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The Immunomodulatory Effects of Plasma Exchange
TPE Overview Safety Resources


Map a Treatment Plan for a Fast Road to Results

Plasma exchange is an established immunomodulatory therapy that rapidly reduces disease mediators and circulating immune complexes (CICs). Improvement following plasma exchange can occur within a few days.1,2


Plasma Exchange Mechanism of Action and Immunomodulatory Effect








Results From One Study: Reducing Disease Mediators and Time to Recovery

Improvement following plasma exchange can occur within a few days.1,2
The mean maximum reduction after one course* of plasma exchange was:3
IgA 69.1%
IgM 79.1%
IgG 73.4%
(subclasses 1-4)


*Patients underwent a median of 6 (range 5-27) TPE procedures during the trial.

Article: The Mechanisms of Action of Plasma Exchange

Hollie M. Reeves and Jeffery L. Winters






Plasma Exchange on the Spectra Optia® Apheresis System

Not All Plasma Exchange Is the Same

Spectra Optia uses specific gravity to separate blood components. Centrifugation, as compared to membrane-based methods, produces more efficient separation, which can make important differences in the patient experience.

Because centrifugal therapeutic plasma exchange (cTPE) is more efficient than membrane therapeutic plasma exchange (mTPE), it removes 1.5 to 3 times more plasma per volume of whole blood processed, allowing for shorter procedure times and/or lower whole blood flow rates as desired.4,5,6,7,8,9





Spectra Optia uses differences in the specific gravity and sedimentation velocity of blood cells and plasma to separate specific blood components.

With continuous flow centrifugation, blood is continuously added into the centrifuge; blood cells are separated from plasma, mixed with replacement fluid and returned to the patient.


DISCLAIMER: This graphic is intended to be a high-level representation of an apheresis procedure and therefore does not cover all steps. For a detailed description please contact Terumo Blood and Cell Technologies.







Data from several studies indicate that 64.3%10 to 94.6%11 of apheresis procedures can be performed using peripheral access.12

In some patients, peripheral access may not be feasible.13,14








Plasma Exchange, Therapeutic Plasma Exchange or Plasmapheresis?

These terms are often mistakenly used interchangeably.
Here are their distinctions:15

Plasmapheresis:
Refers only to the removal of plasma.
Plasma Exchange (PLEX) and Therapeutic Plasma Exchange (TPE):
Refer to both the removal and the replacement of plasma.







*Single-needle access is not available in all regions.
  • Automatically monitors the fluids used in the procedure, which allows for the maintenance of fluid balance
  • Can be performed on an inpatient or outpatient basis
  • Has a median procedure time of 1 hour and 45 minutes (based on analyzed data of more than 40,000 procedures)
  • Accommodates smaller patients and supports patient comfort and safety
  • Allows peripheral venous access with single- or dual-needle options*
    • * Single-needle access is not available in all regions.




Spectra Optia Apheresis System Intended Use

The Spectra Optia Apheresis System, a blood component separator, may be used to perform the following therapeutic apheresis, cell collection, and cell processing procedures: Therapeutic plasma exchange; red blood cell exchange, depletion, and depletion/exchange for the transfusion management of sickle cell disease in adults and children; mononuclear cell collection from the peripheral blood; granulocyte collection from the peripheral blood; white blood cell reduction for patients with leukocytosis at risk for leukostasis; and processing of harvested bone marrow for the purpose of facilitating hematopoietic reconstitution.


Apheresis-Related Safety Information

Contraindications

Contraindications for the use of Spectra Optia are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.

Adverse events of apheresis procedures can include

Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable set failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance and inadequate separation of blood components.

Reactions to blood products transfused during procedures can include

Hemolytic transfusion reaction, immune-mediated platelet destruction, fever, allergic reactions, anaphylaxis, transfusion-related acute lung injury (TRALI), alloimmunization, posttransfusion purpura (PTP), transfusion-associated graft-versus-host disease (TA-GVHD), circulatory overload, hypothermia, metabolic complications and transmission of infectious diseases and bacteria.1,2

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel.

1AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2017.

2European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the Preparation, Use and Quality Assurance of Blood Components. 19th edition. Strasbourg, France: EDQM Council of Europe; 2017.



1Saperstein D, Barohn R. Management of myasthenia gravis. Semin Neurology. 2004;24(1):41-48.

2Schwartz J, Padmanabhan A, Aqui N, 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 seventh special issue. J Clin Apher. 2016;31(3):149-162.

3Guptill JT, Juel VC, Massey JM, et al. Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis. Autoimmunity. 2016;49(7):472-479.

4Kes P, Janssens ME, Basic-Jukic N, Kljak M. A randomized crossover study comparing membrane and centrifugal therapeutic plasma exchange procedures. Transfusion. 2016;56(12):3065-3072.

5Hafer C, et al. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study. Int Urol Nephrol. 2016;48:133-138.

6Ward D. Conventional apheresis therapies: a review. Neurology. 1996;47(3):840-843.

7Tormey C, et al. Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform. Transfusion. 2010;50(2):471-477.

8Cid J, et al. Comparison of plasma exchange procedures using three apheresis systems. Transfusion. 2015;55(5):1001-1007.

9Lambert C, et al. Plasma extraction rate and collection efficiency during therapeutic plasma exchange with Spectra Optia in comparison with Haemonetics MCS+. J Clin Apher. 2011;26(1):17-22.

10Mortzell Henriksson M, Newman E, Witt V, et al. Adverse events in apheresis: an update of the WAA registry data. Transfus Apher Sci. 2016;54(1):2-15.

11Noseworthy JH, Shumak KH, Vandervoort MK. Long-term use of antecubital veins for plasma exchange. Transfusion. 1989;29(7):610-613.

12Putensen D, Leverett D, Patel B, Rivera J. Is peripheral access for apheresis procedures underutilized in clinical practice? A single centre experience. J Clin Apher. 2017;32(6):553-559.

13Stegmayr B, Wikdahl A. Access in therapeutic apheresis. Ther Apher Dial. 2003;7(2):209-214.

14Schonermarck U, Bosch T. Vascular access for apheresis in intensive care patients. Ther Apher Dial. 2003;7(2):215-220.

15Assessment of plasmapheresis. Neurology. 1996;47(3):840-843.







THE IMMUNOMODULATORY EFFECTS OF PLASMA EXCHANGE



Proposed Mechanisms of Action for Plasma Exchange1

“In a number of diseases, the bulk removal of pathological substances does not explain all of the findings associated with the use of TPE and therefore TPE appears to have additional therapeutic effects.”1




Removal of pathological antibodies



Correction of altered T helper cell type Th1/Th2

Changes in lymphocyte numbers

Increased T regulatory cells and T suppressor activity
Stimulated proliferation of B cells and plasma cells

Removal of immunocomplexes, enhancing macrophage/monocyte function

Removal of cytokines

Replacement of missing plasma components



The Results of Reducing Disease Mediators

The mean maximum reduction after one course* of plasma exchange was:2
IgA 69.1%
IgM 79.1%
IgG 73.4%
(subclasses 1-4)

*Patients underwent a median of 6 (range 5-27) TPE procedures during the trial.


The Immunomodulatory Role of Therapeutic Plasma Exchange in Peripheral Nervous System and Neuromuscular Diseases
Jean-Marc Léger, Luis Querol, Mazen M Dimachkie






Plasma Exchange on the Spectra Optia® Apheresis System



Not All Plasma Exchange Is the Same

Spectra Optia uses specific gravity to separate blood components. Centrifugation, as compared to membrane-based methods, produces more efficient separation, which can make important differences in the patient experience.

Because centrifugal therapeutic plasma exchange (cTPE) is more efficient than membrane therapeutic plasma exchange (mTPE), it removes 1.5 to 3 times more plasma per volume of whole blood processed, allowing for shorter procedure times and/or lower whole blood flow rates as desired.




Spectra Optia uses differences in the specific gravity and sedimentation velocity of blood cells and plasma to separate specific blood components.

With continuous flow centrifugation, blood is continuously added into the centrifuge; blood cells are separated from plasma, mixed with replacement fluid and returned to the patient.


DISCLAIMER: This graphic is intended to be a high-level representation of an apheresis procedure and therefore does not cover all steps. For a detailed description please contact Terumo BCT.


  • Automatically monitors the fluids used in the procedure, which allows for the maintenance of fluid balance
  • Can be performed on an inpatient or outpatient basis
  • Has a median procedure time of 1 hour and 45 minutes (based on analyzed data of more than 40,000 procedures)
  • Accommodates smaller patients and supports patient comfort and safety
  • Allows peripheral venous access with single- or dual-needle options
    • Other venous access options are available

Learn More




Data from several studies indicate that 64.3 percent3 to 94.6 percent4 of
apheresis procedures can be performed using peripheral access.5

In some patients, peripheral access may not be feasible.6,7


Plasma Exchange, TPE, PLEX or Plasmapheresis?

These terms are often mistakenly used interchangeably.
Here are their distinctions:8

Plasmapheresis:
refers only to the removal of plasma
Plasma Exchange, Therapeutic Plasma Exchange (TPE) and Plex:
refer to both the removal and the replacement of plasma






Apheresis-Related Safety Information

Contraindications

Leukocytapheresis is contraindicated in acute myeloid leukemia FAB M3 (acute promyelocytic leukemia) because of the accompanying disseminated intravascular coagulation.1,2 Other contraindications for the use of the Spectra Optia system are limited to those associated with the infusion of solutions and replacement fluids as required by the apheresis procedure and those associated with all types of automated apheresis systems.

Adverse events of apheresis procedures can include

Anxiety, headache, light-headedness, digital and/or facial paresthesia, fever, chills, hematoma, hyperventilation, nausea and vomiting, syncope (fainting), urticaria, hypotension, allergic reactions, infection, hemolysis, thrombosis in patient and device, hypocalcemia, hypokalemia, thrombocytopenia, hypoalbuminemia, anemia, coagulopathy, fatigue, hypomagnesemia, hypogammaglobulinemia, adverse tissue reaction, device failure/disposable set failure, air embolism, blood loss/anemia, electrical shock, fluid imbalance and inadequate separation of blood components.

Reactions to blood products transfused during procedures can include

Hemolytic transfusion reaction, immune-mediated platelet destruction, fever, allergic reactions, anaphylaxis, transfusion-related acute lung injury (TRALI), alloimmunization, posttransfusion purpura (PTP), transfusion-associated graft-versus-host disease (TA-GVHD), circulatory overload, hypothermia, metabolic complications and transmission of infectious diseases and bacteria.3,4

Restricted to prescription use only

  • Operators must be familiar with the system's operating instructions
  • Procedures must be performed by qualified medical personnel.

1Vahdat L, Maslak P, Miller WH Jr, et al. Early mortality and the retinoic acid syndrome in acute promyelocytic leukemia: impact of leukocytosis, low-dose chemotherapy, PMN/RAR-alpha isoform and CD13 expression in patients treated with all-trans retinoic acid. Blood. 1994;84(11):3843-3849.

2Daver N, Kantarjian H, Marcucci G, et al. Clinical characteristics and outcomes in patients with acute promyelotic leukaemia and hyperleucocytosis. Br J Haematol. 2015;168(5):646-653.

3AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2017.

4European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the Preparation, Use and Quality Assurance of Blood Components. 19th edition. Strasbourg, France: EDQM Council of Europe; 2017.



1Reeves H, Winters J. The mechanisms of action of plasma exchange. Br J Haematol. 2014;164(3):342-351.

2Guptill JT, Juel VC, Massey JM, et al. Effect of therapeutic plasma exchange on immunoglobulins in myasthenia gravis. Autoimmunity. 2016;49(7):472-479.

3Mortzell Henriksson M, Newman E, Witt V, et al. Adverse events in apheresis: an update of the WAA registry data. Transfus Apher Sci. 2016;54(1):2-15.

4Noseworthy JH, Shumak KH, Vandervoort MK. Long-term use of antecubital veins for plasma exchange. Transfusion. 1989;29(7):610-613.

5Putensen D, Leverett D, Patel B, Rivera J. Is peripheral access for apheresis procedures underutilized in clinical practice? A single centre experience. J Clin Apher. 2017;32(6):553-559.

6Stegmayr B, Wikdahl A. Access in therapeutic apheresis. Ther Apher Dial. 2003;7(2):209-214.

7Schonermarck U, Bosch T. Vascular access for apheresis in intensive care patients. Ther Apher Dial. 2003;7(2):215-220.

8Assessment of plasmapheresis. Neurology. 1996;47(3):840-843.






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