Safety and Effectiveness of Intravenous Iron Therapy in Patients Supported by Durable Left Ventricular Assist Devices.

AIMS: While it is common practice to use intravenous (IV) iron in patients with left ventricular assist devices (LVADs) and iron deficiency, there is insufficient evidence regarding outcomes in this patient population. We evaluated the safety and effectiveness of IV iron therapy in patients supported by LVADs with iron deficiency. METHODS: We performed a retrospective analysis of iron deficient patients on continuous LVAD support at a large academic center between 2008 and 2019. Patients were divided into two cohorts based on IV iron sucrose treatment. The primary endpoint was hemoglobin at 12 weeks. Secondary endpoints were mean corpuscular volume (MCV) and New York Heart Association (NYHA) class at 12 weeks. Safety endpoints included hospitalization, infection, pump thrombosis, arrhythmia, and gastrointestinal bleed. Models were weighted by the inverse probability of receiving IV iron using a propensity score, and endpoints were adjusted for their corresponding baseline values. RESULTS: Among 213 patients, 70 patients received IV iron and 143 patients did not. Hemoglobin at 12 weeks was significantly greater among those treated (intergroup difference: 0.6 g/dL; 95% CI, 0.1 to 1.1; p = 0.01), while MCV was similar in both groups (intergroup difference: 0.7 µm3; 95% CI, -1.3 to 2.7; p = 0.50). NYHA class distribution at 12 weeks was significantly different (odds ratio for improvement: 2.84; 95% CI, 1.42 to 4.68; p = 0.003). The hazards of adverse events in each group were similar. CONCLUSIONS: In patients with LVADs and iron deficiency, treatment with IV iron sucrose was safe and associated with improvements in functional status and hemoglobin.

Safety of Intravenous Cangrelor Administration for Antiplatelet Bridging in Hospitalized Patients: A Retrospective Study.

OBJECTIVE: We aimed to characterize outcomes associated with cangrelor administration used in an antiplatelet bridging strategy in real-world clinical scenarios within a large academic medical system. BACKGROUND: Cangrelor has been used for antiplatelet bridging in perioperative settings or for patients unable to take oral medications. Prior studies in these settings have reported bleeding rates from 0%-40%. METHODS: Patients were retrospectively identified via chart review and included if they were over 18 years old, had coronary or peripheral arterial stents, and had received at least 1 hour of cangrelor infusion during inpatient admission. The primary endpoint was Bleeding Academic Research Consortium (BARC) 3-5 bleeding during cangrelor infusion or within 48 hours of discontinuation; secondary endpoints were bleeding events defined by Thrombolysis in Myocardial Infarction (TIMI), Global Use of Strategies to Open Occluded Arteries (GUSTO), and International Society on Thrombosis and Hemostasis (ISTH) criteria, as well as BARC 2 bleeding. RESULTS: Thirty-one patients met the inclusion criteria. Cangrelor indications were bridging to procedure in 22 patients (71.0%) and inability to take oral P2Y12 inhibitors in 9 patients (29.0%). Twenty-three patients (74.2%) were men, 11 patients (35.5%) were in cardiogenic shock, and 4 patients (12.9%) were on extracorporeal membrane oxygenation (ECMO) at the time of administration. No patients received cangrelor for routine percutaneous coronary intervention. Of the 31 patients, 13 (41.9%) had BARC 3-5 bleeding and 7 (22.6%) expired during hospitalization. All 4 patients on ECMO suffered BARC 3-5 bleeding. CONCLUSIONS: We reviewed the use of cangrelor for antiplatelet bridging in real-world clinical scenarios and observed higher rates of clinically significant bleeding than seen in other similar studies. Our study suggests careful consideration when using cangrelor in a sick patient population.

Ventricular Assist Device Driveline Infection and Development of Intracranial Hemorrhage: A Case Series.

Durable left ventricular assist devices (LVAD) are frequently complicated by driveline infection. The objective of this case series was to examine whether an association exists between driveline infection and intracranial hemorrhage. This retrospective case series included patients at a single tertiary care hospital on durable LVAD support who developed intracranial hemorrhage. Physical examination data, vital signs, and laboratory markers of sepsis including blood cultures and imaging of driveline sites were reviewed. A total of nine patients were included in the case series. At the time of hemorrhagic event, five patients had active driveline infection, and five patients were found to be bacteremic. All bacteremic patients were found to have supratherapeutic INR at the time of presentation. Although five patients experienced subarachnoid hemorrhage, only one patient was found to have a cerebral aneurysm. This case series highlights a possible association between LVAD driveline infection and intracranial hemorrhage, and the need for further research to better understand the pathophysiology driving this association.

Treatment of corticosteroid refractory immune checkpoint inhibitor myocarditis with Infliximab: a case series.

BACKGROUND: Glucocorticoid treatment remains the cornerstone of therapy for immune checkpoint inhibitor (ICI) myocarditis, but data supporting the use of additional immunotherapy for steroid refractory cases remains limited. We investigate the safety and efficacy of infliximab in patients with ICI myocarditis who are refractory to corticosteroids. Additionally, we highlight the importance of a multi-disciplinary approach in the care for these complex patients. METHODS: We retrospectively identified consecutive patients who developed ICI myocarditis at our institution between January 2017 and January 2020. Baseline characteristics, laboratory data and clinical outcomes were compared between patients who received infliximab and those who did not. RESULTS: Of a total of 11 patients who developed ICI myocarditis, 4 were treated with infliximab. Aside from age, there were no significant differences in baseline patient characteristics between the two groups including total number of ICI doses received and duration from initial ICI dose to onset of symptoms. The time to troponin normalization was 58 vs. 151.5 days (p = 0.25). The duration of prednisone taper was longer in the infliximab group (90 vs. 150 days p = 0.32). All patients survived initial hospital admission. Over a median follow-up period of 287 days, two of the 4 patients died from sepsis 2 and 3 months after initial treatment of their myocarditis; one of these patients was on a steroid taper and the other patient had just completed a steroid taper. CONCLUSIONS: Infliximab, despite its black box warning in patients with heart failure, may be a safe and effective treatment for ICI myocarditis.

Bleeding risk by intensity of anticoagulation in critically ill patients with COVID-19: A retrospective cohort study.

BACKGROUND: Studies report hypercoagulability in coronavirus disease 2019 (COVID-19), leading many institutions to escalate anticoagulation intensity for thrombosis prophylaxis. OBJECTIVE: To determine the bleeding risk with various intensities of anticoagulation in critically ill patients with COVID-19 compared with other respiratory viral illnesses (ORVI). PATIENTS/METHODS: This retrospective cohort study compared the incidence of major bleeding in patients admitted to an intensive care unit (ICU) within a single health system with COVID-19 versus ORVI. In the COVID-19 cohort, we assessed the effect of anticoagulation intensity received on ICU admission on bleeding risk. We performed a secondary analysis with anticoagulation intensity as a time-varying covariate to reflect dose changes after ICU admission. RESULTS: Four hundred and forty-three and 387 patients were included in the COVID-19 and ORVI cohorts, respectively. The hazard ratio of major bleeding for the COVID-19 cohort relative to the ORVI cohort was 1.26 (95% confidence interval [CI]: 0.86-1.86). In COVID-19 patients, an inverse-probability treatment weighted model found therapeutic-intensity anticoagulation on ICU admission had an adjusted hazard ratio of bleeding of 1.55 (95% CI: 0.88-2.73) compared with standard prophylactic-intensity anticoagulation. However, when anticoagulation was assessed as a time-varying covariate and adjusted for other risk factors for bleeding, the adjusted hazard ratio for bleeding on therapeutic-intensity anticoagulation compared with standard thromboprophylaxis was 2.59 (95% CI: 1.20-5.57). CONCLUSIONS: Critically ill patients with COVID-19 had a similar bleeding risk as ORVI patients. When accounting for changes in anticoagulation that occurred in COVID-19 patients, therapeutic-intensity anticoagulation was associated with a greater risk of major bleeding compared with standard thromboprophylaxis.

COVID-19 and cardiac arrhythmias.

BACKGROUND: Early studies suggest that coronavirus disease 2019 (COVID-19) is associated with a high incidence of cardiac arrhythmias. Severe acute respiratory syndrome coronavirus 2 infection may cause injury to cardiac myocytes and increase arrhythmia risk. OBJECTIVES: The purpose of this study was to evaluate the risk of cardiac arrest and arrhythmias including incident atrial fibrillation (AF), bradyarrhythmias, and nonsustained ventricular tachycardia (NSVT) in a large urban population hospitalized for COVID-19. We also evaluated correlations between the presence of these arrhythmias and mortality. METHODS: We reviewed the characteristics of all patients with COVID-19 admitted to our center over a 9-week period. Throughout hospitalization, we evaluated the incidence of cardiac arrests, arrhythmias, and inpatient mortality. We also used logistic regression to evaluate age, sex, race, body mass index, prevalent cardiovascular disease, diabetes, hypertension, chronic kidney disease, and intensive care unit (ICU) status as potential risk factors for each arrhythmia. RESULTS: Among 700 patients (mean age 50 ± 18 years; 45% men; 71% African American; 11% received ICU care), there were 9 cardiac arrests, 25 incident AF events, 9 clinically significant bradyarrhythmias, and 10 NSVTs. All cardiac arrests occurred in patients admitted to the ICU. In addition, admission to the ICU was associated with incident AF (odds ratio [OR] 4.68; 95% confidence interval [CI] 1.66-13.18) and NSVT (OR 8.92; 95% CI 1.73-46.06) after multivariable adjustment. Also, age and incident AF (OR 1.05; 95% CI 1.02-1.09) and prevalent heart failure and bradyarrhythmias (OR 9.75; 95% CI 1.95-48.65) were independently associated. Only cardiac arrests were associated with acute in-hospital mortality. CONCLUSION: Cardiac arrests and arrhythmias are likely the consequence of systemic illness and not solely the direct effects of COVID-19 infection.

A Novel Clinical Decision Support System for Gastrointestinal Bleeding Risk Stratification in the Critically Ill.

INTRODUCTION: Acid suppression therapy can reduce the development of stress and medication-related mucosal disease when prescribed appropriately. Suboptimal inpatient prescribing of acid suppression therapy therefore may lead to increased development of gastrointestinal hemorrhage in high-risk populations. The aim of this quality improvement study was to improve appropriate acid suppression therapy in patients admitted to ICUs in an academic medical center. INTERVENTION DEVELOPMENT, IMPLEMENTATION, AND ADAPTATION: An adaptable, multifaceted implementation strategy guided by unit-based root cause analysis was initially developed in a single ICU with a high-risk population. Identifiable targets of intervention, including provider awareness, unstructured rounding protocols, and electronic communication tools, were augmented by the development of an automated alert system. This electronic dashboard risk-stratified patients based on information derived from the electronic medical record (EMR). The dashboard then offered clinical decision support. Use of the dashboard and percentage of appropriate acid suppression therapy prescriptions were tracked over time. RESULTS: Appropriate acid suppression therapy prescribing was improved from 72.9% to 86.0% (p < 0.001). CONCLUSION: Automated technology including an EMR-supported electronic dashboard was the foundation of successful intervention. Considering the deleterious effects of both under- and overprescribing of acid suppression therapy, particularly in high-risk patient populations, this type of technology may lead to enhanced patient outcomes.