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Breast: Original Articles

The Goldilocks Procedure with and without Implant-Based Immediate Breast Reconstruction in Obese Patients: The Mayo Clinic Experience

Bustos, Samyd S. M.D.; Nguyen, Minh-Doan M.D., Ph.D.; Harless, Christin A. M.D.; Tran, Nho V. M.D.; Martinez-Jorge, Jorys M.D.; Lin, Jason B.S.; Forte, Antonio J. M.D., M.S., Ph.D.; Casey, William J. III M.D.; Boughey, Judy C. M.D.; McLaughlin, Sarah A. M.D.; Gray, Richard M.D.; Manrique, Oscar J. M.D.

Author Information
Plastic and Reconstructive Surgery: October 2021 - Volume 148 - Issue 4 - p 703-716
doi: 10.1097/PRS.0000000000008362
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Abstract

The rapidly expanding obesogenic environment, culprit of the current obesity pandemic, has considerably increased the number of obese patients, particularly “morbid” (body mass index greater than or equal to 40 kg/m2) and “super” obese (body mass index ≥50 kg/m2), requiring postmastectomy breast reconstruction.1–3 Many of these patients who undergo mastectomy are interested in postmastectomy breast reconstruction. Several recent articles have reported an increased risk of complications in this growing patient population.4–9 Moreover, the expanding number of patients choosing mastectomy and reconstruction for breast cancer or prophylaxis has only magnified this situation.10 These circumstances pose a genuine challenge to the plastic and reconstructive surgeon, who should balance the additional risks posed by obesity with a safe and satisfactory breast reconstruction procedure.

The Goldilocks procedure, which was first described by Richardson and Ma11 in 2012, emerged as a reconstructive option for patients that are poor candidates for traditional methods of breast reconstruction. This technique involves a skin-sparing mastectomy through Wise-pattern incisions and uses the residual mastectomy flaps to recreate a small breast mound.12 Thus, it is particularly useful in obese patients with large or ptotic breasts, in whom redundant tissue from the lower pole may be used to reestablish a small breast mound.13–15 This procedure represents a feasible option for patients that desire reconstruction but do not want or cannot undergo a full breast reconstruction and are willing to have smaller breasts.

The paradigm shift toward implant-based immediate breast reconstruction that started at the beginning of this century has also impacted the practice of the Goldilocks procedure.10,16 In certain circumstances, a mastectomy using Wise-pattern incisions and taking advantage of the vascularized inferior dermal flap (a concept similar to the Goldilocks procedure) has been performed in conjunction with immediate breast reconstruction in an attempt to achieve better outcomes and higher patient satisfaction in large breasted women who are also obese. However, to date, there are no studies assessing the safety of this combined procedure in this high-risk population. In this study, we aimed to assess the safety of the Wise-pattern mastectomy with vascularized inferior dermal flap and simultaneous immediate breast reconstruction (here referred to as Goldilocks with immediate breast reconstruction) and the Goldilocks-only procedure in obese patients, compare their outcomes, and make recommendations for their use in obese patients.

PATIENTS AND METHODS

We conducted an institutional review board–approved retrospective study identifying all consecutive female patients who underwent the skin-sparing Goldilocks procedure for breast reconstruction on all campuses of the Mayo Clinic Health System, over an 8-year period (from 2012 to 2019).

Patient Selection

We included patients who underwent the Goldilocks procedure at the same time as mastectomy, had a body mass index greater than or equal to 30 kg/m2, and were followed for a minimum of 6 months after surgery. We identified two groups: those who underwent the Goldilocks procedure only; and those who underwent a Wise-pattern mastectomy with a vascularized inferior dermal flap and concurrent immediate breast reconstruction (Goldilocks with immediate breast reconstruction) with either a two-stage (i.e., initial placement of a tissue expander and then subsequent implant exchange) or one-stage (i.e., direct-to-implant) procedure. The decision to undergo either of these two surgical options was a personal decision that was made after a serious discussion with the patient. The patient decided whether they wished to proceed with the Goldilocks-only procedure or Goldilocks with immediate breast reconstruction. It is a shared decision-making process after the patients are fully informed. For Goldilocks with immediate breast reconstruction, the use of acellular dermal matrix was based on patient-surgeon discussion. The rationale behind the use of acellular dermal matrix is to better define and support the breast implant pocket in the prepectoral plane and avoid the stretch over time, which tends to create severe ptosis, sometimes with inframammary fold descent and implant malposition. Acellular dermal matrix was used most of the time to cover the superior aspect of the implant in the prepectoral plane when the inferior dermal flap was not sufficient or when better support was desired. We excluded patients who underwent nipple-sparing mastectomy, immediate or delayed autologous reconstruction, delayed immediate breast reconstruction, or other types of breast reconstruction. The surgical technique for the Goldilocks procedure has been described in previous articles.11,15Figures 1 and 2 schematically represent each group. Figure 3 shows intraoperative photographs of the Goldilocks procedure.

Fig. 1.
Fig. 1.:
Schematic representation of the Goldilocks procedure. (Used with permission of Mayo Foundation for Medical Education and Research, all rights reserved.)
Fig. 2.
Fig. 2.:
Schematic representation of the skin-sparing mastectomy through Wise-pattern incisions and concurrent implant-based immediate breast reconstruction (Goldilocks with immediate breast reconstruction). (Used with permission of Mayo Foundation for Medical Education and Research, all rights reserved.)
Fig. 3.
Fig. 3.:
Intraoperative photographs depicting the Goldilocks procedure. A skin-sparing mastectomy through Wise-pattern incisions is shown (above, left). Next, deepithelialization of the inferior dermal flap is performed (above, right, and below, left). Finally, a conventional inverted-T closure is performed (below, right).

Data Extraction

We extracted data on patient demographics and comorbidities. Age and body mass index were recorded at the time of mastectomy. Former smokers were identified as having smoked more than 100 cigarettes and quitting for 1 year or more before surgery, and current smokers were defined as daily or occasional smokers or those having stopped 4 to 6 weeks before surgery. Nonsmokers were identified as those who never smoked. Diagnosis of hypertension, hyperlipidemia, or diabetes was considered only if the patient was on medication for these conditions. Coronary artery disease was defined as patients with a history of myocardial infarction or with previous diagnostic studies evidencing coronary disease. Thrombophilia was limited to hereditary diseases associated with hypercoagulability, such as factor V Leiden, and history of deep venous thrombosis or pulmonary embolism was designated if any of these events occurred before the mastectomy. Degree of breast ptosis17 was extracted from the preoperative physical examination of the plastic surgeon. Surgical characteristics were also recorded.

Complications and surgical outcomes were obtained. If the patient underwent fat grafting, the total volume of fat graft was calculated by adding the amount of fat used in each of the sessions. Revision surgery was restricted to minor scar or standing cone excisions. Nipple reconstruction consisted of tattooing or the use of local flaps. Seroma was counted if it was identified and drained with the use of ultrasound. Hematoma was recorded only if it required surgical evacuation. Surgical-site infection criteria followed the Centers for Disease Control and Prevention definitions. Wound dehiscence and skin flap necrosis were categorized into either partial-thickness (not including all skin layers) or full-thickness (including all skin layers). Tissue expander/implant malposition and capsular contracture were recorded when identified by the plastic surgeon. Tissue expander/implant explantation, unplanned reoperations, or readmissions related to the surgery were also noted. The date of each complication was also recorded for time-to-event analyses.

Complication rates were defined as the number of breasts that had presented any complication rather than obtaining the total complication count per cohort to prevent double-counting of event occurrences. Complication rates were categorized into two groups: minor (partial-thickness wound dehiscence/skin flap necrosis, or tissue expander (tissue expander)/implant malposition) and major (full-thickness wound dehiscence/skin flap necrosis, capsular contracture, tissue expander/implant explantation, or unplanned reoperation or readmission) complications.

Patient-Reported Outcomes

Patient-reported outcomes included patient satisfaction with breasts and physical, psychosocial, and sexual well-being. These were assessed using the corresponding subsection of the BREAST-Q v2.0.18 The questionnaires were sent to patients at least 6 months after their reconstructive surgery.

Statistical Analysis

Univariate analyses comparing proportions were performed using Pearson chi-square or Fisher’s exact test as appropriate. The unpaired two-tailed t test or Wilcoxon rank sum test were used for continuous variables as appropriate. Time-to-event analysis using Kaplan-Meier curve was used to compare complication rates between groups. Multivariable analyses using a Cox proportional hazards model to account for time-to-event differences was used to assess for predictors of complications using SAS JMP version 14 (SAS Institute, Inc., Cary, N.C.). An alpha error of 0.05 was used and values of p < 0.05 were considered statistically significant.

RESULTS

One hundred five patients (181 breasts) underwent mastectomy and Goldilocks procedures and met our inclusion criteria. Fifty-seven patients (96 sides) underwent the Goldilocks-only procedure and 48 patients (85 sides) underwent the Goldilocks procedure with immediate breast reconstruction. Figures 4 and 5 illustrate a clinical case of each group. Overall, median follow-up time was 15.1 months (interquartile range, 10.0 to 28.6 months). In the Goldilocks-only group, the mean ± SEM age and body mass index were 57.1 ± 1.0 years and 40.5 ± 0.7 kg/m2, respectively. In the Goldilocks with immediate breast reconstruction group, the mean ± SEM age and body mass index were 51.5 ± 1.1 years and 35.3 ± 0.4 kg/m2, respectively. Both age and body mass index were found to be statistically higher in the Goldilocks-only group. Patient demographics are presented and compared in Table 1.

Table 1. - Patient Demographics
Characteristic Goldilocks Only (%)* Goldilocks with Implant-Based IBR (%) p
Mean age ± SD, yr 57.1 ± 1.0 51.5 ± 1.1 0.0002
Mean BMI ± SD, kg/m2 40.5 ± 0.7 35.3 ± 0.4 <0.0001
Former or active smoker 39 (40.6) 45 (52.9) 0.0973
Hypertension 53 (55.2) 25 (29.4) 0.0005
Diabetes 15 (15.8) 10 (11.8) 0.4357
Hyperlipidemia 36 (37.5) 36 (42.4) 0.5056
Coronary artery disease 4 (4.2) 0 0.1236
Thrombophilia 2 (2.1) 2 (2.4) 1.0
History of DVT or PE 4 (4.2) 3 (3.5) 1.0
IBR, immediate breast reconstruction; BMI, body mass index; DVT, deep venous thrombosis; PE, pulmonary embolism.
*n = 57 patients and 96 breasts.
n = 48 patients and 85 breasts.
‡Statistically significant.

Fig. 4.
Fig. 4.:
Kaplan-Meier curve for minor complications. (Red graph) Goldilocks-only patients; (blue graph) Goldilocks with implant-based immediate breast reconstruction (log-rank test, p = 0.0106).
Fig. 5.
Fig. 5.:
Kaplan-Meier curve for major complications. (Red graph) Goldilocks-only patients; (blue graph) Goldilocks with immediate implant-based immediate reconstruction (log-rank test, p = 0.0069).

Surgical characteristics of the two groups are displayed in Table 2. Of note, the Goldilocks-only group had a statistically significant higher degree of ptosis compared to the Goldilocks with immediate breast reconstruction group (p = 0.0004). No difference was found for laterality, mastectomy indication, resection weight, or history of prior breast/chest radiation therapy between groups (p > 0.05). A statistically significant higher number of patients underwent neoadjuvant chemotherapy in the Goldilocks with immediate breast reconstruction group (p = 0.0268). Table 3 shows the specifics of the Goldilocks with immediate breast reconstruction group. The vast majority (92.9 percent) underwent a two-stage procedure. Only six breasts underwent direct-to-implant reconstruction. Most of the tissue expander/implants (88.1 percent) were located in the prepectoral plane. Acellular dermal matrix was used in almost half of the sides (49.4 percent) undergoing implant placement.

Table 2. - Surgical Characteristics
Characteristic Goldilocks Only (%)* Goldilocks with Implant-Based IBR (%) p
Degree of breast ptosis 0.0004
 I 1 (1.3) 2 (2.5)
 II 24 (30.4) 49 (60.5)
 III 54 (68.3) 30 (37.0)
Laterality 0.6124
 Bilateral 39 (68.4) 37 (77.1)
 Right breast 10 (17.5) 6 (12.5)
 Left breast 8 (14.1) 5 (10.4)
Mastectomy indication 0.0943
 Prophylactic 12 (12.5) 6 (7.1)
 Contralateral prophylactic§ 30 (31.3) 35 (41.2)
 DCIS 12 (12.5) 6 (7.1)
 Stage I 11 (11.5) 14 (16.5)
 Stage II 14 (14.6) 19 (22.4)
 Stage III 8 (8.3) 4 (4.7)
 Stage IV 1 (1.0) 0
 Other 2 (2.1) 1 (1.2)
Resection weight, g 869.6 ± 42.3 816.5 ± 51.5 0.4271
Intraoperative ICG-A 21 (21.9) 24 (28.2) 0.3231
Sentinel lymph node biopsy 42 (43.8) 42 (49.4) 0.4459
Axillary lymph node dissection 11 (11.5) 9 (10.6) 0.8522
History of breast/chest radiation therapy 7 (7.3) 1 (1.2) 0.0683
Postoperative radiation therapy 15 (15.6) 11 (12.9) 0.6074
Neoadjuvant chemotherapy 16 (16.7) 26 (30.6) 0.0268
Adjuvant chemotherapy 25 (26.0) 15 (17.6) 0.1743
IBR, immediate breast reconstruction; DCIS, ductal carcinoma in situ; ICG-A, indocyanine green angiography.
*n = 96 breasts.
n = 85 breasts.
‡Statistically significant.
§Breast contralateral to the breast with cancer.

Table 3. - Characteristics of Goldilocks with Implant-Based Immediate Reconstruction
Characteristic Goldilocks with Implant-Based IBR (%)*
Anatomical location
 Prepectoral 75 (88.1)
 Subpectoral 10 (11.9)
Acellular dermal matrix use 42 (49.4)
IBR
 Two-stage 79 (92.9)
 One stage (direct-to-implant) 6 (7.1)
Tissue expander 79
 Size, cc 582.5 ± 11.1
 Texture
  Smooth 3 (3.8)
  Textured 76 (96.2)
 Shape
  Anatomical 79 (100)
 Initial air fill, cc 290.5 ± 20.3
 No. of filling sessions before exchange to implant 3.1 ± 0.2
 Total filled volume before  exchange to implant, cc 472.7 ± 18.0
Time from expander to implant, days
 Mean 228
 Interquartile range 170–362.8
Implant 73
 Size, cc 603.2 ± 16.5
 Texture
  Smooth 71 (97.3)
  Textured 2 (2.7)
 Shape
  Round 73 (100)
IBR, immediate breast reconstruction.
*n = 85 breasts.
†Twelve patients did not undergo tissue expander exchange to implant: six breasts have not undergone exchange to implant, one patient (two breasts) died during the first stage, two breasts had their expanders explanted because of infection, and one patient (two breasts) desired to have fat grafting after tissue expander.

Surgical outcomes and complications are shown and analyzed in Table 4. A higher proportion of reconstructions in the Goldilocks with immediate breast reconstruction group had fat grafting compared to the Goldilocks-only group (p < 0.0001); however, total volume of fat graft was higher in the Goldilocks-only group (342.7 cc versus 136.8 cc; p < 0.0001). In the Goldilocks-only group, seven reconstructed breast mounds (7.3 percent) developed seroma, one breast mound (1.0 percent) required surgical evacuation of hematoma, and six breast mounds (6.3 percent) had surgical-site infection (three deep and three superficial). Four reconstructed breast mounds (4.2 percent) had skin flap necrosis (two partial-thickness and two full-thickness). Four reconstructed breast mounds required reoperation for the following reasons: one because of surgical evacuation of hematoma, two for surgical débridement, and one required abscess drainage. Reasons for readmission were as follows: surgical-site infection treatment in three cases, and one patient developed deep venous thrombosis postoperatively. In the Goldilocks with immediate breast reconstruction group, we divided complications into two groups: the first and second stages. In the first stage, five breast mounds (6.3 percent) developed seroma, four (5.1 percent) had hematoma, and six (7.6 percent) presented with surgical-site infection (three deep and three superficial). Eleven reconstructed breasts mounds (13.9 percent) had skin flap necrosis (eight partial-thickness and three full-thickness). Eight breast mounds required unplanned reoperation: four because of hematoma evacuation and four because of surgical débridement. Four patients had unplanned readmissions: three because of surgical-site infection and one because of flap necrosis. In the second stage, none presented with seroma, hematoma or skin flap necrosis, and only four (5.5 percent) developed superficial surgical-site infection and one (1.4 percent) developed partial-thickness wound dehiscence. Three reconstructed breasts mounds (4.1 percent) developed capsular contracture grade 3. Only one patient had unplanned reoperation and readmission because of surgical-site infection.

Table 4. - Complications and Surgical Outcomes
Characteristic Goldilocks Only* Goldilocks with Implant-Based IBR p
Fat grafting 33 (34.4) 54 (63.5) <0.0001
 Total volume, cc§ 342.7 ± 38.7 136.8 ± 30.5 <0.0001
Revision surgery 21 (21.9) 20 (23.5) 0.070
Nipple reconstruction 2 (2.1) 14 (16.5) 0.0010
First-stage complications
 Seroma 7 (7.3) 5 (6.3) 0.8020
 Hematoma 1 (1.0) 4 (5.1) 0.1765
 SSI 6 (6.3) 6 (7.6) 0.7261
  Superficial 3 3
  Deep 3 3
 Wound dehiscence
  Partial thickness 8 (8.3) 13 (16.5) 0.0999
  Full thickness 4 (4.2) 3 (3.8) 1.0
 Skin flap necrosis
  Partial thickness 2 (2.1) 8 (10.1) 0.0225
  Full thickness 2 (2.1) 3 (3.8) 0.6591
TE malposition 2 (2.5)
TE explantation 6 (7.6)
Unplanned reoperation 4 (4.2) 8 (10.1) 0.1205
Unplanned readmission 5 (5.2) 4 (5.1) 1.0
Second-stage complications
 Seroma 0
 Hematoma 0
 SSI 4 (5.5)
  Superficial 4
  Deep 0
 Wound dehiscence 1 (1.4)
  Partial thickness 1
  Full thickness 0
 Skin flap necrosis 0
  Partial thickness 0
  Full thickness 0
Implant malposition 6 (8.2)
Implant explantation 11 (15.1)
Capsular contracture# 3 (4.1)
Unplanned reoperation 1 (1.4)
Unplanned readmission 1 (1.4)
IBR, immediate breast reconstruction; SSI, surgical-site infection; TE, tissue expander.
*n = 96 breasts.
n = 85 breasts.
‡Statistically significant.
§Some patients underwent several fat grafting sessions. This value represents the total fat volume of all sessions.
∥Six breasts underwent tissue explantation: four because of infection and one because of skin flap necrosis. A patient who underwent left tissue expander explantation because of infection requested contralateral tissue expander removal for symmetry.
¶Eleven breasts underwent implant explantation: two because of postoperative breast pain, four because of implant malposition, two because of infection, two had implant pocket change from subpectoral to prepectoral, and one patient (one breast) desired a lower implant size.
#All had capsular contracture grade 3.

Table 5 presents univariate and multivariable analyses for minor and major complication rates. This represents the entire cohort. Figures 6 and 7 show Kaplan-Meier curves comparing both groups for minor and major complications, respectively. On univariate analysis, immediate breast reconstruction was associated with increased risk of minor complications at any given time (unadjusted hazard ratio, 2.55; 95 percent CI, 1.24 to 5.64). All other potential risk factors failed to achieve statistical significance for minor complications on univariate analysis. On multivariable analysis, immediate breast reconstruction was still significantly associated with increased minor complication rate at any given time (adjusted hazard ratio, 2.83; 95 percent CI, 1.22 to 7.02), adjusting for age, body mass index and diabetes. Diabetes was also found to be associated with increased risk of minor complications at any given time (adjusted hazard ratio, 2.68; 95 percent CI, 1.11 to 5.86). When analyzing major complications, immediate breast reconstruction showed a statistically significant association with increased risk of major complications at any given time on univariate analysis (unadjusted hazard ratio, 2.26; 95 percent CI, 1.25 to 4.24). On multivariable analysis, immediate breast reconstruction was associated with increased risk of major complications at any given time (adjusted hazard ratio, 4.03; 95 percent CI, 1.93 to 8.83), adjusting for age, body mass index, degree of breast ptosis, and adjuvant chemotherapy.

Table 5. - Risk Factors for Minor and Major Complications
Characteristic Minor Complication Rate Major Complication Rate
Unadjusted HR (95% CI) Adjusted HR (95% CI)* Unadjusted HR (95% CI) Adjusted HR (95% CI)
Implant-based IBR 2.55 (1.24–5.64) 2.83 (1.22–7.02) 2.26 (1.25–4.24) 4.03 (1.93–8.83)
Age, yr 1.00 (0.97–1.04) 1.01 (0.97–1.05) 1.00 (0.97–1.03) 1.01 (0.98–1.04)
BMI, kg/m2 0.96 (0.90–1.03) 1.00 (0.92–1.07) 1.01 (0.96–1.05) 1.04 (0.99–1.10)
Smoking history 1.15 (0.57–2.32) 1.05 (0.59–1.88)
Hypertension 0.78 (0.37–1.57) 1.09 (0.60–1.94)
Diabetes 2.37 (1.00–5.07) 2.68 (1.11–5.86) 1.52 (0.69–3.01)
Hyperlipidemia 1.57 (0.78–3.17) 1.39 (0.77–2.48)
Ptosis grade II 2.00 (0.75–7.01) 1.88 (0.69–6.61) 1.20 (0.42–4.34)
Ptosis grade III 0.54 (0.16–2.07) 2.64 (1.01–9.06) 2.63 (0.97–9.29)
Oncologic indication 0.79 (0.39–1.58) 0.87 (0.49–1.57)
Resection weight 1.00 (1.00–1.00) 1.00 (1.00–1.00)
Intraoperative ICG-A 0.77 (0.30–1.69) 1.58 (0.85–2.86)
SLNB 0.66 (0.32–1.34) 0.78 (0.43–1.40)
ALND 1.16 (0.34–2.96) 1.92 (0.83–3.92)
Postoperative radiation therapy 0.83 (0.25–2.11) 1.34 (0.58–2.73)
Neoadjuvant chemotherapy 1.27 (0.56–2.65) 0.64 (0.28–1.31)
Adjuvant chemotherapy 1.47 (0.64–3.08) 2.21 (1.17–4.01) 1.97 (1.51–5.72)
HR, hazard ratio; IBR, immediate breast reconstruction; BMI, body mass index; ICG-A, indocyanine green angiography; SLNB, sentinel lymph node biopsy; ALND, axillary lymph node dissection.
*Adjusted to implant-based immediate breast reconstruction, age, body mass index, and diabetes.
†Adjusted to implant-based immediate breast reconstruction, age, body mass index, ptosis grade, and adjuvant chemotherapy.
‡Statistically significant.

Fig. 6.
Fig. 6.:
A 54-year-old patient with a body mass index of 43 kg/m2 and a diagnosis of left breast cancer stage I underwent bilateral Goldilocks-only reconstruction. Preoperative (left) and 1-year-postoperative (right) clinical photographs are shown. A total of 900 g and 1185 g were removed from the right and left breasts, respectively. The patient did not have any major postoperative complications. She underwent one session of fat grafting with a total of 120 cc and 180 cc fat transferred to the right and left breast mounds, respectively. In the same surgical procedure, a revision of bilateral lateral chest incisions was performed.
Fig. 7.
Fig. 7.:
A 56-year-old patient with a body mass index of 33.8 kg/m2 and a diagnosis of right breast cancer stage I underwent bilateral Wise-pattern skin-sparing mastectomy with vascularized inferior dermal flap and concurrent two-stage implant-based immediate breast reconstruction (Goldilocks with immediate breast reconstruction) without the use of acellular dermal matrix. A total of 1295 g and 1205 g were removed from the right and left breasts, respectively. Tissue expanders of 700 cc were placed in the prepectoral plane. The patient underwent a total of three filling sessions with a final volume of 520 cc and 450 cc in the right and left breast mounds, respectively. Eight months after initial surgery, the tissue expanders were exchanged to permanent implants of 745 cc each. The patient did not have any major complication in the first or second reconstructive stages. Preoperative (left) and 1-year-postoperative (right) clinical photographs are shown.

Subgroup analyses were performed for patients with a body mass index greater than or equal to 35 kg/m2 and a body mass index greater than or equal to 40 kg/m2. Patients with a body mass index greater than or equal to 35 kg/m2 who underwent the Goldilocks procedure with immediate breast reconstruction were 3.3 times more likely to have a minor complication (unadjusted hazard ratio, 3.26; 95 percent CI, 1.35 to 8.33) and 3.4 times more likely to experience a major complication at any given time (unadjusted hazard ratio, 3.36; 95 percent CI, 1.74 to 6.66) than patients who underwent the Goldilocks-only procedure. For patients with a body mass index greater than or equal to 40 kg/m2, patients who underwent Goldilocks with immediate breast reconstruction were 3.8 more likely to have a major complication at any given time (unadjusted hazard ratio, 3.79; 95 percent CI, 1.02 to 11.72) compared with patients who underwent the Goldilocks-only procedure.

Response rate for the BREAST-Q was 40.4 percent in the Goldilocks-only group and 58.3 percent in the Goldilocks with immediate breast reconstruction group. Patient satisfaction with breasts, and physical, psychosocial, and sexual well-being were not found to be statistically different between groups. Table 6 shows BREAST-Q results.

Table 6. - BREAST-Q Results*
Category Goldilocks Only (IQR) Goldilocks with Implant-Based IBR (IQR) p
Response rate 40.4% 58.3%
Satisfaction with breasts 83.3 (66.7–91.7) 90.0 (74.2–95.0) 0.2005
Physical well-being 96.7 (81.7–100) 95.3 (69.7–100) 0.7714
Psychosocial well-being 86.0 (78.0–96.0) 91.0 (72.5–100) 0.6032
Sexual well-being 52.0 (40.0–81.7) 73.3 (43.3–96.7) 0.1473
IQR, interquartile range; IBR, immediate breast reconstruction.
*Data are presented as median and interquartile range. BREAST-Q results were converted to a 0–100 numeric scale, with higher numbers indicating higher satisfaction or well-being. Statistical significance was obtained using Wilcoxon ranked sum test.

DISCUSSION

This study is the largest report on a cohort of patients undergoing mastectomy with the Goldilocks procedure. It is also the first, to our knowledge, to compare the surgical and patient-reported outcomes between patients that undergo this procedure in conjunction with immediate breast reconstruction and those without immediate breast reconstruction. Our analyses yielded important insights into the difficulties of immediate breast reconstruction in obese patients who underwent the Goldilocks procedure, with potential consequences in preoperative planning and surgical indications. We found that at any particular time, obese patients that underwent the Goldilocks procedure with immediate breast reconstruction during the study period were more likely to experience a minor or major complication compared to those who underwent the Goldilocks-only procedure. Furthermore, among patients with a body mass index greater than or equal to 35 kg/m2, those with immediate breast reconstruction were 3.4 times more likely to have a major complication at any given time than patients who underwent the Goldilocks-only procedure, and in patients with body mass index greater than or equal to 40 kg/m2, they were 3.8 more likely to experience a major complication at any given time. In addition, no statistically significant differences were found for patient satisfaction with their breasts between groups using the BREAST-Q questionnaire.

Implant-based immediate breast reconstruction is the most common type of reconstruction performed worldwide.10,19 However, in obese patients, risk of complications may be higher.4–9 The current study is in line with previous studies suggesting a higher risk of complication in this patient population. The associated mammary hypertrophy in these patients often results in technical difficulties that translate into longer operative times both for the mastectomy and for the reconstructive part of the operation.20–23 Complications particularly associated with obesity include but are not limited to seroma, delayed wound healing, and potentially infection.4,5,24 It is hypothesized that a larger dead space after the removal of abundant breast tissue may contribute to a higher risk of seroma formation.25 Longer operative times, in addition to metabolic and immune alterations, may explain the increased risk of infection and wound dehiscence rates.26 Moreover, diabetes mellitus, which is more common in obese patients, can increase the risk of infection and delay wound healing among breast reconstruction patients. Our study showed that the risk of having minor complications at any given time were 2.7 times higher in patients with diabetes compared to those who did not have diabetes (adjusted hazard ratio, 2.68; 95 percent CI, 1.11 to 5.86), adjusting for immediate breast reconstruction, age, and body mass index. For all these reasons, this high-risk population deserves a more careful approach when choosing breast reconstruction options.

The Goldilocks procedure appears to be a reasonable and feasible option for obese patients, particularly those with ptotic breasts, seeking postmastectomy breast reconstruction; there is still a paucity of published literature regarding indications for and outcomes of this procedure.11–16,27–33 Possibly one of the reasons for its lag within the surgical community and failure to permeate through many institutions may lie in its relatively recent description. However, one of the greatest concerns is that this procedure does not represent a full reconstruction, because it is not a traditional reconstruction. This could affect patient satisfaction and trigger the patient to request additional breast operations. For instance, in a small case series conducted in Japan, the Goldilocks procedure was performed in five obese Japanese female patients with breast ptosis.31 They reported good aesthetic results in only two patients, although the authors did not specify how this was evaluated. They also acknowledged that although the reconstructed breasts were small, the Goldilocks procedure resulted in better aesthetic results than what would be achieved with the usual method of mastectomy for severely obese Japanese patients.31 Nevertheless, with regard to patient satisfaction, they reported that one patient was highly satisfied and three others did not complain about the cosmetic results. Interestingly, the last patient was not satisfied, as she thought that she had received full breast reconstruction. This depicts the main caveat for this type of procedure, in particular, which is an adequate surgeon-patient discussion to set expectations and clear doubts preoperatively.

The Goldilocks procedure was originally described as a surgical alternative for high-risk patients undergoing postmastectomy breast reconstruction, in which a more formal reconstruction is not offered because of the potential high risk of complications. In our study, we identified that at least one-third of breasts that underwent the Goldilocks-only procedure and almost two-thirds of breasts that underwent Goldilocks and immediate breast reconstruction underwent fat grafting. Understandably, the Goldilocks-only group had a relatively larger volume injected compared to the Goldilocks with immediate breast reconstruction group. Moreover, at least 20 percent of breasts in each group required any type of revision surgery, such as lateral chest incision revisions. These considerations have to be discussed openly with the patient when offering this procedure.

Using the Wise pattern to take advantage of the excess skin and subcutaneous tissue in this challenging patient population has proven successful from both patient safety and patient satisfaction perspectives. Its relatively simple technique and flexibility confer the Goldilocks procedure with a vast range of uses. It has also been described as an alternative method for patients with failed prosthetic breast reconstruction.14 Other authors have proposed its use as a first-stage procedure followed by skin tailoring and fat grafting sessions as a second stage, or as a safe bridge to a delayed immediate breast reconstruction.16,33 Moreover, it has the potential advantage of not relying as much on acellular dermal matrix for soft-tissue reinforcement or support in cases of immediate breast reconstruction. In our experience, it has shown successful outcomes and can be a preferred option in patients with higher than average body mass index or excess local breast tissue.13,15 Moreover, the Goldilocks procedure (without immediate breast reconstruction) could be a first-line option in patients with a body mass index greater than or equal to 40 kg/m2 based on the results of the current study. This study gives patients and providers, in particular, a comprehensive overview of the risks and benefits of the Goldilocks procedure in the obese population and the care to be taken when the procedure is performed with immediate breast reconstruction.

Limitations

This study is not without limitations. Despite conducting multivariable analyses and controlling for several covariates, particularly age and body mass index, there remains the possibility of confounding or effect modification by other unknown variables that might have accounted for the observed results. For instance, seven patients had a history of radiation therapy in the Goldilocks-only group versus only one patient in the Goldilocks with immediate breast reconstruction group. Although the difference was not statistically significant (p = 0.07), reconstructive surgeons might have been less likely inclined to use implants in previously irradiated breasts. The use of randomization would have allowed better control for these variables; however, because of the retrospective nature of this study design, this was not possible. Another limitation of this study was the low response rate for the patient-reported outcome surveys. Even though low response rate (<50 percent) need not necessarily lead to biased results and bias is more likely to result from examining a simple univariate distribution, we expected a higher response rate to adequately represent our study population.34 However, response rates were similar in both groups, and none of the comparisons among different categories were close to reaching statistical significance. In addition, the results of this study may not be generalizable to all patient population, because these cases were all performed in tertiary care institutions.

CONCLUSIONS

Breast reconstruction in patients with a high body mass index can be performed in many ways. Based on our experience and the results of this study, our recommendation as an institution is that the Goldilocks procedure can be a good reconstructive option to offer in obese patients with ptotic breasts that desire an immediate reconstruction and are willing to have smaller breasts. Immediate breast reconstruction may be offered in conjunction with the Goldilocks procedure; however, for patients with a body mass index greater than or equal to 35 kg/m2, special care should be taken because of the increased risk of complications. If the Goldilocks procedure is considered for patients with a body mass index greater than or equal to 40 kg/m2, we recommend the Goldilocks-only procedure, as Goldilocks with immediate breast reconstruction procedures were associated with a significantly higher risk of complications; instead, other options may be preferred, such as the Goldilocks-only procedure.

ACKNOWLEDGMENT

The authors thank Michael King, M.F.A., senior medical illustrator at the Division of Biomedical and Scientific Visualization, Mayo Clinic, Rochester, Minnesota, for his valuable contribution with the medical illustrations here presented.

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