Journal List > Ann Lab Med > v.42(6) > 1516078809

Chung, Kim, and Ko: Proposal of the Need for New Korean Guidelines on the Use of Therapeutic Apheresis in Clinical Practice
Dear Editor,
Therapeutic apheresis is performed for numerous indications in various medicine fields [1-5]. The primary reference on the use of therapeutic apheresis are the evidence-based guidelines issued by the Writing Committee of the American Society for Apheresis (ASFA) [6]. These guidelines provide structured evidence for therapeutic apheresis and are offered for medical consideration worldwide. Recently, new guidelines were issued by the Japanese Society for Apheresis (JSFA) [7]. The main difference between the two guidelines lies in the primary modality used in each country and clinical indications for therapeutic apheresis. The primary apheresis modality used in Japan is the membrane separation method, whereas in the USA, the centrifugal separation method is mainly used. As the target diseases and their backgrounds differ between these countries, there was a need to develop new guidelines in Japan.
The most noticeable difference between the ASFA and JSFA guidelines is that various new techniques are suggested in the latter. New technologies and tools have been developed and applied in clinical apheresis in Japan, including hollow-fiber devices such as double filtration plasmapheresis (DFPP), adsorption devices such as polymyxin B-immobilized endotoxin adsorption columns, and selective plasma exchange devices. In the JSFA guidelines, out of four categories, plasma filtration with dialysis (PDF) for liver failure is classified as category II, implying that therapeutic apheresis can be applied as a second-line therapy, independent of plasma exchange and continuous hemodiafiltration (CHDF) for acute liver failure (category I). In the ASFA guidelines, plasma exchange is the only option suggested for acute liver failure. As for the diseases included in the two guidelines, 39 diseases are included only in the ASFA guidelines and 32 diseases only in the JSFA guidelines (Table 1). This likely reflects the variability in the prevalence of certain diseases according to country and ethnicity. Specifically, babesiosis, malaria, and sickle cell disease are included only in the ASFA guidelines as their prevalence in Asia is extremely low. Extracorporeal photopheresis (ECP) for graft-versus-host disease (GVHD) is classified into category II in the ASFA guidelines, whereas there is no mention of ECP for GVHD in the JSFA guidelines.
Guidelines for therapeutic apheresis have yet to be developed in Korea. At present, medical decisions and national health insurance reimbursements for apheresis are based on the ASFA guidelines. Like in the USA, the main modality used for clinical apheresis in Korea is centrifugal separation. However, the target diseases are closer to those in Japan because of shared ethnic and geographical backgrounds. Due to the language barrier, literature published in Korean was not included in either of the guidelines. There is a need to develop Korean guidelines on therapeutic apheresis using both guidelines as a reference, while considering Korea’s unique demands. For example, severe fever with thrombocytopenia syndrome (SFTS) is uncommon in the USA and is therefore not included in the ASFA guidelines. Despite there being a few cases of SFTS in Japan, it is not included in the JSFA guidelines either. However, in Korea, the incidence of SFTS is relatively high, at 200–250 cases annually, and the clinical utility of therapeutic plasma exchange (TPE) for the treatment of SFTS has been suggested in case reports [8, 9]. In the guidelines published by the Korea Disease Control and Prevention Agency, TPE has been suggested as a treatment option for removing cytokines in SFTS [10]. New Korean guidelines should be introduced that enable the clinical application of therapeutic apheresis for diseases unique to the Korean population as well as the reimbursement from insurance for apheresis in such cases.
The frequency and modalities used for apheresis in different diseases vary among countries, as does the reimbursement from insurance [5]. Optimal guidelines for clinical apheresis should be established for each country’s unique population and could guide physicians in deciding whether to perform apheresis. There should be continuous academic and political efforts to establish clinical apheresis guidelines in Korea.

ACKNOWLEDGEMENTS

None.

Notes

AUTHOR CONTRIBUTIONS

Chung Y: Investigation, Writing—original draft preparation; Kim Y: Writing—reviewing and editing; Ko DH: Conceptualization, Writing—reviewing and editing.

CONFLICTS OF INTEREST

The authors have no competing interests to declare.

RESEARCH FUNDING

This study did not receive any grant from funding agencies in the public, commercial, or not-for-profit sectors.

REFERENCES

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3. De Silvestro G, Tison T. Italian Society of Apheresis and Cell Manipulation (SIdEM). 2018; Italian registry of therapeutic apheresis. Transfus Apher Sci. 57:143–7. DOI: 10.1016/j.transci.2018.04.002. PMID: 29703557.
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4. Mörtzell Henriksson M, Newman E, Witt V, Derfler K, Leitner G, Eloot S, et al. 2016; Adverse events in apheresis: an update of the WAA registry data. Transfus Apher Sci. 54:2–15. DOI: 10.1016/j.transci.2016.01.003. PMID: 26776481.
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5. Stegmayr B, Mörtzell Henriksson M, Newman E, Witt V, Derfler K, Leitner G, et al. 2017; Distribution of indications and procedures within the framework of centers participating in the WAA apheresis registry. Transfus Apher Sci. 56:71–4. DOI: 10.1016/j.transci.2016.12.023. PMID: 28162978.
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6. Padmanabhan A, Connelly-Smith L, Aqui N, Balogun RA, Klingel R, Meyer E, et al. 2019; Guidelines on the use of therapeutic apheresis in clinical practice-evidence-based approach from the Writing Committee of the American Society for Apheresis: the eighth special issue. J Clin Apher. 34:171–354. DOI: 10.1002/jca.21705. PMID: 31180581.
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7. Abe T, Matsuo H, Abe R, Abe S, Asada H, Ashida A, et al. 2021; The Japanese Society for Apheresis clinical practice guideline for therapeutic apheresis. Ther Apher Dial. 25:728–876. DOI: 10.1111/1744-9987.13749. PMID: 34877777.
8. Yoo JR, Kim SH, Kim YR, Lee KH, Oh WS, Heo ST. 2019; Application of therapeutic plasma exchange in patients having severe fever with thrombocytopenia syndrome. Korean J Intern Med. 34:902–9. DOI: 10.3904/kjim.2016.194. PMID: 29117665. PMCID: PMC6610197.
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10. Korea Disease Control and Prevention Agency. Guidelines for treatment of severe febrile thrombocytopenia syndrome. http://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=312&CONT_SEQ=333510. Updated on Jul 2016.

Table 1
Diseases included in only one of the ASFA and JSFA guidelines and their modalities, indications, categories, and grades
Guidelines Diseases Therapeutic apheresis modality Indication Category Grade
ASFA only Age-related macular degeneration, dry Rheopheresis High-risk II 2B
Atopic (neuro-)dermatitis (atopic eczema), recalcitrant ECP
IA
TPE/DFPP
III
III
III
2A
2C
2C
Autoimmune hemolytic anemia, severe TPE
TPE
Severe cold agglutinin disease
Severe warm autoimmune
II
III
2C
2C
Babesiosis RBC exchange Severe II 2C
Burn shock resuscitation TPE III 2B
Cardiac neonatal lupus TPE III 2C
Catastrophic antiphospholipid syndrome TPE III 2C
Erythropoietic protoporphyria, liver disease TPE
RBC exchange
III
III
2C
2C
Graft-versus-host disease ECP
ECP
Acute
Chronic
II
II
1C
1B
Hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome TPE
TPE
Postpartum
Antepartum
III
IV
2C
2C
Hemophagocytic lymphohistiocytosis; hemophagocytic syndrome; macrophage activating syndrome TPE III 2C
Heparin-induced thrombocytopenia and thrombosis TPE
TPE
Pre-cardiopulmonary bypass
Thrombosis
III
III
2C
2C
Hereditary hemochromatosis Erythrocytapheresis I 1B
IgA nephropathy (Berger’s disease) TPE
TPE
Crescentic
Chronic progressive
III
III
2B
2C
Immune thrombocytopenia TPE/IA Refractory III 2C
Malaria RBC exchange Severe III 2B
Myeloma cast nephropathy TPE II 2B
Nephrogenic systemic fibrosis ECP/TPE III 2C
Pemphigus vulgaris TPE
ECP/IA
Severe
Severe
III
III
2B
2C
Peripheral vascular diseases LA II 1B
Post-transfusion purpura TPE III 2C
Pruritus due to hepatobiliary diseases TPE Treatment resistant III 1C
Scleroderma (systemic sclerosis) TPE
ECP
III
III
2C
2A
Sickle cell disease, acute RBC exchange
RBC exchange
RBC exchange
Acute stroke
Acute chest syndrome, severe
Other complications
I
II
III
1C
1C
2C
Sickle cell disease, non-acute RBC exchange
RBC exchange
RBC exchange
RBC exchange
Stroke prophylaxis
Pregnancy
Recurrent vaso-occlusive pain crisis
Pre-operative management
I
II
II
III
1A
2B
2B
2A
Sudden sensorineural hearing loss LA/rheopheresis/TPE III 2A
Thrombocytosis Thrombocytapheresis
Thrombocytapheresis
Symptomatic
Prophylactic or secondary
II
III
2C
2C
Thrombotic microangiopathy, coagulation mediated TPE THBD, DGKE, and PLG mutations III 2C
Thrombotic microangiopathy, drug-associated TPE
TPE
TPE
Ticlopidine
TPE Clopidogrel
Gemcitabine/quinine
I
III
IV
2B
2B
2C
Thrombotic microangiopathy, transplantation associated TPE III 2C
Thyroid storm TPE II 2C
Transplantation, cardiac ECP
ECP
TPE
TPE
Cellular/recurrent rejection
Rejection prophylaxis
Desensitization
Antibody-mediated rejection
II
II
II
III
1B
2A
1C
2C
Transplantation, hematopoietic stem cell, ABO incompatible (ABOi) TPE
TPE
RBC
TPE
Major ABOi HPC(M) II
Major ABOi HPC(A) II
Minor ABOi HPC(A) III
Major/minor ABOi with pure RBC aplasia
II
II
III
III
1B
2B
2C
2C
Transplantation, hematopoietic stem cell, human leukocyte antigen desensitization TPE III 2C
Transplantation, liver TPE
TPE
ECP
ECP
Desensitization, ABOi living donor
Desensitization, ABOi deceased donor/antibody-mediated rejection
Desensitization, ABOi
Acute rejection/immune suppression withdrawal
I
III
III
III
1C
2C
2C
2B
Transplantation, lung ECP
TPE
Bronchiolitis obliterans syndrome
Antibody-mediated rejection/desensitization
II
III
1C
2C
Vasculitis, IgA (Henoch–Schönlein purpura) TPE
TPE
Crescentic rapidly progressive glomerulonephritis
Severe extrarenal manifestations
III
III
2C
2C
Vasculitis, other TPE
TPE
Adsorptive cytapheresis
TPE
Hepatitis B polyarteritis nodosa
Idiopathic polyarteritis nodosa
Adsorptive cytapheresis Behcet’s disease
Behcet’s disease
II
IV
II
III
2C
1B
1C
2C
Wilson’s disease, fulminant TPE I 1C
JSFA only Acute autonomic sensory neuropathy TPE III 2C
Acute exacerbation of interstitial pneumonia PMX-DHP III 2C
Acute pancreatitis CHDF, PDF II 2B
Acute respiratory distress syndrome CHDF III 2C
Amyopathic dermatomyositis and polymyositis with complications of interstitial pneumonia PMX-DHP, LCAP III 2B/3C
Arteriosclerosis obliterans LDL-A II 1C
Ascites CART II 1C
Autoimmune autonomic ganglionopathy TPE III 2C
Autoimmune encephalitis/cerebellitis LGI1/Caspr2/GABAbR/ AMPAR/GAD/GlyR/NAE TPE, IAPP, CAP III 2C
Bickerstaff brainstem encephalitis TPE, IAPP III 2C
Calciphylaxis LDL-A, TPE, cryofiltration III 2C
Cholesterol crystal embolism LDL-A II or III 2C
Chronic hepatitis C DFPP III 2C
Diabetic nephropathy LDL-A III 1C
Drug-induced lung damage PMX-DHP III 2C
Fisher’s syndrome TPE, DFPP, IAPP III 2C
HTLV-1-associated myelopathy TPE, IAPP, LCAP III 2C
Hypertrophic pachymeningitis LCAP III 2C
Isaacs’ syndrome TPE, DFPP III 2B
Neuropsychiatric SLE IAPP, TPE, DFPP II 2C
Palmoplantar pustulosis GMA III 1C
Pemphigoid TPE, DFPP II 1C
Psoriatic arthritis GMA II 1C
Pyoderma gangrenosum GMA III 2C
Rapidly progressive interstitial pneumonia associated with anti-MDA5 antibody-positive dermatomyositis PE III 2C
Refractory nephrotic syndrome PE, DFPP, LDL-A III/III –/2C
Renal failure with unstable hemodynamics CHDF I
Severe sepsis and septic shock CHDF (without AN-69ST)
Sjögren’s syndrome PE, DFPP III 2C
Tumefactive demyelinating disease PE III 2C
Liver failure PDF II 1C
Severe acute pancreatitis PDF III 2C

Abbreviations: ASFA, American Society for Apheresis; CART, cell-free and concentrated ascites reinfusion therapy; CHDF, continuous hemodiafiltration; DFPP, double filtration plasmapheresis; ECP, extracorporeal photopheresis; GMA, granulocyte and monocyte adsorption apheresis; HPC, hematopoietic progenitor cell; IA, immunoadsorption; IAPP, immunoadsorption plasmapheresis; JSFA, Japanese Society for Apheresis; LA, lipoprotein apheresis; LCAP, leukocytapheresis; LDL-A, LDL apheresis; PDF, plasma filtration with dialysis; PMX-DHP, polymyxin B-immobilized fiber column direct hemoperfusion; TPE, therapeutic plasma exchange; RBC: red blood cell.

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