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Position Statement onVenous Thromboembolism Prophylaxis

for Patients Undergoing Breast Operations

1. The risk of venous thromboembolism (VTE) associated with breast surgery is extremely low.

2. VTE prophylaxis guidelines and compliance measures relevant to patients undergoing major

abdominal, pelvic, and orthopedic operations should not be uniformly applied to breast surgery

patients.

3.

Decisions regarding VTE prophylaxis in breast surgery patients should be individualized,

taking into consideration the risk of VTE and the risk of bleeding complications. The type of

procedure and the type of anesthesia should also be considered. Early ambulation should be

encouraged and is sufficient prophylaxis in the majority of breast surgery patients. MechanicalVTE prophylaxis is appropriate in patients at increased risk. Chemical prophylaxis may be

considered in highly selected patients.

4. Except for other medical co-morbid conditions and long reconstructive procedures, most

breast surgery patients do not need VTE prophylaxis.

According to NCCN Categories of Consensus, these recommendations are Category 2A:

Based upon lower-level evidence, there is un iform American Society of Br east Surgeons

consensus that the recommendations are appropriate.

VTE is a serious and potentially fatal consequence of certain disease states and medical

interventions, including hospitalization and surgery. The Institute of Medicine estimates that

200,000 to 500,000 patients are affected by VTE and that 40,000 to 80,000 deaths related to VTEoccur annually in the United States. It is believed that this is a largely preventable condition with

appropriate prophylaxis.1,2

Various organizations have made recommendations regarding VTE prophylaxis in medical andsurgical patients.

3,4Other groups have established measures by which organizations, primarily

hospitals, can be judged regarding their compliance with these recommendations. For example,

the Centers for Medicare & Medicaid Services (CMS) Physician Quality Reporting System

(PQRS) perioperative measures set includes VTE prophylaxis.5

Prevention of VTE and associated complications is clearly an important goal. The majority of

VTE preventionguidelines were established using evidence-based medicine based on valid high-quality data. However, the generalizability of these guidelines to breast surgery and breast cancer

patients has not been established. Presently, there are no established guidelines for the use of

VTE prophylaxis in breast surgery patients.

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This is an important issue because in the absence of guidelines breast surgeons could be subject

to criticism for not following guidelines that were established for a very different surgical patientpopulation. Furthermore, arbitrary application of guidelines not appropriate to breast surgery

patients may lead to an increase in complications and cost of health care. Specifically, if there is

uncertain or no associated benefit with chemoprophylaxis, then routine application of suchguidelines could lead to increased risk of bleeding complications in breast surgery patients.

Contemporary studies demonstrate a very low rate of clinically significant VTE-related

complications in ambulatory breast surgery patients.6,7

Patiar et al recently concluded, Allpatients undergoing surgery for breast cancer should receive both intermittent pneumatic

compression (IPC) and graduated compression (GC) stockings, with heparin reserved for those at

very high risk.8

In a study from the MD Anderson Cancer Center,3898 patients were treated on clinical

pathways with mechanical anti-embolism devices and early ambulation.9

Seven patients with

postoperative VTE within 60 days were identified, for a rate of 0.16% per procedure. Six patientspresented with only a deep venous thrombosis (DVT) or a pulmonary embolism (PE); 1 patient

had both. The median time from surgery to diagnosis of VTE was 14 days (range, 260 days;

mean, 22 days). No relationship was identified between stage of breast cancer or type of breast

surgery and development of VTE. Two (29%) of the 7 patients with VTE had receivedneoadjuvant chemotherapy. VTE treatment consisted of subcutaneous low-molecular-weight

heparin (n = 5) or intravenous heparin (n = 2) followed by warfarin. There were no deaths. The

authors concluded, VTE following breast cancersurgery is rare in patients who are treated onclinical pathways with mechanical anti-embolism devices and early ambulation in the

postoperative period. We conclude that systemic VTE prophylaxis is not indicated in this group

of patients.

Two studies used National Surgical Quality Improvement Program (NSQIP) methodology to

study the incidence of VTE in breast cancer patients undergoing surgery.6,7

One study compared

VTE incidence in the U.S. Department of Veterans Affairs patients to private sector patients andthe other study compared mastectomy to breast-conserving therapy patients. Deep venous

thrombosis and pulmonary embolism occurred in less than 0.4% and 0.2% of patients,

respectively.6,7

Collectively, more than 6,900 patients were included in these two studies.

The use of chemical VTE prophylaxis in breast surgery patients is not without potential for

serious harm. A literature review of hemorrhagic complications after breast cancer surgery

concluded that chemical prophylaxis was associated with increased bleeding complications, withup to an 11% incidence of significant bleeding after breast excision with heparin prophylaxis.

8In

a retrospective institutional review, Friis et al reported a statistically significant three-fold

increase in bleeding complications in comparison of low-molecular-weight heparin to

compression stockings as follows: Of the 310 patients in the heparin group 58 (18.7%)developed a hematoma: 29 (9.4%) were reoperated, and 29 (9.4%) were managed by aspiration.

Among the 102 patients in the TED stockings group, 7 (6.8%) developed a hematoma: 3 (2.9%)

were reoperated, and 4 (3.9%) were managed by aspiration.10

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The most widely applied criteria by which organizations are judged regarding VTE prophylaxis,

as well as other measures of the quality of surgical care, are the Surgical Care Improvement

Project (SCIP) measures.11

(SCIP is sponsored by the CMS.) Many organizations, includingCMS in the PQRS, apply these measures to breast surgery, although breast surgery does not meet

the SCIP definition of moderate- or high-risk surgery (open surgical procedure >30 minutes

requiring in hospital stay >24 hours post-op).

Furthermore, the Caprini scoring system,12,13

the SCIP manual,11

the American College of Chest

Physicians guidelines,2

and the Cochrane review3

do not list breast surgery or breast

reconstruction as major surgery.

The Cochrane Systematic Review on VTE states, The type of surgery is the primary

determinant of the risk of deep venous thrombosis (DVT). Most individuals undergoing

outpatient surgery have low rates of DVT. For example, only 1 symptomatic VTE occurred inthe first month following 2,281 day-case hernia repairs (0.04%).

3

Because most patients undergoing breast surgery are ambulatory, and many are dischargedwithin 24 hours of the surgery, it may be that the following Cochrane recommendations made for

low-risk patients are most appropriate: 2.1.1. For low-risk general surgery patients who are

undergoing minor procedures and have no additional thromboembolic risk factors, we

recommend against the use of specific thromboprophylaxis other than early and frequentambulation(Grade 1A).

3

A diagnosis of cancer has been included among factors that predispose to VTE-relatedcomplications. However, the National Comprehensive Cancer Network (NCCN) guidelines

4and

other references do not list breast cancer as one of the malignancies predisposing to VTE. Breast

cancer is not in the NCCN list as a cancer type at high risk for VTE.

Some breast surgery patients have multiple predisposing factors for VTE for whom chemical

prophylaxis could be considered in addition to mechanical VTE prophylaxis and early

ambulation. Predisposing VTE risk factors include both host and operative factors. Host factorsmay include a personal history of DVT/PE, known or suspected inherited or acquired

hypercoagulability disorders, limitations in ambulation, a history of a recent major surgical

procedure that predisposes to VTE, older age, heart failure, advanced disease, estrogen therapy,morbid obesity, or an indwelling central venous catheter. Khorana has recently reviewed these

risk factors.14

Operative factors predisposing to VTE include type of anesthesia (local/regional vs general),length of general anesthesia, blood transfusions, and type of reconstruction (expander/implant vs

myocutaneous flap). In patients undergoing immediate reconstruction, the Caprini score may aid

in VTE risk stratification.12,13

Chemical prophylaxis should be considered in patients undergoing

major myocutaneous flap procedures or lengthy reconstructive surgery. Pannucci et al reviewedVTE risk in the 5 centers comprising the Plastic Surgery VTE Prevention Study Network

(VTEPSN).13

More than 3000 patients underwent breast reconstruction without chemical

prophylaxis in this review. Approximately 1 in 9 (11.3%) patients with a Caprini score greaterthan 8 had a VTE event and the 60-day hazard ratio was 49 for this group compared to patients

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with a lower Caprini score. The VTEPSN concluded that chemical prophylaxis is underutilized

in this patient population. Kim et al reported a 16.7% chance of pulmonary embolism in an

institutional review of patients undergoing TRAM breast reconstruction without chemicalprophylaxis compared to 0% in patients receiving enoxaparin.

15

These factors, as well as the risk and possible consequences of bleeding complications, should allbe considered when making a decision regarding the use of chemical VTE prophylaxis in breastsurgery patients.

References

1. Lyman G, Khorana A, Falanga A, et al. American Society of Clinical Oncology guideline:

recommendations for venous thromboembolism prophylaxis and treatment in patients with

cancer.J Clin Oncol. 2007;25:5490-5505.

2. Geerts W, Bergqvist D, Pineo G, et al. Prevention of venous thromboembolism: American

College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest.

2008;133:381S-453S.

3. Kakkos SK, Caprini JA, Geroulakos G, Nicolaides AN, Stansby GP, Reddy DJ. Combined

intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of

venous thromboembolism in high-risk patients. Cochrane Database of Syst Rev. Oct 8,2008;4:CD005258.

4. National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology:Venous Thromboembolic Disease. v.2.2011.

Available at:http://www.nccn.org/professionals/physician_gls/pdf/vte.pdf. Accessed August 2,

2011.

5. Centers for Medicare & Medicaid Services. 2011 Physician Quality Reporting System Quality

Measures. Available at:

http://www4a.cms.gov/PQRS/Downloads/2011_PhysQualRptg_MeasuresList_033111.pdfAccessed August 2, 2011.

6. Neumayer L, Schifftner TL, Henderson WG, Khuri SF, El-Tamer M. Breast cancer surgery inVeterans Affairs and selected university medical centers: results of the patient safety in surgery

study.J Am Coll Surg. 2007;204:1235-1241.

7. El-Tamer MB, Ward BM, Schifftner T, Neumayer L, Khuri S, Henderson W. Morbidity andmortality following breast cancer surgery in women: national benchmarks for standards of care.

Ann Surg. 2007;245:665-671.

8. Patiar S, Kirwan C, McDowell G, Bundred N, McCollum C, Byrne G. Prevention of venousthromboembolism in surgical patients with breast cancer.Br J Surg. 2007;94:412-420.

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9. Andtbacka R, Babiera G, Singletary SE, et al. Incidence and prevention of venous

thromboembolism in patients undergoing breast cancer surgery and treated according to clinical

pathways.Ann Surg. 2006;243;96-101.

10. Friis E, Hrby J, Srensen L, et al. Thromboembolic prophylaxis as a risk factor for

postoperative complications after breast cancer surgery. World J Surg. 2004;28:540-543.

11. The Joint Commission online topic library. Surgical Care Improvement Project. February 7,

2011. Available at:http://www.jointcommission.org/surgical_care_improvement_project/.

Accessed August 10, 2011.

12. Venture M, Davison S, Caprini J. Prevention of venous thromboembolism in the plastic

surgery patient: current guidelines and recommendations.Aesthet SurgJ. 2009;29:421431.

13. Pannucci CJ, Bailey SH, Dreszer G, et al. Validation of the Caprini risk assessment model in

plastic and reconstructive surgery patients.J Am Coll Surg. 2011;212:105-112.

14. Khorana AA. Risk assessment and prophylaxis for VTE in cancer patients.J Natl Compr

Canc Netw. 2011;9:789-797. PMID: 21715725.

15. Kim EK, Eom JS, Ahn HS, Son BH, Lee TK. The efficacy of prophylactic low-molecular-weight heparin to prevent pulmonary thromboembolism in immediate breast reconstruction using

the TRAM flap.Plast Reconstr Surg. 2009;123:9-12.

Approved September 29, 2011

Board of Directors

The American Society of Breast Surgeons

http://www.jointcommission.org/surgical_care_improvement_project/http://www.jointcommission.org/surgical_care_improvement_project/http://www.jointcommission.org/surgical_care_improvement_project/http://www.jointcommission.org/surgical_care_improvement_project/