Abstract
BACKGROUND
Post-operative drains help reduce seroma formation, which is associated with infection and delayed wound healing. However, multiple drains may increase patient discomfort and prolong hospital stays. The impact of drain quantity on complications after immediate breast reconstruction remains unclear. This study evaluates the association between the number of drains used and post-operative complications after mastectomy and tissue expander (TE) placement.
METHODS
A single-institution, propensity score-matched analysis included patients who underwent a unilateral mastectomy and immediate TE placement from January 2017 to December 2023. Patients were grouped by the use of one or two drains and matched on body mass index, implant plane placement, acellular dermal matrix use, sentinel lymph node biopsy, intraoperative TE fill volume, and mastectomy weight. Outcomes of interest were post-operative complications, including seroma, surgical site infection, and TE removal within 90 days.
RESULTS
After matching, 984 patients (492 per group) were analyzed. No significant differences were observed in the rates of seroma (13% vs.10%, p=0.23), infection (12% vs. 12%, p=0.76), or TE removal (7.5% vs.6.1%, p=0.46) between patients who had one drain as compared to those who had two. Overall 90-day complication rates were comparable (28% vs. 27%, p=0.66) between groups, and seroma management did not differ based on one vs. two drains (p=0.89).
CONCLUSION
Patients who receive one drain after TE placement do not have an increased risk of complications, including seroma formation, compared to those with two drains. Generally, reconstructive surgeons can safely opt for a single drain after TE placement.
Keywords: Breast reconstruction, tissue expander, drain, two-stage, complications
INTRODUCTION
Two-stage implant-based breast reconstruction is the most common reconstructive procedure performed nationwide.1 However, approximately 20–30% of patients are reported to suffer from a post-operative complication after tissue expander placement.2, 3 Seromas are one of the most common complications after tissue expander reconstruction, occurring in up to 20% of patients. Seromas increase the risk of infection and wound dehiscence and may ultimately require aspiration or operative intervention.3–6 To mitigate the risk of seroma formation, closed-suction drains are placed after surgery to apply negative pressure and eliminate dead space.6, 7 However, the use of drains is associated with patient discomfort and increased anxiety in the post-operative period.8 Furthermore, some surgeons argue that the prolonged duration of a drain may increase the risk of tissue expander infection by providing a direct path to the device.9, 10
Previous studies have examined post-operative outcomes and rates of complications in immediate two-stage reconstruction with tissue expander placement using one versus two drains.5, 11, 12 However, these reports present conflicting results and are limited by relatively small sample sizes and heterogeneity in patient cohorts. Currently, there is no consensus regarding an ideal number of drains to use in two-stage implant-based reconstruction, and data from larger patient cohorts are needed.
This study aimed to evaluate the impact of one versus two post-operative drains on the rates of seroma formation, surgical site infection, and tissue expander explant in patients undergoing unilateral mastectomy with immediate tissue expander placement. Secondarily, we sought to analyze differences in the rates of tissue expander salvage, hematoma, mastectomy skin flap necrosis, implant exposure, and seroma management plans. We hypothesized that patients who received only one drain would not experience a higher rate of 90-day seroma formation, infection, or tissue expander loss than those who received two drains.
METHODS
Study Design
A propensity score-matched analysis was performed on adult female patients who had a unilateral mastectomy followed by immediate tissue expander placement from January 2017 to December 2023 at Memorial Sloan Kettering Cancer Center. Patients from eleven plastic surgeons were included in this study and were categorized into two cohorts based on whether they received one or two post-operative drains. The number of drains used was based on surgeon discretion according to individual patient characteristics and intraoperative findings. Patients who underwent direct-to-implant reconstruction, delayed placement of the tissue expander, or bilateral reconstruction were excluded. Patients were also excluded if they underwent axillary lymph node dissection (ALND) as these patients typically receive two drains at the study institution. Patients were also excluded if they did not have at least 90 days of follow-up from the index surgery. This study received approval by the institutional review board at Memorial Sloan Kettering Cancer Center.
Study Variables
Independent variables analyzed included patient age at the time of surgery, race, ethnicity, body mass index (BMI), smoking history, marital status, timing of chemotherapy (neoadjuvant or adjuvant), and timing of radiation (neoadjuvant or adjuvant). Operative variables of interest included mastectomy weight, mastectomy type (nipple-sparing or skin-sparing), whether the patient received a sentinel lymph node biopsy, tissue expander plane placement (prepectoral, subpectoral, or complete submuscular), intraoperative tissue expander fill volume, and use of acellular dermal matrix. The predominant practice at the study institution is to remove a drain if there is less than 30 cc of output over 24 hours, for two consecutive days.
Outcomes of Interest
The primary outcomes of interest included 90-day rates of seroma, cellulitis or wound infection, and tissue expander explant. Seroma was defined as any clinically detected fluid collection requiring intervention including bedside aspiration, drainage by interventional radiology, or operative management. Cellulitis or wound infection was defined as any surgical site infection requiring oral or intravenous antibiotics with or without operative intervention. Tissue expander explant was defined as any complication requiring operative intervention and tissue expander removal without replacement. Secondary outcomes of interest included rates of mastectomy skin flap necrosis, hematoma, device exposure, and tissue expander salvage. Salvage was defined as any complication requiring operative intervention with tissue expander removal and replacement of the device at the same operation.
Propensity Score Matching
Propensity score matching was performed to minimize confounding variables when comparing outcomes among patients in the one-drain and two-drain cohorts. Patients were matched on BMI, sentinel lymph node biopsy, tissue expander plane placement, acellular dermal matrix use, intraoperative tissue expander fill volume, and mastectomy weight (< 400 grams, 400–700 grams, >700 grams). Variables and mastectomy weight categories were selected a priori based on clinical experience. Patients were matched without replacement using a 1:1 nearest neighbor matching method with a caliper width equal to 0.05. This value was determined by decreasing the caliper width until balance, defined as an absolute standardized mean difference < 0.1, was satisfied for each variable in the propensity score match.13
Statistical Analysis
Patient demographics, treatment-related variables, and surgical characteristics were summarized using medians and interquartile ranges for continuous variables and frequencies and percentages for categorical variables. After propensity score matching, patient variables and complications were compared between cohorts using the Wilcoxon signed rank test, McNemar’s Chi-squared test, or random intercept logistic regression as appropriate to take into account the matched nature of the data. For some categorical variables with small cells where a matched test could not be applied, Fisher’s exact test was used. Secondarily, we examined patient, treatment, and surgical variables where the Wilcoxon rank sum test, Pearson’s Chi-squared test, and Fisher’s exact test were used, as appropriate. P-values < 0.05 were used to signify statistical significance. All analyses were conducted using R version 4.4.1.
RESULTS
Characteristics of Unmatched Cohort
A total of 1,634 patients met the inclusion criteria; 528 patients received one drain, and 1,106 patients received two drains after tissue expander placement. The median age of the cohort was 52 years [Interquartile Range (IQR) 44–62] and had a median BMI of 24.3 (IQR 21.5–28.3). Most patients were White (62%), and more than half did not receive any chemotherapy (57%) or radiation (78%) in their oncologic treatment. Regarding surgical characteristics, 91% of patients underwent a skin-sparing mastectomy, 41% had prepectoral tissue expander placement, 43% had acellular dermal matrix placed, and 96% of patients underwent sentinel lymph node biopsy. The median total intraoperative fill volume for the tissue expander was similar between patients who had one vs. two drains (200 mL vs.195 mL, p=0.60). However, patients with one drain had significantly lower mastectomy specimen weights than those who received two drains (482 grams vs.555 grams, p<0.001). The characteristics of the unmatched patient cohort are summarized in Table 1.
Table 1.
Patient Characteristics by Drain Number, Unmatched Cohort
| Characteristic | Overall N = 1,6341 |
1 Drain N = 5281 |
2 Drains N = 1,1061 |
p-value2 |
|---|---|---|---|---|
|
| ||||
| Age at TE Placement | 52 (44, 62) | 52 (45, 62) | 53 (44, 62) | 0.79 |
| Race | 0.46 | |||
| White | 1,016 (62%) | 341 (65%) | 675 (61%) | |
| Asian | 253 (15%) | 80 (15%) | 173 (16%) | |
| Black | 196 (12%) | 55 (10%) | 141 (13%) | |
| Other | 169 (10%) | 52 (9.8%) | 117 (11%) | |
| Ethnicity | 0.05 | |||
| Not Hispanic | 1,317 (81%) | 408 (77%) | 909 (82%) | |
| Hispanic or Latino | 185 (11%) | 67 (13%) | 118 (11%) | |
| Unknown | 132 (8.1%) | 53 (10%) | 79 (7.1%) | |
| Body Mass Index | 24.3 (21.5, 28.3) | 23.7 (21.2, 27.6) | 24.5 (21.7, 28.8) | <0.001 |
| Smoking Status | 0.02 | |||
| Never Smoker | 1,435 (88%) | 461 (87%) | 974 (88%) | |
| Former smoker | 161 (9.9%) | 59 (11%) | 102 (9.2%) | |
| Unknown | 25 (1.5%) | 2 (0.4%) | 23 (2.1%) | |
| Current smoker | 13 (0.8%) | 6 (1.1%) | 7 (0.6%) | |
| Marital Status | 0.03 | |||
| Married/Partner | 1,071 (66%) | 350 (66%) | 721 (65%) | |
| Single | 348 (21%) | 97 (18%) | 251 (23%) | |
| Divorced/Separated/Widowed | 186 (11%) | 74 (14%) | 112 (10%) | |
| Unknown | 29 (1.8%) | 7 (1.3%) | 22 (2.0%) | |
| Timing of Chemotherapy | 0.25 | |||
| None | 927 (57%) | 300 (57%) | 627 (57%) | |
| Adjuvant | 370 (23%) | 109 (21%) | 261 (24%) | |
| Neoadjuvant | 337 (21%) | 119 (23%) | 218 (20%) | |
| Timing of Radiation | 0.90 | |||
| None | 1,267 (78%) | 406 (77%) | 861 (78%) | |
| Postoperative | 302 (18%) | 101 (19%) | 201 (18%) | |
| Preoperative | 65 (4.0%) | 21 (4.0%) | 44 (4.0%) | |
| SLNB | 1,566 (96%) | 501 (95%) | 1,065 (96%) | 0.18 |
| Pocket Dissection | <0.001 | |||
| Prepectoral | 665 (41%) | 278 (53%) | 387 (35%) | |
| Complete Submuscular | 580 (35%) | 173 (33%) | 407 (37%) | |
| Subpectoral | 373 (23%) | 71 (13%) | 302 (27%) | |
| Other | 16 (1.0%) | 6 (1.1%) | 10 (0.9%) | |
| Mastectomy Type | 0.45 | |||
| Skin Sparing | 1,497 (91.1%) | 479 (91%) | 1,018 (92.2%) | |
| Nipple Sparing | 137 (8.4%) | 49 (9.3%) | 88 (8.0%) | |
| Total Intraoperative Fill | 200 (100, 250) | 200 (100, 250) | 195 (100, 250) | 0.62 |
| ADM | 708 (43%) | 216 (41%) | 492 (44%) | 0.17 |
| Mastectomy Weight Overall | <0.001 | |||
| Median (Q1, Q3) | 527 (342, 762) | 482 (310, 684) | 555 (355, 809) | |
| Min, Max | 101, 2,580 | 101, 2,000 | 103, 2,580 | |
| Mastectomy Weight Overall (Categorical) | <0.001 | |||
| <400 | 520 (32%) | 190 (36%) | 330 (30%) | |
| 400–700 | 598 (37%) | 212 (40%) | 386 (35%) | |
| >700 | 516 (32%) | 126 (24%) | 390 (35%) | |
Median (Q1, Q3); n (%)
Wilcoxon rank sum test; Pearson’s Chi-squared test; Fisher’s exact test
Characteristics of Matched Cohort
After propensity score matching, 984 patients were included in the analysis with 492 patients in each study cohort. Balance was satisfied for all clinical characteristics chosen a priori, reflected by the absolute standardized mean differences all below 0.1 (Figure 1). When analyzing the matched pairs, there were no significant differences in demographic characteristics between the study cohorts, except for smoking and marital status. There were more current (1.2% vs. 0.4%, p=0.02) and former smokers (12% vs. 7.5%, p=0.02) and fewer married patients in the one-drain cohort compared to the two-drain cohort (66% vs. 72%, p=0.01). Surgical characteristics were similar between matched patient cohorts. The characteristics of the matched patient cohort are shown in Table 2.
Figure 1.
Standardized Mean Differences Following Propensity Score Matching
Table 2.
Patient Characteristics by Drain Number, Matched Cohort
| Characteristic | Overall N = 9841 |
1 Drain N = 4921 |
2 Drains N = 4921 |
p-value2 |
|---|---|---|---|---|
|
| ||||
| Age at TE Placement | 52 (44, 62) | 52 (45, 62) | 51 (44, 61) | 0.14 |
| Race | 0.31 | |||
| White | 631 (64%) | 322 (65%) | 309 (63%) | |
| Asian | 147 (15%) | 69 (14%) | 78 (16%) | |
| Black | 98 (10.0%) | 53 (11%) | 45 (9.1%) | |
| Other | 108 (11%) | 48 (9.8%) | 60 (12%) | |
| Ethnicity | 0.53 | |||
| Not Hispanic | 765 (78%) | 379 (77%) | 386 (78%) | |
| Hispanic or Latino | 125 (13%) | 61 (12%) | 64 (13%) | |
| Unknown | 94 (9.6%) | 52 (11%) | 42 (8.5%) | |
| Body Mass Index | 23.8 (21.4, 27.7) | 23.9 (21.3, 27.7) | 23.8 (21.4, 27.7) | 0.70 |
| Smoking Status | 0.02 | |||
| Never Smoker | 873 (89%) | 427 (87%) | 446 (91%) | |
| Former smoker | 94 (9.6%) | 57 (12%) | 37 (7.5%) | |
| Current smoker | 8 (0.8%) | 6 (1.2%) | 2 (0.4%) | |
| Unknown | 9 (0.9%) | 2 (0.4%) | 7 (1.4%) | |
| Marital Status | 0.01 | |||
| Married/Partner | 678 (69%) | 324 (66%) | 354 (72%) | |
| Single | 180 (18%) | 93 (19%) | 87 (18%) | |
| Divorced/Separated/Widowed | 106 (11%) | 68 (14%) | 38 (7.7%) | |
| Unknown | 20 (2.0%) | 7 (1.4%) | 13 (2.6%) | |
| Timing of Chemotherapy | 0.14 | |||
| None | 558 (57%) | 283 (58%) | 275 (56%) | |
| Adjuvant | 217 (22%) | 97 (20%) | 120 (24%) | |
| Neoadjuvant | 209 (21%) | 112 (23%) | 97 (20%) | |
| Timing of Radiation | 0.24 | |||
| None | 764 (78%) | 380 (77%) | 384 (78%) | |
| Postoperative | 178 (18%) | 92 (19%) | 86 (17%) | |
| Preoperative | 42 (4.3%) | 20 (4.1%) | 22 (4.5%) | |
| SLNB | 943 (96%) | 471 (96%) | 472 (96%) | 1.0 |
| Pocket Dissection | 0.35 | |||
| Prepectoral | 499 (51%) | 246 (50%) | 253 (51%) | |
| Complete Submuscular | 319 (32%) | 171 (35%) | 148 (30%) | |
| Subpectoral | 157 (16%) | 71 (14%) | 86 (17%) | |
| Other | 9 (0.9%) | 4 (0.8%) | 5 (1.0%) | |
| Mastectomy Type | 0.19 | |||
| Skin Sparing | 894 (91.1%) | 453 (92%) | 441 (89.2%) | |
| Nipple Sparing | 90 (9.1%) | 39 (7.9%) | 51 (10%) | |
| Total Intraoperative Fill | 190 (100, 250) | 200 (100, 250) | 180 (100, 265) | 0.50 |
| ADM | 440 (45%) | 211 (43%) | 229 (47%) | 0.20 |
| Mastectomy Weight Overall | 495 (326, 697) | 486 (312, 704) | 510 (337, 691) | 0.22 |
| Mastectomy Weight Overall (Categorical) | 0.63 | |||
| <400 | 345 (35%) | 176 (36%) | 169 (34%) | |
| 400–700 | 400 (41%) | 191 (39%) | 209 (42%) | |
| >700 | 239 (24%) | 125 (25%) | 114 (23%) | |
Median (Q1, Q3); n (%)
Wilcoxon signed rank test with continuity correction; McNemar’s Chi-squared test; random intercept logistic regression; McNemar’s Chi-squared test with continuity correction; Fisher’s exact test
Number of Drains and Post-Operative Complications
When analyzing 90-day post-operative outcomes in the matched cohort, 269 (27%) patients experienced a post-operative complication with no significant difference between those who had one drain and those who had two drains (28% vs. 27%, p=0.66). Rates of seroma (13% vs. 10%, p=0.23), cellulitis or wound infection (12% vs. 12%, p=0.76), and tissue expander explant (7.5% vs. 6.1%, p=0.46) did not differ significantly between the two groups. Similarly, the rates of mastectomy skin flap necrosis, tissue expander exposure, hematoma, and tissue expander salvage were comparable between the one-drain and two-drain cohorts (Table 3).
Table 3.
Post-op Complications by Drain Number, Matched Cohort
| Characteristic | Overall N = 9841 |
1 Drain N = 4921 |
2 Drains N = 4921 |
p-value2 |
|---|---|---|---|---|
|
| ||||
| Any Complication | 269 (27%) | 138 (28%) | 131 (27%) | 0.66 |
| Cellulitis / Wound Infection | 118 (12%) | 61 (12%) | 57 (12%) | 0.76 |
| Seroma | 111 (11%) | 62 (13%) | 49 (10.0%) | 0.23 |
| TE, Not salvaged | 67 (6.8%) | 37 (7.5%) | 30 (6.1%) | 0.46 |
| Mastectomy Skin Flap Necrosis | 48 (4.9%) | 19 (3.9%) | 29 (5.9%) | 0.18 |
| Implant Exposure | 29 (2.9%) | 13 (2.6%) | 16 (3.3%) | 0.71 |
| Hematoma | 27 (2.7%) | 13 (2.6%) | 14 (2.8%) | 1.0 |
| TE, Salvaged | 12 (1.2%) | 7 (1.4%) | 5 (1.0%) | 0.77 |
n (%)
McNemar’s Chi-squared test with continuity correction
Among the 111 patients who experienced a seroma within 90 days after surgery, 62 (56%) had one drain, and 49 (44%) had two drains (p=0.23). The two cohorts had no significant differences in seroma management plans (p=0.89). Almost all seroma occurrences were managed with bedside aspiration (90%), while 7.2% required drainage in the operating room, and 2.7% required drainage by interventional radiology (Table 4).
Table 4.
Seroma Management by Drain Number, Matched Cohort
| Characteristic | Overall N = 1111 |
1 Drain N = 621 |
2 Drains N = 491 |
p-value2 |
|---|---|---|---|---|
|
| ||||
| Seroma Management Plan | 0.89 | |||
| Aspiration | 100 (90%) | 55 (89%) | 45 (92%) | |
| Interventional Radiology | 3 (2.7%) | 2 (3.2%) | 1 (2.0%) | |
| Operative Intervention | 8 (7.2%) | 5 (8.1%) | 3 (6.1%) | |
n (%)
Fisher’s exact test
DISCUSSION
This propensity score-matched analysis of 984 patients who received either one drain or two drains after mastectomy and two-stage breast reconstruction with tissue expander placement found no significant differences in 90-day rates of seroma, surgical site infection, or tissue expander removal between patients who had one or two drains placed after surgery. Additionally, there were no significant differences in overall complication rates and seroma severity in patients with one drain compared to those with two drains. These results suggest that surgeons may safely use one drain after mastectomy and tissue expander placement without increasing the risk of post-operative complications.
Closed-suction drains are commonly used to prevent seroma formation in patients undergoing breast reconstruction.7, 14 However, the number of drains used after surgery varies according to institutional practices and individual surgeon preferences.15 A survey of the American Society of Plastic Surgeons and the Canadian Society of Plastic Surgeons found that approximately 53% of surgeons use one drain and 46% use two drains after mastectomy and tissue expander placement.16 Drains can be uncomfortable and painful for patients, and potentially serve as a source of bacterial entry into surgical wounds.17–19 A meta-analysis by Xue et al. identified post-operative drain use as a significant risk factor for surgical site infection in breast surgery.20 Post-operative drains may also adversely impact a patient’s psychosocial well-being. A qualitative study by Tian et al. found that patients who underwent breast reconstruction frequently expressed concerns regarding the infection risk of drains, pain at the insertion site, and discomfort from drains tugging on clothing.8 Similarly, Saratzis et al. demonstrated that patients with one drain experienced significantly lower rates of discomfort and shorter hospital stays compared to those with two or more drains.21 Reducing the number of drains used after surgery, without compromising post-operative outcomes, could improve patient comfort and reduce the psychological burden associated with breast cancer treatment.22
Several studies have examined whether the number of drains used after immediate two-stage breast reconstruction impacts the rates of post-operative complications. Escandon et al. found no difference in 30-day complication rates, including seroma formation and surgical site infection, in a propensity score-matched analysis of 192 patients who underwent tissue expander placement.12 Similarly, a retrospective study by Ollech et al. found that the use of one drain compared to two drains did not increase the rates of major complications requiring a return to the operating room or the incidence of seroma formation and surgical site infection.23 These findings were supported by a meta-analysis which also demonstrated no major differences in the rates of seroma formation among studies reporting the use of one drain or two drains after tissue expander placement.6 Our study corroborates these findings of no difference in the rates of seroma formation based on the placement of one versus two drains and provides further data on 90-day complications and seroma management in a larger patient cohort. The frequency of seroma management strategies in our study aligns with the existing literature, with the majority of cases managed by in-office aspiration.24 Furthermore, we found no differences in seroma management between patients who received one drain and those who received two, suggesting that severity of seroma is not dependent on the number of drains used post-operatively.
The findings of our study uniquely contribute to the existing literature by providing data from a large patient cohort that matches patients on prepectoral or submuscular plane placement; a significant factor given the shift of reconstructive practices to prepectoral placement of the tissue expander. There remains a lack of consensus regarding drain management in patients undergoing prepectoral reconstruction, particularly since acellular dermal matrix is more frequently used in these cases, which has historically been associated with increased rates of seroma.25, 26 Furthermore, prepectoral plane placement has been independently associated with an increased risk of seroma formation as compared to submuscular placement, due to an increased amount of dead space around the prosthetic device.27, 28 Previous studies examining post-operative complications in a one versus two drain cohort after breast reconstruction have smaller patient cohorts that fail to capture current reconstructive practices. In our study, approximately 51% of the patient cohort underwent prepectoral reconstruction and 40–50% had acellular dermal matrix placed, with no difference in rates of seroma occurrence between the matched cohorts with one versus two drains. Our results align with those of Naemonitou et al., who primarily perform prepectoral implant-based reconstruction with a single drain and report a 7% post-operative seroma rate and an implant loss and skin necrosis rate of less than 2%.29 Thus, our study provides insight into the safety of using a single drain in a contemporary patient cohort that reflects current reconstructive practices and accounts for prepectoral plane placement.12
Study Limitations
This study has several limitations. First, its retrospective design inherently introduces selection bias, despite the use of propensity score matching to control for confounding variables. The decision regarding the number of drains used was based on surgeon discretion, which may reflect differences in patient-specific factors that were not fully captured in our analysis. Variability in individual surgeon practice patterns and technique on a case-by-case basis cannot be controlled for using a retrospective study design. However, all surgeons at the study institution adhere to a protocol of drain removal when the output is less than 30 cc for two consecutive days. Second, while we examined a large patient cohort, the study was conducted at a single institution, which may limit the generalizability of our findings to other institutions with different surgical protocols and patient populations. Another limitation is the reliance on medical records to assess post-operative complications, which may have led to underreporting of certain outcomes such as minor infections or seromas that resolved without formal documentation. Finally, while we focused on short-term 90-day complications, a proportion of complications may have occurred outside of the 90-day window and were not included in this analysis.
CONCLUSION
The results of this study suggest that the number of drains used after immediate breast reconstruction with tissue expander placement does not significantly impact the rates of seroma formation, surgical site infection, or tissue expander loss within 90 days after surgery. These findings challenge the necessity of the routine placement of two drains after surgery and support using a single drain to optimize patient comfort without compromising post-operative outcomes. While our findings contribute to the growing body of literature advocating for reduced drain use, future prospective, multicenter studies with standardized protocols are warranted to validate these results and establish evidence-based guidelines for drain management in implant-based breast reconstruction.
SYNOPSIS.
Propensity score-matched analysis found no significant difference in complication rates between using one versus two drains after mastectomy with tissue expander placement. A single drain is a safe option, offering potential benefits like reduced discomfort without increasing post-operative risk.
Footnotes
Financial Disclosure: Dr. Mehrara has the following disclosures: Investigator-initiated awards from Pfizer, Regeneron, Integra, Royalties from Elsevier, Mediflix, UpToDate. The other authors have no financial disclosures to report.
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