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Practical Aspects of Therapeutic Plasma Exchange (PLEX / TPE) for Neurologists

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Practical Aspects of Therapeutic Plasma Exchange (PLEX / TPE) for Neurologists Saturday, May 31st Symposium on Plasma Exchange for CNS Demyelinating Diseases 11:00 a.m. – 11:55 a.m. Practical Aspects of Therapeutic Plasma Exchange (PLEX / TPE) for Neurologists David M. Ward, MD, FRCP Professor, Division of Nephrology, University of California San Diego Medical Director, Therapeutic Apheresis Program Associate Medical Director, Kidney/Pancreas Transplantation Practical Aspects of Plasma Exchange for Neurologists DISCLOSURES: The speaker has the following potential conflicts . TerumoBCT, Inc. – Honoraria, Consulting . Therakos, Inc. – Honoraria . Alexion Pharmaceuticals – Advisory Board . Aethlon Medical Inc. – Consulting WARNING: OFF-LABEL USES Therapeutic plasma exchange (plasmapheresis) is widely acknowledged as standard treatment for many diseases. In the USA, the FDA has approved numerous devices for the performance of plasma exchange, but not for specific indications. Thus all specific indications are regarded as “off-label” uses. [email protected] 1 Practical Aspects of Plasma Exchange for Neurologists OUTLINE: . Types of therapeutic apheresis . Expanding utilization of apheresis therapies . Methods and technologies of plasma exchange (TPE / PLEX): • centrifugal • membrane . TPE / PLEX treatment options and prescription . Kinetics of removal of autoantibodies . Intensity and adequacy of plasma exchange therapy . Adverse events . Applications in neurology [email protected] Practical Aspects of Plasma Exchange for Neurologists . Plasma Exchange (“PLEX”) = Therapeutic Plasma Exchange (“TPE”) ~– Plasmapheresis (“PE”) . “Apheresis” derives from . Ancient Greek “” = “to remove forcibly” . different root than “phoresis”, as in “electrophoresis”. PLEX / TPE / PE is one type of Therapeutic Apheresis [email protected] 2 Therapeutic Plasma Exchange PLASMA REMOVAL WITH RETURN OF CORPUSCLES (PLASMAPHAERESIS) FIRST PAPER JOHN J. ABEL, L. G. ROWNTREE AND B. B. TURNER From the Pharmacological Laboratory of the Johns Hopkins University Received for publication, July 16, 1914 I. In connection with our experiments on vividiffusion with a view to the ultimate use of the method for the relief of toxae- mia the idea suggested itself to try the effects of the repeated removal of considerable quantities of blood, replacing the plasma by Locke’s solution and reinjecting this together with the sedi- mented corpuscles. J Pharmacol Exp Ther, 5:625, 1914 [email protected] Therapeutic Plasma Exchange Aminco Celltrifuge, IBM 2997 centrifuge, Glasgow, circa 1973 UCSD, 1982 Membrane plasmafiltration, UCSD, 1983 3 UC San Diego Therapeutic Apheresis Program Status as of May 2014: . Now at 32 years of the program (inception January 1982). Approximately 28,000 apheresis procedures performed. Of those, about 20,000 were plasma exchange procedures. 15 apheresis RN’s . 19 faculty attending physicians with apheresis privileges http://health.ucsd.edu/specialties/apheresis Conventional Therapeutic Apheresis Modalities Plasmapheresis Cytapheresis = plasma removal or exchange = cell removal or exchange (requires centrifugal machine) (requires centrifugal machine or plasmafiltration system) Erythrocyt Thrombocyt- Leukapheresis -apheresis apheresis = white cell apheresis Replace Replace with = red cell = platelet with FFP albumin exchange reduction WBC Blood (for (for all (sickle cell, (thrombo- reduction stem cells TTP) other uses) etc.) cytosis) (leukemia) (for BM transplant) Less-Conventional Apheresis Modalities (require additional equipment) Online plasma purification Online WBC processing WBC’s Blood (for stem cells Immuno- Filtration LDL Photopheresis other ex-vivo (for ex-vivo adsorption selective apheresis (= ECP) immune genetic removal modulation) modification) Okafor C, Ward DM, Mokrzycki M, et al. J Clin Apheresis, 25:240-249, 2010 [email protected] 4 Conventional Therapeutic Apheresis Modalities Plasmapheresis Cytapheresis = plasma removal or exchange = cell removal or exchange (requires centrifugal machine) (requires centrifugal machine or plasmafiltration system) Erythrocyt Thrombocyt- Leukapheresis -apheresis apheresis = white cell apheresis Replace Replace with = red cell = platelet with FFP albumin exchange reduction WBC Blood (for (for all (sickle cell, (thrombo- reduction stem cells TTP) other uses) etc.) cytosis) (leukemia) (for BM transplant) Less-Conventional Apheresis Modalities (require additional equipment) Online plasma purification Online WBC processing WBC’s Blood (for stem cells Immuno- Filtration LDL Photopheresis other ex-vivo (for ex-vivo adsorption selective apheresis (= ECP) immune genetic removal modulation) modification) Okafor C, Ward DM, Mokrzycki M, et al. J Clin Apheresis, 25:240-249, 2010 [email protected] 08-09 2009-10 2010-11 2011-12 2012-13 2013-14 977 1245UC 2167San Diego 2016 Therapeutic 2104 2330 Apheresis Program 354 151 136 134 188 112 347 326 333 233 248 184 2500214Number 376 of procedures 469 574 per 964 year by 1232 modality 26Plasmapheresis 19 26 (TPE) - 25 outpatient 37 66 2000 Plasmapheresis (TPE) - inpatient* Stem cell harvest (HPC-A)9 55 100 11Photopheresis 10 23 (ECP) 31 2 2 Cytapheresis (WBC, Plt., RBCX) 1500 LDL-apheresis (since March 2012) Research 1000 500 0 2007‐08 2008‐09 2009‐10 2010‐11 2011‐12 2012‐13 2013‐14 (projected) (Academic years run from July 1st to June 30th) 5 UC San Diego Therapeutic Apheresis Program Status by modality as of May 2014: Plasma exchange (TPE/PLEX) 61% of procedures, of which two-thirds (Removes antibodies that cause are for neurological indications. autoimmune diseases, etc.) Photopheresis (ECP) 30% of procedures. (Modulates cellular immunity towards tolerance: heart/lung rejection, GVHD) Stem cell harvest (HPC-A) 5.2% of procedures. (Harvests hematopoietic stem cells for subsequent Blood-Marrow Transplant) LDL-apheresis (LDL-A) 2.1% of procedures. (For severe hypercholesterolemia) RBC Exchange (RBCX-A) 0.9% of procedures. (For sickle cell, etc.) WBC / platelet depletion 0.3% of procedures. Research (ex-vivo cell modification) 0.2% of procedures. Practical Aspects of Plasma Exchange for Neurologists OUTLINE: . Types of therapeutic apheresis . Expanding utilization of apheresis therapies . Methods and technologies of plasma exchange (TPE / PLEX): • centrifugal • membrane . TPE / PLEX treatment options and prescription . Kinetics of removal of autoantibodies . Intensity and adequacy of plasma exchange therapy . Adverse events . Applications in neurology [email protected] 6 Manual plasma exchangePlasma exchange methods - still used in pediatrics PLASMA REMOVAL WITH RETURN OF CORPUSCLES (PLASMAPHAERESIS) FIRST PAPER JOHN J. ABEL, L. G. ROWNTREE AND B. B. TURNER From the Pharmacological Laboratory of the Johns Hopkins University Received for publication, July 16, 1914 I. In connection with our experiments on vividiffusion with a view to the ultimate use of the method for the relief of toxae- mia the idea suggested itself to try the effects of the repeated removal of considerable quantities of blood, replacing the plasma by Locke’s solution and reinjecting this together with the sedi- mented corpuscles. Centrifugal plasma exchange and cytapheresis Membrane plasma exchange Evolution of centrifugal apheresis systems Some modern continuous-flow centrifuges Cobe Fresenius Kabi Fenwal Terumo Spectra Com.Tec Amicus Optia 7 Evolution of membrane plasmafiltration Modern hollow-fiber membrane plasmafiltration on a CRRT machine on the NxStage machine Separation by membrane filtration Hollow-fiber plasma-filter Pore size: ~0.3 microns from Cut-off: >1000 kDa patient Replace- ment fluid (albumin/ saline) Effluent plasma blood Membrane specifications are those of return Asahi products (Asahi Kasei Kuraray Medical Co., Tokyo 101-8,101, Japan) [email protected] 8 Separation by centrifugation Whole Blood in Cobe Spectra – disposable RBC out centrifuge insert WBC out Plasma out Separation by centrifugation Whole Blood in Cobe Spectra RBC out WBC out Plasma out Tubing set harness connects via “omega-1 omega-2” principle 9 Separation by centrifugation Whole Blood in Cobe Spectra RBC out WBC out Plasma out Tubing set harness connects via “omega-1 omega-2” principle Separation by centrifugation “Omega-1 Omega-2” principle Terumo Optia Clockwise Counter- clockwise [email protected] 10 Separation by centrifugation Whole Blood in Cobe Spectra RBC out WBC out Plasma out Separation by centrifugation Whole Blood in Specific Gravity RBC out Plasma 1.027 WBC out Plasma out Plt’s 1.04 Lymph’s Mono’s 1.06 Blasts PMN’s 1.085 RBC’s 1.095 [email protected] 11 Separation by centrifugation Specific Gravity Stoke’s Law: 2 2 R r (cell - plasma) Plasma 1.027 S = __________________ V 9 Stoke’s law says that the cellular velocity of sedimentation (SV) is proportional to: • Centrifugal acceleration ( R) or g Plt’s 1.04 • Square of the cell radius (r2) • Difference between the density of cell and plasma Lymph’s ( - ) cell plasma Mono’s 1.06 • Inverse of the fluid viscosity () Blasts Centrifugal separation is a function of: PMN’s 1.085 • SV and • Dwell time (inverse of inlet blood flow rate) RBC’s 1.095 [email protected] Separation by centrifugation Specific Gravity Plasma exchange (“TPE” or “PLEX”) Plasma 1.027 High G-force (= high RPM’s) to create a platelet-poor plasma Thrombocyt- apheresis (platelet Plt’s 1.04 To get pure cell product: removal) (1) interface position Lymph’s Leukocyt- (2) accurate RPM’s (G’s) Mono’s 1.06 (3) flow rate (dwell time) apheresis = Leukapheresis Blasts (WBC removal) PMN’s 1.085 Low G-force to Erythrocyte keep WBC’s out exchange or RBC’s 1.095 of packed RBC’s apheresis (RBCs) [email protected]
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