The American Journal of Surgery (2015) -, -–-
National trends and complication rates after bilateral mastectomy and immediate breast reconstruction from 2005 to 2012 Alvin C. Kwok, M.D., M.P.H.a, Isak A. Goodwin, M.D.a, Jian Ying, M.S., Ph.D.b, Jayant P. Agarwal, M.D., F.A.C.S.a,* a
Division of Plastic Surgery, Department of Surgery, University of Utah, School of Medicine, 30 N 1900 E, 3B400, Salt Lake City, UT 84132, USA; bDivision of Epidemiology, Department of Family and Preventative Medicine, University of Utah, School of Medicine, 295 Chipeta Way, Salt Lake City, UT 84108, USA
KEYWORDS: Breast cancer; Bilateral mastectomy; Immediate breast reconstruction
Abstract BACKGROUND: This study’s purpose was to examine the national rate of breast cancer patients undergoing bilateral mastectomy (BM) and immediate breast reconstruction (IBR) and their associated complication rates. METHODS: Using the National Surgical Quality Improvement Program database, breast cancer patients undergoing mastectomy between 2005 and 2012 were identified. Rates in BM and IBR as well as associated complication rates were evaluated. Logistic regression was used to identify predictors of BM, IBR, and complications. RESULTS: A total of 56,905 breast cancer patients underwent mastectomy. The rate of BM tripled (9.14% vs 25.44%, P , .0001) and the rate of IBR increased by 50% (29.73% vs 44.68%, P , .0001). Complication rates were higher in patients undergoing BM compared with unilateral mastectomy (11.49% vs 9.52%, P , .0001) and in patients undergoing IBR compared with mastectomy alone (11.62% vs 8.91%, P , .0001). White race and age less than 40 years were predictors of patients undergoing BM and IBR. CONCLUSIONS: The rates of BM and associated IBR have increased significantly since 2005 despite higher complication rates. Further research is needed to understand the reasons for these trends. Published by Elsevier Inc.
NSQIP Disclosure: The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors. There are no conflicts of interest. Presented at the 2014 Surgical Forum at the American College of Surgeons Clinical Congress. * Corresponding author. Tel.: 11-801-581-7719; fax: 11-801-581-5794. E-mail address: [email protected] Manuscript received October 28, 2014; revised manuscript March 18, 2015
0002-9610/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjsurg.2015.03.019
Operations performed for the surgical treatment of breast cancer have become increasingly less invasive. At the end of the 19th century, William Halsted advocated for the radical mastectomy as the standard of treatment for women with all stages of breast cancer. In 1948, Patey and Dyson published their modified radical mastectomy technique for the treatment of breast cancer in which the pectoralis major was preserved.1–3 Fifty years later, Fisher et al4 demonstrated that rates of survival were equivalent between women with early-stage breast cancer who
The American Journal of Surgery, Vol -, No -, - 2015
2 Table 1 Demographics of study cohort in the ACS NSQIP database from 2005 to 2012 Demographics N (breast cancer patients undergoing mastectomy) Age (years) Bilateral mastectomies Immediate breast reconstruction Implant reconstruction White race
56,905 58.4 6 13.7 12,249 (21.5%) 21,795 (38.3%) 18,324 (84.1%) 41,681 (73.3%)
Data are expressed as mean 6 standard deviation or number (percentage). ACS NSQIP 5 American College of Surgeons National Surgical Quality Improvement Program.
underwent lumpectomy with radiation therapy compared with those who underwent mastectomy. Recent data suggest that patients undergoing breast conservation therapy have a higher breast cancer-specific survival rate compared with those with mastectomy for early-stage invasive ductal carcinoma.5 Advances in diagnostic technologies and therapeutic modalities, as well as a better understanding of molecular mechanisms have allowed for earlier, more precise, and more targeted treatment of breast cancer. Despite evidence establishing equivalent survival outcomes between breast conservation therapy and mastectomy, the rates of bilateral mastectomy (BM) appear to be increasing.6,7 We used the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database to examine the national trends and predictors of patients undergoing BM and immediate breast reconstruction (IBR), as well as their associated complication rates.
Methods Patient selection The history and methods of the ACS NSQIP including data collection, sampling, monitoring, and validation have
Table 2 2005 2006 2007 2008 2009 2010 2011 2012 Overall
been previously described in detail.8–11 In brief, this national program is a prospectively collected, peercontrolled, validated database that collects 295 variables including preoperative risk factors, intraoperative variables, and 30-day postoperative mortality and morbidity outcomes for patients undergoing both inpatient and outpatient surgical procedures. The patient cohort comprised breast cancer patients who underwent a mastectomy between January 2005 and December 2012. Breast cancer patients were identified using the following International Classification of Diseases, Ninth revision codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 217.0, and 233.0. Mastectomies were defined using the following Current Procedural Terminology codes: 19303, 19304, 19305, 19306, 19307, 19180, 19182, 19200, 19220, and 19240. Breast reconstruction cases, including implant and autologous tissue reconstruction techniques, were defined by the following Current Procedural Terminology codes: 19364, 19340, 19357, 19361, 19367, 19368, 19369, and 19366. An exemption was obtained from our local institutional review board.
Predictors An a priori set of 15 variables was identified as possible preoperative predictors of BM, IBR, and postoperative complications. Among this set of predictors were demographic variables including age less than 40 years, race (white and non-white), smoking status, and drinking status. Cancer-related perioperative characteristics/therapies were included in the analysis including preoperative weight loss (.10% loss of body weight during the 6 months before surgery), regular administration of steroids and/or immunosuppressant medications within 30 days of the principal procedure, chemotherapy and/or radiation therapy within 30 days of surgery, and history of metastatic cancer. The following comorbidities were also included in the regression model: American Society of Anesthesiologists’ classification, body mass index (BMI) greater than or equal to 30, history of
Temporal trends in the incidence of unilateral mastectomy and bilateral mastectomy Unilateral mastectomy, n (%)
Bilateral mastectomy, n (%)
OR (95% CI), P value
865 2,655 4,883 6,233 7,264 7,183 7,252 8,321 44,656
87 491 1,111 1,496 2,106 2,120 1,999 2,839 12,249
1.08 (1.07–1.10), P , .001
(90.86%) (84.39%) (81.46%) (80.64%) (77.52%) (77.21%) (78.39%) (74.56%) (78.47%)
CI 5 confidence interval; OR 5 odds ratio.
(9.14%) (15.61%) (18.54%) (19.36%) (22.48%) (22.79%) (21.61%) (25.44%) (21.53%)
Trends after bilateral mastectomy
3
1.10 (1.08–1.13), P , .0001
diabetes, chronic obstructive pulmonary disease (COPD), elevated creatinine greater than 1.5 mg/dL, and hypoalbuminemia (albumin , 2.5 g/dL).
Outcomes The yearly incidence of unilateral mastectomy (UM) and BM was identified. Morbidity was defined as the following complications within 30 days of the index procedure: death, surgical site infection, wound disruption, pneumonia, reintubation, pulmonary embolism, ventilator dependence greater than 48 hours, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, coma greater than 24 hours, peripheral nerve damage, cardiac arrest, myocardial infarction, transfusion, flap failure, deep vein thrombosis, sepsis, and reoperation. BM 5 bilateral mastectomy; CI 5 confidence interval; IBR 5 immediate breast reconstruction; OR 5 odds ratio; UM 5 unilateral mastectomy.
(49.43%) (51.12%) (56.80%) (56.82%) (60.59%) (63.16%) (64.98%) (66.64%) (61.89%) 43 251 631 850 1,276 1,339 1,299 1,892 7,581 1.10 (1.09–1.11), P , .0001 (27.75%) (27.57%) (26.05%) (28.56%) (29.16%) (32.03%) (36.91%) (37.18%) (31.83%) 240 732 1,272 1,780 2,118 2,301 2,677 3,094 14,214 1.10 (1.09–1.11), P , .0001 (29.73%) (31.25%) (31.75%) (34.03%) (36.22%) (39.13%) (42.98%) (44.68%) (38.30%)
IBR following UM, n (%) OR (95% CI), P value Total IBR, n (%)
283 983 1,903 2,630 3,394 3,640 3,976 4,986 21,795 2005 2006 2007 2008 2009 2010 2011 2012 Overall
Table 3
Temporal trends in the incidence of IBR following UM and BM
OR (95% CI), P value
IBR following BM, n (%)
OR (95% CI), P value
A.C. Kwok et al.
Statistical analysis Logistic regression was performed to assess the temporal trends in the rates of BM and IBR following both UM and BM. Chi-square tests were performed to test the association between choosing BM and IBR. Multivariate logistic regression models were fitted to relate the probability of BM, IBR, and overall complications with a list of preoperative comorbidities. Forward selection was used to identify the significant predictors. SAS 9.4 (SAS, Inc, Cary, NC) was used for all statistical analyses.
Results From 2005 to 2012, we identified 56,905 breast cancer patients who underwent mastectomy. The data comprise cases from 374 sites throughout the United States. During this period, the overall rate of BM was 21.5% and the overall rate of IBR was 38.3%. Of those who underwent IBR, 84.1% underwent implant reconstruction (Table 1). The rate of BM rose from 9.14% in 2005 to 25.44% in 2012 (P , .001) (Table 2). Of those who had a mastectomy, 29.73% underwent IBR in 2005 compared with 44.68% in 2012 (Table 3). Patients who underwent BM were twice as likely to undergo IBR compared with those who underwent UM (61.89% vs 31.83%, P , .0001; Table 3). From 2005 to 2012, the rate of IBR following BM increased by 17.2%, while the rate of IBR following UM increased by 9.4%. Overall complication rates were higher in patients undergoing BM compared with UM (11.49% vs 9.52%, P , .0001) and in patients undergoing IBR compared with mastectomy alone (11.62% vs 8.91%, P , .0001) (Table 4). Patients less than 40 years of age had the lowest likely of having complications (odds ratio [OR] .82, 95% confidence interval [CI] .70 to .96). American Society of Anesthesiologists class greater than 2, obesity (BMI R 30), history of diabetes, smoking, COPD, metastatic cancer, greater than 10% body weight loss during the 6 months before surgery, elevated creatinine (creatinine . 1.5 mg/dL), and
The American Journal of Surgery, Vol -, No -, - 2015
4
Table 4 Comparison of complication rates between unilateral versus bilateral mastectomy and immediate breast reconstruction versus mastectomy only
Complications (5,661) Complications (5,661)
Unilateral mastectomy (44,656)
Bilateral mastectomy (12,249)
P value
4,253 (9.52%)
1,408 (11.49%)
,.0001
Mastectomy without immediate breast reconstruction (35,110)
Immediate breast reconstruction (21,795)
P value
3,129 (8.91%)
2,532 (11.62%)
,.0001
hypoalbuminemia (hypoalbuminemia , 2.5 g/dL) were predictive of an increased rate of postoperative complications (Table 5). White race and age less than 40 years were predictors of patients undergoing BM (OR 1.52, 95% CI 1.42 to 1.62 and OR 2.21, 95% CI 2.03 to 2.41, respectively) and IBR (OR 1.34, 95% CI 1.27 to 1.42 and OR 2.29, 95% CI 2.10 to 2.49, respectively). Patients with comorbidities including a history of metastatic cancer, diabetes, COPD, elevated creatinine, and hypoalbuminemia were less likely to undergo BM and less likely to have IBR. While obese patients (BMI R 30) and patients who had had chemotherapy within 30 days of surgery are more likely to undergo BM (OR 1.07, 95% CI 1.01 to 1.14 and OR 1.24, 95% CI 1.12 to 1.37, respectively), and these same patients were less likely to undergo IBR (OR .78, 95% CI .74 to .82 and OR .52, 95% CI .47 to .57, respectively] (Table 5). A lower proportion of black patients underwent BM and IBR (14.58% and 28.90%, respectively) compared with white patients (23.29% and 40.58%, respectively). Table 5
Comments The rising rate of bilateral mastectomies suggests that despite evidence supporting the effectiveness of breast conservation therapy, patients are having increasingly aggressive surgical management of their breast cancer. In a similar trend, the rate of IBR is also increasing especially for those who are undergoing bilateral mastectomies. Our data suggest that white race, younger patients, and patients with fewer comorbidities were more likely to undergo BM and IBR. With more invasive surgery comes increased risk for complications. Our data demonstrate higher rates of complications with BM compared with UM, and IBR compared with mastectomy alone. Using the ACS NSQIP database, Fischer et al demonstrate similar findings. They recently examined the complication rates associated with mastectomy alone and immediate tissue expander reconstruction using the ACS NSQIP dataset from 2005 to 2011. While they concluded that there were no statistically significant differences in overall complication rates,
Predictors of bilateral mastectomy, immediate breast reconstruction, and complications
Age , 40 years ASA class . 2 White Obesity (BMI R 30) History of diabetes History of smoking History of COPD Disseminated cancer Immunosuppressants used within 30 days of surgery .10% body weight loss during the 6 months before surgery Chemotherapy within 30 days of surgery Radiotherapy within 30 days of surgery Elevated creatinine (creatinine . 1.5 mg/dL) Hypoalbuminemia (albumin, 2.5 g/dL)
Predictors of BM
Predictors of IBR
Predictors of complications
OR
CI
OR
CI
OR
CI
2.21 .85 1.52 1.07 .63 N/A .50 .62 N/A
2.03–2.41 .80–.90 1.42–1.62 1.01–1.14 .57–.70 N/A .40–.63 .50–.77 N/A
2.29 .58 1.34 .78 .46 .86 .32 .44 .71
2.10–2.49 .55–.61 1.27–1.42 .74–.82 .42–.50 .80–.92 .26–.40 .36–.54 .58–.87
.82 1.18 N/A 1.48 1.15 1.38 1.26 1.41 N/A
.70–.96 1.09–1.28 N/A 1.37–1.60 1.03–1.29 1.25–1.52 1.02–1.54 1.14–1.75 N/A
N/A
N/A
.51
.32–.82
1.93
1.38–2.71
1.24 .55 .46 .58
1.12–1.37 .34–.88 .34–.61 .34–1.00
.52 N/A .31 .51
.47–.57 N/A .24–.41 .32 –.82
N/A N/A 1.42 2.73
N/A N/A 1.13–1.79 1.84–4.04
ASA 5 American Society of Anesthesiologists; BMI 5 body mass index; CI 5 confidence interval; COPD 5 chronic obstructive pulmonary disease; N/A 5 not applicable; OR 5 odds ratio.
A.C. Kwok et al.
Trends after bilateral mastectomy
immediate tissue expander reconstruction conferred statistically significant increases in the risk of specific complications such as the development of a deep wound infection, the rate of unplanned reoperation, and the rates of venous thromboembolic events.12 The trend toward more aggressive treatment of breast cancer that we have seen nationwide suggests that there is much more involved in a patient’s surgical decision making than just the medical risks and benefits. The NSQIP database supports what has been seen from other institutional and national database studies. Using the Surveillance, Epidemiology, and End Results (SEER) database, Mahmood et al13 found that the proportion of women treated with mastectomy decreased from 40.1% in 2000 to 35.6% in 2005 (P , .0001) but that there was a subsequent increase in the rate to 38.4% in 2008 (P ,.0001). In 2009, Tuttle et al14 used SEER data from 1998 to 2005 to show that the rate of contralateral prophylactic mastectomy increased by 148% from 1998 to 2005. Younger patients may have an increasing incidence of BM and IBR because they are generally healthier and thus more able to tolerate a larger surgery. These same women may feel that by having both breasts removed, it may decrease the likelihood of developing recurrent or contralateral cancer. Han et al recently published survey data which suggest that a fear of another breast cancer was the most important reason for choosing a contralateral prophylactic mastectomy (81% of those surveyed). In addition, 36% stated that available reconstructive options influenced their decision to undergo BM. The increasing availability of breast reconstruction, improved breast symmetry, and recent celebrity publicity may be contributors to the increasing rates of IBR. In their survey, Han et al15 also demonstrated that nearly all patients who underwent BM (98%) felt good about their decision. The racial disparities in the rate of breast reconstruction have also been demonstrated elsewhere. Using the SEER database, Agarwal et al16 reported a significantly lower likelihood of breast reconstruction between African Americans and Caucasian patients (OR .6 vs 1.00, P , .001). It would be helpful for surgeons and policy makers to better understand the cultural and socioeconomic reasons for these disparities. There are several important limitations of this study that must be addressed. While the ACS NSQIP captures a large sampling of the United States, it does not provide any cancer stage or socioeconomic data for each patient. The data also does not allow us to determine whether the mastectomy was in fact prophylactic or whether each breast had cancer. As the reported rate of synchronous breast cancer is less than 1%, we made the assumption that nearly all the bilateral mastectomies performed had one side that was prophylactic.17–19
Conclusions Despite the higher risks for complications associated with BM and IBR and despite the availability of breast
5 conservation therapy, rates of BM and associated IBR have been rising since 2005. Younger white patients are most likely to choose the most aggressive surgical management of their breast cancer and subsequent reconstruction.
References 1. Sakorafas GH, Safioleas M. Breast cancer surgery: an historical narrative. Part I. From prehistoric times to Renaissance. Eur J Cancer Care (Engl) 2009;18:530–44. 2. Sakorafas GH, Safioleas M. Breast cancer surgery: an historical narrative. Part II. 18th and 19th centuries. Eur J Cancer Care (Engl) 2009; 19:6–29. 3. Sakorafas GH, Safioleas M. Breast cancer surgery: an historical narrative. Part III. From the sunset of the 19th to the dawn of the 21st century. Eur J Cancer Care (Engl) 2009;19:145–66. 4. Fisher B, Bauer M, Margolese R, et al. Five-year results of randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med 1985;312:665–73. 5. Agarwal S, Pappas J, Neumayer L, et al. Effect of breast conservation therapy vs mastectomy on disease-specific survival for early-stage breast cancer. JAMA Surg 2014;149:267–74. 6. Yao K, Stewart AK, Winchester DJ, et al. Trends in contralateral prophylactic mastectomy for unilateral cancer: a report from the National Cancer Data Base, 1998-2007. Ann Surg Oncol 2010;17:2554–62. 7. Neuburger J, Macneill F, Jeevan R, et al. Trends in the use of bilateral mastectomy in England from 2002 to 2011: retrospective analysis of hospital episode statistics. BMJ Open 2013;3. 8. Khuri SF, Henderson WG, Daley J, et al. Successful implementation of the Department of Veterans Affairs’ National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study. Ann Surg 2008;248:329–36. 9. ACS NSQIP. About ACS NSQIP. Available at: http://site.acsnsqip.org/ about. Accessed April 17, 2014. 10. ACS NSQIP. Data Collection, Analysis, and Reporting. Available at: http://site.acsnsqip.org/program-specifics/data-collection-analysisand-reporting. Accessed April 17, 2014. 11. ACS NSQIP. User Guide for the 2012 ACS NSQIP Participant Use Data File. Available at: http://site.acsnsqip.org/wp-content/uploads/2013/10/ ACSNSQIP.PUF_.UserGuide.2012.pdf. Accessed April 17, 2014. 12. Fischer JP, Wes AM, Tuggle CT, et al. Mastectomy with or without immediate implant reconstruction has similar 30-day perioperative outcomes. J Plast Reconstr Aesthet Surg 2014;67:1515–22. 13. Mahmood U, Hanlon AL, Koshy M, et al. Increasing national mastectomy rates for the treatment of early stage breast cancer. Ann Surg Oncol 2013;20:1436–43. 14. Tuttle TM, Jarosek S, Habermann EB, et al. Increasing rates of contralateral prophylactic mastectomy among patients with ductal carcinoma in situ. J Clin Oncol 2009;27:1362–7. 15. Han E, Johnson N, Glissmeyer M, et al. Increasing incidence of bilateral mastectomies: the patient perspective. Am J Surg 2011;201:615–8. 16. Agarwal S, Pappas L, Neumayer L, et al. An analysis of immediate postmastectomy breast reconstruction frequency using the Surveillance, Epidemiology, and End Results database. Breast 2011;17:352–8. 17. Diaz R, Munarriz B, Santaballa A, et al. Synchronous and metachronous bilateral breast cancer: a long-term single-institution experience. Med Oncol 2012;29:16–24. 18. Kruper L, Holt A, Xu XX, et al. Disparities in reconstruction rates after mastectomy: patterns of care and factors associated with the use of breast reconstruction in Southern California. Ann Surg Oncol 2011;18: 2158–65. 19. Yang RL, Newman AS, Reinke CE, et al. Racial disparities in immediate breast reconstruction after mastectomy: impact of state and federal health policy changes. Ann Surg Oncol 2013;20:399–406.
National trends and complication rates after bilateral mastectomy and immediate breast reconstruction from 2005 to 2012 Alvin C. Kwok, M.D., M.P.H.a, Isak A. Goodwin, M.D.a, Jian Ying, M.S., Ph.D.b, Jayant P. Agarwal, M.D., F.A.C.S.a,* a
Division of Plastic Surgery, Department of Surgery, University of Utah, School of Medicine, 30 N 1900 E, 3B400, Salt Lake City, UT 84132, USA; bDivision of Epidemiology, Department of Family and Preventative Medicine, University of Utah, School of Medicine, 295 Chipeta Way, Salt Lake City, UT 84108, USA
KEYWORDS: Breast cancer; Bilateral mastectomy; Immediate breast reconstruction
Abstract BACKGROUND: This study’s purpose was to examine the national rate of breast cancer patients undergoing bilateral mastectomy (BM) and immediate breast reconstruction (IBR) and their associated complication rates. METHODS: Using the National Surgical Quality Improvement Program database, breast cancer patients undergoing mastectomy between 2005 and 2012 were identified. Rates in BM and IBR as well as associated complication rates were evaluated. Logistic regression was used to identify predictors of BM, IBR, and complications. RESULTS: A total of 56,905 breast cancer patients underwent mastectomy. The rate of BM tripled (9.14% vs 25.44%, P , .0001) and the rate of IBR increased by 50% (29.73% vs 44.68%, P , .0001). Complication rates were higher in patients undergoing BM compared with unilateral mastectomy (11.49% vs 9.52%, P , .0001) and in patients undergoing IBR compared with mastectomy alone (11.62% vs 8.91%, P , .0001). White race and age less than 40 years were predictors of patients undergoing BM and IBR. CONCLUSIONS: The rates of BM and associated IBR have increased significantly since 2005 despite higher complication rates. Further research is needed to understand the reasons for these trends. Published by Elsevier Inc.
NSQIP Disclosure: The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors. There are no conflicts of interest. Presented at the 2014 Surgical Forum at the American College of Surgeons Clinical Congress. * Corresponding author. Tel.: 11-801-581-7719; fax: 11-801-581-5794. E-mail address: [email protected] Manuscript received October 28, 2014; revised manuscript March 18, 2015
0002-9610/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.amjsurg.2015.03.019
Operations performed for the surgical treatment of breast cancer have become increasingly less invasive. At the end of the 19th century, William Halsted advocated for the radical mastectomy as the standard of treatment for women with all stages of breast cancer. In 1948, Patey and Dyson published their modified radical mastectomy technique for the treatment of breast cancer in which the pectoralis major was preserved.1–3 Fifty years later, Fisher et al4 demonstrated that rates of survival were equivalent between women with early-stage breast cancer who
The American Journal of Surgery, Vol -, No -, - 2015
2 Table 1 Demographics of study cohort in the ACS NSQIP database from 2005 to 2012 Demographics N (breast cancer patients undergoing mastectomy) Age (years) Bilateral mastectomies Immediate breast reconstruction Implant reconstruction White race
56,905 58.4 6 13.7 12,249 (21.5%) 21,795 (38.3%) 18,324 (84.1%) 41,681 (73.3%)
Data are expressed as mean 6 standard deviation or number (percentage). ACS NSQIP 5 American College of Surgeons National Surgical Quality Improvement Program.
underwent lumpectomy with radiation therapy compared with those who underwent mastectomy. Recent data suggest that patients undergoing breast conservation therapy have a higher breast cancer-specific survival rate compared with those with mastectomy for early-stage invasive ductal carcinoma.5 Advances in diagnostic technologies and therapeutic modalities, as well as a better understanding of molecular mechanisms have allowed for earlier, more precise, and more targeted treatment of breast cancer. Despite evidence establishing equivalent survival outcomes between breast conservation therapy and mastectomy, the rates of bilateral mastectomy (BM) appear to be increasing.6,7 We used the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database to examine the national trends and predictors of patients undergoing BM and immediate breast reconstruction (IBR), as well as their associated complication rates.
Methods Patient selection The history and methods of the ACS NSQIP including data collection, sampling, monitoring, and validation have
Table 2 2005 2006 2007 2008 2009 2010 2011 2012 Overall
been previously described in detail.8–11 In brief, this national program is a prospectively collected, peercontrolled, validated database that collects 295 variables including preoperative risk factors, intraoperative variables, and 30-day postoperative mortality and morbidity outcomes for patients undergoing both inpatient and outpatient surgical procedures. The patient cohort comprised breast cancer patients who underwent a mastectomy between January 2005 and December 2012. Breast cancer patients were identified using the following International Classification of Diseases, Ninth revision codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 217.0, and 233.0. Mastectomies were defined using the following Current Procedural Terminology codes: 19303, 19304, 19305, 19306, 19307, 19180, 19182, 19200, 19220, and 19240. Breast reconstruction cases, including implant and autologous tissue reconstruction techniques, were defined by the following Current Procedural Terminology codes: 19364, 19340, 19357, 19361, 19367, 19368, 19369, and 19366. An exemption was obtained from our local institutional review board.
Predictors An a priori set of 15 variables was identified as possible preoperative predictors of BM, IBR, and postoperative complications. Among this set of predictors were demographic variables including age less than 40 years, race (white and non-white), smoking status, and drinking status. Cancer-related perioperative characteristics/therapies were included in the analysis including preoperative weight loss (.10% loss of body weight during the 6 months before surgery), regular administration of steroids and/or immunosuppressant medications within 30 days of the principal procedure, chemotherapy and/or radiation therapy within 30 days of surgery, and history of metastatic cancer. The following comorbidities were also included in the regression model: American Society of Anesthesiologists’ classification, body mass index (BMI) greater than or equal to 30, history of
Temporal trends in the incidence of unilateral mastectomy and bilateral mastectomy Unilateral mastectomy, n (%)
Bilateral mastectomy, n (%)
OR (95% CI), P value
865 2,655 4,883 6,233 7,264 7,183 7,252 8,321 44,656
87 491 1,111 1,496 2,106 2,120 1,999 2,839 12,249
1.08 (1.07–1.10), P , .001
(90.86%) (84.39%) (81.46%) (80.64%) (77.52%) (77.21%) (78.39%) (74.56%) (78.47%)
CI 5 confidence interval; OR 5 odds ratio.
(9.14%) (15.61%) (18.54%) (19.36%) (22.48%) (22.79%) (21.61%) (25.44%) (21.53%)
Trends after bilateral mastectomy
3
1.10 (1.08–1.13), P , .0001
diabetes, chronic obstructive pulmonary disease (COPD), elevated creatinine greater than 1.5 mg/dL, and hypoalbuminemia (albumin , 2.5 g/dL).
Outcomes The yearly incidence of unilateral mastectomy (UM) and BM was identified. Morbidity was defined as the following complications within 30 days of the index procedure: death, surgical site infection, wound disruption, pneumonia, reintubation, pulmonary embolism, ventilator dependence greater than 48 hours, progressive renal insufficiency, acute renal failure, urinary tract infection, stroke, coma greater than 24 hours, peripheral nerve damage, cardiac arrest, myocardial infarction, transfusion, flap failure, deep vein thrombosis, sepsis, and reoperation. BM 5 bilateral mastectomy; CI 5 confidence interval; IBR 5 immediate breast reconstruction; OR 5 odds ratio; UM 5 unilateral mastectomy.
(49.43%) (51.12%) (56.80%) (56.82%) (60.59%) (63.16%) (64.98%) (66.64%) (61.89%) 43 251 631 850 1,276 1,339 1,299 1,892 7,581 1.10 (1.09–1.11), P , .0001 (27.75%) (27.57%) (26.05%) (28.56%) (29.16%) (32.03%) (36.91%) (37.18%) (31.83%) 240 732 1,272 1,780 2,118 2,301 2,677 3,094 14,214 1.10 (1.09–1.11), P , .0001 (29.73%) (31.25%) (31.75%) (34.03%) (36.22%) (39.13%) (42.98%) (44.68%) (38.30%)
IBR following UM, n (%) OR (95% CI), P value Total IBR, n (%)
283 983 1,903 2,630 3,394 3,640 3,976 4,986 21,795 2005 2006 2007 2008 2009 2010 2011 2012 Overall
Table 3
Temporal trends in the incidence of IBR following UM and BM
OR (95% CI), P value
IBR following BM, n (%)
OR (95% CI), P value
A.C. Kwok et al.
Statistical analysis Logistic regression was performed to assess the temporal trends in the rates of BM and IBR following both UM and BM. Chi-square tests were performed to test the association between choosing BM and IBR. Multivariate logistic regression models were fitted to relate the probability of BM, IBR, and overall complications with a list of preoperative comorbidities. Forward selection was used to identify the significant predictors. SAS 9.4 (SAS, Inc, Cary, NC) was used for all statistical analyses.
Results From 2005 to 2012, we identified 56,905 breast cancer patients who underwent mastectomy. The data comprise cases from 374 sites throughout the United States. During this period, the overall rate of BM was 21.5% and the overall rate of IBR was 38.3%. Of those who underwent IBR, 84.1% underwent implant reconstruction (Table 1). The rate of BM rose from 9.14% in 2005 to 25.44% in 2012 (P , .001) (Table 2). Of those who had a mastectomy, 29.73% underwent IBR in 2005 compared with 44.68% in 2012 (Table 3). Patients who underwent BM were twice as likely to undergo IBR compared with those who underwent UM (61.89% vs 31.83%, P , .0001; Table 3). From 2005 to 2012, the rate of IBR following BM increased by 17.2%, while the rate of IBR following UM increased by 9.4%. Overall complication rates were higher in patients undergoing BM compared with UM (11.49% vs 9.52%, P , .0001) and in patients undergoing IBR compared with mastectomy alone (11.62% vs 8.91%, P , .0001) (Table 4). Patients less than 40 years of age had the lowest likely of having complications (odds ratio [OR] .82, 95% confidence interval [CI] .70 to .96). American Society of Anesthesiologists class greater than 2, obesity (BMI R 30), history of diabetes, smoking, COPD, metastatic cancer, greater than 10% body weight loss during the 6 months before surgery, elevated creatinine (creatinine . 1.5 mg/dL), and
The American Journal of Surgery, Vol -, No -, - 2015
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Table 4 Comparison of complication rates between unilateral versus bilateral mastectomy and immediate breast reconstruction versus mastectomy only
Complications (5,661) Complications (5,661)
Unilateral mastectomy (44,656)
Bilateral mastectomy (12,249)
P value
4,253 (9.52%)
1,408 (11.49%)
,.0001
Mastectomy without immediate breast reconstruction (35,110)
Immediate breast reconstruction (21,795)
P value
3,129 (8.91%)
2,532 (11.62%)
,.0001
hypoalbuminemia (hypoalbuminemia , 2.5 g/dL) were predictive of an increased rate of postoperative complications (Table 5). White race and age less than 40 years were predictors of patients undergoing BM (OR 1.52, 95% CI 1.42 to 1.62 and OR 2.21, 95% CI 2.03 to 2.41, respectively) and IBR (OR 1.34, 95% CI 1.27 to 1.42 and OR 2.29, 95% CI 2.10 to 2.49, respectively). Patients with comorbidities including a history of metastatic cancer, diabetes, COPD, elevated creatinine, and hypoalbuminemia were less likely to undergo BM and less likely to have IBR. While obese patients (BMI R 30) and patients who had had chemotherapy within 30 days of surgery are more likely to undergo BM (OR 1.07, 95% CI 1.01 to 1.14 and OR 1.24, 95% CI 1.12 to 1.37, respectively), and these same patients were less likely to undergo IBR (OR .78, 95% CI .74 to .82 and OR .52, 95% CI .47 to .57, respectively] (Table 5). A lower proportion of black patients underwent BM and IBR (14.58% and 28.90%, respectively) compared with white patients (23.29% and 40.58%, respectively). Table 5
Comments The rising rate of bilateral mastectomies suggests that despite evidence supporting the effectiveness of breast conservation therapy, patients are having increasingly aggressive surgical management of their breast cancer. In a similar trend, the rate of IBR is also increasing especially for those who are undergoing bilateral mastectomies. Our data suggest that white race, younger patients, and patients with fewer comorbidities were more likely to undergo BM and IBR. With more invasive surgery comes increased risk for complications. Our data demonstrate higher rates of complications with BM compared with UM, and IBR compared with mastectomy alone. Using the ACS NSQIP database, Fischer et al demonstrate similar findings. They recently examined the complication rates associated with mastectomy alone and immediate tissue expander reconstruction using the ACS NSQIP dataset from 2005 to 2011. While they concluded that there were no statistically significant differences in overall complication rates,
Predictors of bilateral mastectomy, immediate breast reconstruction, and complications
Age , 40 years ASA class . 2 White Obesity (BMI R 30) History of diabetes History of smoking History of COPD Disseminated cancer Immunosuppressants used within 30 days of surgery .10% body weight loss during the 6 months before surgery Chemotherapy within 30 days of surgery Radiotherapy within 30 days of surgery Elevated creatinine (creatinine . 1.5 mg/dL) Hypoalbuminemia (albumin, 2.5 g/dL)
Predictors of BM
Predictors of IBR
Predictors of complications
OR
CI
OR
CI
OR
CI
2.21 .85 1.52 1.07 .63 N/A .50 .62 N/A
2.03–2.41 .80–.90 1.42–1.62 1.01–1.14 .57–.70 N/A .40–.63 .50–.77 N/A
2.29 .58 1.34 .78 .46 .86 .32 .44 .71
2.10–2.49 .55–.61 1.27–1.42 .74–.82 .42–.50 .80–.92 .26–.40 .36–.54 .58–.87
.82 1.18 N/A 1.48 1.15 1.38 1.26 1.41 N/A
.70–.96 1.09–1.28 N/A 1.37–1.60 1.03–1.29 1.25–1.52 1.02–1.54 1.14–1.75 N/A
N/A
N/A
.51
.32–.82
1.93
1.38–2.71
1.24 .55 .46 .58
1.12–1.37 .34–.88 .34–.61 .34–1.00
.52 N/A .31 .51
.47–.57 N/A .24–.41 .32 –.82
N/A N/A 1.42 2.73
N/A N/A 1.13–1.79 1.84–4.04
ASA 5 American Society of Anesthesiologists; BMI 5 body mass index; CI 5 confidence interval; COPD 5 chronic obstructive pulmonary disease; N/A 5 not applicable; OR 5 odds ratio.
A.C. Kwok et al.
Trends after bilateral mastectomy
immediate tissue expander reconstruction conferred statistically significant increases in the risk of specific complications such as the development of a deep wound infection, the rate of unplanned reoperation, and the rates of venous thromboembolic events.12 The trend toward more aggressive treatment of breast cancer that we have seen nationwide suggests that there is much more involved in a patient’s surgical decision making than just the medical risks and benefits. The NSQIP database supports what has been seen from other institutional and national database studies. Using the Surveillance, Epidemiology, and End Results (SEER) database, Mahmood et al13 found that the proportion of women treated with mastectomy decreased from 40.1% in 2000 to 35.6% in 2005 (P , .0001) but that there was a subsequent increase in the rate to 38.4% in 2008 (P ,.0001). In 2009, Tuttle et al14 used SEER data from 1998 to 2005 to show that the rate of contralateral prophylactic mastectomy increased by 148% from 1998 to 2005. Younger patients may have an increasing incidence of BM and IBR because they are generally healthier and thus more able to tolerate a larger surgery. These same women may feel that by having both breasts removed, it may decrease the likelihood of developing recurrent or contralateral cancer. Han et al recently published survey data which suggest that a fear of another breast cancer was the most important reason for choosing a contralateral prophylactic mastectomy (81% of those surveyed). In addition, 36% stated that available reconstructive options influenced their decision to undergo BM. The increasing availability of breast reconstruction, improved breast symmetry, and recent celebrity publicity may be contributors to the increasing rates of IBR. In their survey, Han et al15 also demonstrated that nearly all patients who underwent BM (98%) felt good about their decision. The racial disparities in the rate of breast reconstruction have also been demonstrated elsewhere. Using the SEER database, Agarwal et al16 reported a significantly lower likelihood of breast reconstruction between African Americans and Caucasian patients (OR .6 vs 1.00, P , .001). It would be helpful for surgeons and policy makers to better understand the cultural and socioeconomic reasons for these disparities. There are several important limitations of this study that must be addressed. While the ACS NSQIP captures a large sampling of the United States, it does not provide any cancer stage or socioeconomic data for each patient. The data also does not allow us to determine whether the mastectomy was in fact prophylactic or whether each breast had cancer. As the reported rate of synchronous breast cancer is less than 1%, we made the assumption that nearly all the bilateral mastectomies performed had one side that was prophylactic.17–19
Conclusions Despite the higher risks for complications associated with BM and IBR and despite the availability of breast
5 conservation therapy, rates of BM and associated IBR have been rising since 2005. Younger white patients are most likely to choose the most aggressive surgical management of their breast cancer and subsequent reconstruction.
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