Venous Thromboembolism Prophylaxis: Checked!

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1 Venous Thromboembolism Prophylaxis: Checked! William Geerts, MD, FRCPC Director, Thromboembolism Program, Sunnybrook HSC Professor of Medicine, University of Toronto National Lead, VTE Prevention, Safer Healthcare Now!

2 Disclosures (for our TE group) Personal/family investments Research grants Program support Advisory boards, consultancies Honoraria for education None Bayer Healthcare, Boehringer Ingelheim Bayer Healthcare, Boehringer Ingelheim, Pfizer, Sanofi Aventis, Canadian Patient Safety Institute Bayer Healthcare, Boehringer Ingelheim, Pfizer, Sanofi Aventis Bayer Healthcare, Boehringer Ingelheim, Pfizer, Sanofi Aventis

3 Even 29 y.o. elite athletes can get PE! 13-time Grand Slam singles champion July, 2010 stepped on broken glass 2 surgeries to repair tendon Attended Oscars few days later: PE

4 Objectives Thromboprophylaxis in surgical patients: Recommended options Timing of prophylaxis Regional anesthesia issues New oral anticoagulants

5 Surgical Checklist Safe Surgery Saves Lives VTE Prophylaxis: The Checklist Coordinator should ensure that the OR team has instituted an appropriate plan for the intraoperative and/or post-operative prevention of VTE, consistent with hospital policy.

6 Risk of DVT in Surgical Patients No prophylaxis + routine screening for DVT Patient group DVT prevalence General surgery, bariatric 15 40% Major gyne / urol surgery 15 40% Neurosurgery 15 40% Hip, knee arthroplasty, hip fracture 40 60% Major trauma 40 80% Spinal cord injury 60 80% 8 th ACCP Guidelines on Antithrombotic Therapy Chest 2008;133:381S

7 Symptomatic VTE after Surgery California Patient Discharge Database (N = 1,653,275) VTE during surgical admission or within 3 mos Benign disease THR 2.4 % Craniot/excision 2.3 % TKR 1.7 % CABG 1.1 % Colectomy 1.1 % Hysterectomy 0.3 % TURP 0.3 % Lap chole 0.2 % Malignant disease Craniot/excision 3.6 % Colectomy 1.7 % Pneumonectomy 1.6 % Rad prostatect 1.5 % Hysterectomy 1.2 % Mastectomy 0.4 % White - Thromb Haemost 2003;90:446

8 VTE Risk Factors in General Surgery Procedure-related: Cancer > benign Open > laparoscopic GA > regional anesthesia (only if no prophylaxis) Duration of procedure Patient-related: Age Previous VTE Obesity Reduced mobility Infection

9 Complications after Non-cancer and Cancer Surgery Double-blind RCT of LDH TID vs certoparin QD Non-cancer Cancer Outcome N=16,954) (N=6,124) RR P Fatal PE* 0.09 % 0.33 % Death 0.7 % 3.1 % Abn bleeding 0.04 % 0.29% * autopsy-proven Haas Thromb Haemost 2005;94:814

10 VTE is Preventable More than 400 randomized studies prove that VTE CAN be prevented safely and inexpensively Guidelines have recommended routine prophylaxis use for 25 years Thromboprophylaxis is the number 1 ranked patient safety strategy in hospitalized patients Making Health Care Safer: A Critical Analysis of Patient Safety Practices - Shojania (2001) -

11 Who Should Get DVT Prophylaxis? After most surgery: - major general surgery - thoracic surgery - major gynecologic surgery - major urologic surgery - major orthopedic surgery All major trauma Most surgical patients in hospital

12 Mechanical Methods of Prophylaxis 1. Graduated compression/elastic stockings (TEDS ) 2. Intermittent pneumatic compression devices (SCDs, leg squeezers) 3. Venous foot pumps Work in some patient groups if used properly, but Much less evidence than for anticoagulants, and Generally don t work as well as anticoagulants, and They require a big effort to work at all.

13 Mechanical Methods of Prophylaxis Therefore, Use primarily in patients at high risk for bleeding Patient must be properly measured Should start prior to surgery Switch to or add anticoagulant when bleeding risk decreases Legal obligation to ensure proper use, compliance

14 What is the Evidence? General Surgery ~150 RCTs LDH ~ LMWH ~ fondaparinux DVT risk reduction: 60-75% Prevents fatal PE For cancer patients, dose is important e.g. LDH TID better than BID Small increase in wound hematoma No increase in major bleeding

15 Thromboprophylaxis in Surgery in 2011 Surgical Group Options Duration General, thoracic, gyne, urol, bariatric, vascular Major orthopedics LMWH low dose heparin (TID if cancer) rivaroxaban, dabigatran LMWH fondaparinux Discharge days Major trauma LMWH Discharge High bleeding risk mechanical Until anticoagulant can start

16 When should thromboprophylaxis be started? Is preop anticoagulant thromboprophylaxis necessary?

17 Important NOT to delay initiation of anticoagulant thromboprophylaxis Pelvic trauma Routine LMWH prophylaxis (enoxaparin 40 mg) Doppler ultrasound day Start time Prox Major after injury No. DVT PE bleeding < 24 hrs 66 3% 0 0 > 24 hrs 37 22% 14% 0 p<0.01 Steele - JBJS 2005;87-B:209

18 THR R dalteparin 2,500 U 2h preop + 6h postop 5,000 U daily dalteparin 2,500 U 6h postop 5,000 U daily surgery venogram day Hull - Arch Intern Med (2000)

19 THR R dalteparin 2,500 U 2h preop + 6h postop 5,000 U daily dalteparin 2,500 U 6h postop 5,000 U daily surgery venogram day Pre-op dalteparin (n=413) Post-op dalteparin (n=414) Total DVT 10.7 % < 13.1 % Proximal DVT 0.8 % = 0.8 % Major bleeding 8.9 % > 6.5 % Hull - Arch Intern Med (2000)

20 Is preop anticoagulant thromboprophylaxis necessary? NOT if it affects: - use of regional anesthesia - concerns about intra-operative bleeding AND if effective prophylaxis is used postop: - an efficacious drug - an appropriate dose - don t wait too long to start - continue long enough But start preop if no disadvantage: - this is surgical tradition, and - might reduce VTE rate

21 If Surgery Delayed e.g. hip fracture, general surgery, trauma start preop Admit OR LMWH (or LDH) LMWH LDH or LMWH Discharge days

22 Prophylaxis in Hip and Knee Arthroplasty start postop Admit OR Discharge or rehab rivaroxaban, dabigatran low molecular weight heparin days

23 Is anticoagulant thromboprophylaxis compatible with epidural analgesia?

24 Is anticoagulant thromboprophylaxis compatible with epidural analgesia? Use of regional anesthesia / analgesia + anticoagulant prophylaxis are compatible. ACCP (2008), ASRA (2010) But there needs to be common sense about: - patient selection - timing of anticoagulant - timing of catheter removal Institutional written policy protects patients, physicians, hospitals

25 Spinal/Epidural Anesthesia and Prophylactic LMWH Avoid in patients with bleeding disorders No preop LMWH 1st dose of LMWH 2-4 hrs after epidural (or day after surgery) Remove epidural catheter just before a scheduled dose of LMWH After catheter removal, next LMWH dose > 2 hrs 8 th ACCP Guidelines on the Prevention of VTE (2008)

26 1st Dose of Thromboprophylaxis: Anesthesia decision often made in the OR No anticoagulant prophylaxis prior to arrival in OR GA RA LMWH or LDH Operation Operation 2-4 hrs after spinal/epidural LMWH or LDH Day 1 Day 2 LMWH or LDH LMWH or LDH Day 1 Day 2 LMWH or LDH * Remove epidural LMWH or LDH LMWH or LDH LMWH or LDH *2-4 hrs later

27 Traditional Anticoagulants XII XI IX VIII VII X Heparin LMWH V warfarin II I Fibrin clot

28 New Anticoagulants XII XI IX VIII X VII Oral Xa inhibitors rivaroxaban apixaban Heparin LMWH V warfarin II Oral IIa inhibitors dabigatran I Fibrin clot

29 Rivaroxaban vs Dabigatran Feature Rivaroxaban Dabigatran Target Factor Xa Factor IIa Bioavailability >80% <6% Time to peak 2-3 hrs hrs Half life 6-13 hrs hrs Renal excretion 65% 85% Lab monitoring?pt (INR), AXa?aPTT Reversal agent No No Current indications THR, TKR THR, TKR Atrial fib

30 Discontinuation of Dabigatran for Not based on clinical data Consider preop aptt Renal function (Cr Cl, ml/min) Elective Surgery Half-life (hrs) [range] Discontinuation of dabigatran before surgery Standard bleeding risk High bleeding risk >80 13 [11-22] 24 hrs 2-4 days [12-34] 24 hrs 2-4 days [13-23] >2 days 4 days <30 27 [22-35] 2-5 days >5 days van Ryn Thromb Haemost 2010;103:1116

31 Summary Most surgical patients need thromboprophylaxis LMWH, rivaroxaban/dabigatran, LDH Start: - intraop or postop if regional anesth, high bleeding risk - preop if not Stop dabigatran 2-4 days before (aptt normal)

32 Now, putting thromboprophylaxis into clinical practice...

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