Pamela R. Portschy

Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients.

Background: Venous thromboembolism is a major patient safety issue. The Plastic Surgery Foundation–sponsored Venous Thromboembolism Prevention Study examined whether postoperative enoxaparin prevents symptomatic venous thromboembolism in adult plastic surgery patients. Methods: In 2009, four sites uniformly adopted a clinical protocol. Patients with a Caprini score of 3 or higher received postoperative enoxaparin prophylaxis for the duration of inpatient stay. Venous Thromboembolism Prevention Study historical control patients had an operation between 2006 and 2008 but received no chemoprophylaxis for 60 days after surgery. The primary study outcome was symptomatic 60-day venous thromboembolism. Results: Three thousand three hundred thirty-four patients (1876 controls and 1458 enoxaparin patients) were included. Notable risk reduction was present in patients with a Caprini score greater than 8 (8.54 percent versus 4.07 percent; p = 0.182) and a Caprini score of 7 to 8 (2.55 percent versus 1.15 percent; p = 0.230) who received postoperative enoxaparin. Logistic regression was limited to highest risk patients (Caprini score ≥7) and demonstrated that length of stay greater than or equal to 4 days (adjusted odds ratio, 4.63; p = 0.007) and Caprini score greater than 8 (odds ratio, 2.71; p = 0.027) were independent predictors of venous thromboembolism. When controlling for length of stay and Caprini score, receipt of postoperative enoxaparin was protective against venous thromboembolism (odds ratio, 0.39; p = 0.042). Conclusions: In high-risk plastic surgery patients, postoperative enoxaparin prophylaxis is protective against 60-day venous thromboembolism when controlling for baseline risk and length of stay. Hospitalization for 4 or more days is an independent risk factor for venous thromboembolism. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Survival outcomes after contralateral prophylactic mastectomy: a decision analysis.

BACKGROUND Contralateral prophylactic mastectomy (CPM) rates have substantially increased in recent years and may reflect an exaggerated perceived benefit from the procedure. The objective of this study was to evaluate the magnitude of the survival benefit of CPM for women with unilateral breast cancer. METHODS We developed a Markov model to simulate survival outcomes after CPM and no CPM among women with stage I or II breast cancer without a BRCA mutation. Probabilities for developing contralateral breast cancer (CBC), dying from CBC, dying from primary breast cancer, and age-specific mortality rates were estimated from published studies. We estimated life expectancy (LE) gain, 20-year overall survival, and disease-free survival with each intervention strategy among cohorts of women defined by age, estrogen receptor (ER) status, and stage of cancer. RESULTS Predicted LE gain from CPM ranged from 0.13 to 0.59 years for women with stage I breast cancer and 0.08 to 0.29 years for those with stage II breast cancer. Absolute 20-year survival differences ranged from 0.56% to 0.94% for women with stage I breast cancer and 0.36% to 0.61% for women with stage II breast cancer. CPM was more beneficial among younger women, stage I, and ER-negative breast cancer. Sensitivity analyses yielded a maximum 20-year survival difference with CPM of only 1.45%. CONCLUSIONS The absolute 20-year survival benefit from CPM was less than 1% among all age, ER status, and cancer stage groups. Estimates of LE gains and survival differences derived from decision models may provide more realistic expectations of CPM.

Assessment of postoperative venous thromboembolism risk in plastic surgery patients using the 2005 and 2010 Caprini Risk score.

Background: Venous thromboembolism is an important patient safety issue. The authors sought to compare the predictive capacity of the 2005 and 2010 Caprini Risk Assessment Models for perioperative venous thromboembolism risk. Methods: The authors performed a retrospective, observational, crossover study using an established surgical outcomes database. A total of 3334 adult plastic surgery patients were identified. Patients were risk-stratified using both the 2005 and 2010 Caprini Risk Assessment Models. Each patient served as his or her own control, resulting in precise matching for identified and unidentified confounders. The outcome of interest was 60-day, symptomatic venous thromboembolism. The predictive capacities of the 2005 and 2010 Caprini risk scores were compared. Results: Use of the 2010 Caprini Risk Assessment Model resulted in a systematic increase in the aggregate risk score. The median 2010 Caprini score was significantly higher than the median 2005 Caprini score (6 versus 5, p < 0.001). When compared with the 2010 model, the 2005 Caprini Risk Assessment Model was able to better separate the lowest and highest risk patients from one another. Patients classified as “super-high” risk (Caprini score >8) using the 2005 Caprini Risk Assessment Model were significantly more likely to have a 60-day venous thromboembolism event when compared with patients classified as super-high risk using the 2010 guidelines (5.85 percent versus 2.52 percent, p = 0.021). Conclusions: When compared with the 2010 Caprini Risk Assessment Model, the 2005 Caprini Risk Assessment Model provides superior risk stratification. The 2005 Caprini Risk Assessment Model is the more appropriate method to risk-stratify plastic surgery patients for perioperative venous thromboembolism risk. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

The effect of postoperative enoxaparin on risk for reoperative hematoma.

Background: The risk of postoperative bleeding is the chief concern expressed by plastic surgeons who do not use pharmacologic prophylaxis against venous thromboembolism. The Plastic Surgery Foundation–funded Venous Thromboembolism Prevention Study examined whether receipt of postoperative enoxaparin prophylaxis changed 60-day reoperative hematoma rates. Methods: In 2009, the studys network sites uniformly adopted a “best practice” clinical protocol to provide postoperative enoxaparin to adult plastic surgery patients at risk for perioperative venous thromboembolism. Historical control patients (2006 to 2008) received no chemoprophylaxis for 60 days after surgery. Retrospective chart review identified demographic and surgery-specific risk factors that potentially contributed to bleeding risk. The primary study outcome was 60-day reoperative hematoma. Stratified analyses examined reoperative hematoma in the overall population and among high-risk patients. Multivariable logistic regression controlled for identified confounders. Results: Complete data were available for 3681 patients (2114 controls and 1567 enoxaparin patients). Overall, postoperative enoxaparin did not change the reoperative hematoma rate when compared with controls (3.38 percent versus 2.65 percent, p = 0.169). Similar results were seen in subgroup analyses for breast reconstruction (5.25 percent versus 4.21 percent, p = 0.737), breast reduction (7.04 percent versus 8.29 percent, p = 0.194), and nonbreast plastic surgery (2.20 percent versus 1.46 percent, p = 0.465). In the regression model, independent predictors of reoperative hematoma included breast surgery, microsurgical procedure, and post–bariatric surgery body contouring. Receipt of postoperative enoxaparin was not an independent predictor (odds ratio, 1.16; 95 percent CI, 0.77 to 1.76). Conclusion: Postoperative enoxaparin does not produce a clinically relevant or statistically significant increase in observed rates of reoperative hematoma. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk: II

Prospective multicenter trial evaluating balloon-catheter partial-breast irradiation for ductal carcinoma in situ.

PURPOSE To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. METHODS AND MATERIALS We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). RESULTS A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. CONCLUSIONS Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

Prophylactic mastectomy: Who needs it, when and why

Prophylactic mastectomy generally occurs in two different patient populations: (1) high‐risk women without breast cancer who undergo bilateral prophylactic mastectomy (BPM) to reduce their risk of developing breast cancer and (2) women with unilateral breast cancer who choose contralateral prophylactic mastectomy (CPM) to prevent cancer in the contralateral breast. The purpose of this article is to review the indications, outcomes, and trends in the use of BPM and CPM. J. Surg. Oncol. 2015 111:91–95.

Lymph node evaluation for treatment of adenocarcinoma of the pancreas

BACKGROUND Increased lymph node evaluation has been associated with improved survival rates in patients with pancreatic cancer. We sought to evaluate the trends and factors associated with lymph node examination over time and the effects on survival. METHODS Using the Surveillance, Epidemiology and End Results database, we conducted an analysis of adults with adenocarcinoma of the pancreas who underwent surgical resection. Using the Cochrane Armitage test for trend and logistic regression we identified factors associated with lymph node evaluation. Kaplan-Meier and Cox proportional hazards modeling were used to examine survival. RESULTS We identified 4831 patients who underwent surgical resection from 1990 to 2010. The proportion of patients with 15 or more lymph nodes evaluated increased from 16% to 42% (p < 0.05) and the median number of lymph nodes examined increased from 7 to 15 nodes (p < 0.05) during the study period. Overall, 56% of patients had lymph node metastases; this proportion significantly increased during the study period. Factors that were independently associated with less than 15 lymph nodes evaluated included male gender, receipt of pre-operative radiation therapy, early year of diagnosis, older age, and missing information on tumor grade and size (p < 0.05). Survival rates significantly improved when 15 or more lymph nodes were examined. CONCLUSION We observed a significant increase in the number of lymph nodes evaluated with pancreas cancer resection over time. Lymph node evaluation was significantly associated with patient, tumor, and treatment characteristics. Our results suggest that adequate lymph node evaluation is associated with improved survival.

Contralateral prophylactic mastectomy: are we overtreating patients?

Patients with unilateral breast cancer are at increased risk for developing cancer in the contralateral breast. As a result, some patients choose contralateral prophylactic mastectomy (CPM) to prevent cancer in the contralateral breast. Several studies have reported that the CPM rates have markedly increased in recent years in the United States. In this article, we will discuss recent CPM trends, potential reasons patients choose CPM, outcomes after CPM, and alternative strategies for managing the increased risk of contralateral breast cancer among survivors of unilateral breast cancer. In addition, we will try to determine if women undergoing CPM are adequately informed about their decision.

Rise of mastectomy.

After the NIH Consensus Statement was released in 1990, the rates of BCS markedly increased in the United States throughout the 1990s and 2000s. However, several single‐institutional studies have reported that mastectomy rates hadmarkedly increased with a corresponding decrease in BCS rates [1,2]. In a study of 5,865 patients treated at the Moffitt Cancer Center, McGuire et al. reported that the mastectomy rates increased from 35% in 2004 to 60% in 2007; young age (<40 years), larger tumor size, and lymphovascular invasion were independent predictors of mastectomy [1]. In another study of 5,405 patients treated at the Mayo Clinic, Katipamula et al. [2] reported that mastectomy rates increased from 31% in 2003 to 43% in 2006; young age (<50), TNM stage, lobular histology, breast density, concurrent or prior contralateral breast cancer, laterality, family history, and use of MRI were independent predictors of mastectomy. Habermann et al. [3] recently evaluated mastectomy/BCS trends in the United States using the Surveillance Epidemiology and End Results (SEER) database to determine if the findings from single‐institutional studies reflected national trends. A total of 233,754 patients with ductal carcinoma in situ or stage I–III breast cancer were identified in the SEER database from 2000 to 2006. The proportion of women treated with mastectomy significantly decreased from 41% in 2000 to 37% in 2006. Mastectomy rates decreased over time for patients with all tumor sizes, grades, and stages. In this study, patient age 40 years, stage I or II breast cancer, low‐grade tumors, estrogen‐receptor positive tumors, negative lymph nodes, and non‐lobular histology were associated with lower mastectomy rates. Significant geographic variation in mastectomy rates was observed (Louisiana, 51%; Connecticut, 27%). Interestingly, the mastectomy rates slightly increased from 2005 to 2006, perhaps indicating future trends in the United States. Variations in referral patterns and patient selection are potential explanations for the reported differences between single institutional and population‐based studies. Patients may select larger institutions to undergo more aggressive surgery (mastectomy). Likewise, physicians may be more likely to refer patients with a strong family history of breast cancer or a documented BRCA gene mutation to a large institution for unilateral or bilateral mastectomy. In addition, patients may seek large institutions to receive breast reconstructive surgery. Since significant geographic variations in mastectomy rates have been observed in the United States, the results from a large single‐institutional study may simply reflect practice patterns of that particular geographic region. Race and ethnicity may be associated with surgical treatment of breast cancer, patient demographic characteristics at a particular institution may impact reported mastectomy rates. Nevertheless, we cannot exclude the possibility that national trends trail the findings reported from single institutional studies, and that mastectomy rates in the United States may increase in the future.

Contralateral Prophylactic Mastectomy: Perceptions Versus Reality

In this issue, Rosenberg and colleagues evaluated preferences, knowledge, decision making, and experiences of young women with breast cancer who chose contralateral prophylactic mastectomy and foun...