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Reduced CT iodine perfusion score is associated with adverse clinical outcomes in acute pulmonary embolism [Letter]

Yuriditsky, Eugene; Mitchell, Oscar J L; Moore, William H; Sista, Akhilesh K; Brosnahan, Shari B; Cruz, Rogelio; Amoroso, Nancy E; Goldenberg, Ronald M; Smith, Deane E; Jamin, Catherine; Maldonado, Thomas S; Horowitz, James M
PMID: 36567600
ISSN: 1477-0377
CID: 5409492

Prospective Multicenter Trial of Pharmacomechanical-Catheter-Directed Thrombolysis with the Bashir Endovascular Catheter for Acute Pulmonary Embolism

Bashir, Riyaz; Foster, Malcolm; Iskander, Ayman; Darki, Amir; Jaber, Wissam; Rali, Parth M; Lakhter, Vladimir; Gandhi, Ripal; Klein, Andrew; Bhatheja, Rohit; Ross, Charles; Natarajan, Kannan; Nanjundappa, Aravinda; Angle, John F; Ouriel, Kenneth; Amoroso, Nancy E; Firth, Brian G; Comerota, Anthony J; Piazza, Gregory; Rosenfield, Kenneth; Sista, Akhilesh K
OBJECTIVES/OBJECTIVE:This study sought to evaluate the efficacy and safety of tissue-plasminogen activator (t-PA) infused via a Pharmacomechanical catheter-directed thrombolysis (PM-CDT) device called the Bashir Catheter in intermediate-risk acute pulmonary embolism (PE) patients. BACKGROUND:Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels like the pulmonary artery (PA) with lower doses of t-PA. METHODS:Patients with symptoms of acute PE with CT evidence of RV dilatation were enrolled. The Bashir Catheter was used to deliver 7 mgs of t-PA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory assessed change in CTA-derived right ventricular/left ventricular (RV/LV) diameter ratio at 48 hours and the primary safety endpoint was serious adverse events including major bleeding at 72 hours. RESULTS:At 18 US sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT the RV/LV ratio decreased by 0.56 (33.3%: p<0.0001). The PA obstruction as measured by the Refined Modified Miller Index (RMMI) was reduced by 35.9% (p <0.0001). One patient (0.92%) had two serious adverse events (SAE) which included a retroperitoneal bleed (procedure-related) and iliac vein thrombosis (device-related). Two other procedure-related SAEs included epistaxis, and non-access site hematoma with anemia. CONCLUSIONS:PM-CDT with the Bashir endovascular catheter is associated with significant reduction in RV/LV ratio and a very low rate of adverse events or major bleeding in intermediate-risk acute PE patients. The notable finding was a significant reduction in PA obstruction with low dose t-PA. (Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the redUction of thrombus burdEn - The RESCUE Study IDE # G200009 NCT - 04248868).
PMID: 36121244
ISSN: 1876-7605
CID: 5335282

Impact of pulmonary embolism response teams on acute pulmonary embolism: a systematic review and meta-analysis

Fleitas Sosa, Derlis; Lehr, Andrew L; Zhao, Huaqing; Roth, Stephanie; Lakhther, Vlad; Bashir, Riyaz; Cohen, Gary; Panaro, Joseph; Maldonado, Thomas S; Horowitz, James; Amoroso, Nancy E; Criner, Gerard J; Brosnahan, Shari B; Rali, Parth
BACKGROUND:The impact of pulmonary embolism response teams (PERTs) on treatment choice and outcomes of patients with acute pulmonary embolism (PE) is still uncertain. OBJECTIVE:To determine the effect of PERTs in the management and outcomes of patients with PE. METHODS:PubMed, Embase, Web of Science, CINAHL, WorldWideScience and MedRxiv were searched for original articles reporting PERT patient outcomes from 2009. Data were analysed using a random effects model. RESULTS:16 studies comprising 3827 PERT patients and 3967 controls met inclusion criteria. The PERT group had more patients with intermediate and high-risk PE (66.2%) compared to the control group (48.5%). Meta-analysis demonstrated an increased risk of catheter-directed interventions, systemic thrombolysis and surgical embolectomy (odds ratio (OR) 2.10, 95% confidence interval (CI) 1.74-2.53; p<0.01), similar bleeding complications (OR 1.10, 95% CI 0.88-1.37) and decreased utilisation of inferior vena cava (IVC) filters (OR 0.71, 95% CI 0.58-0.88; p<0.01) in the PERT group. Furthermore, there was a nonsignificant trend towards decreased mortality (OR 0.87, 95% CI 0.71-1.07; p=0.19) with PERTs. CONCLUSIONS:The PERT group showed an increased use of advanced therapies and a decreased utilisation of IVC filters. This was not associated with increased bleeding. Despite comprising more severe PE patients, there was a trend towards lower mortality in the PERT group.
PMID: 35831010
ISSN: 1600-0617
CID: 5269262

The Use of High-Dose Corticosteroids Versus Low-Dose Corticosteroids With and Without Tocilizumab in COVID-19 Acute Respiratory Distress Syndrome

Katz, Alyson; Altshuler, Diana; Papadopoulos, John; Amoroso, Nancy; Goldenberg, Ronald; Tarras, Elizabeth; Krolikowski, Kelsey; Hagedorn, Jacklyn; Fridman, David; Chen, Xian Jie Cindy; Iturrate, Eduardo; Brosnahan, Shari B
BACKGROUND/UNASSIGNED:Corticosteroids and tocilizumab have been shown to improve survival in patients who require supplemental oxygen from coronavirus disease 2019 (COVID-19) pneumonia. The optimal dose of immunosuppression for the treatment of COVID-19 acute respiratory distress syndrome (ARDS) is still unknown. OBJECTIVE/UNASSIGNED:The objective of this study was to evaluate the effectiveness and safety of high- versus low-dose corticosteroids with or without tocilizumab for the treatment of COVID-19 ARDS. METHODS/UNASSIGNED:This was a retrospective study of patients admitted to the intensive care unit (ICU) requiring mechanical ventilation who received high- versus low-dose corticosteroids with or without tocilizumab. The primary outcome was survival to discharge. Safety outcomes included infections and incidence of hyperglycemia. RESULTS/UNASSIGNED:= 0.01). The highest rate of a bacterial pneumonia was in patients who received high-dose corticosteroids with tocilizumab. CONCLUSIONS/UNASSIGNED:In critically ill patients with COVID-19 ARDS requiring mechanical ventilation, we found no difference in high- versus low-dose corticosteroids with regard to survival to hospital discharge. However, patients receiving only low-dose corticosteroids without tocilizumab did worse than the other groups. Larger prospective studies are needed to determine the optimal immunosuppression dosing strategy in this patient population.
PMID: 35590468
ISSN: 1542-6270
CID: 5247692

Inhaled pulmonary vasodilators are not associated with improved gas exchange in mechanically ventilated patients with COVID-19: A retrospective cohort study

Lubinsky, Anthony Steven; Brosnahan, Shari B; Lehr, Andrew; Elnadoury, Ola; Hagedorn, Jacklyn; Garimella, Bhaskara; Bender, Michael T; Amoroso, Nancy; Artigas, Antonio; Bos, Lieuwe D J; Kaufman, David
PURPOSE/OBJECTIVE:Measure the effect of inhaled pulmonary vasodilators on gas exchange in mechanically ventilated patients with COVID-19. METHODS:ratio, oxygenation Index (OI), and ventilatory ratio (VR) after initiation of inhaled pulmonary vasodilators. RESULTS:, OI and VR did not significantly change over a five day period starting the day prior to drug initiation in patients who received either iNO or iEPO assessed with a fixed effects model. CONCLUSION/CONCLUSIONS:Inhaled pulmonary vasodilators were not associated with significant improvement in gas exchange in mechanically ventilated patients with COVID-19.
PMCID:8847100
PMID: 35180636
ISSN: 1557-8615
CID: 5163672

Microbial signatures in the lower airways of mechanically ventilated COVID-19 patients associated with poor clinical outcome

Sulaiman, Imran; Chung, Matthew; Angel, Luis; Tsay, Jun-Chieh J; Wu, Benjamin G; Yeung, Stephen T; Krolikowski, Kelsey; Li, Yonghua; Duerr, Ralf; Schluger, Rosemary; Thannickal, Sara A; Koide, Akiko; Rafeq, Samaan; Barnett, Clea; Postelnicu, Radu; Wang, Chang; Banakis, Stephanie; Pérez-Pérez, Lizzette; Shen, Guomiao; Jour, George; Meyn, Peter; Carpenito, Joseph; Liu, Xiuxiu; Ji, Kun; Collazo, Destiny; Labarbiera, Anthony; Amoroso, Nancy; Brosnahan, Shari; Mukherjee, Vikramjit; Kaufman, David; Bakker, Jan; Lubinsky, Anthony; Pradhan, Deepak; Sterman, Daniel H; Weiden, Michael; Heguy, Adriana; Evans, Laura; Uyeki, Timothy M; Clemente, Jose C; de Wit, Emmie; Schmidt, Ann Marie; Shopsin, Bo; Desvignes, Ludovic; Wang, Chan; Li, Huilin; Zhang, Bin; Forst, Christian V; Koide, Shohei; Stapleford, Kenneth A; Khanna, Kamal M; Ghedin, Elodie; Segal, Leopoldo N
Respiratory failure is associated with increased mortality in COVID-19 patients. There are no validated lower airway biomarkers to predict clinical outcome. We investigated whether bacterial respiratory infections were associated with poor clinical outcome of COVID-19 in a prospective, observational cohort of 589 critically ill adults, all of whom required mechanical ventilation. For a subset of 142 patients who underwent bronchoscopy, we quantified SARS-CoV-2 viral load, analysed the lower respiratory tract microbiome using metagenomics and metatranscriptomics and profiled the host immune response. Acquisition of a hospital-acquired respiratory pathogen was not associated with fatal outcome. Poor clinical outcome was associated with lower airway enrichment with an oral commensal (Mycoplasma salivarium). Increased SARS-CoV-2 abundance, low anti-SARS-CoV-2 antibody response and a distinct host transcriptome profile of the lower airways were most predictive of mortality. Our data provide evidence that secondary respiratory infections do not drive mortality in COVID-19 and clinical management strategies should prioritize reducing viral replication and maximizing host responses to SARS-CoV-2.
PMID: 34465900
ISSN: 2058-5276
CID: 4998422

Percutaneous Dilational Tracheostomy for Coronavirus Disease 2019 Patients Requiring Mechanical Ventilation

Angel, Luis F; Amoroso, Nancy E; Rafeq, Samaan; Mitzman, Brian; Goldenberg, Ronald; Shekar, Saketh Palasamudram; Troxel, Andrea B; Zhang, Yan; Chang, Stephanie H; Kwak, Paul; Amin, Milan R; Sureau, Kimberly; Nafday, Heidi B; Thomas, Sarun; Kon, Zachary; Sommer, Philip M; Segal, Leopoldo N; Moore, William H; Cerfolio, Robert
OBJECTIVES/OBJECTIVE:To assess the impact of percutaneous dilational tracheostomy in coronavirus disease 2019 patients requiring mechanical ventilation and the risk for healthcare providers. DESIGN/METHODS:Prospective cohort study; patients were enrolled between March 11, and April 29, 2020. The date of final follow-up was July 30, 2020. We used a propensity score matching approach to compare outcomes. Study outcomes were formulated before data collection and analysis. SETTING/METHODS:Critical care units at two large metropolitan hospitals in New York City. PATIENTS/METHODS:Five-hundred forty-one patients with confirmed severe coronavirus disease 2019 respiratory failure requiring mechanical ventilation. INTERVENTIONS/METHODS:Bedside percutaneous dilational tracheostomy with modified visualization and ventilation. MEASUREMENTS AND MAIN RESULTS/RESULTS:Required time for discontinuation off mechanical ventilation, total length of hospitalization, and overall patient survival. Of the 541 patients, 394 patients were eligible for a tracheostomy. One-hundred sixteen were early percutaneous dilational tracheostomies with median time of 9 days after initiation of mechanical ventilation (interquartile range, 7-12 d), whereas 89 were late percutaneous dilational tracheostomies with a median time of 19 days after initiation of mechanical ventilation (interquartile range, 16-24 d). Compared with patients with no tracheostomy, patients with an early percutaneous dilational tracheostomy had a higher probability of discontinuation from mechanical ventilation (absolute difference, 30%; p < 0.001; hazard ratio for successful discontinuation, 2.8; 95% CI, 1.34-5.84; p = 0.006) and a lower mortality (absolute difference, 34%, p < 0.001; hazard ratio for death, 0.11; 95% CI, 0.06-0.22; p < 0.001). Compared with patients with late percutaneous dilational tracheostomy, patients with early percutaneous dilational tracheostomy had higher discontinuation rates from mechanical ventilation (absolute difference 7%; p < 0.35; hazard ratio for successful discontinuation, 1.53; 95% CI, 1.01-2.3; p = 0.04) and had a shorter median duration of mechanical ventilation in survivors (absolute difference, -15 d; p < 0.001). None of the healthcare providers who performed all the percutaneous dilational tracheostomies procedures had clinical symptoms or any positive laboratory test for severe acute respiratory syndrome coronavirus 2 infection. CONCLUSIONS:In coronavirus disease 2019 patients on mechanical ventilation, an early modified percutaneous dilational tracheostomy was safe for patients and healthcare providers and associated with improved clinical outcomes.
PMID: 33826583
ISSN: 1530-0293
CID: 4839312

Thrombosis at Hospital Presentation in Patients with and without COVID-19

Brosnahan, Shari B; Smilowitz, Nathaniel R; Amoroso, Nancy E; Barfield, Michael; Berger, Jeffery S; Goldenberg, Ronald; Ishida, Koto; Talmor, Nina; Torres, Jose; Yaghi, Shadi; Yuriditsky, Eugene; Maldonado, Thomas
OBJECTIVE:To better characterize COVID-19 patients most at risk for severe, outpatient thrombosis by defining patients hospitalized with COVID-19 with an arterial or venous thrombosis diagnosed at admission METHODS AND RESULTS: We conducted a single center retrospective analysis of COVID-19 patients. There was a shift in the proportions of thrombosis subtypes from 2019 to 2020, with declines in STEMI (from 22.0% to 10.1% of thrombotic events) and stroke (from 48.6% to 37.2%), and an increase in the proportion of patients with VTE (29.4% to 52.7%). COVID-associated thrombosis were younger (58 years vs. 64 years, p=0.043), trended to be less frequently female (31.3% vs. 43.9%, p =0.16), but there was no difference body mass index or major comorbidities between those with and without COVID-19. COVID-19-associted thrombosis was correlated with a higher mortality (15.2% vs. 4.3%, p=0.016). The biometric profile of patients admitted with COVID-associated thrombosis compared to regular thrombosis had significant changes in the complete blood count, liver function tests, d-dimer, c-related protein, ferritin, and coagulation panels. CONCLUSIONS:Outpatients with COVID-19 who developed thrombosis requiring hospitalization have an increased mortality over non-COVID-19 outpatients who develop thrombosis requiring hospitalization. Given the significantly higher inflammatory markers, it is possible this is related to different mechanisms of thrombotic disease in these patients. The inflammation may be a target to reduce the risk of or aid in the treatment of thrombosis. We call for more studies elucidating the role immunothrombosis maybe playing in COVID.
PMCID:7655032
PMID: 33186750
ISSN: 2213-3348
CID: 4672082

Prevalence and symptomatology of post COVID syndrome in patients who required hospitalization during acute illness [Meeting Abstract]

Nayar, C; Bhatt, A; Hagedorn, J; Amoroso, N E; Condos, R; Hasan, E; Brosnahan, S
Background The long-term effects of SARS-CoV-2 are just now coming to light. These remaining symptoms are sometimes referred to as "Post-COVID syndrome." The types and incidence of prolonged symptoms from the acute viral illness are unknown. Yet understanding the prevalence and which symptoms persist would help normalize post COVID syndrome and help providers recognize these issues in their COVID survivors. Methods We conducted a single-center retrospective analysis with patients discharged from New York University (NYU) Langone Hospital with primary diagnosis of COVID-19. Each patient was then called and given a phone survey 45-60 days post discharge. In the survey they were consented and asked about residual symptoms. Study data were collected and managed using REDCap electronic data capture tools hosted at NYU hospital. Patient surveys were then merged with their medical record from their COVID hospitalization. All statistical analysis was processed in SPSS. The study was approved through our institutional IRB. Results Overall, 101 patients were surveyed post discharge. The median age was 59, with the most common co-morbidities being DM (N = 20) and HTN (N = 45). Most patients (N= 57) reported residual lethargy and malaise as compared to prior. Thirty-eight patients continued to have limited exercise tolerance. Thirty- eight patients experienced shortness of breath more than prior to getting COVID, while 24 patients continued to have shortness of breath while walking within their house. Some experienced chest pain with breathing (N=5), dry cough (N=14) and productive cough (N=5) that was not present prior to COVID infection. Conclusion We found that COVID patients continued to have symptoms 2 months post discharge. More than half of patients reached reported continued lethargy post discharge. Other symptoms were quite common, with 1/4-1/3 having continued shortness of breath and decreased exercise tolerance. The full pathophysiology between continued symptoms and post COVID syndrome is not yet known; however, clinicians need to understand the prevalence to treat patients accordingly. Physicians should help to normalize these symptoms to patients. Treatment should include supportive care such as rehab and physical therapy with consideration of referral to post COVID centers
EMBASE:635308980
ISSN: 1535-4970
CID: 4915532

Microbial signatures in the lower airways of mechanically ventilated COVID19 patients associated with poor clinical outcome

Sulaiman, Imran; Chung, Matthew; Angel, Luis; Koralov, Sergei; Wu, Benjamin; Yeung, Stephen; Krolikowski, Kelsey; Li, Yonghua; Duerr, Ralf; Schluger, Rosemary; Thannickal, Sara; Koide, Akiko; Rafeq, Samaan; Barnett, Clea; Postelnicu, Radu; Wang, Chang; Banakis, Stephanie; Perez-Perez, Lizzette; Jour, George; Shen, Guomiao; Meyn, Peter; Carpenito, Joseph; Liu, Xiuxiu; Ji, Kun; Collazo, Destiny; Labarbiera, Anthony; Amoroso, Nancy; Brosnahan, Shari; Mukherjee, Vikramjit; Kaufman, David; Bakker, Jan; Lubinsky, Anthony; Pradhan, Deepak; Sterman, Daniel; Heguy, Adriana; Uyeki, Timothy; Clemente, Jose; de Wit, Emmie; Schmidt, Ann Marie; Shopsin, Bo; Desvignes, Ludovic; Wang, Chan; Li, Huilin; Zhang, Bin; Forst, Christian; Koide, Shohei; Stapleford, Kenneth; Khanna, Kamal; Ghedin, Elodie; Weiden, Michael; Segal, Leopoldo
Mortality among patients with COVID-19 and respiratory failure is high and there are no known lower airway biomarkers that predict clinical outcome. We investigated whether bacterial respiratory infections and viral load were associated with poor clinical outcome and host immune tone. We obtained bacterial and fungal culture data from 589 critically ill subjects with COVID-19 requiring mechanical ventilation. On a subset of the subjects that underwent bronchoscopy, we also quantified SARS-CoV-2 viral load, analyzed the microbiome of the lower airways by metagenome and metatranscriptome analyses and profiled the host immune response. We found that isolation of a hospital-acquired respiratory pathogen was not associated with fatal outcome. However, poor clinical outcome was associated with enrichment of the lower airway microbiota with an oral commensal ( Mycoplasma salivarium ), while high SARS-CoV-2 viral burden, poor anti-SARS-CoV-2 antibody response, together with a unique host transcriptome profile of the lower airways were most predictive of mortality. Collectively, these data support the hypothesis that 1) the extent of viral infectivity drives mortality in severe COVID-19, and therefore 2) clinical management strategies targeting viral replication and host responses to SARS-CoV-2 should be prioritized.
PMCID:8010736
PMID: 33791687
ISSN: n/a
CID: 4830952