pankaj handa senior consultant internal medicine; vascular ... senior consultant . internal...
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PANKAJ HANDA Senior Consultant
Internal Medicine; Vascular Medicine & Hypertension Tan Tock Seng Hospital, Singapore
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1. Introduction
2. Magnitude of the problem
3. VTE Prophylaxis Guidelines at TTSH
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Venous thromboembolism (PE and DVT) is a common clinical problem in hospitalised patients and has substantial morbidity and mortality
Unrecognised VTE : Acute : recurrent PE (fatal) Chronic : post-thrombotic syndrome (PTS) chronic thromboembolic pulmonary hypertension (CTPH)
High incidence of VTE and the availability of effective methods of
prevention mandate that thromboprophylaxis should be considered in suitable hospitalised patients
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Often a Silent Disease
Proven DVT but no clinical suspicion of PE - Half of these "asymptomatic" patients have undiagnosed PE.
2/3 of patients with proven PE have no DVT symptoms.
1/3 of the cases: it is impossible to find the original site of DVT without an autopsy Studies show that between 5% and 10% of all in-hospital deaths are a direct result of PE
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Proximal Lower Limb DVT – Clinically Important
50% untreated cases PE 30% untreated PE DEATH
(Death usually results from Recurrent PE)
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68,183 patients; 32 countries; 358 sites First patient enrolled August 2, 2006;Last patient enrolled January 4, 2007
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Africa 8%PE 150,000
Death 190,000
The Americas 14%PE 270,000
Death 340,000
Europe 21%PE 400,000
Death 500,000
Asia 57%PE 870,000
Death 1,000,000
Distribution of the world's population“Extrapolated non-fatal and fatal PE”
Cohen AT et al. Thromb and Haem 2007; 98:756-764
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9
900,000 VTE each year
300,000 Fatal (33%) - most unsuspected and undiagnosed before death
600,000 non-fatal VTE - 60% DVT - 40% PE
2/3 of VTE are related to hospitalisation Heit J et al. American Society of Hematology, Dec 2005
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Deaths due to VTE (543,454)1 exceed combined deaths due to:2,3
AIDS (5,860) Breast cancer (86,831) Prostate cancer (63,636) Road traffic accidents (53,599)
1Cohen AT et al. Thromb and Haem 2007; 98:756-764; 2Eurostat statistics on health and safety 2001 (http://epp.eurostat.cec.eu.int), 3Hirsh J, Hoak J. Circulation 1996;93:2212—45
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Increasing rate of autopsy-detected PE over time %
Years
Leizorovicz A et al. Intern J Angiol 2004
0
5
10
15
20
1965 1970 1975 1980 1985 1989 1994
All PE Fatal PE
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- SMART (Surgical Multinational Asian Registry in Thrombosis)2005 - SMART venography (2007)
- AIDA (Assessment of the Incidence of DVT in Asia) 2005 - ENDORSE (Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting) 2008
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Number of Patients
Asymptomatic DVT, % Symptomatic VTE, %
Total Proximal DVT PE
ASIAN Studies SMART study (1)* Major orthopaedic surgery
2,420 - - 0.9 0.3
Total hip replacement
408 - - 1.0 0
Total knee replacement
944 - - 1.4 0.3
Hip fracture surgery 1,068 - - 0.5 0.3
SMART venography study (2) Major orthopaedic surgery
326 36.5 9.2 0.9 0
Total hip replacement
134 16.4 2.2 0.7 0
Total knee replacement
192 49.0 14.0 1.0 0
(1) Leizorovicz A, Turpie AGG, Cohen AT, et al. Epidemiology of venous thromboembolism in Asian patients undergoing major orthopedic surgery without thromboprophylaxis. The SMART study. J Thromb Haemost 2005; 3: 28–34 (2) Leizorovica A, on behalf of the SMART Venography Study Steering Committee. Epidemiology of post-operative venous thromboembolism in Asian patients. Results of the SMART venography study. Haematologica 2007; 92: 1194–200
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Number of Patients
Asymptomatic DVT, % Symptomatic VTE, %
Total Proximal DVT PE
AIDA Study (3)
Major orthopaedic surgery
407 41.0 10.2 - 0.5
Total hip replacement
175 25.6 5.8 - -
Total knee replacement
136 58.1 17.1 - -
Hip fracture surgery
96 42.0 7.2 - -
SAKON et al (4) Major abdominal surgery
173 23.7 2.9 - 0.6
(3) Piovella F, Wang C-J, Lu H, et al. Deep-vein thrombosis rates after major orthopedic surgery in Asia. An epidemiological study based on postoperative screening with centrally adjudicated bilateral venography. J Thromb Haemost 2005; 3: 2664–2670. (4) Sakon M, Maehara Y, Yoshikawa H, et al. Incidence of venous thromboembolism following major abdominal surgery: a multi-center, prospective epidemiological study in Japan. J Thromb Haemost 2006; 4: 581–586
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Number of Patients
Asymptomatic DVT, % Symptomatic VTE, %
Total Proximal DVT PE
WESTERN Studies**
Samama et al (5)
Total hip replacement
85 37.3 16.0 1.3 0
Leclerc et al (6)
Total knee replacement
65 57.8 18.6 - 1.5
Agnelli et al (7) Hip fracture surgery 82 57.5 35.6 0 1.2
Ockelford surgery (8) Major abdominal surgery
88 15.9 - - 2.3
(5) Samama CM, Clergue F, Barre J, et al. Low molecular weight heparin associated with spinal anaesthesia and gradual compression stockings in total hip replacement surgery. Br J Anaesth 1997; 78: 660–665. (6) Leclerc JR, Geerts WH, Desjardins L, et al. Prevention of deep vein thrombosis after major knee surgery – a randomized, double-blind trial comparing a low mo-lecular weight heparin fragment (enoxaparin) to placebo. Thromb Haemost 1992; 67: 417–423. (7) Agnelli G, Cosmi B, Filippo PD, et al. A randomised, double-blind, placebo-controlled trial of dermatan sulphate for prevention of deep vein thrombosis in hip fracture. Thromb Haemost 1992; 67: 203–208. (8) Ockelford PA, Patterson J, Johns AS. A double-blind randomized placebo controlled trial of thromboprophyl axis in major elective general surgery using once daily injections of a low molecular weight heparin fragment (Fragmin). Thromb Haemost 1989; 62: 1046–1049
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WEST EAST
Hip Replacement 40% 20%
Knee Replacement 80% 60%
General Surgery 28% 3%
Colorectal Surgery 44% 28%
Liew NC,et al. Asian J Surg 2003; Kakkar VV ,et al. Lancet 1972
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VTE : Singapore • Prevalence - LH Lee et al, 2002
» January 1996 to December 1997 » Duplex US Symptomatic DVT » Acute DVT: 15.8 per 10, 000 hospital admissions » Versus 7.9 per 10, 000 hospital admissions (1989 –
1990) - HJ Ng et al, 2009
» 2002 – 2003 » Primary and secondary DVT prevalence: 45.3 per
10, 000 hospital admissions
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• 721 patients admitted to Level 5 wards Department of General Medicine. • November through December 2009
– Follow-up period: 3 months
• Mortality (n = 42) – Infection (Pneumonia, UTI): 3.61% (n = 27) – Sudden death: 2.23% (n = 15)
VTE :Tan Tock Seng Hospital
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Sudden or acute death: 2.23% (n = 15) • Acute Myocardial Infarction (n = 2) • Death secondary to PE (n = 13, 1.80%)
Diagnosis No of cases Criteria
Definite PE 2 (0.27%) CT scan or autopsy diagnosis of PE
Probable PE 3(0.42 %) Wells score > 6, with evidence of malignancy and no other obvious cause of death like infection (normal CRP or CV event)
Suspected PE 8(1.1%) Wells score > 6,with no other obvious cause of death
VTE :Tan Tock Seng Hospital
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• Patients with confirmed diagnosis of DVT / PE • March – Sep 2010 • Number of VTE cases : (30 days of prior or current admission) = 86
– Medical (22)
Breakdown of DVT/PE numbers in relation to disciplines
5%5%
9%9%9%
14%14%
27%
5% 5%
0
1
2
3
4
5
6
7
GMD REH RES GRM ORT CVM GSD URO NLD IDS
Disciplines
No. o
f pati
ents
with
DVT
/PE
VTE :Tan Tock Seng Hospital
*No documentation of DVT / PE on admission
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Number of VTE Patients
Total LL- DVT PE Both 314 177( 67% Prox.) 91(28.9%) 46(14.6%)
Demographics Mean Age Male Female 64.2 (SD +/- 0.9) 132(42%) 182(52%)
Ethnicity Chinese Malay Indian Others
212 (67.5%) 39 (12.4%) 34 (10.8%) 29( 9.3%) Hospitalization (Within 1 month)
Total Medical Surgical 127(40.4%) 76(59.8%) 51(40.2%)
New VTE including DVT/ PE /Both - 2 years (Oct. 2010 - Dec. 2012)
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VTE is a Disease of Hospitalised and Recently Hospitalised Patients
1000
100
1
10
Hospitalised patients Community residents
Recently hospitalized
Heit – Mayo Clin Proc 2001;76:1102
Cas
es p
er 1
0,00
0 pe
rson
-yea
rs
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•
• Acutely ill medical patients - ~60% of all hospital admissions1 - ¾ of the fatal PE occurring in the hospital2
• •
1. Cohen AT. Semin Thromb Hemost 2002;28 S3:13-7. 2. Sandler DA, et al. J R Soc Med 1989;82(4):203-5.
25% Medical patients
Morbidity due to PE3
Surgical patients 75%
Acutely Ill Medical Patients are the most vulnerable
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VTE prophylaxis remains substantially underutilized in
medical patients − Non surgical patients are less likely to receive prophylaxis
than surgical patients − Recent studies show that up to 2/3 of medical patients do
not receive appropriate thromboprophylaxis
Goldhaber SZ. Am J Cardiol 2004;93:259-262. Ageno W, et al. Haematologica 2002;87(7):746-50. Bergmann JF, et al. Semin Thromb Hemost 2002;28(S3):51-5.
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Heterogeneity of the conditions in medical patients, makes it difficult to assess risk level of patients.
Lack of evidence for a mortality reduction associated
with pharmacologic prophylaxis in acutely ill medical patients
Other Concerns - bleeding - unfamiliarity with anticoagulants, - cost of prophylaxis, particularly in the developing countries
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A systematic review ranked 79 safety interventions
Based on the strength of evidence, the highest ranked
safety practice was the "appropriate use of prophylaxis to prevent VTE"
- Reduces adverse patient outcomes and decreases
overall costs Shojania KG. Agency for Healthcare Research and Quality 2001; 20 July. Available at http://www.ahrq.gov/clinic/ ptsafety / Collins R, et al. N Eng J Med. 1988;318:1162-1173
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2014- TTSH VTE Prophylaxis Guidelines Workgroup Pankaj Handa et al.
Hospital patients are a heterogeneous population. Therefore, all
patients must be routinely assessed for risk of thromboembolism and bleeding prior to initiation of VTE prophylaxis.
Following patient groups are excluded from VTE risk assessment - Patients attending emergency department - Patients attending day care surgery/endoscopy - Patients under the age of 18 years - Patients already on anticoagulation ( VKA, NOAC, Heparin)
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1. Risk Stratification Consider patient at increased risk of VTE if they have :
Risk Factors Points Active cancer 3 Previous VTE (personal/ first degree relative) 3 Reduced mobility 3 Known thrombophilic condition 3 Recent Surgery(<1 month) 1 Elderly(>70yrs) 1 Heart and \ or Respiratory failure 1 Acute myocardial infarction/ ischaemic stroke 1 Acute infection and/ or rheumatologic disorder 1 Ongoing Hormonal Treatment 1 Obesity (BMI more than 30 kg/m 2) 1
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2. Bleeding Risk Assessment Consider high bleeding risk if the patient has :
Active bleeding
Platelet count <75 x10^9/L
Recently diagnosed peptic ulcer
Liver Disease (INR >1.5) / Severe Renal Disease(Cr Cl <30 ml/mt)
Acute Stroke
Lumbar puncture/ epidural /spinal anaesthesia in previous 4 hours / in next 12 hours
Uncontrolled hypertension ( > 230/120 mmHg)
Age >85 years
Inherited Bleeding Disorders( e.g. Haemophila)
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Asses the risk of thrombosis and bleeding (based on tables 1 and 2)
All hospitalized medical patients
who have had or are expected to have reduced mobility for more than 72 hours
Recommendations - High risk VTE : LMWH/ UFH - Low risk of VTE: No VTE prophylaxis - High VTE risk and High Bleeding risk : Mechanical prophylaxis.
Once bleeding risk decreases consider switching over to pharmacologic prophylaxis
- Duration – until resolution of medical
illness /discharge. Do not extend after hospital discharge
Classify patients into - High Risk VTE: 4 or > - Low Risk VTE: < 4
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Major surgery – intra-abdominal surgery or any general surgery operation >45 minutes . #Minor surgery – surgeries <45 minutes (other than intra-abdominal surgery) using general or regional anaesthesia
Risk Type of surgery Recommended prophylaxis High • Multiple trauma
• Major surgery at age > 60 years • Major surgery at age 40-60 years with risk
factors (Table 1) • Major surgery at any age + history of VTE
• LMWH / UFH ( 12 hours post operatively once the bleeding risk is considered Low) and IPCD
• IPCD only if anticoagulants contraindicated
Intermediate • Major surgery, age 40-60 years without risk factors
• Minor surgery, age < 40 with risk factors (Table 1)
• Minor surgery, age > 60 years • Minor surgery, < 60 years with risk factors
• LMWH/UFH
with / without TED/IPCD
Low • Major surgery, age < 40, without risk factors • Minor surgery, age < 60, without risk factors
• Consider TED/ IPCD
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Type of Surgery VTE Prophylaxis Duration
Total Hip Replacement OR Total Knee Replacement
- On Admission:Offer mechanical prophylaxis to all - Post Operatively: Add pharmacological
prophylaxis, if No contraindications. Choose 1 : LMWH / UFH /NOAC : 12 hours after surgery
Mechanical Prophylaxis: Till there is no significant immobility
Pharmacological Prophylaxis:
Minimum: 10-14 days Preferably : 35 days from the date of
surgery
Hip Fracture Surgery
⁃ On Admission:Offer mechanical prophylaxis to all ⁃ ⁃ Add pharmacological prophylaxis, if NO
contradictions (Table 2) ⁃ Choose either of LMWH /UFH
Start on admission Stop 12 hours before surgery Resume 12 hours after surgery
Mechanical Prophylaxis: Till there is no
significant immobility Pharmacological Prophylaxis:
Minimum: 10-14 days Preferably : 35 days from the date of
surgery Knee Arthroscopy AND Below Knee Injuries
Consider VTE prophylaxis if the VTE risk is assessed to be High. - Offer mechanical prophylaxis on admission - Add pharmacological prophylaxis post operatively if Bleeding risk is considered Low. Continue VTE prophylaxis till patients no longer has significantly reduced mobility
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Weight <50kg 50-100kg 100-150kg
Cr Cl<30 ml/m
UFH 5000 units BD SC
UFH 5000 units BD SC
UFH 7500-10000 units BD SC
Cr Cl >30 ml/m * Enoxaparin 20mg OD SC
Enoxaparin 40mg OD SC
Enoxaparin 40mg BD SC
NOACs
Rivaroxaban 10 mg po OD / Apixaban 2.5 mg BD
Dabigatran : Initial dose of 110mg, taken within 1-4h post-op continue with 220mg OD thereafter
LMWH : the drug of choice in most of the patients (Cr Cl >30) UFH : the drug of choice in patients with renal failure (Cr Cl < 30 ml /mt) NOACs : Avoid use in patients with renal failure
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VTE is essentially a disease of Caucasians only Low incidence of VTE in Asians doesn’t justify VTE risk
assessment in hospitalised patients Studies show that VTE is a global disease and 5% to
10% of all in-hospital deaths are a direct result of PE
VTE prophylaxis should be considered for only surgical patients
√
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A 60-year-old gentleman has undergone TKR. He weighs 65 kg and has creatinine clearance of 70 ml/min. Appropriate pharmacological prophylaxis would include: 1. Enoxaparin 20 mg x sc x od 2. Enoxaparin 40 mg x sc x od 3. Rivaroxaban 10 mg x od 4. UFH 1000 units x sc x bd √ √
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A 75 –year-old patient has been admitted with hyperosmolar hyperglycaemic state. She has background history of DM/CKD(Cr Cl 15 ml/min). The drug of first choice for VTE prophylaxis would be:
Enoxaparin 40mg x sc x od Warfarin 2mg x po x od Apixaban 2.5 x mg x bd UFH x 5000 units x sc x bd
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VTE is a “winnable battle” It is a global disease and evidence shows that it is a significant problem in Asia as well. ` VTE remains the most common preventable cause of
hospital death.
VTE risk assessment should be implemented for all hospitalised patients at admission and at discharge
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VTE prophylaxis should be carefully weighed against the risk of bleeding
After assessment, consider appropriate prophylaxis ( ambulation, mechanical or pharmacological) and duration based on risk
Universal assessment doesn’t mean universal prophylaxis.
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