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Update in Perioperative Care: Perioperative Anticoagulation 2008

Update in Perioperative Care: Perioperative Anticoagulation 2008 . Steven B. Deitelzweig,M.D. FACP,FSVMB,RVT System Chairman - Dept. of Hospital Medicine Vice President – Medical Affairs Ochsner Health System Clinical Assoc Professor of Medicine Tulane University Medical College

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Update in Perioperative Care: Perioperative Anticoagulation 2008

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  1. Update in Perioperative Care: Perioperative Anticoagulation2008 Steven B. Deitelzweig,M.D. FACP,FSVMB,RVT System Chairman - Dept. of Hospital Medicine Vice President – Medical Affairs Ochsner Health System Clinical Assoc Professor of Medicine Tulane University Medical College New Orleans, LA

  2. Outline 1. Describe current state-of-the-art evidence-based clinical practice for venous thromboembolism in adult peri-operative Anticoagulation 2. Describe the prevalence of VTE, its association with morbidity and mortality, and current deficiencies in recognition of patients at risk and use of prophylaxis 3. Explain best strategies for prophylaxis, including choice of agent, patient population, and duration of therapy 4. Identify specific surgical patient populations at risk for VTE and recognition of consequences of not using prophylactic therapy (ie improve patient safety)

  3. Magnitude of VTE in the USA Pulmonary Emboli • Cause 5-10% hospital deaths • Pre-fatal PE not recognized In-hospital VTE • ~ 70% in medical patients • ~ 30% in surgical patients BMJ 1992. Arch Intern Med 1991; 151:933-8. Clin Chest Med 1995;16:235.

  4. The Risk of DVT in Hospitalized Patients Is Significant Absolute risk in hospitalized patients VTE, venous thromboembolism, deep vein thrombosis (DVT), and/or pulmonary embolism (PE). Geerts WH et al. Chest. 2004;126(suppl):338S-400S.

  5. DVT May Have Significant Long-term Health Complications • 355 patients with first episode of DVT (mostly proximal) followed for up to 8 years in prospective cohort study • Cumulative incidence of subsequent DVT/PE was 30% • 23% of DVT sufferers developed postthrombotic syndrome (PTS) within 2 years • Cumulative incidence of PTS was 29% over 8 years Prandoni P et al. Ann Intern Med. 1996;125:1-7.

  6. DVT FREE Registry • Patient status at the time of diagnosis (N=5451) • Outpatient 2725 (50%) • Inpatient 2726 (50%) • Inpatient status at diagnosis (n=2726) • Non-ICU 2118 (78%) • ICU 605 (22%) • Mechanical ventilation 441 (16%) Only 42% of inpatients were receiving some form of prophylaxis; 58% NO PROPHYLAXIS Goldhaber SZ, Tapson VF. Am J Cardiol. 2004;93:259-262.

  7. VTE Prophylaxis Compliance with American College of Chest Physicians (ACCP) Guidelines Is Low* *Data collected January 2001 to March 2005; 895,410 hospital admissions. Compliance assessment was based on the 6th ACCP guidelines. Adapted from Yu HT, et al. Am J Health Syst Pharm. 2007;64(1):69-76.

  8. Utilization of DVT Prophylaxis • 2000 patients in 10 teaching hospitals receiving “optimal” antithrombotic therapy • THR – 84.3% • TKR – 75.9% • Hip Fx – 45.2% • Major Abdominal Surgery – 50.3% • Multiple high risk factors – only 39% Stratton MA, et al. Arch Intern Med 2000;160(3):334-40.

  9. Change is good, you go first… Dilbert

  10. Leading Change • Establish a sense of urgency • Create a guiding coalition • Develop a vision and strategy • Communicate the change vision • Empower broad-based action • Generate short-term wins • Consolidate gains and produce more change • Anchor new changes in the culture Kotter JP: Leading Change, 1996.

  11. Proposed 2008 National Consensus Standards for Prevention & Care of VTE Risk-assessment/prophylaxis • VTE risk-assessment/prophylaxis within 24 hours of hospital admission • VTE risk-assessment/prophylaxis within 24 hours of transfer to ICU Treatment • Documentation of inferior vena cava filter indication • VTE patients with overlap of anticoagulation therapy • VTE patients receiving UFH with platelet count monitoring • VTE patients receiving UFH management by nomogram/protocol • VTE discharge instructions Outcome • Incidence of potentially preventable hospital-acquired VTE • note: as testing proceeds, there may be subsequent modifications of the above measures www.jointcommission.org/PerformanceMeasurement/PerformanceMeasurement/VTE

  12. SCIP: Approved Measures • Prevention of VTE • the proportion of patients who have been ordered the recommended VTE prophylaxis-48 • the proportion of patients who have received the appropriate form of VTE prophylaxis (based on the ACCP Consensus Recommendations) within 24 hours before or after surgery

  13. DVT/PE Measures for the FutureAddressing the Continuum of Care In the future, 2 other measures from SCIP may be implemented by Medicare: • SCIP VTE-3 Intra- or postoperative PE diagnosed during index hospitalization and within 30 days of surgery • SCIP VTE-4Intra- or postoperative DVT diagnosed during index hospitalization and within 30 days of surgery SCIP, Surgical Care Improvement Partnership. SCIP Process and Outcome Measures. October 2005. Available at: http://www.medqic.org. Accessed January 1, 2007.

  14. Percentage of patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for low molecular weight heparin (LMWH), low-dose unfractionated heparin (LDUH), adjusted-dose warfarin, fondaparinux, or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time Physician Quality Reporting Initiative (PQRI)—Perioperative DVT/PE Prophylaxis Measure #23: Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When indicated in ALL patients) CMS. 2007 Physician Quality Reporting Initiative Specifications Document. Available at: http://www.cms.hhs.gov/PQRI/Downloads/Specifications_2007-02-04.pdf. Accessed April 4, 2007.

  15. Numerator CPT II 4044F Documentation of order for VTE prophylaxis to be given within 24 hours prior to incision time or 24 hours after surgery with modifier 1P VTE prophylaxis NOT ordered for medical reasons with modifier 8P VTE prophylaxis NOT ordered, reason not specified Denominator CPT I code for surgical procedure for which VTE prophylaxis is indicated Quality Reporting Initiative (PQRI)—Medicare Coding Specifications for DVT/PE Prophylaxis Measure #23: Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When indicated in ALL patients) CMS. 2007 Physician Quality Reporting Initiative Specifications Document. Available at: http://www.cms.hhs.gov/PQRI/Downloads/Specifications_2007-02-04.pdf. Accessed April 4, 2007.

  16. Which best describes the process of risk stratification at your institution to prophylax a surgical patient for DVT? • Risk stratification is not done without the support of a guideline • Risk stratification is performed with a guideline that provides practitioners with direction • Risk stratification is not done with the support of a guideline, but one is being developed • Risk stratification is left to the practitioner, and no guideline is being considered

  17. AT III: Heparin / LMWH / VKA XII XIIa Tissue Factor XI XIa IX IXa VIIa Tissue Factor Ca++ IXa VIIIa Ca++ Pentasaccharide Direct thrombin inhibitors Thrombin VIII VIIIa VII VIIa Treating Thrombus Formation Inhibit thrombin generation Xa Inhibit thrombin activity

  18. Audience Question: What Modes of DVT/PE Prophylaxis Are Most Commonly Used for Medical Patients at Your Hospital? • Graduated compression stockings • Intermittent pneumatic compression • Venous foot pump • Aspirin • LMWH • Low-dose UFH • Other

  19. FDA labeling in orthopedic (hip fracture, THR, TKR) surgery Caution on superiority claims vs. enoxaparin (FDA) Clinical trial design ? Timing of administration ?  bleeding in TKR PENTAMAKS Average wholesale price ~ 2X enoxaparin 40mg qd Complete safety and efficacy profile remains to be determined Contraindicated in renal dysfunction and/or patients weighing <50kg Caution in elderly Not pharmacologically reversible Prolonged t1/2 Fondaparinux Pentasaccharide Amer Heart J,2001:142(2):S1-S2, S9-S15.

  20. Therapeutic Range for Warfarin:Balancing Safety and Efficacy 15 * thrombosis Intracranial Hemorrhage 10 Odds Ratio 5 1 0 1 2 3 4 5 6 7 8 INR *Warfarin has a very narrow therapeutic window, <2 or >3. Hylek. Ann Intern Med. 1994;120:897-902. Hylek.N Engl J Med. 1996;335:540-546.

  21. Improving AC Management: Usual-Care Monitoring vs AC-Clinic Monitoring Average Time With an INR of 2-3 (%) Anticoagulated Patients (%) Samsa et al. Arch Intern Med. 2000;160:967-973.

  22. FDA Approval Status - Ximelagatran • Based on recommendations from a September 2004 hearing of the Cardiovascular and Renal Drugs Advisory Committee, the US FDA has not granted approval for ximelagatran (brand name: Exanta) for the three indications • Short-term prevention of VTE in patients undergoing knee-replacement surgery • Long-term, secondary prevention of venous thromboembolism (VTE) after standard treatment for an acute episode • Long-term prevention of stroke, & other thromboembolic complications associated with atrial fibrillation www.fdaadvisorycommittee.com. Accessed on Oct 12, 2004.

  23. What Research Supports Aspirin as Prophylaxis in Orthopedic Surgery Patients?

  24. Low-dose Aspirin PEP Trial: Study Design • Pulmonary Embolism Prevention (PEP) trial • Multicenter, randomized, placebo-controlled trial of low-dose aspirin • Aspirin 160 mg/day vs placebo for 5 weeks • Aspirin started preoperatively • ~40% also received UFH or LMWH • Hip fracture and hip and knee arthroplasty patients • Hip fracture patients (n=13,356) • Arthroplasty patients (n=4088) • Patients evaluated on day 35 PEP Trial Collaborative Group. Lancet. 2000;355:1295-1302.

  25. Low-dose Aspirin PEP Trial: Results Hip Fracture Hip/Knee Arthroplasty P=0.03 P=0.002 PEP Trial Collaborative Group. Lancet. 2000;355:1295-1302.

  26. Seventh ACCP Recommendations Aspirin as Thromboprophylaxis “We recommendagainstthe use of aspirin alone as prophylaxis against VTE* for any patient group (Grade 1A)” *Includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Geerts WH et al. Chest. 2004;126:338S-400S.

  27. Categories of Risk for Venous Thromboembolism in Surgical Patients Low risk: • Minor surgery in patients <40 years of age with no additional risk factors present* Moderate risk: • Minor surgery in patients with additional risk factor present*, or Surgery in patients aged 40-60 with no additional risk factor High risk: • Surgery in patients >60 or >40 or with additional risk factors* Highest risk: • Surgery in patients with multiple risk factors present*, or Cancer Surgery, Hip or knee arthroplasty, hip fracture surgery, or Major trauma, spinal cord injury *Additional risk factors include one or more of the following: advanced age, prior venous thromboembolism, obesity, heart failure, paralysis, cancer or presence of a molecular hypercoagulable state (eg, protein C deficiency, factor V Leiden). Geerts et al. Chest 2004;126:338S-400S

  28. Levels of VTE Risk and Recommendations for Prophylaxis Calf DVT % Proximal DVT % Clinical PE % Fatal PE % Prevention strategies Level of Risk Low risk 2 0.4 0.2 0.002 No specific measures Aggressive mobilization Moderate risk 10-20 2-4 1-2 0.1-0.4 LDUH q12h or LMWH, or GCS or IPC High risk 20-40 4-8 2-4 0.4-1.0 LDUH q8h or LMWH or IPC Highest risk 40-80 10-20 4-10 0.2-5 LMWH or OA or Fondaparinux IPC/ES + LDUH/LMWH, or ADH Geerts et al. Chest 2004;126:338S-400S

  29. Major surgery in patients > 40 YO plus prior VTE, cancer, or hypercoagulable state Hip or knee arthroplasty, hip fracture surgery Major trauma Spinal cord injury Calf DVT: 40 - 80% Proximal DVT: 10 - 20% Clinical PE: 4 - 10% Fatal PE 0.2 - 5% VTE Risk in Orthopedic PatientsHighest Risk Patients Level of Risk VTE Event Rate * CHEST 2004;126(3):338S-400S.

  30. Major surgery in patients > 40 YO plus prior VTE, cancer, or hypercoagulable state Hip or knee arthroplasty, hip fracture surgery Major trauma Spinal cord injury Calf DVT: 40 - 80% Proximal DVT: 10 - 20% Clinical PE: 4 - 10% Fatal PE 0.2 - 5% VTE Risk in Surgical PatientsHighest Risk Patients Level of Risk VTE Event Rate * CHEST 2004;126(3):338S-400S.

  31. Need for Venous Thromboembolism Prophylaxis • VTE risk without prophylaxis1,2 • Hip-replacement patients • 45% to 57% risk of DVT1,2 • 23% to 36% risk of proximal DVT1,2 • 0.7% to 30% risk of PE2 • Knee-replacement patients • 40% to 84% risk of DVT1,2 • 9% to 20% risk of proximal DVT1,2 • 1.8% to 7.0% risk of PE1,2 • Zimlich, et al. J Am Acad Orthop Surg 1996 * CHEST 2004;126(3):338S-400S.

  32. Quiz Question... Clots in Progress...

  33. High-Risk Surgery Recommendations * CHEST 2004;126(3):338S-400S. q = every, h = hours

  34. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Other Prophylaxis Issues • for Major Orthopedic Surgery • Extended out-of-hospital LMWH prophylaxis (beyond 7 to 10 days after surgery) may reduce the incidence of clinically important thromboembolic events, and we recommend this approach at least for high-risk patients (grade 2A because of uncertainty regarding cost-effectiveness) • We do not recommend routine duplex ultrasonography screening at the time of hospital discharge or during outpatient follow-up in asymptomatic THR or TKR patients (grade 1A)

  35. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Other Prophylaxis Issues • for Major Orthopedic Surgery • Extended out-of-hospital LMWH prophylaxis (beyond 7 to 10 days after surgery) may reduce the incidence of clinically important thromboembolic events, and we recommend this approach at least for high-risk patients (grade 2A because of uncertainty regarding cost-effectiveness) • We do not recommend routine duplex ultrasonography screening at the time of hospital discharge or during outpatient follow-up in asymptomatic THR or TKR patients (grade 1A) • Other Prophylaxis Issues • for Major Orthopedic Surgery • We recommend that patients undergoing THR or HFS be given extended prophylaxis for up to 28 to 35 days after surgery (Grade 1A). The recommended options for THR include LMWH (Grade 1A), a VKA (Grade 1A), or fondaparinux (Grade 1C+) • We recommend against the routine use of DUS screening at the time of hospital discharge in asymptomatic patients following major orthopedic surgery (Grade 1A)

  36. LMWH Extended Prophylaxis in THR RR (95% CI) Bergqvist et al. (1996) Planes et al. (1996) RR (all DVT during out-of-hospital time period): Dahl et al. (1997) Lassen et al. (1998) 0.41 (95% CI 0.32-0.54) p < 0.001 Hull et al. (2000) Comp et al. (2001) RR = risk reduction 0.10 0.5 1.00 2.0 Favors out-of–hospital LMWH Favors out-of-hospital placebo Extended VTE prophylaxis recommended for up to 28 – 35 days post THR surgery (ACCP grade 1A) Ann Intern Med 2001;135:858-69. CHEST 2004;126(3):338S-400S.

  37. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Elective Hip Replacement • For patients undergoing elective THR surgery, we recommend either SC LMWH therapy (started 12 h before surgery, 12 to 24 h after surgery, or 4–6 h after surgery at half the usual high-risk dose and then continuing with the usual high-risk dose the following day), or adjusted-dose warfarin (INR target 2.5, range 2.0 to 3.0; started preoperatively or immediately after surgery) (all grade 1A). • Adjusted-dose heparin therapy (started preoperatively) is an acceptable but more complex alternative (grade 2A). • Adjuvant prophylaxis with ES or IPC may provide additional efficacy (grade 2C). • Although other agents such as LDUH, aspirin, dextran, and IPC alone may reduce the overall incidence of VTE, they are less effective, and we do not recommend that these options be used.

  38. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Elective Hip Replacement • For patients undergoing elective THR surgery, we recommend either SC LMWH therapy (started 12 h before surgery, 12 to 24 h after surgery, or 4–6 h after surgery at half the usual high-risk dose and then continuing with the usual high-risk dose the following day), or adjusted-dose warfarin (INR target 2.5, range 2.0 to 3.0; started preoperatively or immediately after surgery) (all grade 1A). • Adjusted-dose heparin therapy (started preoperatively) is an acceptable but more complex alternative (grade 2A). • Adjuvant prophylaxis with ES or IPC may provide additional efficacy (grade 2C). • Although other agents such as LDUH, aspirin, dextran, and IPC alone may reduce the overall incidence of VTE, they are less effective, and we do not recommend that these options be used. • Elective Hip Replacement • For all patients undergoing elective THR surgery, we recommend the routine use of one of the following three anticoagulants: (1) LMWH (at a usual high-risk dose, started 12 hours before surgery or 12 to 24 hours after surgery, or 4 to 6 hours after surgery at half the usual high-risk dose the following day); (2) fondaparinux (2.5 mg started 6 to 8 hours after surgery); or (3) adjusted dose VKA started preoperatively or the evening after surgery (INR target, 2.5; INR range 2.0 to 3.0) [all Grade 1A] • We have not recommended the use of fondaparinux over LMWH and VKA, or the use of LMWH over VKA, because we place a relatively low value on the prevention of venographic thrombosis, and a relatively high value on minimizing bleeding complications • We recommend against the use of aspirin, dextran, LDUH, GCSs, IPC, or VFP as the only method of thromboprophylaxis in these patients (Grade 1A)

  39. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Elective Knee Replacement • For patients undergoing elective TKR surgery, we recommend either LMWH or adjusted-dose warfarin (grade 1A) • Optimal use of IPC is an alternative option (grade 1B recommendation because of the few trials and small sample sizes) • LDUH is not recommended (grade 1C+)

  40. Antithrombotic Therapy for Venous Thromboembolic Disease ACCP Conference on Antithrombotic and Thrombolytic Therapy Guidelines • Elective Knee Replacement • For patients undergoing elective TKR surgery, we recommend either LMWH or adjusted-dose warfarin (grade 1A) • Optimal use of IPC is an alternative option (grade 1B recommendation because of the few trials and small sample sizes) • LDUH is not recommended (grade 1C+) • Elective Knee Replacement • For patients undergoing elective TKA surgery, we recommend routine thromboprophylaxis using LMWH (at the usual high-risk dose), fondaparinux, or adjusted-dose VKA (target INR, 2.5; INR range, 2.0 to 3.0) [all Grade 1A] • Underlying Values and preferences • We have not recommended therapy with fondaparinux over that with LMWH and VKA, or therapy with LMWH over that with VKA, because we place relatively low value on the prevention of venographic thrombosis and a relatively high value on minimizing bleeding complications. • The optimal use of IPC is an alternative option to anticoagulant prophylaxis (grade 1B recommendation because of the fewer number of trials with smaller sample sizes) • We recommend against the use of any of the following as sole methods of thromboprophylaxis: aspirin (Grade 1A), LDUH (Grade 1A), or VFP (Grade 1B)

  41. Orthopedic Surgery: LMWH vs. Warfarin THR = total hip replacement; TKR = total knee replacement J Bone Joint Surg Am 1999;81:932-40. Arch Intern Med 2000;160:2199-207. Ann Intern Med 1996;124:619-26. J Bone Joint Surg 2001;83-A:900-6.

  42. What Data Are Available on VTE Prophylaxis in Hip Fracture Surgery?

  43. Hip Fracture Surgery TIFDED Pilot Study: Design and Results • Compared prophylaxis with danaparoid, enoxaparin, and dalteparin in hip fracture surgery • 197 patients randomized • No statistically significant differences in the frequency of DVT, blood loss, or major bleeding among the 3 groups Conclusion: • No significant difference in efficacy or safety TIFDED Study Group. Haemostasis. 1999;29:310-317.

  44. Fondaparinux vs Enoxaparin in Hip Fracture Surgery PENTHIFRA: Study Design and Results • Double-blind, randomized study of 1711 consecutive hip fracture surgery patients • Patients received either 2.5 mg of fondaparinux once daily, initiated postoperatively, or 40 mg of enoxaparin once daily, initiated preoperatively, for at least 5 days • Incidence of DVT/PE by day 11 was 8.3% (52 of 626 patients) in the fondaparinux group and 19.1% (119 of 624 patients) in the enoxaparin group (P<0.001) • No significant differences between the 2 groups in the incidence of death or clinically relevant bleeding Eriksson et al for the Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study. N Engl J Med. 2001;345:1298-1304.

  45. Seventh ACCP Recommendations Hip Fracture • 3.4.1. For patients undergoing HFS, we recommend the routine use of fondaparinux (Grade 1A), LMWH at the usual high-risk dose (Grade 1C), adjusted-dose VKA [target INR, 2.5; INR range, 2.0 to 3.0] (Grade 2B),or LDUH (Grade 1B). Geerts,WH et al. CHEST 2004;126:338S–400S.

  46. Venous Thromboembolism (VTE) Prophylaxis in the Surgical Cancer Patient Guidelines & Implications for Clinical Practice

  47. DVT and PE in Cancer Facts, Findings, and Natural History VTE is the second leading cause of death in hospitalized cancer patients 1,2 The risk of VTE in cancer patients undergoing surgery is 3- to 5-fold higher than those without cancer 2 Up to 50% of cancer patients may have evidence of asymptomatic DVT/PE 3 Ambrus JL et al. J Med. 1975;6:61-64 Donati MB. Haemostasis. 1994;24:128-131 Johnson MJ et al. Clin Lab Haem. 1999;21:51-54

  48. VTE Risk Factors in Surgical Oncology Patients Age >40 years Cancer procoagulants Thrombophilias Adjuvant chemotherapy or hormonal treatment Complicated, lengthy surgery (tissue trauma, immobilization) Debilitation and slower recovery Indwelling venous access

  49. Prevention and Managementof VTE in Cancer Sparse data specifically related to cancer patients were available until recently Cancer patients are a small subset (< 20%) in most of the largest trials of antithrombotic therapy Therefore, until the last two or three years, we needed to extrapolate from non-cancer patients, bearing in mind that cancer patients are in the highest risk groups

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