Abstract
Background
There is a lack of consensus detailing the optimal approach to free-flap breast reconstruction when considering immediate, delayed, or staged techniques. This study compared costs, complications, and healthcare resource utilization (HCRU) across staged, delayed, and immediate free-flap breast reconstruction.
Patients and Methods
Retrospective study using MarketScan databases to identify women who underwent mastectomies and free-flap reconstructions between 2014 and 2018. Complications, costs, and HCRU [readmission, reoperation, emergency department (ED) visits] occurring 90 days after mastectomy and 90 days after free flap were compared across immediate, delayed, and staged reconstruction.
Results
Of 3310 women identified, 69.8% underwent immediate, 11.7% underwent delayed, and 18.5% underwent staged free-flap reconstruction. Staged reconstruction was associated with the highest rate (57.8% staged, 42.3% delayed, 32.0% immediate; p < 0.001) and adjusted relative risk [67% higher than immediate (95% CI: 49–87%; p < 0.001)] of surgical complications. Staged displayed the highest HCRU (staged 47.9%, delayed, 38.4%, immediate 25.2%; p < 0.001), with 16.5%, 30.7%, and 26.5% of staged patients experiencing readmission, reoperation, or ED visit, respectively. The adjusted probability of HCRU was 206% higher (95% CI: 156–266%; p < 0.001) for staged compared with immediate. Staged had the highest mean total cost (staged $106,443, delayed $80,667, immediate $76,756; p < 0.001) with regression demonstrating the adjusted mean cost for staged is 31% higher (95% CI: 23–39%; p < 0.001) when compared with immediate.
Conclusions
Staged free-flap reconstruction is associated with increased complications, costs, and HCRU, while immediate demonstrated the lowest. The potential esthetic benefits of a staged approach should be balanced with the increased risk for adverse events after surgery.
Supplementary Information
The online version contains supplementary material available at 10.1245/s10434-022-12896-0.
Approximately 250,000 new cases of invasive breast cancer are diagnosed each year, with 50–60% of mastectomy patients electing to undergo reconstructive surgery.1 When considering reconstructive options, there has been a gradual rise in the rates of free-flap breast reconstruction with an increasing amount of evidence supporting superior long-term satisfaction and improved quality of life compared with implant-based techniques.2 However, there remains a lack of consensus regarding the optimal timing and approach to free-flap reconstruction, with improved patient well-being and superior esthetic outcomes being associated with immediate (performed at the time of mastectomy) as opposed to delayed (performed after mastectomy) reconstructive techniques.3,4
In 2002, Kronowitz et al. introduced the concept of a staged (i.e., delayed–immediate) approach to free-flap breast reconstruction.5 With this technique, a tissue expander is placed at the time of mastectomy to preserve the native breast skin envelope, allowing for decreased skin requirements during free-flap reconstruction and improved esthetic outcomes.6 While the indications for a staged approach were initially described for patients with an uncertain need for radiation therapy, these indications have expanded to include patients with significant medical comorbidities, tenuous mastectomy skin flaps, and those who have not yet made a final decision regarding their preferred type of breast reconstruction. Furthermore, with evidence suggesting that an immediate form of reconstruction to preserve the breast mound may confer improved psychosocial well-being, a two-stage approach has been increasingly utilized when immediate reconstruction is unable to be performed.7–9
Complications following staged reconstruction are reported to approach 30–40%, especially in the setting of radiation therapy.10–13 However, there remains a lack of consensus detailing the optimal timing of free-flap breast reconstruction when considering an immediate, delayed, or staged approach. Thus, to inform high-quality treatment decisions, this study aimed to compare costs, complications, and healthcare utilization across patients undergoing immediate, delayed, or staged free-flap breast reconstruction.
Patients and Methods
Data Source and Study Cohort
This study utilized the IBM MarketScan commercial claims and encounters and medicare supplemental databases to identify women ≥ 18 years old who were diagnosed with breast cancer and underwent a mastectomy with eventual free-flap breast reconstruction. The MarketScan research databases capture receipt of care in inpatient and outpatient settings and patient-level utilization of healthcare services in a longitudinal manner, making it uniquely suited to capture episodes of care related to breast reconstruction. Women who were diagnosed with breast cancer and underwent a mastectomy between 1 January 2014 and 31 December 2018, were identified and included, utilizing International Classification of Diseases, Ninth Revision (ICD-9) procedure codes, ICD-10 procedure codes, and/or Current Procedural Terminology (CPT) codes. The algorithm proposed by Nattinger et al. was used to identify whether patients with a mastectomy were incident and prevalent cases of breast cancer.14 Only patients who underwent a form of free-flap breast reconstruction after mastectomy were included. Relevant ICD and CPT codes used for identification of the cohort are included in Supplementary Digital Content (SDC) Tables 1 and 2.
Table 1.
Demographics and clinical characteristics by reconstruction method
| Immediate (N = 2310) | Delayed (N = 388) | Staged (N = 612) | Total (N = 3310) | |
|---|---|---|---|---|
| Age at mastectomy (years) | ||||
| Mean (SD) | 51.3 (8.3) | 49.6 (8.8) | 49.4 (8.1) | 50.7 (8.4) |
| Median | 52.0 | 50.0 | 49.0 | 51.0 |
| Q1, Q3 | 45.0, 58.0 | 43.0, 57.0 | 44.0, 56.0 | 45.0, 57.0 |
| Range | (21.0–75.0) | (19.0–68.0) | (22.0–68.0) | (19.0–75.0) |
| Urban MSA | ||||
| No | 139 (6.0%) | 56 (14.4%) | 35 (5.7%) | 230 (6.9%) |
| Yes | 2171 (94.0%) | 332 (85.6%) | 577 (94.3%) | 3080 (93.1%) |
| Geographic region | ||||
| Northeast | 636 (27.5%) | 34 (8.8%) | 103 (16.8%) | 773 (23.4%) |
| North Central | 280 (12.1%) | 54 (13.9%) | 89 (14.5%) | 423 (12.8%) |
| South | 1137 (49.2%) | 229 (59.0%) | 347 (56.7%) | 1713 (51.8%) |
| West | 243 (10.5%) | 69 (17.8%) | 69 (11.3%) | 381 (11.5%) |
| Unknown | 14 (0.6%) | 2 (0.5%) | 4 (0.7%) | 20 (0.6%) |
| Insurance plan type | ||||
| Missing | 45 | 8 | 15 | 68 |
| Comprehensive | 52 (2.3%) | 7 (1.8%) | 24 (4.0%) | 83 (2.6%) |
| EPO or HMO | 322 (14.2%) | 51 (13.4%) | 66 (11.1%) | 439 (13.5%) |
| POS or PPO | 1495 (66.0%) | 255 (67.1%) | 364 (61.0%) | 2114 (65.2%) |
| Basic/major medical, CDHP, HDHP | 396 (17.5%) | 67 (17.6%) | 143 (24.0%) | 606 (18.7%) |
| Employment status | ||||
| Active full or part time | 1522 (65.9%) | 270 (69.6%) | 459 (75.0%) | 2251 (68.0%) |
| Retiree | 186 (8.1%) | 25 (6.4%) | 28 (4.6%) | 239 (7.2%) |
| Other/unknown | 595 (25.8%) | 91 (23.5%) | 119 (19.4%) | 805 (24.3%) |
| Long term disability | 7 (0.3%) | 2 (0.5%) | 6 (1.0%) | 15 (0.5%) |
| Bilateral mastectomy | ||||
| No | 1455 (63.0%) | 312 (80.4%) | 435 (71.1%) | 2202 (66.5%) |
| Yes | 855 (37.0%) | 76 (19.6%) | 177 (28.9%) | 1108 (33.5%) |
| Lymph node surgery at time of mastectomy | ||||
| No | 901 (39.0%) | 187 (48.2%) | 182 (29.7%) | 1270 (38.4%) |
| Yes | 1409 (61.0%) | 201 (51.8%) | 430 (70.3%) | 2040 (61.6%) |
| Chemotherapy | ||||
| None | 1543 (66.8%) | 129 (33.2%) | 261 (42.6%) | 1933 (58.4%) |
| Before mastectomy | 184 (8.0%) | 58 (14.9%) | 84 (13.7%) | 326 (9.8%) |
| After mastectomy | 421 (18.2%) | 110 (28.4%) | 167 (27.3%) | 698 (21.1%) |
| Before and after mastectomy | 162 (7.0%) | 91 (23.5%) | 100 (16.3%) | 353 (10.7%) |
| Radiation | ||||
| None | 2178 (94.3%) | 198 (51.0%) | 367 (60.0%) | 2743 (82.9%) |
| Before mastectomy | 37 (1.6%) | 2 (0.5%) | 2 (0.3%) | 41 (1.2%) |
| After mastectomy | 95 (4.1%) | 188 (48.5%) | 242 (39.5%) | 525 (15.9%) |
| Before and after mastectomy | 0 (0.0%) | 0 (0.0%) | 1 (0.2%) | 1 (0.0%) |
| Other cancer diagnosis in year prior to or within 90 days of mastectomy | ||||
| No | 2048 (88.7%) | 351 (90.5%) | 536 (87.6%) | 2935 (88.7%) |
| Yes | 262 (11.3%) | 37 (9.5%) | 76 (12.4%) | 375 (11.3%) |
| Dermal matrix placed at index mastectomy or reconstruction | ||||
| No | 2113 (91.5%) | 351 (90.5%) | 162 (26.5%) | 2626 (79.3%) |
| Yes | 197 (8.5%) | 37 (9.5%) | 450 (73.5%) | 684 (20.7%) |
| NCI comorbidity index | ||||
| Missing | 0 | 0 | 0 | 0 |
| Mean (SD) | 0.2 (0.3) | 0.2 (0.3) | 0.2 (0.3) | 0.2 (0.3) |
| Median | 0.0 | 0.0 | 0.0 | 0.0 |
| Q1, Q3 | 0.0, 0.3 | 0.0, 0.5 | 0.0, 0.3 | 0.0, 0.3 |
| Range | (0.0–2.2) | (0.0–1.9) | (0.0–1.6) | (0.0–2.2) |
Table 2.
Complications within 90 days after mastectomy or free flap
| Immediate (N = 2310) | Delayed (N = 388) | Staged (N = 612) | Total (N = 3310) | p-Value | |
|---|---|---|---|---|---|
| Individual systemic complications | |||||
| Stroke | |||||
| Mastectomy | – | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Free flap | – | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Mastectomy or free flap | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | – |
| Urinary | |||||
| Mastectomy | – | 0 (0.0%) | 1 (0.2%) | 1 (0.1%) | |
| Free flap | – | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Mastectomy or free flap | 4 (0.2%) | 0 (0.0%) | 1 (0.2%) | 5 (0.2%) | 0.71611 |
| DVT/PE | |||||
| Mastectomy | – | 1 (0.3%) | 6 (1.0%) | 7 (0.7%) | |
| Free flap | – | 13 (3.4%) | 18 (2.9%) | 31 (3.1%) | |
| Mastectomy or free flap | 73 (3.2%) | 14 (3.6%) | 21 (3.4%) | 108 (3.3%) | 0.86981 |
| Digestive | |||||
| Mastectomy | – | 4 (1.0%) | 3 (0.5%) | 7 (0.7%) | |
| Free flap | – | 2 (0.5%) | 9 (1.5%) | 11 (1.1%) | |
| Mastectomy or free flap | 33 (1.4%) | 6 (1.5%) | 12 (2.0%) | 51 (1.5%) | 0.63651 |
| Cardiovascular | |||||
| Mastectomy | – | 9 (2.3%) | 26 (4.2%) | 35 (3.5%) | |
| Free flap | – | 10 (2.6%) | 38 (6.2%) | 48 (4.8%) | |
| Mastectomy or free flap | 94 (4.1%) | 18 (4.6%) | 60 (9.8%) | 172 (5.2%) | < 0.00011 |
| Respiratory | |||||
| Mastectomy | – | 3 (0.8%) | 5 (0.8%) | 8 (0.8%) | |
| Free flap | – | 11 (2.8%) | 18 (2.9%) | 29 (2.9%) | |
| Mastectomy or free flap | 65 (2.8%) | 14 (3.6%) | 22 (3.6%) | 101 (3.1%) | 0.48241 |
| Individual surgical complications | |||||
| Wound dehiscence | |||||
| Mastectomy | – | 9 (2.3%) | 47 (7.7%) | 56 (5.6%) | |
| Free flap | – | 48 (12.4%) | 75 (12.3%) | 123 (12.3%) | |
| Mastectomy or free flap | 266 (11.5%) | 52 (13.4%) | 113 (18.5%) | 431 (13.0%) | < 0.00011 |
| Wound infection | |||||
| Mastectomy | – | 18 (4.6%) | 66 (10.8%) | 84 (8.4%) | |
| Free flap | – | 20 (5.2%) | 46 (7.5%) | 66 (6.6%) | |
| Mastectomy or free flap | 93 (4.0%) | 13 (3.4%) | 64 (10.5%) | 170 (5.1%) | < 0.00011 |
| Flap revision | |||||
| Mastectomy | – | 0 (0.0%) | 2 (0.3%) | 2 (0.2%) | |
| Free flap | – | 9 (2.3%) | 13 (2.1%) | 22 (2.2%) | |
| Mastectomy or free flap | 51 (2.2%) | 9 (2.3%) | 15 (2.5%) | 75 (2.3%) | 0.93481 |
| Hematoma | |||||
| Mastectomy | – | 17 (4.4%) | 10 (1.6%) | 27 (2.7%) | |
| Free flap | – | 19 (4.9%) | 23 (3.8%) | 42 (4.2%) | |
| Mastectomy or free flap | 132 (5.7%) | 36 (9.3%) | 33 (5.4%) | 201 (6.1%) | 0.01821 |
| Microvascular | |||||
| Mastectomy | – | 0 (0.0%) | 1 (0.2%) | 1 (0.1%) | |
| Free flap | – | 27 (7.0%) | 95 (15.5%) | 122 (12.2%) | |
| Mastectomy or free flap | 138 (6.0%) | 27 (7.0%) | 96 (15.7%) | 261 (7.9%) | < 0.00011 |
| Transfusion | |||||
| Mastectomy | – | 3 (0.8%) | 0 (0.0%) | 3 (0.3%) | |
| Free flap | – | 1 (0.3%) | 5 (0.8%) | 6 (0.6%) | |
| Mastectomy or free flap | 9 (0.4%) | 4 (1.0%) | 5 (0.8%) | 18 (0.5%) | 0.16841 |
| Seroma | |||||
| Mastectomy | – | 18 (4.6%) | 33 (5.4%) | 51 (5.1%) | |
| Free flap | – | 15 (3.9%) | 21 (3.4%) | 36 (3.6%) | |
| Mastectomy or free flap | 80 (3.5%) | 31 (8.0%) | 53 (8.7%) | 164 (5.0%) | < 0.00011 |
| Fat necrosis | |||||
| Mastectomy | – | 12 (3.1%) | 34 (5.6%) | 46 (4.6%) | |
| Free flap | – | 20 (5.2%) | 21 (3.4%) | 41 (4.1%) | |
| Mastectomy or free flap | 126 (5.5%) | 31 (8.0%) | 53 (8.7%) | 210 (6.3%) | 0.00561 |
| Mechanical complications | |||||
| Mastectomy | – | 0 (0.0%) | 35 (5.7%) | 35 (3.5%) | |
| Free flap | – | 11 (2.8%) | 29 (4.7%) | 40 (4.0%) | |
| Mastectomy or free flap | 62 (2.7%) | 11 (2.8%) | 60 (9.8%) | 133 (4.0%) | < 0.00011 |
| Individual surgical complications requiring a return to OR | |||||
| Hematoma requiring reoperation | |||||
| Mastectomy | – | 25 (6.4%) | 19 (3.1%) | 44 (4.4%) | |
| Free flap | – | 18 (4.6%) | 28 (4.6%) | 46 (4.6%) | |
| Mastectomy or free flap | 128 (5.5%) | 41 (10.6%) | 45 (7.4%) | 214 (6.5%) | 0.00061 |
| Wound infection requiring reoperation | |||||
| Mastectomy | – | 9 (2.3%) | 32 (5.2%) | 41 (4.1%) | |
| Free flap | – | 15 (3.9%) | 30 (4.9%) | 45 (4.5%) | |
| Mastectomy or free flap | 148 (6.4%) | 24 (6.2%) | 57 (9.3%) | 229 (6.9%) | 0.03481 |
| Tissue expander requiring reoperation | |||||
| Mastectomy | – | 2 (0.5%) | 68 (11.1%) | 70 (7.0%) | |
| Free flap | – | 2 (0.5%) | 52 (8.5%) | 54 (5.4%) | |
| Mastectomy or free flap | 5 (0.2%) | 4 (1.0%) | 114 (18.6%) | 123 (3.7%) | < 0.00011 |
| Wound complication requiring reoperation | |||||
| Mastectomy | – | 0 (0.0%) | 16 (2.6%) | 16 (1.6%) | |
| Free flap | – | 10 (2.6%) | 17 (2.8%) | 27 (2.7%) | |
| Mastectomy or free flap | 46 (2.0%) | 10 (2.6%) | 32 (5.2%) | 88 (2.7%) | 0.00011 |
| Flap compromise requiring reoperation | |||||
| Mastectomy | – | 0 (0.0%) | 2 (0.3%) | 2 (0.2%) | |
| Free flap | – | 7 (1.8%) | 17 (2.8%) | 24 (2.4%) | |
| Mastectomy or free flap | 39 (1.7%) | 7 (1.8%) | 19 (3.1%) | 65 (2.0%) | 0.07811 |
| Microvascular requiring reoperation | |||||
| Mastectomy | – | 0 (0.0%) | 1 (0.2%) | 1 (0.1%) | |
| Free flap | – | 27 (7.0%) | 95 (15.5%) | 122 (12.2%) | |
| Mastectomy or free flap | 138 (6.0%) | 27 (7.0%) | 96 (15.7%) | 261 (7.9%) | <0.00011 |
| Reconstruction failure | |||||
| Additional flap | |||||
| Mastectomy | – | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Free flap | – | 16 (4.1%) | 17 (2.8%) | 33 (3.3%) | |
| Mastectomy or free flap | 68 (2.9%) | 16 (4.1%) | 17 (2.8%) | 101 (3.1%) | 0.41611 |
| Tissue expander replacement or extrusion | |||||
| Mastectomy | – | 0 (0.0%) | 68 (11.1%) | 68 (6.8%) | |
| Free flap | – | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | |
| Mastectomy or free flap | 0 (0.0%) | 0 (0.0%) | 68 (11.1%) | 68 (2.1%) | |
| Grouped complication | |||||
| Systemic complication | |||||
| Mastectomy | – | 15 (3.9%) | 38 (6.2%) | 53 (5.3%) | |
| Free flap | – | 32 (8.2%) | 79 (12.9%) | 111 (11.1%) | |
| Mastectomy or free flap | 241 (10.4%) | 46 (11.9%) | 107 (17.5%) | 394 (11.9%) | < 0.00011 |
| Surgical complication | |||||
| Mastectomy | – | 69 (17.8%) | 167 (27.3%) | 236 (23.6%) | |
| Free flap | – | 124 (32.0%) | 273 (44.6%) | 397 (39.7%) | |
| Mastectomy or free flap | 739 (32.0%) | 164 (42.3%) | 354 (57.8%) | 1257 (38.0%) | < 0.00011 |
| Complication requiring return to OR | |||||
| Mastectomy | – | 32 (8.2%) | 100 (16.3%) | 132 (13.2%) | |
| Free flap | – | 67 (17.3%) | 188 (30.7%) | 255 (25.5%) | |
| Mastectomy or free flap | 402 (17.4%) | 93 (24.0%) | 252 (41.2%) | 747 (22.6%) | < 0.00011 |
| Reconstruction failure | |||||
| Mastectomy | – | 0 (0.0%) | 82 (13.4%) | 82 (8.2%) | |
| Free flap | – | 26 (6.7%) | 44 (7.2%) | 70 (7.0%) | |
| Mastectomy or free flap | 120 (5.2%) | 26 (6.7%) | 116 (19.0%) | 262 (7.9%) | < 0.00011 |
| Primary outcome | |||||
| Any complication | |||||
| Mastectomy | – | 78 (20.1%) | 187 (30.6%) | 265 (26.5%) | |
| Free flap | – | 145 (37.4%) | 314 (51.3%) | 459 (45.9%) | |
| Mastectomy or free flap | 887 (38.4%) | 182 (46.9%) | 393 (64.2%) | 1462 (44.2%) | < 0.00011 |
1Chi-square
To be eligible for inclusion in the final study cohort, a patient had to demonstrate continuous enrollment 12 months pre-mastectomy to 90 days post free-flap breast reconstruction. Patients were excluded from analysis if they: (1) displayed codes for a free-flap prior to their mastectomy, (2) did not have a breast cancer diagnosis on the date of or in the year prior to mastectomy, (3) had distant metastasis, (4) had a breast implant procedure within 1 year of mastectomy to 90 days after the free-flap was performed, (5) had a tissue expander placed prior to their mastectomy and not on the index surgery, (6) had a free-flap performed within 2 weeks of the index mastectomy but not within the index admission, (7) had a tissue expander placed after the index admission but before free-flap reconstruction, and (8) had a pedicled flap performed prior to their free-flap procedure. For the cost analysis, patients with capitated service claims and patients with outlying values below the 1st percentile or above the 99th percentile were excluded. The ICD-9, ICD-10, and CPT codes used to identify patients fitting the exclusion criteria are included in SDC Table 3.
Table 3.
Modified Poisson regression of at least one complication
| Variable | Relative risk (95% confidence interval) | p-Value |
|---|---|---|
| Reconstruction method | ||
| Immediate | Reference | – |
| Delayed | 1.28 (1.13, 1.46) | < 0.001 |
| Staged | 1.67 (1.49, 1.87) | < 0.001 |
| Staged versus delayed | 1.30 (1.13, 1.50) | < 0.001 |
| Age (years) | 1.01 (1.00, 1.01) | 0.014 |
| NCI comorbidity index | 1.18 (1.06, 1.31) | 0.002 |
| Rural versus urban | 0.92 (0.79, 1.08) | 0.303 |
| Region | ||
| South | Reference | – |
| North Central | 1.06 (0.95, 1.19) | 0.324 |
| Northeast | 0.98 (0.89, 1.08) | 0.667 |
| West | 0.99 (0.87, 1.11) | 0.834 |
| Employment status | ||
| Employed full or part-time | Reference | – |
| Disability | 0.80 (0.44, 1.46) | 0.473 |
| Other/unknown | 1.05 (0.96, 1.15) | 0.302 |
| Retiree | 0.98 (0.83, 1.15) | 0.778 |
| Bilateral mastectomy | 1.08 (0.99, 1.17) | 0.071 |
| Lymph node surgery at time of mastectomy | 0.90 (0.84, 0.98) | 0.012 |
| Chemotherapy before or after mastectomy | 1.01 (0.93, 1.10) | 0.756 |
| Radiation before or after mastectomy | 0.91 (0.82, 1.02) | 0.095 |
| Other cancer diagnosis | 1.07 (0.95, 1.19) | 0.266 |
| Dermal matrix | 1.10 (0.99, 1.22) | 0.083 |
Episodes of Care Duration and Categorization of Study Groups
The episodes of care durations were designed to capture complications, costs, and healthcare utilization related to the mastectomy, tissue expander, or free-flap procedure for patients undergoing reconstruction in either an immediate, delayed, or staged setting. Thus, complications, costs, and healthcare utilization were assessed in periods of 90 days after the index mastectomy and 90 days after the free-flap procedure. Immediate reconstruction was classified as patients who underwent a free flap for breast reconstruction on the date of mastectomy or within the index admission. Staged reconstruction was classified as patients who had a tissue expander placed on the date of mastectomy or within the index admission and who underwent a free flap for breast reconstruction after tissue expander placement. Delayed reconstruction was classified as patients who had a mastectomy without tissue-expander or free-flap reconstruction on the date of mastectomy or within the index admission and who later underwent a free flap for breast reconstruction. A flow diagram detailing selection of the patient cohort is shown in SDC Fig. 1.
Fig. 1.
Flow diagram of patient selection criteria
Study Variables
Clinical and socioeconomic variables were identified using 1-year pre-mastectomy claims to characterize the study population and to be utilized as covariates in the univariable and multivariable analyses. The National Cancer Institute (NCI) comorbidity index was used to estimate the comorbidity burden across the study population.15,16 The primary outcomes of interest were complications, costs, and healthcare resource utilization (HCRU), which occurred within 90 days after the index mastectomy and 90 days after the free-flap procedure. Complications were categorized as systemic or surgical complications. Individual systemic complications were identified in addition to individual surgical complications, which were further subcategorized as those requiring a return to the operating room and those denoting reconstructive failure.13,17–19 Reconstructive failure was defined as having the following events: (1) Tissue expander removal without replacement prior to the free-flap being performed, (2) a second flap procedure being performed after the index free-flap, and/or (3) tissue expander extrusion. The claims codes used to define the outcomes of interests are shown in SDC Table 4.
Table 4.
Healthcare resource utilization
| Immediate (N = 2310) | Delayed (N = 388) | Staged (N = 612) | Total (N = 3310) | p-Value | |
|---|---|---|---|---|---|
| Any readmissions within 90 days | |||||
| Mastectomy | – | 21 (5.4%) | 64 (10.5%) | 85 (8.5%) | |
| Free flap | – | 30 (7.7%) | 49 (8.0%) | 79 (7.9%) | |
| Mastectomy or free flap | 189 (8.2%) | 49 (12.6%) | 101 (16.5%) | 339 (10.2%) | < 0.00011 |
| Any reoperations within 90 days | |||||
| Mastectomy | – | 28 (7.2%) | 97 (15.8%) | 125 (12.5%) | |
| Free flap | – | 42 (10.8%) | 113 (18.5%) | 155 (15.5%) | |
| Mastectomy or free flap | 276 (11.9%) | 67 (17.3%) | 188 (30.7%) | 531 (16.0%) | < 0.00011 |
| Any ED visits within 90 days | |||||
| Mastectomy | – | 46 (11.9%) | 104 (17.0%) | 150 (15.0%) | |
| Free flap | – | 57 (14.7%) | 80 (13.1%) | 137 (13.7%) | |
| Mastectomy or free flap | 325 (14.1%) | 95 (24.5%) | 162 (26.5%) | 582 (17.6%) | < 0.00011 |
| Any readmission, reoperation, or ED visit within 90 days | |||||
| Mastectomy | – | 77 (19.8%) | 182 (29.7%) | 259 (25.9%) | |
| Free flap | – | 94 (24.2%) | 177 (28.9%) | 271 (27.1%) | |
| Mastectomy or free flap | 582 (25.2%) | 149 (38.4%) | 293 (47.9%) | 1024 (30.9%) | < 0.00011 |
1Chi-square
Costs and Healthcare Resource Utilization
Costs incurred within 90 days of the index mastectomy and free-flap reconstruction were calculated and compared. For patients undergoing delayed and staged reconstruction, costs within 90 days of both the mastectomy and the free flap were calculated. The following components of cost were considered: (1) index reconstruction (initial free-flap procedure or tissue expander placement) and index mastectomy, (2) complications, (3) complications requiring reoperation, (4) inpatient readmission, and (5) emergency department (ED) visits. Unplanned costs were defined as those incurred due to complications, ED visits, readmission, and reoperation. Rates of HCRU were also defined across the cohort as readmission, reoperation, and ED visits.
Statistical Analysis
Demographic characteristics, clinical characteristics, and payments to healthcare providers were summarized using means with standard deviation, medians with interquartile range, or frequencies with percentage as appropriate, and presented by reconstruction approaches. The proportions of individuals experiencing various complications and different types of all-cause HCRU were summarized using frequencies with percentages and compared between approaches using chi-square tests. The relative risks of any complication and HCRU were compared between approaches using modified Poisson regression, adjusting for age, NCI comorbidity index, urban/rural ZIP code, geographic region, employment status, laterality of mastectomy, lymph node surgery at the time of mastectomy, chemotherapy before or after mastectomy, radiation before or after mastectomy, and presence of other cancer diagnoses. The analysis of complications also adjusted for the use of dermal matrix. Payments to healthcare providers were compared between approaches using Kruskal–Wallis tests. Adjusted mean payments were compared using Gamma regression, adjusting for the same variables. Marginal mean costs for each reconstruction approach were calculated using separate Gamma regression models to assess the incremental costs associated with each type of adverse event for each type of reconstruction. Models adjusted for all covariates considered in the analysis of cost and included the interaction between adverse events and the reconstruction approach. All analyses were performed using SAS software version 9.4 (SAS Institute, Cary, NC). Statistical significance was defined as p < 0.05, without accounting for multiple testing due to the exploratory nature of the analysis. Any positive results should be confirmed in further studies.
Results
Participant Characteristics
Overall, 3310 women were included with 2310 (69.8%) undergoing immediate reconstruction, 388 (11.7%) undergoing delayed reconstruction, and 612 (18.5%) undergoing staged free-flap breast reconstruction. The average age of the patient cohort was 50.7 (SD 8.4) years. Most patients were in the South (51.8%), had full or part-time employment (68.0%), underwent a unilateral mastectomy (66.5%) with a sentinel or axillary lymph node dissection (61.6%), did not receive chemotherapy (58.4%) or radiation therapy (82.9%), and had minimal comorbidities with an average NCI comorbidity index of 0.2 (SD 0.3). Patient demographics and clinical characteristics are presented in Table 1.
Complications
When analyzing complications within 90 days after the mastectomy and/or free-flap procedure, patients undergoing staged reconstruction were found to have the highest overall rate of any complication that occurred (64.2% staged, 46.9% delayed, 38.4% immediate; p < 0.001). Staged reconstruction was associated with higher rates of systemic (17.5% staged, 11.9% delayed, 10.4% immediate; p < 0.001) and surgical complications (57.8% staged, 42.3% delayed, 32.0% immediate; p < 0.001), in addition to higher rates of complications that required a return to the operating room (OR) (41.2% staged, 24.0% delayed, and 17.4% immediate; p < 0.001) or resulted in reconstruction failure (19.0% staged, 6.7% delayed, 5.2% immediate; p < 0.001). Specifically, patients undergoing staged reconstruction displayed significantly higher rates of wound dehiscence, seroma, and mechanical complications (p < 0.001), with 15.7% of staged patients experiencing microvascular complications compared with 7.0% delayed and 6.0% immediate, and 11.1% of staged patients requiring tissue expander replacement or explant (Table 2).
A modified Poisson regression assessed the independent association of the modality of free-flap breast reconstruction with complications in the 90 days following mastectomy and/or the free-flap procedure. After adjusting for covariates, the estimated probability of experiencing a complication was 67% higher (95% CI: 49–87%; p < 0.001) for those undergoing staged when compared with immediate, 30% higher (95% CI: 13–50%; p < 0.001) for those undergoing staged when compared with delayed, and 28% higher (95% CI: 13–46%; p < 0.001) for those undergoing delayed when compared with immediate (Table 3). Overall, immediate reconstruction demonstrated the lowest rate of overall complications.
Healthcare Resource Utilization
HCRU in the 90-day period following mastectomy, reconstruction, and the combined periods following either was assessed by examining the occurrence of reoperations, all-cause readmission, and all-cause ED visits. Immediate reconstruction was found to have the lowest rate of all types of HCRU, with staged reconstruction displaying the highest (staged 47.9%, delayed 38.4%, immediate 25.2%; p < 0.001). More specifically, 16.5%, 30.7%, and 26.5% of patients undergoing staged reconstruction experienced readmission, reoperation, or an ED visit respectively within 90 days of their mastectomy and/or free-flap (Table 4).
A modified Poisson regression assessed the association of the type of reconstruction with any HCRU, finding that the adjusted probability of experiencing any post-operative HCRU was 206% higher (95% CI: 156–266%; p < 0.001) for those undergoing staged when compared with immediate, 63% higher (95% CI: 28–106%; p < 0.001) for those undergoing staged when compared with delayed, and 88% higher (95% CI: 50–137%; p < 0.001) for those undergoing delayed when compared with immediate (Table 5).
Table 5.
Modified Poisson regression of healthcare resource utilization
| Variable | Relative risk (95% confidence interval) | p-Value |
|---|---|---|
| Reconstruction method | ||
| Immediate | Reference | – |
| Delayed | 1.88 (1.50, 2.37) | < 0.001 |
| Staged | 3.06 (2.56, 3.66) | < 0.001 |
| Staged versus delayed | 1.63 (1.28, 2.06) | < 0.001 |
| Age (years) | 1.00 (0.99, 1.01) | 0.836 |
| NCI comorbidity index | 1.27 (1.04, 1.55) | 0.017 |
| Rural versus urban | 1.06 (0.81, 1.39) | 0.681 |
| Region | ||
| South | Reference | – |
| North Central | 1.08 (0.86, 1.35) | 0.514 |
| Northeast | 1.08 (0.89, 1.32) | 0.422 |
| West | 0.80 (0.62, 1.03) | 0.078 |
| Employment status | ||
| Employed full or part-time | Reference | – |
| Disability | 0.60 (0.22, 1.61) | 0.306 |
| Other/unknown | 1.16 (0.97, 1.38) | 0.101 |
| Retiree | 0.87 (0.64, 1.17) | 0.344 |
| Bilateral mastectomy | 1.28 (1.09, 1.51) | 0.003 |
| Lymph node surgery at time of mastectomy | 0.96 (0.82, 1.11) | 0.558 |
| Chemotherapy before or after mastectomy | 1.10 (0.94, 1.30) | 0.233 |
| Radiation before or after mastectomy | 0.83 (0.66, 1.04) | 0.104 |
| Other cancer diagnosis | 1.21 (0.98, 1.50) | 0.076 |
Costs of Care
Total costs were calculated and analyzed for each reconstruction type. The costs of the index procedures, that is the costs associated with the mastectomy (and placement of tissue expanders, dermal matrix, etc.) and the initial free-flap reconstruction, were significantly higher for the staged cohort as compared with immediate or delayed (mean costs: staged $106,443, delayed $80,667, immediate $76,756; p < 0.001). Among those who experienced a complication, staged patients displayed significantly higher costs associated with each complication than delayed or immediate reconstruction (mean costs: staged $44,479, delayed $37,148, immediate $40,975; p = 0.03), with similar trends seen among patients who required reoperation (staged $13,861, delayed $7601, immediate $9925; p = 0.004). However, no significant differences in cost were seen according to the method of reconstruction when evaluating readmission (p = 0.31) or ED visits (p = 0.12) (Table 6). In addition, out-of-pocket expenses did not differ across the study cohorts (data not shown).
Table 6.
Payments to healthcare providers
| Immediate (N = 2081) | Delayed (N = 353) | Staged (N = 560) | Total (N = 2994) | p-Value | |
|---|---|---|---|---|---|
| Index procedures | |||||
| Mastectomy and free flap | < 0.0011 | ||||
| N | 2039 | 350 | 539 | 2928 | |
| Mean (SD) | 76,756.8 (50,231.3) | 80,667.7 (44,433.0) | 106,443.2 (53,781.9) | 82,689.1 (51,505.4) | |
| Median | 61,969.5 | 68,950.1 | 92,873.3 | 68,634.0 | |
| Q1, Q3 | 41,729.7, 98,102.2 | 51,473.8, 100,628.8 | 68314.8, 130,166.4 | 45,836.2, 104,966.6 | |
| Range | (14,197.8–329,564.5) | (15,309.1–265,721.8) | (19,710.4–337,884.4) | (14,197.8–337,884.4) | |
| Complications | |||||
| Mastectomy | |||||
| N | 71 | 168 | 239 | ||
| Mean (SD) | 11,610.8 (17,144.4) | 18,937.1 (20,318.3) | 16,760.7 (19,682.1) | ||
| Median | 5343.4 | 11,578.1 | 9508.0 | ||
| Q1, Q3 | 548.1, 16,161.6 | 3935.5, 25,188.9 | 1977.5, 23,533.6 | ||
| Range | (16.3–87,845.8) | (15.7–96245.4) | (15.7–96,245.4) | ||
| Free flap | |||||
| N | 129 | 289 | 418 | ||
| Mean (SD) | 39,188.9 (47049.5) | 46,379.8 (50,707.6) | 44,160.6 (49,662.7) | ||
| Median | 28,848.0 | 36,274.0 | 33,327.7 | ||
| Q1, Q3 | 2475.0, 57,539.3 | 4426.8, 73,202.8 | 3212.9, 68,307.9 | ||
| Range | (0.0–242,821.8) | (0.0–285,981.0) | (0.0–285,981.0) | ||
| Mastectomy or free flap | 0.03261 | ||||
| N | 792 | 161 | 354 | 1307 | |
| Mean (SD) | 40,975.1 (49,444.3) | 37,147.7 (45,234.4) | 44,578.6 (45,773.3) | 41,479.7 (47,987.0) | |
| Median | 19294.6 | 21323.4 | 33458.7 | 23,133.7 | |
| Q1, Q3 | 3920.9, 62,285.0 | 2773.0, 54,734.9 | 6446.0, 68,376.3 | 4594.4, 64,291.2 | |
| Range | (48.5–261,618.9) | (30.9–242,821.8) | (17.4–276,921.9) | (17.4–276,921.9) | |
| Reoperations | |||||
| Mastectomy | |||||
| N | 26 | 89 | 115 | ||
| Mean (SD) | 6358.1 (7168.7) | 13,992.8 (12,734.6) | 12,266.7 (12,113.7) | ||
| Median | 4902.9 | 10,239.2 | 8584.5 | ||
| Q1, Q3 | 986.8, 8336.1 | 4226.1, 19,209.0 | 3648.4, 18,099.5 | ||
| Range | (84.2–29,952.0) | (173.7–68,335.2) | (84.2–68,335.2) | ||
| Free flap | |||||
| N | 38 | 105 | 143 | ||
| Mean (SD) | 8250.0 (11,524.6) | 10,278.5 (14,954.8) | 9739.4 (14,114.3) | ||
| Median | 3238.0 | 5380.6 | 4153.5 | ||
| Q1, Q3 | 1376.8, 12,699.6 | 633.1, 14,017.9 | 764.2, 13,398.1 | ||
| Range | (82.6–54,729.5) | (0.0–82,257.8) | (0.0–82,257.8) | ||
| Mastectomy or free flap | 0.0041 | ||||
| N | 249 | 63 | 173 | 485 | |
| Mean (SD) | 9925.0 (12,247.9) | 7600.9 (10,208.8) | 13,861.0 (16,134.0) | 11,027.1 (13,702.0) | |
| Median | 6071.0 | 3826.7 | 9572.5 | 6385.6 | |
| Q1, Q3 | 2020.1, 11,896.5 | 1084.4, 10,589.0 | 2195.5, 18,433.2 | 1877.4, 14,557.4 | |
| Range | (0.0–69,158.8) | (0.0–54,729.5) | (0.0–82,257.8) | (0.0–82,257.8) | |
| Readmissions | |||||
| Mastectomy | |||||
| N | 19 | 56 | 75 | ||
| Mean (SD) | 21,439.4 (20,479.7) | 30,296.4 (28,444.1) | 28,052.6 (26,802.9) | ||
| Median | 17,348.7 | 22,103.6 | 19,715.1 | ||
| Q1, Q3 | 11,093.1, 22,940.0 | 12,771.8, 37,517.0 | 12,320.1, 31,545.7 | ||
| Range | (6307.1–101,254.2) | (5031.4–138,444.3) | (5031.4–138444.3) | ||
| Free flap | |||||
| N | 25 | 43 | 68 | ||
| Mean (SD) | 43,642.8 (42,655.2) | 30,174.1 (24,088.4) | 35,125.8 (32,531.4) | ||
| Median | 31,865.9 | 23,506.3 | 24,291.9 | ||
| Q1, Q3 | 13,564.4, 58,085.3 | 12,492.0, 44,017.4 | 13,028.2, 44,769.3 | ||
| Range | (5782.1–153,354.2) | (4983.2–98,500.3) | (4983.2–153,354.2) | ||
| Mastectomy or free flap | 0.311 | ||||
| N | 169 | 41 | 91 | 301 | |
| Mean (SD) | 28,160.5 (25,259.7) | 32,806.4 (33,233.7) | 32,695.3 (29,472.3) | 30,164.3 (27,754.6) | |
| Median | 18,814.1 | 18,445.9 | 23,506.3 | 19,863.3 | |
| Q1, Q3 | 11,696.0, 36,407.0 | 11,892.5, 36,741.4 | 13,680.3, 39,417.0 | 12,241.0, 37,406.1 | |
| Range | (2073.2–128283.3) | (5782.1–13,6854.7) | (4983.2–138,444.3) | (2073.2–138,444.3) | |
| ED visits | |||||
| Mastectomy | |||||
| N | 41 | 85 | 126 | ||
| Mean (SD) | 2495.4 (2159.8) | 3288.3 (3972.9) | 3030.3 (3498.4) | ||
| Median | 2635.1 | 1788.4 | 1883.1 | ||
| Q1, Q3 | 801.6, 3150.4 | 836.9, 3381.1 | 801.6, 3265.5 | ||
| Range | (63.3–9585.8) | (11.8–19242.3) | (11.8–19242.3) | ||
| Free flap | |||||
| N | 50 | 69 | 119 | ||
| Mean (SD) | 3128.2 (3253.0) | 2877.1 (3589.9) | 2982.6 (3440.4) | ||
| Median | 2239.2 | 1783.0 | 1791.2 | ||
| Q1, Q3 | 1184.3, 4402.2 | 826.2, 3107.7 | 983.7, 3348.6 | ||
| Range | (45.0–15,941.7) | (10.1–19,117.4) | (10.1–19,117.4) | ||
| Mastectomy or free flap | 0.121 | ||||
| N | 286 | 118 | 195 | 599 | |
| Mean (SD) | 2892.7 (3097.5) | 3712.5 (5121.6) | 3794.3 (4439.1) | 3347.7 (4035.8) | |
| Median | 1936.8 | 2650.9 | 2235.9 | 2099.5 | |
| Q1, Q3 | 1005.8, 3441.7 | 1083.8, 4274.9 | 1031.1, 4497.8 | 1007.1, 3883.8 | |
| Range | (0.0–18,724.3) | (7.5–45,423.3) | (0.0–26,201.2) | (0.0–45,423.3) | |
| Total pay within 90 days of procedure(s) | |||||
| Mastectomy | |||||
| N | 343 | 550 | 893 | ||
| Mean (SD) | 52,936.7 (34,178.7) | 69,433.3 (36,910.5) | 63,097.0 (36,753.9) | ||
| Median | 44,665.9 | 62,074.9 | 55,081.4 | ||
| Q1, Q3 | 27,761.0, 68,257.7 | 41,118.5, 91,734.6 | 35,748.5, 83,215.1 | ||
| Range | (8916.9–183,553.1) | (9474.2–210,533.6) | (8916.9–210,533.6) | ||
| Free flap | |||||
| N | 346 | 545 | 891 | ||
| Mean (SD) | 73,354.3 (47,529.5) | 82,752.9 (54,895.8) | 79,103.2 (52,332.5) | ||
| Median | 59,924.2 | 68,612.9 | 65,131.6 | ||
| Q1, Q3 | 40,218.4, 93,538.2 | 45,734.8, 98,376.4 | 43,847.1, 96,863.8 | ||
| Range | (10,884.9–309,972.9) | (11,116.6–341,769.2) | (10,884.9–341,769.2) | ||
| Mastectomy or free flap | < 0.0011 | ||||
| N | 2041 | 350 | 538 | 2929 | |
| Mean (SD) | 97,687.5 (59,546.4) | 124,405.4 (63,682.3) | 147,476.6 (65,949.9) | 110,025.5 (64,343.1) | |
| Median | 81,612.4 | 110,467.7 | 136,033.3 | 95,483.4 | |
| Q1, Q3 | 54,697.8, 124,833.8 | 78,158.2, 152,687.0 | 99,133.1, 179,311.1 | 62,751.9, 141,316.2 | |
| Range | (20,025.2–407,256.9) | (20,117.3–354,747.4) | (20,957.7–395,388.8) | (20,025.2–407,256.9) | |
1Kruskal–Wallis
This table only includes patients who did not have a capitated service plan. Costs greater than 99th percentile or below 1st percentile were excluded.
A gamma regression assessed the association of the type of reconstruction with total cost, demonstrating that after adjusting for covariates, the mean cost was 31% higher (95% CI: 23–39%; p < 0.001) for those undergoing staged when compared with immediate, 11% higher (95% CI: 3–20%; p = 0.008) for staged when compared with delayed, and 18% higher (95% CI: 10–25%; p < 0.001) for delayed when compared with immediate (Table 7).
Table 7.
Gamma regression of cost
| Variable | Cost ratio (95% confidence interval) | p-value |
|---|---|---|
| Reconstruction method | ||
| Immediate | Reference | – |
| Delayed | 1.18 (1.10, 1.25) | <0 .001 |
| Staged | 1.31 (1.23, 1.39) | < 0.001 |
| Staged versus delayed | 1.11 (1.03, 1.20) | 0.008 |
| Age (years) | 1.00 (1.00, 1.00) | 0.148 |
| NCI comorbidity index | 1.02 (0.97, 1.08) | 0.401 |
| Rural versus urban | 0.96 (0.89, 1.03) | 0.267 |
| Region | ||
| South | Reference | – |
| North Central | 1.05 (0.99, 1.11) | 0.104 |
| Northeast | 1.19 (1.14, 1.25) | < 0.001 |
| West | 1.03 (0.97, 1.09) | 0.362 |
| Employment status | ||
| Employed full or part-time | Reference | – |
| Disability | 0.93 (0.72, 1.21) | 0.602 |
| Other/unknown | 0.82 (0.78, 0.86) | < 0.001 |
| Retiree | 1.12 (1.04, 1.21) | 0.003 |
| Bilateral mastectomy | 1.04 (1.00, 1.09) | 0.034 |
| Lymph node surgery at time of mastectomy | 1.07 (1.03, 1.12) | < 0.001 |
| Chemotherapy before or after mastectomy | 1.26 (1.21, 1.31) | < 0.001 |
| Radiation before or after mastectomy | 1.12 (1.05, 1.18) | < 0.001 |
| Other cancer diagnosis | 1.07 (1.01, 1.13) | 0.022 |
| Dermal matrix | 1.11 (1.05, 1.18) | < 0.001 |
Sensitivity Analysis
Due to the significant impact of radiation therapy on surgical outcomes,20 a sensitivity analysis was conducted with patients who did not undergo radiation. Increased costs and risk of complications and HCRU continued to be observed with staged reconstruction irrespective of the status of radiation therapy. The demographics and results of the sensitivity analysis are presented in SDC Tables 5 and 6, respectively.
Discussion
In this study, we conducted a longitudinal assessment of complications, costs, and HCRU across patients who underwent a mastectomy and free-flap breast reconstruction. Specifically, we focused on comparing outcomes between the staged technique with immediate and delayed techniques for free-flap breast reconstruction. We observed that when compared with immediate or delayed techniques, patients who undergo staged reconstruction experience a significantly increased risk of developing complications, both after the mastectomy and after the free flap is performed. Furthermore, we observed that this increased risk of complications translates into significantly increased costs and HCRU, including ED visits, reoperation, and readmission. Overall, staged free-flap breast reconstruction is associated with a higher rate of complications and significant consumption of healthcare resources in the 90 days following both the mastectomy and the free-flap procedure.
Overall complication rates after free-flap breast reconstruction are reported to approach 20–50%.13,18,21–25 Most studies, however, have excluded patients undergoing staged free-flap breast reconstruction. Olsen et al. reported in a claims-based analysis that rates of infection and wound healing complications were not influenced by the timing of immediate, delayed, or staged autologous reconstruction. However, their study captured all forms of autologous reconstruction including pedicled flap procedures, and reported a relatively small cohort size of 95 patients who underwent two-stage autologous reconstruction.24 Phillips et al. reported in an institutional review that patients undergoing staged free-flap breast reconstruction display a three-times higher rate of skin complications following radiation therapy and a 7.5-times higher rate of microvascular-related complications (flap loss and vessel thrombosis) when compared with standard delayed patients.10 This increased complication rate was supported in a separate institutional review that described significantly increased rates of surgical complications that predominately occurred after mastectomy in the first reconstructive stage with tissue expander placement.11
The results of this study provide a granular evaluation of complications that occur after each reconstructive stage and echo previous institutional reports demonstrating a significantly increased risk of all-cause complications among patients undergoing staged free-flap breast reconstruction. This includes over a tenth of patients experiencing tissue expander infection, extrusion, and/or microvascular-related complications after the free-flap procedure. High rates of tissue expander-related complications may be attributed to the placement of the tissue expander in a hypovascular field with a large amount of dead space following mastectomy, leading to complication rates that parallel those seen with direct implant reconstruction.13,24 In addition, as previously proposed, we believe that an increased rate of microvascular-related complications may be attributed to increased compression and scarring of the chest wall secondary to tissue expander placement, ultimately leading to increased fibrosis and friability of the internal mammary vessels.
Prior studies have focused on comparing healthcare expenditures between implant and autologous techniques, with all studies concluding that early postoperative complications and risk profiles favor implant-based reconstruction; however, long-term resource utilization favors autologous and free-flap procedures.18,21 To date, no studies have provided an in-depth examination of the effect of the timing of free-flap breast reconstruction on costs and HCRU to better inform clinical decision-making. The results of this study suggest that immediate free-flap breast reconstruction is associated with the lowest rate of readmission, reoperation, and ED visits. However, patients who undergo a staged procedure demonstrate a significantly increased risk of experiencing HCRU, with nearly 50% of staged patients experiencing a component of HCRU within 90 days of their mastectomy and/or free-flap. These significantly increased rates of utilization may be attributed to more than 60% of staged patients experiencing a systemic or surgical complication after their mastectomy and/or free-flap procedure.
Reconstructive pathways, comorbidities, and adjuvant therapies distinctly contribute to the total costs of reconstructive care. As the costs accrued following free-flap reconstruction are most pronounced within the first year, it is important to understand how different timings and modalities of free-flap reconstruction may influence total costs. Additionally, as operating room efficiency continues to be prioritized in the COVID-19 era and staffing shortages lead to decreased operating room availability, renewed emphasis has been placed on staged reconstruction to offer an efficient treatment to breast cancer patients.26,27 Fischer et al. conducted a longitudinal assessment of costs accrued following immediate tissue expander, implant, or autologous breast reconstruction, demonstrating that tissue expander reconstruction was associated with the lowest charges ($39,470) within 90 days and autologous reconstruction was associated with the highest ($54,309).18 Expanding on these results, Berlin et al. demonstrated how costs accrued secondary to complications, comorbidities, or adjuvant therapies differ significantly based on the reconstructive modality.28 Our results uniquely contribute to these findings by expounding on the influence of the timing of free-flap reconstruction on costs accrued within 90 days following the mastectomy and free-flap procedure. More specifically, our results demonstrate that combining tissue expander and free-flap reconstruction for a staged procedure is associated with significantly higher costs throughout both 90-day episodes of reconstructive care. Notably, among patients experiencing an adverse event, those who undergo staged reconstruction had significantly higher costs associated with complications and reoperations as compared with patients undergoing immediate or delayed reconstruction. As physician reimbursement for breast reconstruction continues to change with mean payments for tissue expanders shown to increase over time (estimated 6.5% growth of a 4-year period) future research should assess how changes in reimbursement patterns may ultimately influence surgeon decision-making for a staged approach to free-flap breast reconstruction.29,30
Berlin et al. suggest that adjuvant chemotherapy and/or post-mastectomy radiation therapy (PMRT) independently contribute significant amounts to the total cost of reconstructive care; thus, a higher total cost among the staged cohort may partially be attributed to a higher proportion of staged patients receiving chemotherapy and/or PMRT.28 This finding may also be attributed to attempts to salvage the tissue expander, including intravenous antibiotics, tissue expander replacement, and/or prolonged readmissions. Interestingly, in our study, out-of-pocket costs did not demonstrate a clinically significant difference when comparing the patient cohorts. These results echo findings by Bailey et al. that demonstrated no differences in out-of-pocket costs according to breast reconstruction subtype, possibly due to most financial exposure being accepted by the insurer regardless of the reconstructive modality; however, future studies are needed to further examine the potential financial toxicity attributed to staged free-flap procedures.31
A primary goal of staged free-flap reconstruction is to preserve the direct psychosocial and esthetic benefits that are seen with an immediate procedure. Albino et al. previously reported that staged reconstruction was associated with improved esthetic outcomes compared with delayed reconstruction.6 This finding was attributed to a staged approach allowing for more native mastectomy skin to be available at the time of reconstruction, resulting in improved scar placement and shaping of the breast mound. However, previous studies have suggested that long-term satisfaction is not influenced by the timing of breast reconstruction, with staged, immediate, and delayed techniques reporting similar degrees of long-term satisfaction after surgery.12,32,33 The findings of our study suggest that staged free-flap reconstruction is associated with significantly increased rates of complications, costs, and HCRU as compared with immediate and delayed techniques. When counseling a patient who has decided to pursue free-flap reconstruction, the potential esthetic benefits of a staged approach should be balanced with an increased risk of complications, costs, and HCRU.
Study Limitations
Clinical data were derived from claims, which were dependent on accurate medical coding. Additionally, women who undergo a bilateral mastectomy may have mixed timing of their reconstruction. We were unable to reliably identify these cases of mixed-reconstruction timing because the contralateral reconstruction may be mistakenly identified as a reconstruction failure. However, we anticipate that mixed-reconstruction timing is rare and should not impact the analysis. In addition, due to the immediate cohort requiring less time for continuous enrollment, this patient population is likely over-represented in our study sample as compared with patients who underwent staged and delayed free-flap reconstruction.
Conclusions
Staged free-flap breast reconstruction is associated with significantly increased complications, costs, and HCRU, while immediate reconstruction is associated with the lowest. These results emphasize the need for health systems to support coordinated, multidisciplinary care to facilitate immediate reconstruction when possible. Patients considering a staged approach should be counseled about the potential esthetic benefit of this procedure in the context of an increased risk for experiencing adverse outcomes, increased costs, and increased HCRU.
Supplementary Information
Below is the link to the electronic supplementary material.
Acknowledgment
The Duke Biostatistics, Epidemiology, and Research Design Core’s support was made possible by the CTSA grant (UL1TR002553) from the National Center for Advancing Translational Sciences (NCATS) of the NIH and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not represent the official views of NCATS or NIH.
Funding
CTSA Grant (UL1TR002553) from the National Center for Advancing Translational Sciences (NCATS) of the NIH and the NIH Roadmap for Medical Research.
Disclosure
No conflicts of interest pertaining to this manuscript are present or need to be disclosed
Footnotes
Publisher's Note
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