Plastic & Reconstructive Surgery:
Breast: Outcomes Article
A Paradigm Shift in U.S. Breast Reconstruction: Increasing Implant Rates
Albornoz, Claudia R. M.D., M.Sc.; Bach, Peter B. M.D., M.A.P.P.; Mehrara, Babak J. M.D.; Disa, Joseph J. M.D.; Pusic, Andrea L. M.D., M.H.S.; McCarthy, Colleen M. M.D., M.S.; Cordeiro, Peter G. M.D.; Matros, Evan M.D., M.M.Sc.
New York, N.Y.
From the Plastic and Reconstructive Surgical Service and the Center for Health Policy and Outcomes, Memorial Sloan-Kettering Cancer Center.
Received for publication May 15, 2012; accepted July 20, 2012.
Presented at the 91st Annual Meeting of the American Association of Plastic Surgeons, in San Francisco, California, April 14 through 17, 2012.
Disclosure: Dr. Bach is a consultant for Genentech. Dr. Cordeiro collaborates in a multicentric study sponsored by Allergan. The remaining authors have no financial interest to disclose. No external funding was received.
Evan Matros, M.D., M.M.Sc.; Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, MRI 1036, New York, N.Y. 10065, email@example.com
Background: Despite its benefits in body image, self-esteem, sexuality, and quality of life, historically fewer than 25 percent of patients undergo immediate breast reconstruction. After passage of the Women Health and Cancer Rights Act, studies failed to demonstrate changes in reconstructive rates. A recent single-year report suggests significant shifts in U.S. breast reconstruction patterns. The authors' goal was to assess long-term trends in rates and types of immediate reconstruction.
Methods: A serial cross-sectional study of immediate breast reconstruction trends was performed using the Nationwide Inpatient Sample database from 1998 to 2008. Data on mastectomies, reconstructive method (autologous/implant), and sociodemographic/hospital predictors were obtained.
Results: Immediate breast reconstruction rates increased on average 5 percent per year, from 20.8 percent to 37.8 percent (p < 0.01). Autologous reconstruction rates were unchanged. Implant use increased by an average of 11 percent per year (p < 0.01), surpassing autologous methods as the leading reconstructive modality after 2002. The strongest predictors of implant use were procedures performed after 2002, bilateral mastectomies, patients operated on in Midwest/West regions, and Medicare recipients. In contrast to bilateral mastectomies, which increased by 17 percent per year (p < 0.01), unilateral mastectomies decreased by 2 percent per year (p < 0.01). Bilateral mastectomy defects had significantly higher reconstruction rates than unilateral counterparts (p < 0.01).
Conclusions: The significant rise in immediate reconstruction rates in the United States correlates closely to a 203 percent expansion in implant use. Although the reason for the increase in implant use is multifactorial, changes in mastectomy patterns, such as increased use of bilateral mastectomies, are one important contributor.
Breast reconstruction following total mastectomy has benefits in body image, self-esteem, sexuality, and quality of life.1–6 Although 35 to 40 percent of women diagnosed annually with breast cancer will be treated with a total mastectomy, historically fewer than 25 percent undergo immediate reconstruction.7–13 The Women's Health and Cancer Right Act was federally enacted in 1998 to ensure economic coverage for reconstruction fees after mastectomy. Multiple population-based studies have failed to demonstrate a significant change in reconstruction rates following passage of this law.14,15 A recent study analyzing the Nationwide Inpatient Sample database for 2008 documented two intriguing findings: (1) an immediate reconstruction rate of 37.8 percent, and (2) greater numbers of implant than autologous tissue reconstructions (61 percent versus 41 percent), a reversal of prior findings.3,16,17 As a single-year study, the significance of these results was unclear, prompting a longitudinal investigation. The aim of the current study was to assess U.S. trends over the past 10 years in rates and types of immediate breast reconstruction.
PATIENTS AND METHODS
An observational longitudinal analysis of patients who underwent total mastectomy, between 1998 and 2008, was performed using the Nationwide Inpatient Sample database. The Nationwide Inpatient Sample is the largest all-payer inpatient care database in the United States, with data from approximately 1000 hospitals and 8 million inpatient hospital stays. It constitutes a 20 percent stratified sample of all hospital discharges from nonfederal facilities and is part of the Healthcare Cost and Utilization Project sponsored by the Agency for Healthcare Research and Quality.18
Inclusion criteria were patients with breast cancer or increased risk of breast cancer (International Classification of Diseases, Ninth Revision diagnosis codes 174.0 to 174.9, 233.0, v16.3, v10.3, v84.01, and v50.41) who underwent total mastectomy (International Classification of Diseases, Ninth Revision procedure codes 85.4, 85.33 to 85.36, and 85.41 to 85.48) (Table 1). Lumpectomy or partial mastectomies were excluded. Delayed reconstructions were not included because the year of reconstruction could not be linked with the year of the original mastectomy. Immediate reconstructive procedures using autologous tissue (International Classification of Diseases, Ninth Revision procedure codes 85.7, 85.70 to 85.76, 85.79, and 85.84 to 85.85) and implant-based techniques were analyzed. Implant-based reconstructions included either immediate tissue expander insertion or immediate permanent implant placement (International Classification of Diseases, Ninth Revision procedure codes 85.53 to 85.54 and 85.95) (Table 2). Before 2008, the Nationwide Inpatient Sample did not differentiate between the types of autologous reconstruction [e.g., pedicle versus microsurgical transverse rectus abdominis myocutaneous (TRAM) flap], so specific procedural trends were unable to be determined. Patients with simultaneous autologous and implant techniques, such as a latissimus flap with implant, were included in the autologous group. Because the annual number of mastectomies performed changes, all rates were adjusted per 1000 mastectomies to allow for comparison over time.
All analyzed variables were provided by the Nationwide Inpatient Sample database. Race categories were provided by the primary data source to the Nationwide Inpatient Sample. Hospital teaching status is determined by the Nationwide Inpatient Sample as those hospitals with American Medical Association–approved residency programs, or are members of the Council of Teaching Hospitals, or have a ratio of full-time residents to beds of 0.25 or greater.
Trends were analyzed using Poisson regression, a form of analysis that measures changes in rate over time. Incidence rate ratios with a value of p < 0.05 were considered a significant rate change. A multivariable logistic regression was performed to analyze associations between reconstruction type and sociodemographic/hospital variables in patients who underwent reconstructive procedures. Variables previously shown to influence reconstruction type were included.3,16 Statistical analyses were performed using Stata 11.0 (Stata Corp., College Station, Texas).
From 1998 to 2008, the Nationwide Inpatient Sample database registered 178,603 total mastectomies for which 51,410 immediate breast reconstructions were performed. Figure 1 and Table 3 show a 78 percent increase in rates of U.S. immediate breast reconstruction from 20.8 percent in 1998 to 37.8 percent in 2008. This trend was significant, at an average increase of 5 percent per year (incidence rate ratio, 1.05; p < 0.01).
Rates of the reconstructive method used over time are shown in Table 3. Autologous reconstructions remained stable during the study period (incidence rate ratio, 0.99; p = 0.3), whereas implant use increased significantly, on average 11 percent per year (incidence rate ratio, 1.11; p < 0.01). In 1998, autologous reconstructions were more frequent compared with implant reconstructions (123 versus 85 per 1000 total mastectomies); however, after 2002, the relationship switched. By 2008, immediate implants outnumbered autologous reconstructions by a ratio of 2:1 (258 versus 120 per 1000 mastectomies). As autologous reconstructions remained level over the study period, the increased number of immediate reconstructions correlates to a 203 percent rise in implant use (Fig. 1).
A multivariable logistic regression analysis was performed to better understand factors related to implant use over the study period (Table 4). The strongest predictors of implant reconstruction were procedures performed during the years 2003 to 2008 (odds ratio, 1.41 to 2.26; p < 0.01) compared with 1998, bilateral (odds ratio, 1.86; p < 0.01) compared with unilateral mastectomies, patients operated on in the West (odds ratio, 1.52; p < 0.01) and Midwest (odds ratio, 1.22; p <0.01) region compared with the Northeast, and Medicare recipients (odds ratio, 1.45; p < 0.01) compared with private insurance carriers. Other factors independently associated with implant use are listed in Table 4.
A post hoc analysis was performed separately, analyzing implant use in both unilateral and bilateral mastectomies. Figure 2 shows that implant reconstruction rates have increased over the study period for both mastectomy types; however, the rate has increased an average of 6 percent per year (incidence rate ratio, 1.06; p < 0.01) for unilateral mastectomies, whereas in bilateral mastectomies, it increased 22 percent per year (incidence rate ratio, 1.22; p < 0.01).
Analysis of mastectomy type shows that the number of bilateral mastectomies has risen on average 17 percent per year (incidence rate ratio, 1.17; p < 0.01), whereas unilateral mastectomies have decreased a mean of 2 percent per year (incidence rate ratio, 0.98; p < 0.01) (Fig. 3). Finally, examination of reconstruction rates by mastectomy type shows consistently higher reconstruction rates following bilateral compared with unilateral mastectomies throughout the study period (Table 5). In 1998, 18.8 percent of unilateral versus 64.4 percent of bilateral mastectomies underwent reconstruction, whereas in 2008, 28.4 percent and 75.3 percent underwent reconstruction, respectively.
Analysis of the past 11 years of data available from the Nationwide Inpatient Sample found an average increase of 5 percent per year in rates of U.S. immediate breast reconstruction. Multiple factors may contribute to this trend. The Women's Health and Cancer Right Act was passed in 1998 to ensure economic coverage for breast reconstruction following mastectomy.14 Although direct causality for a rise in reconstruction rates following passage of this law is difficult to prove, the steady increase in reconstruction rates since its introduction is suggestive. Moreover, the age distribution of the reconstructive pool has shifted. Women younger than 49 years represent an increasing proportion of patients undergoing reconstruction and have higher reconstruction rates than more senior women (data not shown). Changing patterns of oncologic care may serve as an additional stimulus. Although nipple-sparing mastectomies currently represent only 2 percent of ablative procedures, they are remarkable for an immediate reconstruction rate exceeding 88 percent (data not shown). Awareness of breast cancer treatment has also risen dramatically in recent years. Through advocacy groups, television, the Internet, charity walks, and publications, women are increasingly knowledgeable about breast cancer therapeutics, including reconstruction. Moving forward, new legislation in states such as New York is likely to contribute further to increases in reconstruction rates. It is now mandatory for practitioners caring for women with breast cancer to inform them about reconstruction.19,20
The observed increase in immediate reconstruction rates corresponds closely to a rise in implant use over the study period. Although autologous reconstruction rates remained level from 1998 to 2008, implant use rose 203 percent. After 2002, implants surpassed autologous tissue as the leading reconstructive modality (Fig. 1 and Table 3). Although this finding may not be surprising for plastic surgeons, no longitudinal study has documented the reversal of this trend. Older population-based studies consistently reported an autologous-to-implant reconstruction ratio of 2:1.3,17
The unchanged rate of autologous reconstructions over the study period is surprising for multiple reasons. First, outcomes research suggests that patients with autologous compared with implant reconstructions have higher long-term satisfaction and more stable aesthetic results.21,22 Second, refinements in microsurgical technique have led to the advent of perforator flaps, such as the deep inferior epigastric artery perforator and superficial inferior epigastric artery flaps, the current state-of-the-art in autologous reconstruction. Perforator flaps minimize abdominal donor-site morbidity compared with TRAM flaps through muscle preservation, maintenance of abdominal strength, and decreased hernia formation.23,24 Operating room availability may be a bottleneck to the number of autologous reconstructions that can be performed. During the time it takes to finish a single autologous reconstruction, multiple implant reconstructions can be completed. For example, a unilateral tissue expander reconstruction takes under 1 hour to complete, whereas a pedicled TRAM flap reconstruction lasts approximately 4 hours. This problem may be exacerbated by increased demand for deep inferior epigastric artery perforator/superficial inferior epigastric artery flaps, which can take up to 6 hours or more. Finally, insufficient numbers of surgeons trained in perforator flap techniques may further contribute to the shift toward implants.
To identify variables independently related to implant use, a logistic regression analysis was performed. Because of the extensive use of implants over the study period, associations were identified with almost all of the measured sociodemographic/hospital variables (Table 4). The strongest predictors of implant reconstruction were procedures performed after 2002, Medicare recipients, bilateral mastectomy defects, and patients operated on in the West and Midwest regions. Some associations may not be able to be accurately explained by the limited data in this registry; however, certain variables permit a more detailed discussion.
Year of surgery was the strongest independent predictor for whether or not a woman underwent implant reconstruction. Although there is no clear explanation for the 2.26-fold increase in the likelihood for implant reconstruction in 2008 compared with 1998, year can be considered a proxy for unmeasured variables such as patient/physician preference. Explanations for why more women choose implant reconstruction each year are discussed here. First, regulatory surveillance by the U.S. Food and Drug Administration, particularly with regard to silicone implants, has served to relieve concerns about their safety within the United States. Although silicone implants have had continuous approval by the U.S. Food and Drug Administration for use in reconstruction, their reapproval for cosmetic breast augmentation in 2006 may contribute to more widespread acceptance.25 Second, women younger than 49 years constitute an increasing proportion of the breast reconstructive pool. Younger women may have inadequate adiposity to permit autologous reconstruction or prefer to avoid the extended recovery and donor-site morbidity of this modality.26,27 Third, cultural shifts may be occurring in breast aesthetics. Women may now prefer the nonptotic appearance of implants relative to the natural appearance of autologous tissue. Fourth, previously, women intended for adjuvant irradiation were advised to avoid implant reconstruction in favor of autologous tissue because of an increased complication risk profile. Today, increased experience with implants in the setting of irradiation demonstrates acceptable outcomes.28–30 All of the aforementioned concepts are hypothesis-generating and require further investigation. Recent concerns of a relationship between anaplastic large cell lymphoma and implants could potentially shift the pendulum back toward autologous reconstruction.31–36
Although reimbursement was not directly measured in this study, it can be inferred by analysis of payer. Medicare patients are 1.45 times more likely than private insurance carriers to undergo reconstruction using an implant instead of autologous tissue (Table 4). The older age of Medicare recipients may make them poor candidates for more complex autologous procedures. Alternatively, professional reimbursement may indirectly incentivize implant reconstructions. Medicare payments for autologous reconstruction have decreased over the past 10 years yet remain unchanged for private insurance carriers.37,38 Private insurance carriers increased payment for implant reconstruction by 64 percent from 1997 to 2007, whereas autologous reconstruction reimbursement was level.38 Differential surgeon compensation favoring implants ($587 per hour versus $322 per hour for autologous tissue) for patients with private insurances and the extra operative time required to complete an autologous reconstruction may be additional factors contributing to a rise in implant use.38
Post hoc analysis shows increasing use of implant-based techniques for both unilateral and bilateral mastectomy defects over the study period, but the rise is significantly greater for bilateral than for unilateral mastectomies (Fig. 2). The preference for implant-based reconstructions of bilateral mastectomies demonstrated in the multivariable analysis is reasonable. First, symmetry is easily achieved using bilateral implants. Second, the morbidity of bilateral autologous reconstructions can be great, with an increased risk of abdominal wall embarrassment and prolonged operative and recovery times.39,40 The reason why increasing numbers of women undergoing unilateral mastectomy choose implants rather than autologous tissue is curious. It is difficult to match an implant with the natural appearance of the contralateral remaining breast. Unilateral breast implant reconstructions more frequently require contralateral symmetrization procedures such as a mastopexy, breast reduction, or augmentation than unilateral autologous reconstructions.41,42
The expansion of U.S. breast reconstructions, specifically using implants, is potentiated by two additional findings. First, the number of bilateral mastectomies performed has increased on average 17 percent per year (Fig. 3). Bilateral mastectomies represented 4.4 percent of total mastectomies in 1998 and increased to 22.4 percent by 2008. Studies suggest the increase in bilateral mastectomies is attributable not to the changing incidence of bilateral breast cancer but rather to the growing use of contralateral prophylactic mastectomy.43–46 Contralateral prophylactic mastectomy is performed for cancer worry, elevated risk of contralateral disease, and family predisposition.47 A separate group of patients undergoes bilateral prophylactic mastectomy for risk reduction in the setting of BRCA1/2 mutation.48,49 Second, throughout the entire study period, reconstruction rates have been consistently three times higher following bilateral than unilateral mastectomy (Table 5). The explanation for this finding is unclear. Bilateral mastectomy defects may be considered more deforming and/or these patients could have higher referral rates to reconstructive surgeons. Based on these findings, if the number and/or proportion of bilateral mastectomies performed in the United States continue to increase, a further rise in both reconstruction rates and implant use can be anticipated. Interestingly, although bilateral mastectomies appear to be a driver behind increased reconstruction rates and the paradigm shift toward implants, many contralateral prophylactic mastectomies are performed in patients at low risk for contralateral disease.50
The current study is not exempt from limitations. At present, there is a paucity of information available about patient and provider decision making for the method of breast reconstruction chosen. More information about physician and patient preferences could be obtained by means of qualitative interviews or a survey. Associations identified using large databases need to be carefully considered, as there is potential for overanalysis. Associations can be statistically significant, yet there can be no clinical reason for the finding. The Nationwide Inpatient Sample registry also does not allow for determination of an overall (immediate plus delayed) reconstruction rate. Because delayed reconstructions cannot be linked with the year of the original mastectomy, the rate reported in this article includes only immediate procedures. Since delayed reconstructions are more likely to be performed using a flap, the exclusion of these procedures may potentially bias the results.16
The current study provides a picture of U.S. breast reconstruction trends over the past decade. The observed rise in reconstruction rates correlates to a paradigm shift away from autologous tissue to implant-based techniques as the major reconstructive modality. Reasons for increased implant use are multifactorial. Beyond patient and physician preference, changes in oncologic practice, such as increased number of bilateral mastectomies, may have contributed to the expansion in implant use. More information is needed about patient and physician decision making to more comprehensively understand contemporary preferences.
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