. Decision-making should be individualized.|
|Category IV||Disorder in which published evidence demonstrates or suggests apheresis to be ineffective or harmful. IRB approval is desirable if apheresis treatment is undertaken in these circumstances.|
The following are the recently added category I and II diseases:
- N-methyl D-aspartate receptor antibody encephalitis
- Hashimoto’s encephalopathy: Steroid-responsive encephalopathy associated with autoimmune thyroiditis
- Progressive multifocal leukoencephalopathy associated with nataluzimab
Mobile therapeutic apheresis is available through Carter BloodCare’s Clinical Apheresis Services (CAS) in north Texas, seven days a week. Emergency treatments are available 24 hours a day. CAS nurses will treat referred patients who have a diagnosis that is defined by ASFA as a category I or II. If the diagnosis is defined as a category III, consultations are available with the Carter BloodCare medical director on-call.
The JCA Seventh Special Issue is the summary of analyses of the quality of evidence, strength of evidence, and stringent reviews of published literature. ASFA categories I and II are accepted as first and second lines of treatment; however, category III will be handled on a case-by-case basis since basic, translational, and clinical research are needed to provide better evidence for clinical practice. The recommendation is either strong or weak based on the quality of the published literature.
The fact sheets in the Seventh Edition will appeal to clinicians with a focus in the area of apheresis medicine and other physicians who may need to use therapeutic apheresis occasionally for the care of their patients. The fact sheets provide succinct summaries of disease mechanisms, rationale for apheresis, and technical aspects of the procedures.
- Schwartz et al, JCA 2016, 31:149-338
- Klein HG, Balow JE, et al. J Clin Apher 1986, 3: i-vi, 1-92
- Strauss RG, Ciavarella D, et al. J Clin Apher 1993;8:189-194
- McLeod BC. J Clin Apher 2000;15:1-5
- Szczepiorkowski ZM, Shaz BH, et al. J Clin Apher 2007;22:95-105
- Guidelines on the Use of Therapeutic Apheresis in Clinical Practice; Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Seventh Special Issue; Joseph Schwartz, Anand Padmanabhan, et. Al. Journal of Clinical Apheresis. 2016 31:149-338