Publications by authors named "Lena M Napolitano"

195 Publications

Predicting Intensive Care Transfers and Other Unforeseen Events: Analytic Model Validation Study and Comparison to Existing Methods.

JMIR Med Inform 2021 Apr 21;9(4):e25066. Epub 2021 Apr 21.

Michigan Center for Integrative Research in Critical Care, Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, United States.

Background: COVID-19 has led to an unprecedented strain on health care facilities across the United States. Accurately identifying patients at an increased risk of deterioration may help hospitals manage their resources while improving the quality of patient care. Here, we present the results of an analytical model, Predicting Intensive Care Transfers and Other Unforeseen Events (PICTURE), to identify patients at high risk for imminent intensive care unit transfer, respiratory failure, or death, with the intention to improve the prediction of deterioration due to COVID-19.

Objective: This study aims to validate the PICTURE model's ability to predict unexpected deterioration in general ward and COVID-19 patients, and to compare its performance with the Epic Deterioration Index (EDI), an existing model that has recently been assessed for use in patients with COVID-19.

Methods: The PICTURE model was trained and validated on a cohort of hospitalized non-COVID-19 patients using electronic health record data from 2014 to 2018. It was then applied to two holdout test sets: non-COVID-19 patients from 2019 and patients testing positive for COVID-19 in 2020. PICTURE results were aligned to EDI and NEWS scores for head-to-head comparison via area under the receiver operating characteristic curve (AUROC) and area under the precision-recall curve. We compared the models' ability to predict an adverse event (defined as intensive care unit transfer, mechanical ventilation use, or death). Shapley values were used to provide explanations for PICTURE predictions.

Results: In non-COVID-19 general ward patients, PICTURE achieved an AUROC of 0.819 (95% CI 0.805-0.834) per observation, compared to the EDI's AUROC of 0.763 (95% CI 0.746-0.781; n=21,740; P<.001). In patients testing positive for COVID-19, PICTURE again outperformed the EDI with an AUROC of 0.849 (95% CI 0.820-0.878) compared to the EDI's AUROC of 0.803 (95% CI 0.772-0.838; n=607; P<.001). The most important variables influencing PICTURE predictions in the COVID-19 cohort were a rapid respiratory rate, a high level of oxygen support, low oxygen saturation, and impaired mental status (Glasgow Coma Scale).

Conclusions: The PICTURE model is more accurate in predicting adverse patient outcomes for both general ward patients and COVID-19 positive patients in our cohorts compared to the EDI. The ability to consistently anticipate these events may be especially valuable when considering potential incipient waves of COVID-19 infections. The generalizability of the model will require testing in other health care systems for validation.
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http://dx.doi.org/10.2196/25066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8061893PMC
April 2021

Vitamin D supplementation and hemoglobin: dosing matters in prevention/treatment of anemia.

Nutr J 2021 03 19;20(1):23. Epub 2021 Mar 19.

University of Michigan Health System, Room 1C340-UH, University Hospital, 1500 East Medical Drive, SPC 5033, Ann Arbor, MI, 48109-5033, USA.

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http://dx.doi.org/10.1186/s12937-021-00680-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980333PMC
March 2021

The effect of timing of initiation of renal replacement therapy on mortality: A retrospective case-control study.

J Intensive Care Soc 2021 Feb 5;22(1):8-16. Epub 2019 Dec 5.

Department of Surgery, University of Michigan, Ann Arbor, MI, USA.

Purpose: To determine if earlier initiation of renal replacement therapy (RRT) is associated with improved survival in patients with severe acute kidney injury.

Methods: We performed a retrospective case-control study of propensity-matched groups with multivariable logistic regression using Akaike Information Criteria to adjust for non-matched variables in a surgical ICU in a tertiary care hospital.

Results: We matched 169 of 205 (82%) patients with new initiation of RRT (EARLY group) to 169 similar patients who did not initiate RRT on that day (DEFERRED group). Eighteen (11%) of DEFERRED eventually received RRT before discharge. By univariate analysis, ICU mortality was higher in EARLY (n = 60 (36%) vs. n = 23 (14%),  < 0.001) as was hospital mortality (n = 73 (43%) vs. n = 44 (26%),  = 0.001). Of the 18 RRT patients in DEFERRED, 12 (67%) died in ICU and 13 (72%) in hospital. After propensity matching and logistic regression, we found that EARLY initiation of RRT was associated with a more than doubling of ICU mortality (aOR = 2.310, 95% confidence interval = 1.254-4.257,  = 0.007). However, after similar adjustment, there was no difference in hospital mortality (aOR = 1.283, 95% CI = 0.753-2.186,  = 0.360).

Conclusions: While ICU mortality was increased in the EARLY group, there was no difference in hospital mortality between EARLY and DEFERRED groups.
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http://dx.doi.org/10.1177/1751143719892792DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7890751PMC
February 2021

Hemostatic defects in massive transfusion: an update and treatment recommendations.

Expert Rev Hematol 2021 Feb 6;14(2):219-239. Epub 2021 Jan 6.

Department of Surgery, University of Michigan Health System, University Hospital, Ann Arbor, Michigan, USA.

Introduction: Acute hemorrhage is a global healthcare issue, and remains the leading preventable cause of death in trauma. Acute severe hemorrhage can be related to traumatic, peripartum, gastrointestinal, and procedural causes. Hemostatic defects occur early in patients requiring massive transfusion. Early recognition and treatment of hemorrhage and hemostatic defects are required to save lives and to achieve optimal patient outcomes.

Areas Covered: This review discusses current evidence and trials aimed at identifying the optimal treatment for hemostatic defects in hemorrhage and massive transfusion. Literature search included PubMed and Embase.

Expert Opinion: Patients with acute hemorrhage requiring massive transfusion commonly develop coagulopathy due to specific hemostatic defects, and accurate diagnosis and prompt correction are required for definitive hemorrhage control. Damage control resuscitation and massive transfusion protocols are optimal initial treatment strategies, followed by goal-directed individualized resuscitation using real-time coagulation monitoring. Distinct phenotypes exist in trauma-induced coagulopathy, including 'Bleeding' or 'Thrombotic' phenotypes, and hyperfibrinolysis vs. fibrinolysis shutdown. The trauma 'lethal triad' (hypothermia, coagulopathy, acidosis) has been updated to the 'lethal diamond' (including hypocalcemia). A number of controversies in optimal management exist, including whole blood vs. component therapy, use of factor concentrates vs. blood products, optimal use of tranexamic acid, and prehospital plasma and tranexamic acid administration.
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http://dx.doi.org/10.1080/17474086.2021.1858788DOI Listing
February 2021

Resonance Raman Spectroscopy Derived Tissue Hemoglobin Oxygen Saturation in Critically Ill and Injured Patients.

Shock 2020 Nov 17. Epub 2020 Nov 17.

Department of Emergency Medicine. University of Michigan, Ann Arbor, Michigan.

Background: In this study, we examined the ability of resonance Raman spectroscopy to measure tissue hemoglobin oxygenation (R-StO2) noninvasively in critically ill patients and compared its performance with conventional central venous hemoglobin oxygen saturation (ScvO2).

Methods: Critically ill patients (n = 138) with an indwelling central venous or pulmonary artery catheter in place were consented and recruited. R-StO2 measurements were obtained by placing a sensor inside the mouth on the buccal mucosa. R-StO2 was measured continuously for 5 minutes. Blood samples were drawn from the distal port of the indwelling central venous catheter or proximal port of the pulmonary artery catheter at the end of the test period to measure ScvO2 using standard co-oximetry analyzer. A regression algorithm was used to calculate the R-StO2 based on the observed spectra.

Results: Mean(SD) of pooled R-StO2 and ScvO2 were 64(7.6) % and 65(9.2) % respectively. A paired t-test showed no significant difference between R-StO2 and ScvO2 with a mean(SD) difference of -1(7.5) % (95% CI: -2.2, 0.3%) with a Clarke Error Grid demonstrating 84.8% of the data residing within the accurate and acceptable grids. Area under the receiver operator curve for R-StO2's was 0.8(0.029) (95% CI: 0.7, 0.9 p < 0.0001) at different thresholds of ScvO2 (≤60%, ≤65%, and ≤70%). Clinical adjudication by five clinicians to assess the utility of R-StO2 and ScvO2 yielded Fleiss' Kappa agreement of 0.45 (p < 0.00001).

Conclusions: R-StO2 has the potential to predict ScvO2 with high precision and might serve as a faster, safer, and non-invasive surrogate to these measures.
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http://dx.doi.org/10.1097/SHK.0000000000001696DOI Listing
November 2020

Efficacy and Tolerability of Eravacycline in Bacteremic Patients with Complicated Intra-Abdominal Infection: A Pooled Analysis from the IGNITE1 and IGNITE4 Studies.

Surg Infect (Larchmt) 2020 Nov 17. Epub 2020 Nov 17.

Wayne State University School of Medicine, Detroit, Michigan, USA.

Eravacycline is a novel, fully synthetic fluorocycline antibiotic that was evaluated for the treatment of complicated intra-abdominal infections (cIAI) in two phase 3 clinical trials. The objective of this analysis was to evaluate the clinical cure and microbiologic response at the test-of-cure (TOC) visit and the safety of eravacycline in patients with cIAI and baseline bacteremia who received eravacycline versus comparators. Pooled data of patients with bacteremia from the Investigating Gram-Negative Infections Treated with Eravacycline (IGNITE) 1 and IGNITE4 studies were analyzed. All patients were randomly assigned in a one-to-one ratio to receive eravacycline 1 mg/kg intravenously every 12 hours, ertapenem 1 g intravensouly every 24 hours (IGNITE1), or meropenem 1 g intravenously every eight hours (IGNITE4) for four to 14 days. Blood and intra-abdominal samples were collected from all patients at baseline. Clinical outcome and microbiologic eradiation at the TOC visit (28 days after randomization) and safety in the microbiologic-intent-to-treat population (micro-ITT) were assessed. Of 415 patients treated with eravacycline and 431 treated with carbapenem comparators, concurrent bacteremia was identified in 32 (7.7%) and 31 (7.2%) patients, respectively. Demographic and baseline characteristics were similar among treatment groups. In the micro-ITT population, the pooled clinical response at the TOC visit for eravacycline was 28 of 32 (87.5%) and was 24 of 31 (77.0%) for comparators among the subgroup with baseline bacteremia (treatment difference 5.9; 95% confidence interval [CI], -6.5 to 17.4). At TOC, microbiologic eradication of pathogens isolated from blood specimens occurred for 34 of 35 (97.1%) pathogens with eravacycline and 35 of 36 (97.2%) pathogens with comparators. The incidence of adverse events was comparable between treated groups and similar to that observed in the non-bacteremic population. Eravacycline demonstrated a similar clinical outcome and microbiologic eradication rate as comparator carbapenems in patients with cIAI and associated secondary bacteremia. Future clinical trials of cIAI should report outcomes of this important clinical cohort (cIAI with concurrent bacteremia) given their high risk for adverse outcomes.
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http://dx.doi.org/10.1089/sur.2020.241DOI Listing
November 2020

Comment on Tracheotomy in Ventilated Patients with COVID-19: Is it Time to Rethink Timing?

Ann Surg 2020 Jul 14. Epub 2020 Jul 14.

Department of Otolaryngology - Head & Neck Surgery, University of Michigan Medical School, Ann Arbor, MI Interventional Pulmonology, Johns Hopkins University, Baltimore, MD Department of Surgery, University of Michigan Medical School, Ann Arbor, MI Department of Surgery, Department of Anesthesiology / Critical Care Medicine, Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD.

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http://dx.doi.org/10.1097/SLA.0000000000004220DOI Listing
July 2020

Venous thrombosis epidemiology, pathophysiology, and anticoagulant therapies and trials in severe acute respiratory syndrome coronavirus 2 infection.

J Vasc Surg Venous Lymphat Disord 2021 01 8;9(1):23-35. Epub 2020 Sep 8.

Section of Vascular Surgery, Department of Surgery, Samuel and Jean Frankel Cardiovascular Center, University of Michigan, Ann Arbor, Mich. Electronic address:

Objective: Infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus confers a risk of significant coagulopathy, with the resulting development of venous thromboembolism (VTE), potentially contributing to the morbidity and mortality. The purpose of the present review was to evaluate the potential mechanisms that contribute to this increased risk of coagulopathy and the role of anticoagulants in treatment.

Methods: A literature review of coronavirus disease 2019 (COVID-19) and/or SARS-CoV-2 and cell-mediated inflammation, clinical coagulation abnormalities, hypercoagulability, pulmonary intravascular coagulopathy, and anticoagulation was performed. The National Clinical Trials database was queried for ongoing studies of anticoagulation and/or antithrombotic treatment or the incidence or prevalence of thrombotic events in patients with SARS-CoV-2 infection.

Results: The reported rate of VTE among critically ill patients infected with SARS-CoV-2 has been 21% to 69%. The phenomenon of breakthrough VTE, or the acute development of VTE despite adequate chemoprophylaxis or treatment dose anticoagulation, has been shown to occur with severe infection. The pathophysiology of overt hypercoagulability and the development of VTE is likely multifactorial, with evidence supporting the role of significant cell-mediated responses, including neutrophils and monocytes/macrophages, endothelialitis, cytokine release syndrome, and dysregulation of fibrinolysis. Collectively, this inflammatory process contributes to the severe pulmonary pathology experienced by patients with COVID-19. As the infection worsens, extreme D-dimer elevations, significant thrombocytopenia, decreasing fibrinogen, and prolongation of prothrombin time and partial thromboplastin time occur, often associated with deep vein thrombosis, in situ pulmonary thrombi, and/or pulmonary embolism. A new phenomenon, termed pulmonary intravascular coagulopathy, has been associated with morbidity in patients with severe infection. Heparin, both unfractionated heparin and low-molecular-weight heparin, have emerged as agents that can address the viral infection, inflammation, and thrombosis in this syndrome.

Conclusions: The overwhelming inflammatory response in patients with SARS-CoV-2 infection can lead to a hypercoagulable state, microthrombosis, large vessel thrombosis, and, ultimately, death. Early VTE prophylaxis should be provided to all admitted patients. Therapeutic anticoagulation therapy might be beneficial for critically ill patients and is the focus of 39 ongoing trials. Close monitoring for thrombotic complications is imperative, and, if confirmed, early transition from prophylactic to therapeutic anticoagulation should be instituted. The interplay between inflammation and thrombosis has been shown to be a hallmark of the SARS-CoV-2 viral infection.
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http://dx.doi.org/10.1016/j.jvsv.2020.08.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834652PMC
January 2021

An Unusual Cause of Severe Hypoxemia and Acute Respiratory Distress Syndrome.

Chest 2020 08;158(2):e71-e77

Division of Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor, MI. Electronic address:

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http://dx.doi.org/10.1016/j.chest.2019.11.058DOI Listing
August 2020

Brain Autopsy Findings in Adult Extracorporeal Membrane Oxygenation: Precipitating Event or Extracorporeal Membrane Oxygenation Treatment? Need More Data….

Crit Care Med 2020 06;48(6):936-937

Department of Surgery, University of Michigan, Ann Arbor, MI Department of Neurosurgery, University of Michigan, Ann Arbor, MI.

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http://dx.doi.org/10.1097/CCM.0000000000004319DOI Listing
June 2020

Joint Society of Critical Care Medicine-Extracorporeal Life Support Organization Task Force Position Paper on the Role of the Intensivist in the Initiation and Management of Extracorporeal Membrane Oxygenation.

Crit Care Med 2020 06;48(6):838-846

Columbia University College of Physicians & Surgeons/New York-Presbyterian Hospital, New York, NY.

Objectives: To define the role of the intensivist in the initiation and management of patients on extracorporeal membrane oxygenation.

Design: Retrospective review of the literature and expert consensus.

Setting: Series of in-person meetings, conference calls, and emails from January 2018 to March 2019.

Subjects: A multidisciplinary, expert Task Force was appointed and assembled by the Society of Critical Care Medicine and the Extracorporeal Life Support Organization. Experts were identified by their respective societies based on reputation, experience, and contribution to the field.

Interventions: A MEDLINE search was performed and all members of the Task Force reviewed relevant references, summarizing high-quality evidence when available. Consensus was obtained using a modified Delphi process, with agreement determined by voting using the RAND/UCLA scale, with score ranging from 1 to 9.

Measurements And Main Results: The Task Force developed 18 strong and five weak recommendations in five topic areas of extracorporeal membrane oxygenation initiation and management. These recommendations were organized into five areas related to the care of patients on extracorporeal membrane oxygenation: patient selection, management, mitigation of complications, coordination of multidisciplinary care, and communication with surrogate decision-makers. A common theme of the recommendations is extracorporeal membrane oxygenation is best performed by a multidisciplinary team, which intensivists are positioned to engage and lead.

Conclusions: The role of the intensivist in the care of patients on extracorporeal membrane oxygenation continues to evolve and grow, especially when knowledge and familiarity of the issues surrounding extracorporeal membrane oxygenation selection, cannulation, and management are applied.
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http://dx.doi.org/10.1097/CCM.0000000000004330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7422732PMC
June 2020

Association Between Adherence to Evidence-Based Practices for Treatment of Patients With Traumatic Rib Fractures and Mortality Rates Among US Trauma Centers.

JAMA Netw Open 2020 03 2;3(3):e201316. Epub 2020 Mar 2.

Institute for Health Informatics, University of Minnesota Academic Health Center, Minneapolis.

Importance: Rib fractures are sustained by nearly 15% of patients who experience trauma and are associated with significant morbidity and mortality. Evidence-based practice (EBP) rib fracture management guidelines and treatment algorithms have been published. However, few studies have evaluated trauma center adherence to EBP or the clinical outcomes of each practice within a national cohort.

Objective: To examine adherence to 6 EBPs for rib fractures across US trauma centers and the association with in-hospital mortality.

Design, Setting, And Participants: A retrospective cohort study was conducted from January 1, 2007, to December 31, 2014, of 777 US trauma centers participating in the National Trauma Data Bank. A total of 625 617 patients (age, ≥16 years) were evaluated. Patients without rib fractures and those with no signs of life or institutions with poor data quality were excluded. Data analysis was performed from January 1, 2007, to December 31, 2014.

Main Outcomes And Measures: Six EBPs were defined: (1) neuraxial blockade, (2) intensive care unit admission, (3) pneumatic stabilization, (4) chest computed tomographic scans for older adults (≥65 years) with 3 or more rib fractures, (5) surgical rib fixation for flail chest, and (6) tube thoracostomy placement for hemothorax and/or pneumothorax. Multiple imputation was used to account for missing data. Patients were propensity score matched in a 1:1 fashion based on demographic characteristics; injury severity parameters, including the Injury Severity Score (range, 0-75; higher scores indicate more severe injuries); and comorbidities. Logistic regression was used to determine the association of each practice with all-cause in-hospital mortality.

Results: Of the 625 617 patients with rib fractures included in this analysis, 456 196 patients (73%) were white and 432 229 patients (69%) were male; the median age of the patients was 51 (interquartile range, 37-65) years, and the mean (SD) Injury Severity Score was 18.3 (11.1). The mean (SD) number of rib fractures was 4.2 (2.6). On univariate analysis, patients treated at verified level I trauma centers were more likely to receive 5 or 6 EBPs (all but pneumatic stabilization). Of those who met eligibility, only 4578 of 111 589 patients (4%) received neuraxial blockade, 46 456 of 111 589 patients (42%) were admitted to the intensive care unit, 3302 of 24 319 patients (14%) received surgical rib fixation, 1240 of 111 589 patients (1%) received pneumatic stabilization, 109 160 of 258 334 patients (42%) received tube thoracostomy, and 32 405 of 81 417 patients (40%) received chest computed tomographic scans. Three EBPs were associated with decreased mortality: neuraxial blockade (odds ratio [OR], 0.64; 95% CI, 0.51-0.79; P < .001) for patients aged 65 years or older with 3 or more rib fractures, surgical rib fixation (OR, 0.13; 95% CI, 0.01-0.18; P < .001), and intensive care unit admission (OR, 0.93; 95% CI, 0.86-1.00; P = .04) for patients aged 65 years or older with 3 or more rib fractures. Pneumatic stabilization (OR, 1.71; 95% CI, 1.25-2.35; P < .001) and chest tube placement (OR, 1.27; 95% CI, 1.21-1.33; P < .001) were associated with increased mortality in older patients with 3 or more rib fractures. On multivariable analysis, insurance status, race/ethnicity, injury severity, hospital bed size, and trauma center verification level were associated with receiving EBPs for rib fractures.

Conclusions And Relevance: Significant variation appears to exist in the delivery of EBPs for rib fractures across US trauma centers. Three EBPs were associated with reduced mortality, but EBP adherence was poor. Multiple factors, including trauma center verification level, appear to be associated with patients receiving EBPs for rib fractures.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.1316DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707110PMC
March 2020

Redefining the Trauma Triage Matrix: The Role of Emergent Interventions.

J Surg Res 2020 07 10;251:195-201. Epub 2020 Mar 10.

Department of Surgery, University of Minnesota, Minneapolis, Minnesota; Department of Surgery, North Memorial Medical Center, Robbinsdale, Minnesota; Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota.

Background: A tiered trauma team activation (TTA) system aims to allocate resources proportional to the patient's need based upon injury burden. The current metrics used to evaluate appropriateness of TTA are the trauma triage matrix (TTM), need for trauma intervention (NFTI), and secondary triage assessment tool (STAT).

Materials And Methods: In this retrospective study, we compared the effectiveness of the need for an emergent intervention within 6 h (NEI-6) with existing definitions. Data from the Michigan Trauma Quality Improvement Program was utilized. The dataset contains information from 31 level 1 and 2 trauma centers from 2011 to 2017. Inclusion criteria were: adult patients (≥16 y) and ISS ≥5.

Results: 73,818 patients were included in the study. Thirty percentage of trauma patients met criteria for STAT, 21% for NFTI, 20% for TTM, and 13% for NEI-6. NEI-6 was associated with the lowest rate of undertriage at 6.5% (STAT 22.3%, NFTI 14.0%, TTM 14.3%). NEI-6 best predicted undertriage mortality, early mortality, in-hospital mortality, and late (>60 h) mortality. Most patients who met criteria for TTM (58%), NFTI (51%), and STAT (62%) did not require emergent intervention. All four methods had similar rates of early mortality for patients who did not meet criteria (0.3%-0.5%).

Conclusions: NEI-6 performs better than TTM, NFTI, and STAT in terms of undertriage, mortality and need for resource utilization. Other methods resulted in significantly more full TTAs than NEI-6 without identifying patients at risk for early mortality. NEI-6 represents a novel tool to determine trauma activation appropriateness.
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http://dx.doi.org/10.1016/j.jss.2019.11.011DOI Listing
July 2020

What's New in Shock, April 2020?

Shock 2020 04;53(4):379-383

University of Michigan, Ann Arbor, Michigan.

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http://dx.doi.org/10.1097/SHK.0000000000001508DOI Listing
April 2020

Predictors of elderly mortality after trauma: A novel outcome score.

J Trauma Acute Care Surg 2020 03;88(3):416-424

From the Department of Surgery (R.S.M., J.G., J.C., C.J.T.), University of Minnesota, Minneapolis, Minnesota; Department of Surgery (D.M.), Medical College of Wisconsin, Milwaukee, Wisconsin; Department of Surgery (L.M.N., M.R.H.), University of Michigan, Ann Arbor; Department of Surgery (B.C.), University of Minnesota, Minneapolis, Minnestoa; Institute for Health Informatics (E.L., E.K., C.J.T.), University of Minnesota, Minneapolis, Minnesota; Department of Surgery (D.S.), University of California San Francisco, San Francisco, California; Department of Surgery (C.J.T.), North Memorial Health Hospital, Robbinsdale; and Department of Surgery (M.R.H.), Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, Minnesota.

Introduction: Elderly trauma patients are at high risk for mortality, even when presenting with minor injuries. Previous prognostic models are poorly used because of their reliance on elements unavailable during the index hospitalization. The purpose of this study was to develop a predictive algorithm to accurately estimate in-hospital mortality using easily available metrics.

Methods: The National Trauma Databank was used to identify patients 65 years and older. Data were split into derivation (2007-2013) and validation (2014-2015) data sets. There was no overlap between data sets. Factors included age, comorbidities, physiologic parameters, and injury types. A two-tiered scoring system to predict in-hospital mortality was developed: a quick elderly mortality after trauma (qEMAT) score for use at initial patient presentation and a full EMAT (fEMAT) score for use after radiologic evaluation. The final model (stepwise forward selection, p < 0.05) was chosen based on calibration and discrimination analysis. Calibration (Brier score) and discrimination (area under the receiving operating characteristic curve [AuROC]) were evaluated. Because National Trauma Databank did not include blood product transfusion, an element of the Geriatric Trauma Outcome Score (GTOS), a regional trauma registry was used to compare qEMAT versus GTOS. A mobile-based application is currently available for cost-free utilization.

Results: A total of 840,294 patients were included in the derivation data set and 427,358 patients in the validation data set. The fEMAT score (median, 91; S.D., 82-102) included 26 factors, and the qEMAT score included eight factors. The AuROC was 0.86 for fEMAT (Brier, 0.04) and 0.84 for qEMAT. The fEMAT outperformed other trauma mortality prediction models (e.g., Trauma and Injury Severity Score-Penetrating and Trauma and Injury Severity Score-Blunt, age + Injury Severity Score). The qEMAT outperformed the GTOS (AuROC, 0.87 vs. 0.83).

Conclusion: The qEMAT and fEMAT accurately estimate the probability of in-hospital mortality and can be easily calculated on admission. This information could aid in deciding transfer to tertiary referral center, patient/family counseling, and palliative care utilization.

Level Of Evidence: Epidemiological Study, level IV.
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http://dx.doi.org/10.1097/TA.0000000000002569DOI Listing
March 2020

Predicting Survival of Adult Respiratory Failure Patients Receiving Prolonged (≥14 Days) Extracorporeal Membrane Oxygenation.

ASAIO J 2020 07;66(7):825-833

From the Division of Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor, Michigan.

Extracorporeal membrane oxygenation (ECMO) for adult respiratory failure has significantly increased, with longer duration ECMO support required in severe hypoxemia. We sought to examine independent predictors of survival of adult respiratory failure patients requiring prolonged (≥14 days) ECMO. We reviewed Extracorporeal Life Support Organization Registry data on all adult (≥18 years) patients who required P- ECMO (n = 4,361) over 10 years (2009-2018). Hospital survival was 51.3%, increased from 45.4% in our prior report of 974 patients (1989-2013). Univariate analysis confirmed factors associated with decreased mortality: younger age, white race, increased body weight, viral/bacterial pneumonia, higher positive end expiratory pressure, neuromuscular blockade, VV-ECMO mode, and decreased time from intubation to ECMO. For Pre-ECLS support, most vasopressor/inotropic drugs and nitric oxide had no association with mortality, but steroids (22% vs. 15%, p < 0.001), epinephrine (15% vs. 12%, p = 0.039), and bicarbonate (9% vs. 7%, p = 0.049) were more common in non-survivors. Extracorporeal membrane oxygenation complications (gastrointestinal hemorrhage, neurologic complications, and CPR) were associated with increased mortality. The RESP score was higher in survivors (-0.31 ± 3.36 vs. -0.83 ± 3.34, P < 0.001); however, discrimination was poor (c-statistic = 0.540 ± 0.009); it did not remain in the final model. A multivariable prediction model based on all information at ECMO initiation was fair (c-statistic = 0.670 + 0.012), but discrimination improved with the addition of ECMO complications (c-statistic = 0.675 + 0.012). These findings suggest that reducing ECMO-related complications will improve survival. We have identified predictors of mortality in prolonged ECMO patients, and inclusion of ECMO complications in a new predictive model improved discrimination.
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http://dx.doi.org/10.1097/MAT.0000000000001067DOI Listing
July 2020

Pneumatic Compression in Venous Thromboprophylaxis.

N Engl J Med 2019 07;381(1):94-95

University of Michigan, Ann Arbor, MI

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http://dx.doi.org/10.1056/NEJMc1905933DOI Listing
July 2019

Efficacy of antibiotics in acute appendicitis treatment.

Am J Surg 2020 04 21;219(4):690. Epub 2019 Jun 21.

University of Michigan, Ann Arbor, MI, United States. Electronic address:

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http://dx.doi.org/10.1016/j.amjsurg.2019.06.016DOI Listing
April 2020

Should they stay or should they go? Who benefits from interfacility transfer to a higher-level trauma center following initial presentation at a lower-level trauma center.

J Trauma Acute Care Surg 2019 06;86(6):952-960

From the University of Michigan Medical School (T.A.), Ann Arbor, Michigan; Division of Biostatistics (T.M.), University of Minnesota, Minneapolis, Minnesota; Department of Surgery (P.J.), Indiana University, Indianapolis, Indiana; Department of Surgery (J.O., C.J.T.), University of Minnesota, Minneapolis, Minnesota; Department of Surgery (J.O., J.G.P., C.J.T.), North Memorial Health Hospital, Robbinsdale, Minnesota, Department of Surgery (U.I.), Regions Hospital, St. Paul, Minnesota; Department of Surgery (K.R., L.M.N., M.R.H., P.P.), University of Michigan, Ann Arbor, Michigan; and Institute for Health Informatics (C.J.T.), University of Minnesota, Minneapolis, Minnesota.

Background: Interfacility transfer of patients from Level III/IV to Level I/II (tertiary) trauma centers has been associated with improved outcomes. However, little data are available classifying the specific subsets of patients that derive maximal benefit from transfer to a tertiary trauma center. Drawbacks to transfer include increased secondary overtriage. Here, we ask which injury patterns are associated with improved survival following interfacility transfer.

Methods: Data from the National Trauma Data Bank was utilized. Inclusion criteria were adults (≥16 years). Patients with Injury Severity Score of 10 or less or those who arrived with no signs of life were excluded. Patients were divided into two cohorts: those admitted to a Level III/IV trauma center versus those transferred into a tertiary trauma center. Multiple imputation was performed for missing values, and propensity scores were generated based on demographics, injury patterns, and disease severity. Using propensity score-stratified Cox proportional hazards regression, the hazard ratio for time to death was estimated.

Results: Twelve thousand five hundred thirty-four (5.2%) were admitted to Level III/IV trauma centers, and 227,315 (94.8%) were transferred to a tertiary trauma center. Patients transferred to a tertiary trauma center had reduced mortality (hazard ratio, 0.69; p < 0.001). We identified that patients with traumatic brain injury with Glasgow Coma Scale score less than 13, pelvic fracture, penetrating mechanism, solid organ injury, great vessel injury, respiratory distress, and tachycardia benefited from interfacility transfer to a tertiary trauma center. In this sample, 56.8% of the patients benefitted from transfer. Among those not transferred, 49.5% would have benefited from being transferred.

Conclusion: Interfacility transfer is associated with a survival benefit for specific patients. These data support implementation of minimum evidence-based criteria for interfacility transfer.

Level Of Evidence: Therapeutic/Care Management, Level IV.
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http://dx.doi.org/10.1097/TA.0000000000002248DOI Listing
June 2019

The Fragility Index-P Values Reimagined, Flaws and All-Reply.

JAMA Surg 2019 07;154(7):674-675

Department of Surgery, University of Michigan, Ann Arbor.

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http://dx.doi.org/10.1001/jamasurg.2019.0568DOI Listing
July 2019

Utilization of Intensive Care Unit Nutrition Consultation Is Associated With Reduced Mortality.

JPEN J Parenter Enteral Nutr 2020 02 22;44(2):213-219. Epub 2019 Mar 22.

Department of Surgery, University of Michigan, Ann Arbor, Michigan, USA.

Background: The aim of this project was to investigate the prevalence of nutrition consultation (NC) in U.S. intensive care units (ICUs) and to examine its association with patient outcomes.

Methods: Data from the Healthcare Cost and Utilization Project's state inpatient databases was utilized from 2010 - 2014. A multilevel logistic regression model was used to evaluate the relationship between NC and clinical outcomes.

Results: Institutional ICU NC rates varied significantly (mean: 14%, range: 0.1%-73%). Significant variation among underlying disease processes was identified, with burn patients having the highest consult rate (P < 0.001, mean: 6%, range: 2%-25%). ICU patients who received NC had significantly lower in-hospital mortality (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.48-0.74, P < 0.001), as did the subset with malnutrition (OR 0.72, 95% CI 0.53-0.99, P = 0.047) and the subset with concomitant physical therapy consultation (OR 0.53, 95% CI 0.38-0.74, P < 0.001). NC was associated with significantly lower rates of intubation, pulmonary failure, pneumonia, and gastrointestinal bleeding (P < 0.05). Furthermore, patients who received NC were more likely to receive enteral or parenteral nutrition (ENPN) (OR 1.8, 95% CI 1.4-2.3, P < 0.001). Patients who received follow-up NC were even more likely to receive ENPN (OR 3.0, 95% CI 2.1-4.2, P < 0.001).

Conclusions: Rates of NC were low in critically ill patients. This study suggests that increased utilization of NC in critically ill patients may be associated with improved clinical outcomes.
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http://dx.doi.org/10.1002/jpen.1534DOI Listing
February 2020

Intra-Abdominal Hypertension in the ICU: Who to Measure? How to Prevent?

Crit Care Med 2019 04;47(4):608-609

Division of Acute Care Surgery, [Trauma, Burns, Surgical Critical Care, Emergency Surgery], Department of Surgery, University of Michigan Health System, Ann Arbor, MI.

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http://dx.doi.org/10.1097/CCM.0000000000003675DOI Listing
April 2019

Vancomycin Enema in the Treatment of Infection.

Surg Infect (Larchmt) 2019 May/Jun;20(4):311-316. Epub 2019 Feb 4.

Department of Surgery, University of Michigan Health System, Ann Arbor, Michigan.

Current guidelines for the treatment of infections (CDIs) recommend vancomycin enemas for patients with adynamic ileus. There is significant variability in guideline recommendations for vancomycin dose and enema volume and whether a retention enema should be used. The most recent (2017) guidelines from the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America recommend rectal instillation of 500 mg of vancomycin in 100 mL of physiologic saline every 6 hours as a retention enema. Published studies regarding vancomycin enema use in CDI (1990-present) were reviewed to compare drug dose, volume, and whether a retention enema was used in order to determine the efficacy and make recommendations for optimal dosing. Case series with higher vancomycin dose, higher enema volume, and use of retention enema demonstrated greater efficacy. Use of smaller volumes and lower doses (100 mL; 125-250 mg q 6 hours) demonstrated no efficacy of intracolonic vancomycin. We recommend revision of the current CDI guideline recommendations for patients with adynamic ileus to the following: Vancomycin per rectum (500 mg in a volume of 500 mL q 6 hours) by retention enema (18F Foley catheter with 30-cc balloon inserted into the rectum, balloon inflated, solution instilled, and catheter clamped for 60 minutes) for optimal efficacy.
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http://dx.doi.org/10.1089/sur.2018.238DOI Listing
August 2019

Gender Disparities in Trauma Care: How Sex Determines Treatment, Behavior, and Outcome.

Anesthesiol Clin 2019 Mar 27;37(1):107-117. Epub 2018 Nov 27.

Acute Care Surgery [Trauma, Burn, Critical Care, Emergency Surgery], Department of Surgery, Trauma and Surgical Critical Care, University of Michigan Health System, University Hospital, Room 1C340, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5033, USA.

Trauma data bank and other research reveal sex disparities in trauma care. Risk-taking behaviors leading to traumatic injury have been associated with sex, menstrual cycle timing, and cortisol levels. Trauma patient treatment stratified by sex reveals differences in access to services at trauma centers as well as specific treatments, such as venous thromboembolism prophylaxis and massive transfusion component ratios. Trauma patient outcomes, such as in-hospital mortality, multiple organ failure, pneumonia, and sepsis are associated with sex disparities in the general trauma patient. Outcome after general trauma and specifically traumatic brain injury show mixed results with respect to sex disparity.
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http://dx.doi.org/10.1016/j.anclin.2018.09.007DOI Listing
March 2019

The Future of Emergency General Surgery.

Ann Surg 2019 08;270(2):221-222

Division of Acute Care Surgery, University of Michigan Health System, Ann Arbor, MI.

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http://dx.doi.org/10.1097/SLA.0000000000003183DOI Listing
August 2019

Update on Extracorporeal Membrane Oxygenation Coding.

ASAIO J 2020 01;66(1):e5-e7

From the Division of Acute Care Surgery, Department of Surgery, University of Michigan Health System, Ann Arbor, Michigan.

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http://dx.doi.org/10.1097/MAT.0000000000000940DOI Listing
January 2020

Empirical systemic anticoagulation is associated with decreased venous thromboembolism in critically ill influenza A H1N1 acute respiratory distress syndrome patients.

J Vasc Surg Venous Lymphat Disord 2019 05 23;7(3):317-324. Epub 2018 Nov 23.

Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor, Mich. Electronic address:

Background: An association between increased venous thromboembolism (VTE) events and influenza A H1N1 (H1N1) was noted in the first 10 patients with severe acute respiratory distress syndrome (ARDS). An empirical systemic anticoagulation protocol (heparin intravenous infusion) was initiated when autopsy of patients with severe hypoxemia confirmed multiple primary pulmonary thrombi and emboli. The purpose of this study was to examine the relationship between H1N1 and VTE events and to assess the efficacy of empirical systemic heparin anticoagulation in preventing VTE and death in H1N1 severe ARDS patients.

Methods: An observational cohort study of critically ill severe ARDS patients with possible H1N1 viral pneumonia was performed in a surgical intensive care unit in a single 990-bed academic tertiary care center. Early empirical systemic heparin anticoagulation for all severe ARDS patients with possible H1N1 viral pneumonia was initiated as a VTE preventive strategy.

Results: Univariate comparisons and multivariate logistic regression were used to identify risk factors for VTE. Independent risk factors for VTE included H1N1, culture-positive bacterial pneumonia, and vasopressor requirement. Independent risk factors for pulmonary embolism included H1N1, culture-positive bacterial pneumonia, and male sex. H1N1 ARDS patients had 23.3-fold higher risk for pulmonary embolism and 17.9-fold increased risk for VTE. Kaplan-Meier analysis and log-rank test confirmed that empirical systemic heparin anticoagulation provided significant protection from thrombotic events in the H1N1-positive but not in the H1N1-negative critically ill ARDs patients. In multivariate analysis, adjusting for H1N1 status, patients without empirical systemic anticoagulation were 33 times more likely to have any VTE compared with those treated with empirical systemic heparin anticoagulation (P = .01).

Conclusions: Critically ill patients with H1N1 ARDS have increased risk of venous thrombotic complications, particularly pulmonary thromboembolism. Empirical systemic heparin anticoagulation in this cohort of patients significantly reduced VTE incidence without increased hemorrhagic complications.
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http://dx.doi.org/10.1016/j.jvsv.2018.08.010DOI Listing
May 2019

The Fragility Index in Randomized Clinical Trials as a Means of Optimizing Patient Care.

JAMA Surg 2019 Jan;154(1):74-79

Division of Acute Care Surgery, Department of Surgery, University of Michigan, Ann Arbor.

Importance: The Fragility Index (FI) is the minimum number of participants in a randomized clinical trial (RCT) whose status would have to change from a nonevent (not experiencing the primary end point) to an event (experiencing the primary end point) required to turn a statistically significant result to a nonsignificant result. The FI measures the robustness (or fragility) of the results of an RCT and is an important aid to the clinician's interpretation of RCT results. It has now been recognized that RCTs, which provide the foundation for treatment guideline recommendations, may not be robust.

Observations: Most RCTs in surgery and general medicine are fragile (with a low FI score), in contrast to those in cardiac disease and heart failure, where most RCTs are robust (with high FI scores). For clinical trials of trauma, we identified that the median (interquartile range) FI score was 3 (1-8), which means that adding 3 events to the opposite treatment arm in a given RCT eliminated statistical significance. The median Fragility Quotient (the FI score divided by the total study sample size) was 0.016 (0.0043-0.0408).

Conclusions And Relevance: The provision of high-quality, evidence-based clinical care in surgery for optimal patient outcomes requires a foundation of robust clinical research evidence, and knowledge of the FI will assist in future surgical RCT design. We strongly recommend the routine reporting of FI scores for all future trauma and surgical RCTs to assist in appropriate and optimal decision making in the care of patients who have experienced trauma and/or need surgery. We also recommend the routine inclusion of the FI score in the development of clinical guidelines to assist the clinician in ascertaining whether guideline recommendations are robust. Surgeons should be aware to particularly exercise caution when considering a potential change in clinical practice based on RCTs with a low FI score.
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http://dx.doi.org/10.1001/jamasurg.2018.4318DOI Listing
January 2019