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Introduction Inhaled therapeutics may act to directly target and attenuate lung inflammation due to COVID-19. An inhalation form of a novel biologic drug, AMP5A, is being developed as an immunomodulatory agent to treat dysregulated immune responses and is being studied in hospitalized patients to treat respiratory complications due to COVID-19. Methods A randomized, controlled, phase I trial was conducted to evaluate hospitalized adults with respiratory distress secondary to COVID-19. Patients received the standard care (SOC) for COVID-19, including respiratory therapy, corticosteroids, and antiviral therapies such as remdesivir. Patients were randomized 1:1 to inhalation treatment with AMP5A as an adjunct to SOC or to SOC alone (control). AMP5A was administered via inhalation daily for 5 days via hand-held nebulizer, non-invasive ventilator, or mechanical ventilation. Safety and clinical efficacy endpoints were evaluated. Results Forty subjects were enrolled and randomized (n = 19 AMP5A, n = 21 control). Remdesivir was used in fewer AMP5A subjects (26%) than control (52%), and dexamethasone was administered for most subjects (84% AMP5A, 71% control). The study met its primary endpoint with no AMP5A treatment-related adverse events (AEs), and the incidence and severity of AEs were comparable between groups: 18 AEs for control (8 mild, 1 moderate, 9 severe) and 19 AEs for AMP5A (7 mild, 7 moderate, 5 severe). Notably, subjects treated with AMP5A had fewer deaths (5% vs. 24%), shorter hospital stay (8 days vs. 12 days), fewer ICU admissions (21% vs. 33%), and a greater proportion with improved clinical outcomes than control. Conclusion The phase I clinical results indicate inhaled AMP5A is safe, is well tolerated, and could lead to fewer patients experiencing deterioration or death. Based on the treatment effect (i.e., reduced mortality), a phase II trial has been initiated. Trial registration Clinicaltrials.gov identifier: NCT04606784.

Objectives Results of pre-post intervention studies of sepsis early warning systems have been mixed, and randomized clinical trials showing efficacy in the emergency department setting are lacking. Additionally, early warning systems can be resource-intensive and may cause unintended consequences such as antibiotic or IV fluid overuse. We assessed the impact of a pharmacist and provider facing sepsis early warning systems on timeliness of antibiotic administration and sepsis-related clinical outcomes in our setting. Design A randomized, controlled quality improvement initiative. Setting The main emergency department of an academic, safety-net healthcare system from August to December 2019. Patients Adults presenting to the emergency department. Intervention Patients were randomized to standard sepsis care or standard care augmented by the display of a sepsis early warning system-triggered flag in the electronic health record combined with electronic health record-based emergency department pharmacist notification. Measurements and main results The primary process measure was time to antibiotic administration from arrival. A total of 598 patients were included in the study over a 5-month period (285 in the intervention group and 313 in the standard care group). Time to antibiotic administration from emergency department arrival was shorter in the augmented care group than that in the standard care group (median, 2.3 hr [interquartile range, 1.4-4.7 hr] vs 3.0 hr [interquartile range, 1.6-5.5 hr]; p = 0.039). The hierarchical composite clinical outcome measure of days alive and out of hospital at 28 days was greater in the augmented care group than that in the standard care group (median, 24.1 vs 22.5 d; p = 0.011). Rates of fluid resuscitation and antibiotic utilization did not differ. Conclusions In this single-center randomized quality improvement initiative, the display of an electronic health record-based sepsis early warning system-triggered flag combined with electronic health record-based pharmacist notification was associated with shorter time to antibiotic administration without an increase in undesirable or potentially harmful clinical interventions.

Introduction Longer prehospital times were associated with increased odds for survival in trauma patients. The purpose of this study was to determine how the COVID-19 pandemic affected emergency medical services (EMS) prehospital times for trauma patients. Methods This retrospective cohort study compared trauma patients transported via EMS to six US level I trauma centers admitted 1/1/19–12/31/19 (2019) and 3/16/20–6/30/20 (COVID-19). Outcomes included: total EMS pre-hospital time (dispatch to hospital arrival), injury to dispatch time, response time (dispatch to scene arrival), on-scene time (scene arrival to scene departure), and transportation time (scene departure to hospital arrival). Fisher's exact, chi-squared, or Kruskal-Wallis tests were used, alpha = 0.05. All times are presented as median (IQR) minutes. Results There were 9400 trauma patients transported by EMS: 79% in 2019 and 21% during the COVID-19 pandemic. Patients were similar in demographics and transportation mode. Emergency room deaths were also similar between 2019 and COVID-19 [0.6% vs. 0.9%, p = 0.13].There were no differences between 2019 and during COVID-19 for total EMS prehospital time [44 (33, 63) vs. 43 (33, 62), p = 0.12], time from injury to dispatch [16 (6, 55) vs. 16 (7, 77), p = 0.41], response time [7 (5, 12) for both groups, p = 0.27], or on-scene time [16 (12−22) vs. 17 (12,22), p = 0.31]. Compared to 2019, transportation time was significantly shorter during COVID-19 [18 (13, 28) vs. 17 (12, 26), p = 0.01]. Conclusion The median transportation time for trauma patients was marginally significantly shorter during COVID-19; otherwise, EMS prehospital times were not significantly affected by the COVID-19 pandemic.

Background Concerns of contracting the highly contagious disease COVID-19 have led to a reluctance in seeking medical attention, which may contribute to delayed hospital arrival among traumatic patients. The study objective was to describe differences in time from injury to arrival for patients with traumatic hip fractures admitted during the pandemic to pre-pandemic patients. Materials and methods This retrospective cohort study at six level I trauma centers included patients with traumatic hip fractures. Patients with a non-fall mechanism and those who were transferred in were excluded. Patients admitted 16 March 2019–30 June 2019 were in the “pre-pandemic” group, patients were admitted 16 March 2020–30 June 2020 were in the “pandemic” group. The primary outcome was time from injury to arrival. Secondary outcomes were time from arrival to surgical intervention, hospital length of stay (HLOS), and mortality. Results There were 703 patients, 352 (50.1%) pre-pandemic and 351 (49.9%) during the pandemic. Overall, 66.5% were female and the median age was 82 years old. Patients were similar in age, race, gender, and injury severity score. The median time from injury to hospital arrival was statistically shorter for pre-pandemic patients when compared to pandemic patients, 79.5 (56, 194.5) min vs. 91 (59, 420), p = 0.04. The time from arrival to surgical intervention (p = 0.64) was statistically similar between groups. For both groups, the median HLOS was 5 days, p = 0.45. In-hospital mortality was significantly higher during the pandemic, 1.1% vs 3.4%, p = 0.04. Conclusions While time from injury to hospital arrival was statistically longer during the pandemic, the difference may not be clinically important. Time from arrival to surgical intervention remained similar, despite changes made to prevent COVID-19 transmission.

Background Since the national stay-at-home order for COVID-19 was implemented, clinicians and public health authorities worldwide have expressed growing concern about the potential repercussions of drug and alcohol use due to social restrictions. We explored the impact of the national stay-at-home orders on alcohol or drug use and screenings among trauma admissions. Methods This was a retrospective cohort study at six Level I trauma centers across four states. Patients admitted during the period after the onset of the COVID-19 restrictions (defined as March 16, 2020-May 31, 2020) were compared with those admitted during the same time period in 2019. We compared 1) rate of urine drug screens and blood alcohol screens; 2) rate of positivity for drugs or alcohol (blood alcohol concentration ≥ 10 mg/dL); 3) characteristics of patients who were positive for drug or alcohol, by period using chi-squared tests or Fisher’s exact tests, as appropriate. Two-tailed tests with an alpha of p Results There were 4762 trauma admissions across the study period; 2602 (55%) in 2019 and 2160 (45%) in 2020. From 2019 to 2020, there were statistically significant increases in alcohol screens (34% vs. 37%, p = 0.03) and drug screens (21% vs. 26%, p p = 0.007), while the rate of drug positive patients was unchanged (57% vs. 52%, p = 0.13). Of the 1025 (22%) patients who were positive for alcohol or drugs, there were significant increases in a history of alcoholism (41% vs. 26%, p Conclusions Our first wave of COVID-19 data suggests that trauma centers were admitting significantly more patients who were alcohol positive, as well those with substance use disorders, potentially due to the impact of social restrictions and guidelines. Further longitudinal research is warranted to assess the alcohol and drug positive rates of trauma patients over the COVID-19 pandemic.

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ObjectivesTo measure trauma patient and caregiver satisfaction before and after implementation of standardised palliative care (PC) guidelines.MethodsProspective pre–post study at two level-I trauma centres. PC satisfaction surveys were administered prior to discharge for consented trauma patients (Family Satisfaction with Advanced Cancer Scale, Patient (FAMCARE-P13) survey)≥55 years, and their caregivers (FAMCARE survey), from 1 November 2016 to 30 November 2018. Standardised PC guidelines were implemented January 2018 and included consultations, prognostication assessments, identification of proxies, review of advanced directives and do not resuscitate orders within 24 hours of admission, while advanced goals of care, formal family meetings and spiritual care support were recommended within 72 hours of admission. Generalised linear models were used to determine whether differences in patient or caregiver satisfaction existed pre versus post implementation.ResultsThere were 572 patients (299 pre; 273 post) and 595 caregivers (334 pre; 261 post) included. Overall patient satisfaction significantly increased post implementation (82.0 vs 86.0, p=0.001). After adjustment, the implementation of the guidelines was an independent predictor of higher overall patient satisfaction (least squares mean (LSM= (83.8% (95%CI 81.2%-86.5%) vs 80.3% (77.7%-82.9%), p=0.003)). Compared with preimplementation, patient satisfaction was significantly higher post implementation in the following domains: information giving (80.9 vs 85.5, p=0.001), followed by physical care (82.2 vs 86.0, p=0.002), availability of care (83.4 vs 86.8, p=0.007) and psychosocial care (84.7 vs 87.6, p=0.04). No significant differences in caregiver satisfaction were found before or after adjustment (LSMpre: 83.1% (95%CI 80.9%-85.3%) vs. post: 82.4% (80.3%-84.5%), p=0.56))ConclusionsOur data suggest that the implementation of PC guidelines significantly improved patient satisfaction following traumatic injury, while maintaining robust caregiver satisfaction.

Objective Cerebral venous thrombosis (CVT) is a rare type of stroke whose pathophysiology differs from arterial stroke. CVT is treated with systemic anticoagulant therapy even in the setting of intracerebral hemorrhage. Patients who do not respond adequately may require decompressive surgery. The study objective was to examine the timing of anticoagulation in patients with CVT who require decompressive surgery through systematic literature review and consecutive case series. Methods A review of the literature was performed through PubMed using key word search to identify case series and cohort studies examining timing of anticoagulation following decompressive surgery. Our case series included 4 patients who had decompressive surgery for hemorrhagic CVT between 1 January, 2015 and 31 December, 2016 at our comprehensive stroke center. Results The literature review summarizes 243 patients from 15 studies whose timing of anticoagulation varied. The review suggests anticoagulation can be safely resumed at 48 hours postoperatively based on larger series and as early as 12 hours in smaller series, especially when delivered as a half or prophylactic dose. In our case series, timing of anticoagulation varied slightly but was started or resumed within 38–44 hours postoperatively in 3 patients and was started at the time of decompressive surgery without interruption in 1 patient. No patient had worsening hemorrhage or new hemorrhage while 2 patients rethrombosed. Conclusions Despite the lack of high-quality studies, this systematic review of patients with CVT requiring decompressive surgery indicates that anticoagulation can be safely initiated or resumed around 24–48 hours postoperatively; our series supports the existing literature.

Introduction There is practice variability in non-operative management (NOM) of blunt splenic trauma. This is particularly true for management decisions following failure of NOM, i.e. splenectomy versus angioembolization (AE). The objective of this study was to identify predictors of splenectomy versus AE in patients who failed NOM. Methods We included adult patients from the National Trauma Data Bank for 2013–2014, who had a splenic injury and who were admitted to a Level I Trauma Center (L1TC). Patients undergoing splenectomy after 2 h of emergency department arrival were deemed to have failed NOM. Multivariate logistic regression modeling was used to identify independent predictors of intervention after failed NOM. Results There were 2284 patients admitted for splenic injury between 2013 and 2014 who failed NOM. A total of 1253 patients underwent AE and 1031 patients underwent splenectomy. Seven independent factors were identified that predicted failure of NOM: penetrating injury, community L1TC, hospital bed size, number of trauma surgeons on call, functional dependence, chronic steroid use, and cirrhosis. Conclusions Seven independent variables were identified that predicted failure of NOM. These results contribute to the body of data regarding management of blunt splenic injury. Knowing predictive factors could help personalize management of patients, minimize delay of care, efficient resource allocation, and inform future studies.

BACKGROUND: There are multiple reports on the effect of time to surgery for geriatric hip fractures; it remains unclear if earlier intervention is associated with improved mortality, hospital length of stay (HLOS), or cost. METHODS: This was a multi-center retrospective cohort study. Patients (≥65y.) admitted (1/14-1/16) to six level 1 trauma centers for isolated hip fractures were included. Patients were dichotomized into early (≤24 h of admission) or delayed surgery (>24 h). The primary outcome was mortality using the CDC National Death Index. Secondary outcomes included HLOS, complications, and hospital cost. RESULTS: There were 1346 patients, 467 (35%) delayed and 879 (65%) early. The early group had more females (70% vs. 61%, p < 0.001) than the delayed group. The delayed group had a median of 2 comorbidities, whereas the early group had 1, p < 0.001. Mortality and complications were not significantly different between groups. After adjustment, the delayed group had no statistically significant increased risk of dying within one year, OR: 1.1 (95% CI:0.8, 1.5), compared to the early group. The average difference in HLOS was 1.1 days longer for the delayed group, when compared to the early group, p-diff

Objective Hip fracture surgery in geriatric patients on anticoagulants may increase the risk for blood loss. Anticoagulation reversal may lower these risks; however, data on blood loss and transfusions are limited. The study purpose was to compare outcomes between hip fracture patients 1) not on anticoagulants 2) whose anticoagulants were reversed, and 3) whose anticoagulants were not reversed. Methods This four-year retrospective cohort study at six Level 1 Trauma Centers enrolled geriatric patients (≥65) with isolated hip fractures. The primary outcome was total hospital blood loss (ml). Secondary outcomes: hospital length of stay (HLOS) and volume of packed red blood cells (pRBC) transfusions (ml). Statistical analyses included: Fisher’s, chi-squared, Kruskal-Wallis, linear mixed-effect and logistic regression. Bonferroni adjusted alpha = 0.025. Results Of the 459 patients, 189 (41%) were not on anticoagulants, 186 (41%) were reversed, and 84 (18%) were not reversed. The LS mean (SE) blood loss was 134 ml (12) for not reversed patients and 159 (17) for reversed patients; no significant difference compared to those not on anticoagulants [138 (12)], p-diff = 0.14 and 0.83, respectively. The LS mean (SE) HLOS was significantly longer for the reversed patients, 7.7 (0.4) days, when compared to those not on anticoagulants, 6.8 (0.4), p = 0.02, and when compared to those not reversed, 6.3 (0.6), p = 0.01. There was no significant difference in pRBC transfusions. Conclusion Not reversing anticoagulants for geriatric hip fractures was not associated with increased volume of blood loss or transfusions when compared to those reversed. Delayed surgery for anticoagulant reversal may be unnecessary and contributing to an increased HLOS.

Background Most guidelines recommend both pelvic packing (PP) and angioembolization for hemodynamically unstable pelvic fractures, however their sequence varies. Some argue to use PP first because orthopaedic surgeons are more available than interventional radiologists; however, there is no data confirming this. Methods This cross-sectional survey of 158 trauma medical directors at US Level I trauma centers collected the availability of orthopaedic surgeons and interventional radiologists, the number of orthopaedic trauma surgeons trained to manage pelvic fractures, and priority treatment sequence for hemodynamically unstable pelvic fractures. The study objective was to compare the availability of orthopaedic surgeons to interventional radiologists and describe how the availability of orthopaedic surgeons and interventional radiologists affects the treatment sequence for hemodynamically unstable pelvic fractures. Fisher’s exact, chi-squared, and Kruskal-Wallis tests were used, alpha = 0.05. Results The response rate was 25% (40/158). Orthopaedic surgeons (86%) were on-site more often than interventional radiologists (54%), p = 0.003. Orthopaedic surgeons were faster to arrive 39% of the time, and interventional radiologists were faster to arrive 6% of the time. There was a higher proportion of participants who prioritized PP before angioembolization at centers with above the average number (> 3) of orthopaedic trauma surgeons trained to manage pelvic fractures, as among centers with equal to or below average, p = 0.02. Arrival times for orthopaedic surgeons did not significantly predict prioritization of angioembolization or PP. Conclusions Our results provide evidence that orthopaedic surgeons typically are more available than interventional radiologists but contrary to anecdotal evidence most participants used angioembolization first. Familiarity with the availability of orthopaedic surgeons and interventional radiologists may contribute to individual trauma center’s treatment sequence.

Purpose The Biotronik LinoxSmart DX implanted cardioverter defibrillator (ICD) lead is a novel VDD lead with the advantage of integrated atrial sensing dipole combined with a special augmentation and filtering mechanisms. We sought to determine the efficacy of the Biotronik LinoxSmart DX ICD lead. Methods Non-randomized consecutive patients implanted with Biotronik LinoxSmart DX lead at Sheba Medical Center were included in this study. Electrical parameters and arrhythmic events were recorded during follow up of one year. Results Seventy-three patients (69 males (94.5%), mean age 61 ± 12 years) were included. All patients were successfully implanted with a Biotronic VR-T DX device and LinoxSmart DX ICD lead (DX-17 in 37% and DX-15 in 63% patients). Mean P wave amplitude at time of implantation was 3.66 ± 2.9 mV and improved significantly throughout the follow-up (5.29 ± 4.39 mV, p = 0.009). Appropriate atrial sensing (defined as P wave amplitude of ≥0.8 mV) rate of 100% at implantation significantly decreased to 89% (p = 0.015) at 12 months. Three out of 67 (4.5%) patients without a known history of atrial fibrillation had documented new onset paroxysmal atrial fibrillation. Appropriate shocks occurred in 4 (5.5%) patients. One patient with atrial sensing less than 0.4 mV had inappropriate shock. Conclusions Among patients implanted with the Biotronik LinoxSmart DX ICD lead in our single center, appropriate atrial sensing rate decreased over 12 months. Larger studies are needed to evaluate the reliability of long term appropriate atrial sensing.

BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) is not widely adopted for pelvic fracture management. Western Trauma Association recommends REBOA for hemodynamically unstable pelvic fractures, whereas Eastern Association for the Surgery of Trauma and Advanced Trauma Life Support do not.MethodUtilizing a prospective cross-sectional survey, all 158 trauma medical directors at American College of Surgeons-verified Level I trauma centers were emailed survey invitations. The study aimed to determine the rate of REBOA use, REBOA indicators, and the treatment sequence of REBOA for hemodynamically unstable pelvic fractures.ResultsOf those invited, 25% (40/158) participated and 90% (36/40) completed the survey. Nearly half of trauma centers [42% (15/36)] use REBOA for pelvic fracture management. All participants included hemodynamic instability as an indicator for REBOA placement in pelvic fractures. In addition to hemodynamic instability, 29% (4/14) stated REBOA is used for patients who are ineligible for angioembolization, 14% (2/14) use REBOA when interventional radiology is unavailable, 7% (1/14) use REBOA for patients with a negative FAST. Fifty percent (7/14) responded that hemodynamically unstable pelvic fractures exclusively indicates REBOA placement. Hemodynamic instability for pelvic fractures was most commonly defined as systolic blood pressure of ConclusionsThere is little consensus on REBOA use for pelvic fractures at US Level I Trauma Centers, except that hemodynamically unstable pelvic fractures consistently indicated REBOA use.

Background American College of Surgeons level I trauma center verification requires an active research program. This study investigated differences in the research programs of academic and non-academic trauma centers. Methods A 28-question survey was administered to ACS-verified level I trauma centers in 11/12/2020–1/7/2021. The survey included questions on center characteristics (patient volume, staff size), peer-reviewed publications, staff and resources dedicated to research, and funding sources. Results The survey had a 31% response rate: 137 invitations were successfully delivered via email, and 42 centers completed at least part of the survey. Responding level I trauma centers included 36 (86%) self-identified academic and 6 (14%) self-identified non-academic centers. Academic and non-academic centers reported similar annual trauma patient volume (2190 vs. 2450), number of beds (545 vs. 440), and years of ACS verification (20 vs. 14), respectively. Academic centers had more full-time trauma surgeons (median 8 vs 6 for non-academic centers) and general surgery residents (median 30 vs 7) than non-academic centers. Non-academic centers more frequently ranked trauma surgery (100% vs. 36% academic), basic science (50% vs. 6% academic), neurosurgery (50% vs. 14% academic), and nursing (33% vs. 0% academic) in the top three types of studies conducted. Academic centers were more likely to report non-profit status (86% academic, 50% non-academic) and utilized research funding from external governmental or non-profit grants more often (76% vs 17%). Conclusions Survey results suggest that academic centers may have more physician, resident, and financial resources available to dedicate to trauma research, which may make fulfillment of ACS level I research requirements easier. Structural and institutional changes at non-academic centers, such as expansion of general surgery resident programs and increased pursuit of external grant funding, may help ensure that academic and non-academic sites are equally equipped to fulfill ACS research criteria.

The low molecular weight fraction of human serum albumin (LMWF5A) has proven immunomodulatory activity via its effects on multiple inflammatory mediators and transcription factors. This biologic drug is currently being evaluated for the treatment of conditions characterized by hyperactive or persistent immune responses. To gain further insight into the mechanism of action of LMWF5A, an unbiased investigation of its effects on activated immune cells was performed. Peripheral blood mononuclear cells (PBMC) were treated with vehicle control or LMWF5A and stimulated with lipopolysaccharide (LPS), LPS/interferon γ, or interleukin (IL)-4/IL-13 for 24h. Differential gene expression analysis by RNAseq was performed to determine transcriptional changes due to LMWF5A treatment in each stimulation condition. Ingenuity Pathway Analysis software was employed to reveal overall biological trends observed in the RNAseq datasets and to identify compounds with comparable or contrasting activities to LMWF5A. Analysis of each RNA dataset revealed broad anti-inflammatory and pro-resolving activities for LMWF5A, with predicted inhibition of key pro-inflammatory mediators and functions as well as activation of some anti-inflammatory mediators. Upstream regulator analysis confirmed these activities and identified the corticosteroid dexamethasone as the most significantly similar regulator. Further comparison of LMWF5A and dexamethasone revealed similar, but not identical, targets and directional regulation. This study supports our current knowledge on the mode of action of LMWF5A and provides new hypotheses for future investigations. Due to its analogous biological effects with dexamethasone and known safety profile, LMWF5A may be used to treat conditions that are supported for dexamethasone with fewer or less harmful side effects.

It is generally believed that pharmacologic prophylaxis for venous thromboembolism (VTE) is underused. However, previous studies have not shown associations between increased prophylaxis administration and reductions in VTE. We here investigated prophylaxis administration and VTE incidence among trauma patients at our facility to determine whether to further increase prophylaxis administration after implementation of a standardized monitoring protocol. Univariate analyses and regression models were used to evaluate the protocol's effect on VTE, identify clinical factors associated with VTE and with receiving prophylaxis, and identify over- or under-prophylaxed patients. A final prophylaxis rate of 71.2% was achieved, an increase from the 40.8% reported by the Trauma Quality Improvement Program in 2015, with no accompanying reduction in VTE (1.5% pre and postintervention). Factors that identified patients at lower probability of receiving prophylaxis were those that increased bleeding risk: severe head injuries (odds ratio [OR] = 0.13) and preexisting bleeding (OR = 0.69) and renal/kidney (OR = 0.46) disorders. A large group of patients was both at increased odds of receiving prophylaxis and at low risk of VTE, representing a group that may be considered for nonpharmacologic options. Examination of current prophylaxis practices and identification of underuse or overuse is beneficial before expending effort to increase prophylaxis administration to reduce VTE.

Background An early failure of Biotronik Linox implantable cardioverter defibrillator (ICD) leads has been reported from several centers. Aim To compare the performance of Linox ICD leads with different other ICD leads as a report of the Sheba Medical Center experience. Methods All patients who had implantation of Linox ICD leads between 2007 and 2016 were included in this study. ICD lead failure was defined as low- or high-voltage impedance; failure to capture, sense, or defibrillate; or the presence of nonphysiological signals not due to external interference. The survival probability of Linox leads was determined and compared to Medtronic Sprint Quattro ICD leads. Results A total of 340 patients (age 64.4 ± 1.8 years) were included in this analysis. They were followed up to 105 months (mean 45.7 ± 7, median 44 (Interquartile range (IQR) 26-63) months). Twelve patients (3.5%) met the criteria for lead failure within 61.2 ± 22.9 months (median 66.5 [IQR 48-85 months]) post implantation. Noise with inappropriate ventricular arrhythmias detection, with or without therapy, was seen in 10 patients (83%). High pacing thresholds and high impedances were detected in two patients (17%). The survival probability of Linox leads at 60 months (97.3%) was similar to the survival probability of Sprint Quattro leads (98.2%) (P = .58). Nevertheless, the survival probability at 105 months was much lower (81% vs 97%, Linox ICD lead and Sprint Quattro lead, respectively, P = .0039). Conclusion Linox ICD leads have higher late failure rates compared to Sprint Quattro leads. These findings need to be confirmed in larger scale studies.

The low molecular weight fraction of commercial human serum albumin (LMWF5A) has been shown to successfully relieve pain and inflammation in severe osteoarthritis of the knee (OAK). LMWF5A contains at least three active components that could account for these antiinflammatory and analgesic effects. : We summarize in vitro experiments in bone marrow–derived mesenchymal stem cells, monocytic cell lines, chondrocytes, peripheral blood mononuclear cells, fibroblast-like synoviocytes, and endothelial cells on the biochemistry of anti-inflammatory changes induced by LMWF5A. We then look at four of the major pathways that cut across cell-type considerations to examine which biochemical reactions are affected by mTOR, COX-2, CD36, and AhR pathways. All three components show anti-inflammatory activities in at least some of the cell types. : The in vitro experiments show that the effects of LMWF5A in chondrocytes and bone marrow– derived stem cells in particular, coupled with recent data from previous clinical trials of single and multiple injections of LMWF5A into OAK patients demonstrated improvements in pain, function, and Patient Global Assessment (PGA), as well as high responder rates that could be attributed to the multiple mechanism of action (MOA) pathways are summarized here. In vitro and in vivo data are highly suggestive of LMWF5A being a disease-modifying drug for OAK.

Background: Catheter-based regional analgesia has been proposed as an alternative to systemic analgesia for patients with multiple rib fractures (MRF). This study sought to compare the efficacy of regional techniques for decreasing pain and improving clinical outcomes. Study design: This was a multi-institutional, retrospective cohort study of adult (≥18 years) patients admitted to four nonacademic trauma centers over two years (from 07/1/2014 to 06/30/2016). Study inclusion was MRF (≥3 fractures) with no other severe injuries. Two primary regional analgesia techniques were utilized and compared: continuous intercostal nerve blocks (CINB) and epidural (EPI) analgesia. The primary outcome, average pain scores on treatment, was examined using a repeated measures, linear regression mixed model. Secondary outcomes included hospital LOS, ICU LOS, ICU admission and hospital readmission, pulmonary complications, and incentive spirometry volumes during treatment, and were examined with univariate statistics. Results: There were 339 patients with isolated MRF; 85 (25%) required regional analgesia (CINB, n=41; EPI, n=44) and the remaining 75% received systemic analgesia only (IV, n=195; PO, n=59). There were demographic and clinical differences between regional analgesia and systemic analgesia groups; on the contrary, there were no demographic or clinical differences between the CINB and EPI groups. Adjusted pain scores were similar for the EPI and CINB groups (4.0 vs 4.4, p=0.49). Secondary outcomes were worse in the EPI group compared to the CINB group: less improvement in incentive spirometry volume (p=0.004), longer ICU LOS (p=0.03), longer hospital LOS (p

OBJECTIVEA paucity of studies have examined neurosurgical interventions in the mild traumatic brain injury (mTBI) population with intracranial hemorrhage (ICH). Furthermore, it is not understood how the dimensions of an ICH relate to the risk of a neurosurgical intervention. These limitations contribute to a lack of treatment guidelines. Isolated subdural hematomas (iSDHs) are the most prevalent ICH in mTBI, carry the highest neurosurgical intervention rate, and account for an overwhelming majority of all neurosurgical interventions. Decision criteria in this population could benefit from understanding the risk of requiring neurosurgical intervention. The aim of this study was to quantify the risk of neurosurgical intervention based on the dimensions of an iSDH in the setting of mTBI.METHODSThis was a 3.5-year, retrospective observational cohort study at a Level I trauma center. All adult (≥ 18 years) trauma patients with mTBI and iSDH were included in the study. Maximum length and thickness (in mm) of acute SDHs, the presence of acute-on-chronic (AOC) SDH, mass effect, and other hemorrhage-related variables were double–data entered; discrepant results were adjudicated after a maximum of 4 reviews. Patients with coagulopathy, skull fractures, no acute hemorrhage, a non-SDH ICH, or who did not undergo imaging on admission were excluded. Tentorial SDHs were not measured. The primary outcome was neurosurgical intervention (craniotomy, burr holes, intracranial pressure monitor placement, shunt, ventriculostomy, or SDH evacuation). Multivariate stepwise logistic regression was used to identify significant covariates, to assess interactions, and to create the scoring system.RESULTSThere were a total of 176 patients included in our study: 28 patients did and 148 did not receive a neurosurgical intervention. There were no significant differences between neurosurgical intervention groups in 11 demographic and 22 comorbid variables. Patients with neurosurgical intervention had significantly longer and thicker SDHs than nonsurgical controls. Logistic regression identified thickness and AOC hemorrhage as being the most important variables in predicting neurosurgical intervention; SDH length was not. Risk of neurosurgical intervention was calculated based on the SDH thickness and presence of an AOC hemorrhage from a multivariable logistic regression model (area under the receiver operating characteristic curve 0.94, 95% CI 0.90–0.97; p < 0.001). With a decision point of 2.35% risk, we predicted neurosurgical intervention with 100% sensitivity, 100% negative predictive value, and 53% specificity.CONCLUSIONSThis is the first study to quantify the risk of neurosurgical intervention based on hemorrhage characteristics in patients with mTBI and iSDH. Once validated in a second population, these data can be used to inform the necessity of interhospital transfers and neurosurgical consultations.

OBJECTIVEIsolated subdural hematomas (iSDHs) are one of the most common intracranial hemorrhage (ICH) types in the population with mild traumatic brain injury (mTBI; Glasgow Coma Scale score 13–15), account for 66%–75% of all neurosurgical procedures, and have one of the highest neurosurgical intervention rates. The objective of this study was to examine how quantitative hemorrhage characteristics of iSDHs in patients with mTBI at admission are associated with subsequent neurosurgical intervention.METHODSThis was a 3.5-year, retrospective observational cohort study at a Level I trauma center. All adult trauma patients with mTBI and iSDHs were included in the study. Maximum length and thickness (in mm) of acute SDHs, the presence of acute-on-chronic SDH, mass effect, and other hemorrhage-related variables were double–data entered; discrepant results were adjudicated after a maximum of 4 reviews. Patients with coagulopathy, skull fractures, no acute hemorrhage, a non-SDH ICH, or who did not undergo imaging on admission were excluded. The primary outcome was neurosurgical intervention (craniotomy, burr hole, catheter drainage of SDH, placement of intracranial pressure monitor, shunt, or ventriculostomy). Multivariate stepwise logistic regression was used to identify significant covariates and to assess interactions.RESULTSA total of 176 patients were included in our study: 28 patients did and 148 patients did not receive a neurosurgical intervention. Increasing head Abbreviated Injury Scale score was significantly associated with neurosurgical interventions. There was a strong correlation between the first 3 reviews on maximum hemorrhage length (R2 = 0.82) and maximum hemorrhage thickness (R2 = 0.80). The neurosurgical intervention group had a mean maximum SDH length and thickness that were 61 mm longer and 13 mm thicker than those of the nonneurosurgical intervention group (p < 0.001 for both). After adjusting for the presence of an acute-on-chronic hemorrhage, for every 1-mm increase in the thickness of an iSDH, the odds of a neurosurgical intervention increase by 32% (95% CI 1.16–1.50). There were no interventions for any SDH with a maximum thickness ≤ 5 mm on initial presenting scan.CONCLUSIONSThis is the first study to quantify the odds of a neurosurgical intervention based on hemorrhage characteristics in patients with an iSDH and mTBI. Once validated in a second population, these data can be used to better inform patients and families of the risk of future neurosurgical intervention, and to evaluate the necessity of interhospital transfers.

Background Mortality from hemodynamically unstable pelvic fractures remains high. Guidelines offer varying care approaches including the use of pelvic packing (PP), which was recently adopted for potential control of bleeding for this condition. However, the implementation of PP is uncertain as the debate on the optimal resuscitation strategy, angioembolization or PP continues. The study was designed to assess current practices among level 1 trauma centers in the US in regard to PP treatment for hemodynamically unstable pelvic fractures. Methods A cross-sectional survey was created to assess when to apply PP, application approach, and the respondent’s anecdotal perception on safety and effectiveness. Trauma Medical Directors at 158 US level 1 trauma centers were sent biweekly email invitations for 3 months. Participants were allowed to skip questions for any reason. The study hypothesis was that PP practices vary by US census bureau region, annual trauma admissions, and length of time in years since each trauma center received their respective level 1 trauma center designation. Results Twenty-five percent (40/158) of trauma medical directors participated and 75% (118/158) of the trauma medical directors did not participate. Of those who took the survey, 36/40 (90%) completed the survey and 4/40 (10%) partially completed the survey. Only 36 trauma medical directors responded on their perception of safety and effectiveness; 72% (26/36) of participants perceived PP as safe, whereas only a third (12/36) of participants perceived PP as effective. There were 25 trauma medical directors who provided the sequence of treatment modalities utilized at their level 1 trauma center, 76% (19/25) of participants reported that PP is utilized as the third or fourth priority. None of the participating level 1 trauma centers reported a preference towards utilization of PP as the first priority treatment. Half of the participants reported a preference towards applying PP only as a last resort to control hemorrhage. Northeastern and Western level 1 trauma centers were significantly more likely than Midwestern and Southern level 1 trauma centers to have reported application of PP to all hemodynamically unstable patients (p = 0.05). Midwestern, Southern, and Western level 1 trauma centers were significantly more likely to have perceived PP as safe than Northeastern level 1 trauma centers (p = 0.04). All low-volume and 38% high-volume level 1 trauma centers perceived PP to increase infection risks, (p = 0.03). We observed no association between the length of time each trauma center was designated a level 1 trauma center, and all participant responses. Conclusion Controversy and varying anecdotal perception regarding safety and effectiveness of PP prevails among trauma medical directors at level 1 trauma centers in the US.

As online streaming becomes a primary method for music consumption, the various modalities that many people with hearing loss rely on for their enjoyment need to be supported. While visual or tactile representations can be used to experience music in a live event or from a recording, DRM anti-piracy encryption restricts access to audio data needed to create these multimodal experiences for music streaming. We introduce BufferBeats, a toolkit for building multimodal music streaming experiences. To explore the flexibility of the toolkit and to exhibit its potential use cases, we introduce and reflect upon building a collection of technical demonstrations that bring previous and new multimodal music experiences to streaming. Grounding our work in critical theories on design, making, and disability, as well as experiences from a small group of community partners, we argue that support for multimodal music streaming experiences will not only be more inclusive to the deaf and hard of hearing, but it will also empower researchers and hobbyist makers to use streaming as a platform to build creative new representations of music.

Introduction: As a result of the novel coronavirus 2019 (COVID-19) pandemic, the Society for Neurointerventional Surgery (SNIS) issued guidelines for patient management during COVID-19. Specifically, they suggested intubating COVID-19 positive or those with unknown COVID-19 status prior to emergent endovascular thrombectomy, cohorting by COVID-19 status, early ICU discharge, and postponing elective cases. We sought to determine how the implementation of SNIS guidelines affected outcomes for patients with ischemic stroke. Methods: This was a retrospective cohort study comparing ischemic stroke patients who were treated with thrombectomy admitted during the COVID-19 pandemic 4/1/20-6/30/20 “COVID-19 peak” to patients admitted 4/1/19-6/30/19 “2019”. Statistical tests used for analysis included Kruskal-Wallis, chi-squared and Fisher’s exact test. Results: The proportion of patients treated with thrombectomy was not significantly different, 23% in 2019 vs. 24% during the COVID-19 peak, p=0.67. There were 112 patients treated with thrombectomy: 57 (51%) in 2019, 55 (49%) during the COVID-19 peak. No patients treated with thrombectomy were positive for COVID-19, but 27 (49%) were tested. The median age was 69 for those treated in 2019 and 69 for those during the COVID-19 peak, p=0.44. Patients were similar in sex, race, and comorbidities. The time from onset to arrival was also statistically similar, p=0.19. In 2019, 16% received tPA compared to 9% during the COVID-19 peak, p=0.28. The median time to groin puncture was significantly shorter in 2019, 38 minutes, than during the COVID-19 peak, 44 minutes, p=0.01. The recanalization rate and mRS were similar between groups, p=0.06, and p=0.91, respectively. Conclusions: After implementing the SNIS guidelines, including pre-treatment intubation, we observed a significantly longer time to groin puncture. Anecdotally, the increased observed was remarkably small given the changes to care and did not negatively impact patient outcomes. This suggests that hospitals managing patients efficiently can implement changes in response to COVID-19 and continue high level of care without impacting outcomes. Therefore, we recommend following the SNIS guidelines to prevent the spread of COVID-19.

BackgroundIt is not clear whether the COVID-19 pandemic and subsequent Society of Neurointerventional Surgery (SNIS) recommendations affected hospital stroke metrics.MethodsThis retrospective cohort study compared stroke patients admitted to a comprehensive stroke center during the COVID-19 pandemic April 1 2020 to June 30 2020 (COVID-19) to patients admitted April 1 2019 to June 30 2019. We examined stroke admission volume and acute stroke treatment use.ResultsThere were 637 stroke admissions, 52% in 2019 and 48% during COVID-19, with similar median admissions per day (4 vs 3, P=0.21). The proportion of admissions by stroke type was comparable (ischemic, P=0.69; hemorrhagic, P=0.39; transient ischemic stroke, P=0.10). Acute stroke treatment was similar in 2019 to COVID-19: tPA prior to arrival (18% vs, 18%, P=0.89), tPA treatment on arrival (6% vs 7%, P=0.85), and endovascular therapy (endovascular therapy (ET), 22% vs 25%, P=0.54). The door to needle time was also similar, P=0.12, however, the median time from arrival to groin puncture was significantly longer during COVID-19 (38 vs 43 min, P=0.002). A significantly higher proportion of patients receiving ET were intubated during COVID-19 due to SNIS guideline implementation (45% vs 96%, PConclusionsThe COVID-19 pandemic did not significantly affect stroke admission volume or acute stroke treatment utilization. Outcomes were not affected by implementing SNIS guidelines. Although there was a statistical increase in time to groin puncture for ET, it was not clinically meaningful. These results suggest hospitals managing patients efficiently can implement practices in response to COVID-19 without impacting outcomes.

BackgroundDamage control laparotomy (DCL) is a life-saving procedure in patients with abdominal hemorrhage. After DCL, patients are sometimes left with an open abdomen (OA) so they may undergo multiple exploratory laparotomies (EXLAP), or re-explorations. Patients with OA are at increased risk of infectious complications (ICs). The association between number of re-explorations after DCL and the number of ICs is not clear. We hypothesized that each additional re-exploration increases the risk of developing IC.MethodsThis 6-year retrospective cohort study included patients aged ≥16 years from the NTDB who had DCL defined as EXLAP within 2 hours of arrival (ICD-9: 54.11, 54.12, 54.19) with at least one re-exploration. The primary outcome was IC (ie, superficial surgical site infection (SSI), organ space SSI, deep SSI, sepsis, pneumonia, or catheter-related bloodstream infection), examined dichotomously (present/absent) and ordinally as the number of ICs. Multivariate Poisson regression was used to assess the association between number of re-explorations and number of ICs. Significance was assigned at pResultsThere were 7431 patients who underwent DCL; 2509 (34%) patients developed at least one IC. The rate of IC was lowest in patients who were closed during the first re-exploration (27%) and significantly increased with each re-exploration to 59% in patients who had five or more re-explorations (Cochran-Armitage trend pDiscussionFor patients requiring DCL, each re-exploration of the abdomen is associated with increased rate of ICs.Level of evidenceIII, retrospective epidemiological study.

IntroductionThe COVID-19 pandemic has had major effects on hospitals’ ability to perform scientific research while providing patient care and minimizing virus exposure and spread. Many non-COVID-19 research has been halted, and funding has been diverted to COVID-19 research and away from other areas.MethodsA 28-question survey was administered to all level 1 trauma centers in the USA that included questions about how the pandemic affected the trauma centers’ ability to fulfill the volume and research requirements of level 1 verification by the American College of Surgeons (ACS).ResultsThe survey had a 29% response rate (40/137 successful invitations). Over half of respondents (52%) reported reduced trauma admissions during the pandemic, and 7% reported that their admissions dropped below the volume required for level 1 verification. Many centers diverted resources from research during the pandemic (44%), halted ongoing consenting studies (33%), and had difficulty fulfilling research requirements because of competing clinical priorities (40%).DiscussionResults of this study show a need for flexibility in the ACS verification process during the COVID-19 pandemic, potentially including reduction of the required admissions and/or research publication volumes.Level of evidenceLevel IV, cross-sectional study.

Background The purpose of this study was to examine if satisfaction with care differs among older trauma patients with and without preexisting mental illness (PMI+/PMI-). Methods Data from two level I trauma centers were examined from 11/2016 through 12/2017. Trauma patients ≥55 years were included and satisfaction of those who had a diagnosis of mental illness prior to the trauma admission (PMI+) to those without a diagnosis (PMI-) (n = 299; 62 PMI+ and 237 PMI-) were compared. Enrolled patients completed the Family Satisfaction with Advanced Care Cancer Scale Patient Survey (FAMCARE-P13) prior to discharge. Associations between mental illness status and patient baseline characteristics, overall mean satisfaction, and mean satisfaction by question were compared. Generalized linear models adjusted for differences in patient satisfaction by mental illness status. Analyses were stratified by hospital to account for the interaction between hospital and mental illness status. Results Compared to PMI- patients, PMI+ patients were more likely to be younger, female, have multiple comorbidities, and to report lower overall satisfaction with care. Among PMI+ patients, the most common diagnoses were depression and anxiety. After adjustment, PMI+ was associated with lower patient satisfaction at hospital 1; after examining individual questions lower satisfaction was associated with information provided on procedures and questions surrounding “Physical care.” Conversely, PMI+ did not affect satisfaction at hospital 2 after adjustment. Conclusions At hospital 1, room for improvement was identified in providing information about prognosis and procedures, symptom management, and continuity of care. Reexamining practices for older PMI+ trauma patients is warranted.

BACKGROUND The Glasgow Coma Scale (GCS) score is the most frequently used neurologic assessment in traumatic brain injury (TBI). The risk for neurosurgical intervention based on GCS is heavily modified by age. The objective is to create a recalibrated Glasgow Coma Scale (GCS) score that accounts for an interaction by age and determine the predictive performance of the recalibrated GCS (rGCS) compared to the standard GCS for predicting neurosurgical intervention. METHODS This retrospective cohort study utilized the National Trauma Data Bank and included all patients admitted from 2010-2015 with TBI (ICD9 diagnosis code 850-854.19). The study population was divided into 2 subsets: a model development dataset (75% of patients) and a model validation dataset (remaining 25%). In the development dataset, logistic regression models were used to calculate conditional probabilities of having a neurosurgical intervention for each combination of age and GCS score, to develop a point-based risk score termed the rGCS. Model performance was examined in the validation dataset using area under the receiver operating characteristic (AUROC) curves and calibration plots. RESULTS There were 472,824 patients with TBI. The rGCS ranged from 1-15, where rGCS 15 denotes the baseline risk for neurosurgical intervention (4.4%) and rGCS 1 represents the greatest risk (62.6%). In the validation dataset there was a statistically significant improvement in predictive performance for neurosurgical intervention for the rGCS compared to the standard GCS (AUROC: 0.71 versus 0.67, difference, -0.04, P

Introduction: As the COVID-19 pandemic spread, patient care guidelines were published and elective surgeries postponed. However, trauma admissions are not scheduled and cannot be postponed. There is a paucity of information available on continuing trauma care during the pandemic. The study purpose was to describe multicenter trauma care process changes made during the COVID-19 pandemic. Methods: This descriptive survey summarized the response to the COVID-19 pandemic at six Level I trauma centers. The survey was completed in 05/2020. Questions were asked about personal protective equipment, ventilators, intensive care unit (ICU) beds, and negative pressure rooms. Data were summarized as proportions. Results: The survey took an average of 5 days. Sixty-seven percent reused N-95 respirators; 50% sanitized them with 25% using ultraviolet light. One hospital (17%) had regional resources impacted. Thirty-three percent created ventilator allocation protocols. Most hospitals (83%) designated more beds to the ICU; 50% of hospitals designated an ICU for COVID-19 patients. COVID-19 patients were isolated in negative pressure rooms at all hospitals. Conclusions: In response to the COVID-19 pandemic, Level I trauma centers created processes to provide optimal trauma patient care and still protect providers. Other centers can use the processes described to continue care of trauma patients during the COVID-19 pandemic.

Inflammatory responses to the novel coronavirus SARS-CoV-2, which causes COVID-19, range from asymptomatic to severe. Here we present a follow-up analysis of a longitudinal study characterizing COVID-19 immune responses from a father and son with distinctly different clinical courses. The father required a lengthy hospital stay for severe symptoms, whereas his son had mild symptoms and no fever yet tested positive for SARS-CoV-2 for 29 days. Father and son, as well as another unrelated COVID-19 patient, displayed a robust increase of SERPING1, the transcript encoding C1 esterase inhibitor (C1–INH). We further bolstered this finding by incorporating a serum proteomics dataset and found that serum C1–INH was consistently increased in COVID-19 patients. C1–INH is a central regulator of the contact and complement systems, potentially linking COVID-19 to complement hyperactivation, fibrin clot formation, and immune depression. Furthermore, despite distinct clinical cases, significant parallels were observed in transcripts involved in interferon and B cell signaling. As symptoms were resolving, widespread decreases were seen in immune-related transcripts to levels below those of healthy controls. Our study provides insight into the immune responses of likely millions of people with extremely mild symptoms who may not be aware of their infection with SARS-CoV-2 and implies a potential for long-lasting consequences that could contribute to reinfection risk., SARS-CoV-2; COVID-19; SERPING1; Complement; B cell; Interferon; MHC class II

Objective Frailty is a state of systematic physiologic decline and reduced ability to recover from illness. There are no rapid quantitative biological measures to assess frailty. The study objective was to determine whether oxidation-reduction potential (ORP) is correlated with frailty score. Methods This prospective, observational cohort study was performed using plasma samples of geriatric trauma patients (≥65 years) admitted to a level I trauma center. Frailty was measured with the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (7-point scale; 1 = robust health and 7 = severely frail). Plasma ORP was determined using the RedoxSYS™ system to measure static ORP (aggregate measure of oxidative stress) and capacity ORP (antioxidant reserves; log transformed). Spearman rank correlation (presented as rs) and ordinal logistic regression (presented as adjusted odds ratios, AOR) were used to examine the unadjusted and adjusted relationship between frailty score and ORP values. Results There were 93 geriatric trauma patients in our study. The majority (86%) had frailty scores 1-5, 11% were moderately frail and 3% were severely frail. There was a u-shaped relationship between ORP and frailty scale that became monotonic for scores 1-5. Each increase in frailty score demonstrated significant decreases in antioxidant reserves (log cORP rs = -0.26, p = 0.02) and nonsignificant increases in oxidative stress (sORP rs = 0.17, p = 0.15). After adjustment, variables significantly associated with frailty included log cORP (e.g., fewer antioxidant reserves, AOR: 0.70), age (AOR: 1.82), injury severity score (AOR: 0.50), admission lactate ≥2.5 mMol (AOR: 4.31), and alcohol use (AOR: 0.34). Conclusions The amount of antioxidant reserves (cORP) appears to be a quantitative marker to differentiate the degree of frailty ranging from robust health to mild frailty in geriatric trauma patients. We propose that direct quantification of frailty by way of a biomarker for oxidative reserves could have application in emergent trauma situations.

BackgroundThe COVID-19 pandemic resulted in nationwide social distancing and shelter-in-place orders meant to curb transmission of the SARS-CoV-2 virus. The effect of the pandemic on injury patterns has not been well described in the USA. The study objective is to determine the effect of the COVID-19 pandemic on the distribution and determinants of traumatic injuries.MethodsThis retrospective multi-institutional cohort study included all hospital admissions for acute traumatic injury at six community level I trauma centers. Descriptive statistics were used to compare injury causes, diagnoses and procedures over two similar time periods: prepandemic (March 11–June 30, 2019) and pandemic (March 11–June 30, 2020).ResultsThere were 7308 trauma patients included: 3862 (53%) prepandemic and 3446 (47%) during the pandemic. Cause of injury significantly differed by period (pDiscussionCauses of traumatic injury, diagnoses, and procedures were significantly changed by the pandemic. Trauma centers must adjust to meet the changing demands associated with altered injury patterns, as they were associated with increased use of hospital resources.Level of evidenceIII (epidemiological).

BackgroundIncreased unemployment during the COVID-19 pandemic has likely led to widespread loss of employer-provided health insurance. This study examined trends in health insurance coverage among trauma patients during the COVID-19 pandemic, including differences in demographics and clinical characteristics by insurance type.MethodsThis was a retrospective study on adult patients admitted to six level 1 trauma centers between January 1, 2018 and June 30, 2020. The primary exposure was hospital admission date: January 1, 2018 to December 31, 2018 (Period 1), January 1, 2019 to March 15, 2020 (Period 2), and March 16, 2020 to June 30, 2020 (Period 3). Covariates included demographic and clinical variables. χ² tests examined whether the rates of patients covered by each insurance type differed between the pandemic and earlier periods. Mann-Whiney U and χ² tests investigated whether patient demographics or clinical characteristics differed within each insurance type across the study periods.ResultsA total of 31 225 trauma patients admitted between January 1, 2018 and June 30, 2019 were included. Forty-one per cent (n=12 651) were admitted in Period 1, 49% (n=15 258) were from Period 2, and 11% (n=3288) were from Period 3. Percentages of uninsured patients increased significantly across the three periods (Periods 1 to 3: 15%, 16%, 21%) (ptrend=0.02); however, there was no accompanying decrease in the percentages of commercial/privately insured patients (Periods 1 to 3: 40%, 39%, 39%) (ptrend=0.27). There was a significant decrease in the percentage of patients on Medicare during the pandemic period (Periods 1 to 3: 39%, 39%, 34%) (pDiscussionThis study found that job loss during the COVID-19 pandemic resulted in increases of uninsured trauma patients. However, there was not a corresponding decrease in commercial/privately insured patients, as may have been expected; rather, a decrease in Medicare patients was observed. These findings may be attributable to a growing workforce during the study period, in combination with a younger overall patient population during the pandemic.Level of evidenceRetrospective, level III study.

Background Many studies report on the patient-caregiver relationship during palliative care (PC); however, this relationship has yet to be examined following traumatic injury. Methods This prospective cohort study included trauma patients (≥55 years) and their primary caregivers admitted at two level I trauma centers for 2 years (November 2016 to November 2018), who received PC and who completed satisfaction surveys before discharge; surveys were analyzed by four domains: information giving, availability of care, physical care, and psychosocial care, and by PC assessments: consultations, prognostications, formal family meetings (FFMs), and advanced goals of care discussions. The primary outcome was the percentage of patients and caregivers who were satisfied (defined as ≥80%) and was analyzed using McNemar's test. Adjusted mixed models identified PC assessments that were associated with satisfaction scores ≥80% for patients and caregivers. Results Of the 441-patient and 441-caregiver pairs, caregivers were significantly less satisfied than patients during prognostications (information giving, physical care), FFMs (information giving, physical care), and consultations (physical care), while caregivers were significantly more satisfied than patients during advanced goals of care discussions (availability of care, psychosocial care). After adjustment, significant predictors of caregiver satisfaction (≥80%) included longer patient hospital length of stay (>4 days), caring for a male patient (physical care, availability of care), higher caregiver age (≥55 years; availability of care), and higher patient age (≥65 years; psychosocial care). Conversely, all PC assessments decreased odds of satisfaction for caregivers in every domain except physical care. Significant predictors of higher patient satisfaction included FFMs (for every domain) and PC consultations (psychosocial care), and decreased odds included advanced goals of care discussions and prognostication assessments (information giving, psychosocial care). Conclusions Palliative care increased satisfaction of patients, especially family meetings and consultations, while assessments were predictive of lower caregiver satisfaction, suggesting that caregivers may be experiencing some of the patient burden. Level of evidence Therapeutic/Care Management, level IV.

Inflammatory responses to the novel coronavirus SARS-CoV-2, which causes COVID-19, range from asymptomatic to severe. Here we present a follow-up analysis of a longitudinal study characterizing COVID-19 immune responses from a father and son with distinctly different clinical courses. The father required a lengthy hospital stay for severe symptoms, whereas his son had mild symptoms and no fever yet tested positive for SARS-CoV-2 for 29 days. Father and son, as well as another unrelated COVID-19 patient, displayed a robust increase of SERPING1, the transcript encoding C1 esterase inhibitor (C1-INH). We further bolstered this finding by incorporating a serum proteomics dataset and found that serum C1-INH was consistently increased in COVID-19 patients. C1-INH is a central regulator of the contact and complement systems, potentially linking COVID-19 to complement hyperactivation, fibrin clot formation, and immune depression. Furthermore, despite distinct clinical cases, significant parallels were observed in transcripts involved interferon and B cell signaling. As symptoms were resolving, widespread decreases were seen in immune-related transcripts to levels below those of healthy controls. Our study provides insight into the immune responses of likely millions of people with extremely mild symptoms who may not be aware of their infection with SARS-CoV-2 and implies a potential for long-lasting consequences that could contribute to reinfection risk.

For mechanically ventilated patients undergoing surgery, interrupting enteral feeding to prevent pulmonary aspiration is common; however, there are no published preoperative fasting guidelines for these patients, resulting in fasting practices that often vary greatly between hospitals. This retrospective study described fasting practices and surgical outcomes of mechanically ventilated patients across five trauma centres. The primary exposure was hours nil per os before surgery and was stratified into short (

Background Warfarin reversal is typically sought prior to surgery for geriatric hip fractures; however, patients often proceed to surgery with partial warfarin reversal. The effect of partial reversal (defined as having an international normalized ratio [INR] > 1.5) remains unclear. Methods This was a retrospective cohort study. Geriatric patients (≥65 y/o) admitted to six level I trauma centers from 01/2014-01/2018 with isolated hip fractures requiring surgery who were taking warfarin pre-injury were included. Warfarin reversal methods included: vitamin K, factor VIIa, (a)PCC, fresh frozen plasma (FFP), and the “wait and watch” method. An INR of ≤ 1.5 defined complete reversal. The primary outcome was the volume of blood loss during surgery; other outcomes included packed red blood cell (pRBC) and FFP transfusions, and time to surgery. Results There were 135 patients, 44% partially reversed and 56% completely reversed. The median volume of blood loss was 100 mL for both those completely and partially reversed, p = 0.72. There was no difference in the proportion of patients with blood loss by study arm, 95% vs. 95%, p > 0.99. Twenty-five percent of those completely reversed and 39% of those partially reversed had pRBCs transfused, p = 0.08. Of those completely reversed 5% received an FFP transfusion compared to 14% of those partially reversed, p = 0.09. There were no statistically significant differences observed for the volume of pRBC or FFP transfused, or for time to surgery. Conclusions Partial reversal may be safe for blood loss and blood product transfusions for geriatric patients with isolated hip fractures. Complete warfarin reversal may not be necessary prior to hip fracture surgery, especially for mildly elevated INRs.

Background Previous studies have provided initial data suggesting that small-bore (SB, ≤ 14Fr) chest tubes have the same efficacy as large-bore (LB, > 14 Fr) chest tubes for acute hemothorax (HTX), but data continue to be lacking in the setting of delayed HTX. This study compared complications of SB chest tubes to LB tubes in patients with delayed HTX. Methods This was a retrospective observational study across 7.5 yrs. at 6 Level 1 trauma centers. Patients were included if 1) diagnosed with a HTX or > 1 rib fracture with bloody effusion from chest tube; 2) initial chest tube placed ≥36 h of hospital admission. Patients were excluded for hemopneumothoraces. The primary endpoint was having at least one of the following chest tube complications: tube replacement, VATS, tube falling out, tube clogging, pneumonia, retained HTX, pleural empyema. Secondary outcomes included chest tube output volume and drainage rate. Dependent/independent and parametric/non-parametric analyses were used to assess primary and secondary outcomes. Results There were 160 SB patients (191 tubes) and 60 LB patients (72 tubes). Both comparison groups were similar in multiple demographic, injury, clinical features. The median (IQR) tube size for each group was as follows: SB [12 Fr (12–14)] and LB [32 Fr (28–32)]. The risk of having at least one chest tube complication was similar for LB and SB chest tubes (14% vs. 18%, p = 0.42). LB tubes had significantly larger risk of VATS, while SB tubes had significantly higher risk of pneumonia. SB tubes had significantly slower least squares (LS) mean initial output drainage rate compared to LB tubes (52.2 vs. 213.4 mL/hour, p p = 0.81. LB and SB groups had similar initial output volume (738.0 mL vs. 810.9, p = 0.59). Conclusions There was no clearly superior chest tube diameter size; both chest tube sizes demonstrated risks and benefits. Clinicians must be aware of these potential tradeoffs when deciding on the diameter of chest tube for the treatment of delayed HTXs.

BACKGROUND Perinatal exposure to hepatitis C virus (HCV) is a major public health issue, and poor testing rates leave many children with infection unidentified. We sought to use the electronic health record (EHR) to promote guideline-directed HCV testing among infants born to mothers with HCV infection in an urban, safety-net hospital system. METHODS Our study population was identified using our EHR database, Epic. Children were included in the study if they had perinatal HCV exposure, were 18 months to 18 years of age and had at least 1 encounter in a primary or urgent care clinic during the study period. Our study included retrospective (October 2011 to February 2015) and prospective (February 2015 to May 2018) arms. Our EHR-based intervention was initiated in the prospective arm and recommended a one-time HCV antibody test at or after the age of 18 months using a health maintenance reminder. The health maintenance reminder activated a point-of-care alert and a linked HCV testing order set in all prespecified encounters during the intervention period. RESULTS Median time to appropriate HCV testing decreased from 96.2 months preintervention to 9.1 months postintervention (P < 0.0001), and rate of completed antibody testing increased from 14% to 61% (P < 0.0001). CONCLUSIONS Among children with perinatal HCV exposure, using a point-of-care alert within the EHR significantly increased the HCV antibody testing rate in accordance with American Academy of Pediatrics (AAP) recommendations. More effective EHR-based interventions combined with increased provider awareness of appropriate HCV testing in perinatally exposed infants is imperative.

BACKGROUND: Accelerated translation of real-world interventions for hypertension management is critical to improving cardiovascular outcomes and reducing disparities. OBJECTIVE: To determine whether a positive deviance approach would improve blood pressure (BP) control across diverse health systems. DESIGN: Quality improvement study using 1-year cross sections of electronic health record data over 5 years (2013–2017). PARTICIPANTS: Adults ≥ 18 with hypertension with two visits in 2 years with at least one primary care visit in the last year (N = 114,950 at baseline) to a primary care practice in Better Health Partnership, a regional health improvement collaborative. INTERVENTIONS: Identification of a “positive deviant” and dissemination of this system’s best practices for control of hypertension (i.e., accurate/repeat BP measurement; timely follow-up; outreach; standard treatment algorithm; and communication curriculum) using 3 different intensities (low: Learning Collaborative events describing the best practices; moderate: Learning Collaborative events plus consultation when requested; and high: Learning Collaborative events plus practice coaching). MAIN MEASURES: We used a weighted linear model to estimate the pre- to post-intervention average change in BP control (< 140/90 mmHg) for 35 continuously participating clinics. KEY RESULTS: BP control post-intervention improved by 7.6% [95% confidence interval (CI) 6.0–9.1], from 67% in 2013 to 74% in 2017. Subgroups with the greatest absolute improvement in BP control included Medicaid (12.0%, CI 10.5–13.5), Hispanic (10.5%, 95% CI 8.4–12.5), and African American (9.0%, 95% CI 7.7–10.4). Implementation intensity was associated with improvement in BP control (high: 14.9%, 95% CI 0.2–19.5; moderate: 5.2%, 95% CI 0.8–9.5; low: 0.2%, 95% CI−3.9 to 4.3). CONCLUSIONS: Employing a positive deviance approach can accelerate translation of real-world best practices into care across diverse health systems in the context of a regional health improvement collaborative (RHIC). Using this approach within RHICs nationwide could translate to meaningful improvements in cardiovascular morbidity and mortality. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-020-06480-z.

Background A common complication of viral pulmonary infections, such as in the ongoing COVID-19 pandemic, is a phenomenon described as a “cytokine storm”. While poorly defined, this hyperinflammatory response results in diffuse alveolar damage. The low molecular weight fraction of commercial human serum albumin (LMWF5A), a novel biologic in development for osteoarthritis, demonstrates beneficial in vitro immunomodulatory effects complimentary to addressing inflammation, thus, we hypothesize that LMWF5A could improve the clinical outcomes of COVID-19 by attenuating hyperinflammation and the potential development of a cytokine storm. Presentation of the hypothesis A variety of human in vitro immune models indicate that LMWF5A reduces the production of pro-inflammatory cytokines implicated in cytokine storm associated with COVID-19. Furthermore, evidence suggests LMWF5A also promotes the production of mediators required for resolving inflammation and enhances the barrier function of endothelial cultures. Testing the hypothesis A randomized controlled trial, to evaluate the safety and efficacy of nebulized LMWF5A in adults with Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19 infection, was developed and is currently under review by the Food and Drug Administration. Implications of hypothesis If successful, this therapy may attenuate the cytokine storm observed in these patients and potentially reduce mortality, increase ventilation free days, improve oxygenation parameters and consequently lessen the burden on patients and the intensive care unit. Conclusions In conclusion, in vitro findings suggest that the immunomodulatory effects of LMWF5A make it a viable candidate for treating cytokine storm and restoring homeostasis to the immune response in COVID-19.

Introduction There is a lack of data on the use and effectiveness of pre-hospital pelvic circumferential compression devices (PCCD) as a temporary intervention for pelvic fracture management; they are thought to decrease pelvic volume and hemorrhage but are not without risks. The purpose of this study is to examine pre-hospital PCCD practices at US Level I trauma centers. Methods This was a prospective cross-sectional survey of trauma medical directors at US Level I trauma centers. The aim of this study was to describe patterns of pre-hospital PCCD utilization for pelvic fractures. Responses were compared by region, length in time the center was designated Level I, trauma patient volume, pelvic management guideline followed and blood product guidelines. Data were compared using Fisher’s exact and chi-squared tests. Results Of the 158 Level I trauma centers invited, 25% responded. All Level I trauma centers use in-hospital PCCDs, whereas 71% of participant’s paramedic agencies trained on pre-hospital PCCD application. Of those, 44% trained to apply pre-hospital PCCDs to all suspected pelvic fractures. A higher proportion of high-volume centers (77%) than low-volume centers (25%) trained on pre-hospital PCCD placement, p = 0.06. PCCD practices were not dependent on the trauma center’s region, trauma volume, length in time as a Level I trauma center, or pelvic fracture guideline followed. Conclusions There is widespread application of in-hospital and pre-hospital PCCD at US Level I trauma centers, however pre-hospital PCCDs are not applied to all suspected pelvic fractures. Future studies should focus on efficacy, safety, and contraindications for pre-hospital PCCDs.

Delta-9-tetrahydrocannabinol (Δ9-THC) and other cannabinoids present in cannabis (marijuana) have been shown to affect the normal inhibitory pathways that influence nociception in humans. The potential benefits of cannabinoids as an analgesic are likely greatest in hyperalgesic and inflammatory states, suggesting a role as a therapeutic agent for treating acute pain following injury. Dronabinol is a licensed form of Δ9-THC. The primary objective of this single center randomized controlled trial is to evaluate the efficacy of adjunctive dronabinol versus control (systemic analgesics only, no dronabinol) for reducing opioid consumption in adults with traumatic injury. Study inclusion is based on high baseline utilization of opioids ≥50 morphine equivalents (mg) within 24 h of admission for adults aged 18–65 years with traumatic injury. There is a 48-hour screening period followed by a 48-hour treatment period after randomization. A total of 122 patients will be randomized 1:1 across 2 study arms: adjunctive dronabinol versus control (standard of care using systemic analgesics, no adjunctive dronabinol). Patients randomized to the dronabinol arm should receive their first dose within 12 h of randomization, with a dose range of 5 mg up to 30 mg daily in divided doses, in addition to systemic analgesics as needed for pain. The primary efficacy endpoint is a change in opioid consumption (morphine equivalents), assessed post-randomization (48 h after randomization) minus pre-randomization (24 h prior to randomization). This is the first randomized trial to investigate whether adjunctive dronabinol is effective in reducing opioid consumption in acute pain management of traumatic injury. Trial Registration: ClinicalTrials.gov Identifier: NCT03928015.

Objective: Undergoing mild traumatic brain injury (mTBI) increases mortality risk, but it is unclear what drives this finding. This study explored associations with mortality in patients with mTBI.Methods: This was a retrospective study of patients with mTBI and controls admitted to six level 1 trauma centers in 1/1/2009-12/31/2013. Mortality data were from the CDC National Death Index. Patients with mTBI were identified by ICD-9 code, Glasgow Coma Scale 13-15, Injury Severity Score (ISS)

Introduction: Most patients with acute neurological events present hypertensive. It is unknown whether blood pressure (BP) can aid in differentiating stroke type: acute ischemic stroke (AIS) or primary intracerebral hemorrhage (PICH). If BP is indicative, management could be expedited before confirmatory neuroimaging, such as pre-mixing IV tPA and lowering elevated blood pressure. The study objectives are a) to determine whether arrival BP can differentiate stroke type and b) to determine an optimal BP cut-off to aid in pre-mixing tPA. Methods: Our study population was selected from two NINDS clinical trials that did not use blood pressure as a selection criterion: ALIAS 1 trial (AIS, n=434) and ERICH trial (PICH, n=3,000). Multivariate logistic regression and t-tests were used to analyze the first recorded BP (systolic: SBP; diastolic: DBP) for patients with AIS vs. PICH. Receiver operator characteristic (ROC) curves were used to determine an optimal BP cutoff for ruling out PICH and pre-mixing tPA (specificity) and conversely for correctly identifying AIS (sensitivity). Results: Compared to AIS, patients with PICH had significantly higher mean SBP (186 vs. 158, p Conclusion: Although our study demonstrated arrival blood pressure was significantly associated with stroke type, the significant overlap and moderate AUROC suggest BP is not indicative and sufficiently dichotomous to delay pre-mixing tPA.

BackgroundIn patients with hemodynamically stable blunt splenic injury (BSI), there is no consensus on whether quantity of hemoperitoneum (HP) is a predictor for intervention with splenic artery embolization (SAE) or failing nonoperative management (fNOM). We sought to analyze whether the quantity of HP was associated with need for intervention.MethodsThis retrospective cohort study included adult trauma patients with hemodynamically stable BSI admitted to six trauma centers between 2014 and 2016. Quantity of HP was defined as small (perisplenic blood or blood in Morrison’s pouch), moderate (blood in one or both pericolic gutters), or large (additional finding of free blood in the pelvis). Multivariate logistic regression was performed to identify predictors of intervention with SAE or fNOM versus successful observation.ResultsThere were 360 patients: hemoperitoneum was noted in 214 (59%) patients, of which the quantity was small in 92 (43%), moderate in 76 (35.5%), and large in 46 (21.5%). Definitive management was as follows: 272 (76%) were observed and 88 (24%) had intervention (83 SAE, 5 fNOM). The rate of intervention was univariately associated with quantity of HP, even after stratification by American Association for the Surgery of Trauma (AAST) grade. After adjustment, larger quantities of HP significantly increased odds of intervention (p=0.01). Compared with no HP, the odds of intervention were significantly increased for moderate HP (OR=3.51 (1.49 to 8.26)) and large HP (OR=2.89 (1.03 to 8.06)), with similar odds for small HP (OR=1.21 (0.46 to 2.76)). Other independent predictors of intervention were higher AAST grade, older age, and presence of splenic vascular injury.ConclusionGreater quantity of HP was associated with increased odds of intervention, with no difference in risk for moderate versus large HP. These findings suggest quantity of HP should be incorporated in the management algorithm of BSI as a consideration for angiography and/or embolization to maximize splenic preservation and reduce the risk of splenic rupture.Level of evidenceIII, retrospective epidemiological study.

Background: Advanced aged adults have the highest rate of traumatic brain injury (TBI) related hospital admissions, compared to younger age groups. Data were published in 2014 indicating differential injury and neurological responses to a TBI by age categories. In a recent article examining patients with mTBI and isolated subdural hematoma, it was found that older patients had a decreased risk of documented loss of consciousness (LOC). The primary objective was to determine the extent to which the odds of documented LOC changes with increasing age in a population of older adults suffering an isolated concussion and uncomplicated mTBI.Methods: This was a retrospective study utilizing 6 years (2010–2015) of National Trauma Data Bank data. This study included patients with (1) diagnosis of concussion; (2) positive or negative loss of consciousness; (3) loss of consciousness durations no longer than 59 min or undefined; (4) age ≥50 years; (5) had a “fall” mechanism of injury; and (6) a valid emergency department Glasgow coma scale 13–15. We excluded patients (1) with any intracranial hemorrhage or intracranial injury of other and unspecified nature; (2) skull fracture; (3) an injury severity scale score >17; (4) a concussion with “unspecified” LOC (ICD-9: 850.9).Results: There were 7,466 patients included in the study; the median (IQR) age was 70 (60–80) years. The risk of documented LOC was 71% (n = 5,319). An 80-year-old had 72% decreased odds of having a documented LOC, compared to a 50-year-old (OR = 0.28, 99.5%CI [0.23–0.34], P < 0.001). This association held when controlling for multiple demographic, comorbid, and clinical variables, and in sensitivity analyses.Conclusion: These nationwide data suggest that in patients aged ≥50 years, a significant inverse association exists between age and odds of documented LOC after sustaining a fall-related concussion. Additional studies are needed to validate these findings and to investigate the triad of age, documented LOC, and intracranial hemorrhage. Clinical diagnostic criteria relying on LOC might be at risk of being modified by the association between increasing age and decreasing odds of LOC.

Background Hospital length of stay (HLOS) is a commonly used measure of hospital quality and is influenced by clinical and non-clinical factors. To reduce HLOS, it is key to identify factors placing patients at increased risk of lengthy HLOS and discharge delays. Methods This was a retrospective cohort study of patients age ≥ 18 admitted to four level 1 trauma centers between 1/1/2015 and 3/31/2018 with traumatic brain injury (TBI). The primary outcome was discharge delay, defined as discharge ≥24 h after case management notes indicated the patient was ready for discharge. The independent variables of interest were primary insurance provider and discharge destination. Chi-square, Fisher exact, and unadjusted and adjusted logistic regression analyses were used to assess associations between discharge delay and the two primary independent variables, as well as other patient demographic and clinical characteristics. Complications developing during the delay period were also examined. Results A total of 1543 patients with TBI were included. The median age was 61 years, and the median HLOS was 5 days. Approximately half of patients were discharged home (54%). The most common insurance providers were Medicare (35%) and commercial/private (35%). Two-hundred ten (14%) patients experienced a discharge delay. The median delay period was 3 days, and the most common reasons for delay were insurance authorization (52%) and lack of accepting bed (41%). Compared to being discharged home, patients discharged to a skilled nursing facility (adjusted odds ratio (AOR) = 10.35) or intermediate care facility (AOR = 10.64) had the highest odds of discharge delay. Compared to Medicare patients, uninsured/self-pay patients (AOR = 2.98) and those with Medicaid (AOR = 2.83) or commercial/private insurance (AOR = 2.22) had higher odds of delay. Thirty-two patients (15% of those delayed) experienced at least one complication during the delay, some of which were clinically severe. Conclusions A substantial portion of TBI patients in this study experienced discharge delays, and discharge destination and primary insurance provider were significant drivers of these delays. Evaluation of a facility’s quality of care should consider the specific causes of these delays.