Perioperative Venous Thromboembolism Risk in Patients Undergoing Hysterectomy for Fibroids: A US Retrospective Cohort Study.

OBJECTIVES: Venous thromboembolism (VTE) occurs in 0.4%-0.7% of benign hysterectomies. Pelvic vascular compression secondary to fibroids may elevate VTE risk. We aimed to evaluate the incidence and timing of VTE among individuals undergoing hysterectomy for fibroids and other benign indications. METHODS: Retrospective cohort study of patients who underwent a hysterectomy for fibroid and non-fibroid indications from January 2015 to December 2021. Main outcome measure was VTE consisting of pulmonary embolism or deep venous thrombosis diagnosed during 3 periods: (1) preoperative (1 year before surgery until day before surgery), (2) early postoperative (surgery date through 6 weeks after surgery), and (3) late postoperative (6 weeks to 1 year after surgery). Demographics, comorbidities, surgical characteristics, and VTE rates were compared by indication. RESULTS: A total of 263 844 individuals with fibroids and 203 183 without were identified. In total, 1.1% experienced VTE. On multivariable regression (adjusted demographic confounders and route of surgery), the presence of fibroids was associated with increased odds of preoperative (adjusted odds ratio [aOR] 1.12; 95% CI 1.03-1.22, P = 0.011) and reduced odds of late postoperative VTE (aOR 0.81; 95% CI 0.73-0.91, P < 0.001). For individuals with fibroids, uterine weight ≥250 g and undergoing laparotomy were independently associated with preoperative (aOR 1.29; 95% CI 1.09-1.52, P = 0.003 and aOR 2.32; 95% CI 2.10-2.56, P < 0.001) and early postoperative VTE (aOR 1.32; 95% CI 1.08-1.62, P = 0.006 and aOR 1.72; 95% CI 1.50-1.96, P < 0.001). CONCLUSIONS: Patients with fibroids were at increased odds of having VTE 1 year before hysterectomy. For those with fibroids, elevated uterine weight and laparotomy were associated with greater risk of preoperative and early postoperative VTEs.

The relationship between COVID-19 vaccination status in pregnancy and birthweight.

BACKGROUND: Despite findings that maternal COVID-19 infection in pregnancy is associated with low birthweight (weight of ≤2500 g), previous studies demonstrate no difference in low birthweight risk between COVID-19 vaccinated and unvaccinated pregnant persons. Few studies, however, have examined the association between unvaccinated, incomplete vaccination, and complete vaccination on low birthweight, and they have been limited by small sample sizes and lack of adjustment for covariates. OBJECTIVE: We sought to address key limitations of prior work and evaluate this association between unvaccinated, incomplete, and complete COVID-19 vaccination status in pregnancy and low birthweight. We predicted a protective association of vaccination on low birthweight that varies by number of doses received. STUDY DESIGN: We performed a population-based retrospective study using the Vizient clinical database, which included data from 192 hospitals in the United States. Our sample included pregnant persons who delivered between January 2021 and April 2022 at hospitals that reported maternal vaccination data and birthweight at delivery. Pregnant persons were categorized into 3 groups as follows: unvaccinated; incompletely vaccinated (1 dose of Pfizer or Moderna); or completely vaccinated (1 dose of Johnson & Johnson or ≥2 doses of Moderna or Pfizer). Demographics and outcomes were analyzed using standard statistical tests. We performed multivariable logistic regression to account for potential confounders between vaccination status and low birthweight in the original cohort. Propensity score matching was used to reduce bias related to the likelihood of vaccination, and the multivariable logistic regression model was then applied to the propensity score-matched cohort. Stratification analysis was performed for gestational age and race and ethnicity. RESULTS: Of the 377,995 participants, 31,155 (8.2%) had low birthweight, and these participants were more likely to be unvaccinated than those without low birthweight (98.8% vs 98.5%, P<.001). Incompletely vaccinated pregnant persons were 13% less likely to have low birthweight neonates compared to unvaccinated persons (odds ratio, 0.87; 95% confidence interval, 0.73-1.04), and completely vaccinated persons were 21% less likely to have low birthweight neonates (odds ratio, 0.79; 95% confidence interval, 0.79-0.89). After controlling for maternal age, race or ethnicity, hypertension, pregestational diabetes, lupus, tobacco use, multifetal gestation, obesity, use of assisted reproductive technology, and maternal or neonatal COVID-19 infections in the original cohort, these associations remained significant for only complete vaccination (adjusted odds ratio, 0.80; 95% confidence interval, 0.70-0.91) and not incomplete vaccination (adjusted odds ratio, 0.87; 95% confidence interval, 0.71-1.04). In the propensity score-matched cohort, pregnant persons who were completely vaccinated against COVID-19 were 22% less likely to have low birthweight neonates compared to unvaccinated and incompletely vaccinated individuals (adjusted odds ratio, 0.78; 95% confidence interval, 0.76-0.79). CONCLUSION: Pregnant persons who were completely vaccinated against COVID-19 were less likely to have low birthweight neonates compared to unvaccinated and incompletely vaccinated individuals. This novel association was observed among a large population after adjusting for confounders of low birthweight and factors influencing the likelihood of receiving the COVID-19 vaccine.

Association Between the COVID-19 Pandemic and Insurance-Based Disparities in Mortality After Major Surgery Among US Adults.

Importance: The COVID-19 pandemic caused significant disruptions in surgical care. Whether these disruptions disproportionately impacted economically disadvantaged individuals is unknown. Objective: To evaluate the association between the COVID-19 pandemic and mortality after major surgery among patients with Medicaid insurance or without insurance compared with patients with commercial insurance. Design, Setting, and Participants: This cross-sectional study used data from the Vizient Clinical Database for patients who underwent major surgery at hospitals in the US between January 1, 2018, and May 31, 2020. Exposures: The hospital proportion of patients with COVID-19 during the first wave of COVID-19 cases between March 1 and May 31, 2020, stratified as low (≤5.0%), medium (5.1%-10.0%), high (10.1%-25.0%), and very high (>25.0%). Main Outcomes and Measures: The main outcome was inpatient mortality. The association between mortality after surgery and payer status as a function of the proportion of hospitalized patients with COVID-19 was evaluated with a quasi-experimental triple-difference approach using logistic regression. Results: Among 2 950 147 adults undergoing inpatient surgery (1 550 752 female [52.6%]) at 677 hospitals, the primary payer was Medicare (1 427 791 [48.4%]), followed by commercial insurance (1 000 068 [33.9%]), Medicaid (321 600 [10.9%]), other payer (140 959 [4.8%]), and no insurance (59 729 [2.0%]). Mortality rates increased more for patients undergoing surgery during the first wave of the pandemic in hospitals with a high COVID-19 burden (adjusted odds ratio [AOR], 1.13; 95% CI, 1.03-1.24; P = .01) and a very high COVID-19 burden (AOR, 1.38; 95% CI, 1.24-1.53; P < .001) compared with patients in hospitals with a low COVID-19 burden. Overall, patients with Medicaid had 29% higher odds of death (AOR, 1.29; 95% CI, 1.22-1.36; P < .001) and patients without insurance had 75% higher odds of death (AOR, 1.75; 95% CI, 1.55-1.98; P < .001) compared with patients with commercial insurance. However, mortality rates for surgical patients with Medicaid insurance (AOR, 1.03; 95% CI, 0.82-1.30; P = .79) or without insurance (AOR, 0.85; 95% CI, 0.47-1.54; P = .60) did not increase more than for patients with commercial insurance in hospitals with a high COVID-19 burden compared with hospitals with a low COVID-19 burden. These findings were similar in hospitals with very high COVID-19 burdens. Conclusions and Relevance: In this cross-sectional study, the first wave of the COVID-19 pandemic was associated with a higher risk of mortality after surgery in hospitals with more than 25.0% of patients with COVID-19. However, the pandemic was not associated with greater increases in mortality among patients with no insurance or patients with Medicaid compared with patients with commercial insurance in hospitals with a very high COVID-19 burden.

Association Between the COVID-19 Pandemic and Disparities in Access to Major Surgery in the US.

Importance: Racial minority groups account for 70% of excess deaths not related to COVID-19. Understanding the association of the Centers for Medicare & Medicaid Services' (CMS's) moratorium delaying nonessential operations with racial disparities will help shape future pandemic responses. Objective: To evaluate the association of the CMS's moratorium on elective operations during the first wave of the COVID-19 pandemic among Black individuals, Asian individuals, and individuals of other races compared with White individuals. Design, Setting, and Participants: This cross-sectional study assessed a 719-hospital retrospective cohort of 3 470 905 adult inpatient hospitalizations for major surgery between January 1, 2018, and October 31, 2020. Exposure: The first wave of COVID-19 infections between March 1, 2020, and May 31, 2020. Main Outcomes and Measures: The main outcome was the association between changes in monthly elective surgical case volumes and the first wave of COVID-19 infections as a function of patient race, evaluated using negative binomial regression analysis. Results: Among 3 470 905 adults (1 823 816 female [52.5%]) with inpatient hospitalizations for major surgery, 70 752 (2.0%) were Asian, 453 428 (13.1%) were Black, 2 696 929 (77.7%) were White, and 249 796 (7.2%) were individuals of other races. The number of monthly elective cases during the first wave was 49% (incident rate ratio [IRR], 0.49; 95% CI, 0.486-0.492; P < .001) compared with the baseline period. The relative reduction in unadjusted elective surgery cases for Black (unadjusted IRR, 0.99; 95% CI, 0.97-1.01; P = .36), Asian (unadjusted IRR, 1.08; 95% CI, 1.03-1.14; P = .001), and other race individuals (unadjusted IRR, 0.97; 95% CI, 0.95-1.00; P = .05) during the surge period compared with the baseline period was very close to the change in cases for White individuals. After adjustment for age, sex, comorbidities, and surgical procedure, there was still no evidence that the first wave of the pandemic was associated with disparities in access to elective surgery. Conclusions and Relevance: In this cross-sectional study, the CMS's moratorium on nonessential operations was associated with a 51% reduction in elective operations. It was not associated with greater reductions in operations for racial minority individuals than for White individuals. This evidence suggests that the early response to the pandemic did not increase disparities in access to surgical care.

Socioeconomic and Racial Disparity in Chimeric Antigen Receptor T Cell Therapy Access.

Chimeric antigen receptor (CAR) T cell therapy is changing the paradigm in hematologic malignancies, but disparities in access exist in the real-world setting. Efforts to address and eliminate these disparities will ensure availability of this life-saving therapy. This study aimed to determine patterns of racial/ethnic distribution, socioeconomic strata, insurance coverage, and travel time of CAR T cell recipients. We used the Vizient Clinical Database (CDB) to capture and analyze elective encounters for CAR T administration as well as encounters for any reason other than CAR T administration (non-CAR T) in patients with lymphoma, myeloma, and acute lymphoblastic leukemia. Travel time and median household income were calculated based on ZIP code of residence. We found that African Americans (AA) were less likely than other racial/ethnic groups to receive CAR T cell therapy. In addition, AA and Hispanic participants were underrepresented in clinical trials. Among the patients with myeloma, all of whom received CAR T cell therapy on a clinical trial, only 1% were African American and 5.4% were Hispanic, and only 7.3% of CAR T cell therapy-related admissions were of patients from neighborhoods with a mean income <$40,000. Almost one-third of the CAR T cell recipients lived >2 hours away from the center in which they were treated; the majority of these patients were from the higher socioeconomic stratum (P < .001). There were fewer patients with Medicare and uninsured patients in the CAR T cell group. Our data indicate that socioeconomic stratum and insurance coverage are important underlying determinants of the identified disparities. Low clinical trial enrollment of minorities also feeds the inequity. Strategies to improve access need to be framed around addressing the causes for the observed disparities.

Perioperative outcomes in a nationwide sample of patients undergoing surgical treatment of ovarian endometriomas.

OBJECTIVE: To evaluate the perioperative outcomes of premenopausal women undergoing cystectomy or oophorectomy for ovarian endometriomas (OMAs) and other benign neoplasms. DESIGN: Retrospective cohort study. SETTING: Clinical database containing information from 580 US hospitals. PATIENT(S): Women 18 to 50 years old who underwent ovarian cystectomy or oophorectomy for benign indications between 2010 and 2020. INTERVENTION(S): We compared procedure route, length of hospital stay, and complication rates by surgical indication (OMA vs. other benign neoplasms) and surgical procedure (cystectomy vs. oophorectomy). MAIN OUTCOME MEASURE(S): Thirty-day perioperative adverse events following adnexal surgery, including conversion to laparotomy, blood transfusion, ileus, urinary tract injury, bowel injury, readmission, and death. RESULT(S): We identified 120,208 ovarian cystectomies (28,182 OMAs and 92,026 other indications) and 53,476 oophorectomies (8,622 OMAs and 44,854 other indications). During cystectomy, patients with OMAs more commonly experienced conversion to laparotomy (5.1% vs. 3.1%) and readmission (8.5% vs. 7.1%). For oophorectomies, patients with OMAs less frequently had minimally invasive surgery (55.8% vs. 64.8%) or outpatient procedures (33.8% vs. 41.8%). Urinary tract and bowel injuries were rare. Multivariable logistic regression demonstrated that the presence of OMA predicted composite complications during cystectomy (adjusted odds ratio [aOR] 1.23, 95% confidence interval [CI] 1.18-1.28) but not during oophorectomy (aOR 1.05, 95% CI 0.99-1.12). Patients with OMAs had 1.37 times the odds of a composite complication during oophorectomy than during cystectomy (95% CI 1.28-1.47). CONCLUSION(S): Patients undergoing ovarian cystectomy for OMAs had higher rates of perioperative adverse events than patients undergoing ovarian cystectomy for other benign neoplasms. Laparotomies were performed more often during oophorectomies for OMAs than for other benign indications.

Endovascular thrombectomy in acute ischemic stroke patients with COVID-19: prevalence, demographics, and outcomes.

BACKGROUND: We aimed to compare the outcome of acute ischemic stroke (AIS) patients who received endovascular thrombectomy (EVT) with confirmed COVID-19 to those without. METHODS: We performed a retrospective analysis using the Vizient Clinical Data Base and included hospital discharges from April 1 to July 31 2020 with ICD-10 codes for AIS and EVT. The primary outcome was in-hospital death and the secondary outcome was favorable discharge, defined as discharge home or to acute rehabilitation. We compared patients with laboratory-confirmed COVID-19 to those without. As a sensitivity analysis, we compared COVID-19 AIS patients who did not undergo EVT to those who did, to balance potential adverse events inherent to COVID-19 infection. RESULTS: We identified 3165 AIS patients who received EVT during April to July 2020, in which COVID-19 was confirmed in 104 (3.3%). Comorbid COVID-19 infection was associated with younger age, male sex, diabetes, black race, Hispanic ethnicity, intubation, acute coronary syndrome, acute renal failure, and longer hospital and intensive care unit length of stay. The rate of in-hospital death was 12.4% without COVID-19 vs 29.8% with COVID-19 (P<0.001). In mixed-effects logistic regression that accounted for patient clustering by hospital, comorbid COVID-19 increased the odds of in-hospital death over four-fold (OR 4.48, 95% CI 3.02 to 6.165). Comorbid COVID-19 was also associated with lower odds of a favorable discharge (OR 0.43, 95% CI 0.30 to 0.61). In the sensitivity analysis, comparing AIS patients with COVID-19 who did not undergo EVT (n=2139) to the AIS EVT patients with COVID-19, there was no difference in the rate of in-hospital death (30.6% vs 29.8%, P=0.868), and AIS EVT patients had a higher rate of favorable discharge (32.4% vs 47.1%, P=0.002). CONCLUSION: In AIS patients treated with EVT, comorbid COVID-19 infection was associated with in-hospital death and a lower odds of favorable discharge compared with patients without COVID-19, but not compared with AIS patients with COVID-19 who did not undergo EVT. AIS EVT patients with COVID-19 were younger, more likely to be male, have systemic complications, and almost twice as likely to be black and over three times as likely to be Hispanic.