Thrombotic Events and Anticoagulation-Related Bleeding Complications in Critically Ill Patients with Coronavirus Disease 2019.

Background: Thrombosis (T) is common in coronavirus disease 2019 (COVID-19) patients, and d-dimer concentrations correlate with outcomes. Controversy exists with regards to anticoagulation (AC) for patients. We implemented a full-heparinization AC protocol from the onset of the pandemic and hypothesized that a safety signal would be undetectable. Patients and Methods: Prospective evaluation of 111 patients with COVID-19 critical illness hospitalized from March to June 2020. All patients received therapeutic heparinoid-based AC from admission. Incidences of T, bleeding (B), or both (BT) were noted. The primary outcome was mortality. Kruskal-Wallis test and logistic regression were performed. Results are expressed as n (%), median (interquartile range) and odds ratios with 95% confidence intervals. Alpha was set at 0.05. Results: Thirty-two patients (28%) had T, 23 (20%) had B, and 14 (12%) had BT; 42 (40%) patients were unaffected. Two logistic regression models (outcome = mortality) evaluated BT as T, or BT as B. For BT as T, neither T, B, nor male gender predicted mortality; similarly, for BT as B, neither T, B, nor male gender predicted mortality. Factors associated with higher odds of death included higher Acute Physiology and Chronic Health Evaluation (APACHE) II score (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00-1.13; p = 0.0045), higher d-dimer concentration (OR, 1.00; 95% CI, 1.00-1.01; p = 0.043), and higher activated partial thromboplastin time (aPTT; OR, 1.09; 95% CI, 1.02-1.16; p = 0.010). Conclusions: Neither T nor B predicted mortality in this prospective cohort of anticoagulated patients with COVID-19 critical illness. These data support continued full-dose heparinoid prophylaxis.

Rotational thromboelastometry in patients with acute respiratory distress syndrome owing to coronavirus disease 2019: Is there a viscoelastic fingerprint and a role for predicting thrombosis?

OBJECTIVES: We evaluated rotational thromboelastometry tracings in 44 critically ill coronavirus disease 2019 patients, to determine whether there is a viscoelastic fingerprint and to test the hypothesis that the diagnosis and prediction of venous thromboembolism would be enhanced by the addition of rotational thromboelastometry testing. RESULTS: Rotational thromboelastometry values reflected an increase in clot strength for the EXTEM, INTEM, and FIBTEM assays beyond the reference range. No hyperfibrinolysis was noted. Fibrinolysis shutdown was present but did not correlate with thrombosis; 32% (14/44) of patients experienced a thrombotic episode. For every 1 mm increase of FIBTEM maximum clot formation, the odds of developing thrombosis increased 20% (95% confidence interval, 0-40%, P = .043), whereas for every 1,000 ng/mL increase in D-dimer, the odds of thrombosis increased by 70% (95% confidence interval, 20%-150%, P = .004), after adjustment for age and sex (AUC 0.96, 95% confidence interval, 0.90-1.00). There was a slight but significant improvement in model performance after adding FIBTEM maximum clot formation and EXTEM clot formation time to D-dimer in a multivariable model (P = .04). CONCLUSIONS: D-dimer concentrations were more predictive of thrombosis in our patient population than any other parameter. Rotational thromboelastometry confirmed the hypercoagulable state of coronavirus disease 2019 intensive care unit patients. FIBTEM maximum clot formation and EXTEM clot formation time increased the predictability for thrombosis compared with only using D-dimer. Rotational thromboelastometry analysis is most useful in augmenting the information provided by the D-dimer concentration for venous thromboembolism risk assessment when the D-dimer concentration is between 1,625 and 6,900 ng/dL, but the enhancement is modest. Fibrinolysis shutdown did not correlate with thrombosis.

Probative Value of the D-Dimer Assay for Diagnosis of Deep Venous Thrombosis in the Coronavirus Disease 2019 Syndrome.

OBJECTIVES: To describe the predictive utility of the D-dimer assay among patients with the coronavirus disease 2019 syndrome for unprovoked lower extremity deep venous thrombosis. DESIGN: Prospective observational study with retrospective data analysis. SETTING: Academic medical center surgical ICU. PATIENTS: Seventy-two intubated patients with critical illness from coronavirus disease 2019. INTERVENTIONS: Therapeutic anticoagulation after imaging diagnosis of the first three deep venous thrombosis cases was confirmed; therapeutic anticoagulation as prophylaxis thereafter to all subsequent ICU admissions. MEASUREMENTS AND MAIN RESULTS: Seventy-two patients with severe coronavirus disease 2019 were screened for deep venous thrombosis after ICU admission with 102 duplex ultrasound examinations, with 12 cases (16.7%) of lower extremity deep venous thrombosis identified. There were no differences between groups with respect to age, renal function, or biomarkers except for D-dimer (median, 12,858 ng/mL [interquartile range, 3,176-30,770 ng/mL] for lower extremity deep venous thrombosis vs 2,087 ng/mL [interquartile range, 638-3,735 ng/mL] for no evidence of deep venous thrombosis; p < 0.0001). Clinical screening tools (Wells score and Dutch Primary Care Rule) had no utility. The C-statistic for D-dimer concentration was 0.874 ± 0.065. At the model-predicted cutoff value of 3,000 ng/mL, sensitivity was 100%, specificity was 51.1%, positive predictive value was 21.8%, and negative predictive value was 100%. CONCLUSIONS: Lower extremity deep venous thrombosis is prevalent in coronavirus disease 2019 disease and can be present on ICU admission. Screening has been recommended in the context of the pro-inflammatory, hypercoagulable background milieu. D-dimer concentrations are elevated in nearly all coronavirus disease 2019 patients, and the test appears reliable for screening for lower extremity deep venous thrombosis at or above a concentration of 3,000 ng/mL (more than 13-fold above the normal range). Full anticoagulation is indicated if the diagnosis is confirmed, and therapeutic anticoagulation should be considered for prophylaxis, as all coronavirus disease 2019 patients are at increased risk.

Disclosure at #SAGES2018: An analysis of physician-industry relationships of invited speakers at the 2018 SAGES national meeting.

BACKGROUND: Financial conflicts of interest (COI) have been shown to affect the interpretation of scientific findings. Publications with unreported COI tend to be more favorable to industry. Since 2014 industry payments to United States (US) physicians are publicly reported in the Open Payments Database (OPD). Several studies show high levels of unreported COI in medical literature; however, there is no research examining COI reporting at surgical conferences. We hypothesized that compliance with the COI disclosure requirement would be high at the 2018 SAGES meeting. However, we expected to find significant discrepancy between speaker-reported and OPD-reported COI. A secondary aim was to characterize the amount, source, and variation in industry payments to invited speakers. METHODS: We reviewed all available presentations from SAGES 2018 as recorded and publicly available on YouTube™ for the presence of COI disclosure and the disclosed industry relationships. For US physicians we searched the OPD and recorded all industry payments > $500. We compared the self-disclosed COI for each speaker with OPD records. Presentation topics were divided into ten groups to determine which topics received the most funding. RESULTS: Of the 526 invited presentations, 479 (91%) videos were available. Disclosures were reported by 414 presenters (86.4%). There were 420 unique presenters of which 315 were listed in the OPD. Speaker-reported disclosures were fully concordant with the OPD in 38.3% (121/315) of cases with 39% (123/315) under-reporting disclosures. Of presenters listed in OPD, the median payment was $992 ($0-$374,502) with a total of $6,389,097 paid in 2017. SAGES speakers failed to disclose $2,049,535 worth of industry payments with an average undisclosed payment of $16,662.88 (± $40,733.19). The largest financial contributor was Intuitive Surgical with $1,981,169 paid. Among topics, robotics and hernia received the most funding with $2,593,925 (40.6%) and $2,591,671 (40.5%) paid, respectively. CONCLUSIONS: Overall compliance with SAGES disclosure rules is high. There remains a discrepancy between speaker- and industry-reported disclosures, including a number of undisclosed payments, some of which are substantial. Adjustments to disclosure rules to include the relative amount of compensation may be warranted.

Variability in CT imaging of blunt trauma among ED physicians, surgical residents, and trauma surgeons.

BACKGROUND: Trauma triage decisions can be influenced by both knowledge and experience. Consequently, there may be substantial variability in computed tomography (CT) scans desired by emergency medicine physicians, surgical chief residents, and attending trauma surgeons. We quantified this difference and studied the effects of each group's decisions on missed injuries, cost, and radiation exposure. METHODS: All blunt trauma activations at an urban level 1 trauma center were studied over a 6-mo period. Three months into the study, a pan-scan protocol was introduced. Prior to CT imaging, providers separately completed a survey that asked which CT scans were desired for each patient. Based on the completed surveys, hypothetical missed injuries, radiation exposure, and cost were determined. RESULTS: The variability in the number of CT scans desired by each of the three providers and the resulting cost and radiation exposure were not statistically significant. Substantial variability was predominantly seen in the indications for the desired scans, with the difference between proportions ranging from 3.1%-68.7%. Agreement among the three providers was highest for head and c-spine scans (80%-100%) and lowest for maxillary face (57%-80%) and chest scans (52%-74%). Overall, the missed injury rate was similar for all the providers; chief residents missed significantly more major injuries than trauma attendings during the pan-scan period (P = 0.03). CONCLUSIONS: Trauma training and level of training did not have a substantial effect on radiological decisions during the initial trauma assessment. This study sheds light on the growing uniformity among providers with regard to medical decision-making in the initial work-up of trauma.

Variation in resource utilization in liver transplantation at freestanding children's hospitals.

We sought to examine the relationship between liver transplant-related total cost, patient outcome, and hospital resource utilization at freestanding children's hospitals. Using the PHIS database, a retrospective study of 374 patients that underwent liver transplantation at 15 freestanding children's hospitals from July 2010 to December 2012 was performed. One-year graft failure and patient mortality rates from July 2010 to December 2012 for each center were also obtained from the SRTR. There was a 5.1-fold difference in median cost (median $146 444, range $59 487-302 058, P<.001) between all centers. A 2.4-fold difference existed in median LOS (median 15 days, range 9-22 days, P<.001) across centers. Median postoperative ICU stay varied from 0 to 7 days (median 4 days, P<.001). Overall, 30-day readmission rate was 55% (31.3%-100%, P<.001). One-year graft failure varied from 0% to 19.1%, with an overall rate of 5.5% (P=.279). One-year patient mortality for all centers was 2.3% (range 0%-11.1%, P=.016). Higher total cost did not correlate with lower readmission rates, patient mortality, graft failure, or any other variable. These data suggest that identifying practice patterns at low-cost centers and implementing them at higher-cost centers may decrease the cost of pediatric liver transplantation without compromising outcomes.