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EBM SPECIAL TOPIC

Evidence-Based Practices for Thromboembolism


Prevention: Summary of the ASPS Venous
Thromboembolism Task Force Report
Robert X. Murphy, Jr., M.D.
Summary: In July of 2011, the American Society of Plastic Surgeons Executive
Amy Alderman, M.D. Committee approved the Venous Thromboembolism Task Force Report. The
Karol Gutowski, M.D. report includes a summary of the scientific literature relevant to venous throm-
Carolyn Kerrigan, M.D. boembolism and plastic surgery along with five evidence-based recommenda-
Karie Rosolowski, M.P.H. tions. The recommendations are divided into two sections: risk stratification and
Loren Schechter, M.D. prevention. The risk stratification recommendations are based on the 2005
DeLaine Schmitz, R.N., Caprini Risk Assessment Module, which has been validated in the scientific
M.S.H.L. literature as an effective tool for risk-stratifying plastic and reconstructive surgery
Edwin Wilkins, M.D. patients based on individual risk factors for 60-day venous thromboembolism.
Arlington Heights, Ill. The three prophylaxis recommendations are dependent on an individual pa-
tient’s 2005 Caprini Risk Assessment Module score. (Plast. Reconstr. Surg. 130:
168e, 2012.)

A
ccording to the 2008 article, “The Surgeon thrombosis/pulmonary embolism prevention and
General’s Call to Action to Prevent Deep treatment.
Vein Thrombosis and Pulmonary Embo-
lism,” best estimates indicate that 350,000 to DISCLAIMER
600,000 Americans each year suffer from deep This Task Force report provides strategies for
vein thrombosis and pulmonary embolism, and patient management and was developed to assist
that at least 100,000 deaths may be directly or physicians in clinical decision making. This Task
indirectly related to these diseases.1 Although the Force report, based on a thorough evaluation of
exact incidence of venous thromboembolism in the present scientific literature and relevant clin-
the plastic surgery population is unknown, venous ical experience, describes a range of generally ac-
thromboembolism prophylaxis has been a topic of ceptable approaches for management or preven-
interest for some time. In response, the focus of tion of specific diseases or conditions. This report
the 2009 American Society of Plastic Surgeons attempts to define principles of practice that
(ASPS) Partners in Quality Leadership Summit should generally meet the needs of most patients
was on venous thromboembolism in plastic sur- in most circumstances.
gery. The primary action item to emerge from the This report, however, should not be construed
Summit was the appointment of a venous throm- as a rule, nor should it be deemed inclusive of all
boembolism task force charged with: (1) evaluat- proper methods of care or exclusive of other
ing the literature as it relates to venous thrombo- methods of care reasonably directed at obtaining
embolism risk assessment in plastic surgery cases; the appropriate results. It is anticipated that it will
(2) developing a modified Caprini Risk-Assess- be necessary to approach some patients’ needs in
ment Module and recommendations specific to different ways. The ultimate judgment regarding
plastic surgery cases; and (3) developing tools and the care of a particular patient must be made by
aids to assist plastic surgeons across the health the physician in light of all the circumstances pre-
system to implement best practices for deep vein sented by the patient, the diagnostic and treat-
ment options available, and available resources.

From the American Society of Plastic Surgeons.


Received for publication November 15, 2011; accepted Jan- Disclosure: The authors have no financial interest
uary 18, 2012. in any of the products, devices, or drugs mentioned
Copyright ©2012 by the American Society of Plastic Surgeons in this article.
DOI: 10.1097/PRS.0b013e318254b4ee

168e www.PRSJournal.com
Volume 130, Number 1 • Venous Thromboembolism Task Force Report

This Task Force report is not intended to de- inclusion criteria and passing the critical appraisal
fine or serve as the standard of medical care. Stan- process. Because of the very limited evidence on
dards of medical care are determined on the basis venous thromboembolism prophylaxis in the plas-
of all the facts or circumstances involved in an tic surgery literature, the search was expanded to
individual case and are subject to change as sci- include the orthopedic and general surgery liter-
entific knowledge and technology advance, and as ature. Orthopedic and general surgery literature
practice patterns evolve. This Task Force report was included because, from a venous thrombo-
reflects the state of knowledge current at the con- embolism risk perspective, they are similar in pa-
clusion of the Task Force’s activities. Given the tient population, anatomical location, and degree
inevitable changes in the state of scientific infor- of invasiveness. The search time frame was January
mation and technology, periodic review and revi- 1, 2005, to May 1, 2011. Two hundred eighteen
sion will be necessary. citations were initially identified in the orthopedic
and general surgery literature, with 10 meeting
TASK FORCE COMPOSITION both the inclusion criteria and passing the critical
In response to the 2009 Partners in Quality appraisal process.
Leadership Summit: Assessing the Impacts of DVT The plastic surgery, orthopedic, and general
and the Surgeon General’s Call to Action in Plastic surgery literature was searched for studies related
Surgery, held from July 15 through 16, 2008, in to the effectiveness of the Caprini Risk-Assessment
Chicago, Illinois, the ASPS convened the Venous Module for venous thromboembolism. Study in-
Thromboembolism Task Force. The ASPS presi- clusion criteria included relevance to the topic
dent at the time, Michael McGuire, M.D., selected and validated venous thromboembolism risk-as-
Robert X. Murphy, Jr., M.D., to chair the Task sessment scale. Fifty-four citations were initially
Force. The remaining members of the Task Force identified, with three both meeting the inclusion
were selected based on their involvement in rel- criteria and passing the critical appraisal process.
evant committees, their clinical content expertise, A complete summary of the specific clinical ques-
and/or their knowledge of evidence-based medi- tions, search terms, Medical Subject Headings,
cine. None of the Task Force members who are methods used to conduct the systematic review,
authors of this report disclosed conflicts of interest and the critical appraisal process for the report,
or financial affiliations. Evidence-Based Practices for Thromboembolism Preven-
tion, can be found at http://www.plasticsurgery.
TASK FORCE PURPOSE org/vte.
One of the primary purposes of the Task Force
was to evaluate the scientific literature in two ar-
eas, venous thromboembolism risk stratification LITERATURE FINDINGS
methods and venous thromboembolism prophy-
laxis regimens including chemoprophylaxis drug, Venous Thromboembolism Risk-Assessment
dosage, length of therapy, efficacy, and complica- Scales
tions associated with chemoprophylaxis. Using a There were several venous thromboembolism
consensus process, the Task Force developed the risk-assessment tools reported in the literature,
clinical questions, search terms, and inclusion cri- including the 2005 Caprini Risk-Assessment Mod-
teria for the two areas before the literature search. ule,2,3 the 2010 Caprini Risk-Assessment Module,4
the Davison-Caprini scale,5 and numerous propri-
LITERATURE SEARCH etary tools adopted by individual hospitals. To en-
A thorough literature search of the PubMed, sure that the Task Force recommendations could
Cumulative Index to Nursing and Allied Health be consistently associated with a set of risk factors,
Literature, and Cochrane Library databases was one risk-assessment tool was needed as a reference
performed. Study inclusion criteria for the venous point or benchmark for comparison. The 2005
thromboembolism prophylaxis regimen question Caprini scale was selected as this reference point
included relevance, evaluates the efficacy of chem- because it was formally validated to stratify plastic
ical prophylaxis and the chemical prophylaxis surgery patients based on their individual risk fac-
drug was approved by the U.S. Food and Drug tors (Fig. 1).2 The 2010 Caprini Risk-Assessment
Administration. The plastic surgery–specific liter- Module was not selected because the additional
ature search time frame was January 1, 2000, to points allotted for longer surgery times, com-
May 1, 2011. One hundred nineteen citations were mon in many plastic surgery procedures, and
identified initially, with three meeting both the higher body mass indexes, could result in an

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Plastic and Reconstructive Surgery • July 2012

Fig. 1. Thrombosis risk factor assessment.

Table 1. ASPS Evidence Rating Scale for Therapeutic Studies


Level of Evidence Qualifying Studies
I Highest-quality, multicenter or single-center, randomized controlled trial with adequate power;
or systematic review of these studies
II Lesser-quality, randomized controlled trial; prospective cohort or comparative study; or
systematic review of these studies
III Retrospective cohort or comparative study; case-control study; or systematic review of these studies
IV Case series with pre/post test; or only post test
V Expert opinion developed by means of consensus process; case report or clinical example; or
evidence based on physiology, bench research, or “first principles”

Table 2. ASPS Evidence Rating Scale for Diagnostic Studies


Level of Evidence Qualifying Studies
I Highest-quality, multicenter or single-center, cohort study validating a diagnostic test (with criterion
standard as reference) in a series of consecutive patients; or a systematic review of these studies
II Exploratory cohort study developing diagnostic criteria (with criterion standard as reference) in a
series of consecutive patient; or a systematic review of these studies
III Diagnostic study in nonconsecutive patients (without consistently applied criterion standard as
reference); or a systematic review of these studies
IV Case-control study; or any of the above diagnostic studies in the absence of a universally accepted
criterion standard
V Expert opinion developed by means of consensus process; case report or clinical example; or
evidence based on physiology, bench research, or “first principles”

overscoring phenomenon, artificially placing imens did not include the study population’s
patients in a higher than necessary risk category. venous thromboembolism risk levels. To ensure
Many of the therapeutic studies identified in that like groups were evaluated, Task Force
the literature search addressing prophylaxis reg- members analyzed the patient characteristics

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Volume 130, Number 1 • Venous Thromboembolism Task Force Report

and risks in studies without a 2005 Caprini risk See Tables 1 through 3 for ASPS evidence
rating and estimated a venous thromboembo- rating scales. Table 4 includes the litera-
lism risk score using the 2005 Caprini Risk-As- ture findings with corresponding levels of
sessment Module. evidence.2,3,5–19

Table 3. ASPS Evidence Rating Scale for Prognostic/Risk Studies


Level of Evidence Qualifying Studies
I Highest-quality, multicenter or single-center, prospective cohort or comparative study with adequate
power; or a systematic review of these studies
II Lesser-quality prospective cohort or comparative study; retrospective cohort or comparative study;
untreated controls from a randomized controlled trial; or a systematic review of these studies
III Case-control study; or systematic review of these studies
IV Case series with pre/post test; or only post test
V Expert opinion developed by means of consensus process; case report or clinical example; or
evidence based on physiology, bench research, or “first principles”

Table 4. Literature Search: Evidence Summaries


Findings in the Orthopedic, General Surgery, Supporting Literature and
and Plastic Surgery Literature Level of Evidence
1. Risk stratification: Risk studies:
The 2005 Caprini RAM is a valid scoring method that effectively stratifies ● Bahl et al., 20106: level II
patients into a VTE risk category based on their individual risk factors. ● Hatef et al., 20085†: level II
2. Plastic surgery risk stratification: Identified in May of 2011 search:
The 2005 Caprini RAM effectively risk-stratifies plastic and reconstructive Risk study
surgery patients for increased 60-day VTE risk. Among patients with a ● Pannucci et al., 20112†: level II
2005 Caprini score ⬎8, 11.3% had a postoperative VTE when
chemoprophylaxis was not provided. Patients with a Caprini score ⬎8
were significantly more likely to develop VTE when compared with
patients with a Caprini score of 3 to 4, 5 to 6, or 7 to 8. There was no
evidence that VTE risk was limited to the immediate postoperative
period in patients with Caprini score of 7 to 8 or ⬎8.
3. In patients with estimated* 2005 Caprini RAM scores ⬎3, the use of Therapeutic studies:
postoperative chemoprophylaxis, LMWH, UH, and fondaparinux, for 1 ● Turpie et al., 20077: level I
wk was effective in preventing VTE without significantly increasing ● Kim et al., 20098†: level III
bleeding risks. ● Edwards et al., 20089: level II
● Senaran et al., 200610: level II
● Chin et al., 200911: level II
● Colwell et al., 200612: level II
4. In patients with estimated* 2005 Caprini RAM scores ⬎7, extended Therapeutic studies:
LMWH prophylaxis for up to 4 wk is more effective at reducing the risk ● Barrellier et al., 201013: level I
of VTE compared to 1 wk of LMWH, without significantly increasing the ● Bottaro et al., 200814: level II
risk of hematoma or bleeding complications. ● Rasmussen et al., 200615: level II
● Rasmussen et al., 200916: level II
5. Inpatient plastic surgery patients who received general anesthesia and Therapeutic study: level III
received prophylactic-dose enoxaparin during the duration of their ● Pannucci et al., 20113†: level III
hospitalization (starting 6–8 hr after surgery):
● Enoxaparin was effective in reducing VTE rates (compared to no VTE
prophylaxis).
– Minimal risk reduction was seen in 2005 Caprini RAM scores of 3–6.
– Notable risk reduction was present in 2005 Caprini RAM scores ⬎7.
● Enoxaparin was not associated with increased rates of reoperative
hematoma in the overall patient population or the high-risk breast
surgery subgroups.
● Length of stay ⬎4 days and 2005 Caprini RAM score ⬎8 were
independent predictors of VTE.
● When controlling for length of stay and 2005 Caprini RAM score,
postoperative enoxaparin was protective against 60-day VTE.
6. Evidence suggests that combined UH or LMWH plus mechanical Therapeutic studies:
prophylaxis throughout the duration of chemical prophylaxis is more ● Kakkos et al., 200817: level II
effective in preventing VTE in patients than either alone. ● Seruya et al., 200818†: level III
● Liao et al., 200819†: level III
RAM, Risk-Assessment Module; VTE, venous thromboembolism; LMLH, low-molecular weight heparin; UH, unfractionated heparin.
*Task Force members analyzed the patient characteristics and risks in studies without a 2005 Caprini risk rating and estimated a venous
thromboembolism risk score using the 2005 Caprini Risk-Assessment Module.
†Plastic surgery study.

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Table 5. Plastic Surgery Venous Thromboembolism Prophylaxis Study Protocols
Venous Thromboembolism University of Texas Georgetown University Asan Medical Center,
Prevention Study, Southwestern, Hospital, Korea,
Pannucci et al., 20113 Hatef et al., 20085 Seruya et al., 200818 Kim et al., 20098
Patients Various operations, general Excisional body contouring Various; head and neck reconstruction; TRAM flap immediate breast
anesthesia, at least one patients breast reconstruction; abdominal reconstruction patients
overnight stay wall reconstruction
Risk-assessment 2005 Caprini Risk Assessment Caprini-Davison Risk Assessment Caprini-Davison Risk Assessment Model None
scale Model Model
Protocol
Risk score 2005 Caprini RAM Score ⬎3 Moderate, high, and highest risk 2005 Caprini RAM score ⬎4 N/A
groups
Drug Enoxaparin Enoxaparin Enoxaparin Enoxaparin
Dose Sliding scale: 30 mg SQ 40 mg SQ Dose: 40 or 60 mg SQ
● BMI ⬍40: 40 mg SQ every (dependent on weight)
day
● BMI ⬎40: 30 mg SQ two
times per day
Timing First dose 6–8 hr postoperatively, ● 49 patients received first dose Starting 12 hr postoperatively, then 1 hr preoperatively, then
then daily until patient preoperatively daily until ambulatory; additional daily
released ● 88 patients received first dose prophylaxis measures: IPC with
intraoperatively or immediately elastic compression stockings (on at
postoperatively all times when not ambulating)
● Every 12 hr after initial dose
Length of
prophylaxis Varied Varied Varied, averaged 7.4 days 7 days
Results When controlling for independent Enoxaparin significantly decreased Mechanical prophylaxis supplemented Enoxaparin was effective in
risk factors, postoperative DVT risk in patients undergoing with low-molecular-weight heparin preventing VTE without
enoxaparin was protective circumferential abdominoplasty. was effective in preventing VTE significantly increasing
against VTE without increased Enoxaparin administration was without significant increase in bleeding-related
rates of reoperative hematoma. associated with increased bleeding or hematoma rates. complications such as
hematoma and postoperative transfusions or hematoma.
bleeding requiring transfusion.
RAM, Risk-Assessment Model; TRAM, transverse rectus abdominis musculocutaneous; N/A, not applicable; SQ, subcutaneously; BMI, body mass index; IPC, intermittent pneumatic
compression; VTE, venous thromboembolism; DVT, deep vein thrombosis.
Plastic and Reconstructive Surgery • July 2012
Volume 130, Number 1 • Venous Thromboembolism Task Force Report

Prophylaxis Medication Dosage and Timing agreement was achieved on each recommenda-
The available evidence on chemoprophylaxis tion statement.
medication choice, postoperative timing, and
dosage varied among the studies. Administra- Rationale for Task Force Recommendations
tion of the first chemoprophylaxis dosage Based on the types of cases included in the
ranged from preoperative administration to 1 to literature review, Task Force members agreed that
12 hours postoperatively. Several different low- there was not enough evidence to make all-inclu-
molecular-weight heparin medications were used sive recommendations for plastic surgery prophy-
in the studies, including enoxaparin, dalteparin, laxis medication, dosage, or length of prophylaxis.
tinzaparin, and fondaparinux. Enoxaparin was the However, the Task Force agreed that some plastic
most common low-molecular-weight heparin pre- surgery procedures warranted additional prophy-
scribed; the dosage ranged from 30 to 60 mg/day. laxis considerations, and accepted the premise
Task Force members agreed that there was not that the surgical cases included in the orthopedic
enough evidence to make all-inclusive recommen- and general surgery literature search were similar
dations for plastic surgery prophylaxis medica- enough in their anatomical location, degree of
tion, dosage, or length of prophylaxis. See Table invasiveness, and patient population to make
5 for study protocols. them comparable (from a venous thromboem-
bolism risk perspective) to the following plastic
Medication Costs surgery cases: major body contouring, abdomi-
Venous thromboembolism prophylaxis costs noplasty, major breast reconstruction, major
vary greatly because of the specific medication, lower extremity procedures, and major head/
regimen, and pharmacy selected. A breakdown of neck cancer procedures. This belief was rein-
cost estimates can be found at http://www. forced by the publication in August of 2010 by
plasticsurgery.org/vte. Murphy et al. that documented the reality of
venous thromboembolism events in abdomino-
RECOMMENDATIONS plasty and panniculectomy cases despite compli-
Recommendation Development Process ance with nationally recognized venous thrombo-
Task Force recommendations were developed embolism prophylaxis measures.20 Therefore,
through a consensus process. After thorough re- recommendations 3 to 5 were developed to ad-
view of the evidence, the Task Force members dress this subset of plastic surgery procedures. See
jointly developed draft statements for each rec- Table 6 for the ASPS grading scale and Table 7 for
ommendation during a conference call discus- the Venous Thromboembolism Task Force rec-
sion. After the conference call, Task Force mem- ommendations.
bers had an opportunity to individually comment
and revise the draft recommendations by means of TOOLS AND AIDS
an e-mail discussion. The Task Force participated The ASPS Web site includes a page dedicated
in several rounds of revisions until unanimous to its campaign for venous thromboembolism

Table 6. ASPS Grading Scale


Grade Descriptor Qualifying Evidence Implications for Practice
A Strong Level I evidence or consistent findings Clinicians should follow a strong recommendation
recommendation from multiple studies of level II, III, unless a clear and compelling rationale for an
or IV alternative approach is present.
B Recommendation Level II, III, or IV evidence and Generally, clinicians should follow a
findings are generally consistent recommendation but should remain alert to
new information and sensitive to patient
preferences.
C Option Level II, III, or IV evidence, but Clinicians should be flexible in their decision-
findings are inconsistent making regarding appropriate practice,
although they may set bounds on alternatives;
patient preference should have a substantial
influencing role.
D Option Level V: little or no systematic Clinicians should consider all options in their
empirical evidence decision-making and be alert to new published
evidence that clarifies the balance of benefit
versus harm; patient preference should have a
substantial influencing role.

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Plastic and Reconstructive Surgery • July 2012

Table 7. ASPS Venous Thromboembolism Task Force Risk-Assessment and Prevention Recommendations
Step One: Risk Stratification

Patient Population Recommendation


Inpatient: adult aesthetic and reconstructive plastic surgery patients Should complete a 2005 Caprini risk factor
who undergo general anesthesia assessment tool to stratify patients into a VTE
risk category based on their individual risk
factors. Grade B
Or
Should complete a VTE risk-assessment tool
comparable to the 2005 Caprini RAM to
stratify patients into a VTE risk category
based on their individual risk factors. Grade D
Outpatient: adult aesthetic and reconstructive plastic surgery patients Should consider completing a 2005 Caprini
who undergo general anesthesia risk factor assessment tool to stratify patients
into a VTE risk category based on their
individual risk factors. Grade B
Or
Should consider completing a VTE risk-
assessment tool comparable to the 2005
Caprini RAM to stratify patients into a VTE
risk category based on their individual risk
factors.Grade D
Step Two: Prevention
2005 Caprini
Patient Population RAM Score Recommendations*

Elective surgery patients (when the procedure is ⱖ7 Should consider using risk-reduction strategies
scheduled in advance and is not performed to such as limiting operating room times,
treat an emergency or urgent condition) weight reduction, discontinuing hormone
replacement therapy, and early postoperative
mobilization. Grade C
Patients undergoing the following major procedures 3–6 Should consider the option to use
when the procedure is performed under general postoperative LMWH or UH. Grade B
anesthesia lasting more than 60 minutes:
● Body contouring
● Abdominoplasty
● Breast reconstruction
● Lower extremity procedures
● Head/neck cancer procedures
VTE, Venous thromboembolism; RAM, Risk-Assessment Module; LMWH, low-molecular-weight heparin; UH, unfractionated heparin.
*The scores associated with the recommendations apply to the 2005 Caprini RAM and were not intended for use with alternative VTE
risk-assessment tools.

awareness. There are numerous downloadable re- DeLaine Schmitz, R.N., M.S.H.L.
sources available, including the full Task Force American Society of Plastic Surgeons
444 East Algonquin Road
Report, the 2005 Caprini Scale accompanied by Arlington Heights, Ill. 60005-4664
the Task Force recommendations, a patient ve-
nous thromboembolism risk self-assessor form, REFERENCES
and a patient handout on venous thromboembo- 1. U.S. Department of Health and Human Services. The Sur-
lism signs and symptoms. These resources can be geon General’s call to action to prevent deep vein throm-
found at http://www.plasticsurgery.org/vte. bosis and pulmonary embolism. 2008. Available at: http://
The Task Force also developed evidence-based www.surgeongeneral.gov/topics/deepvein/calltoaction/
performance measures that may be used for a call-to-action-on-dvt-2008.pdf.
2. Pannucci CJ, Bailey SH, Dreszer G, et al. Validation of the
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