Apheresis Anticoagulant Removal. Oluwatoyosi Onwuemene, MD MS May 6th, 2017
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1 Apheresis Anticoagulant Removal Oluwatoyosi Onwuemene, MD MS May 6th, 2017
2 Talk Outline Case presentation Factors associated with drug removal TPE s effects on hematologic parameters Anticoagulant properties Studies of anticoagulant removal TPE s effects on warfarin TPE s effects on heparin TPE-associated bleeding risk Summary and conclusions
3 Case Presentation
4 Case Presentation History of Present Illness 44 y.o female with tumefactive MS Admitted with encephalopathy Plasma exchange requested Past Medical History H/o FVL and recurrent strokes Plasma cell dyscrasia Pertinent Meds Rivaroxaban, 20 mg PO once daily
5 TPE Course Date TPE # Hgb Hct Plt FGN aptt PT PRBC 10/ / / / / / /14 7.1/ U 10/ / / / /19 8.2/7.1 25/22 10/
6 Hemoglobin Trends Heparin stopped U PRBC 4 5 6
7 CT Showed RP Bleed CT abdomen and pelvis Right psoas hematoma Right rectus abdominus hematoma
8 Clinical Question Did TPE contribute to bleeding risk?
9 Factors Associated with TPE Drug Removal
10 TPE Characteristics Plasma Volume Exchanged Plasma solutes removed (%) Shelat. Am J Med 123: , 2010
11 TPE-mediated Drug Effects Direct removal of circulating drug Drug action prolongation
12 TPE Drug Removal Drug Characteristics Volume of Distribution (V D ) Pharmacotherapy 27: , 2007 Plasma Ther Transfus Technol 5: , 1984
13 Protein Binding Protein Binding TPE Drug Removal Pharmacotherapy 27: , 2007 Plasma Ther Transfus Technol 5: , 1984
14 Drug Removal Determinants Drug-dependent Time from dose to TPE initiation Protein binding Volume of distribution Blood levels vs. biologic effect TPE-dependent Duration of TPE Successive TPE sessions Plasma volume removed Seminars in Dialysis 2: , 2012
15 TPE hematologic effects
16 TPE Hematologic Effects Lab Parameter Pre Post 24 Hrs Hgb (g/dl) 13.1 (6 16.5) Platelets (x 10 9 /L) 296 ( ) Prothrombin Index (% of normal) 88 (76 100) PTT (s) 36 (30 - > 120) Fibrinogen (g/l) 3.6 ( ) ATIII 130 (91 146) Factor VIII 144 ( ) 11.5 ( ) 264 ( ) 35 (10 92) 59 (39 - > 120) 0.86 ( ) 39 (27 45) 25 (14 95) 12.5 ( ) 278 ( ) 80 (69 96) 38 (55-32) 2.17 ( ) 107 (68 160) 89 (31 161) Wood and Jacobs. J Clin Apher 3:l (1986)
17 TPE Effects on Clotting Assays Flaum et al. Blood :
18 TPE Effects on Clotting Factors Flaum et al. Blood :
19 All Factors Decreased
20 TPE Effects on Fibrinogen Flaum et al. Blood :
21 TPE Effect on Fibrinogen Zantek et al. J Clini Apher 29:75 82 (2014)
22 TPE Effect on Factor II Zantek et al. J Clin Apher 29:75 82 (2014)
23 TPE-Relevant Anticoagulant Properties
24 Warfarin AC R Mode of Action V d (L) Protein Binding (%) t 1/2α (h) Warfarin PO Blocks vitamin K oxide reductase to decrease factors II, VII, IX, X, C & S Holford. Clin Pharmacokinet Nov-Dec;11(6):
25 Heparin AC R Mode of Action V d (L) Protein Binding (%) t 1/2α (h) Heparin IV SC Binds AT, HCII, & IXa to inactivate IIa, Xa, IXa, & XIIa high 1.5 LMWH SC Inactivates Xa &, to a lesser extent, IIa Hirsh & Raschke. Chest 2004; 126:188S 203S
26 Xa Inhibitors AC R Mode of Action V d (L) Protein Binding (%) t 1/2α (h) Fondaparinux SC Binds AT, inactivates Xa Apixaban PO Inhibits free and clot-bound Xa Edoxaban PO Inhibits free Xa & IIase activity & IIainduced platelet aggregation Rivaroxaban PO Inhibits free, IIase-associated & clotassociated Xa J Clin Pharmacol Aug;54(8): Eur J Clin Pharmacol Nov;70(11): Br J Clin Pharmacol Feb;75(2): Clin Pharmacokinet. 2002;41 Suppl 2:1-9
27 Direct Thrombin Inhibitors AC R Mode of Action V d (L) Protein binding (%) t 1/2α (h) Bivalirudin IV Inhibits free & clot-bound IIa & IIamediated platelet activation/aggregation 14 ~0 0.4 Argatroban IV Direct thrombin inhibitor Dabigatran PO Competitive direct IIa inhibitor J Clin Pharmacol Jun;51(6): J Thromb Haemost Nov;9(11): Expert Rev Cardiovasc Ther Dec;8(12):
28 Anticoagulant properties AC R Mode of Action V d (L) Heparin Bivalirudin IV SC IV 1) Binds AT, HCII, & IXa to inactivate IIa, Xa, IXa, & XIIa Inhibits free & clot-bound IIa & IIamediated platelet activation/aggregation Protein Binding (%) t 1/2α (h) high ~0 0.4 Argatroban IV Direct thrombin inhibitor LMWH SC Inactivates Xa &, to a lesser extent, IIa Fondaparinux SC Binds AT, inactivates Xa Warfarin PO Blocks vitamin K oxide reductase to decrease factors II, VII, IX, X, C & S Apixaban PO Inhibits free and clot-bound Xa Dabigatran PO Competitive direct IIa inhibitor Edoxaban Rivaroxaban PO PO Inhibits free Xa & IIase activity & IIainduced platelet aggregation Inhibits free, IIase-associated & clotassociated Xa
29 Anticoagulant Removal Studies
30 Anticoagulant Removal studies Author/Year (N) AC Indication Procedure TPE effect Bleeding or Thrombosis Rahawi 2017 (1) Enoxaparin PE atpe t 1/2 from 7 to 1.6h CVC oozing Hematuria* Lam 2017 (1) Apixaban Afib ptpe Anti Xa Hemorrhagic pericardial effusion Zantek 2013 (8) Warfarin - atpe INR CVC oozing (n=1) Fistula thrombosis Kaplan 2016 (6) Heparin - ptpe atpe aptt Anti Xa NR
31 TPE Effects on Warfarin
32
33 TPE Effects on INR Zantek et al. J Clin Apher 29:75 82 (2014)
34 Zantek et al. J Clin Apher 29:75 82 (2014)
35 TPE Effects on INR Zantek et al. J Clin Apher 29:75 82 (2014)
36 TPE Effects on Heparin
37
38 With Albumin Replacement Kaplan et al. J Clin Apher 31: (2016)
39 With Plasma Replacement Unchanged infusion rate Infusion rate 25% Infusion stopped Infusion rate 65% Kaplan et al. J Clin Apher 31: (2016)
40 Post-aTPE Anti Xa and aptt TPE# Infusion Anti Xa aptt (s) AT(%) Pre Post Pre Post Pre Post > Kaplan et al. J Clin Apher 31: (2016)
41 The anti Xa Assay Typically chromogenic Known amounts AT & Xa added Inhibitory complex inactivates Xa Excess Xa measured heparin levels = intensity Use endogenous/add exogenous AT Results confounded Factor deficiency AC removal ates and Weitz. Circulation. 2005;112:e53- Newall. Methods Mol Biol. 2013;992:265-72
42 TPE and Bleeding Risk
43 Studies of TPE Bleeding Risk Author Year Sutton 1989 N 627 (5235) Albumin only replacement Bleeding Precautions 69%* NR Bleeding Complications Bleeding (<1%) Brain hemorrhage (1), groin hematoma (1) Couriel (381) NR NR Hemothorax (1.6%) Brain hemorrhage (1.6%) Yeo (568) 50% NR Mild bleeding (13%) Major bleeding (1%) Shemin (1727) 57% Plasma for bleeding risk Exit site bleeding (1.2%) Cid (2730) 73% Plasma for bleeding risk GI hemorrhage (1.5%) Samanci (734) 11.8% NR Catheter-related hematoma (1%)
44 Summary and Conclusions
45 Summary and Conclusions TPE affects anticoagulation Removal of anticoagulant drugs Removal of procoagulant proteins Removal of coagulant proteins Contribution to bleeding risk unclear Other factors should be considered Available data is limited More prospective studies needed
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See Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Fragmin) Reference Number: CP.PHAR.225 Effective Date: 05.01.16 Last Review Date: 02.18 Line of Business: Commercial, Medicaid Coding Implications Revision Log See Important Reminder