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Apheresis
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Apheresis
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Apheresis
Whole blood enters the centrifuge (1) and separates into plasma (2), leukocytes (3), and erythrocytes (4). Selected components are then drawn off (5).
MeSHD016238

Apheresis (ἀφαίρεσις (aphairesis, "a taking away")) is a medical technology in which the blood of a person is passed through an apparatus that separates one particular constituent and returns the remainder to the circulation. It is thus an extracorporeal therapy.

One of the uses of apheresis is for collecting hematopoietic stem cells.[1]

Method

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Depending on the substance that is being removed, different processes are employed in apheresis. If separation by density is required, centrifugation is the most common method. Other methods involve absorption onto beads coated with an absorbent material[2] and filtration.[3]

The centrifugation method can be divided into two basic categories:[4]

Continuous flow centrifugation

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Continuous flow centrifugation (CFC) historically required two venipunctures , as "continuous" means the blood is collected, spun, and returned simultaneously. Newer systems can operate with a single venipuncture by collecting blood in a vessel and alternating between drawing and returning it through the same needle, while the centrifuge continuously processes the blood held in the vessel.[5] The main advantage of this system is the low extracorporeal volume (calculated by volume of the apheresis chamber, the donor's hematocrit, and total blood volume of the donor) used in the procedure, which may be advantageous in the elderly and for children.[citation needed]

Intermittent flow centrifugation

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Intermittent flow centrifugation (IFC) works in cycles, taking blood, spinning/processing it and then giving back the unused parts to the donor in a bolus. The main advantage is a single venipuncture site. It does require a larger extracorporeal volume and takes significantly longer to perform the procedure via IFC. As a result, it is less commonly used for therapeutic purposes and is more frequently found in Donation Center settings.[6] To stop the blood from coagulating, an anticoagulant is automatically mixed with the blood as it is pumped from the body into the apheresis machine.[7]

Centrifugation variables

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The centrifugation process itself has four variables that can be controlled to selectively remove desired components. The first is spin speed and bowl diameter, the second is "sit time" in the centrifuge, the third is solutes added, and the fourth is not as easily controllable: plasma volume and cellular content of the donor. The result in most cases is the classic sedimented blood sample with the RBCs at the bottom, the buffy coat of platelets and WBCs (lymphocytes, granulocytes, monocytes) in the middle and the plasma on top.[8]

Types

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Disinfect, insert the cannula, pull out the cannula, and dress the wound. The blue pressure cuff is controlled by the platelet apheresis machine in newer models.

There are numerous types of apheresis.

Donation

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Blood taken from a healthy donor can be separated into its parts during blood donation, where the needed component is collected and the unharvested components are returned to the donor. Fluid replacement is usually not needed in this type of collection. In many countries, apheresis donors can donate platelets more often than those donating whole blood. There are several categories of component collections:

  • Plasmapheresis – blood plasma. Plasmapheresis is useful in collecting FFP (fresh frozen plasma) of a particular ABO group. Commercial uses aside from FFP for this procedure include immunoglobulin products, plasma derivatives, and the collection of rare WBC and RBC antibodies.
A Fenwal Erythropheresis machine is being used for plasmapheresis.
  • Erythrocytapheresis – red blood cells. Erythrocytapheresis is the separation of erythrocytes from whole blood. It is most commonly accomplished using the method of centrifugal sedimentation. The automated red blood cell collection procedure for donating erythrocytes is referred to as 'Double Reds' or 'Double Red Cell Apheresis.'[9]
  • Plateletpheresis (thrombapheresis, thrombocytapheresis) – blood platelets. Plateletpheresis is the collection of platelets by apheresis while returning the RBCs, WBCs, and component plasma. The yield is normally the equivalent of between six and ten random platelet concentrates. Quality control demands the platelets from apheresis be equal to or greater than 3.0 × 1011 in number and have a pH of equal to or greater than 6.2 in 90% of the products tested and must be used within five days.
  • Leukapheresis – leukocytes (white blood cells). Leukopheresis is the removal of PMNs, basophils, eosinophils for transfusion into patients whose PMNs are ineffective or where traditional therapy has failed. There is limited data to suggest the benefit of granulocyte transfusion. The complications of this procedure are the difficulty in collection and short shelf life (24 hours at 20 to 24 °C). Since the "buffy coat" layer sits directly atop the RBC layer, HES, a sedimenting agent, is employed to improve yield while minimizing RBC collection. Quality control demands the resultant concentrate be 1.0 × 1010 granulocytes in 75% of the units tested and that the product be irradiated to avoid graft-versus-host disease (inactivate lymphocytes). Irradiation does not affect PMN function. Since there is usually a small amount of RBCs collected, ABO compatibility should be employed when feasible.[10]
  • Stem cell harvesting – hematopoietic stem cells. Circulating peripheral blood stem cells (PBSCs) are harvested to use in peripheral stem cell transplantation following administration of a mobilizing agent, such as granulocyte colony stimulating factor (G-CSF).
  • Lymphapheresis – lymphocytes. Lymphocytes are harvested to use in manufacture of CAR T cell products for T-cell-based immunotherapies.[11]

Donor safety

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  • Single use kits – Apheresis is done using single-use kits, so there is no risk of infection from blood-contaminated tubing or centrifuge. Blood does not contact the device and during the separation, blood does not exit the kit.[8]
  • Reinfusion – At the end of the procedure, the remaining blood in the kit is given back to the donor with a process called 'reinfusion'.
  • Immune system effects – "the immediate decreases in blood lymphocyte counts and serum immunoglobulin concentrations are of slight to moderate degree and are without known adverse effects. Less information is available regarding long-term alterations of the immune system".[12]
Kit problems
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Two apheresis kit recalls were:

  • Baxter Healthcare Corporation (2005), in which "pinhole leaks were observed at the two-omega end of the umbilicus (multilumen tubing), causing a blood leak."[13]
  • Fenwal Incorporated (2007), in which there were "two instances where the anticoagulant citrate dextrose (ACD) and saline lines were reversed in the assembly process. The reversed line connections may not be visually apparent in the monitor box, and could result in excessive ACD infusion and severe injury, including death, to the donor."[14]
Donor selection
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People who do not use a drug that may prevent blood donation, who do not have the risk of the carrier of a disease, and who have suitable vascular structure may be apheresis donors. For apheresis platelet donation the donor's pre platelet count should be above 150 x 10^9/L. For apheresis plasma donation, the donor's total protein level should be greater than 60 g/L. For double red cell apheresis, donors of either gender require a minimum hemoglobin level of 14.0 g/dl.[15]

Plasticizer exposure
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Apheresis uses plastics and tubing, which come into contact with the blood. The plastics are made of PVC in addition to additives such as a plasticizer, often DEHP. DEHP leaches from the plastic into the blood, and people have begun to study the possible effects of this leached DEHP on donors as well as transfusion recipients.[16]

  • "current risk or preventive limit values for DEHP such as the RfD of the US EPA (20 μg/kg/day) and the TDI of the European Union (20–48 μg/kg/day) can be exceeded on the day of the plateletpheresis. ... Especially women in their reproductive age need to be protected from DEHP exposures exceeding the above mentioned preventive limit values."[17]
  • "Commercial plateletpheresis disposables release considerable amounts of DEHP during the apheresis procedure, but the total dose of DEHP retained by the donor is within the normal range of DEHP exposure of the general population."[18]
  • The Baxter company manufactured blood bags without DEHP, but there was little demand for the product in the marketplace
  • "Mean DEHP doses for both plateletpheresis techniques (18.1 and 32.3 μg/kg/day) were close to or exceeded the reference dose (RfD) of the US EPA and tolerable daily intake (TDI) value of the EU on the day of the apheresis. Therefore, margins of safety might be insufficient to protect especially young men and women in their reproductive age from effects on reproductivity. At present, discontinuous-flow devices should be preferred to avert conceivable health risks from plateletpheresis donors. Strategies to avoid DEHP exposure of donors during apheresis need to be developed."[19]

Therapy

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The assembly (A–D), operation (E) and disassembly (F) of the platelet apheresis machine, which can be configured to separate other components as well

The various apheresis techniques may be used whenever the removed constituent is causing severe symptoms of disease. Generally, apheresis has to be performed fairly often, and is an invasive process. It is therefore only employed if other means to control a particular disease have failed, or the symptoms are of such a nature that waiting for medication to become effective would cause suffering or risk of complications. For autoimmune diseases in which apheresis is effective, it is used not as a standalone treatment, but rather in conjunction with therapies that reduce production of autoantibodies.

Indications

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Platelets collected by using apheresis at an American Red Cross donation center

ASFA categories

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In 2023,[21] the American Society for Apheresis published the 9th Special Edition of evidence based guidelines for the practice of Apheresis Medicine. These guidelines are based upon a systematic review of available scientific literature. Clinical utility for a given disease is denoted by assignment of an ASFA Category (I – IV). The quality and strength of evidence are denoted by standard GRADE recommendations. ASFA Categories are defined as follows:

  • Category I for disorders where therapeutic apheresis is accepted as a first line treatment,
  • Category II for disorders where therapeutic apheresis is accepted as a second-line treatment,
  • Category III for disorders where the optimal role of therapeutic apheresis is not clearly established and
  • Category IV for disorders where therapeutic apheresis is considered ineffective or harmful.


Diseases and disorders

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Only diseases (or mentioned special conditions thereof) with ASFA category I or II are displayed in bold, with category I being underlined in addition.

Disease Special condition ABO-incompatible hematopoietic stem cell transplantation Plasmapheresis II
ABO-incompatible solid organ transplantation Kidney Plasmapheresis II
Heart (<40 months of age) II
Liver (perioperative) III
Acute disseminated encephalomyelitis Plasmapheresis II
Acute inflammatory demyelinating polyneuropathy Plasmapheresis I
Acute liver failure Plasmapheresis III
Age-related macular degeneration (AMD) Dry AMD Rheopheresis III
Systemic amyloidosis Plasmapheresis IV
Amyotrophic lateral sclerosis Plasmapheresis IV
Anti-neutrophil cytoplasmic antibody-associated rapidly progressive glomerulonephritis Dialysis dependence Plasmapheresis III
Diffuse alveolar hemorrhage (DAH) III
Dialysis independence III
Goodpasture syndrome Dialysis independence Plasmapheresis I
Diffuse alveolar hemorrhage (DAH) I
Dialysis dependence and no DAH III
Aplastic anemia or pure red cell aplasia Aplastic anemia Plasmapheresis III
Pure red cell aplasia II
Autoimmune hemolytic anemia Warm antibody autoimmune hemolytic anemia Plasmapheresis III
Cold agglutinin disease, life-threatening II
Babesiosis Severe Erythrocytapheresis I
High-risk population II
Burn with circulatory shock Plasmapheresis IV
Heart transplant with allograft Prophylaxis of rejection Photopheresis I
Treatment of rejection II
Treatment of antibody-mediated rejection Plasmapheresis I
Catastrophic antiphospholipid syndrome Plasmapheresis I
Rasmussen's encephalitis Plasmapheresis or immunoadsorption II
Chronic inflammatory demyelinating polyneuropathy Plasmapheresis I
Coagulation factor inhibitors Immunoadsorption III
Plasmapheresis III
Cryoglobulinemia Severe/symptomatic Plasmapheresis II
Secondary to Hepatitis C Immunoadsorption II
Cutaneous T cell lymphoma: mycosis fungoides or Sézary disease Erythrodermic Photopheresis I
Non-erythrodermic III
Dermatomyositis or polymyositis Plasmapheresis IV
Leukapheresis IV
Dilated cardiomyopathy NYHA class II-IV Immunoadsorption or plasmapheresis III
Familial hypercholesterolemia Homozygotes LDL apheresis I
Heterozygotes II
Homozygotes with small blood volume Plasmapheresis II
Focal segmental glomerulosclerosis Recurrent Plasmapheresis I
Graft-versus-host disease Skin Photopheresis II
Non-skin II
Hemolytic disease of the fetus and newborn Before intrauterine transfusion availability Plasmapheresis III
Hereditary haemochromatosis Erythrocytapheresis III
Hemolytic–uremic syndrome (HUS) Atypical HUS due to mutations in complement factor genes Plasmapheresis II
Atypical HUS due to factor H autoantibodies I
Typical HUS, or diarrhea-associated HUS III
Leukocytosis Leukostasis Leukapheresis III
Prophylaxis of leukostasis III
Hyperviscosity in monoclonal gammopathy Treatment of symptoms Plasmapheresis I
Prophylaxis in rituximab
Immune thrombocytopenic purpura Plasmapheresis IV
Immune complex-type of rapidly progressive glomerulonephritis Plasmapheresis III
Inclusion body myositis Plasmapheresis or leukapheresis IV
Inflammatory bowel disease Leukapheresis II
Kidney transplantation Antibody-mediated rejection Plasmapheresis I
Desensitization in living donor in positive crossmatch due to donor specific HLA antibody I
High PRA and cadaveric donor III
Lambert–Eaton myasthenic syndrome Plasmapheresis II
Lung transplantation Allograft rejection Plasmapheresis II
Malaria Severe Erythrocytapheresis II
Multiple sclerosis Acute inflammatory demyelinating diseases of the central nervous system, unresponsive to steroids Plasmapheresis II
Chronic progressive III
Myasthenia gravis Moderate to severe Plasmapheresis I
Pre-thymectomy I
Myeloma cast nephropathy Plasmapheresis II
Nephrogenic systemic fibrosis Photopheresis or Plasmapheresis III
Neuromyelitis optica Plasmapheresis II
Venoms, poisoning and overdose Mushroom poisoning Plasmapheresis II
Other III
Paraneoplastic syndrome Neurologic Plasmapheresis or immunoadsorption III
Pancreatitis Secondary to hypertriglyceridemia Plasmapheresis III
Polyneuropathy due to monoclonal gammopathy IgG, IgA or IgM Plasmapheresis I
Multiple myeloma III
IgG/IgA or IgM Immunoadsorption III
PANDAS and Sydenham's chorea Plasmapheresis I
Pemphigus vulgaris Plasmapheresis IV
Photopheresis III
Refsum disease Plasmapheresis II
Polycythemia vera or erythrocytosis Erythrocytapheresis III
POEMS syndrome Plasmapheresis IV
Post-transfusion purpura Plasmapheresis III
Psoriasis Plasmapheresis IV
Rheumatoid arthritis Refractory Immunoadsorption II
Schizophrenia Plasmapheresis IV
Systemic scleroderma Plasmapheresis III
Photopheresis IV
Sepsis with multi-organ failure Plasmapheresis III
Sickle cell disease Acute stroke Erythrocytapheresis I
Acute chest syndrome II
Prophylaxis of stroke or transfusional iron overload II
Multi-organ failure III
Stiff-person syndrome Plasmapheresis IV
Systemic lupus erythematosus Severe, such as cerebritis or diffuse alveolar hemorrhage Plasmapheresis II
Nephritis IV
Thrombocytosis Symptomatic Plateletpheresis II
Prophylactic III
Thrombotic microangiopathy, drug-associated Plasmapheresis I
III
IV
Thrombotic microangiopathy, hematopoietic stem cell transplantation-related Plasmapheresis III
Thrombotic thrombocytopenic purpura Plasmapheresis I
Thyroid storm Plasmapheresis III
Wilson's disease Fulminant hepatic failure with hemolysis Plasmapheresis I

Fluid replacement during apheresis

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When an apheresis system is used for therapy, the system is removing relatively small amounts of fluid (not more than 10.5 mL/kg body weight). That fluid must be replaced to keep correct intravascular volume. The fluid replaced is different at different institutions. If a crystalloid like normal saline (NS) is used, the infusion amount should be triple what is removed as the 3:1 ratio of normal saline for plasma is needed to keep up oncotic pressure. Some institutions use human serum albumin, but it is costly and can be difficult to find. Routine use of fresh frozen plasma (FFP) is not generally appropriate because of the dangers including citrate toxicity (from the anticoagulant), ABO incompatibility, infection, and allergic reactions. However, FFP should be used in cases of thrombotic thrombocytopenic purpura or patients at high risk of bleeding.

See also

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References

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[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Apheresis

View on Grokipedia
from Grokipedia
Apheresis is a in which is withdrawn from a or donor, separated into its components—such as red blood cells, , platelets, and plasma—using a specialized , typically via , and then the targeted components are either collected or removed while the remaining is returned to the body. This process allows for the selective harvesting of elements for or the therapeutic removal of harmful substances, distinguishing it from by minimizing volume loss and enabling repeated collections. The origins of apheresis trace back to early 20th-century experiments in blood separation, with —a form of plasma removal—first described in 1914 by John Jacob Abel and colleagues using animal models to filter toxins from blood. Modern therapeutic apheresis emerged in the 1960s, with plasmapheresis techniques refined for human use to treat conditions like hyperviscosity in , and apheresis machines for component separation became widespread in the 1970s, revolutionizing blood banking and . Today, apheresis encompasses two primary categories: donor apheresis, which collects specific components like platelets or stem cells from healthy individuals for transfusion or transplant, and therapeutic apheresis, which treats diseases by removing pathogenic elements such as autoantibodies in or malignant cells in . Key applications include peripheral blood stem cell collection for hematopoietic transplants, where mobilized stem cells are harvested after administration of (G-CSF), achieving rapid engraftment in patients with blood cancers like or . Other notable uses involve plasma exchange for (TTP), red cell exchange for crises, and to reduce high counts in acute leukemias. Procedures typically last 2 to 4 hours, processing 7 to 12 liters of blood per session, and are performed under anticoagulation with citrate to prevent clotting, though this can cause transient . While generally safe with low complication rates—primarily mild symptoms like or oral numbness—monitoring for volume shifts and allergic reactions is essential, and apheresis has become a cornerstone of in and .

Overview and History

Definition and Principles

Apheresis is an extracorporeal medical procedure that selectively separates blood into its components—such as plasma, platelets, leukocytes, or erythrocytes—for purposes including collection from donors, removal of pathogenic elements in therapeutic settings, or treatment of specific components, while reinfusing the non-targeted elements back into the patient. This process contrasts with simpler blood treatments like dialysis, which primarily filters solutes across a without component separation, by employing physical separation techniques to isolate and manipulate discrete blood fractions. The fundamental principles of apheresis involve withdrawing from the patient or donor through , typically using a large-bore needle inserted into a peripheral . To prevent within the extracorporeal circuit, the is immediately anticoagulated, most commonly with citrate-based solutions like (ACD), which chelate ionized calcium essential for the clotting cascade. The anticoagulated then flows into an apheresis device where it undergoes separation via physical means, such as or , to isolate the desired component; this target fraction is either collected, discarded, or processed (e.g., for removal), while the remaining elements are returned to the circulation through a reinfusion line. A key distinction from donation lies in apheresis's selective nature: whereas donation collects an undivided unit of approximately 450-500 mL for storage and later use, apheresis extracts only specific components (e.g., platelets or plasma) while promptly returning the rest, minimizing donor loss and enabling more frequent procedures for certain products. The procedure's extracorporeal circuit holds a typical of 100-400 mL of outside the body, which is managed to avoid hemodynamic , particularly in patients with low body weight or cardiovascular concerns. Early experiments with in the early laid the groundwork for these principles by demonstrating feasible plasma separation and return.

Historical Development

The roots of apheresis trace back to ancient bloodletting practices, which emerged around 1000 BC in Egyptian and Greek civilizations as a means to restore humoral balance by removing . These early techniques laid the conceptual groundwork for selective blood component removal, though they lacked modern separation methods. By the early , scientific advancements shifted focus to targeted plasma extraction; in 1914, American pharmacologist John J. Abel and colleagues coined the term "" during experiments on animal models, using a tube apparatus to separate plasma while returning cellular components. In the 1950s, plasmapheresis evolved into a practical tool for donor plasma collection to produce albumin and other plasma derivatives, marking the transition from experimental to clinical application. The 1960s saw further expansion, with techniques adapted for platelet and leukocyte collection to meet growing transfusion needs, alongside the first therapeutic uses in treating hyperviscosity syndromes associated with leukemia, such as through leukapheresis to alleviate symptoms in chronic myelocytic leukemia patients. This period highlighted apheresis's potential beyond donation, focusing on symptom relief in hematologic disorders. The 1970s brought pivotal technological innovation when American medical technologist Herb Cullis developed the first automated apheresis machine in 1972, enabling efficient continuous-flow separation and initial therapeutic applications like white cell removal in . During the 1980s and 1990s, adoption surged for harvesting to support transplantation and therapeutic plasma exchange for autoimmune and renal conditions, with professional societies emerging to guide practice, including the founding of the American Society for Apheresis (ASFA) in 1982 and the Italian Society of Hemapheresis (SIdEM) in 1984. From the 2000s onward, automation enhancements improved procedural safety, efficiency, and integration with , while organizations like ASFA standardized guidelines to promote evidence-based use. In the 2020s, further advancements include next-generation apheresis platforms introduced in 2024 by companies like and Terumo BCT, enhancing efficiency and patient comfort, alongside annual ASFA reviews of new indications and safety data as of 2025.

Methods

Centrifugation Techniques

Centrifugation techniques in apheresis rely on the application of to separate blood components based on their differing densities, with red blood cells being the heaviest and settling first, followed by platelets and leukocytes of intermediate density, and plasma as the lightest component remaining at the top. This differential sedimentation occurs as is subjected to high-speed in a , allowing targeted components to be isolated and collected while others are returned to the patient. Factors such as spin speed influence separation efficiency by enhancing the force applied to denser particles. Continuous flow centrifugation (CFC) processes in a steady stream, where is withdrawn, enters a spinning channel or bowl for separation, and the desired component is continuously collected while the remainder is returned to . This method maintains a relatively low extracorporeal volume, typically 150–300 mL depending on the device and protocol, minimizing the amount of outside the body at any time. Modern CFC systems often use a single venipuncture for both withdrawal and return, reducing procedural complexity, and are particularly suited for extended procedures such as hematopoietic stem cell collections due to their efficiency and lower volume requirements. Devices like the Spectra Optia exemplify this approach, employing optical detection alongside for precise component isolation. Intermittent flow centrifugation (IFC), in contrast, operates in discrete cycles, drawing a batch of into the for processing, separating components, and then returning the non-target elements before the next cycle begins. It involves higher extracorporeal volumes, up to 500 mL during peak draw phases, and can utilize either a single or dual , often with a single access in practice. These systems typically require longer overall durations due to the cyclic nature but are well-suited for platelet collection (thrombocytapheresis), where they can achieve high yields through repeated processing. Compared to IFC, CFC generally reduces patient discomfort by avoiding repeated draw-return cycles and maintaining steadier flow, which is advantageous for prolonged sessions, though IFC may offer higher collection yields for certain cellular components like platelets in specific protocols. Both methods ensure effective density-based separation but differ in throughput and volume management, with CFC prioritizing minimal extracorporeal exposure.

Alternative Separation Methods

While centrifugation remains the predominant method for blood component separation in apheresis due to its efficiency in handling large volumes, alternative approaches such as and adsorption provide viable options for specific clinical scenarios. Filtration methods employ membrane-based systems where blood is passed through filters with defined pore sizes, typically ranging from 0.2 to 0.7 micrometers, allowing plasma to permeate while retaining cellular components like red blood cells and platelets. These systems, often configured as hollow-fiber or flat-sheet , facilitate rapid plasma separation in therapeutic plasma exchange procedures by exploiting size-based exclusion rather than density differences. Membrane filtration is particularly suited for settings requiring portability and simplicity, as it operates under lower pressure gradients compared to density-driven techniques. Absorption techniques, including immunoadsorption, utilize selective binding matrices within extracorporeal columns to target specific plasma solutes such as immunoglobulins, immune complexes, or pathogens. In immunoadsorption, ligands like , synthetic peptides, or tryptophan-linked polymers on column surfaces bind to antibodies (e.g., IgG subclasses) with high specificity, enabling their removal without broadly depleting other plasma proteins. These columns are integrated into apheresis circuits post-plasma separation, allowing for repeated use in twin-column systems to maintain continuous flow. Absorption excels in applications demanding precision, as it avoids the non-selective loss associated with bulk plasma removal. Hybrid systems combine elements of filtration and adsorption, or incorporate centrifugal preprocessing with membrane filtration, to optimize efficiency in constrained environments such as low-volume or settings. For instance, centrifugal-membrane hybrid plasmapheresis uses initial spinning to concentrate plasma before membrane-based secondary separation or adsorption, reducing overall processing time and equipment footprint. These integrated approaches enhance selectivity and throughput by leveraging complementary mechanisms, making them adaptable for targeted solute removal in resource-limited scenarios. Filtration offers advantages in speed and ease of setup, enabling higher plasma flow rates (up to 80-100 mL/min) and portability for bedside use, but it is susceptible to membrane clogging from cellular aggregates or high levels, potentially limiting treatment duration and requiring frequent filter replacement. Absorption provides superior specificity, preserving essential plasma components like fibrinogen and factors to minimize risks, and eliminates the need for replacement fluids, yet it is slower ( rates often below 50 mL/min) and more expensive due to specialized, regenerable columns. Hybrid systems mitigate some drawbacks by balancing speed and selectivity, though they increase procedural complexity and cost compared to standalone methods.

Key Procedural Variables

In apheresis procedures, key procedural variables are meticulously adjusted to optimize the separation of blood components, ensuring high in target yield while minimizing risks to the patient or donor. These variables include parameters, dosing, flow rates, and volume calculations, which are tailored based on individual physiological factors such as and total . Optimization of these elements directly impacts the procedure's safety profile and therapeutic or collection outcomes, with modern apheresis systems incorporating automated controls to maintain precision. Centrifugation variables play a central role in achieving effective layering of components by . Spin speed, typically ranging from 1000 to 3000 RPM depending on the rotor size and system, generates the necessary (often 800-1000 × g) for optimal separation of plasma from cellular elements without causing . Interface dwell time, the duration resides in the chamber, is adjusted inversely to flow rates to sharpen separation boundaries and enhance collection efficiency; longer dwell times improve of heavier components like red cells while allowing lighter plasma to be siphoned off. Plasma-to-solute ratios, which refer to the proportional distribution of plasma relative to the and cellular layers post-separation, are influenced by these settings, aiming for a clear demarcation that maximizes plasma yield in or minimizes contamination in cytapheresis. Anticoagulant dosing is critical to prevent clotting in the extracorporeal circuit without inducing systemic complications. , the most commonly used agent, is administered at concentrations yielding a to anticoagulant ratio of 10:1 to 16:1, which chelates calcium to inhibit while protocols monitor for through ionized calcium levels and adjust infusion rates accordingly. Lower ratios (higher citrate) may be employed for patients with higher clotting risks, but this increases the potential for or , necessitating calcium supplementation if symptoms arise. Flow rates dictate the pace of blood processing and are calibrated to patient tolerance and hematocrit. Inlet flow rates typically range from 50 to 150 mL/min in centrifugal systems, with higher rates (up to 100-150 mL/min) feasible in donors with normal to expedite procedures, while outlet rates match or slightly exceed inlet to maintain circuit priming; adjustments are made downward for elevated to avoid viscosity-related alarms or incomplete separation. Procedure duration, often 1-3 hours, is inversely related to these rates, balancing throughput with hemodynamic stability. Volume calculations ensure safety by limiting extracorporeal exposure. The extracorporeal volume, encompassing the centrifuge bowl, tubing, and reservoirs, is restricted to less than 15% (and ideally under 10%) of the patient's total to prevent , particularly in pediatric or low-weight individuals where priming with saline or may be required. In donor plasmapheresis, plasma collection is adjusted based on estimated total plasma (calculated via formulas incorporating height, weight, and ), targeting 625-800 mL per session to achieve desired yields without exceeding 30-40% of total plasma , thereby optimizing protein recovery while preserving donor health.

Types of Apheresis

Donor Apheresis

Donor apheresis involves the collection of specific components from healthy individuals using automated separation techniques, primarily for transfusion purposes or applications. This procedure allows for the targeted extraction of components such as plasma, platelets, leukocytes, or red blood cells while returning the remaining elements to the donor, thereby enabling more frequent donations compared to collection. Common subtypes include , which collects up to 800 mL of plasma per session based on donor weight and via FDA-approved nomograms; plateletpheresis, yielding at least 3.0 × 10¹¹ platelets per unit; , used to harvest granulocytes (with yields of at least 1 × 10¹⁰ per unit) or hematopoietic stem cells (targeting ≥2 × 10⁶ + cells/kg for transplantation); and erythrocytapheresis, often as double red cell collection equivalent to two units of . Eligibility for donor apheresis is strictly regulated to ensure donor safety and product quality, with candidates typically aged 17 to 65 years, weighing more than 50 kg, exhibiting hemoglobin levels of at least 12.5 g/dL for women and 13.0 g/dL for men, and maintaining a platelet count greater than 150 × 10⁹/L for plateletpheresis. Donors undergo comprehensive health screening, including review and physical assessment, to exclude conditions like recent infections, cardiovascular issues, or use that could impair donation. Frequency limits further protect donors: plasma collection is permitted up to twice weekly with at least 48 hours between sessions, while plateletpheresis is limited to a maximum of 24 times per year, with no more than two procedures in any seven-day period and a minimum two-day interval between donations. These criteria align with established standards to minimize risks such as volume depletion or hematologic changes. The primary applications of donor apheresis center on supplying products essential for , including for clotting factor replacement, apheresis platelets for patients with , and units for management. Additionally, facilitates the harvesting of peripheral blood stem cells from mobilized donors, supporting autologous transplants for conditions like or allogeneic transplants for , where the collected cells enable hematopoietic reconstitution post-chemotherapy. These products undergo rigorous testing and processing to ensure sterility and compatibility before distribution.

Therapeutic Apheresis

Therapeutic apheresis is an extracorporeal procedure designed to treat patients by selectively removing pathogenic components from the , such as harmful antibodies, toxins, or abnormal cells, while returning the remaining elements to the body. This approach contrasts with donor apheresis, which collects components from healthy individuals, by focusing on therapeutic removal to alleviate disease processes. The technique employs or to separate constituents, often requiring vascular access via peripheral veins or central lines. Key subtypes include therapeutic plasma exchange (TPE), which targets plasma by discarding it and replacing it with , saline, or to eliminate autoantibodies and plasma-borne toxins. Cytapheresis, another subtype, removes specific cellular elements; for instance, erythrocytapheresis discards defective red blood cells, such as those in sickle cell crises, and replaces them with healthy donor cells, while returning plasma and other components. These procedures are tailored to the patient's condition, with TPE typically processing 1 to 1.5 plasma volumes per session to achieve effective removal. Therapeutic apheresis is frequently integrated as an adjunct to other treatments, including immunosuppressive drugs, , or infusions of replacement products like intravenous immunoglobulin, to enhance overall efficacy in managing inflammatory or neoplastic disorders. For acutely ill patients, sessions are often shortened to 1-2 hours to minimize hemodynamic stress, and central venous catheters are employed for reliable access in pediatric cases or individuals with compromised peripheral veins. Clinical outcomes demonstrate that therapeutic apheresis can rapidly reduce disease burden; for example, in Guillain-Barré syndrome, plasma exchange clears inflammatory mediators, leading to faster improvement in disability grades and reduced ventilator dependency compared to supportive care alone. This modality's success relies on timely initiation, often within days of symptom onset, to optimize symptom relief and recovery.

Indications

ASFA Guidelines

The American Society for Apheresis (ASFA), established in 1982, develops evidence-based guidelines to standardize the clinical use of therapeutic apheresis. The latest edition, the Ninth Special Issue published in 2023, evaluates 166 specific indications for apheresis across 91 diseases and conditions, incorporating updates from seven new fact sheets and nine revised indications based on recent literature. ASFA categorizes indications into four levels to reflect the strength of recommendation for apheresis use: Category I denotes first-line therapy with a strong recommendation, either as standalone treatment or in combination with other modalities; Category II indicates second-line therapy; Category III signifies an unclear or unestablished role, requiring individualized decision-making; and Category IV identifies procedures as ineffective or potentially harmful based on available evidence. Each category is paired with a grade assessing the quality of supporting evidence, derived from randomized controlled trials, observational studies, case series, or expert opinion; for instance, Grade 1A represents a strong recommendation backed by high-quality evidence from multiple well-designed randomized trials, while Grade 2C indicates a weak recommendation supported by low-quality or very low-quality evidence such as case reports. As of 2025, no major revisions to the core guidelines have occurred since the 2023 edition, maintaining the focus on therapeutic apheresis applications while excluding donor apheresis procedures. For example, is classified as Category I with Grade 1A evidence. In clinical practice, the ASFA guidelines inform protocol development, patient selection, and treatment optimization by providing a standardized framework for evaluating apheresis efficacy. They also play a key role in reimbursement processes, as payers often reference ASFA categories and grades to determine coverage; the society's 2025 Reimbursement Guide specifically outlines billing codes, documentation requirements, and strategies for securing appropriate payment under systems like Medicare.

Specific Diseases and Disorders

Apheresis plays a critical therapeutic role in managing various autoimmune, hematological, and metabolic disorders by selectively removing pathogenic components from the , such as autoantibodies, , or excess cells. According to the American Society for Apheresis (ASFA) guidelines, indications are categorized based on evidence strength, with Category I representing conditions where apheresis is considered first-line or essential therapy. In (TTP), a life-threatening characterized by and organ ischemia due to ADAMTS13 deficiency, therapeutic plasma exchange (TPE) is essential as the cornerstone of treatment, rapidly replenishing ADAMTS13 and removing ultra-large multimers. TPE has dramatically improved survival rates from less than 20% to over 80% by initiating daily exchanges promptly upon diagnosis. For acute inflammatory demyelinating polyneuropathy, commonly known as Guillain-Barré syndrome (GBS), TPE accelerates recovery by removing circulating antibodies and inflammatory mediators, with a standard regimen involving five exchanges totaling 200–250 mL plasma per kg body weight. In homozygous (HoFH), a causing profoundly elevated cholesterol (LDL-C) levels and premature , LDL apheresis selectively extracts LDL particles, achieving acute reductions of up to 70–80% per session and maintaining interval mean LDL-C levels below 100 mg/dL when performed weekly. For conditions classified as ASFA Category II, where apheresis serves as an adjunctive or second-line option, TPE is employed in crises to rapidly deplete anti-acetylcholine receptor antibodies, improving muscle strength within days and averting in severe exacerbations. In , red cell exchange transfusion replaces deformable sickle erythrocytes with normal red blood cells, reducing blood viscosity and preventing complications such as stroke or , with procedures typically spaced every 4–8 weeks to sustain S levels below 30%. In neurological disorders beyond GBS, TPE addresses steroid-refractory relapses in by clearing humoral factors that exacerbate demyelination, offering moderate to marked improvement in 40–60% of cases when initiated after high-dose corticosteroids fail. Hematological malignancies with hyperleukocytosis, defined as counts exceeding 100 × 10⁹/L, benefit from to mitigate symptoms like pulmonary or , rapidly lowering counts by 20–60% per procedure while bridging to . In cases of severe poisoning, TPE facilitates the removal of protein-bound toxins or their metabolites, such as amatoxins in mushroom intoxication, enhancing elimination when supportive measures alone are insufficient.

Procedure and Safety

Fluid Replacement Strategies

During apheresis procedures, particularly therapeutic plasma exchange (TPE), fluid replacement is essential to maintain intravascular volume and prevent hypovolemia, as up to 1.5 times the patient's plasma volume—approximately 60 mL/kg body weight—may be removed. This replacement compensates for the extracorporeal circuit volume and ensures hemodynamic stability, with total plasma volume (TPV) typically calculated as body weight in kg multiplied by 40 mL/kg, adjusted by the formula TPV = estimated total blood volume × (1 - hematocrit). For precision, estimated total blood volume can be derived from patient height and weight, and the procedure targets 1-1.5 TPV exchanges to achieve therapeutic efficacy while minimizing risks to fluid balance. Replacement options include crystalloids, colloids, and plasma products, selected based on the need to restore volume, , and specific plasma components. Crystalloids such as 0.9% normal saline are used when cost or availability is a concern, but require a 3:1 volume ratio to the removed plasma to approximate oncotic effects due to their distribution into the extravascular . Colloids, particularly 5% solution, are preferred for most indications because they effectively maintain with isovolemic replacement and have a low risk of allergic reactions or transmission; combinations like 80% to 20% saline are common for conditions such as . (FFP) is reserved for scenarios requiring replenishment of clotting factors, such as (TTP) or active bleeding, where 1-1.5 TPV (typically 2.5-4 liters for adults) is replaced daily until clinical improvement, like platelet counts exceeding 150 × 10⁹/L. Specific protocols emphasize as the default for non-coagulopathic s to avoid depleting pro- and factors by 50-60%, with adjustments for size via body weight-based dosing (e.g., 2.7 L TPV for a 50 kg with 18% ). In TTP, FFP protocols involve daily exchanges of 1-1.5 TPV to restore activity, while for general therapeutic apheresis, is documented to ensure isovolemic conditions and hemodynamic monitoring guides real-time adjustments. These strategies align with guidelines prioritizing use to support without excessive volume overload.

Complications and Risks

Apheresis procedures, while generally safe, carry risks of acute complications primarily related to anticoagulation, vascular access, and procedural mechanics. Citrate, commonly used as an anticoagulant, can induce hypocalcemia by binding ionized calcium, leading to symptoms such as perioral and peripheral paresthesia, muscle cramps, and in severe cases, arrhythmias or tetany. Treatment involves prompt administration of calcium gluconate, typically as a 10 mL bolus over 10 minutes, which effectively reverses symptoms in most instances. Risk factors include hepatic or renal impairment, which exacerbate citrate toxicity. Hypotension is another frequent acute issue, often resulting from volume shifts or vasovagal reactions during the procedure, manifesting as , , , or syncope. Management includes pausing the procedure, placing the patient in a shock position, and providing supportive care, with resolution typically rapid. reactions, such as urticaria or anaphylactoid responses, may occur due to replacement fluids, presenting with , wheezing, or ; these are managed by halting the infusion and administering antihistamines or epinephrine as needed. For instance, plasma-based replacements have been associated with higher rates of urticaria compared to other fluids. Procedure-specific risks include anaphylactoid reactions to used in certain apheresis modalities, which can arise even without use and require immediate discontinuation and supportive therapy. Additionally, may result from high shear forces in the apheresis device, leading to or renal strain, though this is minimized with modern . Vascular access complications are common, particularly with peripheral or central lines, including bleeding, hematoma formation, infection, or thrombophlebitis at the insertion site. Rare but serious events involve or from central venous catheterization, with incidence influenced by operator experience and access type. Overall, mild complications such as citrate reactions or minor vascular issues occur in approximately 1-5% of procedures, while severe events like significant or affect fewer than 1%. In frequent donors, long-term risks are primarily linked to repeated citrate exposure, potentially causing bone demineralization through chronic calcium mobilization and a hypothesized increased risk, though evidence remains limited and prospective studies are ongoing. Immune effects appear minimal, with no significant long-term alterations in humoral or cellular immunity observed in most donors, despite occasional reports of transient lymphopenia in high-frequency plateletpheresis. Donor is further enhanced by the use of sterile, single-use kits, which substantially reduce infection and cross-contamination risks. Using as a replacement fluid, for example, may help mitigate some risks compared to plasma-based options.

Equipment and Regulations

Modern Equipment and Technology

Modern apheresis equipment primarily utilizes automated systems, such as the Spectra Optia Apheresis System, which employs continuous-flow combined with optical detection technology via the Automated Interface Management (AIM) system to separate blood components efficiently. These devices monitor and adjust the interface between plasma and cellular layers in real time, enabling precise collection of target components like platelets or stem cells while returning others to the patient. In addition to centrifugation-based systems, membrane separators facilitate filtration-based apheresis by using hollow fiber membranes with pore sizes tailored to retain cellular elements and allow plasma passage, offering an alternative for procedures requiring high plasma volumes. Key advancements in apheresis technology include the widespread adoption of single-use disposable kits, which significantly reduce the risk of infection and cross-contamination compared to reusable components. Integrated monitoring systems, such as sensors like the CRIT-LINE, provide continuous real-time feedback on parameters, allowing automated adjustments to flow rates and volumes to optimize procedure safety and efficacy. For pediatric patients, equipment adaptations incorporate smaller extracorporeal volumes and lower, gentler flow rates—typically 30-100 mL/min—to accommodate reduced total and minimize hemodynamic instability. Post-2020 developments have focused on enhanced automation to improve collection yields, with systems like updated apheresis platforms streamlining peripheral blood harvesting through optimized protocols that increase + cell recovery. Emerging integration of aids in variable optimization, such as predicting donor responses and adjusting parameters dynamically to enhance collection efficiency. Additionally, the shift to DEHP-free plastics in disposable sets and tubing minimizes patient exposure to potential endocrine disruptors, addressing toxicity concerns associated with traditional phthalate plasticizers. In plateletpheresis, modern devices typically achieve yields equivalent to 3-6 units of random donor platelets in a single session, supporting efficient transfusion needs while reducing donor exposure.

Regulatory and Ethical Considerations

In the United States, the (FDA) oversees apheresis devices, classifying most automated separators as Class II medical devices subject to special controls, including premarket notification under 510(k), to ensure safety and effectiveness. The (AABB) establishes standards for donor apheresis collections, emphasizing donor qualification, screening for infectious diseases, and procedural validation to maintain quality. is mandatory for all apheresis procedures, with the responsible physician required to obtain it from donors or patients prior to the first donation or treatment, detailing risks, benefits, and alternatives as per federal regulations. Internationally, the (WHO) provides guidelines on good manufacturing practices for blood establishments, promoting safe apheresis through donor screening, quality controls, and infection prevention to assure blood safety globally. In the , Directive 2002/98/EC sets standards for blood quality and safety, including apheresis-derived components, while Directive 2004/33/EC outlines donor eligibility criteria; these result in variations such as stricter plasma donation frequency limits in (up to 33 times per year) compared to the (up to 104 times), influencing supply dynamics. Ethical considerations in apheresis include ongoing debates over donor compensation, particularly for plasma collection, where the U.S. model of paid donations boosts supply but raises concerns about exploitation and donor , contrasting with Europe's preference for voluntary non-remunerated donations aligned with WHO principles to prioritize and equity. Access to therapeutic apheresis remains inequitable in low-resource settings, where high costs, limited equipment, and infrastructure challenges restrict availability for conditions like , exacerbating global disparities. Documentation is governed by the American Society for Apheresis (ASFA) protocols, which require detailed logging of therapeutic procedures, including patient assessments, procedure specifics, and outcomes, to support clinical decision-making and reimbursement. Adverse events must be reported to registries such as the World Apheresis Association (WAA) registry, which tracks global procedure data to monitor safety trends and inform practice improvements. As of , regulatory emphasis has shifted toward in apheresis, with initiatives to reduce in disposable kits through reusable components and eco-friendly materials, aligning with broader environmental standards in healthcare.

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