Every few years, the American Society for Apheresis (ASFA) Journal of Clinical Apheresis Special Issue Writing Committee publishes Guidelines on the Use of Therapeutic Apheresis in Clinical Practice.1 Referred to in routine communication as “the ASFA Guidelines”, this document is used by many apheresis centers to determine the applicability of a therapeutic apheresis treatment to a given patient’s clinical care. The document is also sometimes utilized by insurance companies to determine whether to cover therapeutic apheresis for a given indication.
The latest version of the ASFA Guidelines was published earlier this year and contained 166 indications across 91 fact sheets. Each of the 166 indications comes with both a “categorization” as well as a “grade.” The categorizations are ranked I-IV: I (first-line therapy), II (second-line therapy), III (encouraging decision making on a patient-by-patient basis) or IV (apheresis believed to be either harmful or ineffective). The “grade” consists of two portions. The first portion is a numeric designation, which can be 1 (strong recommendation) or 2 (weak recommendation). The second portion of the grade is alphabetical and consists of A (high-quality evidence), B (medium-quality evidence) or C (low- or very-low-quality evidence). Thus, a category I, grade 1A indication would mean that the Special Issue Writing Committee considered the use of apheresis to be first-line, strongly recommended, and supported by high-quality evidence. On the other hand, a category III, grade 2C indication would reflect that optimal role of apheresis is not established, the recommendation to perform apheresis is weak, and the medical evidence supporting the use of apheresis is low- or very-low-quality. The two most common categorizations/grades are category III, grade 2C (56 indications) and category III, grade 2B (22 indications). Thus, inclusion of a medical indication for apheresis in the ASFA Guidelines is best understood as an aid to medical decision making, and does not constitute, in and of itself, an endorsement of the practice.
In the 2023 edition of the ASFA Guidelines, 7 new fact sheets were added. All seven new fact sheets were for category III, grade 2 indications for plasma exchange–mild or moderate Alzheimer’s disease, autoimmune dysautonomia, specific idiopathic inflammatory myopathies, immune-related adverse events due to immune checkpoint inhibitors, paraneoplastic autoimmune retinopathies, antibody mediated rejection or desensitization for intestinal transplantation, and refractory vaccine-induced immune thrombotic thrombocytopenia.
In addition to these new indications, 2 existing indications changed from category III to category II: “erythropoietic protoporphyria, liver disease” and “inflammatory bowel disease, ulcerative colitis.” Three indications changed from category II to category III: “age related macular degeneration, dry, high risk”, “babesiosis, severe”, and “hyperleukocytosis.” Of note, the controversial practice of performing a red blood cell exchange on a pregnant patient to prevent alloimmunization to the D antigen in the aftermath of an inadvertent or emergency Rh positive RBC transfusion was changed from category III to category IV.
A SUCCESS webinar on the 7 new indications for therapeutic apheresis is planned for the first quarter of 2024.
Reference
- Connelly-Smith L et al. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice – Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue. J Clin Apher 2023;38:77-278.
