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Item Analysis of standards of quality for outcomes in acute heart failure patients directly discharged home from emergency departments and their relationship with the emergency department direct discharge rate(Elsevier, 2021) Miró, Òscar; López-Díez, María Pilar; Rossello, Xavier; Gil, Víctor; Herrero, Pablo; Jacob, Javier; Llorens, Pere; Escoda, Rosa; Aguiló, Sira; Alquézar, Aitor; Tost, Josep; Valero, Amparo; Gil, Cristina; Garrido, José Manuel; Alonso, Héctor; Lucas-Invernón, Francisco Javier; Torres-Murillo, José; Torres-Gárate, Raquel; Mecina, Ana B.; Traveria, Lissette; Agüera, Carmen; Takagi, Koji; Möckel, Martin; Pang, Peter S.; Collins, Sean P.; Mueller, Christian E.; Martín-Sánchez, Francisco Javier; ICA-SEMES Research Group; Emergency Medicine, School of MedicineObjective: Experts recommended that direct discharge without hospitalization (DDWH) for emergency departments (EDs) able to observe acute heart failure (AHF) patients should be >40%, and these discharged patients should fulfil the following outcome standards: 30-day all-cause mortality <2% (outcome A); 7-day ED revisit due to AHF < 10% (outcome B); and 30-day ED revisit/hospitalization due to AHF < 20% (outcome C). We investigated these outcomes in a nationwide cohort and their relationship with the ED DDWH percentage. Methods: We analyzed the EAHFE registry (includes about 15% of Spanish EDs), calculated DDWH percentage of each ED, and A/B/C outcomes of DDWH patients, overall and in each individual ED. Relationship between ED DDWH and outcomes was assessed by linear and quadratic regression models, non-weighted and weighted by DDWH patients provided by each ED. Results: Among 17,420 patients, 4488 had DDWH (25.8%, median ED stay = 0 days, IQR = 0-1). Only 12.9% EDs achieved DDWH > 40%. Considering DDWH patients altogether, outcomes A/C were above the recommended standards (4.3%/29.4%), while outcome B was nearly met (B = 10.1%). When analyzing individual EDs, 58.1% of them achieved the outcome B standard, while outcomes A/C standards were barely achieved (19.3%/9.7%). We observed clinically relevant linear/quadratic relationships between higher DDWH and worse outcomes B (weighted R2 = 0.184/0.322) and C (weighted R2 = 0.430/0.624), but not with outcome A (weighted R2 = 0.002/0.022). Conclusions: The EDs of this nationwide cohort do not fulfil the standards for AHF patients with DDWH. High DDWH rates negatively impact ED revisit or hospitalization but not mortality. This may represent an opportunity for improvement in better selecting patients for early ED discharge and in ensuring early follow-up after ED discharge.Item B-line quantification: comparing learners novice to lung ultrasound assisted by machine artificial intelligence technology to expert review(Springer, 2021-06-30) Russell, Frances M.; Ehrman, Robert R.; Barton, Allen; Sarmiento, Elisa; Ottenhoff, Jakob E.; Nti, Benjamin K.; Emergency Medicine, School of MedicineBackground: The goal of this study was to assess the ability of machine artificial intelligence (AI) to quantitatively assess lung ultrasound (LUS) B-line presence using images obtained by learners novice to LUS in patients with acute heart failure (AHF), compared to expert interpretation. Methods: This was a prospective, multicenter observational study conducted at two urban academic institutions. Learners novice to LUS completed a 30-min training session on lung image acquisition which included lecture and hands-on patient scanning. Learners independently acquired images on patients with suspected AHF. Automatic B-line quantification was obtained offline after completion of the study. Machine AI counted the maximum number of B-lines visualized during a clip. The criterion standard for B-line counts was semi-quantitative analysis by a blinded point-of-care LUS expert reviewer. Image quality was blindly determined by an expert reviewer. A second expert reviewer blindly determined B-line counts and image quality. Intraclass correlation was used to determine agreement between machine AI and expert, and expert to expert. Results: Fifty-one novice learners completed 87 scans on 29 patients. We analyzed data from 611 lung zones. The overall intraclass correlation for agreement between novice learner images post-processed with AI technology and expert review was 0.56 (confidence interval [CI] 0.51-0.62), and 0.82 (CI 0.73-0.91) between experts. Median image quality was 4 (on a 5-point scale), and correlation between experts for quality assessment was 0.65 (CI 0.48-0.82). Conclusion: After a short training session, novice learners were able to obtain high-quality images. When the AI deep learning algorithm was applied to those images, it quantified B-lines with moderate-to-fair correlation as compared to semi-quantitative analysis by expert review. This data shows promise, but further development is needed before widespread clinical use.Item Biased ligand of the angiotensin II type 1 receptor in patients with acute heart failure: a randomized, double-blind, placebo-controlled, phase IIB, dose ranging trial (BLAST-AHF)(Oxford University Press, 2017-08-07) Pang, Peter S.; Butler, Javed; Collins, Sean P.; Cotter, Gad; Davison, Beth A.; Ezekowitz, Justin A.; Filippatos, Gerasimos; Levy, Phillip D.; Metra, Marco; Ponikowski, Piotr; Teerlink, John R.; Voors, Adriaan A.; Bharucha, David; Goin, Kathleen; Soergel, David G.; Felker, G. Michael; Emergency Medicine, School of MedicineAims: Currently, no acute heart failure (AHF) therapy definitively improves outcomes. Reducing morbidity and mortality from acute heart failure (AHF) remains an unmet need. TRV027 is a novel 'biased' ligand of the angiotensin II type 1 receptor (AT1R), selectively antagonizing the negative effects of angiotensin II, while preserving the potential pro-contractility effects of AT1R stimulation. BLAST-AHF was designed to determine the safety, efficacy, and optimal dose of TRV027 to advance into future studies. Methods and results: BLAST-AHF was a multi-centre, international, randomized, double-blind, placebo-controlled, parallel group, phase IIb dose-ranging study, enrolling patients with AHF into 4 groups: placebo, 1, 5, or 25 mg/h of TRV027. Treatment was by IV infusion for 48-96 h. The primary composite endpoint was comprised of the following: (i) time from baseline to death through day 30, (ii) time from baseline to heart failure re-hospitalization through day 30, (iii) the first assessment time point following worsening heart failure through day 5, (iv) change in dyspnea visual analogue scale (VAS) score calculated as the area under the curve (AUC) representing the change from baseline over time from baseline through day 5, and (v) length of initial hospital stay (in days) from baseline. Analyses were by modified intention-to-treat. Overall, 621 patients were enrolled. After 254 patients, a pre-specified interim analysis resulted in several protocol changes, including a lower blood pressure inclusion criterion as well as a new allocation scheme of 2:1:2:1, overweighting both placebo, and the 5 mg/h dose. TRV027 did not confer any benefit over placebo at any dose with regards to the primary composite endpoint or any of the individual components. There were no significant safety issues with TRV027. Conclusion: In this phase IIb dose-ranging AHF study, TRV027 did not improve clinical status through 30-day follow-up compared with placebo.Item Characteristics and clinical outcomes of patients with acute heart failure with a supranormal left ventricular ejection fraction(Wiley, 2023) van Essen, Bart J.; Tromp, Jasper; Ter Maaten, Jozine M.; Greenberg, Barry H.; Gimpelewicz, Claudio; Felker, G. Michael; Davison, Beth A.; Severin, Thomas; Pang, Peter S.; Cotter, Gad; Teerlink, John R.; Metra, Marco; Voors, Adriaan A.; Emergency Medicine, School of MedicineAim: Recent data suggest that guideline-directed medical therapy of patients with heart failure (HF) with reduced ejection fraction (HFrEF) might improve clinical outcomes in patients with HF up to a left ventricular ejection fraction (LVEF) of 55-65%, whereas patients with higher LVEF do not seem to benefit. Recent data have shown that LVEF may have a U-shaped relation with outcome, with poorer outcome also in patients with supranormal values. This suggests that patients with supranormal LVEF may be a distinctive group of patients. Methods and results: RELAX-AHF-2 was a multicentre, placebo-controlled trial on the effects of serelaxin on 180-day cardiovascular (CV) mortality and worsening HF at day 5 in patients with acute HF. Echocardiograms were performed at hospital admission in 6128 patients: 155 (2.5%) patients were classified as HF with supranormal ejection fraction (HFsnEF; LVEF >65%), 1440 (23.5%) as HF with preserved ejection fraction (HFpEF; LVEF 50-65%), 1353 (22.1%) as HF with mildly reduced ejection fraction (HFmrEF; LVEF 41-49%) and 3180 (51.9%) as HFrEF (LVEF <40%). Patients with HFsnEF compared to HFpEF were more often women, had higher prevalence of non-ischaemic HF, had lower levels of natriuretic peptides, were less likely to be treated with beta-blockers and had higher blood urea nitrogen plasma levels. All-cause mortality was not statistically different between groups, although patients with HFsnEF had the highest numerical rate. A declining trend was seen in the proportion of 180-day deaths due to CV causes from HFrEF (290/359, 80.8%) to HFsnEF (14/24, 58.3%). The reverse was observed with death from non-CV causes. No treatment effect of serelaxin was observed in any of the subgroups. Conclusions: In this study, only 2.5% of patients were classified as HFsnEF. HFsnEF was primarily characterized by female sex, lower natriuretic peptides and a higher risk of non-CV death.Item Discordance between estimated and measured changes in plasma volume among patients with acute heart failure(Wiley, 2022) Swolinsky, Jutta S.; Tuvshinbat, Enkhtuvshin; Leistner, David M.; Edelmann, Frank; Knebel, Fabian; Nerger, Niklas P.; Lemke, Caroline; Roehle, Robert; Haase, Michael; Costanzo, Maria Rosa; Rauch, Geraldine; Mitrovic, Veselin; Gasanin, Edis; Meier, Daniel; McCullough, Peter A.; Eckardt, Kai-Uwe; Molitoris, Bruce A.; Schmidt-Ott, Kai M.; Medicine, School of MedicineAims: In acute heart failure (AHF), changes of venous haemoglobin (Hb) concentrations, haematocrit (Hct), and estimated plasma volume (ePV) have been proposed as surrogates of decongestion. These estimates are based on the theoretical assumptions that changes of Hb concentrations and Hct are driven by the intravascular volume status and that the intravascular Hb pool remains stable. The objective of this study was to assess the relationship of changes of measured plasma volume (mPV) with changes of Hb, Hct, and ePV in AHF. Methods and results: We studied 36 AHF patients, who received two sequential assessments of mPV, measured red cell volume (mRCV) and measured total blood volume (mTBV) (48 h apart), during the course of diuretic therapy using a novel visible fluorescent injectate (VFI) technique based on the indicator dilution principle. Changes of ePV were calculated based on the Kaplan-Hakim or Strauss formula. AHF patients receiving diuretics (median intravenous furosemide equivalent 160 mg/48 h) displayed a wide range of changes of mPV (-25.4% to +37.0%). Changes in mPV were not significantly correlated with changes of Hb concentration [Pearson's r (r) = -0.241, P = 0.157], Hct (r = -0.307, P = 0.069), ePVKaplan-Hakim (r = 0.228, P = 0.182), or ePVStrauss (r = 0.237, P = 0.163). In contrast to theoretical assumptions, changes of mTBV were poorly correlated with changes of Hb concentrations and some patients displayed unanticipated variability of mRCV, suggesting an unstable intravascular red cell pool. Conclusions: Changes of Hb or Hct were not reflective of directly measured changes of intravascular volume status in AHF patients. Basing clinical assessment of decongestion on changes of Hb or Hct may misguide clinical decision-making on an individual patient level.Item Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study(Elsevier, 2021) Felker, G. Michael; McMurray, John J. V.; Cleland, John G.; O’Connor, Christopher M.; Teerlink, John R.; Voors, Adriaan A.; Belohlavek, Jan; Böhm, Michael; Borentain, Maria; Bueno, Hector; Cole, Robert T.; DeSouza, Mary M.; Ezekowitz, Justin A.; Filippatos, Gerasimos; Lang, Ninian N.; Kessler, Paul D.; Martinez, Felipe A.; Mebazaa, Alex; Metra, Marco; Mosterd, Arend; Pang, Peter S.; Ponikowski, Piotr; Sato, Naoki; Seiffert, Dietmar; Ye, June; Emergency Medicine, School of MedicineObjectives: The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were to identify signals of efficacy, including biomarkers, symptoms, and clinical events. Background: Nitroxyl (HNO) donors have vasodilator, inotropic and lusitropic effects. Bristol-Myers Squibb-986231 (cimlanod) is an HNO donor being developed for acute heart failure (AHF). Methods: This was a phase IIb, double-blind, randomized, placebo-controlled trial of 48-h treatment with cimlanod compared with placebo in patients with left ventricular ejection fraction ≤40% hospitalized for AHF. In part I, patients were randomized in a 1:1 ratio to escalating doses of cimlanod or matching placebo. In part II, patients were randomized in a 1:1:1 ratio to either of the 2 highest tolerated doses of cimlanod from part I or placebo. The primary endpoint was the rate of clinically relevant hypotension (systolic blood pressure <90 mm Hg or patients became symptomatic). Results: In part I (n = 100), clinically relevant hypotension was more common with cimlanod than placebo (20% vs. 8%; relative risk [RR]: 2.45; 95% confidence interval [CI]: 0.83 to 14.53). In part II (n = 222), the incidence of clinically relevant hypotension was 18% for placebo, 21% for cimlanod 6 μg/kg/min (RR: 1.15; 95% CI: 0.58 to 2.43), and 35% for cimlanod 12 μg/kg/min (RR: 1.9; 95% CI: 1.04 to 3.59). N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation. Conclusions: Cimlanod at a dose of 6 μg/kg/min was reasonably well-tolerated compared with placebo. Cimlanod reduced markers of congestion, but this did not persist beyond the treatment period.Item Emergency physician risk tolerance in acute heart failure is higher than previously thought and compatible with modern disposition decision instruments(Wiley, 2023) Harrison, Nicholas E.; Koester, Jami; Farmer, Annabelle; Hannon, Aidan; Jakupco, Nicholas; Nanagas, Jill; Park, Seho; Li, Xiaochun; Collins, Sean; Monahan, Patrick; Pang, Peter S.; Emergency Medicine, School of MedicineItem Lung Ultrasound Guided Emergency Department Management of Acute Heart Failure (BLUSHED-AHF): A Randomized, Controlled Pilot Trial(Elsevier, 2021) Pang, Peter S.; Russell, Frances M.; Ehrman, Robert; Ferre, Rob; Gargani, Luna; Levy, Phillip D.; Noble, Vicki; Lane, Kathleen A.; Li, Xiaochun; Collins, Sean P.; Emergency Medicine, School of MedicineObjectives: The goal of this study was to determine whether a 6-hour lung ultrasound (LUS)-guided strategy-of-care improves pulmonary congestion over usual management in the emergency department (ED) setting. A secondary goal was to explore whether early targeted intervention leads to improved outcomes. Background: Targeting pulmonary congestion in acute heart failure remains a key goal of care. LUS B-lines are a semi-quantitative assessment of pulmonary congestion. Whether B-lines decrease in patients with acute heart failure by targeting therapy is not well known. Methods: A multicenter, single-blind, ED-based, pilot trial randomized 130 patients to receive a 6-hour LUS-guided treatment strategy versus structured usual care. Patients were followed up throughout hospitalization and 90 days' postdischarge. B-lines ≤15 at 6 h was the primary outcome, and days alive and out of hospital (DAOOH) at 30 days was the main exploratory outcome. Results: No significant difference in the proportion of patients with B-lines ≤15 at 6 hours (25.0% LUS vs 27.5% usual care; P = 0.83) or the number of B-lines at 6 hours (35.4 ± 26.8 LUS vs 34.3 ± 26.2 usual care; P = 0.82) was observed between groups. There were also no differences in DAOOH (21.3 ± 6.6 LUS vs 21.3 ± 7.1 usual care; P = 0.99). However, a significantly greater reduction in the number of B-lines was observed in LUS-guided patients compared with those receiving usual structured care during the first 48 hours (P = 0.04). Conclusions: In this pilot trial, ED use of LUS to target pulmonary congestion conferred no benefit compared with usual care in reducing the number of B-lines at 6 hours or in 30 days DAOOH. However, LUS-guided patients had faster resolution of congestion during the initial 48 hours.Item Lymphocytic myocarditis with suspected granulomatosis with polyangiitis presenting as cardiogenic shock, restrictive cardiomyopathy and complete heart block(Elsevier, 2021-02) Anderson, Wesley L.; Bahrami, Mubashir H.; Guglin, Maya; Rao, Roopa; Medicine, School of MedicineWe report a case of restrictive cardiomyopathy from lymphocytic myocarditis in a patient with suspected granulomatosis with polyangiitis (GPA). The case was complicated by complete heart block and renal failure. The diagnosis was supported by upper airway involvement, elevated serum serine proteinase 3 antibodies, and endomyocardial biopsy with lymphocytic infiltration. The patient responded appropriately to aggressive immunosuppressive therapy.Item Predictors of Post-discharge Mortality Among Patients Hospitalized for Acute Heart Failure(Radcliffe Cardiology, 2017-11) Chioncel, Ovidiu; Collins, Sean P.; Greene, Stephen J.; Pang, Peter S.; Ambrosy, Andrew P.; Antohi, Elena-Laura; Vaduganathan, Muthiah; Butler, Javed; Gheorghiade, Mihai; Emergency Medicine, School of MedicineAcute Heart Failure (AHF) is a " multi-event disease" and hospitalisation is a critical event in the clinical course of HF. Despite relatively rapid relief of symptoms, hospitalisation for AHF is followed by an increased risk of death and re-hospitalisation. In AHF, risk stratification from clinically available data is increasingly important in evaluating long-term prognosis. From the perspective of patients, information on the risk of mortality and re-hospitalisation would be helpful in providing patients with insight into their disease. From the perspective of care providers, it may facilitate management decisions, such as who needs to be admitted and to what level of care (i.e. floor, step-down, ICU). Furthermore, risk-stratification may help identify patients who need to be evaluated for advanced HF therapies (i.e. left-ventricle assistance device or transplant or palliative care), and patients who need early a post-discharge follow-up plan. Finally, risk stratification will allow for more robust efforts to identify among risk markers the true targets for therapies that may direct treatment strategies to selected high-risk patients. Further clinical research will be needed to evaluate if appropriate risk stratification of patients could improve clinical outcome and resources allocation.