thromboprophylaxis in orthopaedic trauma k thrombosis_in... · 2018. 6. 4. · thromboprophylaxis...
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Thromboprophylaxis in Orthopaedic TraumaJF Keating
Edinburgh Orthopaedic Trauma Unit
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Thromboprophylaxis in Orthopaedic Trauma
Does it matter?
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ThromboprophylaxisOrthopaedic Trauma
• Bimalleolar ankle fracture
• Required fixation
• Bed pressures
• Waited 2 weeks as an out-patient
• No risk factors/no prophylaxis
• Internal fixation – fatal PE in recovery
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ThromboprophylaxisOrthopaedic Trauma
• DVT – not good
• PE – bad
• Fatal PE – very bad
• But rare
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Death After MultipleTraumaMajor cause in early survivors
• Multiple organ failure
• Head injury
• Fatal PE
• PE most common late cause
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ThromboprophylaxisOrthopaedic Trauma
• Literature has many limitations
• Dearth of fracture specific data
• Particularly for less common injuries
• Distal femur/plateau = 2 – 3% of operative workload
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Management of FracturesEpidemiology
• Edinburgh Royal Infirmary
• Catchment 750,000
• One trauma centre
• Prospective studies
• What we do with fractures
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Management of Fractures
• 7863 fractures
• Nonoperative 75%
• Adult nonop 67%
• Paediatric nonop 92%
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Common Fractures
Which fractures occur most freqently?
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9 most common fractures5576 fractures
• Distal radius
• Hip fracture
• Metacarpal fractures
• Ankle fractures
• Proximal humerus
• Hand phalangeal fractures
• Metatarsal fractures
• Foot phalanges
• Carpal bones
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9 most common fractures
• Distal radius
• Hip fracture
• Metacarpal fractures
• Ankle fractures
• Proximal humerus
• Phalangeal fractures
• Metatarsal fractures
• Foot phalanges
• Carpal bones
4629/595377% of fracture workload
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9 most common fractures
• Distal radius
• Hip fracture
• Metacarpal fractures
• Ankle fractures
• Proximal humerus
• Phalangeal fractures
• Metatarsal fractures
• Foot phalanges
• Carpal bones
4629/595377% of fracture workload
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% of top 9 treated operatively
• Hip fractures 98%
• Ankle fractures 40%
• Distal radius 30%
• Others <20%
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Orthopaedic Trauma
How often do patients develop DVT/PE?
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Incidence after TraumaGerman trauma database analysis 2010
7937 cases
DVT 1.16%
PE 0.93%
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Incidence after TraumaGudipati et al, UK database analysis 2010
18,151 cases
85 PE (0.47%)
Fatal PE 13 (15%)
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Mortality due to PE
Elective 0.02%
Trauma 0.15%
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ThromboprophylaxisOrthopaedic risk factors
• Spinal injury
• Pelvic injury
• Multiple trauma
• Age, surgery, hospital stay
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ThromboprophylaxisIncidence of DVT
• Abelseth et al, 1996
• Incidence of DVT 9 days post injury
• Venography – 176 cases
• Occult DVT = 28%
• Femoral shaft 40%
• Plateau fracture 43%
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ThromboprophylaxisIncidence of DVT/PE – Gudipati et al, 2010
• 18151 patients
• PE 85 (0.47%)
• Fatal PE 13 (15%)
• Concomitant DVT 33%
• Median time to PE 23 days
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ThromboprophylaxisIncidence of DVT/PE – Gudipati et al, 2010
• 18151 patients
• PE 85 (0.47%)
• Fatal PE 13 (15%)
• Concomitant DVT 33%
• Median time to PE 23 days
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Relative incidence of PE
• Hip fracture 23%
• Lower limb trauma 57%
• Upper limb trauma 15%
• Pelvis/acetabulum 3%
• Spine 1.5%
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Relative incidence of PE
• Hip fracture 23%
• Lower limb trauma 57%
• Upper limb trauma 15%
• Pelvis/acetabulum 3%
• Spine 1.5%
80%
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Thromboembolic events
Poorly reported in orthopaedic literatureWhat about trauma inpatients?
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Thromboprophylaxis – hip fractures Incidence of DVT/PE at 90 days
• Hip fractures – RIE
• 1000/yr
• VTE 2% in 2017
• Scottish mean 1.7%
• P < 0.001
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ThromboprophylaxisIncidence of DVT – early vs late
• Elsworth et al, 2016
• Plateau fractures
• 29 early ORIF; 20 late
• 1 DVT in early group
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Meta-analysis of exfix vs ORIF
• Metcalfe et al, 2015
• Complex plateau fractures
• 7 studies; 419 fractures
• 3 studies reported DVT
• 3.8% - no difference
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Cochrane Review 2013Incidence of DVT – plateau fractures
• Fine wire exfix vs ORIF ?
• LISS vs ORIF no difference
• MIF vs ORIF ?
• Bone graft vs cement ?
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ThromboprophylaxisIncidence of DVT – distal femur fracture
• Hart et al, 2017
• 38 cases
• ORIF vs DFA
• DVT 1/38 (2.6%)
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ThromboembolismOrthopaedic Trauma
• Pelvis/lower limb main risk
• Risk diminishes proximal – distal
• Hip
• Knee
• Ankle
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ThromboembolismOrthopaedic Trauma
• Hip• DVT 2 – 6%• PE 1.5%
• Knee• DVT < 5%• PE < 1%
• Ankle• DVT < 2%• PE < 0.5%
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ThromboprophylaxisLower limb fractures
We do not have good data on the true incidence of DVT/PE after many lower
limb fractures
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ThromboprophylaxisLower limb fractures
Prevention of DVT/PE after lower limb fractures
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ThromboprophylaxisLower limb fractures
• External mechanical devices
• Foot pumps
• Compression stockings
• Internal mechanical devices
• IVC filters
• Pharmacological
• LMWH
• Warfarin/aspirin/rivoroxaban
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ThromboprophylaxisLower limb fractures
• External mechanical devices
• Foot pumps
• Compression stockings
• Internal mechanical devices
• IVC filters
• Pharmacological
• LMWH
• Warfarin/aspirin/rivoroxaban
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ThromboprophylaxisLower limb fractures
• External mechanical devices
• Foot pumps
• Compression stockings
• Internal mechanical devices
• IVC filters
• Pharmacological
• LMWH
• Warfarin/aspirin/rivoroxaban
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ThromboprophylaxisLower limb fractures
There are is a dearth of trials specifically addressing the issue of thromboprophylaxis
after many lower limb fractures
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Thromboprophylaxis in TraumaCochrane review 2013
• 16 studies; 3005 patients
• Prophylaxis vs nothing decreases DVT
• Chemical better than mechanical
• UH = LMWH
• Mechanical and chemical best
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Thromboprophylaxis in TraumaHip fractures
• RCTs
• Meta-analysis
• Thromboprophylaxis works
• Rate of symptomatic DVT down
• LMWH most popular
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ThromboprophylaxisLower limb fractures
Cochrane review 2013Prophylaxis reduces rate of DVT
No effect on mortality or PE
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ThromboprophylaxisNICE report 2017
“Although other types of non-arthroplasty knee surgery were
searched for, including osteotomy, fracture surgery and peri-
articular trauma, no studies involving these populations were
identified for inclusion in this review.”
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ThromboprophylaxisFractures Around the Knee
NICE Recommendation
Consider VTE prophylaxis for people undergoing other knee
surgery (for example, osteotomy or fracture surgery) whose
risk of VTE outweighs their risk of bleeding.
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Thromboprophylaxis in TraumaWhat should we use? TKR literature
• Aspirin for 14 days
• or
• LMWH for 14 days
• or
• Rivaroxaban
• + Compression stockings
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ThromboprophylaxisPlateau fractures
• Davidson and Keating, 2017
• 225 plateau fractures
• All had ORIF
• LMWH while in hospital
• DVT 4/225 (1.7%)
• Non-fatal PE 1 case – 0.4%
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ThromboprophylaxisLower limb fracture inpatients
• Incidence of asymptomatic DVT probably > 20%
• Symptomatic DVT < 2%
• PE < 1%
• Use LMWH for in-patients
• Post discharge prophylaxis?
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Thromboembolic events
What about trauma outpatients?The majority!
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Zee AAG. LMWH for prevention VTE in patients with lower limb immobilisation. Cochrane library 2017 Issue 8
Meta-analyses show LMWH reduces DVT after lower limb injury
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Meta-analyses show LMWH reduces DVT after lower limb injury
Zee AAG. LMWH for prevention VTE in patients with lower limb immobilisation. Cochrane 2017 issue 8
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Meta-analyses show LMWH reduces DVT after lower limb injury
Zee AAG. LMWH for prevention VTE in patients with lower limb immobilisation. Cochrane 2017 issue 8
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N Duration VTE rate Conclusion
Treatment % Control % Beneficial?
LapidusActa Orth 2007
272 5/52 21 28 no
GoellJBJS Br 2009
238 14/7 9 13 no
KockLancet 1995
339 ? 0 4.3 yes
LassenNEJM 2002
440 5/52 9 19 yes
BruntinkInjury 2017
467 4/52 0 11 yes
RCTs of thromboprophylaxis
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N Duration VTE rate Conclusion
Treatment % Control % Beneficial?
LapidusActa Orth 2007
272 5/52 21 28 no
GoellJBJS Br 2009
238 14/7 9 13 no
KockLancet 1995
339 ? 0 4.3 yes
LassenNEJM 2002
440 5/52 9 19 yes
BruntinkInjury 2017
467 4/52 0 11 yes
RCTs of thromboprophylaxis
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Inclusion criteria
LapidusActa 2007
Ankle fractures
GoellJBJS Br 2009
Leg fractures
KockLancet 1995
Leg casts
LassenNEJM 2002
Fracture or TA rupture
BruntinkInjury 2017
Ankle or foot in cast
RCTs of thromboprophylaxis
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Venography Doppler US
30 %
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Venography Doppler US Clinically Important DVT and PE (CIVTE)
< 30 % 1 %
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Venography Doppler US Clinically Important DVT and PE (CIVTE)
< 30 % 1 % 0.01 %
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80%0%
Neth J Med. 2015 Jan;73(1):23-9.Thromboprophylaxis for lower leg cast immobilisation and knee arthroscopy: a survey study.van Adrichem RA1, van Oosten JP, Cannegieter SC, Schipper IB, Nelissen RG.
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0%
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Edinburgh dataAnkle fractures
AIM
• Primary• Identify incidence of CIVTEs
• Secondary• Compare this to
• Background rate of CIVTE • Rate following arthroplasty• Risk of thromboprophylaxis
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Methods
1,283 consecutive patients
Operatively managed
Non operatively managed
415 (32%) 868 (68%)
Early mobilisationWeight bearing
Supportive cast or orthosis
No pharmacological thromboprophylaxis except as in-patient
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Identification of CIVTEs
• Scottish Hospital Episode Statistics
• Local hospital database backup
• All episodes of clinical DVT or PE: 1981 to 2014
• 22 / 1,283 patients diagnosed with CIVTEs
1.7% of patients over 34 year period
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12Prior to ankle
fracture
6<90 days
ankle fracture
4> 90 days
ankle fracture
• 22 patients diagnosed with VTEs
Timing of VTEs
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Comparison with background rate
Background rate
5 VTEs / 10,000
patients / year
90 days post fracture
190 VTEs / 10,000
patients / year
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Comparison with background rate
Background rate
5 VTEs / 10,000
patients / year
90 days post fracture
190 VTEs / 10,000
patients / year
38 times higher
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Comparison with arthroplasty rate
90 days post arthroplasty
2.41%
90 days post fracture
0.72%
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Comparison with arthroplasty rate
90 days post arthroplasty
2.41%
90 days post fracture
0.72%
3.3 times lower
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Comparison with risk of pharmacological thromboprophylaxis
Major haemorrhagic complications
2%
Symptomatic VTE 90 days post fracture
0.72%
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Comparison with risk of pharmacological thromboprophylaxis
Major haemorrhagic complications
2%
Symptomatic VTE 90 days post fracture
0.72%
2.7 times lower
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Conclusion from Edinburgh Data
• Incidence of VTE is very low following ankle fracture
• Although higher than the background rate it is far lower than• Incidence of VTE following arthroplasty
• Incidence of major bleeding following pharmacological thromboprophylaxis
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JOT 2015 ; 29 ; 224-30
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1926 screened
265 patients
156 ankles
1611 excluded50% refused
134 Dalteparin 131 placebo
2 CIVTE 3
2 DVT 2
0 PE 1
2 Minor bleeding 1
Interim analysis
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1926 screened
265 patients
156 ankles
1611 excluded50% refused
134 Dalteparin 131 placebo
2 CIVTE 3
2 DVT 2
0 PE 1
2 Minor bleeding 1
2% overall rate CIVTE
Interim analysis
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1926 screened
265 patients
156 ankles
1611 excluded50% refused
134 Dalteparin 131 placebo
2 CIVTE 3
2 DVT 2
0 PE 1
2 Minor bleeding 1
Unable to show an effect -even if groups doubled in
size –
Steering committee stopped study early
Interim analysis
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1519 enrolled
719 Dalteparin 716 placebo
10 CIVTE 13
6 DVT 8
3 PE 4
1 Minor bleeding 0
1.4% vs 1.8% CIVTE
-ns
Final analysis
1435 patients
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Conclusions from two RCTs
• Incidence of CIVTE is low
• Prophylaxis is ineffective in reducing these events
1. Ratio of risk : benefit unlikely to be favourable• Number needed to harm (HIT, bleeding)• Unless a high-risk group can be detected
2. Ratio of cost : benefit unlikely to be favourable
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Conclusions from two RCTs
• Incidence of CIVTE is low
• Prophylaxis is ineffective in reducing these events
1. Ratio of cost : benefit unlikely to be favourable
2. Ratio of risk : benefit unlikely to be favourable• Number needed to harm (HIT, bleeding)
• Irrelevant unless a high-risk group can be detected
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Thromboembolic events
Is there a role of thromboprophylaxis in trauma outpatients?
Not for the majority!
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Thromboembolic events
Is there a role of thromboprophylaxis in trauma outpatients?
But what about high risk patients?
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ThromboprophylaxisOutpatient trauma population
• Some injuries higher risk – TA rupture
• High risk patients
• History of DVT/FH of DVT
• Prothrombotic condition
• Other risk factors e.g. malignancy
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ThromboprophylaxisOutpatient trauma population
• Change of policy
• Risk screening
• High risk injuries
• Other risk factors
• Offer thromboprophylaxis
• Evidence – duration and agent?
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ThromboprophylaxisInpatient trauma population
• Routine thromboprophylaxis
• LMWH and mechanical
• Duration of inpatient stay
• Extended prophylaxis for high risk
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ThromboprophylaxisSummary – Outpatient trauma population
• Upper limb fractures – no prophylaxis
• Lower limb fractures immobilised
• Risk assess patients
• High risk patients
• Offer prophylaxis
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ThromboprophylaxisSummary
• Thromboprophylaxis prevents DVT in trauma patients
• Many agents are effective
• Chemical and mechanical for inpatients
• Newer oral anti-coagulants for high risk outpatients
• Fatal PE – RCT of > 100,000 patients needed
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Thank you
• None