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Changing Paradigms in VTE Surgical Prophylaxis

Changing Paradigms in VTE Surgical Prophylaxis. The Challenge of Assessing VTE. Fact Sheet: VTE as a major health crisis concern In 2001, the number of DVT PE totalized 1,2 million PE causes 18% death in the hospital (1) 2/3 DVT are non-symptomatic (2)

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Changing Paradigms in VTE Surgical Prophylaxis

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  1. Changing Paradigms in VTE Surgical Prophylaxis

  2. The Challenge of Assessing VTE Fact Sheet: VTE as a major health crisis concern In 2001, the number of DVT PE totalized 1,2 million PE causes 18% death in the hospital (1) 2/3 DVT are non-symptomatic (2) 80% patients who died of PE had no clinical sign as of DVT (3) Most PE are sub-clinical or misdiagnosed Most PE deaths are within 30–60 min of onset “This is why prophylaxis in patients at risk of DVT is needed” In the US, thrombotic events kill more people than AIDS, breast cancer and highway fatalities combined. Some causes of death in the US: Annual death PE ……………………………………..< 200 000 AIDS (1998) ……………..…….……..13,426 Breast cancer (2001) ……..…………40,200 Highway Fatalities (2000)…….……. 41,800 Accidents (1998) ……………………..97,835 References: (1)Lindblad.et al. Incidence of VTE verified by necropsy over 30 years. BMJ 1991; 302 (6778): 709-11 (2) Anderson FA. Venous thromboembolism. Clinics in chest Medicine 1995; 16:235-51 (3)Couturaud F. Prevention de la TVP en milieu medical. Presse Med 1996 ; 25 :1935-40. Fatal PE Symptomatic DVT/PE Asymptomatic VTE

  3. Approximately 80% of VTE exhibit no apparent symptoms1,2 (asymptomatic) At least 70% of fatal PE detected post-mortem was not suspected or diagnosed2,3 At autopsy, approximately 63% of DVT cases were clinically undiagnosed3 1. Lethen H et al. Am J Cardiol 1997;80:1066—9 2. Stein PD, et al. Chest 1995;110:978-981. 3. Sandler DA, et al. J R Soc Med 1989;82:203-205. Most postoperative VTE cases are not detected

  4. Pulmonary Embolism kills more people in Europe* Breast Cancer AIDS Highway Accidents Prostate Cancer = 543,454 Pulmonary Embolism = 209,926 + + + * Cohen AT, Tapson VF, Bergman JF, et al. Venous Thromboembolism (VTE) in Europe. Thromb Haemost. 2007; 98:756-64

  5. Despite the existence of Risk Assesment Models …. First global view of VTE risk and prophylaxis practices  68,183 Patients  32 Countries  358 Hospitals Feb. 2008 The Lancet Epidemiologic International Day For the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting

  6. 40%receiving ACCPRec. Px Medical Patients at risk for VTE and receiving recommended prophylaxis Overall (N= 68,183) Primary objectives 52% at Risk for VTE 50%receiving ACCPRec. Px Secondary objectives Surgical ( n= 30,827) Medical (n=37,356) 64% at Risk for VTE 42% at Risk for VTE 59 %receiving ACCPRec. Px

  7. Differing risk levels in different types of surgery (1) Type of surgery . Spine with neurologic disorders. Pelvis, hip, lower limb III High risk High risk High risk . Plaster cast of the lower limb. Spine without neurologic disorder (except nucleus pulposus herniation). Therapeutic arthroscopy (except meniscectomy) II Moderate risk Moderate risk Moderate risk ORTHOPEDIC SURGERY . Upper limb. Diagnostic arthroscopy. Forefoot. Removal of osteosynthesis material. Herniated disk Low riskNo thromboprophylactic drug Low riskNo thromboprophylactic drug Moderate risk I Risk related to the patient 1No risk factor 3cancer, prior history of VTE, paraplegia, myeloproliferative disorder, hypercoagulability 2>40 yr, oral contraceptives decompensated heart disease, immobilization >4 days, varicose veins, infection, post-partum, obesity CO/8 (1) Recommandations pour la pratique clinique. Service Evaluation et Qualité. AP-HP, janvier 1998.

  8. VTE prevalence after major orthopaedic surgery *DVT rates are based on the use of mandatory venography in prospective clinical trials published since 1980, in which patients received either no prophylaxis or placebo. §PE rates were derived from prospective studies that may have included prophylaxis. Geerts WH, et al. Chest. 2004;126(3 Suppl):338S-400S.

  9. VTE incidence extends beyond Hospital discharge (eg in TKA and THA surgeries) THR: VTE events occurring after discharge 76% TKR: VTE events occurring after discharge 47% Primary hip Primary knee 2.8 THR 2.1 TKR Thromboembolic events (%) N = 43,645 patients Days White RH, et al.Arch Intern Med. 1998;158:1525-31.

  10. Incidence of DVT determined by mandatory postoperative fibrinogen uptake test or venography ORTHOPEDIC SURGERY P Mismetti –Actualités Thrombose N° 38/may 2001

  11. Arthroscopy and risk of DVT Local and regional anesthesia +++ Tourniquet: 30 min – 60 min (even 90 min/ligamentoplasty) DVT  0-18%, PE 0-9% (symptomatic or not) Fatal on rare occasions Frequency sometimes underestimatedvs personal experience Demers 1998 / 184 pts  18% DVT venography Day 6 - Day 12 Schippinger 1998 / 101 pts with LMWH 12% VTE (US or scanning) Risk factors Age > 40 yr Tourniquet > 60 min Prior history of VTE Varicose veins ORTHOPEDIC SURGERY D. Mainard-Risque de TVP au cours de l’arthroscopie/Actualités Thrombose N° 38/may 2001

  12. Thromboprophylaxis in orthopedic surgery:Clexane, no dose-adjustment according to weight Clexane 2 000 IU anti-Xa / 0.2 mL Corresponding to 20 mg 1 SC injection / day As long as the thromboembolic risk persists (until the patient is fully ambulant)* Moderate risk Clexane 4 000 UI anti-Xa / 0.4 mL Corresponding to 40 mg 1 injection SC / day - As long as the thromboembolic risk persists (until the patient is fully ambulant) - 4 to 5 weeks of prophylaxis after THR Highrisk ORTHOPEDIC SURGERY Follow-on by oral anticoagulants is possible Blood platelet count must be monitored throughout the entire treatment duration Prior to initiating treatment, renal function must be evaluated in elderly subjects 75 years old or more (Cockroft formula) * Treatment combined with the common practice of elastic compression of lower limbs

  13. Feasibility and Acceptability of self-injection of anticoagulants Several studies have shown the feasibility and acceptability of sel-finjection of anticoagulants in the outpatient setting after major orthopedic surgery. In a study on prolonged outpatient use of enoxaparin after hip or knee replacement, the inability or unwillingness to self-administer injectable thromboprophylaxis was 6 of 873 (.7%) ~ the Ability or Willingness to self-administer Enoxaparin was >99% The American Journal of Surgery (2010) 200, 413–421

  14. DVT Prophylaxis After THAAgents Available • Unfractionated heparin • LMWH • Coumadin • Aspirin

  15. Current Guidelines for DeepVein Thrombosis Prophylaxis in Orthopedic Surgery: ACCP Guidanceand Risk Stratification Strategies – Matching Intensity of Therapy with Patient Subgroups

  16. Evidence-Based Guidelines Recommendations Two Components: • Methodological Quality of a Recommendation • Grade A • Grade B Or • Grade C • Benefit/Risk • Grade 1 Or • Grade 2 The 7th ACCP Conference on Antithrombotic and Thrombolytic Therapy.Chest 2004; 126: 179S-187S.

  17. Methodologic Quality Grade A Consistent findings by randomized trials Grade B Randomized clinical trials with inconsistent results Grade C Observational studies Chest 2004; 126: 179S-187S.

  18. Grade 1 If we are very certain that the benefits do, or do not, outweigh the risks, burdens, and cost, we make a strong recommendation (in our formulation, Grade 1) Grade 2 If we are less certain of the magnitude of the benefits and the risks, burdens, and costs, and thus of their relative impact, we make a weaker Grade 2 recommendations Benefit/Risk Chest 2004; 126: 179S-187S.

  19. Thromboprophylaxis in High Risk surgeries: What do Global Guidelines tell us? International Union of Angiology (IUA), (ICS 2006)1 American College of Chest Physicians, (ACCP 2008)2 “Prophylaxis with LMWH should be initiated either before or after operation depending on the adopted regimen (Grade A). Fondaparinux should be started at least 6 to 8 h after surgery. Prophylaxis should be continued for 4-6 weeks with LMWH (Grade A) or fondaparinux (Grade C, extrapolation from hip fracture trial).” 3.5.3.2. For patients undergoing THR, we recommend that thromboprophylaxis be extended beyond 10 days and up to 35 days after surgery (Grade 1A). The recommended options for extended thromboprophylaxis in THR include LMWH (Grade 1A), a VKA (Grade 1B), or fondaparinux (Grade 1C). 1- Nicolaides AN, Fareed J, Kakkar AK, et al. Int Angiol. 2006; 25(2):101-6 2- Geerts WH, Pineo GF, Heit JA, et al. Chest. 2008

  20. ASPIRIN (ASA) AAOS recommends against the use of ASPIRIN alone as prophylaxis against VTE for any patient group (Grade 1A) Chest 2004; 126: 179S-187S.

  21. X Antiplatelets: -ASA

  22. Screening for DVT AAOS recommends againstthe routine use of DUS screening at the time of hospital discharge in asymptomatic patients following major orthopedic surgery (Grade 1A) Chest 2004; 126: 338S-400S.

  23. Elective Knee Arthroplasty • The optimal use of IPC is an alternative option to anticoagulant prophylaxis (Grade 1B) • We recommend against the use of any of the following as sole methods of thromboprophylaxis: • ASA (Grade 1A) • LDUH (Grade 1A) • Or venous foot pump (Grade 1B) Chest 2004; 126: 338S-400S.

  24. Primary Knee Primary Knee 3 3 Primary Hip Primary Hip % 2 2 Incidence 1 1 0 0 14 28 42 56 70 91 14 28 42 56 70 91 Days Days Rationale for Extended Prophylaxis After THR/TKR Cumulative Risk of Thromboembolic Events DuringFirst 3 Months Postoperatively All VTE PE The incidence of thromboembolic events does not stabilize untilapproximately 10 weeks after THR White et al. Arch Intern Med. 1998;158:1525-1531.

  25. Rationale for Extended Prophylaxis Incidence of PE within 3 months post-surgery 1.1% % of patients with PE 1.0 0.8% 0.5 0 Total Knee Arthroplasty n = 24,000 Total Hip Arthroplasty n = 19,000 White et al. Arch Intern Med. 1998;158:1525-1531.

  26. % DVT Diagnosis Made Post-Discharge Rationale for Extended Prophylaxis 76 80 60 47 40 20 0 Total Hip Total Knee Replacement Replacement n=19,000 n=24,000 White et al. Arch Intern Med. 1998;158:1525-1531.

  27. Rationale for Extended Prophylaxis Median Time of DVT Diagnosis After Surgery (Days) Total Hip Arthroplasty 17 Days n=19,000 Total Knee 7 Days Arthroplasty n=24,000 0 5 10 15 20 White et al. Arch Intern Med. 1998;158:1525-1531.

  28. Anticoagulation andthe Orthopedic Patient:the Anesthesiologist’s Perspective

  29. Overview • Venous thromboembolism (VTE), DVT and PE are real and significant threats to the orthopedic patient • The anesthesia and analgesia plan must accommodate treatment of VTE • Anesthesia and pain management can be challenging and pose risks to the patient in the absence of communication and cooperation between care teams

  30. Overview • The ACCP recommendations further increased the level and duration of thromboprophylasis • These changes create new challenges for managing neuraxial (Spinal, Epidural) and invasive non-compressible peripheral blockade (Regional Block) i.e save or FDA approved . 1. Murray DW, et al. J Bone Joint Surg. 1996;78:863-870. 2. Mantilla CB, et al. Anesthesiology. 2002;96:1140-1146.

  31. Clexane dosing is compatible with ASRA* Guidelines for Neuro-axial Anesthesia *Regional Anesthesia in the Anticoagulated Patient – Defining the RisksPublished by the American Society of Regional Anesthesia and Pain Medicine Pre-operatively Thromboprophylaxis Curative Treatment  10 –12 hrs  24 hrs Enoxaparin injection Needle insertion Enoxaparin injection Needle insertion

  32. Clexane dosing is compatible with ASRA* Guidelines for Neuro-axial Anesthesia *Regional Anesthesia in the Anticoagulated Patient – Defining the RisksPublished by the American Society of Regional Anesthesia and Pain Medicine Post-operatively Thromboprophylaxis OD Surgical Operation 1stEnoxaparin injection 2nd Enoxaparin injection 6 - 8 hrs  24 hrs  10-12 up to 22 hrs Needle removal Catheter removed at Min 10-12 hrs After the last dose of C/L Subsequent C/L Min 2 hrs after cath removal

  33. Summary • Safe and effective anesthesia and pain management for the orthopedic patient can be achieved in the presence of VTE prophylaxis when the entire care team (orthopedics, anesthesiology, nursing) understands the limitations, risks and works together

  34. Comparison of Enoxaparin (a Low-Molecular-Weight Heparin) with Placebo in the Long-Term Prevention of Deep-Vein Thrombosis in Patients who have Undergone Total Hip Replacement Surgery. (Planes Study)

  35. Background Risk of DVT and PE is reduced by effective prophylaxis with antithrombotic drugs Antithrombotic therapy is usually stopped at discharge but the risk of DVT may persist beyond hospitalization The extent of the risk of fatal PE after discharge is unknown but can be as high as 54.2% DVT, deep-vein thrombosis;PE, pulmonary embolism

  36. Risk of deep-venous thrombosis after hospital discharge in patients having undergone total hip replacement: double-blind randomised comparison of enoxaparin versus placebo Planes et al. Lancet 1996;348:224-8 Objective: to investigate the rate of delayed venous thromboembolic complications in patients who had undergone THR and did not have venogram-proven DVT at hospital discharge, and to assess the efficacy and safety of continuing LMWH prophylaxis after discharge from hospital THR, total hip replacement;DVT, deep-vein thrombosis; LMWH; low-molecular-weight heparin

  37. Inclusion criteria • Randomization following a negative venogram • >45 years old • Bodyweight 45-95 kg • Undergone primary THR or conversion or revision THR surgery • Receiving LMWH prophylaxis for postoperative venous thromboembolism • Able to walk with crutches without assistance • Negative diagnosis of DVT • Available for follow-up assessment THR, total hip replacement;DVT, deep-vein thrombosis;LMWH; low-molecular-weight heparin Planes et al. Lancet 1996;348:224-228

  38. Exclusion criteria • History of DVT or pulmonary embolism in the previous 6 months • Active cancer • Underlying bleeding disorder or haemostatic abnormality • Active gastroduodenal ulcer • History of hypersensitivity to heparin or radiopaque media • Renal or hepatic insufficiency • Uncontrolled hypertension • Stroke within the previous 6 months Planes et al. Lancet 1996;348:224-228 DVT, deep-vein thrombosis

  39. Study design Surgery Hospitalization (13-15 daysafter surgery) Enoxaparin 40 mg o.d. s.c. Negative venogram Randomization Discharged Enoxaparin40 mg o.d. s.c. for 21 days Placebo o.d. s.c. for 21 days Venography at 21 days 3-month follow-up Planes et al. Lancet 1996;348:224-228 s.c., subcutaneous; o.d., once daily

  40. Assessment criteria Assessments: • Venogram at day 21 (signs of DVT, laboratory tests, venography) • Spontaneous reporting of symptoms of DVT, PE or other adverse events • Major and minor haemorrhages Efficacy evaluations (ITT and PP analyses): • Primary: occurrence of DVT, PE or both (analysed using chi-square and Fisher’s exact tests) • Secondary: onset of proximal or distal DVT DVT, deep-vein thrombosis;PE, pulmonary embolism;ITT, intention-to-treat; PP, per protocol Planes et al. Lancet 1996;348:224-228

  41. Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement Bergqvist et al. N Engl J Med 1996;335:696-700. Objective:to determine whether one month of anticoagulant therapy with the low-molecular-weight heparin, enoxaparin, is more effective than enoxaparin therapy given only during hospitalization for surgery

  42. Exclusion criteria • <40 years old or <60 kg in weight • Hypersensitivity to contrast medium, UFH or LMWH • Past or present risk of haemorrhage • Endocarditis, severe liver disease, renal insufficiency or untreated hypertension • VTE in the previous 3 months • Received treatment with UFH, LMWH, oral anticoagulants or NSAIDs within 5 days of surgery • Ipsilateral hip surgery in the previous 6 months • Pregnant or lactating • Did not give informed consent UFH, unfractionated heparin;LMWH, low-molecular-weight heparinVTE, venous thromboembolism;NSAIDs, non-steroidal anti-inflammatory drugs Bergqvist et al. N Engl J Med 1996;335:696-700

  43. Study design Surgery Hospitalization(7-11 days) Enoxaparin 40 mg o.d. s.c. for up to 11 days Discharged Randomization Enoxaparin 40 mg o.d. s.c. for 21 days Placeboo.d. s.c. for 21 days Post-discharge phlebography on day 21 (range 19-23) 3-month follow-up s.c., subcutaneous; o.d., once daily Bergqvist et al. N Engl J Med 1996;335:696-700

  44. Assessment criteria Assessments: • Bilateral ascending phlebography on day 21 after discharge • Intraoperative blood loss and blood drained postoperatively • Transfusion requirements • Postoperative haemorrhage, wound haematoma and reoperation Efficacy evaluations: • Incidence of thromboembolic events and haemorrhagic complications (using chi-square test and odds ratio) • Safety analysed using Fisher’s exact test Bergqvist et al. N Engl J Med 1996;335:696-700

  45. Demographic and baseline characteristics Planes et al, 1996 Bergqvist et al, 1996 Enox Placebo Enox Placebo Number of patients 90 89 131 131 Male (%) 67 62 43 44 Age (years) 70a 68a 70b 70b Body mass index (kg/m2) 25.55 25.85 25.8 26.8 Previous VTE (%) 1 1 6 9 Varicose veins or leg ulcers (%) 14 15 23 26 amean age, bmedian age Planes et al. Lancet 1996;348:224-228Bergqvist et al. N Engl J Med 1996;335:696-700 Enox, enoxaparin;VTE, venous thromboembolism

  46. Incidence of DVTEnoxaparin significantly reduced the risk of DVT Planes et al, 1996 Bergqvist et al, 1996 25 45 P<0.001 Enoxaparin 40 P=0.018 39 Placebo 20 35 19.1 30 15 P<0.001 25 P=0.006 24 18 20 11.4 10 7.9 7.1 13 15 5.9 11 7 10 5 1.2 5 0 0 All DVT Proximal Distal All DVT Proximal Distal DVT DVT DVT DVT Planes et al. Lancet 1996;348:224-228Bergqvist et al. N Engl J Med 1996;335:696-700 DVT, deep-vein thrombosis

  47. Bleeding complications after discharge Risk of major bleeding was similar in both groups Planes et al, 1996 Bergqvist et al, 1996 Enox Placebo Enox Placebo Major bleeding, n (%) 0 0 2 (1,5%) 4 (3.1%) Minor bleeding, n (%) 17 (18.9) 4 (4.5) 6 (4.6%) 1 (0.8%) Haematemesis 1000 Epistaxis 1 0 0 0 Wound haematoma 1 1 6 1 Bruising at injection site 14 3 0 0 Planes et al. Lancet 1996;348:224-228Bergqvist et al. N Engl J Med 1996;335:696-700 Enox, enoxaparin

  48. Safety findings • No deaths occurred in either study • No patients in the study by Planes et al and two patients receiving placebo in the study by Bergqvist et al developed pulmonary embolism • Incidence of adverse events leading to discontinuation of study medication, except those related to venous thromboembolism, was similar in both treatment groups

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