Guidelines on the Use of Therapeutic Apheresis in Clinical ...

1 Guidelines on the Use of Therapeutic Apheresis in ClinicalPractice Evidence-Based Approach from the WritingCommittee of the American Society for Apheresis :The Eighth Special IssueAnand Padmanabhan1| Laura Connelly-Smith2| Nicole Aqui3| Rasheed A. Balogun4|Reinhard Klingel5| Erin Meyer6| Huy P. Pham7| Jennifer Schneiderman8|Volker Witt9| Yanyun Wu10| Nicole D. Zantek11| Nancy M. Dunbar12|Guest Editor: Joseph Schwartz131 Medical Sciences Institute & Blood Research Institute, Versiti & Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin2 Department of Medicine, Seattle Cancer Care Alliance & University of Washington, Seattle, Washington3 Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania4 Department of Medicine, University of Virginia, Charlottesville, Virginia5 Apheresis Research Institute, Cologne, Germany & First Department of Internal Medicine, University of Mainz, Mainz, Germany6 Department of Hematology/Oncology/BMT/Pathology, Nationwide Children s Hospital, Columbus, Ohio7 Department of Pathology, Keck School of Medicine of the University of Southern California.

2 Los Angeles, California8 Department of Pediatric Hematology/Oncology/Neuro-oncology/Stem Cell Transplant, Ann & Robert H. Lurie Children s Hospital of Chicago, NorthwesternUniversity, Chicago, Illinois9 Department for Pediatrics, St. Anna Kinderspital, Medical University of Vienna, Vienna, Austria10 Bloodworks NW & Department of Laboratory Medicine, University of Washington, Seattle, Washington, Yale University School of Medicine, New Haven,Connecticut11 Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota12 Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire13 Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New YorkCorrespondenceNancy M.

3 Dunbar, MD; Dartmouth-Hitchcock Medical Center, Lebanon,NH : American Society for Apheresis (ASFA) Journal of Clinical Apheresis (JCA)Special Issue Writing Committee is charged with reviewing, updating and categoriz-ing indications for the evidence-based use of Therapeutic Apheresis (TA) in human dis-ease. Since the 2007 JCA Special Issue (Fourth edition ), the committee hasincorporated systematic review and evidence-based approaches in the grading and cat-egorization of Apheresis indications. This Eighth edition of the JCA Special Issue con-tinues to maintain this methodology and rigor in order to make recommendations onthe use of Apheresis in a wide variety of diseases/conditions. The JCA Eighth edition ,like its predecessor, continues to apply the category and grading system definitions infact sheets.

4 The general layout and concept of a fact sheet that was introduced in theFourth edition , has largely been maintained in this edition . Each fact sheet succinctlyDOI: Clin ;34:171 2019 Wiley Periodicals, the evidence for the use of TA in a specific disease entity or medical con-dition. The Eighth edition comprises 84 fact sheets for relevant diseases and medicalconditions, with 157 graded and categorized indications and/or TA modalities. TheEighth edition of the JCA Special Issue seeks to continue to serve as a key resourcethat guides the utilization of TA in the treatment of human |INTRODUCTIONThe Writing Committee of the Journal of Clinical Apheresis (JCA) Special Issue 2019 is pleased to present the Eighth Edi-tion of the JCA Special Issue. After more than 2 years ofengaging collaborative work, and the rigorous critical reviewof fact sheets contained herein, we believe that this documentwill appeal to both practitioners with a focus in the area ofapheresis medicine and other physicians who may need to uti-lize Therapeutic Apheresis (TA) occasionally for the care oftheir patients.

5 This latest iteration of evidence-based ASFA categories is based upon a stringent review of up-to-date liter-ature, analysis of the quality of evidence, and the strength ofrecommendation derived from this Special Issue is a compilation of fact sheets for 84 dis-eases (Table 1). To clarify terminology used in this table andthroughout this document, Disease refers to a specific dis-ease or medical condition ( , myasthenia gravis [disease];transplantation, liver [medical condition]) and represents thepathology discussed in the fact sheet. Indication refers tothe use of Apheresis in specific situations encountered in thedisease ( acute, short-term treatment [indication]). Eachdisease, TA modality and indication is assigned a category(Table 2) and grade (Table 3) as in previous editions.

6 In thisedition, we have continued to use the table format at the startof each fact sheet to summarize disease name, TA modality(Table 4), indication(s), category, and grade. Several diseasesor conditions that are category IV, which have been describedin detail in previous editions and do not have significant newevidence since the last publication, are summarized in a sepa-rate table (Table 5).The 2019 JCA Special Issue Writing Committee com-prised 13 members from diverse fields including Transfu-sion Medicine/ Apheresis , Hematology/Oncology, Pediatrics,Nephrology, and Critical Care Medicine from locations acrossthe United States and Europe. Each disease or condition wasassigned to one committee member as primary author. Thatprimary author reviewed any new developments in the under-standing, current management , and treatment of the disease orcondition as well as any changes in the evidence surroundingthe use of TA as a treatment modality.

7 Only peer-reviewedPubMed-indexed publications available in English were con-sidered when reviewing literature published since the last factsheet update. The primary author updated each fact sheettable, disease description, current management , rationale forTA, technical notes ( , volumes treated, frequency, replace-ment fluid), duration and discontinuation of treatment, andprovided a maximum of 20 key references highlightingimportant or new studies and/or reviews (Figure 1). Two othercommittee members, along with an external expert for selectfact sheets, provided secondary peer-review of each fact entire writing committee performed a third and final reviewof all fact sheets with category and grade assigned by consensusin the same manner as described in previous editions with con-sistent application of evaluation criteria.

8 This evidence-basedapproach is designed to achieve several objectives. First, it pro-vides uniformity to ASFA category assignment and disease dis-cussion while minimizing personal bias. Second, it provides thestrength of recommendation [strong (1) vs. weak (2)] using adefined grading schema. Finally, it provides comprehensive, yetsuccinct information easily shared with healthcare providersrequesting information on the potential utility of Apheresis in agiven Clinical setting. The entire process of fact sheet develop-ment is shown in Figure diseases or conditions underwent review in con-sideration for the development of a new fact sheet (Table 6).To meet criteria for a new fact sheet, the committee requireda minimum of 10 cases published in the last decade in peer-reviewed journals, ideally by more than one group.

9 Basedon these criteria, there were no new disease categories addedto the JCA 2019 Special Issue. Strong consideration wasgiven for the addition of a new fact sheet on Alzheimer sdisease. The published evidence for the use of TPE inAlzheimer s disease is currently limited. Preliminary datafrom the recently concluded phase IIb/III Alzheimer Man-agement by Albumin Replacement (AMBAR) study is avail-able in abstract form but is not yet published in a peer-reviewed journal. Thus, Alzheimer s disease was notselected for inclusion in the JCA 2019 Special previously published fact sheets were renamed togroup fact sheets together by similar disease pathology and/ortreatment. For example, ANCA-associated rapidly progressiveglomerulonephritis and Henoch-Sch nlein purpura wererenamed Vasculitis, ANCA-associated and Vasculitis, IgA(Henoch-Sch nlein purpura) respectively with a separate factsheet for Vasculitis, other.

10 All fact sheets involving trans-plantation have been renamed Transplantation, The Aplastic anemia, pure red cell aplasia fact sheet172 PADMANABHANET 1 Category and Grade Recommendations for Therapeutic ApheresisDiseaseTA modalityIndicationCategoryGradePageAcute disseminatedencephalomyelitis (ADEM)TPES teroid RefractoryII2C187 Acute inflammatory demyelinatingpolyradiculoneuropathy (Guillain-Barr syndrome)TPEP rimary TreatmentI1A189 IAPrimary TreatmentI1 BAcute liver failureTPE-HVI1A191 TPEIII2 BAge related macular degeneration,dryRheopheresisHigh-riskII2 B193 Amyloidosis, systemic 2-microglobulincolumnDialysis-relatedamy loidosisII2B195 TPEO ther causesIV2 CAnti-glomerular basementmembrane disease (Goodpasturesyndrome)TPED iffuse alveolarhemorrhage (DAH)I1C197 TPED ialysis- independenceI1 BTPED ialysis-dependence, noDAHIII2 BAtopic (neuro-) dermatitis(atopic eczema), recalcitrantECPIII2A199 IAIII2 CTPE/DFPPIII2 CAutoimmune hemolytic anemia,severeTPES evere cold agglutinindiseaseII2C201 TPES evere warm autoimmuneIII2 CBabesiosisRBC exchangeSevereII2C203 Burn shock resuscitationTPEIII2B205 Cardiac neonatal lupusTPEIII2C207 Catastrophic antiphospholipidsyndrome (CAPS)TPEI2C209 Chronic focal encephalitis(Rasmussen Encephalitis)TPEIII2C211 Chronic inflammatorydemyelinatingpolyradiculoneu ropathy (CIDP)TPE/IAI1B213 Coagulation factor inhibitorsTPEIII2C215 IAIII2 BComplex regional pain syndromeTPEC hronicIII2C217 CryoglobulinemiaTPES evere/symptomaticII2A219 IASevere/symptomaticII2 BCutaneous T cell lymphoma(CTCL).