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Thursday, Thursday, December December 3, 3, 2015 2015 11:00 11:00 a.m. a.m. Eastern Eastern Dial Dial In: In: 888.863.0985 888.863.0985 Conference Conference ID: ID: 62201128 62201128 Slide 1 Speakers Alexander Friedman, MD, MPH, FACOG Columbia University Medical Center New York, NY Douglas Montgomery, MD, FACOG Southern California Permanente Medical Group Riverside Medical Center, Riverside California Director Maternal Fetal Medicine Chair Southern California Kaiser Obstetric VTE committee Co- Chair California Maternal Quality Care Collaborative VTE Task Force Slide 2 Disclosures Alexander Friedman, MD, MPH FACOG has no real or perceived conflicts of interest to disclose. Douglas Montgomery, MD, FACOG has no real or perceived conflicts of interest to disclose. Slide 3 Objectives Provide an in-depth overview of the Maternal Venous Thromboembolism Prevention Patient Safety Bundle. Take a look at the processes, methods, and tools that were used to develop the bundle. Give suggestions for how to effectively implement and utilize the bundle within your organization. Identify resources to customize the bundle for use within your organization. Slide 4 National Partnership for Maternal Safety Focus on decreasing Maternal Mortality & Morbidity Three core bundles focus on leading causes of maternal mortality and morbidity that are amenable to prevention. Bundles are sets of critical clinical practices when performed systematically, have been validated to improve outcomes. Safety Bundles are not meant to introduce new guidelines but rather organize existing materials in ways that facilitate systematic implementation in every maternity unit in the United States Venous Thromboembolism Severe Hypertension in pregnancy Obstetric Hemorrhage Slide 5 D'Alton M.E. et al. The national partnership for maternal safety. Obstet Gynecol 2014;123:973. Institute for Healthcare Improvement. Evidence-Based Care Bundles. Ihi.org. VTE WORKING GROUP Comprised of the following individuals with representation from obstetrics, nursing, midwifery, and anesthesia: • • • • • • • • • • STEVEN CLARK, MD MARY D’ALTON, MD ROBYN D’ORIA, MA, RNC, APC ALEXANDER FRIEDMAN, MD JENNIFER FROST, MD, MPH AFSHAN HAMEED, MD DEBORAH KARSNITZ, DNP, CNM DOUGLAS MONTGOMERY, MD MICHAEL PAIDAS, MD RICHARD SMILEY, MD Slide 6 Pregnancy Related Mortality United States (1987-2010) Slide 7 Creanga, A.A., et al. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. (2015 Jan);125(1):5-12. doi: 10.1097/AOG.0000000000000564. New York City 2006-2010 Pregnancy-Associated Mortality Slide 8 NYC Department of Health and Hygiene, Bureau of Maternal, Infant and Reproductive Health. (2015). Report of the Pregnancy-Associated Mortality Review Project. Morbidity Long-term sequelae include: • Recurrent VTE • Post-thrombotic syndrome May develop in up to 50% of patients who experience DVT Chronic leg pain, edema, erythema and ulcerations • Lung damage • Cardiovascular Slide 9 Vasquez, SR et al. Cardiology Patient Page: Postthrombotic Syndrome. Circulation. (2010); 121:217-219 Venous Thromboembolism (VTE) Prophylaxis “single cause of death most amenable to reduction by systematic change in practice” – Steven Clark, M.D., Semin Perinatol 2012;36(1):42-7 Direct Deaths per Million Maternities by Cause UK 1994-2008 Slide 10 Saving Mothers’ Lives 2006-2008, National Launch, March 2011 Professor Gwyneth Lewis OBE FRCOG FACOG VTE Prophylaxis The Agency for Healthcare Research and Quality defined VTE as the “number one patient safety practice” for hospitalized patients. Safe practices published by the National Quality Forum (NQF) recommend: • Routine evaluation of hospitalized patients for risk of VTE • Use of appropriate prophylaxis ENDORSE Survey • Evaluated prophylaxis rates in 17,084 major surgery patients • More than one third of patients at risk for VTE (38%) did not receive prophylaxis • Rates varied by surgery type Shojania KG, Duncan BW, McDonald DM, et al. (Eds.). (2001). "Making healthcare safer; A critical analysis of patient safety practices (Evidence Report/Technology Assessment No. 43)." Prepared by the University of California at San Francisco-Stanford Evidenced-based Practice Center under Contract no. 290-97-0013 (AHRQ Publication NO.01-E058). Rockville, MD: Agency for Healthcare Research and Quality. National Quality Forum. National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism. (2006). Slide 11 Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. The Lancet. 2008; 371: 387-394. Prophylaxis in Vaginal Delivery Hospitalizations No Prophylaxis Characteristic Any Prophylaxis n % n % 2,605,151 97.4 68,835 2.6 2006 366,317 98.4 5950 1.6 2007 374,851 98.3 6662 1.8 2008 352,438 97.8 7825 2.2 2009 354,460 97.3 9884 2.7 2010 367,470 96.9 11,675 3.1 2011 402,359 97.1 11,911 2.9 2012 390,881 97.2 11,303 2.8 All Patients Year of Delivery Slide 12 Friedman A, et al. Thromboembolism incidence and prophylaxis during vaginal delivery hospitalizations. Am J Obstet Gynecol. 2015 Feb; 212(2): 221.e1-12. Underuse of Post-cesarean Thromboembolic Prophylaxis Characteristic None Mechanical Pharmacologic Combination 955,787 (75.7) 278,669 (22.1) 16,639 (1.3) 12,110 (1.0) 2003 115,663 (91.6) 8,717 (6.9) 1,274 (1.0) 664 (0.5) 2004 124,230 (87.4) 15,674 (11.0) 1,319 (0.9) 923 (0.7) 2005 131,220 (84.6) 21,013 (13.5) 1,889 (1.2) 1,051 (0.7) 2006 154,876 (81.0) 32,302 (16.9) 2,413 (1.3) 1,608 (0.8) 2007 145,589 (74.7) 44,842 (23.0) 2,451 (1.3) 2,053 (1.1) 2008 131,250 (66.0) 62,545 (31.4) 2,852 (1.4) 2,294 (1.2) 2009 125,096 (60.5) 75,315 (36.4) 3,609 (1.8) 2,753 (1.3) 2010 27,863 (58.4) 18,261 (38.3) 832 (1.7) 764 (1.6) Year of Surgery Slide 13 Friedman A.M., Ananth C.V., et al. (2013). Underuse of post cesarean thromboembolic prphylaxis. Am J Obstet and Gynecol, 122(6):1197-204. Underuse of Post-cesarean Thromboembolic Prophylaxis Lack of Protocol Adherence • Systematic review of over 2,500 surgical patients demonstrated up to one fourth are noncompliant with post operative mechanical thromboprophylaxis. • Observational study demonstrated noncompliance with post-cesarean mechanical thromboprophylaxis in 21% of 293 patients. • Lack of adherence persist despite education & audits. Craigie, Samantha et al. Adherence to mechanical thromboprophylaxis after surgery: A systematic review and metaanalysis. Thrombosis Research. (2015). 136 (4): 723 – 72. Palmerola KL, et al. A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines. BJOG. (2015 Oct). DOI: 10.1111/1471-0528.13706. Slide 14 Brady, et al. Sequential Compression Device Compliance in Postoperative Obstetrics and Gynecology Patients Obstet & Gynecol. (2015 Jan); 125 (1): 19. Maternal Venous Thromboembolism Prevention Safety Bundle READINESS (Every Unit) • Use a standardized thromboembolism risk assessment tool for VTE during: • Outpatient prenatal care • Antepartum hospitalization • Hospitalization after cesarean or vaginal deliveries • Postpartum period (up to 6 weeks after delivery) RECOGNITION (Every Patient) • Apply standardized tool to all patient to asses VTE risk at time point designated under “Readiness” • Apply standardized tool to identify patients for thromboprophylaxis • Provide patient education • Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis RESPONSE (Every Unit) • Use standardized recommendations for mechanical thromboprophylaxis • Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation • Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia REPORTING/SYSTEMS LEARNING (Every Unit) • Review all thromboembolism events for systems issues and compliance with protocols • Monitor process metrics and outcomes in a standardized fashion • Assess for complications of pharmacologic thromboprophylaxis Slide 15 VTE Prevention: Readiness • Thromboembolism prophylaxis is a Joint Commission quality measure • The Joint Commission states that all patients should receive VTE prophylaxis or have documentation why no VTE prophylaxis was given "the day of or the day after hospital admission" "the day of or the day after surgery end date for surgeries that start the day of or the day after hospital admission” Slide 16 Specifications Manual for National Hospital Inpatient Safety. The Joint Commission. (2015); 5. VTE Prevention: Readiness Excluded populations Joint Commission measure: Patients with ICD-9-CM Principal or Other Diagnosis Codes of Obstetrics Sample Codes: 826 Slide 17 Full list available in the 2015 Joint Commission Specifications Manual for National Hospital Inpatient Safety (Appendix A, Table 7.02) VTE Prevention: Readiness Recommendation: The National Partnership recommends that this Joint Commission measure be extended to the obstetric population All patients should be assessed for VTE risk multiple times in pregnancy including during: • Presentation for prenatal care • Hospitalization for an antepartum indication • Delivery hospitalization (in-house postpartum) • Discharge from a delivery hospitalization Slide 18 VTE Prevention: Readiness VTE RISK ASSESSMENT MULTIPLE TIMES IN PREGNANCY 60 30 Antepartum ½ of all VTE 5 Initial Risk Assessment Slide 19 Marik, P.E. Venous thromboembolism in pregnancy. Clin Chest Med. (2010 Dec); 31(4):731-40. DOI: 10.1016/j.ccm.2010.06.004. Delivery & Postpartum Discharge VTE Prevention: Recognition • VTE risk assessment tools should be applied to every patient to determine risk for VTE • Risk assessment tools based on recommendations from major society guidelines American College of Obstetricians and Gynecology (ACOG) American College of Chest Physicians (ACCP) Royal College of Obstetricians and Gynaecologists (RCOG) • Pharmacologic prophylaxis may be with unfractionated heparin (UFH) or low-molecular weight heparin (LMWH) Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. American College of Obstetricians and Gynecologists. Thromboembolism in Pregnancy. Practice Bulletin No. 123. Obstet Gynecol (2011); 118: 718–29 Slide 20 Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015. VTE Prevention: Recognition ANTEPARTUM MANAGEMENT – ACOG • Anticoagulation during pregnancy and postpartum for women with a history of thrombosis or those those with high-risk acquired or inherited thrombophilias. Immobility considered as a modifying risk factor – ACCP • Thromboprophylaxis recommended for: reduced mobility, history of VTE or high risk thrombophilia – RCOG • Thromboprophylaxis recommended for: reduced mobility, history of VTE or high risk thrombophilia Guidelines agree on recommendations for high-risk patients Slide 21 Recognition and Response at First Prenatal Visit Clinical history Multiple VTE episodes VTE with high-risk (HR) thrombophilia VTE with acquired thrombophilia Anticoagulation Treatment dose LMWH or UFH Idiopathic VTE VTE with pregnancy or oral contraceptive VTE with low risk (LR) thrombophilia Family history of VTE with HR thrombophilia HR thrombophilia 1st VTE provoked Family history of VTE with LR thrombophilia LR thrombophilia (no prior event) Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. Slide 22 American College of Obstetricans and Gynecologists. Thromboembolism in Pregnancy. Practice Bulletin No. 123. Obstet Gynecol (2011); 118: 718–29 Prophylactic LMWH or UFH No treatment In-Patient Antepartum Hospitalization Recognition & Response In-Patient Antepartum Hospitalization for at least All patients: 72 hours: • All patients should be considered for pharmacologic prophylaxis. • For women at high risk of delivery or bleeding, mechanical thromboprophylaxis should be utilized. • Consider prophylaxis with unfractionated heparin near time of expected delivery rather than low molecular weight heparin (LMWH) to facilitate intrapartum conduction anesthesia. Slide 23 In-Patient Antepartum Hospitalization Recognition ANTEPARTUM ADMISSION: Length of Stay TWO LARGE COHORTS SIMILAR RESULTS : HOSPITALIZED >/= 3 days ~ 12 times increased risk of VTE * “The association between admission and venous thromboembolism remained when we restricted our analysis to women without medical comorbidities including obesity, cardiac disease, and varicose veins”. *HOSPITALIZED < 3 days ~ 4 times increased VTE risk *Sultan, et al. Risk of first venous thromboembolism in pregnant women in hospital: population based cohort study from England. BMJ. (2013 Nov); 7: 347 Slide 24 Virkus, et al. Risk Factors for Venous Thromboembolism in 1.3 Million Pregnancies: A Nationwide Prospective Cohort. PLoS One. (2014 May); e96495 In-Patient Antepartum Hospitalization Recognition ANTEPARTUM ADMISSION: BMI & Immobility Slide 25 Bates, S.M. et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST. (2012 Feb); 141(2)(Suppl):e691S–e736S VIRCHOW’S TRIAD LEFT Slide 26 OB MODIFIED PADUA RISK ASSESSMENT MODEL Risk factors Previous VTE Reduced mobility (bed rest with bathroom privileges for at least 3 days) Thrombophilia* Acute infection and/or rheumatologic disorder Obesity (BMI >25kg/m2) Pregnancy * Antithrombin deficiency, Protein C or S deficiency, factor V Leiden, G20210A prothrombin gene mutation, antiphospholipid antibody syndrome. Slide 27 Barbar, S. et al, A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. (2010 Nov); 8 (11):2450-7. doi: 10.1111/j.1538-7836.2010.04044.x. Kahn, S.R. et al. Prevention of VTE in nonsurgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. (2012 Feb); 141(2 Suppl):e195S-226S. doi: 10.1378/chest.11-2296. Points 3 3 3 1 1 1 RCOG Clinical Recommendations • If admitted to hospital antenatally consider thromboprophylaxis • If prolonged admission (> 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis Slide 28 Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015. Antepartum Hospitalization RR Warrants VTE Prophylaxis 1. Biologic Plausibility RR 12 - 60 2. Epidemiologic Data 3. RCOG & PADUA RAM A Major Risk Factor Slide 29 D M I T Recognition and Response: Postpartum patients in the hospital • How should patients be prophylaxed? • After a vaginal delivery • After a cesarean delivery • Scoring systems • RCOG • ACCP • Caprini Slide 30 Vaginal Delivery • All patients Early mobilization Avoid dehydration • Very high-risk patients should receive postpartum pharmacologic prophylaxis with LMWH or UFH History of VTE or thrombophilia Already receiving LMWH or UFH as outpatients • For women with multiple, lesser risk factors for VTE by RCOG criteria Pharmacologic prophylaxis with LMWH or UFH may be considered Slide 31 Cesarean Delivery Women undergoing cesarean delivery should: • Receive mechanical prophylaxis devices perioperatively and postpartum • Receive pharmacologic prophylaxis (LMWH or UFH) based on risk factors An “opt-out” strategy where all women undergoing cesarean delivery receive prophylaxis with LMWH or UFH unless there is a specific contraindication is also an acceptable approach Slide 32 ACCP Recommendations Pharmacologic prophylaxis (LMWH) recommended for one major or two or more minor risk factors Mechanical prophylaxis recommended for those with contraindications to pharmacologic prophylaxis Major risk factors - VTE risk ~ 3% Minor risk factors - VTE risk ~ 3% BMI >30 kg/m2 Chest Post Cesarean Section Immobility (strict bed rest ≥1 week in the antepartum period) Postpartum haemorrhage ≥1000 mL with surgery Previous VTE Pre-eclampsia with fetal growth restriction Thrombophilia Antithrombin deficiency Factor V Leiden (homozygous or heterozygous) Prothrombin G20210A (homozygous or heterozygous) Medical conditions Systemic Lupus erythematosus Heart disease Sickle cell disease Blood transfusion Postpartum infection Recommendations Slide 33 Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. Multiple pregnancy Emergency caesarean Smoking >10 cigarettes/day Fetal growth restriction Thrombophilia Protein C deficiency Protein S deficiency Pre-eclampsia RCOG Recommendations • If total score > 4 antenatally, consider thromboprophylaxis from the first trimester • If total score 3 antenatally, consider thromboprophylaxis from 28 weeks • If total score > 2 postnatally, consider thrombroprophylaxis for at least 10 days • If admitted to hospital antenatally consider thromboprophylaxis • If prolonged admission (> 3 days) or readmission to hospital during the pueperium consider thromboprophylaxis Slide 34 Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015. RCOG Recommendations 4 Points • • 2 Points Previous VTE (except for a single event related to major surgery Ovarian hyperstimulation syndrome (1st trimester only) • • Cesarean in labor Obesity (BMI >40kg/m2) 3 Points • • • • • Previous VTE provoked by major surgery Known high-risk thrombophilia Any surgical procedure in pregnancy or puerperium except immediate repair of the perineum, e.g. appendectomy, postpartum sterilization Hyperemesis Medical comorbidities e.g. cancer, heart failure, active systemic lupus erythematosus, inflammatory polyarthropathy or inflammatory bowel disease, nephrotic syndrome, type I diabetes mellitus with nephropathy, sickle cell disease, current intravenous drug user 1 Point • • • • • • • • Family history of unprovoked or estrogenrelated VTE in first-degree relative Known low-risk thrombophilia (no VTE Age (>35 years) Obesity (BMI >30kg/m2) Parity > 3 Smoker Gross varicose veins Preeclampsia in current pregnancy Slide 35 • • • • • • • • Assisted reproductive technology/in vitro fertilization (antenatal only) Multiple pregnancy Elective cesarean Mid-cavity rotational operative delivery Prolonged labor (>24 hours) Postpartum hemorrhage (>1 liter or blood transfusion) Preterm birth <37 weeks in current pregnancy Stillbirth in current pregnancy Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015. CHEST APPLICATION CAPRINI MODEL General Abdominal or Pelvic Surgery SCORE RISK PROPHYLAXIS estimated VTE risk no prophylaxis 1-2 Pregnancy = 1 point LOW ~ 1.5% risk VTE - intermittent pneumatic compression Surgery < 45 minutes = 1 point 3-4 MECHANICAL MEDIUM ~ 3% risk VTE MECHANICAL OR CHEMICAL - LMWH OR LD UFH >/= 5 Previous VTE= 3 points Thrombophilia = 3 points Consider additional HIGH ~ 6% risk VTE MECHANICAL PLUS CHEMICAL Risks Many pregnant patients will have multiple additional risks (slide ***) Gould, et al. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST (2012 Feb); 141(2)(Suppl):e227S–e277S Slide 36 Caprini, J.A. Caprini DVT Risk Assessment. Venous Resource Center. Web: http://venousdisease.com/caprini-dvtrisk-assessment/ * Original Caprini scoring system condensed to include conditions commonly encountered in obstetric patients Table 1. Modified Caprini risk assessment model * Risk factors Slide 37 Points Age 41-60 1 Minor surgery (less than 45 minutes) 1 Visible varicose veins 1 Swollen legs (current) 1 Overweight or obese (body mass index above 25kg/m2) 1 Currently on bed rest 1 Serious lung disease including pneumonia (<1 month) 1 Pregnancy or postpartum (<1 month) 1 History of unexplained stillborn infant, recurrent spontaneous abortion (> 3), premature birth with toxemia or growth-restricted infant 1 Other risk factors (smoking, diabetes, BMI >40kg/m2, blood transfusions) 1 Central venous access 2 Major surgery (>45 minutes) 2 Patient confined to bed (>72 hours) 2 Family history of thrombosis 3 History of DVT/PE 3 Prothrombin 20210A or factor V Leiden 3 Lupus anticoagulant or elevated anticardiolipin antibodies 3 Elevated serum homocysteine 3 Other congenital or acquired thrombophilia 3 Caesarean Thromboprophylaxis Comparison of 3 Leading Guidelines • 293 patients included in analysis 1% ACOG 35% 85% Slide 38 All based on having a prior event Chest RCOG Emergency caesarean, Pre-eclampsia Obesity, Multiple gestation Postpartum haemorrhage Caesarean during labor, Maternal Age ≥35 Obesity, Pre-eclampsia, Infection, High Parity In Press: Palmerola KL, et al. A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines. BJOG. (2015 Oct). DOI: 10.1111/1471-0528.13706. Recognition and Response Postpartum after delivery hospitalization Clinical history Multiple VTE episodes VTE with high-risk (HR) thrombophilia VTE with acquired thrombophilia Anticoagulation 6 Weeks Treatment LMWH/UFH Idiopathic VTE VTE with pregnancy or oral contraceptive VTE with low risk (LR) thrombophilia Family history of VTE with HR thrombophilia HR thrombophilia (including acquired) 6 Weeks Prophylactic LMWH/UFH VTE provoked* LR thrombophilia and family history of VTE* * (two changes from initial assessment) LR thrombophilia Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. Slide 39American College of Obstetricans and Gynecologists. Thromboembolism in Pregnancy. Practice Bulletin No. 123. Obstet Gynecol (2011); 118: 718–29 No treatment Protocols Protocolsfor forProphylaxis Prophylaxis Agent LMWH Enoxaparin Dalteparin Tinzaparin Weight based UFH Unfractionated heparin Gestational age-based <50kg 20mg daily 2500 units daily 3500 units daily First trimester 5000-7500 units Twice daily 50-90kg 40mg daily 5000 units daily 4500 units daily Second trimester 7500-10000 units Twice daily 91-130kg 60mg daily* 7500 units daily* 7000 units daily* 131-170kg 80mg daily* >170kg 0.6mg/kg/day* 10000 units daily* 75 units/kg/day Third trimester 10000 units Twice daily 9000 units daily 75 units/kg/day Hospitalized antepartum patients may receive 5000 units UFH twice daily for prophylaxis to facilitate regional anesthesia *=may be given in two divided doses Slide 40 Adapted from American College of Obstetricans and Gynecologists. Thromboembolism in Pregnancy. Practice Bulletin No. 123. Obstet Gynecol (2011); 118: 718–29; Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015.; Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. Timing of Neuroaxial Anesthesia Antepartum/Intrapartum UFH ≤10,000IU/day No contraindications to timing of heparin dose and performance of neuraxial blockade¥ UFH >10,000IU/day Wait 12 hours after last dose prior to neuraxial blockade or check aPPT * IV Heparin Wait 4-6 hours after discontinuation of IV heparin; consider checking aPPT LMWH prophylaxis Wait 12 hours post last dose prior to neuraxial blockade LMWH therapeutic Wait 24 hours post last dose prior to neuraxial blockade Postpartum UFH ≤10,000IU/day Heparin may be administered at any time interval after epidural catheter removal or spinal needle placement UFH >10,000IU/day or IV Heparin Wait ≥1 hour after epidural catheter removal or spinal needle placement LMWH prophylaxis Wait ≥4 hours after epidural catheter removal or spinal needle placement LMWH therapeutic Avoid therapeutic dosing with epidural catheter in situ. Wait at least 24 hours after catheter removal or spinal needle ¥ No specific society guidelines for management of patients also receiving aspirin * No specific society guidelines for management Slide 41 FDA. FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. (2013 Nov). New York Presbyterian Hospital. Surgical Prophylaxis: Antibiotic Recommendations for Adult Patients. Horlocker, T.T., et al. Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition). Regional Anesthesia and Pain Medicine. (2010); 35 (1): 64-101 Post-Cesarean VTE Prophylaxis • Unfractionated heparin (UFH) The patient may receive standard order of 5000 units SC every 12 hours starting at any time before or after spinal anesthesia placement or epidural catheter placement or removal A reasonable clinical strategy is to administer the first dose of 5000 units SC when the patient meets PACU discharge criteria Slide 42 New York Presbyterian Hospital. Surgical Prophylaxis: Antibiotic Recommendations for Adult Patients. NYP protocol Post-Cesarean VTE Prophylaxis • Low-molecular-weight heparin (LMWH) The patient should receive the first dose of LMWH no sooner than 6 hours postoperatively regardless of anesthesia technique If an epidural catheter remains in situ for pain control, it should not be removed until 12 hours after last dose of LMWH If the epidural catheter is to be removed prior to a dose of LMWH, the LMWH may not be given until 4 hours after removal Slide 43 Sources: FDA Drug Safety Communication Nov, 2013; NYP protocol New York Presbyterian Hospital. Surgical Prophylaxis: Antibiotic Recommendations for Adult Patients. Heparin Induced Thrombocytopenia (HIT) • Extremely rare complication in the obstetric population receiving UFH/LMWH for VTE prevention • For patients expected to be on either UFH or LMWH for greater than >7 days a reasonable clinical strategy is to check a complete blood count 7-10 days after initiation of therapy • Some guidelines, such as those from ASRA, recommend that patients receiving prophylaxis have a CBC checked 4 days after prophylaxis is initiated Slide 44 Reporting/Systems Learning Recommendation Review all thromboembolism events for systems issues and compliance with protocols Monitor process metrics and outcomes in a standardized fashion Assess for complications of pharmacologic thromboprophylaxis Slide 45 Conclusion • All patients require VTE risk assessment at multiple time points in pregnancy and postpartum • All patients undergoing cesarean delivery require mechanical prophylaxis, early ambulation, and adequate hydration • Women with additional risk factors for VTE after delivery will benefit from pharmacologic prophylaxis • Empiric pharmacologic prophylaxis is a reasonable option for all women undergoing cesarean delivery all antepartum hospital admissions >72 hours Slide 46 Bundle Resources READINESS – Bahl V, et al. A validation study of a retrospective venous thromboembolism risk scoring method. Ann Surg. 2010 Feb;251(2):344-50. Note: Abstract only; must be subscriber to access full-text. – Barbar S, et al. A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost. 2010 Nov;8(11):2450-7. – Bates S, et al. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-736S. – Royal College of Obstetricians and Gynaecologists. Thrombosis and Embolism during Pregnancy and the Puerperium, Reducing the Risk. Green-top Guideline No. 37a; April 2015. – Thromboembolism in Pregnancy. ACOG practice bulletin No. 123. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2011 Sep;118(3):718-29. Available until 10/28/16 RECOGNITION – National Blood Clot Alliance. Available at: http://www.stoptheclot.org/. Retrieved October 29, 2015. – Partnership for Patients Venous Thromboembolism (VTE) Resource List. – Available at: http://partnershipforpatients.cms.gov/p4p_resources/tspvenusthromboembolism/toolvenousthromboembolismvte.html. Retrieved October 29, 2015. RESPONSE – American College of Obstetricians and Gynecologists. Safe motherhood initiative. Available – at: http://www.acog.org/About-ACOG/ACOG-Districts/District-II/SMI-Registration. Retrieved September 22, 2014. – Dresang L, et al. Venous Thromboembolism During Pregnancy. Am Fam Physician. 2008 Jun 15;77(12):1709-1716. – Venous Thromboembolism Prevention in the Hospital Presentation (AHRQ); May 2010. Available at: http://archive.ahrq.gov/news/events/conference/2009/maynard2/index.html. Retrieved October 29, 2015. REPORTING/SYSTEMS LEARNING No resources selected. Slide 47 Q&A Session Press *1 to ask a question You will enter the question queue Your line will be unmuted by the operator for your turn A recording of this presentation will be made available on our website: www.safehealthcareforeverywoman.org Slide 48 Next Safety Action Series Empowering Patients, Improving Outcomes Maternal Mental Health Presentation Monday, December 14th, 2015 | 12:00 p.m. Eastern Lisa Kay Lynne McIntyre Katherine Stone 2020 Mom Postpartum Support International Postpartum Progress Click Here to Register Slide 49