Four-factor prothrombin complex concentrate is not inferior to andexanet alfa for the reversal or oral factor Xa inhibitors: An Eastern Association for the Surgery of Trauma multicenter study.

BACKGROUND: Andexanet alfa (AA) is the only FDA-approved reversal agent for apixaban and rivaroxaban (DOAC). There are no studies comparing its efficacy with four-factor prothrombin complex concentrate (PCC). This study aimed to compare PCC to AA for DOAC reversal, hypothesizing noninferiority of PCC. METHODS: We performed a retrospective, noninferiority multicenter study of adult patients admitted from July 1, 2018, to December 31, 2019, who had taken a DOAC within 12 hours of injury, were transfused red blood cells (RBCs) or had traumatic brain injury, and received AA or PCC. Primary outcome was PRBC unit transfusion. Secondary outcome with intensive care unit length of stay. MICE imputation was used to account for missing data and zero-inflated Poisson regression was used to account for an excess of zero units of RBC transfused. Two units difference in RBC transfusion was selected as noninferior. RESULTS: Results: From 263 patients at 10 centers, 77 (29%) received PCC and 186 (71%) AA. Patients had similar transfusion rates across reversal treatment groups (23.7% AA vs. 19.5% PCC) with median transfusion in both groups of 0 RBC. According to the Poisson component, PCC increases the amount of RBC transfusion by 1.02 times (95% confidence interval, 0.79-1.33) compared with AA after adjusting for other covariates. The average amount of RBC transfusion (nonzero group) is 6.13. Multiplying this number by the estimated rate ratio, PCC is estimated to have an increase RBC transfusion by 0.123 (95% confidence interval, 0.53-2.02) units compared with AA. CONCLUSION: PCC appears noninferior to AA for reversal of DOACs for RBC transfusion in traumatically injured patients. Additional prospective, randomized trials are necessary to compare PCC and AA for the treatment of hemorrhage in injured patients on DOACs. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Patient reported outcomes of emergency general surgery procedures.

BACKGROUND: Emergency general surgery (EGS) involves care of a patient's often previously unknown disease in the setting of an unplanned interaction with the healthcare system. This leads to challenges collecting and interpreting patient reported outcome measures (PROMs). METHODS: We performed a qualitative and mixed methods study using semi-structured interviews during the index hospitalization and at 6-12 months to capture peri-operative patient experiences. We compared interview findings to clinical characteristics. RESULTS: Among 30 patients, two-thirds reported feeling no choice but to pursue emergency surgery with many reporting exclusion from decision-making. Females reported these themes more commonly. Patients with minor complications less frequently reported trust in their team and discussed communication issues and delays in care (all p â€‹< â€‹0.05). Patients with major complications more frequently reported confidence in their team and gratefulness, but also communication limitations (all p â€‹< â€‹0.05). Patients not admitted to the ICU more frequently discussed good communication and expeditious treatment. CONCLUSIONS: PROMs developed for EGS patients should consider patient outcomes and reflections that they felt excluded from decision-making. Severity of complications may also differentially impact PROMs.

Effects of novel Coronavirus (COVID-19) on presentation, management, and outcomes of acute cholecystitis at an academic tertiary care center cholecystitis management during COVID-19.

Background: The COVID-19 pandemic necessitated adjustments to nearly all aspects of healthcare, including surgical care. The effects of these adjustments have not been well studied on acute surgical problems conventionally managed non-electively in large, tertiary care centers. Methods: A retrospective analysis of admitted patients with acute cholecystitis at a US academic tertiary care center was performed. We compared the presentation, management, and 30-day outcomes of patients admitted during a 2-month time period during early COVID, to a pre-COVID control group of admitted cholecystitis patients over a 2-month span. Results: The study cohort captured 24 patients, while the control cohort encompassed 53 patients. A non-significant trend toward non-operative management in the COVID cohort is reported. There was no delay in time-to-surgery or complication rate. No surgically managed patient developed COVID within 30 days of operation. Conclusions: Operative management of acute cholecystitis during the COVID-19 pandemic, with pre-operative testing and personal protective equipment guidelines, remained safe and effective.

Does lower extremity fracture fixation technique influence neurologic outcomes in patients with traumatic brain injury? The EAST Brain vs. Bone multicenter trial.

OBJECTIVE: This study aimed to determine whether lower extremity fracture fixation technique and timing (≤24 vs. >24 hours) impact neurologic outcomes in TBI patients. METHODS: A prospective observational study was conducted across 30 trauma centers. Inclusion criteria were age 18 years and older, head Abbreviated Injury Scale (AIS) score of >2, and a diaphyseal femur or tibia fracture requiring external fixation (Ex-Fix), intramedullary nailing (IMN), or open reduction and internal fixation (ORIF). The analysis was conducted using analysis of variamce, Kruskal-Wallis, and multivariable regression models. Neurologic outcomes were measured by discharge Ranchos Los Amigos Revised Scale (RLAS-R). RESULTS: Of the 520 patients enrolled, 358 underwent Ex-Fix, IMN, or ORIF as definitive management. Head AIS was similar among cohorts. The Ex-Fix group experienced more severe lower extremity injuries (AIS score, 4-5) compared with the IMN group (16% vs. 3%, p = 0.01) but not the ORIF group (16% vs. 6%, p = 0.1). Time to operative intervention varied between the cohorts with the longest time to intervention for the IMN group (median hours: Ex-Fix, 15 [8-24] vs. ORIF, 26 [12-85] vs. IMN, 31 [12-70]; p < 0.001). The discharge RLAS-R score distribution was similar across the groups. After adjusting for confounders, neither method nor timing of lower extremity fixation influenced the discharge RLAS-R. Instead, increasing age and head AIS score were associated with a lower discharge RLAS-R score (odds ratio [OR], 1.02; 95% confidence interval [CI], 1.002-1.03 and OR, 2.37; 95% CI, 1.75-3.22), and a higher Glasgow Coma Scale motor score on admission (OR, 0.84; 95% CI, 0.73-0.97) was associated with higher RLAS-R score at discharge. CONCLUSION: Neurologic outcomes in TBI are impacted by severity of the head injury and not the fracture fixation technique or timing. Therefore, the strategy of definitive fixation of lower extremity fractures should be dictated by patient physiology and the anatomy of the injured extremity and not by the concern for worsening neurologic outcomes in TBI patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level III.

Imaging acute cholecystitis, one test is enough.

BACKGROUND: Patients with right upper quadrant pain are often imaged using multiple modalities with no established gold standard. A single imaging study should provide adequate information for diagnosis. METHODS: A multicenter study of patients with acute cholecystitis was queried for patients who underwent multiple imaging studies on admission. Parameters were compared across studies including wall thickness (WT), common bile duct diameter (CBDD), pericholecystic fluid and signs of inflammation. Cutoff for abnormal values were 3 mm for WT and 6 mm for CBDD. Parameters were compared using chi-square tests and Intra-class correlation coefficients (ICC). RESULTS: Of 861 patients with acute cholecystitis, 759 had ultrasounds, 353 had CT and 74 had MRIs. There was excellent agreement for wall thickness (ICC = 0.733) and bile duct diameter (ICC = 0.848) between imaging studies. Differences between wall thickness and bile duct diameters were small with nearly all <1 mm. Large differences (>2 mm) were rare (<5%) for WT and CBDD. CONCLUSIONS: Imaging studies in acute cholecystitis generate equivalent results for typically measured parameters.

Academic Medical Centers Experienced Higher Rates of Post-Operative Health-Care-Associated Infections during the COVID-19 Pandemic: A Post Hoc Analysis of an Eastern Association for the Surgery of Trauma Multicenter Trial.

Background: We sought to examine health-care-associated infections (HAIs) among patients undergoing an appendectomy at academic medical centers (AMCs) and non-AMCs during the coronavirus disease 2019 (COVID-19) peri-pandemic. We hypothesized that AMCs would have higher rates of post-operative HAIs during the first wave of the pandemic. Patients and Methods: We performed a post hoc analysis of a prospective, observational, multi-center study of patients aged >18 years who underwent an appendectomy for acute appendicitis before (pre-CoV), during (CoV), and after pandemic restrictions were lifted (post-CoV). Patients were grouped according to hospital type (AMC vs. non-AMC). Our primary outcome was the incidence of post-operative HAIs. Results: There were 1,003 patients; 69.5% (n = 697) were treated at AMCs and 30.5% (n = 306) at non-AMCs. Patients at AMCs had greater rates of concomitant COVID-19 infections (5.5% vs. 0.7%; p < 0.0001) and worse operative appendicitis severity (p = 0.01). Greater rates of HAIs were seen at AMCs compared with non-AMCs (4.9% vs. 2%; p = 0.03). Surgical site infections were the most common HAI and occurred more often at AMCs (4.3% vs. 1.6%; p = 0.04). Only during CoV were there more HAIs at AMCs (5.1% vs. 0.3%; p = 0.02). Undergoing surgery at an AMC during CoV was a risk factor for HAIs (adjusted odds ratio [aOR], 8.55; 95% confidence interval [CI], 1.03-71.03; p = 0.04). Conclusions: During the COVID-19 pandemic, appendectomies performed at AMCs were an independent risk factor for post-operative HAIs. Our findings stress the importance of adherence to standard infection prevention efforts during future healthcare crises.

Revision of the AAST grading scale for acute cholecystitis with comparison to physiologic measures of severity.

BACKGROUND: Grading systems for acute cholecystitis are essential to compare outcomes, improve quality, and advance research. The American Association for the Surgery of Trauma (AAST) grading system for acute cholecystitis was only moderately discriminant when predicting multiple outcomes and underperformed the Tokyo guidelines and Parkland grade. We hypothesized that through additional expert consensus, the predictive capacity of the AAST anatomic grading system could be improved. METHODS: A modified Delphi approach was used to revise the AAST grading system. Changes were made to improve distribution of patients across grades, and additional key clinical variables were introduced. The revised version was assessed using prospectively collected data from an AAST multicenter study. Patient distribution across grades was assessed, and the revised grading system was evaluated based on predictive capacity using area under receiver operating characteristic curves for conversion from laparoscopic to an open procedure, use of a surgical "bail-out" procedure, bile leak, major complications, and discharge home. A preoperative AAST grade was defined based on preoperative, clinical, and radiologic data, and the Parkland grade was also substituted for the operative component of the AAST grade. RESULTS: Using prospectively collected data on 861 patients with acute cholecystitis the revised version of the AAST grade has an improved distribution across all grades, both the overall grade and across each subscale. A higher AAST grade predicted each of the outcomes assessed (all p ≤ 0.01). The revised AAST grade outperformed the original AAST grade for predicting operative outcomes and discharge disposition. Despite this improvement, the AAST grade did not outperform the Parkland grade or the Emergency Surgery Score. CONCLUSION: The revised AAST grade and the preoperative AAST grade demonstrated improved discrimination; however, a purely anatomic grade based on chart review is unlikely to predict outcomes without addition of physiologic variables. Follow-up validation will be necessary. LEVEL OF EVIDENCE: Diagnostic Test or Criteria, Level IV.

Sex-based differences in helmet performance in bicycle trauma.

OBJECTIVES: To determine the existence of sex-based differences in the protective effects of helmets against common injuries in bicycle trauma. METHODS: In a retrospective cohort study, we identified patients 18 years or older in the 2017 National Trauma Database presenting after bicycle crash. Sex-disaggregated and sex-combined multivariable logistic regression models were calculated for short-term outcomes that included age, involvement with motor vehicle collision, anticoagulant use, bleeding disorder and helmet use. The sex-combined model included an interaction term for sex and helmet use. The resulting exponentiated model parameter yields an adjusted OR ratio of the effects of helmet use for females compared with males. RESULTS: In total, 18 604 patients of average age 48.1 were identified, and 18% were female. Helmet use was greater in females than males (48.0% vs 34.2%, p<0.001). Compared with helmeted males, helmeted females had greater rates of serious head injury (37.7% vs 29.9%, p<0.001) despite less injury overall. In sex-disaggregated models, helmet use reduced odds of intracranial haemorrhage and death in males (p<0.001) but not females. In sex-combined models, helmets conferred to females significantly less odds reduction for severe head injury (p=0.002), intracranial bleeding (p<0.001), skull fractures (p=0.001), cranial surgery (p=0.006) and death (p=0.017). There was no difference for cervical spine fracture. CONCLUSIONS: Bicycle helmets may offer less protection to females compared with males. The cause of this sex or gender-based difference is uncertain, but there may be intrinsic incompatibility between available helmets and female anatomy and/or sex disparity in helmet testing standards.

Multicenter validation of the American Association for the Surgery of Trauma grading scale for acute cholecystitis.

BACKGROUND: The American Association for the Surgery of Trauma (AAST) patient assessment committee has created grading systems for emergency general surgery diseases to assist with clinical decision making and risk adjustment during research. Single-institution studies have validated the cholecystitis grading system as associated with patient outcomes. Our aim was to validate the grading system in a multi-institutional fashion and compare it with the Parkland grade and Tokyo Guidelines for acute cholecystitis. METHODS: Patients presenting with acute cholecystitis to 1 of 8 institutions were enrolled. Discrete data to assign the AAST grade were collected. The Parkland grade was collected prospectively from the operative surgeon from four institutions. Parkland grade, Tokyo Guidelines, AAST grade, and the AAST preoperative grade (clinical and imaging subscales) were compared using linear and logistic regression to the need for surgical "bailout" (subtotal or fenestrated cholecystectomy, or cholecystostomy), conversion to open, surgical complications (bile leak, surgical site infection, bile duct injury), all complications, and operative time. RESULTS: Of 861 patients, 781 underwent cholecystectomy. Mean (SD) age was 51.1 (18.6), and 62.7% were female. There were six deaths. Median AAST grade was 2 (interquartile range [IQR], 1-2), and median Parkland grade was 3 (interquartile range [IQR], 2-4). Median AAST clinical and imaging grades were 2 (IQR, 2-2) and 1 (IQR, 0-1), respectively. Higher grades were associated with longer operative times, and worse outcomes although few were significant. The Parkland grade outperformed the AAST grade based on area under the receiver operating characteristic curve. CONCLUSION: The AAST cholecystitis grading schema has modest discriminatory power similar to the Tokyo Guidelines, but generally lower than the Parkland grade, and should be modified before widespread use. LEVEL OF EVIDENCE: Diagnostic study, level IV.

Spirometry not pain level predicts outcomes in geriatric patients with isolated rib fractures.

BACKGROUND: Geriatric patients with rib fractures are at risk for developing complications and are often admitted to a higher level of care (intensive care units [ICUs]) based on existing guidelines. Forced vital capacity (FVC) has been shown to correlate with outcomes in patients with rib fractures. Complete spirometry may quantify pulmonary capacity, predict outcome, and potentially assist with admission triage decisions. METHODS: We prospectively enrolled 86 patients, 60 years or older with three or more isolated rib fractures presenting after injury. After informed consent, patients were assessed with respect to pain (visual analog scale), grip strength, FVC, forced expiratory volume 1 second (FEV1), and negative inspiratory force on hospital days 1, 2, and 3. Outcomes included discharge disposition, length of stay (LOS), pneumonia, intubation, and unplanned ICU admission. RESULTS: Mean age was 77.4 (SD, 10.2) and 43 (50.0%) were female. Forty-five patients (55.6%) were discharged home, median LOS was 4 days (interquartile range, 3-7). Pneumonias (2), unplanned ICU admissions (3), and intubation (1) were infrequent. Spirometry measures including FVC, FEV1, and grip strength predicted discharge to home and FEV1, and pain level on day 1 moderately correlated with the LOS. Within each subject, FVC, FEV1, and negative inspiratory force did not change for 3 days despite pain at rest and pain after spirometry improving from day 1 to 3 (p = 0.002, p < 0.001 respectively). Change in pain also did not predict outcomes and pain level was not associated with respiratory volumes on any of the 3 days. After adjustment for confounders, FEV1 remained a significant predictor of discharge home (odds ratio, 1.03; 95% confidence interval, 1.01-1.06) and LOS (p = 0.001). CONCLUSION: Spirometry measurements early in the hospital stay predict ultimate discharge home, and this may allow immediate or early discharge. The impact of pain control on pulmonary function requires further study. LEVEL OF EVIDENCE: Diagnostic test, level IV.

Getting used to being a patient: the postoperative experience of living liver transplant donors.

CONTEXT: Living donor liver transplant is a viable option for eligible persons in need of a liver transplant, but little is known about the hospitalization experience of patients undergoing hepatectomy for transplant donation. OBJECTIVE: To explore the hospital experience of patients recovering from donor hepatectomy. DESIGN: A qualitative interpretive descriptive design was used to understand the hospital experience of patients recovering from donor hepatectomy. Semistructured interviews, conducted before discharge, were audiotaped and transcribed verbatim. Coding was performed independently, then jointly by investigators to reach consensus on emerging themes. Setting-Major university hospital in the Northeastern United States. Sample-Adults (>18 years of age) whose primary language was English or Spanish and who could provide written informed consent. RESULTS: The sample consisted of 15 participants who had a mean age of 34.6 years; half were women. Most were white and college educated. The relationship of the donors to recipients varied from immediate family to altruistic donors. "Getting used to being a patient" was the major theme that captured the patients' postoperative experience. Four subthemes explained the experience: regaining consciousness, all those tubes, expecting horrible pain, and feeling special and cared for. These were described in the context of an "amazing and impressive" transplant team. CONCLUSION: As healthy donors are getting used to being patients, these results provide clinicians with a deeper understanding of the transplant experience from the donor's perspective so that care can be tailored to meet their unique needs.

Innovative solutions: using case studies to generate increased nurse's clinical decision-making ability in critical care.

Learning to care for critically ill patients requires a high level of critical thinking, clinical decision-making ability, and a substantial knowledge base. At this nursing school, an elective Critical Care Nursing course for last-semester seniors was designed to include active learning strategies, focusing on the use of case studies to facilitate learning. Results indicate significantly improved final examination scores for those involved with the case-study pedagogy. In addition, students identified enhanced communication skills. Two complex cases are presented for others to use with their educational programs.