Anticoagulant Therapy During Pregnancy

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1 Anticoagulant Therapy During Pregnancy AIM - June 2007 Russell K. Laros, Jr., MD Thromboembolism and Pregnancy Leading Non-Obstetrical Cause of Maternal Mortality Early recognition and proper treatment dramatically improve outcome Pregnant patient actually 2 patients! UC Incidence of DVT Between 0.05 and 0.3 Percent of Pregnancies Antepartum and postpartum occurrence equal Increasing frequency in later pregnancy May occur up to a month postpartum Incidence Of Pulmonary Embolism Dependent on Diagnosis and Treatment of DVT Untreated - 24% DVTs have PE and mortality is 15% Properly treated - only 4.5% have PE and mortality is < 1% UC UC 1

2 Key Issues In Pregnancy Different diagnostic approach Different therapeutic approach Agents Regimens Monitoring Prophylaxis For C/S For PTL Deep Venous Thrombosis High Clinical Suspicion of DVT Medium Doppler Ultrasound Venogram Low - ± + + ± - - ± + Observe Clinical Suspicion of Pulmonary Embolism Begin Ventilation/ Perfusion Scan or Spiral CT Angiogram Deep Venous Thrombosis High Probability V/Q Scan Low Probability V/Q Scan Normal Abnormal PE Other Modalities Doppler Ultrasound + - Pulmonary Arteriogram Or Spiral CT Angiogram - + Stop Continue Stop Fibrinopeptides D-dimer ß-thromboglobulin UC 2

3 Pulmonary Embolism Pulmonary Angiography Assess anticoagulant failures Recurrence versus peripheral migration Low probability with continued symptoms Thromboembolism Treatment Anticoagulation Additional Modalities UC Anticoagulation Coumarin Different Dosing Schedule Required resistance More rapid clearance 3

4 Pharmacology Combines with antithrombin III Increases activated Factor Xa inhibitor Does not cross placenta Unfractionated Proper Monitoring Affects Recurrence Risk and Risk of Hemorrhage Optimal anticoagulation - circulating heparin level of 0.3 U per ml. (aptt( aptt,, 1.5 to 2.5 x control [60 to 80 secs]) Spontaneous hemorrhage frequently if the aptt exceeds 135 secs for > than 12 hours Circulating level is a balance between input, rapid metabolism, and excretion either by the kidneys or diffusion into extravascular spaces Obtain baseline aptt,, PT, aptt,, CBC, platelet count, and urinalysis. contraindicated if the platelet count is <50 x 109/L Loading Dose Dosing 150 U/kg for PE (max - 10,000 U; min - 5,000 U) 100 U/kg for DVT (max - 10,000 U; min - 5,000 U) Infusion Rate U/hr (average - 22 U/hr) Check aptt in 5 hours!60 sec; no change; repeat in 5 hrs <60 or >100 sec; adjust infusion rate Continued adjustment until 2 consecutive values are sec UC 4

5 Infusion Preparation 15,000 U heparin in 250 ml 5% DW Concentration of 60 U/ml aptt ( ss eecc) ) Bolus (U) Adjustment of Infusion Hoo l dd I nnf f uu ssi i oonn (min) Rate Change Ree ppee aat t aap TT TT (U/ ( / hhrr ) (hrs) << U/kg N eexx t AM !! UC UC Adjusted-Dose As Effective As Warfarin Subcutaneous dose q 12 hrs aptt to 1-1/2 control at 6 hrs How Long To Continue Anticoagulation? Schulman (1997) - clear benefit of 6 months versus shorter duration in both 1st and recurrent VTE Kearnon (1997) - clear benefit to 6 to 24 months versus 6 months Recent summary of clinical options by Schulman (2003) UC 5

6 No Identified Thrombophilic Abnormalities and Event 1st event, distal DVT provoked by temporal risk factor 1st event DVT with idiopathic or permanent risk factor; any proximal DVT or PE As above with increased of bleeding Single life-threatening event 2nd event, contralateral DVT 2nd event, ispilateral or PE 3rd or subsequent event 6 weeks 6 months 3 months 12 months 6 months (as a 1st event) 12 months Indefinite Identifiable Thrombophilic Abnormalities and Event Antithrombin Deficiency Protein C or Protein S Deficiency Homozygous form of thrombophilic defect Heterozygous for two thrombophilic defects Antiphospholipid-antibody syndrome Heterozygous Factor V Leiden Heterozygous Prothrombin Life-threatening event and any defect Indefinite 12 months Indefinite Indefinite Years As with no thrombophilia As with no thrombophilia Indefinite Side Effects Hemorrhage Osteoporosis Hypotension Alopecia Allergic reaction Pain and hematoma at injection site Thrombocytopenia UC Thrombocytopenia Mild form Aggregation and self-limiting Severe form -dependent IgG 6

7 Thrombocytopenia Incidence of 3% in prospective study Low molecular weight heparin has been used More common with bovine lung preparation Low Molecular Weight s Rapidly Becoming Agent Of Choice Molecular weight 4,200 to 6,000 Pharmacokinetic advantages Less thrombocytopenia (~ 1%) Less osteopenia UC Advantage! Low-molecular-weight Pharmacokinetics Mechanism More predictable! Less binding to plasma anticoagulant response! proteins and to proteins!!! released from platelets!!! and endothelium Better bioavailability! Less binding to endothelium Dose-independent! Less binding to macrophages clearance mechanism Longer half-life! Less binding to macrophages Low-Molecular-Weight Disadvantages Cost 10 to 20 time unfractunated heparin When is conduction anesthesia safe? How to monitor? Difficult to draw up proper dose UC 7

8 Low-Molecular-Weight Monitor Xa Inhibitor Renal failure Obesity Pregnancy Level 4 hours after dose of IU/ml Prophylactic Dose Low Intensity 40 to 80 mg subcutaneously daily No monitoring necessary Therapeutic Dose High Intensity 1 mg/kg q 12 h Anti-Xa weekly for 1 month with peak level at 3 to 4 hours < 1.2 units. Therapeutic levels are anta Xa units Need not measure trough levels Monitor monthly or less frequently until steady state 1.5 mg/kg effective in non-pregnant patients (Spiro; 2001). No data on the regimen in pregnancy and not advised Mechanical Heart Valve Patients Controversial The use of LMWH for this indication is highly controversial. The manufacturer of enoxaparin issued a warning against using the agent for treatment of pregnant patients with mechanical valves. The Anticoagulation in Prosthetic Valves and Pregnancy Consensus Panel supports the unlabeled use for these patients as opposed to the present warning designation (Fetal-Maternal Medicine Consensus Reports, 2002). The reasons for this opinion are reviewed in great in the Consensus Report. 8

9 Mechanical Heart Valve Patients Controversial 1 mg/kg q 12 hours Anti-Xa levels monitored and dose adjusted to achieve trough level > 0.5 units Peak levels should be kept < 1.2 units to avoid significant risk of bleeding Monitor weekly Use Of Conduction Anesthesia Monitoring of Anti-Xa Levels Not Predictive of Epidural Bleeding Horlacher et al., 2003 UC Horlacher et al., 2003 Use Of Conduction Anesthesia Preoperative LMWH If bleeding occurs during catheter placement, postoperative LMWH should be delayed for 24 hours postoperatively Patients receiving prophylactic doses of LMWH should not have needle and catheter placement for hours after the last dose Patients receiving therapeutic doses will require a delay of at least 24 hours to assure normal hemostasis. UC Use Of Conduction Anesthesia Postoperative LMWH Therapeutic dosing of LMWH should be delayed at least 24 hours after catheter placement Prophylactic dosing should be delayed for 6-8 hours after catheter placement and the 2 nd dose given no sooner than 24 hours Horlacher et al., 2003 UC 9

10 Inhibits vitamin K Warfarin Pharmacology Decreases Factors VII, IX, X and Prothrombin Anticoagulant effect related to IX and X level Bleeding related to VII level Crosses placenta Warfarin Teratogenic Effects Collective of 214 cases Fetal mortality of 11.7% Prospective study of 40 women with heart valves Wastage 80% UC UC Warfarin Teratogenic Effects Warfarin Dosage Adjustment Chrondrodysplasia punctata Nasal hypoplasia IUGR Mental retardation Brachydactyly Monitor INR daily Any increase > units per day should lead to dosage decrease When therapeutic, monitor INR weekly time 3, then monthly UC UC 10

11 Warfarin Dosage Begin 5 mg (7.5 mg for patients > 85 kg) Adjust based on daily PT to proper INR Half-lives VII!! IX!! 6 hrs 30 hrs X!! 30 hrs Prothrombin! 100 hrs Oral Anticoagulation with Warfarin Day!! INR! Warfarin Dosage 1!!!!! 5.0 2! < 1.5!!! 5.0!! !!! 2.5!! !! !! > 2.5!!! 0.0 3! < 1.5!! !! !! !! !! !! > 3.0!!! 0.0!!! UC Day!!! INR!!! Warfarin Dose 4! < 1.5!! !! !! !! !! !! > 3.0!!! 0.0 5! < 1.5!!! 10.0!! !! !! !! !! > 3.0!!! 0.0 6! < 1.5!! !! !! !! !! ! > 3.0!!! 0.0!!! UC International Normalized Ratio (INR) INR = PT patient PT control ISI UC 11

12 Warfarin Breast Feeding Fibrinolytic Agents Limited Experience In Pregnancy Not contraindicated Minute amounts in milk None in plasma of nursing infants Streptokinase and Urokinase Improves pulmonary function in massive PE UC UC Selective Thrombin Inhibitors Little Published Reports in Pregnancy Several agents available Argatroban Bivalirubin Lepirudin Pregnancy Category B and probably safe for lactation Surgical Intervention Caval Interruption Clips Umbrellas Recurrence after 10 days of adequate anticoagulation UC 12

13 Surgical Intervention Randomized Study Cases (Decousus, 1998) Minor recurrence in 10% during 1st few days of heparin and not an indication for filter Initial benefit of preventing PE counterbalanced by an increased risk or recurrence without any decrease in mortality Surgical Intervention Pulmonary Embolectomy Can be lifesaving Angiographically demonstrated Inadequate cardiac output UC Key References ACOG Committee Opinion. Safety of Lovenox in pregnancy. Number 276. October American College of Obstetricians and Gynecologists, Washington, DC > Bates SM, et al.:. Use of antithrombotic agents during pregnancy: The Seventh ACCP Conference on antithrombotic and Thrombolytic therapy. Chest 126:627, 2004 Casele H, et al.: Cost-effectiveness of thromboprophylaxis with intermittent compression at cesarean delivery. Obstet Gynecol 108:535, 2006 Greer IA, et al.: : Low-molecular weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood 106:401, 2005 > Horlocker TT, et al.: Regional anesthesia in the anticoagulated patient: Defining the risks. Reg Anesth Pain Med 28:172, > Nelson-Piercy C: Thromboprophylaxsis during pregnancy, labour and after delivery. Royal College of Obstetricians and Gynaecologists; ; No. 37, 2004 Quinones JN, et al.: Thromboprophylaxsis after cesarean delivery: A decision analysis. Obstet Gynecol 106:733, Address: Larosr@obgyn.ucsf ucsf.edu 13

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