clinical and economic value of anti-xa monitoring in...
TRANSCRIPT
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Clinical and Economic Value of
Anti-Xa Monitoring in Patients
Receiving Unfractionated
Heparin
Kathy Shingler, MT (ASCP)
Clinical Hemostasis
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Disclosure
• Financial relationship of presenter: Employed by
Instrumentation Laboratory
• The study presented in this presentation has been funded
by Instrumentation Laboratory and has been accepted for
publication. The retrospective cohort study assay methods
were not restricted to a specific vendor.
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Affordable Care Act: Triple Aim
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Objectives
• Describe the role of heparin as an anticoagulant
• Explain why monitoring unfractionated heparin (UFH) with
Anti-Xa is superior to aPTT
• Review results of a study comparing Anti-Xa monitoring
with aPTT in patients on UFH therapy
• Outline a plan to ensure a smooth transition from aPTT to
Anti-Xa monitoring
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What is Heparin?
• Widely used anticoagulant
discovered in 1916
• Used for treatment and
prevention of thrombotic
diseases
• Maintains blood fluidity in
extracorporeal devices
• Chains of sulfated
glycosaminoglycans
• Molecular weight: 5,000 –
30,000 daltons
Heparin Molecule
http://circ.ahajournals.org
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Clinical Use of Unfractionated Heparin
• Antithrombotic agent – high dose • Acute thrombosis
• Prophylaxis – low dose to prevent thrombosis • Pre/post-surgery: orthopedic, general, vascular
• Prevention of VTE and preeclampsia recurrence during
pregnancy
• Acutely ill patients: congestive heart failure, severe
respiratory disease
• Maintenance of arterial and venous lines • Possible heparin contamination
• Potentially high-risk
• “Drug widely used…that has a high risk of patient injury when
administered incorrectly.”
Niccolai CS, et al. Unfractionated heparin: focus on a high-alert drug. Pharmacotherapy
2004;24:146S-155S.
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Clotting Enzyme Inactivation by Heparin
AT Clotting
Enzyme
Chest 2012; E25S
AT is a slow Inhibitor without heparin
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Clotting Enzyme Inactivation by Heparin
AT Clotting
Enzyme
AT Clotting
Enzyme
Heparin
Chest 2008;133: 141-159
AT is a slow Inhibitor without heparin
• Heparin binds to AT through a high-affinity pentasaccharide
• Conformational change to AT converts AT from slow to rapid
inhibitor (2-3X)
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Clotting Enzyme Inactivation by Heparin
AT Clotting
Enzyme AT is a slow Inhibitor without heparin
AT Clotting
Enzyme
Heparin
AT Clotting
Enzyme
Heparin
• AT binds covalently to clotting enzyme
• Heparin dissociates itself from the complex and can be
reutilized
Chest 2008;133: 141-159
• Heparin binds to AT through a high affinity pentasaccharide
• Conformational change to AT converts AT from slow to very
rapid inhibitor (2-3X)
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FXI
FIX
FXII
FX
FVII
FII Thrombin
Fibrinogen Fibrin
FVIII
FV
Coagulation Cascade: in vitro Model
HEPARIN A non-specific inhibitor
aPTT PT
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UFH-Binding Candidates
ACCP 2012 9th Edition/CHEST Supplement 2012; chestjournal.chestpubs.org, e28S, e29S
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Monitoring UF Heparin
• For venous thrombosis - Heparin Anti-Xa: 0.3 – 0.7 Anti-Xa units
- aPTT
• Correlated to 0.3 – 0.7 Anti-Xa units
• 0.2 – 0.4 units by protamine sulfate titration
• For coronary indications - The therapeutic range is unknown but is likely to correspond to
heparin levels approximately 10% lower than used to treat patients
with VTE
• Monitoring required - Variable dose-response rate, due to binding to proteins
- Varying rates of heparin clearance
- Ensures patient is not sub-therapeutic or over anti-coagulated
ACCP 2012 9th Edition/CHEST Supplement 2012; chestjournal.chestpubs.org, e28S, e29S
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Heparin Monitoring with aPTT
• aPTT - traditional method (1.5 - 2.5x “control”) - Based on a retrospective study (1970s)
- Not confirmed with randomized clinical trials
• In vitro heparin dose-response curve - Spiked normal plasma with UFH
- Not recommended by CAP, over-estimates when compared with
patient samples
• Ex vivo heparin therapeutic range using aPTT and Anti-Xa
assay - Recommended method by CAP
ACCP 2012 9th Edition/CHEST Supplement 2012; chestjournal.chestpubs.org, e28S
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Drawbacks to aPTT
• Does not directly measure heparin
• Variable responsiveness of aPTT reagents
• aPTT cannot be used to monitor LMWH, fondaparinux,
rivaroxaban, apixaban, edoxaban
• High base-line aPTT (Lupus Anticoagulant, Factor
deficiency)
• Increased Factor VIII, Fibrinogen
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• aPTT response to anticoagulant therapy is exaggerated
• Numerous factors may elevate aPTT - Concomitant warfarin therapy
- Lupus anticoagulant
- Factor deficiency
- Liver disease
Monitoring Anticoagulant Therapy
Using the aPTT
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Monitoring with aPTT Increases in Acute Phase Reactants
• Under-estimates anticoagulation level
• Factor VIII and Fibrinogen increases - Can shorten the aPTT in a clinically significant manner
- Factor VIII increases from 100 - 600% can shorten aPTT by 33-50%
• One cause of in vitro drug “resistance”
Effects of factor VIII levels on the APTT and anti-Xa activity under a therapeutic dose of heparin.Int J Hematol. 2015 Feb ;101(2):119-25. doi: 10.1007/s12185-014-1702-z. Epub 2014 Nov 23
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Heparin Anti-Xa to aPTT Correlation (Treatment Dosing)
0
20
40
60
80
100
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 1.2 1.3 1.4 1.5
Anti-Xa u/ml
aP
TT
se
cs
Y
aPTT vs Anti-Xa in Pregnant Population
Adcock DM; Tillman D. unpublished 1998
Unpublished study courtesy of Dr. D Adcock
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Establishing the Therapeutic Range for aPTT
with Anti-Xa
• Preferred method (e.g., ISTH, CAP)
• Collect samples from patients receiving heparin only - Normal PT - Minimum 50 - No more than two samples from the same patient
• Perform aPTT and Anti-Xa testing - Can freeze samples for Anti-Xa testing later - follow CLSI guidelines - If samples are frozen, repeat aPTT after thawing for quality check
• Plot heparin vs aPTT using regression analysis
• Determine the aPTT therapeutic range corresponding to 0.3 - 0.7 U/mL
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55
85
Anti-Xa Therapeutic Range
Sub-therapeutic
Therapeutic
Supra-therapeutic
Data obtained from a typical hospital laboratory
Therapeutic Heparin Range
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Evaluation of Outcomes in Anti-Xa
Vs aPTT Monitored Patients
Receiving Unfractionated Heparin
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Anti-Xa vs APTT Publications
Outcome Price, Ann
Pharmacother 2013
Guervil, Ann
Pharmacother
2011
Vandiver, Pharmacother
2012
Smith, Am J
Health-Syst
Pharm 2010
Rosborough,
Pharmacother 1999
Length of Stay X
Faster Time to
Therapeutic X X
Discordant Results X
Fewer Dosage
Changes/Tests X X X
Cost per Test Xa $13.30 vs
PTT $13.97
Xa $31.46 vs
PTT $27.10
Adverse Outcomes X
Economic
Outcomes N/A N/A N/A N/A N/A
Number of Sites 1 1 1 1 1
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Key Points of the IL Study
• Scope
- Compare performance of Anti-Xa vs aPTT assays for patients on UFH treatment
• Outcomes with Anti-Xa
- Significant hospital cost savings in patient care
- Significant reduction in patient complications (e.g., major hemorrhage, VTE, mortality)
• Disease state
- Focus on VTE, Acute Coronary Syndrome, Stroke and complications (e.g., hemorrhage, thrombosis)
• Method - Data Analytics Group retrospective review of key markers
in large multi-hospital database
22
Slides 21 – 57: Belk KW, Laposata M, Craver CW, Comparison of bleeding complications between Anti-Xa and aPTT monitoring in patients Receiving unfractionated heparin, International Society on Thrombosis and
Hemostasis 13 (Suppl 2) 213, 2015.
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Database Contents
• Hospital characteristics - region, bed size, teaching status
• Patient demographics - Age, gender
• Diagnosis - ICD-9 diagnosis codes, clinical groupings (MS-DRG)
• Procedure - ICD-9 procedure codes, CPT codes, procedure date
• Metrics - Length of stay, mortality, readmissions
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Anti-Xa Study Design
• Create a patient-matching algorithm to identify “like”
patients in aPTT and Anti-Xa cohorts
• Matching variables for all populations included: - Hospital bed size and teaching status
- Hospital region
- Patient age
- Gender
- Patient comorbidities
- Transfers to another facility and left against medical advice
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Study Population
Patients on IV UFH discharged over 5 years
(2009-2013)
Monitored with aPTT
Venous Thromboembolism
as primary diagnosis (VTE)
Stroke Acute Coronary Syndrome (ACS)
Monitored with Anti-Xa
Venous Thromboembolism
as primary diagnosis (VTE)
Stroke Acute Coronary Syndrome (ACS)
The two cohorts were defined using CPT codes and the name of the assay. Matched cohorts included: • N= 2207 for Venous Thromboembolism (VTE) • N= 784 for Stroke • N= 7411 for Acute Coronary Syndrome (ACS)
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Study Design - Outcomes Included
Overall cost of care Length of stay Number of
monitoring tests
Number of heparin dose changes
Readmissions In-hospital mortality
Complications:
- RBC transfusions
- Protamine Sulfate
- Thromboses
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Statistical Methods Used
• Univariate: Observing only one variable at a time - Numeric data
• Variance (how widely point varies from the mean)
- Qualitative data
• Chi-square (compares the significant difference of two variables)
• Multi-variate analysis: Observing multiple variables to
isolate the impact of Anti-Xa on outcomes - Regression (compares points to show cause and effect)
• p value < 0.05 is considered significant
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Venous Thromboembolism (VTE)
Results
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VTE: Cost of Care
Median cost of care for
patients monitored with
Anti-Xa was $808 less
than those monitored
with aPTT 7,923
8,730
7000
7500
8000
8500
9000
Anti-Xa aPTT
Median Cost
(N = 2207, p = 0.0022)
$
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VTE: Number of Heparin Dose Changes
Average number of
heparin dose
changes was lower
in patients
monitored with
Anti-Xa
1.48 1.61
0.00
0.50
1.00
1.50
2.00
Anti-Xa aPTT
Mean Number of Heparin Dose Changes
(N = 2207, p = 0.0365)
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VTE: Number of Monitoring Tests Administered
On average, patients
monitored with Anti-Xa
had two fewer tests than
patients monitored with
aPTT.
• For a larger hospital with
75-150 VTE patients on
unfractionated heparin
annually, this results in a
difference of 150-300 tests.
5.53
7.51
0.00
2.00
4.00
6.00
8.00
Anti-Xa aPTT
Mean Number of Tests Administered
(N = 2207, p <0.0001)
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VTE: RBC Blood Transfusions
Patients monitored with Anti-Xa had nearly 5% fewer RBC blood transfusions
• Average cost of care for patients with a transfusion is twice as much as those without transfusions ($29,943 vs. $11,248)
3.90
8.61
0%
2%
4%
6%
8%
10%
Anti-Xa aPTT
RBC Blood Transfusions
(N = 2207, p < 0.0001)
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VTE: In-Hospital Mortality
There were no
significant
differences for in-
hospital mortality for
patients monitored with
Anti-Xa compared to
those monitored with
aPTT.
2.36 2.40
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
Anti-Xa aPTT
In-Hospital Mortality
(N = 2207, p = 0.9213)
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VTE: Multivariate Results
• Evaluation of the cost, length of stay, readmission and
mortality measures using multi-variate regression showed
estimated savings of $402 for patients with Anti-Xa
For a large hospital with 75-150 VTE patients on UFH, this saves
$30,000-$60,000 annually
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VTE: Multi-variate Blood Complication Results
• Patients tested with aPTT were 2.8 times more likely to get
a RBC transfusion than those patients tested with Anti-Xa
• Controlled for - Patient age and gender
- Diagnostic risks
- Invasive procedures
The average cost of treating
patients with a transfusion was
2x as those without
transfusions ($29,943 vs.
11,248)
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Stroke Results
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Stroke: Cost of Care
The median cost of
care for patients tested
with Anti-Xa was
$3,454 less than those
who were using the
aPTT; however, this
result is not statistically
significant.
17,387
20,841
15,000
16,000
17,000
18,000
19,000
20,000
21,000
22,000
Anti-Xa aPTT
Median Cost
(N = 784, p = 0.1526)
$
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Our Passion. Your Results.
Stroke: Number of Heparin Dose Changes
The average number
of heparin dose
changes was lower
in patients tested
with Anti-Xa.
1.67
1.96
0.00
0.50
1.00
1.50
2.00
2.50
Anti-Xa aPTT
Mean Number of Heparin Dose Changes
(N = 784, p = 0.0276)
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Our Passion. Your Results.
Stroke: Number of Monitoring Tests
Administered
On average, patients
monitored with Anti-Xa
had approximately one
more test than those
monitored with aPTT.
6.76
5.61
0
2
4
6
8
Anti-Xa aPTT
Mean Number of Tests Administered
(N = 784, p = 0.0104)
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Stroke: Blood Transfusions
Patients monitored with
Anti-Xa had
approximately an 8%
reduction in RBC
transfusions.
• Average cost of care for
patients with transfusion
is >3X those without
($88,630 vs. $25,575)
13.78
21.94
0%
5%
10%
15%
20%
25%
Anti-Xa aPTT
RBC Blood Transfusions
N = 784, p < 0.0001
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Stroke: In-Hospital Mortality
No significant
difference in-hospital
mortality for patients
monitored with Anti-Xa
vs. aPTT
9.44 10.08
0%
2%
4%
6%
8%
10%
12%
Anti-Xa aPTT
In-Hospital Mortality
N = 784, p = 0.6705
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Stroke Multivariate Results
• Evaluation of the cost, length of stay, readmission and
mortality measures using multi-variate regression
demonstrated: - Estimated savings of $1,932 for patients with Anti-Xa
• For a large hospital with 200-350 stroke patients treated with UFH, this would result in estimated $350,000 - $700,000
savings annually*
• No significant differences in length of stay, readmissions or mortality
*Hall MJ, Levant S, DeFrances C, “Hospitalization for Stroke in U.S. Hospitals 1989-2009”, NCHS Data Brief, No. 95, May 2012
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Stroke: Multivariate Blood Complication Results
• Patients monitored with aPTT were 2.5 times more likely
to receive an RBC transfusion than those on Anti-Xa
• Study was controlled for: - Patient age and gender
- Diagnostic risks
• (e.g., anemia, renal insufficiency, trauma)
- Invasive procedures
• (e.g., cardiac catheterization, hemodialysis, coronary artery bypass graft)
.
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Acute Coronary Syndrome (ACS)
Results
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ACS: Cost of Care
Median cost of care
for patients monitored
with Anti-Xa was
$3,982 less than
those monitored with
aPTT 17,162
21,144
15,000
16,000
17,000
18,000
19,000
20,000
21,000
22,000
Anti-Xa aPTT
Median Cost
(N = 7411, p < 0.0001)
$
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ACS: Length of Stay
Average length of stay
for patients monitored
with Anti-Xa was more
than half a day less
than those monitored
with aPTT
7.94 8.60
0.00
2.00
4.00
6.00
8.00
10.00
Anti-Xa aPTT
Mean Length of Stay
N = 7411, p <0.0001
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ACS: Number of Heparin Dose Changes
Average number of
heparin dose changes
was higher in patients
monitored with Anti-Xa
1.80
1.44
0.00
0.50
1.00
1.50
2.00
Anti-Xa aPTT
Mean Number of Heparin Dose Changes
(N = 7411, p < 0.0001)
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Our Passion. Your Results.
ACS: Number of Monitoring Tests Administered
On average, patients
monitored with Anti-Xa
had 0.44 fewer tests than
those monitored with
aPTT.
• For a larger hospital
with 500-900 ACS
patients on
unfractionated heparin
annually, this would
translate to a difference
of 200-400 tests
annually.
3.80 4.24
0
1
2
3
4
5
Anti-Xa aPTT
Mean Number of Tests Administered
N = 7411, p < 0.0001
Te
sts
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ACS: RBC Blood Transfusions
Patients monitored with
Anti-Xa had nearly 18%
fewer RBC blood
transfusions.
• Average cost of
patients with a
transfusion was 2x
that of those without
transfusions ($51,650
vs. $22,373)
7.02
24.56
0%
5%
10%
15%
20%
25%
30%
Anti-Xa aPTT
RBC Blood Transfusions
(N = 7411, p < 0.0001)
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Our Passion. Your Results.
ACS: In-Hospital Mortality
Mortality rate in
patients monitored with
Anti-Xa was nearly 1%
less than that in
patients monitored with
aPTT
9.44% 10.08%
0.00%
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
Anti-Xa aPTT
In-Hospital Mortality
(N = 7411, p = 0.0275)
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ACS Multi-variate Results
Evaluation of the cost, length of stay, readmission and
mortality measures using multi-variate regression
demonstrated:
• Estimated savings of $741 for patients monitored with
Anti-Xa - For a large hospital with 500-900 ACS patients on UFH, annual
mean savings estimated to be $350,000 - 700,000
• Estimated savings of 9.9 hospital hours for patients
monitored with Anti-Xa - For a large hospital with 500-900 ACS patients treated with UFH,
estimated 200-375 days annually
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Our Passion. Your Results.
ACS: Multivariate Blood Complication Results
• Patients monitored with aPTT were 6.3 times more likely
to receive a RBC transfusion and 1.7 times more likely to
receive protamine sulfate than patients monitored with
Anti-Xa.
• Controlled for: - Patient age and gender
- Diagnostic risks
• (e.g., anemia, renal insufficiency, trauma)
- Invasive procedures
• (e.g., cardiac catheterization, hemodialysis, coronary artery bypass graft)
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Our Passion. Your Results.
VTE: Summary of the Advantages of Anti-Xa
Anti-Xa
aPTT
$808 reduction in cost of care pp
Fewer RBC transfusions
2 less tests per
VTE patient
Fewer dose
changes
Note: Length of stay, mortality, readmission, thrombotic complication rate, and
protamine titration incidence were not significantly different
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Stroke: Summary of the Advantages of Anti-Xa
Anti-Xa aPTT
$3,454 lower cost of care pp
fewer RBC transfusions
Fewer dose
changes
Note: Length of stay, mortality, thrombotic complications, readmission rate and
protamine titration incidence were not significantly different
Fewer monitoring
tests
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ACS: Summary of the Advantages of Anti-Xa
Anti-Xa
aPTT
$3,982 lower cost of care
18% fewer RBC
transfusions
Fewer tests ACS
patients
Fewer dose
changes
Note: Re-admission and thrombotic complication rate were not significantly
different
9.9 hour reduction in hospital
stay
Mortality decreased
1%
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Multi-variate Results
• Examination of the cost, length of stay, readmission and mortality measures using multi-variate regression demonstrated:
- Estimated savings of
• $402 for VTE patients with Anti-Xa • For a large hospital with 75–150 VTE patients treated with UFH, this saves
$30,000–$60,000 annually
- $1,932 for Stroke patients with Anti-Xa • For a large hospital with 200-350 Stroke patients on UFH, this saves $350,000–
$700,000 annually
- $741 for ACS patients with Anti-Xa • For a large hospital with 500-900 ACS patients on UFH, this saves $350,000–
$700,000 annually
- 9.9 hours ACS for patients with Anti-Xa • For a large hospital with 500-900 ACS patients on UFH, this saves estimated
200–375 hospital days annually
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Our Passion. Your Results.
VTE Stroke ACS
Patients/
Year
75 – 250 200 – 350 500 - 900
Cost savings/
Patient ($)
402 1932 741
Savings/
year ($)
30,150 – 60,300 386,400 – 676,200 370,500 – 666,900
Estimate of Financial Benefit – Large U.S.
Hospital
57
TOTAL Annual Savings = $790,000 – $1,400,000
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Hypothesis to Explain Link Between Decline in
RBC Transfusions and Anti-Xa Monitoring
• Anti-Xa assay use focuses more attention on the use of blood
products, which causes a reduction in use
• Monitoring Heparin therapy with Anti-Xa assay involves more
specialists in coagulation and transfusion medicine, resulting in
more careful, evidenced-based transfusion decisions
• The use of the Anti-Xa assay provides a more accurate
assessment of anticoagulant-associated bleeding risk and, thus,
reduces the need for RBC transfusions
Dr. Michael Laposata, AACC
Hemostasis workshop July 2015
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Successful Implementation of the
Anti-Xa Assay
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Our Passion. Your Results.
Educate and Convince
• Present to pharmacy department to demonstrate value - Lab leadership: meet with pharmacy leadership and present
data/references demonstrating the benefit of the Anti-Xa assay
• Present the change to caregivers - Lab and Pharmacy jointly present to Nursing and Physician
leadership
- Present the benefits of the change
• Improved patient care
• Cost benefit
• More precise measurement of heparin concentration
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Add to Electronic Medical Record
• Set up new orderable Anti-Xa assay(s) - Include therapeutic ranges for both UFH and LMWH
• UFH = 0.3 – 0.7 IU/mL
• LMWH = varies by type
• List the range for the most commonly used drugs
• Set up new heparin protocol(s) based on Anti-Xa
monitoring - For VTE (DVT and PE)
- For ACS/Stroke – patients with an increased risk of bleeding
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Heparin Dosing for VTE
Anti-Xa
(IU/mL)
Bolus Dose
(units/kg)
Stop Infusion
(min)
Rate Change
(Units/kg/h)
Initial dose 80 18 (initial rate)
<0.2 80 Increase by 4
0.2-0.29 40 Increase by 2
0.3-.07 No No change
0.71-0.8 No Decrease by 1
0.81-0.9 No 30 Decrease by 2
>0.9 No 60 Decrease by 3
Ann Pharmacother 2011;45;861-8
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Low Intensity Heparin Dosing for ACS and
Stroke
Used with permission from Univ of NM MC Pharmacy
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Caregiver Training on New Heparin Protocols
• Nursing continuing
education/competency
program - Available as online
presentation or live
- Educates on why the change to
Anti-Xa and the benefits
• Physician training - Grand Rounds
- Department meetings
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Who to Target:
Pharmacy & Therapeutics Committees
• Pharmacy Newsletter Article - Briefly describe reason behind the change
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Notification of the Change
• Laboratory bulletins - Include other hospitals using
Anti-Xa (local if possible)
- Describe assay and its benefits
vs. the APTT
- Include new therapeutic range
- State what is changing (i.e.
dosing nomogram) and what is
not
- Mention that pharmacy is in
agreement/involved
Letter courtesy of Dr. Higgins, UHS San Antonio, TX
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Challenges to Acceptance
• Need to move beyond a departmental budget and to a
focus on improving patient care - Reagent costs will increase for the lab
- Overall cost to the medical center will be reduced
- Nursing department must have adequate time for complete training
before “going live” with Anti-Xa
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• Monitoring UFH therapy with the Anti-Xa assay can help
achieve the “Triple Aim” for healthcare improvement
- Patient care will improve by maintaining levels of
anticoagulation and reducing RBC transfusions
- Patient experience will improve with fewer tests and fewer
dose changes
- Cost of hospital care is reduced
Conclusions
68
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4/7/2016