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Breast: Original Articles

Stability of Long-Term Outcomes in Implant-Based Breast Reconstruction: An Evaluation of 12-Year Surgeon- and Patient-Reported Outcomes in 3489 Nonirradiated and Irradiated Implants

Seth, Akhil K. M.D.; Cordeiro, Peter G. M.D.

Author Information
Plastic and Reconstructive Surgery: September 2020 - Volume 146 - Issue 3 - p 474-484
doi: 10.1097/PRS.0000000000007117
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Abstract

Breast reconstruction has become an essential part of breast cancer care, with an increasing number of patients seeking reconstruction after mastectomy in the United States.1–6 Among the currently available techniques, two-stage, prosthetic-based reconstruction with immediate tissue expander placement, followed by exchange for permanent implant, remains the most common form of breast reconstruction performed.7,8 Numerous studies have examined outcomes following implant reconstruction, including rates of acute complications and their associated preoperative and operative risk factors.9–16 However, the majority of these studies are limited by their short-term follow-up and/or lack of evaluation of aesthetic outcomes. Furthermore, only more recently have data become available examining patient-reported outcomes, which provide a measurement of patient satisfaction following implant-based reconstruction. Of the available patient-reported outcomes measurement tools, the BREAST-Q has established itself as the gold standard, having been used most frequently within the literature.17–23 However, an understanding of BREAST-Q scores relative to surgeon-reported outcomes, such as long-term aesthetic outcome or capsular contracture, also remains unclear.

Because of the lack of available data, several concepts related to long-term outcomes following prosthetic breast reconstruction have formed from surgical dogma rather than objective data. Several authors have described the overarching idea that implant reconstruction tends to deteriorate over time, with a decline in aesthetic outcomes, an increase in capsular contracture, and an overall decrease in patient satisfaction.23–28 This concept has fueled the push for immediate autologous reconstruction as a more sustainable form of breast reconstruction relative to implants. However, this cannot be considered a universal concept in that many patients are not good candidates for autologous reconstruction, because of either lack of adequate donor-site tissue or preoperative comorbidities. Furthermore, after a discussion of the available options, some patients are not interested in autologous reconstruction because of the increased postoperative recovery secondary to having a tissue donor site. With autologous reconstruction not being an option for every patient, objectively understanding long-term surgeon- and patient-reported outcomes following prosthetic-based breast reconstruction is critical to adequately counseling patients.

The senior author (P.G.C.) has long believed that the concept of implant reconstruction deteriorating over time is unfounded, which has been anecdotally supported by his own extensive experience in performing breast reconstruction. Given this hypothesis, the purpose of this study was to critically and objectively examine long-term surgeon-reported outcomes in patients undergoing two-stage, prosthetic-based reconstruction, using the largest, long-term patient series published to date. Using available BREAST-Q data, the authors hope to better understand the associated long-term changes in patient-reported outcomes in these same patients. Furthermore, given the known deleterious impact of radiation therapy on breast reconstruction complication rates, the authors also examine its impact on long-term surgeon- and patient-reported outcomes.

PATIENTS AND METHODS

This study was performed with approval by the Memorial Sloan Kettering Cancer Center Institutional Review Board. A retrospective review of a prospectively collected database of patients that underwent immediate, two-stage, prosthetic-based breast reconstruction performed by the senior author (P.G.C.) was performed. Two-stage reconstruction included immediate tissue expander reconstruction following mastectomy, followed by tissue expander–to-implant exchange. Of all patients reviewed, only those patients with at least 1-year outpatient follow-up following exchange to permanent implant were reviewed for analysis. Patients with a combined reconstruction (implant plus flap) or delayed reconstruction were excluded. The mastectomies were performed by a variety of oncologic surgeons at the Memorial Sloan Kettering Cancer Center (New York, N.Y.). The surgical technique for tissue expander implantation and exchange to permanent implant was uniform among all patients, with all performed using a total submuscular technique as described previously.29

Demographics, operative characteristics, and surgical and aesthetic outcomes were recorded prospectively in an institutional database. In particular, the status of radiation therapy—either before reconstruction, irradiation of the tissue expander, or irradiation of the permanent implant—was recorded. However, for outcomes analysis, patients in any of these three groups were considered together as having a history of irradiation. Long-term surgeon-reported outcomes evaluated included capsular contracture, using the modified Baker classification for reconstructed breasts, and aesthetic results evaluated by the surgeon using a categorical scale (1 = poor, 2 = fair, 3 = good, 4 = very good, and 5 = excellent). Aesthetic outcomes were scored based on each patient’s overall aesthetic appearance following breast reconstruction, rather than the appearance of an individual breast. Capsular contracture scores were determined for each breast that was reconstructed. Patient-reported outcomes were evaluated with the BREAST-Q Reconstruction module, a condition-specific, validated questionnaire designed to measure quality of life and satisfaction in patients with breast reconstruction.17 Scales used were Satisfaction with Breasts, Satisfaction with Outcome, Psychosocial Well-being, Sexual Well-being, and Physical Well-being (chest and upper body). For each scale, items are summed and transformed on a scale ranging from 0 to 100, with greater values indicating higher levels of satisfaction and health-related quality of life. Aesthetic results and BREAST-Q scores were reported per patient; capsular contracture scores were reported per breast.

Following permanent implant exchange, patients were evaluated at outpatient visits on a yearly basis by the senior author (P.G.C.). During each outpatient evaluation by the surgeon, aesthetic and capsular contracture scores were determined and recorded in real-time. BREAST-Q scores were obtained annually from patients either in-person at the same outpatient appointment or by means of electronic surveys. For long-term analysis, each outpatient visit, and its associated surgeon- and patient-reported outcomes, was considered individually. Individual visits were then organized based on how long after relative permanent implant exchange that they occurred, allowing for the evaluation and comparison of surgeon- and patient-reported outcomes for each patient over time. Although the available patient data set spanned from 1994 to 2016, only a subset of all patients reviewed had patient-reported outcomes data available because of the timing of BREAST-Q implementation at the institution. To maximize overlap between available long-term surgeon- and patient-reported outcomes, a follow-up period of the most recent 12 years following permanent implant exchange was chosen.

Statistical analysis was performed using the t test. Statistical significance was set at p < 0.05. All analyses were performed using GraphPad Prism Version 7.0c (GraphPad Software, Inc., La Jolla, Calif.). For BREAST-Q scores, a minimal important difference was defined as a four-point difference between groups.30

RESULTS

Retrospective review of 4068 patients in a prospectively collected database revealed 2284 patients, or 3489 breasts, that fit the study inclusion criteria (Table 1). Data from a total of 12,202 individual outpatient visits were reviewed, with a mean follow-up time of 66.6 ± 48.5 months (Table 1). Average age and body mass index for all patients was 48.5 ± 10.2 years and 24.8 ± 6.8 kg/m2, respectively. The majority of patients had bilateral reconstruction [n = 1215 (53.5 percent)] with silicone implants [n = 1244 (54.5 percent)]. Three hundred twenty-three patients (14 percent) underwent some form of radiation therapy as part of treating their breast cancer. Eighty-seven patients (3.8 percent) underwent radiation therapy before reconstruction, and the remainder underwent adjuvant radiation therapy of either their tissue expander [n = 43 (1.9 percent)] or their permanent implant [n = 193 (8.4 percent)].

Table 1. - Clinical Characteristics
Characteristic Value (%)
No. of patients 2284
Mean age ± SD, yr 48.5 ± 10.2
Mean BMI ± SD, kg/m2 24.8 ± 6.8
Implant type
 Saline 1040 (45.5)
 Silicone 1244 (54.5)
Laterality
 Unilateral 1069 (46.8)
 Bilateral 1215 (53.2)
Irradiation 323 (14.1)
 Before reconstruction 87 (3.8)
 After TE 43 (1.9)
 After implantation 193 (8.4)
No. of outpatient visits 12,202 (100)
Postimplant follow-up, mo 66.6 ± 48.5
BMI, body mass index; TE, tissue expander.

Aesthetic outcomes over time were collated and evaluated for all patients up to a period of 12 years of follow-up (Fig. 1). Patients were then subdivided to analyze long-term trends within distinct reconstructive groups. In general, patients with bilateral reconstructions had significantly higher aesthetic scores than those with a unilateral reconstruction, and this trend remained over time (p < 0.001). Additional comparison of patients with and without radiation therapy demonstrated a similar consistency, with significantly higher aesthetic ratings among nonirradiated bilateral reconstructions relative to irradiated bilateral reconstructions over the first 9 years of follow-up (p < 0.05). Unilateral irradiated reconstructions also consistently scored the lowest aesthetic scores among all patient groups over the full 12-year follow-up period (p < 0.05). Capsular contracture scores for all reconstructed breasts were similarly evaluated between irradiated and nonirradiated breasts (Fig. 2). Irradiated, reconstructed breasts had significantly higher capsular contracture scores than nonirradiated breasts at every evaluated time point (p < 0.001). Interestingly, both groups demonstrated an inflection point in scores, with a significant drop in the mean nonirradiated [1.38 (year 2) to 1.1 (year 3)] and irradiated [2.21 (year 3) to 1.82 (year 4)] scores (p < 0.05). These decreases in capsular contracture scores were then maintained over the remainder of the study follow-up period.

Fig. 1.
Fig. 1.:
Aesthetic scores over time among different implant-based breast reconstruction patient subsets (asterisks indicate p < 0.05).
Fig. 2.
Fig. 2.:
Capsular contracture rates over time among all breasts, and between nonirradiated and irradiated breast subsets (asterisk indicates p < 0.05).

Figures 1 and 2 also visibly demonstrate stability over time in surgeon-reported outcomes, aesthetics, and capsular contracture following implant-based breast reconstruction. This consistency is further evaluated in Table 2. From year 1 to year 12 of follow-up, aesthetic scores among all bilateral (4.73 ± 0.64 to 4.44 ± 0.82; p < 0.0001) and unilateral (4.02 ± 0.91 to 3.63 ± 0.99; p = 0.0005) reconstructions demonstrated an overall decrease. Although these decreases were statistically significant, because of the statistical power of the individual groups, the clinical difference in scores ranged from 0.29 to 0.39 with overlapping confidence intervals. Similarly, the rate of capsular contracture remained clinically and statistically stable over the entire study period for both nonirradiated (year 1, 1.27 ± 0.53; year 12, 1.23 ± 0.54; p = 0.37) and irradiated (year 1, 1.92 ± 0.89; year 12, 1.66 ± 0.87; p = 0.12) breasts. Representative examples of long-term patient results are shown, demonstrating this stability (Figs. 3 through 6).

Table 2. - Long-Term Comparison of Surgeon-Reported Outcomes at 1 Year versus 12 Years
Outcome 1 Yr 12 Yr p
Aesthetic
 Bilateral
  All 4.73 ± 0.64 4.44 ± 0.82 <0.0001
  Nonirradiated 4.78 ± 0.57 4.43 ± 0.82 <0.0001
  Irradiated 4.38 ± 0.87 4.50 ± 0.85 0.67
 Unilateral
  All 4.02 ± 0.91 3.63 ± 0.99 0.0005
  Nonirradiated 4.17 ± 0.82 3.74 ± 0.92 0.0004
  Irradiated 3.73 ± 1.01 3.32 ± 1.13 0.09
Capsular contracture
 All 1.24 ± 0.56 1.37 ± 0.73 0.004
 Nonirradiated 1.27 ± 0.53 1.23 ± 0.54 0.37
 Irradiated 1.92 ± 0.89 1.66 ± 0.87 0.12

Fig. 3.
Fig. 3.:
Bilateral mastectomy with two-stage tissue expander–to-implant breast reconstruction. Images are shown at initial evaluation (left), after implant exchange (center), and at long-term outcome 14 years after implant exchange (right).
Fig. 4.
Fig. 4.:
Left mastectomy with two-stage tissue expander–to-implant breast reconstruction. Images are shown at initial evaluation (left), after implant exchange (center), and at long-term outcome 9 years after implant exchange (right).
Fig. 5.
Fig. 5.:
Bilateral mastectomy with two-stage tissue expander–to-implant breast reconstruction. Images are shown at initial evaluation (left), after implant exchange (center), and at long-term outcome 10 years after implant exchange (right). Of note, the patient underwent postoperative irradiation to the left reconstruction.
Fig. 6.
Fig. 6.:
Bilateral mastectomy with two-stage tissue expander–to-implant breast reconstruction. Images are shown at initial evaluation (left), after implant exchange (center), and at long-term outcome 9 years after implant exchange (right). Of note, the patient underwent prereconstruction irradiation to the left reconstruction.

A subset analysis of all patients with patient-reported outcome data (i.e., BREAST-Q) was performed and then examined based on irradiation status. With regard to satisfaction with breasts, nonirradiated patients had significantly higher patient-reported outcomes than irradiated patients for the first 6 years (Fig. 7). Although this trend did not maintain statistical significance past this time point, the majority of time points did meet the minimal important difference of four points over the 12-year study period. In contrast, nonirradiated and irradiated patients showed no significant difference in satisfaction with outcomes except in the first year (Fig. 8). A similar trend was seen for patient-reported Psychosocial Well-being and Sexual Well-being over time, with a normalization of scores between nonirradiated and irradiated patients after the first year following implant exchange (Figs. 9 and 10). Physical Well-being scores appeared to mirror the trend seen in breast satisfaction, with nonirradiated patients scoring significantly higher than irradiated patients up to year 6, at which point scores among irradiated patients improved (Fig. 11).

Fig. 7.
Fig. 7.:
BREAST-Q scores over time for the Satisfaction with Breasts scale among all patients, and between nonirradiated and irradiated patient subsets.
Fig. 8.
Fig. 8.:
BREAST-Q scores over time for the Satisfaction with Outcomes scale among all patients, and between nonirradiated and irradiated patient subsets.
Fig. 9.
Fig. 9.:
BREAST-Q scores over time for the Psychosocial Well-being scale among all patients, and between nonirradiated and irradiated patient subsets.
Fig. 10.
Fig. 10.:
BREAST-Q scores over time for the Sexual Well-being scale among all patients, and between nonirradiated and irradiated patient subsets.
Fig. 11.
Fig. 11.:
BREAST-Q scores over time for the Physical Well-being scale among all patients, and between nonirradiated and irradiated patient subsets.

Similar to the stability seen in surgeon-reported outcomes over time, Figures 7 through 11 demonstrate a visible stability in scores among all patient-reported outcomes, with some measured patient-reported outcomes improving over time. Analysis of these long-term trends is shown in Table 3. There was no overall decrease in patient-reported outcomes scores for any measured category over the 12-year study period. In particular, Satisfaction with Breasts and Psychosocial Well-being scores demonstrated no significant changes in overall score over time. Satisfaction with Outcomes scores did significantly increase over time among all patients (70.9 ± 20.9 versus 76.9 ± 16.4; p = 0.03), including reaching the minimal important difference in irradiated patients from year 1 to year 12. Sexual Well-being scores remained statistically similar over time; however, a comparison between year 1 and year 12 did meet the minimal important difference among all patients. Meanwhile, Physical Well-being scores showed a significant improvement in all patients (72.8 ± 16.2 versus 82.8 ± 15.5; p < 0.0001), and in the nonirradiated (74.1 ± 15.9 versus 83.2 ± 15.4; p = 0.0002) and irradiated (67.7 ± 16.5 versus 81.0 ± 17.2; p = 0.02) patient subsets.

Table 3. - Long-Term Comparison of Patient-Reported Outcomes at 1 Year versus 12 Years
Outcome 1 Yr 12 Yr p MID
Satisfaction with Breasts
 All 64.1 ± 17.1 66.3 ± 19.6 0.36 No
 Nonirradiated 65.4 ± 17.6 67.7 ± 19.0 0.40 No
 Irradiated 58.7 ± 14.2 58.9 ± 22.2 0.97 No
Satisfaction with Outcome
 All 70.9 ± 20.9 76.9 ± 16.4 0.03 Yes
 Nonirradiated 72.1 ± 20.9 77.4 ± 15.6 0.09 Yes
 Irradiated 66.1 ± 20.2 74.3 ± 20.7 0.23 Yes
Psychosocial Well-being
 All 74.7 ± 20.3 77.7 ± 16.7 0.26 No
 Nonirradiated 76.0 ± 20.3 78.7 ± 16.6 0.36 No
 Irradiated 69.4 ± 19.5 72.5 ± 17.4 0.63 No
Sexual Well-being
 All 53.8 ± 22.6 59.0 ± 24.0 0.09 Yes
 Nonirradiated 55.2 ± 23.4 59.0 ± 24.8 0.29 No
 Irradiated 47.6 ± 17.9 58.9 ± 20.6 0.07 Yes
Physical Well-being
 All 72.8 ± 16.2 82.8 ± 15.5 <0.0001 Yes
 Nonirradiated 74.1 ± 15.9 83.2 ± 15.4 0.0002 Yes
 Irradiated 67.7 ± 16.5 81.0 ± 17.2 0.02 Yes
MID, minimal important difference.

DISCUSSION

The results of this study, the largest of its kind to date, demonstrate that outcomes following prosthetic breast reconstruction do not deteriorate over time. Long-term analysis of our two surgeon-reported outcomes, aesthetic outcomes, and capsular contracture demonstrates stability in scores over the 12-year study period. Although aesthetic scores demonstrated a statistically significant decrease between the 1- and 12-year time points, the largest absolute decrease in aesthetic scores was less than 0.4 in both unilateral and bilateral patients. The clinical significance of this difference is minimal, with bilateral patients decreasing to an average score of 4.44 from 4.73, both of which would be classified as being a “very good” outcome according to the five-point scale used. Meanwhile, unilateral reconstruction patients showed a similar decrease from 4.02 to 3.63, again indicating a relatively insignificant clinical difference in scores. Similarly, an increase in capsular contracture scores over 12 years from 1.24 to 1.37, despite being statistically significant given the statistical power of our large patient population, also represents a difference with minimal clinical significance. These findings stand in direct contrast to the reconstructive surgical dogma that would predict a significant clinical decrease in these two surgeon-reported outcomes over a 12-year period.

The stability over time of prosthetic reconstruction surgeon-reported outcomes is further supported by our patient-reported outcomes subset analysis. Figures 3 through 7 demonstrate that for all five scales used from the BREAST-Q reconstructive module, patients with prosthetic reconstruction demonstrated stability or an improvement in their patient-reported outcomes over time. These findings mirror the stability seen in aesthetic and capsular contracture outcomes, indicating that stable surgical outcomes contribute to stable or improved patient satisfaction. Interestingly, although Satisfaction with Breasts scores remained stable over the 12-year period, patients’ overall satisfaction with outcomes scores increased significantly over time. This may be explained by the fact that as time passes and patients move further away from their original mastectomy and reconstruction, they will accommodate to a new normal. They may feel better about their overall health with their breast cancer having been treated, and their perspective on what defines a successful outcome may also change with age. Meanwhile, Psychosocial and Sexual Well-being also showed stability or a slight improvement in scores, indicating that an implant reconstruction does not negatively impact these particular aspects of overall satisfaction. The most striking change in patient-reported outcomes over time was seen in Physical Well-being scores, which showed a steady improvement of more than 10 points over the 12-year study period. Although an initial improvement in this score would be expected after patients have fully recovered from surgery and adjuvant therapy, a continued increase in the latter years of follow-up is in line with the improvement in overall patient satisfaction that was seen. It should also be noted that all reconstructions were performed in a submuscular plane, arguing against the idea that subpectoral implant placement may lead to long-term physical impairments, as suggested by proponents of new prepectoral techniques.31–34

The long-term trends seen for our measured surgeon-reported outcomes for different subsets of patients are in line with the expected impact of mastectomy and irradiation on outcomes. Bilateral, nonirradiated patients tended to have the highest aesthetic scores, followed by bilateral irradiated, unilateral nonirradiated, and unilateral irradiated. In general, bilateral implant reconstruction is expected to have a better aesthetic appearance than unilateral reconstructions because of improved symmetry, as matching an implant to an existing native breast can often be challenging. Meanwhile, the impact of irradiation on the soft tissue surrounding the implant, including fibrosis and scar contracture, likely explains why irradiated patients consistently had lower aesthetic scores than their nonirradiated counterparts. These trends are maintained over the course of the study period. A similar discrepancy between irradiated and nonirradiated patients is seen with capsular contracture scores. Interestingly, there appears to be a distinct inflection point among irradiated patients after year 3, at which point capsular contracture scores decrease steadily from a maximum score of 2.21 to 1.71 by year 5. Capsular contracture scores plateau at this level for the remainder of the study period, implying that although irradiation induces a higher rate and degree of capsular contracture, the severity of the contracture tends to dissipate and remain stable rather than worsen over time.

Interestingly, although distinct differences exist in surgeon-reported outcomes between irradiated and nonirradiated patients, the majority of patient-reported outcomes tend to equilibrate over time. At year 1, irradiated patients showed significantly lower patient-reported outcomes scores on all five reconstructive module scales. However, over time, satisfaction with outcome in irradiated patients was similar to that in nonirradiated patients at 12 years, with the majority of the improvement in scores occurring after the first 3 years. Sexual and physical well-being also demonstrated similar trends, although the time to equilibration of irradiated and nonirradiated patient scores was longer at 5 to 7 years. Interestingly, irradiated patients maintained an overall lower satisfaction with their breasts, and lower psychosocial well-being, than nonirradiated patients throughout the study period. These are the only two patient-reported outcomes measures that correlate with the consistently lower surgeon-reported outcomes scores seen in irradiated patients. This discrepancy between surgeon- and patient-reported outcomes speaks to the larger concept of how to interpret the large amount of patient-reported outcomes data now being presented within the literature. Patient-reported outcomes measures are inherent in patient satisfaction, which can be influenced by several factors outside of a patient’s objective surgical outcome. Therefore, although patient-reported outcomes can provide useful information, they can be misrepresentative and must be used in the context of their corresponding surgeon-reported outcomes, as the two may not always be concordant.

Although our study is largest of its kind to date, we recognize the limitations of our data set. In particular, there may be an inherent selection bias, as those patients returning for long-term follow-up may be those that have had an overall positive reconstructive outcome. In addition, we do not capture those patients that underwent implant revision or conversion to an autologous reconstruction, which may also impact our long-term data. However, the senior author’s revision rate has been historically low, with an implant replacement rate of approximately 5 percent as described previously.35 Therefore, we would expect this small group of patients to have only a minimal impact on surgeon- and patient-reported outcomes scores given the significant number of data points collected in this study. We have also presented a single-surgeon series, which can be seen as a disadvantage because of the lack of surgeon or institution variability, introducing an element of selection bias. However, it is also important to recognize the distinct advantages of having a single surgeon, in that there is consistency in how the procedures were performed and how the patients were scored. Over 99 percent of the reconstructions in this series were performed as submuscular, two-stage prosthetic reconstructions, and the measured surgeon-reported outcomes were all scored in a consistent manner using scales conceived by the surgeon. With all scores being compared in both intrapatient and interpatient fashion, rather than against historical standards, this also eliminates the impact of any surgeon-specific bias in terms of the overall trends seen. Furthermore, our validated patient-reported outcomes data, which were collected independent of the senior surgeon, supports the distinct conclusions drawn from our surgeon-reported outcomes.

CONCLUSIONS

We have presented objective, long-term data supporting the concept that prosthetic-based reconstruction is sustainable over time, with stable aesthetic outcomes and capsular contracture rates. This stability in surgeon-reported outcomes is supported by long-term patient-reported outcomes in the same patients, which demonstrate stable or improving patient satisfaction and well-being after implant reconstruction, even in the setting of irradiation. These results contradict the traditional dogma surrounding prosthetic breast reconstruction and therefore should be given significant consideration when counseling patients on their options for breast reconstruction following mastectomy.

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