Publications by authors named "Peter Hu"

178 Publications

The Algorithm Examining the Risk of Massive Transfusion (ALERT) Score Accurately Predicts Massive Transfusion at the Scene of Injury and on Arrival to the Trauma Bay: A Retrospective Analysis.

Shock 2021 Oct;56(4):529-536

Division of Critical Care, Department of Anesthesiology, R. Adams Cowley Shock Trauma Center, Baltimore, Maryland.

Background: Massive transfusion (MT) is required to resuscitate traumatically injured patients with complex derangements. Scoring systems for MT typically require laboratory values and radiological imaging that may delay the prediction of MT.

Study Design: The Trauma ALgorithm Examining the Risk of massive Transfusion (Trauma ALERT) study was an observational cohort study. Prehospital and admission ALERT scores were constructed with logistic regression of prehospital and admission vitals, and FAST examination results. Internal validation was performed with bootstrap analysis and cross-validation.

Results: The development cohort included 2,592 patients. Seven variables were included in the prehospital ALERT score: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR), SpO2, motor Glasgow Coma Scale (GCS) score, and penetrating mechanism. Eight variables from 2,307 patients were included in the admission ALERT score: admission SBP, HR, RR, GCS score, temperature, FAST examination result, and prehospital SBP and DBP.The area under the receiving operator characteristic curve for the prehospital and admission models were 0.754 (95% bootstrapped CI 0.735-0.794, P < 0.001) and 0.905 (95% bootstrapped CI 0.867-0.923, P < 0.001), respectively. The prehospital ALERT score had equivalent diagnostic accuracy to the ABC score (P = 0.97), and the admission ALERT score outperformed both the ABC and the prehospital ALERT scores (P < 0.0001).

Conclusion: The prehospital and admission ALERT scores can accurately predict massive transfusion in trauma patients without the use of time-consuming laboratory studies, although prospective studies need to be performed to validate these findings. Early identification of patients who will require MT may allow for timely mobilization of scarce resources and could benefit patients by making blood products available for treating hemorrhagic shock.
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http://dx.doi.org/10.1097/SHK.0000000000001772DOI Listing
October 2021

Dynamic Intracranial Pressure Waveform Morphology Predicts Ventriculitis.

Neurocrit Care 2021 Jul 30. Epub 2021 Jul 30.

Department of Neurology, Columbia University Vagelos College of Physicians and Surgeons, 177 Fort Washington Ave, 8 Milstein - 300 Center, New York, NY, USA.

Background: Intracranial pressure waveform morphology reflects compliance, which can be decreased by ventriculitis. We investigated whether morphologic analysis of intracranial pressure dynamics predicts the onset of ventriculitis.

Methods: Ventriculitis was defined as culture or Gram stain positive cerebrospinal fluid, warranting treatment. We developed a pipeline to automatically isolate segments of intracranial pressure waveforms from extraventricular catheters, extract dominant pulses, and obtain morphologically similar groupings. We used a previously validated clinician-supervised active learning paradigm to identify metaclusters of triphasic, single-peak, or artifactual peaks. Metacluster distributions were concatenated with temperature and routine blood laboratory values to create feature vectors. A L2-regularized logistic regression classifier was trained to distinguish patients with ventriculitis from matched controls, and the discriminative performance using area under receiver operating characteristic curve with bootstrapping cross-validation was reported.

Results: Fifty-eight patients were included for analysis. Twenty-seven patients with ventriculitis from two centers were identified. Thirty-one patients with catheters but without ventriculitis were selected as matched controls based on age, sex, and primary diagnosis. There were 1590 h of segmented data, including 396,130 dominant pulses in patients with ventriculitis and 557,435 pulses in patients without ventriculitis. There were significant differences in metacluster distribution comparing before culture-positivity versus during culture-positivity (p < 0.001) and after culture-positivity (p < 0.001). The classifier demonstrated good discrimination with median area under receiver operating characteristic 0.70 (interquartile range 0.55-0.80). There were 1.5 true alerts (ventriculitis detected) for every false alert.

Conclusions: Intracranial pressure waveform morphology analysis can classify ventriculitis without cerebrospinal fluid sampling.
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http://dx.doi.org/10.1007/s12028-021-01303-3DOI Listing
July 2021

Virtual "Radiology Rounds": Resident-run Medical Education in the COVID-19 Era.

Acad Radiol 2021 Jul 19. Epub 2021 Jul 19.

Department of Radiology, Keck School of Medicine at USC, 1500 San Pablo St, 2nd Floor, Los Angeles, CA.

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http://dx.doi.org/10.1016/j.acra.2021.07.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8286878PMC
July 2021

Admission Features Associated With Paroxysmal Sympathetic Hyperactivity After Traumatic Brain Injury: A Case-Control Study.

Crit Care Med 2021 Oct;49(10):e989-e1000

R. Adams Cowley Shock Trauma Center, Baltimore, MD.

Objectives: Paroxysmal sympathetic hyperactivity occurs in a subset of critically ill traumatic brain injury patients and has been associated with worse outcomes after traumatic brain injury. The goal of this study was to identify admission risk factors for the development of paroxysmal sympathetic hyperactivity in traumatic brain injury patients.

Design: Retrospective case-control study of age- and Glasgow Coma Scale-matched traumatic brain injury patients.

Setting: Neurotrauma ICU at the R. Adams Cowley Shock Trauma Center of the University of Maryland Medical System, January 2016 to July 2018.

Patients: Critically ill adult traumatic brain injury patients who underwent inpatient monitoring for at least 14 days were included. Cases were identified based on treatment for paroxysmal sympathetic hyperactivity with institutional first-line therapies and were confirmed by retrospective tabulation of established paroxysmal sympathetic hyperactivity diagnostic and severity criteria. Cases were matched 1:1 by age and Glasgow Coma Scale to nonparoxysmal sympathetic hyperactivity traumatic brain injury controls, yielding 77 patients in each group.

Interventions: None.

Measurements And Main Results: Admission characteristics independently predictive of paroxysmal sympathetic hyperactivity included male sex, higher admission systolic blood pressure, and initial CT evidence of diffuse axonal injury, intraventricular hemorrhage/subarachnoid hemorrhage, complete cisternal effacement, and absence of contusion. Paroxysmal sympathetic hyperactivity cases demonstrated significantly worse neurologic outcomes upon hospital discharge despite being matched for injury severity at admission.

Conclusions: Several anatomical, epidemiologic, and physiologic risk factors for clinically relevant paroxysmal sympathetic hyperactivity can be identified on ICU admission. These features help characterize paroxysmal sympathetic hyperactivity as a clinical-pathophysiologic phenotype associated with worse outcomes after traumatic brain injury.
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http://dx.doi.org/10.1097/CCM.0000000000005076DOI Listing
October 2021

Impact of Using Median vs. Mean in Calculating ERBB2 FISH Results in Breast Cancer.

Cancer Med J 2021 Dec 15;4(3):87-96. Epub 2021 Apr 15.

Department of Pathology, The University of Texas Medical Branch, Galveston, Texas, USA.

Introduction: Erb-b2 receptor tyrosine kinase 2 (ERBB2) testing is used to measure the status of ERBB2 gene expression and DNA amplification. Test results have been reported with a discrepancy as high as 20%. The purpose of this study was to improve ERBB2 fluorescence in situ hybridization (FISH) sensitivity by evaluating results generated by median as well as mean calculations.

Methods: We retrospectively identified breast cancer cases at our institution in which ERBB2 FISH testing was performed in-house from June 2018 to May 2020. FISH results were classified using the 2018 American Society of Clinical Oncology/College of American Pathologists guidelines: groups 1 and 5 are FISH positive and negative, respectively, and groups 2-4 are equivocal requiring additional work-up. FISH counting sheets were collected and regrouped by median ERBB2 copy number counts and median ERBB2/CEP17 ratio and compared with the mean ERBB2 and mean ERBB2/CEP17 ratio. Intra-tumor genetic heterogeneity and CEP17 copy number gain (CEP17 ≥3) were assessed to see if they affect the discrepancy between median and mean groups.

Results: Seventy-two breast cancer cases were collected and evaluated. Eleven cases (11 of 72 [15%]) had discrepant grouping by mean and median calculations. A significant number of discrepancies were found for CEP17 copy number gain (p = 0.027) but not for ERBB2 (p = 0.411), the ERBB2/CEP17 ratio (p = 0.445), FISH results (p = 0.194), or genetic heterogeneity (p = 0.465). Among the four cases regrouped to median group 1, 2 were from mean group 3 and underwent anti-ERBB2 targeted therapy and 2 were from mean groups 4 and 5 may have benefitted from targeted therapy with more than 30% amplified cells. The median may be better to reflect the monosomy subclone within tumor tissues for the case 387 moved from mean group 5 to median group 2. The 6 cases moved from mean group 5 to median group 4 with CEP17 copy number gain may have had a poor prognosis based on other study result.

Conclusion: Including the median calculation may increase ERBB2 sensitivity and identification of CEP17 copy number gain. Further clinical studies are necessary to examine the outcome of including median in calculating ERBB2/CEP17 values.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8171267PMC
December 2021

Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer.

Cancer Med 2021 06 7;10(11):3565-3574. Epub 2021 May 7.

Sarcoma Center, Department of Medical Oncology, Dana-Farber Cancer Institute (DFCI), Harvard Medical School and Ludwig Center at Harvard, Boston, MA, USA.

Background: As with other alkylating agents, cardiac dysfunction can occur with trabectedin therapy for advanced soft tissue sarcomas (STS) or recurrent ovarian cancer (ROC) where treatment options for advanced disease are still limited. Cardiac safety for trabectedin monotherapy (T) for STS or in combination with pegylated liposomal doxorubicin (T+PLD) for ROC was evaluated in this retrospective postmarketing regulatory commitment.

Methods: Patient data for multiple cardiac-related treatment-emergent adverse events (cTEAEs) were evaluated in pooled analyses of ten phase 2 trials, one phase 3 trial in STS (n = 982), and two phase 3 trials in ROC (n = 1231).

Results: Multivariate analyses on pooled trabectedin data revealed that cardiovascular medical history (risk ratio [RR (95% CI)]: 1.90 [1.24-2.91]; p = 0.003) and age ≥65 years (RR [95% CI]: 1.78 [1.12-2.83]; p = 0.014) were associated with increased risk for cTEAEs. Multivariate analyses showed increased risk of experiencing cTEAEs with T+PLD compared to PLD monotherapy (RR [95% CI]: 2.70 [1.75-4.17]; p < 0.0001) and with history of prior cardiac medication (RR [95% CI]: 1.88 [1.16-3.05]; p = 0.010).

Conclusions: For patients with STS or ROC who still have limited treatment options, trabectedin may be initiated after carefully considering benefit versus risk. Trial Registration (ClinicalTrials.gov): NCT01343277; NCT00113607; NCT01846611.
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http://dx.doi.org/10.1002/cam4.3903DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178483PMC
June 2021

PREHOSPITAL CONTINUOUS VITAL SIGNS PREDICT NEED FOR REBOA AND RESUSCITATIVE THORACOTOMY.

J Trauma Acute Care Surg 2021 Mar 12. Epub 2021 Mar 12.

Shock, Trauma and Anesthesiology Research (STAR) Center, University of Maryland School of Medicine, Baltimore, Maryland Shock Trauma Center and the University of Maryland School of Medicine, Baltimore, MD Maryland Institute for Emergency Medical Services Systems, Baltimore, MD.

Background: Rapid triage and intervention to control hemorrhage are key to survival following traumatic injury. Patients presenting in hemorrhagic shock may undergo resuscitative thoracotomy (RT) or resuscitative endovascular balloon occlusion of the aorta (REBOA) as adjuncts to rapidly control bleeding. We hypothesized that machine learning along with automated calculation of continuously measured vital signs in the pre-hospital setting would accurately predict need for REBOA/RT and inform rapid life-saving decisions.

Methods: Prehospital and admission data from 1,396 patients transported from the scene of injury to a level-I trauma center via helicopter were analyzed. Utilizing machine learning and pre-hospital autonomous vital signs, a bleeding risk index (BRI) based on features from pulse oximetry and electrocardiography waveforms and blood pressure (BP) trends was calculated. Demographics, injury severity score (ISS) and BRI were compared using Mann-Whitney-Wilcox test. Area under the receiver operating characteristic curve (AUC) was calculated and AUC of different scores compared using DeLong's method.

Results: Of the 1,396 patients, median age was 45 years and 68% were male. Patients who underwent REBOA/RT were more likely to have a penetrating injury (24% vs 7%, p<0.001), higher ISS (25 vs 10, p<0.001) and higher mortality (44% vs 7%, p<0.001). Pre-hospital they had lower BP (96 [70-130] vs 134 [117-152], p<0.001) and higher heart rate (106 [82-118] vs 90 [76-106], p<0.001). BRI calculated using the entire pre-hospital period was 10x higher in patients undergoing REBOA/RT (0.5 [0.42-0.63] vs 0.05 [0.02-0.21], p<0.001) with an AUC 0.93 [95%CI: 0.90-0.97]). This was similarly predictive when calculated from shorter periods of transport: BRI initial 10 minutes pre-hospital AUC 0.89 [5%CI: 0.83-0.94] and initial 5 minutes AUC 0.90 [95%CI: 0.85-0.94].

Conclusion: Automated pre-hospital calculations based on vital sign features and trends accurately predict need for the emergent REBOA/ RT. This information can provide essential time for team preparedness and guide trauma triage and disaster management.

Level Of Evidence: Level IV Therapeutic/Care Management.
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http://dx.doi.org/10.1097/TA.0000000000003171DOI Listing
March 2021

Evaluation of the Oncomine Pan-Cancer Cell-Free Assay for Analyzing Circulating Tumor DNA in the Cerebrospinal Fluid in Patients with Central Nervous System Malignancies.

J Mol Diagn 2021 02;23(2):171-180

Department of Pathology and Laboratory Medicine, McGovern Medical School, University of Texas Health Science Center, Houston, Texas; Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas; Memorial Hermann Hospital, Texas Medical Center, Houston, Texas. Electronic address:

Available tools to evaluate patients with central nervous system (CNS) tumors such as magnetic resonance imaging (MRI), cerebrospinal fluid (CSF) cytology, and brain biopsies, have significant limitations. MRI and CSF cytology have poor specificity and sensitivity, respectively, and brain biopsies are invasive. Circulating tumor DNA in CSF (CSF-ctDNA) could be used as a biomarker in patients with CNS tumors, but studies in this area are limited. We evaluated four CSF-ctDNA extraction methods and analyzed mutations in CSF-ctDNA with the Oncomine Pan-Cancer cell-free assay. CSF-ctDNA was extracted from 38 patients with primary or metastatic CNS tumors and 10 patients without CNS malignancy. Commercial ctDNA controls were used for assay evaluation. CSF-ctDNA yields ranged from 3.65 to 3120 ng. Mutations were detected in 39.5% of samples. TP53 was the most commonly mutated gene and copy number alterations were detected in CCND1, MYC, and ERBB2/HER2. Twenty-five percent of CSF-cytology-negative samples showed mutations in CSF-ctDNA. There was good concordance between mutations in CSF-ctDNA and matching tumors. The QIAamp Circulating Nucleic Acid Kit was the optimal method for extraction of CSF-ctDNA and the Oncomine cell-free DNA assay is suitable for detection of mutations in CSF-ctDNA. Analysis of CSF-ctDNA is more sensitive than CSF-cytology and has the potential to improve the diagnosis and monitoring of patients with CNS tumors.
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http://dx.doi.org/10.1016/j.jmoldx.2020.10.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7874332PMC
February 2021

Comparison of massive and emergency transfusion prediction scoring systems after trauma with a new Bleeding Risk Index score applied in-flight.

J Trauma Acute Care Surg 2021 02;90(2):268-273

From the Departments of Anesthesiology (S.Y., C.F.M., P.R., C.L., F.S., S.G., P.F.H.); Department of Surgery and Program in Trauma (T.S., S.G., D.S., P.F.H.), University of Maryland School of Medicine; Maryland Institute for Emergency Medical Services Systems (MIEMSS) (D.F., C.W.); and US Air Force C-STARS, (C.M.) Baltimore, Maryland.

Background: Assessment of blood consumption (ABC), shock index (SI), and Revised Trauma Score (RTS) are used to estimate the need for blood transfusion and triage. We compared Bleeding Risk Index (BRI) score calculated with trauma patient noninvasive vital signs and hypothesized that prehospital BRI has better performance compared with ABC, RTS, and SI for predicting the need for emergent and massive transfusion (MT).

Methods: We analyzed 2-year in-flight data from adult trauma patients transported directly to a Level I trauma center via helicopter. The BRI scores 0 to 1 were derived from continuous features of photoplethymographic and electrocardiographic waveforms, oximetry values, blood pressure trends. The ABC, RTS, and SI were calculated using admission data. The area under the receiver operating characteristic curve (AUROC) with 95% confidence interval (CI) was calculated for predictions of critical administration threshold (CAT, ≥3 units of blood in the first hour) or MT (≥10 units of blood in the first 24 hours). DeLong's method was used to compare AUROCs for different scoring systems. p < 0.05 was considered statistically significant.

Results: Among 1,396 patients, age was 46.5 ± 20.1 years (SD), 67.1% were male. The MT rate was 3.2% and CAT was 7.6%, most (92.8%) were blunt injury. Mortality was 6.6%. Scene arrival to hospital time was 35.3 ± (10.5) minutes. The BRI prediction of MT with AUROC 0.92 (95% CI, 0.89-0.95) was significantly better than ABC, SI, or RTS (AUROCs = 0.80, 0.83, 0.78, respectively; 95% CIs 0.73-0.87, 0.76-0.90, 0.71-0.85, respectively). The BRI prediction of CAT had an AUROC of 0.91 (95% CI, 0.86-0.94), which was significantly better than ABC (AUROC, 077; 95% CI, 0.73-0.82) or RTS (AUROC, 0.79; 95% CI, 0.74-0.83) and better than SI (AUROC, 0.85; 95% CI, 0.80-0.89). The BRI score threshold for optimal prediction of CAT was 0.25 and for MT was 0.28.

Conclusion: The autonomous continuous noninvasive patient vital signs-based BRI score performs better than ABC, RTS, and SI predictions of MT and CAT. Bleeding Risk Index does not require additional data entry or expert interpretation.

Level Of Evidence: Prognostic test, level III.
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http://dx.doi.org/10.1097/TA.0000000000003031DOI Listing
February 2021

Enhanced Training Benefits of Video Recording Surgery With Automated Hand Motion Analysis.

World J Surg 2021 Apr 3;45(4):981-987. Epub 2021 Jan 3.

Department of Surgery, UMDSOM, Baltimore, MD, 21201, USA.

Background: Hand motion analysis by video recording during surgery has potential for evaluation of surgical performance. The aim was to identify how technical skill during open surgery can be measured unobtrusively by video recording during a surgical procedure. We hypothesized that procedural-step timing, hand movements, instrument use and Shannon entropy differ with expertise and training and are concordant with a performance-based validated individual procedure score.

Methods: Surgeon and non-surgeon participants with varying training and levels of expertise were video recorded performing axillary artery exposure and control (AA) on un-preserved cadavers. Color-coded gloves permitted motion-tracking and automated extraction of entropy data from recordings. Timing and instrument-use metrics were obtained through observational video reviews. Shannon entropy measured speed, acceleration and direction by computer-vision algorithms. Findings were compared with individual procedure score for AA performance RESULTS: Experts had lowest entropy values, idle time, active time and shorter time to divide pectoralis minor, using fewer instruments. Residents improved with training, without reaching expert levels, and showed deterioration 12-18 months later. Individual procedure scores mirrored these results. Non-surgeons differed substantially.

Conclusions: Hand motion entropy and timing metrics discriminate levels of surgical skill and training, and these findings are congruent with individual procedure score evaluations. These measures can be collected using consumer-level cameras and analyzed automatically with free software. Hand motion with video timing data may have widespread application to evaluate resident performance and can contribute to the range of evaluation and testing modalities available to educators, training course designers and surgical quality assurance programs.
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http://dx.doi.org/10.1007/s00268-020-05916-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920885PMC
April 2021

The Cardiac Physiology Underpinning Exsanguination Cardiac Arrest: Targets for Endovascular Resuscitation.

Shock 2021 01;55(1):83-89

R Adams Cowley Shock Trauma Center, University of Maryland Medical System, Baltimore, Maryland.

Abstract: Exsanguination leading to cardiac arrest is the terminal phase of uncontrolled hemorrhage. Resuscitative interventions have focused on preload and afterload support. Outcomes remain poor due to several factors but poor coronary perfusion undoubtedly plays a role. The aim of this study is to characterize the relationship between arterial pressure and flow during hemorrhage in an effort to better describe the terminal phases of exsanguination.Male swine weighing 60 kg to 80 kg underwent splenectomy and instrumentation followed by a logarithmic exsanguination until asystole. Changes in hemodynamic parameters over time were compared using one-way, repeated measures analysis of variance.Nine animals weighing 69 ± 15 kg were studied. Asystole occurred at 53 ± 13 min when 52 ± 11% of total blood volume has been shed. The greatest fall in mean hemodynamic indices were noted in the first 15 min: SBP (80-42 mm Hg, P = 0.02), left ventricular end-diastolic volume (94-52 mL, P = 0.04), cardiac output (4.8-2.4 L/min, P = 0.03), coronary perfusion pressure (57-30 mm Hg, P = 0.01), and stroke volume (60-25 mL, P = 0.02). This corresponds to the greatest rate of exsanguination. Organized cardiac activity was observed until asystole without arrythmias. Coronary flow was relatively preserved throughout the study, with a precipitous decline once mean arterial pressure was less than 20 mm Hg, leading to asystole.In this model, initial hemodynamic instability was due to preload failure, with asystole occurring relatively late, secondary to failure of coronary perfusion. Future resuscitative therapies need to directly address coronary perfusion failure if effective attempts are to be made to salvage these patients.
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http://dx.doi.org/10.1097/SHK.0000000000001607DOI Listing
January 2021

Treatment Pattern and Outcomes in Newly Diagnosed Multiple Myeloma Patients Who Did Not Receive Autologous Stem Cell Transplantation: A Real-World Observational Study : Treatment pattern and outcomes in patients with multiple myeloma.

Adv Ther 2021 01 19;38(1):640-659. Epub 2020 Nov 19.

Janssen Global Medical Affairs, Cilag, Zug, Switzerland.

Introduction: The objective of this study was to describe the treatment patterns among patients with newly diagnosed multiple myeloma (MM) who had not received autologous stem cell transplantation (ASCT). It further compares the safety and clinical outcomes across different frontline regimens as well as explores whether treatment duration predicts outcomes.

Methods: Patients with MM (> 45 years) who had not received ASCT were retrospectively identified from the US SEER-Medicare (Jan 2007-Dec 2016) and Optum (Jan 2007-Sep 2018) databases. Cox proportional hazard models were used to compare overall survival (OS) among bortezomib + lenalidomide + dexamethasone regimen (VRd), lenalidomide + dexamethasone regimen (Rd), cyclophosphamide + bortezomib + dexamethasone regimen (CyBorD), bortezomib + dexamethasone regimen (Vd), and other bortezomib-containing therapies based on propensity score matching. To address immortal time bias, time-fixed and time-dependent Cox models were employed to estimate the association of longer frontline treatment exposure with outcomes.

Results: Mean (standard deviation; SD) age was 71 (9.8) years; and 49.51% were women. Bortezomib and lenalidomide-based combinations were the most common treatment modalities. After matching, the HR (95% CI) of OS by frontline therapies comparing VRd with Vd was 0.76 (0.66, 0.86), CyBorD was 0.87 (0.75, 1.05), for other bortezomib-based therapies was 0.56 (0.49, 0.64), Rd was 0.83 (0.73, 0.95), and for other therapies was 0.70 (0.61, 0.80). Longer frontline treatment duration was associated with better OS for overall frontline [HR (95% CI) 0.86 (0.82, 0.90)]; Vd [0.81 (0.74, 0.89)]; CyBorD [0.79 (0.64, 0.98)] and Rd [0.86 (0.78, 0.95)].

Conclusion: Results demonstrated that the frontline therapies prescribed to most patients who did not receive ASCT for MM in the United States were consistent with the NCCN guideline recommendations. Longer frontline treatment duration was associated with improved OS.
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http://dx.doi.org/10.1007/s12325-020-01546-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854424PMC
January 2021

Severe Mobile Mitral Annular Calcification Mimicking Vegetation.

Circ Cardiovasc Imaging 2020 11 11;13(11):e010541. Epub 2020 Nov 11.

Department of Cardiovascular Medicine (P.T.H., B.X., R.A.G., R.L.M.), Cleveland Clinic, OH.

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http://dx.doi.org/10.1161/CIRCIMAGING.120.010541DOI Listing
November 2020

Association of Pathologic Complete Response with Long-Term Survival Outcomes in Triple-Negative Breast Cancer: A Meta-Analysis.

Cancer Res 2020 12 14;80(24):5427-5434. Epub 2020 Sep 14.

Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.

Pathologic complete response (pCR) following neoadjuvant therapy has been associated with improved event-free survival (EFS) and overall survival (OS) in early-stage breast cancer. The magnitude of this association varies by breast cancer subtype, yet further research focusing on subtype-specific populations is limited. Here we provide an updated and comprehensive evaluation of the association between pCR and survival outcomes in triple-negative breast cancer (TNBC). A literature review identified neoadjuvant studies, including clinical trials, real-world cohort studies, and studies that pooled multiple trials or cohorts, which reported EFS/OS results by pCR in patients with early-stage TNBC. Meta-analyses were performed to evaluate the association between pCR and EFS/OS and to predict long-term survival outcomes based on pCR status. Sensitivity analyses were conducted to assess the impact of cross-study variations. Twenty-five studies with over 4,000 patients with TNBC were identified. A synthesis of evidence from these studies suggested substantial improvement in EFS and OS for pCR versus non-pCR [EFS HR (95% confidence interval): 0.24 (0.20-0.29); OS: 0.19 (0.15-0.24)]; consistent results were reported in sensitivity analyses. Collectively, our findings suggest that adjuvant therapy is associated with improved EFS/OS in patients with TNBC who received neoadjuvant therapy, regardless of pCR status.
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http://dx.doi.org/10.1158/0008-5472.CAN-20-1792DOI Listing
December 2020

A novel method of calculating stroke volume using point-of-care echocardiography.

Cardiovasc Ultrasound 2020 Aug 20;18(1):37. Epub 2020 Aug 20.

Division of Trauma and Surgical Critical Care, Department of Surgery, University of Maryland School of Medicine, 22 South Greene St, Baltimore, MD, 21201, USA.

Background: Point-of-care transthoracic echocardiography (POC-TTE) is essential in shock management, allowing for stroke volume (SV) and cardiac output (CO) estimation using left ventricular outflow tract diameter (LVOTD) and left ventricular velocity time integral (VTI). Since LVOTD is difficult to obtain and error-prone, the body surface area (BSA) or a modified BSA (mBSA) is sometimes used as a surrogate (LVOTD, LVOTD). Currently, no models of LVOTD based on patient characteristics exist nor have BSA-based alternatives been validated.

Methods: Focused rapid echocardiographic evaluations (FREEs) performed in intensive care unit patients over a 3-year period were reviewed. The age, sex, height, and weight were recorded. Human expert measurement of LVOTD (LVOTD) was performed. An epsilon-support vector regression was used to derive a computer model of the predicted LVOTD (LVOTD). Training, testing, and validation were completed. Pearson coefficient and Bland-Altman were used to assess correlation and agreement.

Results: Two hundred eighty-seven TTEs with ideal images of the LVOT were identified. LVOTD was the best method of SV measurement, with a correlation of 0.87. LVOTD and LVOTD had correlations of 0.71 and 0.49 respectively. Root mean square error for LVOTD, LVOTD, and LVOTD respectively were 13.3, 37.0, and 26.4. Bland-Altman for LVOTD demonstrated a bias of 5.2. LVOTD model was used in a separate validation set of 116 ideal images yielding a linear correlation of 0.83 between SV and SV. Bland Altman analysis for SV had a bias of 2.3 with limits of agreement (LOAs) of - 24 and 29, a percent error (PE) of 34% and a root mean square error (RMSE) of 13.9.

Conclusions: A computer model may allow for SV and CO measurement when the LVOTD cannot be assessed. Further study is needed to assess the accuracy of the model in various patient populations and in comparison to the gold standard pulmonary artery catheter. The LVOTD is more accurate with less error compared to BSA-based methods, however there is still a percentage error of 33%. BSA should not be used as a surrogate measure of LVOTD. Once validated and improved this model may improve feasibility and allow hemodynamic monitoring via POC-TTE once it is validated.
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http://dx.doi.org/10.1186/s12947-020-00219-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441555PMC
August 2020

Phenotypes Associated with 16p11.2 Copy Number Gains and Losses at a Single Institution.

Lab Med 2020 Nov;51(6):642-648

Department of Pathology, University of Texas Medical Branch, Galveston, Texas.

Chromosome 16p11.2 is one of the susceptible sites for recurrent copy number variations (CNVs) due to flanking near-identical segmental duplications. Five segmental duplications, named breakpoints 1 to 5 (BP1-BP5), have been defined as recombination hotspots within 16p11.2. Common CNVs on 16p11.2 include a proximal ~593 kb between BP4 and BP5, and a distal ~220 kb between BP2 and BP3. We performed a search for patients carrying 16p11.2 CNVs, as detected using chromosome microarray (CMA), in the Molecular Diagnostic Laboratory at the University of Texas Medical Branch (UTMB), in Galveston. From March 2013 through April 2018, a total of 1200 CMA results were generated for germline testing, and 14 patients tested positive for 16p11.2 CNVs, of whom 7 had proximal deletion, 2 had distal deletion, 4 had proximal duplication, and 1 had distal duplication. Herein, we provide detailed phenotype data for these patients. Our study results show that developmental delay, abnormal body weight, behavioral problems, and hypotonia are common phenotypes associated with 16p11.2 CNVs.
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http://dx.doi.org/10.1093/labmed/lmaa026DOI Listing
November 2020

Prehospital Point of Care Testing for the Early Detection of Shock and Prediction of Lifesaving Interventions.

Shock 2020 12;54(6):710-716

R Adams Cowley Shock Trauma Center, Baltimore, Maryland.

Introduction: Early diagnosis and treatment are essential for enhancing outcomes for the traumatically injured. In this prospective prehospital observational study, we hypothesized that a variety of laboratory results measured in the prehospital environment would predict both the presence of early shock and the need for lifesaving interventions (LSIs) for adult patients with traumatic injuries.

Methods: Adult trauma patients flown by a helicopter emergency medical service were prospectively enrolled. Using an i-STAT portable analyzer, data from 16 laboratory tests were collected. Vital signs data were also collected. Outcomes of interest included detection of shock, mortality, and requirement for LSIs. Logistic regression, including a Bayesian analysis, was performed.

Results: Among 300 patients screened for enrollment, 261 had complete laboratory data for analysis. The majority of patients were male (75%) with blunt trauma (91.2%). The median injury severity score was 29 (IQR, 25-75) and overall mortality was 4.6%. A total of 170 LSIs were performed. The median lactate for patients who required an LSI was 4.1 (IQR, 3-5.4). The odds of requiring an LSI within the first hour of admission to the trauma center was highly associated with increases in lactate and glucose. A lactate level > 4 mmol/L was statistically associated with greater sensitivity and specificity for predicting the need for a LSI compared with shock index.

Conclusions: In this prospective observational trial, lactate outperformed static vital signs, including shock index, for detecting shock and predicting the need for LSIs. A lactate level > 4 mmol/L was found to be highly associated with the need for LSIs.
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http://dx.doi.org/10.1097/SHK.0000000000001567DOI Listing
December 2020

Use of virtual visits for the care of the arrhythmia patient.

Heart Rhythm 2020 10 11;17(10):1779-1783. Epub 2020 May 11.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: Virtual visits (VVs) are a modality for delivering health care services remotely through videoconferencing tools. Data about patient and physician experience in using VVs are limited.

Objective: The purpose of this study was to assess patient and physician experience with the use of VVs in cardiac electrophysiology.

Methods: We performed a prospective survey of cardiac electrophysiology patients and physicians who participated in an outpatient VV from December 2018 to July 2019.

Results: One-hundred consecutive VVs were included. Sixty-four patients elected to complete a survey. Patients rated their experience as either excellent/very good in scheduling a VV (87%), seeing their physician of choice (100%), transmitting arrhythmia data (88%), rating their physician's ability to communicate (98%), asking all questions (98%), rating the level of care received (98%), paying for the cost of a VV (67%), and rating their overall level of satisfaction (98%). Thirty-eight of 64 patients (59.4%) preferred a VV for their next visit, 12 of 64 (18.8%) preferred an in-office visit, 13 of 64 (20.3%) responded that their decision for a virtual or office visit depended on indication, and 1 of 64 (1.6%) had no preference. A total of 14 cardiac electrophysiologists participated in 100 VVs. Nine visits were not included due to technical difficulty. Physician responses to survey questions were rated as excellent/very good in the ability to communicate (92%), accessing monitoring data (95%), and overall level of satisfaction (98%).

Conclusion: In our small study population, most patients and physicians prefer VVs. Convenience, cost, and reason for follow-up were important determinants that affected both patient and physician preference.
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http://dx.doi.org/10.1016/j.hrthm.2020.05.011DOI Listing
October 2020

Comparison of efficacy from two different dosing regimens of bortezomib: an exposure-response analysis.

Br J Haematol 2020 06 18;189(5):860-868. Epub 2020 Feb 18.

University Hospital of Salamanca/IBSAL, Salamanca, Spain.

Bortezomib is a first-in-class proteasome inhibitor, approved for the treatment of multiple myeloma. The originally approved dosing schedule of bortezomib results in significant toxicities that require dose interruptions and discontinuations. Consequentially, less frequent dosing has been explored to optimise bortezomib's benefit-risk profile. Here, we performed exposure-response analysis to compare the efficacy of the original bortezomib dosing regimen with less frequent dosing of bortezomib over nine 6-week treatment cycles using data from the VISTA clinical trial and the control arm of the ALCYONE clinical trial. The relationship between cumulative bortezomib dose and clinical response was evaluated with a univariate logit model. The median cumulative bortezomib dose was higher in ALCYONE versus VISTA (42·2 vs. 38·5 mg/m ) and ALCYONE patients stayed on treatment longer (mean: 7·2 vs. 5·8 cycles). For all endpoints and regimens, probability of clinical response correlated with cumulative bortezomib dose. Similar to results observed for VISTA, overall survival was longer in ALCYONE patients with ≥ 39·0 versus < 39·0 mg/m cumulative dose (hazard ratio, 0·119; P < 0·0001). Less frequent bortezomib dosing results in comparable efficacy, and a higher cumulative dose than the originally approved bortezomib dosing schedule, which may be in part be due to reduced toxicity and fewer dose reductions/interruptions.
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http://dx.doi.org/10.1111/bjh.16446DOI Listing
June 2020

Hypothermia Outcomes After Transvenous Lead Extraction Complications Requiring Cardiothoracic Surgery.

Circ Arrhythm Electrophysiol 2019 12 13;12(12):e007831. Epub 2019 Dec 13.

Department of Cardiovascular Medicine (P.T.H., E.L.K., A.H., K.T., D.P., O.W., B.L.W.), Cleveland Clinic, OH.

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http://dx.doi.org/10.1161/CIRCEP.119.007831DOI Listing
December 2019

The gap between what patients know and desire to learn about their cardiac implantable electronic devices.

Pacing Clin Electrophysiol 2020 01 5;43(1):118-122. Epub 2019 Dec 5.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic Cleveland, Cleveland, Ohio.

Background: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important.

Methods: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED.

Results: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%).

Conclusion: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs.
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http://dx.doi.org/10.1111/pace.13850DOI Listing
January 2020

The authors reply.

Crit Care Med 2019 12;47(12):e1034

Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, and Shock Trauma and Anesthesiology Research Center, University of Maryland School of Medicine, Baltimore, MD Shock Trauma and Anesthesiology Research Center, University of Maryland School of Medicine, Baltimore, MD Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, and Shock Trauma and Anesthesiology Research Center, University of Maryland School of Medicine, Baltimore, MD Shock Trauma and Anesthesiology Research Center, University of Maryland School of Medicine, Baltimore, MD, and R Adams Cowley Shock Trauma Center, Baltimore, MD Department of Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, Shock Trauma and Anesthesiology Research Center, University of Maryland School of Medicine, Baltimore, MD, and R Adams Cowley Shock Trauma Center, Baltimore, MD.

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http://dx.doi.org/10.1097/CCM.0000000000004013DOI Listing
December 2019

The effects of different schedules of bortezomib, melphalan, and prednisone for patients with newly diagnosed multiple myeloma who are transplant ineligible: a matching-adjusted indirect comparison.

Leuk Lymphoma 2020 03 5;61(3):680-690. Epub 2019 Nov 5.

Global Market Access and Health Policy, Janssen Global Services, LLC, Raritan, NJ, USA.

For patients with newly diagnosed multiple myeloma (NDMM) who are transplant ineligible, bortezomib-melphalan-prednisone (VMP) demonstrated superior efficacy based on the VISTA trial. In subsequent trials, twice-weekly bortezomib was limited to the first cycle or completely replaced with once-weekly bortezomib to reduce toxicity. Following a systematic literature review, the efficacy and safety of modified VMP schedules (pooled data from the once-weekly bortezomib VMP arm of the GIMEMA trial and the VMP arm of the ALCYONE trial) were compared to the VISTA schedule using naïve and unanchored matching-adjusted indirect comparison (MAIC). Median progression-free survival was similar between VISTA and modified VMP (20.7 months [95% CI, 18.4-24.3] vs 19.6 months [95% CI, 18.8-21.0]). Peripheral neuropathy was significantly reduced with modified VMP versus VISTA VMP (all grades: naïve, 32.1% vs 46.8% and MAIC, 32.1% vs 46.7%; both  < .0001). These findings support a modified VMP dosing schedule for patients with NDMM who are transplant ineligible.
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http://dx.doi.org/10.1080/10428194.2019.1675881DOI Listing
March 2020

Penguin megrivirus, a novel picornavirus from an Adélie penguin (Pygoscelis adeliae).

Arch Virol 2019 Nov 7;164(11):2887-2890. Epub 2019 Sep 7.

Section of Experimental Virology, Jena University Hospital, Friedrich Schiller University, Hans-Knöll-Str. 2, 07745, Jena, Germany.

The complete genome sequence of a novel megrivirus of the family Picornaviridae was determined from nucleic acid extracted from a pool of six faecal specimens of Adélie penguins. The samples were collected near Bellingshausen Station, King George Island of the South Shetland Islands, Antarctica. Penguin megrivirus is the first megrivirus with a predicted L protein. It has an L-3-5-4 genome layout, a type IV IRES, and a long 3' untranslated region of 668 nt.
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http://dx.doi.org/10.1007/s00705-019-04404-9DOI Listing
November 2019

Non-invasive genotyping of metastatic colorectal cancer using circulating cell free DNA.

Cancer Genet 2019 09 12;237:82-89. Epub 2019 Jun 12.

Department of Translational Molecular Pathology, Division of Pathology and Laboratory Medicine, The University of Texas M.D. Anderson Cancer Center, 6565 MD Anderson Blvd., Houston, TX 77030, United States; Department of Hematopathology, The University of Texas M.D. Anderson Cancer Center, Houston, TX, United States. Electronic address:

Circulating cell-free DNA (ccfDNA) in plasma provides an easily accessible source of circulating tumor DNA (ctDNA) for detecting actionable genomic alterations that can be used to guide colorectal cancer (CRC) treatment and surveillance. The goal of this study was to test the feasibility of using a traditional amplicon-based next-generation sequencing (NGS) on Ion Torrent platform to detect low-frequency alleles in ctDNA and compare it with a digital NGS assay specifically designed to detect low-frequency variants (as low as 0.1%) to provide evidence for the standard care of CRC. The study cohort consisted of 48 CRC patients for whom matched samples of formalin-fixed, paraffin-embedded tumor tissue, plasma, and peripheral blood mononuclear cells were available. DNA samples from different sources were sequenced on different platforms using commercial protocols. Our results demonstrate that the ccfDNA sequencing with the traditional NGS can be reliably used in an integrated workflow to detect low-frequency somatic variants in CRC. We found a high degree of concordance between traditional NGS and digital NGS in profiling mutant alleles in ccfDNA. These findings suggest that the traditional NGS is a viable alternative to digital sequencing of ccfDNA at allele frequency above 1%. ccfDNA sequencing can not only provide real-time monitoring of CRC, but also lay the basis for its application as a clinical diagnostic test to guide personalized therapy.
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http://dx.doi.org/10.1016/j.cancergen.2019.06.004DOI Listing
September 2019

Development and Application of Duplex Sequencing Strategy for Cell-Free DNA-Based Longitudinal Monitoring of Stage IV Colorectal Cancer.

J Mol Diagn 2019 11 8;21(6):994-1009. Epub 2019 Aug 8.

Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas; Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:

Potential applications of cell-free DNA (cfDNA)-based molecular profiling have used in patients with diverse malignant tumors. However, capturing all cfDNA that originates from tumor cells and identifying true variants present in this minute fraction remain challenges to the widespread application of cfDNA-based liquid biopsies in the clinical setting. In this study, we evaluate a systematic approach and identify key components of wet bench and bioinformatics strategies to address these challenges. We found that concentration of enrichment oligonucleotides, elements of the library preparation, and the structure of adaptors are critical for achieving high enrichment of target regions, retaining variant allele frequencies accurately throughout all involved steps of library preparation, and obtaining high variant coverage. We developed a dual molecular barcode-integrated error elimination strategy to remove sequencing artifacts and a background error correction strategy to distinguish true variants from abundant false-positive variants. We further describe a clinical application of this cfDNA-based duplex sequencing approach that can be used to monitor disease progression in patients with stage IV colorectal cancer. The findings also suggest that cfDNA-based molecular testing observations are highly concordant with observations obtained by traditional imaging methods. Overall, the findings presented in this study have potential implications for early detection of cancer, identification of minimal residual disease, and evaluation of therapeutic responses in patients with cancer.
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http://dx.doi.org/10.1016/j.jmoldx.2019.06.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6854476PMC
November 2019

Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe.

Clin Drug Investig 2019 Nov;39(11):1057-1066

Janssen Research and Development, LLC, Raritan, NJ, USA.

Background And Objective: Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures.

Methods: In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM. Four DUS sensitivity analyses (scenarios) evaluated uncertainty regarding domperidone treatment duration and indication.

Results: Among 1805 physicians participating in the survey, most were aware of the approved indication (nausea and vomiting, 80%), treatment duration (≤ 7 days, 70%), and maximum adult daily dose (10 mg three times daily, 84%). Only 33% selected the on-label indication from a list of indications for which they would prescribe domperidone. Awareness was low for medications contraindicated for concomitant use (26%) and contraindicated conditions (4%). In the DUS, under the optimistic scenario, a large improvement in labeling compliance from pre- to post-implementation period was observed in France (27% vs. 69%), while Belgium, Germany, Spain, and the UK showed small improvements (< 10%). In the other scenarios, there was little to no improvement in compliance with the revised labeling from the pre- to post-implementation periods in most countries.

Conclusions: The survey findings documented that most physicians in all five countries were aware of the main aspects of the revised labeling. Results of the DUS were inconclusive regarding the effect of the RMM and compliance with the revised labeling for all countries except France.
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http://dx.doi.org/10.1007/s40261-019-00831-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6800405PMC
November 2019

Handheld Tissue Oximetry for the Prehospital Detection of Shock and Need for Lifesaving Interventions: Technology in Search of an Indication?

Air Med J 2019 Jul - Aug;38(4):276-280. Epub 2019 Apr 25.

R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD. Electronic address:

Improved prehospital methods for assessing the need for lifesaving interventions (LSIs) are needed to gain critical lead time in the care of the injured. We hypothesized that threshold values using prehospital handheld tissue oximetry would detect occult shock and predict LSI requirements. This was a prospective observational study of adult trauma patients emergently transported by helicopter. Patients were monitored with a handheld tissue oximeter (InSpectra Spot Check; Hutchinson Technology Inc, Hutchinson, MN), continuous vital signs, and 21 laboratory measurements obtained both in the field with a portable analyzer and at the time of admission. Shock was defined as base excess ≥ 4 or lactate > 3 mmol/L. Eighty-eight patients were enrolled with a median Injury Severity Score of 16 (interquartile range, 5-29). The median hemoglobin saturation in the capillaries, venules, and arterioles (StO) value for all patients was 82% (interquartile range, 76%-87%; range, 42%-98%). StO was abnormal (< 75%) in 18 patients (20%). Eight were hypotensive (9%) and had laboratory-confirmed evidence of occult shock. StO correlated poorly with shock threshold laboratory values (r = -0.17; 95% confidence interval, -0.33 to 1.0; P = .94). The area under the receiver operating curve was 0.51 (95% confidence interval, 0.39-0.63) for StO < 75% and laboratory-confirmed shock. StO was not associated with LSI need on admission when adjusted for multiple covariates, nor was it independently associated with death. Handheld tissue oximetry was not sensitive or specific for identifying patients with prehospital occult shock. These results do not support prehospital StO monitoring despite its inclusion in several published guidelines.
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http://dx.doi.org/10.1016/j.amj.2019.03.014DOI Listing
July 2020

Concomitant chest trauma and traumatic brain injury, biomarkers correlate with worse outcomes.

J Trauma Acute Care Surg 2019 07;87(1S Suppl 1):S146-S151

From the R Adams Cowley Shock Trauma Center (A.M.C., P.L., T.M.S., D.M.S.), Baltimore, Maryland; Department of Anesthesiology, University of Maryland School of Medicine (S.Y., P.H., Y.I.), Baltimore, Maryland.

Background: Clinical data are lacking on the influence of chest trauma on the secondary injury process after traumatic brain injury (TBI), with some data suggesting that multiple trauma may worsens brain injury. Blunt chest trauma and TBI represent the two major single injury entities with the highest risk of complications and are potential biomarker targets.

Methods: Trauma patients with severe TBI were enrolled. Serum biomarker levels were obtained every 6 hours for 72 hours. Baseline, 6 hours and 24 hours CT head scans were evaluated. Neurologic worsening was defined as increased contusions, ischemia, compression of basal cisterns, and/or midline shift. The TBI patients with chest injury (Abbreviated Injury Scale chest score ≥1) and those without chest injury were compared. Wilcoxon rank sum test, univariate logistic regression and receiver operating characteristic were reported.

Results: Fifty-seven patients. Mean age of 40.5 years. Median motor Glasgow Coma Scale score at admission and 24 hours was 3 (interquartile range, 1-5) and 5 (interquartile range, 3-5). Of the patients enrolled, 12.2% patients underwent craniotomy within 6 hours from the time of admission and 22.8% within 12 hours. Patients with chest trauma, 24.5% had a chest Abbreviated Injury Scale score of 3 or greater, and 73.6% sustained blunt chest trauma. Stratifying TBI patients with and without chest injury revealed higher mean levels of IL-4, IL-5, IL-8, and IL-10 and lower mean IFN-γ and IL-7 levels in patient with chest injury. IL-7 levels adjusted for chest injury predicted neurological worsening with area under the receiver operating characteristic of 0.59 (p value = 0.011). The TBI and chest trauma patients' IL-4 and neuron-specific enolase levels were predictive of mortality (area under the receiver operating characteristic of 0.67 and 0.63, p = 0.0001, 0.003), respectively.

Conclusion: Utilizing biomarkers for early identification of patients with TBI and chest trauma has the capability of modifying adverse factors affecting morbidity and mortality in this subset of TBI patients.

Level Of Evidence: Level III.
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http://dx.doi.org/10.1097/TA.0000000000002256DOI Listing
July 2019
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