key: cord-0702637-231j4c2x
authors: Chiang, Sarah N.; Finnan, Michael J.; Skolnick, Gary B.; Sacks, Justin M.; Christensen, Joani M.
title: The impact of the COVID‐19 pandemic on alloplastic breast reconstruction: An analysis of national outcomes
date: 2022-04-07
journal: J Surg Oncol
DOI: 10.1002/jso.26883
sha: 5c375cf616731a6afffd63e1edd1debb4b94cf98
doc_id: 702637
cord_uid: 231j4c2x

BACKGROUND: Immediate alloplastic breast reconstruction shifted to the outpatient setting during the COVID‐19 pandemic to conserve inpatient hospital beds while providing timely oncologic care. We examine the National Surgical Quality Improvement Program (NSQIP) database for trends in and safety of outpatient breast reconstruction during the pandemic. METHODS: NSQIP data were filtered for immediate alloplastic breast reconstructions between April and December of 2019 (before‐COVID) and 2020 (during‐COVID); the proportion of outpatient procedures was compared. Thirty‐day complications were compared for noninferiority between propensity‐matched outpatients and inpatients utilizing a 1% risk difference margin. RESULTS: During COVID, immediate alloplastic breast reconstruction cases decreased (4083 vs. 4677) and were more frequently outpatient (31% vs. 10%, p < 0.001). Outpatients had lower rates of smoking (6.8% vs. 8.4%, p = 0.03) and obesity (26% vs. 33%, p < 0.001). Surgical complication rates of outpatient procedures were noninferior to propensity‐matched inpatients (5.0% vs. 5.5%, p = 0.03 noninferiority). Reoperation rates were lower in propensity‐matched outpatients (5.2% vs. 8.0%, p = 0.003). CONCLUSION: Immediate alloplastic breast reconstruction shifted towards outpatient procedures during the COVID‐19 pandemic with noninferior complication rates. Therefore, a paradigm shift towards outpatient reconstruction for certain patients may be safe. However, decreased reoperations in outpatients may represent undiagnosed complications and warrant further investigation.

In recent years, an increasing number of women with early-stage breast cancer have opted for mastectomy over breast-conserving surgery. [1] [2] [3] While not all patients desire reconstruction, more than 130 000 breast reconstructions are performed annually, with alloplastic procedures representing approximately 75% of these. 4 The ideal timing for breast reconstruction is a multifactorial decision based on desired reconstructive approach, other medical comorbidities, and whether the patient will require adjuvant radiotherapy.

Immediate reconstruction at the time of mastectomy offers psychological and economic benefits and therefore makes up the majority of breast reconstructions [4] [5] [6] [7] [8] ; however, it has been associated with higher rates of surgical complications. 9, 10 Traditionally, immediate reconstructions have been done on an inpatient basis to monitor drain output, provide pain control, and assess for complications such as hematoma and skin necrosis. In recent years, some centers have begun to offer immediate alloplastic reconstruction as an outpatient procedure, mirroring trends observed for isolated mastectomy and delayed alloplastic reconstruction. 11, 12 Advances in the regional blockade and perioperative blocks have decreased postoperative pain, aiding this shift toward outpatient surgery. 13 Some studies have demonstrated higher patient satisfaction, lower costs, and comparable safety with outpatient surgery but were limited by smaller sample sizes, and this model has accounted for a minority of procedures in recent years. [14] [15] [16] [17] One factor which may accelerate the paradigm shift toward outpatient immediate reconstruction is the SARS-CoV-2 coronavirus disease 2019 (COVID- 19) pandemic. In early 2020, both the American College of Surgeons and the American Society of Plastic Surgeons (ASPS) issued recommendations that all nonurgent elective surgeries be canceled or postponed. In addition, they recommended that urgent elective procedures be shifted to the outpatient setting to conserve inpatient resources, specifically intensive care unit beds, and decrease the risk of transmission of the novel coronavirus. [18] [19] [20] [21] Overall, there was a sharp decline in elective surgical volumes across multiple specialties, including oncologic surgery. [22] [23] [24] Given that cancer patients are at higher risk for serious complications and mortality from COVID-19, 25,26 these recommendations provided a strong incentive to provide immediate reconstruction in the outpatient setting. To conserve resources while still providing care for breast cancer patients, some centers pivoted to "high-efficiency" same-day protocols with encouraging early outcomes. [27] [28] [29] [30] Despite the observed delays and global decreases in elective surgical volumes, relatively little is known about the effects of the COVID-19 pandemic on outcomes of breast reconstruction on a national scale. Understanding how these necessary changes have affected outcomes will inform decision-making for breast cancer surgeons and patients, as the availability of inpatient surgery returns.

To evaluate these trends in a large, national cohort, we surveyed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database 31 to identify patients undergoing immediate alloplastic breast reconstruction to describe aggregate changes in surgical volume, patient demographics, comorbidities, procedure setting, early complications, and reoperation rates as a result of the COVID-19 pandemic.

This study was designated as nonhuman subjects research due to the deidentified nature of the data and thus exempt from IRB approval.

To isolate the effects of COVID-19, which was widespread in the United States by April 2020, 32 (CPT codes 19361, 19364, 19367, 19368, 19369) .

The procedures fitting these inclusion criteria formed the before-COVID and during-COVID groups, containing 4677 and 4083 procedures, respectively. Patient demographic data corresponding to each of these procedures was extracted, including age at operation, sex, race, ethnicity, height, and weight. Body mass index To further examine the safety of outpatient reconstruction specifically, procedures from 2019 to 2020 were pooled and subsequently divided into cohorts based on inpatient or outpatient (postoperative length of stay 0 days) procedures. Demographic, perioperative, and outcomes data were compared between groups as above.

Kolmogorov-Smirnov tests were performed to assess the normality of continuous variables, and these were reported as mean ± standard deviation or median (interquartile range [IQR]). χ 2 and Fisher's exact tests were performed to compare categorical data as appropriate, and Mann-Whitney U tests were performed to compare numerical data.

Post hoc Fisher's exact tests with a Holm-Bonferroni correction for multiple comparisons were performed when indicated for categorical variables with more than two groups. The pairwise deletion was utilized when records were missing data to maximize data retained. p Values were obtained from two-tailed tests, and the significance level was predefined at α = 0.05.

To establish the safety of breast reconstruction in the COVID era, noninferiority tests were performed utilizing the Farrington-Manning approach and a risk difference margin of 1%. 33 In noninferiority analyses, p values were one-sided, with a significance level of α = 0.05. Given baseline differences in patients who underwent outpatient reconstruction, a propensity score-matched analysis was performed to minimize differences between inpatient and outpatient cohorts with respect to known potential confounders. The covariates upon which patients were matched were again identified by pairwise associations with surgical complications with p < 0.20, with the exclusion of operative time, which is not defined before the decision to pursue an inpatient or an outpatient procedure, and COPD, which had a low count (n = 4 in the outpatient group), to prevent overfitting. 34 Surgery type was also added as a matching covariate. Propensity scores were calculated by a logistic regression model utilizing an optimal fixed ratio algorithm, minimizing the total difference in propensity scores across groups. A 1:1 match ratio and a caliper width of 0.25 standard deviations of the logit of the propensity score were used. The distribution of potential confounders before and after propensity score matching was evaluated by standardized mean differences (SMD), where an SMD ≤ 0.10 is considered nonsignificant. For categorical variables with more than 2 levels, the match was evaluated using χ 2 tests.

Listwise deletion was utilized in logistic regression and propensity score analyses, excluding all records missing any of the predictor variables. All statistical analyses were performed in SAS Studio software version 3.8 (SAS Institute Inc.).

During the COVID-19 pandemic, breast reconstruction case volumes and overall surgical case volume reported in the NSQIP database decreased ( Figure 1 ). The database contains a total of 806 016 procedures from April to December 2019 and 644 061 from these months in 2020. In the before-COVID period, 4677 direct-to-implant and immediate tissue expander procedures were reported, accounting for 580 per 100 000 total cases. In the corresponding months of 2020, 4083 of the same procedures were reported, a decrease of 13%; however, these made up 633 per 100 000 of all the surgeries reported, a significant increase in proportion (p = 0.001, Table 1 ).

Notably, there was an increase in the proportion of alloplastic reconstructions performed as outpatient procedures from 10% before COVID to 31% in 2020 during COVID (p < 0.001), a change that is seen most prominently in Quarter 2 of 2020 but is consistently elevated for the remainder of the year (p < 0.001 each quarter).

Patients underwent reconstruction at a median of 50 years of age (IQR: 42-60). Demographics differed between the before-COVID and during-COVID cohorts, with the latter group being more often African American (13% vs. 11%) and less often white (80% vs. 82%, p = 0.003), and more often of Hispanic ethnicity (11% vs. 9.5%, p = 0.01; Table 1 ). Comorbidities generally did not differ across the two cohorts, with the exception of overall higher ASA class in the during-COVID group (65% vs. 67% Class II, 31% vs. 28% Class III, p = 0.01). During the pandemic, fewer direct-to-implant procedures were performed than before COVID (13% vs. 17%, p < 0.001), and the use of acellular dermal matrix became more common ( Table 2) .

Rates of postoperative complications, however, did not significantly increase. In the before-COVID cohort, there were 306 surgical complications (6.5%, 95% confidence interval [CI]: 5.9%-7.3%), while in the during-COVID cohort, there were 244 (6.0%, 95% CI: 5.3%-6.8%, p = 0.001 for noninferiority; Table 3 ; Figure 2A) . The incidence of medical complications in the during-COVID cohort was 1.1% (95% CI: 0.8%-1.4%), noninferior to the 1.5% in the before-COVID cohort (95% CI: 1.2%-1.9%, p < 0.001). The rate of reoperations during COVID was 7.5% (95% CI: 6.7%-8.3%), also noninferior to before COVID (7.4%, p = 0.049).

To adjust for patients' baseline differences, multivariable logistic regression was performed. Bivariate analyses identified age, BMI, operative time, race, ethnicity, diabetes, smoking, hypertension, and COPD as being potentially associated with surgical complication rates (p < 0.2); thus, these were included alongside the year of operation and outpatient procedure as covariates in the regression. The results confirmed that when accounting for the potential confounders listed above, the year of operation was not associated with surgical complications, with an odds ratio (OR) of 0.93 (95% CI: 0.76-1.14, p = 0.48). Outpatient status was similarly independent of surgical complications (OR: 0.90, 95% CI: 0.68-1.20, p = 0.48; Table 4 ).

To verify these findings, analyses were performed utilizing outpatient surgery as the exposure of interest. Baseline data of patients undergoing inpatient and outpatient surgery did differ significantly, with outpatients tending to have fewer comorbidities, including lower rates of obesity and smoking, and lower ASA class (p < 0.05 for all; Table S1 ). Outpatient procedures were more often direct-to-implant (23% vs. 13%, p < 0.001) and had shorter operative times (p < 0.001).

To minimize the impact of these baseline differences, propensity score-matched outpatient and inpatient cohorts were generated, T A B L E 1 Demographic data and comorbidities of immediate alloplastic breast reconstruction patients before-and during-COVID 4.1%-6.5%; vs. 8.0%; p < 0.001 for noninferiority for both; Table 6 , Figure 2B ).

However, the incidence of secondary operations was also statistically significantly lower in the outpatient cohort, largely driven by a decrease in operations for hematoma and seroma drainage to 1.4%, half of the 2.8% seen in the inpatient cohort (p = 0.003; 

In this study, a 13% decrease in immediate alloplastic breast and tissue expander placement, such as incision type, preoperative breast size, and intraoperative mastectomy skin flap quality, it is unlikely that the coronavirus pandemic was the sole causative factor for this shift. [41] [42] [43] In addition, our findings of outpatient alloplastic breast reconstruction during the COVID era being noninferior to the historic standard of care comport with the results of several single-institution studies. Of note, Faulkner et al. examined immediate reconstruction during the first 3 months of COVID-19 restrictions and found no difference in operative and nonoperative complications in comparison to the 3 preceding months, with an emphasis on same-day discharge whenever medically possible. 44 Other centers had begun a shift towards outpatient procedures even before the pandemic, with similarly encouraging results. 14, 17 In this study, outpatient reconstruction was also noninferior in medical complication rates. While these outcomes were 

In the context of the COVID-19 pandemic, at a time when conservation of hospital resources continues to be of great importance, we find that immediate alloplastic breast reconstruction is a generally safe procedure in the outpatient setting, with no increase in short-term surgical complications, medical complications, or reoperations. However, further prospective study is necessary to validate the decreased reoperation rates in outpatients and clarify possible underlying causes. Close postoperative follow-up, particularly in the initial days after surgery, remains essential in patients undergoing breast reconstruction in the inpatient or outpatient setting.

The COVID-19 pandemic has forced us to re-examine surgical dogma: crisis forces innovation. Healthier patients were given the opportunity to undergo what was previously an inpatient procedure T A B L E 6 Postoperative outcomes in inpatient and outpatient surgery with propensity score-matched cohorts as an outpatient, with encouraging results; thus, what constitutes an acceptable outpatient procedure may now be continuously reevaluated in this ongoing time of need.

Program and the hospitals participating in the ACS NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

Justin M. Sacks is a cofounder and equity holder of LifeSprout, and a consultant for 3M. Other authors declare no conflicts of interest.

Sarah N. Chiang https://orcid.org/0000-0002-0965-7100

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