News & Press

Print Copy of the JCA Special Issue 9th Edition Available For Members Only

Tue, 14 Nov 2023 22:33:00 GMT

For a limited time, we are offering the opportunity to purchase one print copy of the Guidelines on the Use of Therapeutic Apheresis in Clinical Practice: The Ninth Special Issue to ASFA members. ASFA is pleased to cover the printing cost as part of membership benefits. Shipping costs are as follows. Orders will be fulfilled following the deadline for arrival by January 2024.

Ship within US and Canada - $20
Ship internationally - $40

Order Deadline: Friday, December 1st

After more than 2 years of engaging collaborative work, and the rigorous critical review of fact sheets, this edition will appeal to both practitioners with a focus in the area of apheresis medicine and other physicians who may need to utilize therapeutic apheresis (TA) occasionally for the care of their patients.

This Ninth Edition of the JCA Special Issue continues to maintain this methodology and rigor to make recommendations on the use of apheresis in a wide variety of diseases/conditions. The general layout and concept of a fact sheet that was used since the fourth edition has largely been maintained in this edition. Each fact sheet succinctly summarizes the evidence for the use of therapeutic apheresis in a specific disease entity.

ASFA members can access the digital Special Issue free of charge, using the JCA Online Access. Non-members looking for the digital or print issue may join ASFA today!

**Click here for shipping within US and Canada.

**Click here for shipping internationally.

JCA Special Issue 9th Edition Now Available

Thu, 6 Apr 2023 19:00:00 GMT

The Writing Committee of the Journal of Clinical Apheresis (JCA) Special Issue 2023 is pleased to present the Ninth Edition of the JCA Special Issue. After more than 2 years of engaging collaborative work, and the rigorous critical review of fact sheets, this edition will appeal to both practitioners with a focus in the area of apheresis medicine and other physicians who may need to utilize therapeutic apheresis (TA) occasionally for the care of their patients.

This Ninth Edition of the JCA Special Issue continues to maintain this methodology and rigor to make recommendations on the use of apheresis in a wide variety of diseases/conditions. The general layout and concept of a fact sheet that was used since the fourth edition has largely been maintained in this edition. Each fact sheet succinctly summarizes the evidence for the use of therapeutic apheresis in a specific disease entity.

The Ninth Edition discusses 91 fact sheets for therapeutic apheresis diseases and medical conditions, with 166 indications, which are separately graded and categorized within the listed fact sheets. Seven new fact sheets were created: Alzheimer’s disease, Autoimmune dysautonomia, Idiopathic inflammatory myopathies, Immune checkpoint inhibitors, Paraneoplastic autoimmune retinopathies, Transplantation-intestine and Vaccine-induced immune thrombotic thrombocytopenia. The 2023 Special Issue also highlights the impact of the COVID-19 infection within several fact sheets including new indications or disease associations. Several diseases that are Category IV which have been described in detail in previous editions and do not have significant new evidence since the last publication are summarized in a separate table. We hope that the Ninth Edition of the JCA Special Issue, like its predecessors, serves as a key resource that guides the utilization of therapeutic apheresis in the treatment of human disease.

ASFA members can access the full Special Issue free of charge, using the JCA Online Access.

Non-members, may join ASFA today or use the direct link to the issue!

Journal of Clinical Apheresis 2019 Special Review Issue Now Available

Tue, 20 Aug 2019 22:12:26 GMT

https://onlinelibrary.wiley.com/doi/abs/10.1002/jca.21705

ASFA's Choosing Wisely Recommendations Now Available

Mon, 7 May 2018 14:00:00 GMT

ASFA's first set of Choosing Wisely Recommendations are now available. The ASFA Choosing Wisely Working Group is now a subcommittee of the Apheresis Applications Committee and will develop future recommendations for things patients and providers should question.

Propose Topics for New JCA Factsheets

Fri, 25 Aug 2017 18:24:15 GMT

The Journal of Clinical Apheresis 2019 Special Edition Committee is beginning its work on factsheet development for the next edition! The committee welcomes input from the ASFA membership on new topics for factsheets that they would like the committee to consider for the next edition.

Please email committee chairs Drs. Anand Padmanabhan, Nancy Dunbar or guest editor, Dr. Yossi Schwartz with any suggestions.

In your email, please include the topic of the new proposed factsheet, a brief description on why you think it should be included in the next edition, and list relevant publications in the literature.

ASFA 2015 Consensus Article

Tue, 8 Nov 2016 18:39:04 GMT

The American Society for Apheresis (ASFA) conducted a one-day consensus conference on red blood cell exchange (RBCx) in sickle cell disease (SCD) during its annual meeting in San Antonio, TX, on May 5, 2015. The authors of this article, a subcommittee of ASFA’s Clinical Applications Committee, developed several questions with regard to pathophysiology of SCD and use of RBCx in the management of various complications. These questions were provided to the seven invited speakers who are the experts in the field of SCD. Two experts in the field moderated the proceedings of the conference, which was attended by more than 150 participants. After each presentation, there was a summary of the main points by the moderators and an open discussion with questions from the audience. A video recording of the proceedings, as well as each presentation, was made available to the authors. Each author’s summary was reviewed and approved by the respective speaker before submission of this manuscript. The subcommittee also developed several key questions to generate a consensus amongst the speakers on key issues for using RBCx for patients with SCD.

Check out the ASFA 2015 Consensus Article, now available online!

Circular Information for the Use of Cellular Therapy Products

Mon, 6 Jun 2016 21:52:31 GMT

The Circular Information for the Use of Cellular Therapy Products was prepared jointly by the AABB, America’s Blood Centers, the American Association of Tissue Banks, the American Red Cross, the American Society for Apheresis, the American Society for Blood and Marrow Transplantation, the College of American Pathologists, the Cord Blood Association, the Foundation for the Accreditation of Cellular Therapy, ICCBBA, the International Society for Cellular Therapy, the Joint Accreditation Committee of ISCT and EBMT, the National Marrow Donor Program, and Netcord. Federal law prohibits dispensing the cellular therapy products described in this circular without a prescription.

Click Here to access the full document.

50% off 2013 JCA Special Issue!

Tue, 10 Jun 2014 17:26:29 GMT

The JCA 2013 Special Issue is 50% off right now in the Online Store! Visit the online store to order a copy for yourself or your workplace.

ASFA TTP Consensus Article

Wed, 11 Dec 2013 18:53:53 GMT

The American Society for Apheresis (ASFA) conducted a 1 day consensus conference on Thrombotic Thrombo-cytopenic Purpura (TTP) during its annual meeting in Atlanta, GA, on April 10, 2012. The authors of this arti-cle, a subcommittee of ASFA’s Clinical Applications Committee, developed several questions with regard todefinitions, classification, pathophysiology, diagnosis, management, and future research in TTP. These questionswere provided to the seven invited speakers who are the experts in the field of TTP. Two moderators conductedthe proceedings of the conference which was attended by more than 100 participants. After each presentation,there was an open discussion that included moderator-selected written questions submitted by the audience. Amedical writer-generated transcript of the proceedings as well as each presentation was made available to theauthors. Each summary was reviewed and approved by the respective speaker before submission of this article.The subcommittee also developed seven key questions for blinded, electronic polling conducted by the modera-tors to generate a consensus amongst the speakers. This article includes these presentation summaries as well asresults of the electronic poll.

Check out the ASFA TTP Consensus Article, now available online!

US Food and Drug Administration adds black boxed warning to Hydroxyethyl starch (HES)

Thu, 12 Sep 2013 17:28:49 GMT

US Food and Drug Administration adds black boxed warning to Hydroxyethyl starch (HES)

Summary of HES related Recommendations for ASFA members:

I. Avoid the use of HES in critically ill patients, patients with renal insufficiency, patients with sepsis, and patients at risk of bleeding who are undergoing TPE. HES use in these settings should be limited only to situations where the benefit of its use outweighs the risk. Examples of such situations would include but are not be limited to:
a. Jehovah’s Witnesses with a life-threatening disease amenable to TPE who refuse albumin and plasma replacement fluids.
b. Patients with severe recurrent allergic reactions to albumin.
c. During severe albumin shortages, after assessment of the benefit of the therapy versus risk of replacement alternatives.

II. Avoid the use of HES or use with caution in critically ill patients, patients with renal insufficiency, and patients at risk of bleeding in the setting of leukocytapheresis.

III. Potential granulocyte donors should be questioned and/or screened for evidence of renal insufficiency and underlying renal disease. Consent for collection should include an explicit discussion of this potential risk and education on signs and symptoms to look for as outlined in the FDA black box warning document.

Background: Hydroxyethyl starch (HES) is a colloidal solution that is used predominantly for volume replacement in a number of clinical settings including sepsis, trauma, and cardiopulmonary bypass. In apheresis, HES has rarely been used as a replacement fluid in plasma exchange (TPE) in patients who refuse albumin or plasma on religious or other grounds and as a partial replacement for albumin to minimize the costs of procedures as it is less expensive than human albumin. In addition, it is also used as a sedimenting agent in the setting of therapeutic leukocytapheresis and the collection of granulocytes. In these two uses, HES induces rouleaux formation which enhances the separation of granulocytes from the red cells. The use of HES in the setting of granulocyte collections has been associated with increased granulocyte product yields.[1] HES has a long half-life, being metabolized by α-amylase with the breakdown products being excreted by the kidneys.[2]

HES is associated with a number of dose dependent side-effects. These side-effects include:
- Prolongation of the aPTT with development of a von Willebrand disease-like state and increased risk of bleeding – HES results in increased turnover of von Willebrand factor (vWF) with a resulting decline in factor VIII. The decreased vWF results in decreased platelet function while a low factor VIII causes prolongation of the aPTT.[3] This is dose-dependent, with a maximum dose of 20mL/kg/24-hour period being suggested in the setting of volume resuscitation.[4]
- Skin deposition with pruritus – Pruritus, sometimes severe, can occur with skin deposition and this is one of the most common side-effects reported with HES.[5, 6]
- Anaphylactoid reactions – HES can activate the alternative complement pathway resulting in the generation of C3a and C5a. This can produce allergic type reactions ranging from urticaria (hives) to life-threatening anaphylaxis. [7, 8, 9]
- Tissue deposition with organ failure – There has been a single case report of a Jehovah’s Witness with myasthenia gravis who suffered from HES deposition in multiple organs after years of TPE using HES as the replacement fluid. The organ deposition resulted in multisystem organ failure that subsequently resolved following discontinuation of TPE.[10]

On June 24 2013, the US Food and Drug Administration added a black boxed warning to HES.[11] The black box warning deals with increased mortality and severe renal injury in critically ill adult patients as well as an increased risk of bleeding in the setting of HES use in cardiopulmonary bypass. This was based upon the publication of three randomized controlled trials in 2012 indicating an increased risk of mortality and renal injury requiring renal replacement therapy in critically ill adult patients with sepsis and those admitted to the ICU.[12, 13, 14] Additional evidence also included meta-analyses and observational studies demonstrating similar findings. Finally, a meta-analysis of 18 randomized controlled trials also showed an increase in bleeding when HES was used in cardiopulmonary bypass.[15]

The FDA made the following recommendations:
- Do not use HES solutions in critically ill adult patients including those with sepsis and those admitted to the ICU.
- Avoid use of HES in patients with pre-existing renal dysfunction.
- Discontinue use of HES at the first sign of renal injury.
- Patients receiving HES should have their renal function monitored for at least 90 days as need for renal replacement therapy has been reported up to 90 days after HES.
- Avoid HES use in patients undergoing open heart surgery in association with cardiopulmonary bypass.
- Discontinue the use of HES at the first sign of coagulopathy.

Because of the FDA black box warnings, the European Medicines Agency has recommended the suspension of marketing of HES containing infusion solutions in Europe. Unfortunately, an alternative sedimenting agent is not available for the collection of granulocytes as the side effects mentioned above as well as the studies cited by the FDA saw similar findings with high-molecular weight HES (Hetastarch) as well as low-molecular weight HES (Pentastarch).

The American Society for Apheresis (ASFA) is issuing this document to remind apheresis practitioners of the risks associated with the use of HES in volume replacement. While the volume of HES administered during therapeutic apheresis procedures and granulocyte collection is less than that reported to be used in the trials cited by the FDA [12, 13, 14], coagulopathy and allergic type reactions have been reported in granulocyte donors.[3, 8] In addition, an ASFA member has reported onset of oliguria in a granulocyte donor with undiagnosed renal insufficiency following exposure to HES.

References
1. Iacone A, Di Bartolomeo P, Di Girolamo G, et al: Hydroxyethyl starch and steroid improved collection of normal granulocytes with continuous flow centrifugation gravity leukapheresis. Haematologica 1981; 66:645–655.
2. Yacobi A, Stoll RG, Sum CY, et al: Pharmacokinetics of hydroxyethyl starch in normal subjects. J Clin Pharmacol 1982; 22:206–212.
3. Strauss RG, Stansﬁeld C, Henriksen RA, et al: Pentastarch may cause fewer effects on
coagulation than hetastarch. Transfusion 1988; 28:257–260.
4. Nearman HS, Herman ML: Toxic effects of colloids in the intensive care unit. Crit Care Clin 1991; 7:713–723.
5. Sirtl C, Laubenthal H, Zumtobel V, et al: Tissue deposits of hydroxyethyl starch (HES): dose-dependent and time-related. Br J Anaesth 1999; 82:510–515.
6. Stander S, Szepfalusi Z, Bohle B, et al: Differential storage of hydroxyethyl starch (HES) in the skin: an immunoelectron-microscopical long-term study. Cell Tissue Res 2001; 304:261–269.
7. Ring J, Messmer K: Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet 1977; 1:466–469.
8. Dutcher JP, Aisner J, Hogge DE, et al: Donor reaction to hydroxyethyl starch during granulocytapheresis. Transfusion 1984; 24:66–67.
9. Kannan S, Milligan KR: Moderately severe anaphylactoid reaction to pentastarch (200/0.5) in a patient with acute severe asthma. Intensive Care Med 1999; 25:220–222.
10. Auwerda JJ, Wilson JH, Sonneveld P: Foamy macrophage syndrome due to hydroxyethyl starch replacement: a severe side effect in plasmapheresis. Ann Intern Med 2002; 137:1013–1014.
11. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm358271.htm
12. Perner A, Haase N, Guttirmsen AB, et al. Hydroxyethyl starch 130/0.4 versus Ringer’s acetate in severe sepsis. N Engl Med 2012;367:124-34
13. Guildet B, Martinet O, Boulain T, et al. Assessment of hemodynamic efficacy and safety of 6% hydroxyethyl starch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Critical Care 2012;16:R94.
14. Myburgh JA, Finfer S, Bellomo R, et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012;367:1901-11.
15. Navicks RJ, Haynes GR, Wilkes MM. Effect of hydroxyethyl starch on bleeding after cardiopulmonary bypass: A meta-analysis of randomized trials. J Thorac Cardiovasc Surg 2012;144:223-30.