Browsing by Author "Levy, Phillip"
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Item Design and rationale of the B-lines lung ultrasound guided emergency department management of acute heart failure (BLUSHED-AHF) pilot trial(Elsevier, 2018) Russell, Frances M.; Ehrman, Robert R.; Ferre, Robinson; Gargani, Luna; Noble, Vicki; Rupp, Jordan; Collins, Sean P.; Hunter, Benton; Lane, Kathleen A.; Levy, Phillip; Li, Xiaochun; O'Connor, Christopher; Pang, Peter S.; Emergency Medicine, School of MedicineBackground Medical treatment for acute heart failure (AHF) has not changed substantially over the last four decades. Emergency department (ED)-based evidence for treatment is limited. Outcomes remain poor, with a 25% mortality or re-admission rate within 30 days post discharge. Targeting pulmonary congestion, which can be objectively assessed using lung ultrasound (LUS), may be associated with improved outcomes. Methods BLUSHED-AHF is a multicenter, randomized, pilot trial designed to test whether a strategy of care that utilizes a LUS-driven treatment protocol outperforms usual care for reducing pulmonary congestion in the ED. We will randomize 130 ED patients with AHF across five sites to, a) a structured treatment strategy guided by LUS vs. b) a structured treatment strategy guided by usual care. LUS-guided care will continue until there are ≤15 B-lines on LUS or 6h post enrollment. The primary outcome is the proportion of patients with B-lines ≤ 15 at the conclusion of 6 h of management. Patients will continue to undergo serial LUS exams during hospitalization, to better understand the time course of pulmonary congestion. Follow up will occur through 90 days, exploring days-alive-and-out-of-hospital between the two arms. The study is registered on ClinicalTrials.gov (NCT03136198). Conclusion If successful, this pilot study will inform future, larger trial design on LUS driven therapy aimed at guiding treatment and improving outcomes in patients with AHF.Item Hemodynamic profiles by non-invasive monitoring of cardiac index and vascular tone in acute heart failure patients in the emergency department: External validation and clinical outcomes(PLOS, 2022-03-31) Harrison, Nicholas Eric; Meram, Sarah; Li, Xiangrui; White, Morgan B.; Henry, Sarah; Gupta, Sushane; Zhu, Dongxiao; Pang, Peter; Levy, Phillip; Emergency Medicine, School of MedicineBackground: Non-invasive finger-cuff monitors measuring cardiac index and vascular tone (SVRI) classify emergency department (ED) patients with acute heart failure (AHF) into three otherwise-indistinguishable subgroups. Our goals were to validate these "hemodynamic profiles" in an external cohort and assess their association with clinical outcomes. Methods: AHF patients (n = 257) from five EDs were prospectively enrolled in the validation cohort (VC). Cardiac index and SVRI were measured with a ClearSight finger-cuff monitor (formerly NexFin, Edwards Lifesciences) as in a previous study (derivation cohort, DC, n = 127). A control cohort (CC, n = 127) of ED patients with sepsis was drawn from the same study as the DC. K-means cluster analysis previously derived two-dimensional (cardiac index and SVRI) hemodynamic profiles in the DC and CC (k = 3 profiles each). The VC was subgrouped de novo into three analogous profiles by unsupervised K-means consensus clustering. PERMANOVA tested whether VC profiles 1-3 differed from profiles 1-3 in the DC and CC, by multivariate group composition of cardiac index and vascular tone. Profiles in the VC were compared by a primary outcome of 90-day mortality and a 30-day ranked composite secondary outcome (death, mechanical cardiac support, intubation, new/emergent dialysis, coronary intervention/surgery) as time-to-event (survival analysis) and binary events (odds ratio, OR). Descriptive statistics were used to compare profiles by two validated risk scores for the primary outcome, and one validated score for the secondary outcome. Results: The VC had median age 60 years (interquartile range {49-67}), and was 45% (n = 116) female. Multivariate profile composition by cardiac index and vascular tone differed significantly between VC profiles 1-3 and CC profiles 1-3 (p = 0.001, R2 = 0.159). A difference was not detected between profiles in the VC vs. the DC (p = 0.59, R2 = 0.016). VC profile 3 had worse 90-day survival than profiles 1 or 2 (HR = 4.8, 95%CI 1.4-17.1). The ranked secondary outcome was more likely in profile 1 (OR = 10.0, 1.2-81.2) and profile 3 (12.8, 1.7-97.9) compared to profile 2. Diabetes prevalence and blood urea nitrogen were lower in the high-risk profile 3 (p<0.05). No significant differences between profiles were observed for other clinical variables or the 3 clinical risk scores. Conclusions: Hemodynamic profiles in ED patients with AHF, by non-invasive finger-cuff monitoring of cardiac index and vascular tone, were replicated de novo in an external cohort. Profiles showed significantly different risks of clinically-important adverse patient outcomes.Item Point-of-care echocardiography of the right heart improves acute heart failure risk stratification for low-risk patients: The REED-AHF prospective study(Wiley, 2022) Harrison, Nicholas E.; Favot, Mark J.; Gowland, Laura; Lenning, Jacob; Henry, Sarah; Gupta, Sushane; Abidov, Aiden; Levy, Phillip; Ehrman, Robert; Emergency Medicine, School of MedicineObjectives: Validated acute heart failure (AHF) clinical decision instruments (CDI) insufficiently identify low-risk patients meriting consideration of outpatient treatment. While pilot data show that tricuspid annulus plane systolic excursion (TAPSE) is associated with adverse events, no AHF CDI currently incorporates point-of-care echocardiography (POCecho). We evaluated whether TAPSE adds incremental risk stratification value to an existing CDI. Methods: Prospectively enrolled patients at two urban-academic EDs had POCechos obtained before or <1 h after first intravenous diuresis, positive pressure ventilation, and/or nitroglycerin. STEMI and cardiogenic shock were excluded. AHF diagnosis was adjudicated by double-blind expert review. TAPSE, with an a priori cutoff of ≥17 mm, was our primary measure. Secondary measures included eight additional right heart and six left heart POCecho parameters. STRATIFY is a validated CDI predicting 30-day death/cardiopulmonary resuscitation, mechanical cardiac support, intubation, new/emergent dialysis, and acute myocardial infarction or coronary revascularization in ED AHF patients. Full (STRATIFY + POCecho variable) and reduced (STRATIFY alone) logistic regression models were fit to calculate adjusted odds ratios (aOR), category-free net reclassification index (NRIcont ), ΔSensitivity (NRIevents ), and ΔSpecificity (NRInonevents ). Random forest assessed variable importance. To benchmark risk prediction to standard of care, ΔSensitivity and ΔSpecificity were evaluated at risk thresholds more conservative/lower than the actual outcome rate in discharged patients. Results: A total of 84/120 enrolled patients met inclusion and diagnostic adjudication criteria. Nineteen percent experiencing the primary outcome had higher STRATIFY scores compared to those event free (233 vs. 212, p = 0.009). Five right heart (TAPSE, TAPSE/PASP, TAPSE/RVDD, RV-FAC, fwRVLS) and no left heart measures improved prediction (p < 0.05) adjusted for STRATIFY. Right heart measures also had higher variable importance. TAPSE ≥ 17 mm plus STRATIFY improved prediction versus STRATIFY alone (aOR 0.24, 95% confidence interval [CI] 0.06-0.91; NRIcont 0.71, 95% CI 0.22-1.19), and specificity improved by 6%-32% (p < 0.05) at risk thresholds more conservative than the standard-of-care benchmark without missing any additional events. Conclusions: TAPSE increased detection of low-risk AHF patients, after use of a validated CDI, at risk thresholds more conservative than standard of care.Item Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure(American Medical Association, 2024-01-02) Pang, Peter S.; Berger, David A.; Mahler, Simon A.; Li, Xiaochun; Pressler, Susan J.; Lane, Kathleen A.; Bischof, Jason J.; Char, Douglas; Diercks, Deborah; Jones, Alan E.; Hess, Erik P.; Levy, Phillip; Miller, Joseph B.; Venkat, Arvind; Harrison, Nicholas E.; Collins, Sean P.; Emergency Medicine, School of MedicineImportance: More than 80% of patients who present to the emergency department (ED) with acute heart failure (AHF) are hospitalized. With more than 1 million annual hospitalizations for AHF in the US, safe and effective alternatives are needed. Care for AHF in short-stay units (SSUs) may be safe and more efficient than hospitalization, especially for lower-risk patients, but randomized clinical trial data are lacking. Objective: To compare the effectiveness of SSU care vs hospitalization in lower-risk patients with AHF. Design, setting, and participants: This multicenter randomized clinical trial randomly assigned low-risk patients with AHF 1:1 to SSU or hospital admission from the ED. Patients received follow-up at 30 and 90 days post discharge. The study began December 6, 2017, and was completed on July 22, 2021. The data were analyzed between March 27, 2020, and November 11, 2023. Intervention: Randomized post-ED disposition to less than 24 hours of SSU care vs hospitalization. Main outcomes and measures: The study was designed to detect at least 1-day superiority for a primary outcome of days alive and out of hospital (DAOOH) at 30-day follow-up for 534 participants, with an allowance of 10% participant attrition. Due to the COVID-19 pandemic, enrollment was truncated at 194 participants. Before unmasking, the primary outcome was changed from DAOOH to an outcome with adequate statistical power: quality of life as measured by the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 scores range from 0 to 100, with higher scores indicating better quality of life. Results: Of the 193 patients enrolled (1 was found ineligible after randomization), the mean (SD) age was 64.8 (14.8) years, 79 (40.9%) were women, and 114 (59.1%) were men. Baseline characteristics were balanced between arms. The mean (SD) KCCQ-12 summary score between the SSU and hospitalization arms at 30 days was 51.3 (25.7) vs 45.8 (23.8) points, respectively (P = .19). Participants in the SSU arm had 1.6 more DAOOH at 30-day follow-up than those in the hospitalization arm (median [IQR], 26.9 [24.4-28.8] vs 25.4 [22.0-27.7] days; P = .02). Adverse events were uncommon and similar in both arms. Conclusions and relevance: The findings show that the SSU strategy was no different than hospitalization with regard to KCCQ-12 score, superior for more DAOOH, and safe for lower-risk patients with AHF. These findings of lower health care utilization with the SSU strategy need to be definitively tested in an adequately powered study.Item The Prognostic Value of Improving Congestion on Lung Ultrasound During Treatment for Acute Heart Failure Differs Based on Patient Characteristics at Admission(Elsevier, 2024) Harrison, Nicholas E.; Ehrman, Robert; Collins, Sean; Desai, Ankit A.; Duggan, Nicole M.; Ferre, Rob; Gargani, Luna; Goldsmith, Andrew; Kapur, Tina; Lane, Katie; Levy, Phillip; Li, Xiaochun; Noble, Vicki E.; Russell, Frances M.; Pang, Peter; Emergency Medicine, School of MedicineBackground: Lung ultrasound congestion scoring (LUS-CS) is a congestion severity biomarker. The BLUSHED-AHF trial demonstrated feasibility for LUS-CS-guided therapy in acute heart failure (AHF). We investigated two questions: 1) does change (∆) in LUS-CS from emergency department (ED) to hospital-discharge predict patient outcomes, and 2) is the relationship between in-hospital decongestion and adverse events moderated by baseline risk-factors at admission? Methods: We performed a secondary analysis of 933 observations/128 patients from 5 hospitals in the BLUSHED-AHF trial receiving daily LUS. ∆LUS-CS from ED arrival to inpatient discharge (scale -160 to +160, where negative = improving congestion) was compared to a primary outcome of 30-day death/AHF-rehospitalization. Cox regression was used to adjust for mortality risk at admission [Get-With-The-Guidelines HF risk score (GWTG-RS)] and the discharge LUS-CS. An interaction between ∆LUS-CS and GWTG-RS was included, under the hypothesis that the association between decongestion intensity (by ∆LUS-CS) and adverse outcomes would be stronger in admitted patients with low-mortality risk but high baseline congestion. Results: Median age was 65 years, GWTG-RS 36, left ventricular ejection fraction 36 %, and ∆LUS-CS -20. In the multivariable analysis ∆LUS-CS was associated with event-free survival (HR = 0.61; 95 % CI: 0.38-0.97), while discharge LUS-CS (HR = 1.00; 95%CI: 0.54-1.84) did not add incremental prognostic value to ∆LUS-CS alone. As GWTG-RS rose, benefits of LUS-CS reduction attenuated (interaction p < 0.05). ∆LUS-CS and event-free survival were most strongly correlated in patients without tachycardia, tachypnea, hypotension, hyponatremia, uremia, advanced age, or history of myocardial infarction at ED/baseline, and those with low daily loop diuretic requirements. Conclusions: Reduction in ∆LUS-CS during AHF treatment was most associated with improved readmission-free survival in heavily congested patients with otherwise reassuring features at admission. ∆LUS-CS may be most useful as a measure to ensure adequate decongestion prior to discharge, to prevent early readmission, rather than modify survival.Item The Significance of Historical Troponin Elevation in Acute Heart Failure: Not as Reassuring as Previously Assumed(Wiley, 2023) Harrison, Nicholas E.; Ehrman, Robert; Pang, Peter; Armitage, Sarah; Abidov, Aiden; Perkins, Daniel; Peacock, Johnathon; Montelauro, Nicholas; Gupta, Sushane; Favot, Mark J.; Levy, Phillip; Emergency Medicine, School of MedicineBackground: Historical cardiac troponin (cTn) elevation is commonly interpreted as lessening the significance of current cTn elevations at presentation for acute heart failure (AHF). Evidence for this practice is lacking. Our objective was to determine the incremental prognostic significance of historical cTn elevation compared to cTn elevation and ischemic heart disease (IHD) history at presentation for AHF. Methods: A total of 341 AHF patients were prospectively enrolled at five sites. The composite primary outcome was death/cardiopulmonary resuscitation, mechanical cardiac support, intubation, new/emergent dialysis, and/or acute myocardial infarction (AMI)/percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) at 90 days. Secondary outcomes were 30-day AMI/PCI/CABG and in-hospital AMI. Logistic regression compared outcomes versus initial emergency department (ED) cTn, the most recent electronic medical record cTn, estimated glomerular filtration rate, age, left ventricular ejection fraction, and IHD history (positive, negative by prior coronary workup, or unknown/no prior workup). Results: Elevated cTn occurred in 163 (49%) patients, 80 (23%) experienced the primary outcome, and 29 had AMI (9%). cTn elevation at ED presentation, adjusted for historical cTn and other covariates, was associated with the primary outcome (adjusted odds ratio [aOR] 2.39, 95% confidence interval [CI] 1.30-4.38), 30-day AMI/PCI/CABG, and in-hospital AMI. Historical cTn elevation was associated with greater odds of the primary outcome when IHD history was unknown at ED presentation (aOR 5.27, 95% CI 1.24-21.40) and did not alter odds of the outcome with known positive (aOR 0.74, 95% CI 0.33-1.70) or negative IHD history (aOR 0.79, 95% CI 0.26-2.40). Nevertheless, patients with elevated ED cTn were more likely to be discharged if historical cTn was also elevated (78% vs. 32%, p = 0.025). Conclusions: Historical cTn elevation in AHF patients is a harbinger of worse outcomes for patients who have not had a prior IHD workup and should prompt evaluation for underlying ischemia rather than reassurance for discharge. With known IHD history, historical cTn elevation was neither reassuring nor detrimental, failing to add incremental prognostic value to current cTn elevation alone.Item Treatment and Outcome Variation in Out-of-hospital Cardiac Arrest Among Four Urban Hospitals in Detroit(Elsevier, 2023) Mathew, Shobi; Harrison, Nicholas; Ajimal, Sukhwindar; Silvagi, Ryan; Reece, Ryan; Klausner, Howard; Levy, Phillip; Dunne, Robert; O’Neil, Brian; Emergency Medicine, School of MedicineAims: To determine whether out-of-hospital cardiac arrest (OHCA) post-resuscitation management and outcomes differ between four Detroit hospitals. Introduction: Significant variation exists in treatment/outcomes from OHCA. Disparities between hospitals serving a similar population is not well known. Methods: Retrospective OHCA data was collected from the Detroit-Cardiac Arrest Registry (DCAR) between January 2014 to December 2019. Four hospitals were compared on two treatments (angiography, do not resuscitate (DNR)) and two outcomes (cerebral performance category (CPC) ≤ 2, in-hospital death). Models for death and CPC were tested with and without coronary angiography and DNR status. Results: 999 patients at hospitals A - D differed (p < 0.05) before multivariable adjustment by age, race, witnessed arrest, dispatch-emergency department (ED) time, TTM, coronary angiography, DNR order, and in-hospital death. Rates of death and CPC ≤ 2 were worse in Hospital A (82.8%, 10%, respectively) compared to others (69.1%, 14.1%). After multivariable adjustment, Hospital A performed angiography less compared to B (OR = 0.17) and was more likely to initiate new DNR status than B (OR = 2.9), C (OR = 16.1), or D (OR = 3.6). CPC ≤ 2 were worse in Hospital A compared to B (OR = 0.27) and D (OR = 0.35). After sensitivity analysis, CPC ≤ 2 odds did not differ for A versus B (OR = 0.58, adjusted for angiography) or D (OR = 0.65, adjusted for DNR). Odds of death, despite angiography and DNR differences, were worse in Hospital A compared to B (OR = 1.87) and D (OR = 1.81). Conclusion: Differing rates of DNR and coronary angiography was associated with observed disparities in favorable neurologic outcome, but not death, between four Detroit hospitals.