Efficacy and safety of phospholipid nanoparticles (VBI-S) in reversing intractable hypotension in patients with septic shock: a multicentre, open-label, repeated measures, phase 2a clinical pilot trial.

Background: Since the 1990's attempts to favorably modulate nitric oxide (NO) have been unsuccessful. We hypothesized that because NO is lipophilic it would preferentially localize into intravascularly infused hydrophobic nanoparticles, thereby reducing its bioavailability and adverse effects without inhibiting its production. We aimed to determine the efficacy and safety of intravenous infusion of a fluid comprised of hydrophobic phospholipid nanoparticles (VBI-S) that reversibly absorb NO in the treatment of hypotension of patients in severe septic shock. Methods: This is a multicentre, open-label, repeated measures, phase 2a clinical pilot trial done at six hospital centers in the USA. Patients in severe septic shock were enrolled after intravenous fluid therapy had failed to raise mean arterial blood pressure (MAP) to at least the generally accepted level of 65 mmHg, requiring the use of vasopressors. The primary endpoint of this study is the proportion of patients in whom MAP increased by at least 10 mmHg. VBI-S was administered intravenously to patients as boluses of 100 ml, 200 ml, 400 ml, and 800 ml at 999 ml/min until the blood pressure goal was reached after which the infusion was stopped, and the MAP was recorded. All patients who received any volume of VBI-S were included in the primary and safety analysis. The study is registered with ClinicalTrials.gov, NCT04257136. Findings: Between February 17, 2020 and January 3, 2023, 20 eligible patients were enrolled in the study. In all 20 (100%) patients, the goal of increasing MAP by at least 10 mmHg using VBI-S was achieved (p = 0.0087, effect size = 0.654). Mean VBI-S volume required to meet the primary goal was 561.0 ± 372.3 ml. The goal of lowering vasopressor dose was also achieved (p = 0.0017). Within 48 h or less after VBI-S, there was a statistically significant improvement in oxygenation, serum creatinine, clotting variables, procalcitonin, lactic acid, and the sequential organ failure assessment (SOFA) score. At 24 h and 48 h following administration of VBI-S, 12/15 (80%) and 9/12 (75%) patients developed hyperlipidemia, respectively. No severe adverse events of VBI-S were observed, and there were no treatment-related deaths. Interpretation: These preliminary findings suggest the safety and efficacy of VBI-S in treating hypotension in patients with septic shock. However, a definitive mortality benefit cannot be demonstrated without a randomized controlled study. Funding: The Naval Medical Research Command-Naval Advanced Medical Development program via the Medical Technology Enterprise Consortium.

Endobronchial ultrasound (EBUS)-guided transbronchial miniforceps biopsy an urban center experience.

Background: The role of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in staging mediastinal and hilar lymph nodes in non-small cell lung cancer (NSCLC) is well established. However, evidence of its diagnostic utility in other pathologies-such as lymphoma-remains inadequate. This retrospective observational study aims to determine the diagnostic yield of EBUS-guided miniforceps biopsy (EBUS-MFB) compared to EBUS-TBNA in both malignant and nonmalignant conditions. Methods: We conducted a retrospective cross-sectional chart review of all adult patients referred for EBUS at our institution between January 2019 and December 2022. All patients who underwent both EBUS-TBNA and EBUS-MFB were included, with some patients also undergoing transbronchial cryobiopsy. Patients without pathology reports available were excluded. Results: The combination of EBUS-MFB and EBUS-TBNA had the highest percentage of diagnostic results both in the overall cohort (34.4%) and in patients who did not undergo transbronchial cryobiopsy (46.2%). EBUS-MFB alone yielded more diagnostic results compared to EBUS-TBNA. Transbronchial cryobiopsy was the sampling method with the highest percentage of diagnostic results in the cryobiopsy group (64.5%). Statistical analysis revealed a significant difference in diagnostic yield between EBUS-MFB and EBUS-TBNA (P<0.001), with EBUS-MFB showing a higher diagnostic yield overall. EBUS-MFB had a significantly higher diagnostic yield than EBUS-TBNA in benign cases, in patients diagnosed with sarcoidosis, but not in malignant disease. Conclusions: Our study suggests that combining EBUS-MFB with EBUS-TBNA can improve the diagnostic yield, particularly in benign cases and sarcoidosis. These findings support the potential superiority of adding EBUS-MFB over EBUS-TBNA alone and highlight the need for further randomized control trials to validate these results. The retrospective nature of this study and certain limitations, such as the lack of adequate longer-term follow-up, selection and operator biases, and the absence of rapid on-site evaluation (ROSE) in some cases, should be considered when interpreting the results. Nonetheless, this study contributes to the growing evidence for the utility of EBUS-MFB in improving the diagnostic yield of EBUS procedures in specific clinical scenarios.

Role of Bronchoscopy in Diagnosis of Sarcoidosis.

Sarcoidosis is a multisystem inflammatory disorder with unclear etiology and can often pose a diagnostic challenge. A tissue diagnosis is often necessary to illustrate the non-caseating granulomas on histopathology. This review aims to synthesize current evidence related to tissue diagnosis of sarcoidosis using various bronchoscopic techniques. We start by discussing standard bronchoscopic techniques which have remained the cornerstone of diagnostic workup such as bronchoalveolar lavage (BAL), endobronchial biopsy (EBB), conventional transbronchial needle aspiration (cTBNA) and transbronchial lung biopsy (TBLB) followed by newer modalities that incorporate real-time image guidance using endobronchial and endoscopic ultrasound. Although BAL, EBB, and TBLB have been employed as a diagnostic tool for several decades, their sensitivity and diagnostic yield is inferior to ultrasound-based endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). More recently, convincing evidence has also emerged to support the diagnostic accuracy and tissue yield of transbronchial lung cryobiopsy which will also be discussed in this review. These advances in bronchoscopic equipment and techniques over the last 2 decades have made it possible to obtain tissue samples using minimally invasive techniques thus avoiding invasive open lung biopsy and the risks that inherently follow. Up-to-date knowledge of these modalities is imperative for ensuring evidence-based medicine and improving patient-centric outcomes.

Clinical predictors and outcomes of pulmonary infarction in patients with central pulmonary embolism.

BACKGROUND: Given the heterogeneity of predisposing factors associated with pulmonary infarction (PI) and the lack of clinically relevant outcomes among patients with acute pulmonary embolism (PE) complicated by PI, further investigation is required. METHODS: Retrospective study of patients with central PE in an 11-year period. Data were stratified according to the diagnosis of PI. Multivariable logistic regression analysis was used to analyze factors associated with PI development and determine if PI was associated with severe hypoxemic respiratory failure and mechanical ventilation use. RESULTS: Of 645 patients with central PE, 24% (n = 156) had PI. After adjusting for demographics, comorbidities, and clinical features on admission, only age (OR 0.98, CI 0.96-0.99; p = 0.008) was independently associated with PI. Regarding outcomes, 35% (n = 55) had severe hypoxemic respiratory failure, and 19% (n = 29) required mechanical ventilation. After adjusting for demographics, PE severity, and right ventricular dysfunction, PI was independently associated with severe hypoxemic respiratory failure (OR 1.78; CI 1.18-2.69, p = 0.005) and mechanical ventilation (OR 1.92; CI 1.14-3.22, p = 0.013). CONCLUSIONS: Aging is a protective factor against PI. In acute central PE, subjects with PI had higher odds of developing severe hypoxemic respiratory failure and requiring mechanical ventilation.

Impact of an integrated classifier using biomarkers, clinical and imaging factors on clinical decisions making for lung nodules.

Background: An integrated classifier that utilizes plasma proteomic biomarker along with five clinical and imaging factors was previously shown to be potentially useful in lung nodule evaluation. This study evaluated the impact of the integrated proteomic classifier on management decisions in patients with a pretest probability of cancer (pCA) ≤50% in "real-world" clinical setting. Methods: Retrospective study examining patients with lung nodules who were evaluated using the integrated classifier as compared to standard clinical care during the same period, with at least 1-year follow-up. Results: A total of 995 patients were evaluated for lung nodules over 1 year following the implementation of the integrated classifier with 17.3% prevalence of lung cancer. 231 patients met the study eligibility criteria; 102 (44.2%) were tested with the integrated classifier, while 129 (55.8%) did not. The median number of chest imaging studies was 2 [interquartile range (IQR), 1-2] in the integrated classifier arm and 2 [IQR, 1-3] in the non-integrated classifier arm (P=0.09). The median outpatient clinic visit was 2.00 (IQR, 1.00-3.00) in the integrated classifier arm and 2.00 (IQR, 2.00-3.00) in the non-integrated classifier (P=0.004). Fewer invasive procedures were pursued in the integrated classifier arm as compared to non-integrated classifier respectively (26.5% vs. 79.1%, P<0.001). All patients in the integrated classifier arm with post-pCA (likely benign n=39) had designated benign diagnosis at 1-year follow-up. Conclusions: In patients with lung nodules with a pCA ≤50%, use of the integrated classifier was associated with fewer invasive procedures and clinic visits without misclassifying patients with likely benign lung nodules results at 1-year follow-up.

Clinical features and risk factors of adverse clinical outcomes in central pulmonary embolism using machine learning analysis.

BACKGROUND: In prior studies, central pulmonary embolism (PE) was associated with high clot burden and was considered an independent predictor for thrombolysis. Further information about predictors of adverse outcomes in these patients is needed for better risk stratification. The objective is to describe independent predictors of adverse clinical outcomes in patients with central PE. METHODS: Large retrospective, observational, and single-center study of hospitalized patients with central PE. Data were gathered on demographics, comorbidities, clinical features on admission, imaging, treatments, and outcomes. Multivariable standard and Least Absolute Shrinkage and Selection Operator (LASSO) machine learning logistic regressions and sensitivity analyses were used to analyze factors associated with a composite of adverse clinical outcomes, including vasopressor use, mechanical ventilation, and inpatient mortality. RESULTS: A total of 654 patients had central PE. The mean age was 63.1 years, 59% were women, and 82% were African American. The composite adverse outcome was observed in 18% (n = 115) of patients. Serum creatinine elevation (odds ratio [OR] = 1.37, 95% CI = 1.20-1.57; p = 0.0001), white blood cell (WBC) count elevation (OR = 1.10, 95% CI = 1.05-1.15; p < 0.001), higher simplified pulmonary embolism severity index (sPESI) score (OR = 1.47, 95% CI = 1.18-1.84; p = 0.001), serum troponin elevation (OR = 1.26, 95% CI 1.02-1.56; p = 0.03), and respiratory rate increase (OR = 1.03, 95% CI = 1.0-1.05; p = 0.02) were independent predictors of adverse clinical outcomes. CONCLUSION: Among patients with central PE, higher sPESI score, WBC count elevation, serum creatinine elevation, serum troponin elevation, and respiratory rate increase were independent predictors of adverse clinical outcomes. Right ventricular dysfunction on imaging and saddle PE location did not predict adverse outcomes.

Clinical characteristics and treatment of patients with central pulmonary embolism and right heart thrombus.

INTRODUCTION: Right heart thrombus (RHT), also known as clot in transit, is an uncommon finding in pulmonary embolism (PE) that is associated with increased inpatient mortality. To date, there is no consensus on the management of RHT. Therefore, we aim to describe the clinical features, treatments, and outcomes of patients with simultaneous RHT and PE. METHODS: This is a retrospective, cross-sectional, and single-center study of hospitalized patients with central PE who had RHT visualized on transthoracic echocardiography (TTE) from January 2012 to May 2022. We use descriptive statistics to describe their clinical features, treatments, and outcomes, including mechanical ventilation, major bleeding, inpatient mortality, length of hospital stay, and recurrent PE on follow-up. RESULTS: Of 433 patients with central PE who underwent TTE, nine patients (2%) had RHT. The median age was 63 years (range 29-87), most were African American (6/9), and females (5/9). All patients had evidence of RV dysfunction and received therapeutic anticoagulation. Eight patients received RHT-directed interventions, including systemic thrombolysis (2/9), catheter-directed suction embolectomy (4/9), and surgical embolectomy (2/9). Regarding outcomes, 4/9 patients were hemodynamically unstable, 8/9 were hypoxemic, and 2/9 were mechanically ventilated. The median length of hospital stay was six days (range 1-16). One patient died during hospital admission, and two patients had recurrent PE. CONCLUSION: We described the different therapeutic approaches and outcomes of patients with RHT treated in our institution. Our study adds valuable information to the literature, as there is no consensus on the treatment of RHT. HIGHLIGHTS: Right heart thrombus (RHT) was a rare finding in central pulmonary embolism. Most patients with RHT had evidence of RV dysfunction and pulmonary hypertension. Most patients received RHT-directed therapies in addition to therapeutic anticoagulation.

Bronchial thermoplasty for the treatment of severe persistent asthma.

PURPOSE OF REVIEW: Severe asthma is associated with frequent hospital visits and impact in quality of life as well as healthcare associated costs. Limited treatment modalities exist to assist in reduction of frequent exacerbations in patients with severe asthma who are already on maximum inhaler therapy. As supporting data becomes more robust, novel treatments have gained attention such as bronchial thermoplasty and immune-directed therapies. RECENT FINDINGS: Based on review of recent studies, bronchial thermoplasty poses itself as a potential intervention for severe asthma, demonstrating a decrease in asthma exacerbations with long term clinical effect and safety profile at the expense of temporary uncontrolled asthma symptoms for the first six weeks following the procedure. SUMMARY: In select patients with severe asthma, bronchial thermoplasty is a well tolerated and effective treatment to reduce asthma exacerbation.

Management of complicated parapneumonic effusions.

PURPOSE OF REVIEW: Approximately 36-57% of cases of pneumonia are associated with a parapneumonic effusion (PPE). It begins as sterile effusion, which can quickly evolve to a fibrinopurulent stage with evidence of infection called complicated parapneumonic effusions (CPPE). Marked fibrinous organization then follows. This study focuses on literature synthesis on management of CPPE. RECENT FINDINGS: Ultrasound has become an indispensable tool in the identification and treatment of CPPE. Prompt antibiotic administration remains the universal standard of care. Decision to drain the fluid is based on fluid staging, characterization and assessment of risk of poor outcomes vs. risk of complications. There is growing evidence to support use of intrapleural fibrinolytic therapy (IPFT) in case of loculated effusions. Newer areas of research include antibodies against plasminogen activator inhibitors and stratification scores that can identify patients at an increased risk. Lastly, timing of surgical referral is an important area under study. SUMMARY: Evolution of medical therapy over recent years has increased treatment success rates. Use of IPFT in conjunction to thoracostomy is now the standard of care for loculated effusions. Understanding available therapeutic options, both medical and interventional, can ensure evidence-based practice and improve patient-centred outcomes.

Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19: A Phase 2 Randomized Clinical Trial.

Importance: The morbidity and mortality associated with COVID-19 remain high despite advances in standard of care therapy, and the role of anti-inflammatory agents that inhibit the interleukin 6/JAK2 pathway is still being elucidated. Objective: To evaluate the efficacy and safety of the oral JAK2/IRAK1 inhibitor pacritinib vs placebo in the treatment of adults with severe COVID-19. Design, Setting, and Participants: This phase 2, double-blind, placebo-controlled, randomized clinical trial enrolled hospitalized adult patients with severe COVID-19 at 21 centers across the US between June 2020 and February 2021, with approximately 1.5 months of safety follow-up per patient. Data analysis was performed from September 2021 to July 2022. Interventions: Patients were randomized 1:1 to standard of care plus pacritinib (400 mg per os on day 1 followed by 200 mg twice daily on days 2-14) vs placebo, for 14 days. Main Outcomes and Measures: The primary end point was death or need for invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) by day 28. All-cause mortality and safety were also assessed. Results: A total of 200 patients were randomized to pacritinib (99 patients; 56 men [56.6%]; median [range] age, 60 [19-87] years) or placebo (101 patients; 64 men [63.4%]; median [range] age 59 [28-94] years). The percentage requiring supplementary oxygen was 99.0% (98 patients) in the pacritinib group vs 98.0% (99 patients) in the placebo group. The percentage who progressed to IMV, ECMO, or death was 17.2% (17 patients) in the pacritinib group vs 22.8% (23 patients) in the placebo group (odds ratio, 0.62; 95% CI, 0.28-1.35; P = .23). Among patients with elevated interleukin 6, the rate was 17.5% (11 of 63 patients) in the pacritinib group vs 30.4% (21 of 96 patients) in the placebo group. The adverse event rate was similar for pacritinib vs placebo (78.1% [75 patients] vs 80.2% [81 patients]), with no excess in infection (14.6% [14 patients] vs 19.8% [20 patients]), bleeding (8.3% [8 patients] vs 10.9% [11 patients]), or thrombosis (8.3% [8 patients] vs 7.9% [8 patients]). Rates of grade 3 or higher adverse events were lower with pacritinib than placebo (29.2% [28 patients] vs 40.6% [41 patients]). Conclusions and Relevance: The study did not meet its primary end point in patients with severe COVID-19. Subgroup analyses may indicate specific populations with hyperinflammation that could benefit from pacritinib, although further clinical trials would be needed to confirm these effects. Trial Registration: ClinicalTrials.gov Identifier: NCT04404361.

Assessment of Tissue Adequacy by EBUS in Conjunction with PET Scan and Operator's Experience.

Mediastinal lymph node assessment is a crucial step in non-small cell lung cancer staging. Positron emission tomography (PET) has been the gold standard for the assessment of mediastinal lymphadenopathy, though it has limited specificity. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is quick, accurate, and a less invasive method for obtaining a diagnostic sample in contrast to mediastinoscopy. We performed a retrospective chart analysis of 171 patients to assess the adequacy of tissue obtained by EBUS for diagnosis and molecular profiling as well as the assessment of staging and lymph node (LN) stations diagnostic yield, in correlation to PET scan and the operator's level of experience. A significantly increased tissue adequacy was observed based on the operators' experience, with the highest adequacy noted in trained Interventional Pulmonologist (IP) (100%), followed by >5 years of experience (93.33%), and 88.89% adequacy with <5 years of experience (p = 0.0019). PET-CT scan 18F-fluorodeoxyglucose (FDG) uptake in levels 1, 2, and 3 LN had a tissue adequacy of 76.67%, 54.64%, and 35.56%, respectively (p = 0.0009). EBUS bronchoscopy method could be used to achieve an accurate diagnosis, with IP-trained operators yielding the best results. There is no correlation with PET scan positivity, indicating that both PET and EBUS are complementary methods needed for staging.

A 62-Year-Old Immunocompromised Man With Halo Sign on Chest Imaging.

CASE PRESENTATION: A 62-year-old White man with a history of orthotopic liver transplantation 16 years ago for alcoholic liver cirrhosis on chronic immunosuppression and recurrent decompensated cirrhosis of his graft liver complicated by ascites, hepatic encephalopathy, and esophageal varices presented to the hospital with altered mental status. Over the last few weeks, he had reduced frequency of bowel movements and subsequently developed altered sensorium 3 days before presentation. On arrival to the hospital, he was disoriented and had asterixis consistent with hepatic encephalopathy. He was not in respiratory distress, he was saturating well on room air, and his lungs were clear to auscultation bilaterally. Plain chest radiograph showed multiple ill-defined bilateral airspace opacities. A CT scan of the abdomen and pelvis done on admission incidentally showed bilateral pulmonary nodules with surrounding ground-glass halo in the lower lung zones. Given these findings, a dedicated CT scan of his chest was performed that showed numerous bilateral randomly distributed nodular airspace opacities, many with a central solid component and surrounding ground-glass halo. Antifungal therapy was initiated empirically. Serum aspergillus antigen and 1,3 beta D-glucan were negative. He subsequently underwent a bronchoscopy with BAL and transbronchial biopsy. BAL fluid was negative for bacterial, fungal, and acid-fast bacilli cultures. Pathology from the transbronchial biopsy showed atypical epithelioid cells in intravascular spaces.

Reclassification of risk of malignancy with Percepta Genomic Sequencing Classifier following nondiagnostic bronchoscopy.

INTRODUCTION: Bronchoscopic sampling of pulmonary lesions suspicious for lung cancer is frequently nondiagnostic. A genomic sequencing classifier utilizing bronchial brushings obtained at the time of the bronchoscopy has been shown to provide an accurate reclassification of the risk of malignancy (ROM) based on pre-procedure risk. Our objectives for this study were to determine the frequency with which the classifier up- or down-classifies risk in regular clinical practice and to model the potential clinical utility of that reclassification. METHODS: This observational study retrospectively assessed data from four clinical sites that regularly use the genomic classifier in the bronchoscopic evaluation of indeterminate lesions. Demographics and pre-bronchoscopy ROM were recorded. The frequency of up- and down-classification was calculated. Modeling based on reclassification rates and the performance characteristics of the classifier was performed to demonstrate the potential clinical utility of the result. RESULTS: 86 patients who underwent classifier testing following a nondiagnostic bronchoscopy were included. 45% of patients with high ROM prior to bronchoscopy were reclassified very high-risk. 38% of patients with intermediate ROM were up-or down-classified. 56% of patients with low ROM were reclassified to very low-risk. Overall, 42% of patients had a change in classification. 35% of the study cohort could potentially have avoided additional unnecessary procedures with subsequent guideline-adherent management. CONCLUSIONS: The classifier can guide decision-making following a nondiagnostic bronchoscopy, reclassifying risk in a significant percentage of cases. Use of the classifier should allow more patients with early-stage cancer to proceed directly to curative therapy while helping more patients with benign disease avoid further unnecessary procedures.

A Multicenter Study Assessing Interventional Pulmonary Fellow Competency in Electromagnetic Navigation Bronchoscopy.

Background: Current medical society guidelines recommend a procedural number for obtaining electromagnetic navigational bronchoscopy (ENB) competency and for institutional volume for training. Objective: To assess learning curves and estimate the number of ENB procedures for interventional pulmonology (IP) fellows to reach competency. Methods: We conducted a prospective multicenter study of IP fellows in the United States learning ENB. A tool previously validated in a similar population was used to assess IP fellows by their local faculty and two blinded independent reviewers using virtual recording of the procedure. Competency was determined by performing three consecutive procedures with a competency score on the assessment tool. Procedural time, faculty global rating scale, and periprocedural complications were also recorded. Results: A total of 184 ENB procedures were available for review with assessment of 26 IP fellows at 16 medical centers. There was a high correlation between the two blinded independent observers (rho = 0.8776). There was substantial agreement for determination of procedural competency between the faculty assessment and blinded reviewers (kappa = 0.7074; confidence interval, 0.5667-0.8482). The number of procedures for reaching competency for ENB bronchoscopy was determined (median, 4; mean, 5; standard deviation, 3.83). There was a wide variation in the number of procedures to reach competency, ranging from 2 to 15 procedures. There were six periprocedural complications reported, four (one pneumomediastinum, three pneumothorax) of which occurred before reaching competence and two pneumothoraces after achieving competence. Conclusion: There is a wide variation in acquiring competency for ENB among IP fellows. Virtual competency assessment has a potential role but needs further studies.

Association of Pre-Admission Statin Use With Reduced In-Hospital Mortality in COVID-19.

BACKGROUND: Coronavirus disease-19 (COVID-19) infection is associated with an uncontrolled systemic inflammatory response. Statins, given their anti-inflammatory properties, may reduce the associated morbidity and mortality. This study aimed to determine the association between statin use prior to hospitalization and in-hospital mortality in COVID-19 patients. METHODS: In this retrospective study, clinical data were collected from the electronic medical records of patients admitted to the hospital with confirmed COVID-19 infection from March 1, 2020 to April 24, 2020. A multivariate regression analysis was performed to study the association of pre-admission statin use with in-hospital mortality. RESULTS: Of 255 patients, 116 (45.5%) patients were on statins prior to admission and 139 (54.5%) were not. The statin group had a higher proportion of end stage renal disease (ESRD) (13.8% vs. 2.9%, p = 0.001), diabetes mellitus (63.8% vs. 35.2%, p<0.001), hypertension (87.9% vs. 61.1%, p < 0.001) and coronary artery disease (CAD) (33.6% vs. 5%, p < 0.001). On multivariate analysis, we found a statistically significant decrease in the odds of in-hospital mortality in patients on statins before admission (OR 0.14, 95% CI 0.03- 0.61, p = 0.008). In the subgroup analysis, statins were associated with a decrease in mortality in those with CAD (OR 0.02, 95% CI 0.0003-0.92 p = 0.045) and those without CAD (OR 0.05, 95% CI 0.005-0.43, p = 0.007). CONCLUSIONS: Our study suggests that statins are associated with reduced in-hospital mortality among patients with COVID-19, regardless of CAD status. More comprehensive epidemiological and molecular studies are needed to establish the role of statins in COVID-19.

The use of transbronchial cryobiopsy for diffuse parenchymal lung disease in critically ill patients with acute hypoxemic respiratory failure-A case series.

OBJECTIVES: Accurate diagnosis and management of undifferentiated diffuse parenchymal lung disease (DPLD) in critically ill patients is challenging. Transbronchial forceps biopsies have limited utility and surgical lung biopsies can be detrimental for critically ill patients. Transbronchial cryobiopsy (TBC) has shown increased diagnostic yield compared to conventional forceps biopsy in DPLD. However, TBC has not been studied in intensive care unit (ICU) patients. In this case series, we describe our experience with TBC for diagnosis of DPLD in ICU patients with acute hypoxemic respiratory failure. METHODS: This case series includes critically ill patients who underwent TBC at two different tertiary care hospitals. Procedures were performed by the same interventional pulmonologist using the two therapeutic bronchoscopes with a 2.8-mm working channel, and a 1.9- or 2.4-mm cryoprobe. RESULTS: We performed TBC in 17 patients of which 12 (70.1%) were performed at bedside in ICU without fluoroscopic guidance. Pathological diagnosis was made in 15 (88%) patients which resulted in changes in management in most of these patients. Six patients (35.3%) developed pneumothorax post-procedure with 5 (29.4%) requiring a chest tube. Moderate bleeding was noted in one (6%) patient and no severe or fatal bleeding occurred. Our 30-day ICU mortality was 47% (n = 8); however, no deaths were directly attributable to the procedure. CONCLUSIONS: TBC is a feasible technique with an acceptable complication rate and a fairly high histopathological yield in ICU patients with DPLD and acute hypoxemic respiratory failure. Appropriate diagnosis can be crucial in making management decisions for these patients.

Clinical Characteristics, Respiratory Mechanics, and Outcomes in Critically Ill Individuals With COVID-19 Infection in an Underserved Urban Population.

BACKGROUND: The COVID-19 outbreak in the United States has disproportionately affected Black individuals, but little is known about the factors that underlie this observation. Herein, we describe these associations with mortality in a largely minority underserved population. METHODS: This single-center retrospective observational study included all adult subjects with laboratory-confirmed SARS-Cov-2 treated in our ICU between March 15 and May 10, 2020. RESULTS: 128 critically ill adult subjects were included in the study (median age 68 y [interquartile range 61-76], 45% female, and 64% Black); 124 (97%) required intubation. Eighty (63%) subjects died during their in-patient stay, which did not differ by race/ethnicity. Compared with other racial/ethnic groups, Blacks had a greater proportion of women (52% vs 30%, P = .02) and subjects with hypertension (91% vs 78%, P = .035). Asthma (P = .03) was associated with lower in-patient death, primarily among Black subjects (P = .02). Among Black subjects, increased age (odds ratio 1.06 [95% CI 1.05-1.22] per year), positive fluid balance (odds ratio 1.06 [95% CI 1.01-1.11] per 100 mL), and treatment with tocilizumab (odds ratio 25.0 [95% CI 3.5-180]) were independently associated with in-patient death, while higher platelets (odds ratio 0.65 [95% CI 0.47-0.89] per 50 × 103/mL) and treatment with intermediate dose anticoagulants (odds ratio 0.08 [95% CI 0.02-0.43]) were protective. Among other race/ethnic groups, higher total bilirubin (odds ratio 1.75 [95% CI 0.94-3.25] per 0.2 mg/dL) and higher maximum lactate (odds ratio 1.43 [95% CI 0.96-2.13] per mmol/L) were marginally associated with increased death, while tocilizumab treatment was marginally protective (odds ratio 0.24 [95% CI 0.05-1.25]). During first 72 h of ventilation, those who died had less increase in [Formula: see text] (P = .046) and less reduction in PEEP (P = .01) and [Formula: see text] requirement (P = .002); these patterns did not differ by race/ethnicity. CONCLUSIONS: Black and other race/ethnicity subjects had similar mortality rates due to COVID-19 but differed in factors that were associated with increased risk of death. In both groups, subjects who died were older, had a positive fluid balance, and less improvement in [Formula: see text], PEEP, and [Formula: see text] requirement on ventilation.