Transfusion medicine

Category definitions for therapeutic apheresis

Category	Description
I	Apheresis is accepted as first line therapy, either as a primary standalone treatment or in conjunction with treatment modalities
II	Apheresis is accepted as second line treatment, either standalone or in conjunction with other treatment modalities
III	Apheresis decision should be individualized; the optimum role of apheresis is not established
IV	Disorders for which apheresis is ineffective or harmful based on the published data

Grading recommendations and evidence for therapeutic apheresis

	Description	Methodological quality of supporting evidence	Implications
Grade 1A	Strong recommendation, high quality evidence	Randomized controlled trials without important limitations or overwhelming evidence from observational studies	Strong recommendation; can apply to most patients in most circumstances without reservation
Grade 1B	Strong recommendation, moderate quality evidence	Randomized controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies	Strong recommendation; can apply to most patients in most circumstances without reservation
Grade 1C	Strong recommendation, low quality or very low quality evidence	Observational studies or case series	Strong recommendation but may change when higher quality evidence becomes available
Grade 2A	Weak recommendation, high quality evidence	Randomized controlled trials without important limitations or overwhelming evidence from observational studies	Weak recommendation; best action may differ depending on circumstances or patients' or societal values
Grade 2B	Weak recommendation, moderate quality evidence	Randomized controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies	Weak recommendation; best action may differ depending on circumstances or patients' or societal values
Grade 2C	Weak recommendation, low quality or very low quality evidence	Observational studies or case series	Very weak recommendation; other alternatives may be equally reasonable

• Reference: Curr Opin Hematol 2019;26:461

A 25 year old man with no significant medical history presents to the emergency department, where his significant other describes that he was not himself for the past day and had a fever. He is also looking pale compared to before. Last night, he hit his arm while trying to get to the bathroom, which caused a large area of bluish discoloration.

• On arrival vitals: temperature of 39.0 °C, heart rate of 110, blood pressure of 110/70, O2 of 95% on radial artery (RA), respiration rate (RR) of 20
• Labs significant for hemoglobin (7 g/dL), hematocrit (14.2%), platelet count (10 x 10⁹/L), haptoglobin (< 30 mg/dL), lactate dehydrogenase (LDH; 1,885 U/L) and indirect bilirubin (3.2 mg/dL)
• Peripheral blood smear revealed an abnormally high reticulocyte count (18.7%) and presence of schistocytes

A medicine resident inquires about the evidence for plasma exchange procedure. What does American Society for Apheresis (ASFA) recommend for this patient?

1. ASFA category I, grade 1A
2. ASFA category I, grade 1B
3. ASFA category II, grade 1A
4. ASFA category II, grade 1B
5. ASFA category III, grade 2C

A. This indication for plasma exchange (PLEX) carries ASFA category I, grade 1A recommendation. This patient presents with profound thrombocytopenia, hemolytic anemia, fever and neurological changes, which are consistent with thrombotic thrombocytopenic purpura (TTP) until proven otherwise. The most recent 2019 ASFA guidelines recommend PLEX as first line therapy, which would be category I indication with grade 1A recommendation (strong recommendation, high quality of evidence). The categories and grading system are explained in tables 1 and 2.

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Reference: ASFA guidelines overview

A 65 year old woman with a history of diabetes and hypertension presents to her primary care office with fatigue and difficulty breathing for the past week. As part of workup, her primary care provider orders a CBC and results come back with WBC 150 x 10⁹/L, hemoglobin (Hgb) 7.5 g/dL and platelet (PLT) count of 10 x 10⁹/L. The primary care provider refers her to the emergency department immediately but she wants to stay home. After a couple of days, she becomes increasingly short of breath and is brought in by ambulance with O2 requirement of 10 L.

• In the emergency department, her WBC went up to 190 x 10⁹/L, Hgb 7.0 g/dL
• Peripheral smear shows 80% of blasts consistent with acute leukemia
• Coagulation profile is within normal limits

A hematology oncology fellow who has already looked at the American Society for Apheresis (ASFA) guidelines calls you and states that he found this indication carries a category II, grade 2C recommendation. What does this ASFA recommendation indicate?

1. Apheresis should be considered as first line standalone therapy with strong recommendation and high quality evidence
2. Apheresis should be considered as a second line treatment with strong recommendation and high quality evidence
3. Apheresis should be considered as a second line treatment with strong recommendation and low quality evidence
4. Apheresis should be considered as a second line treatment with weak recommendation and low quality evidence
5. Apheresis should not be considered with strong recommendation and high quality evidence

D. Apheresis should be considered as a second line treatment with weak recommendation and low quality evidence. Category II: apheresis procedure is considered as a second line treatment either standalone or in conjunction with other treatment modalities. Grade 2C: weak recommendation with low quality of evidence.

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Reference: ASFA guidelines overview