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Robert M. Califf - One of the best experts on this subject based on the ideXlab platform.
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triage after hospitalization with advanced heart failure the escape evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness risk model and discharge score
Journal of the American College of Cardiology, 2010Co-Authors: Christopher M Oconnor, Vic Hasselblad, Mona Fiuzat, Gudaye Tasissa, Robert M. Califf, Carl V. Leier, Rajendra H Mehta, Joseph G. Rogers, Lynne W. StevensonAbstract:Objectives Identifying high-risk heart failure (HF) patients at hospital discharge may allow more effective triage to management strategies. Background Heart failure severity at presentation predicts outcomes, but the prognostic importance of clinical status changes due to interventions is less well described. Methods Predictive models using variables obtained during hospitalization were created using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial and internally validated by the bootstrapping method. Model coefficients were converted to an additive risk score. Additionally, data from FIRST (Flolan International Randomized Survival Trial) was used to externally validate this model. Results Patients discharged with complete data (n = 423) had 6-month mortality and death and rehospitalization rates of 18.7% and 64%, respectively. Discharge risk factors for mortality included BNP, per doubling (hazard ratio [HR]: 1.42, 95% confidence interval [CI]: 1.15 to 1.75), cardioPulmonary resuscitation or mechanical ventilation during hospitalization (HR: 2.54, 95% CI: 1.12 to 5.78), blood urea nitrogen, per 20-U increase (HR: 1.22, 95% CI: 0.96 to 1.55), serum sodium, per unit increase (HR: 0.93, 95% CI: 0.87 to 0.99), age >70 years (HR: 1.05, 95% CI: 0.51 to 2.17), daily loop diuretic, furosemide equivalents >240 mg (HR: 1.49, 95% CI: 0.68 to 3.26), lack of beta-blocker (HR: 1.28, 95% CI: 0.68 to 2.41), and 6-min walk, per 100-foot increase (HR: 0.955, 95% CI: 0.99 to 1.00; c-index 0.76). A simplified discharge score discriminated mortality risk from 5% (score = 0) to 94% (score = 8). Bootstrap validation demonstrated good internal validation of the model (c-index 0.78, 95% CI: 0.68 to 0.83). Conclusions The ESCAPE study discharge risk model and score refine risk assessment after in-hospital therapy for advanced decompensated systolic HF, allowing clinicians to focus surveillance and triage for early life-saving interventions in this high-risk population. (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE]; NCT00000619 )
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)–derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson’s correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (−653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)-derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson's correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (-653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP <500 pg/ml. BNP decreased after hospitalization, but correlated modestly with PAC-derived hemodynamics. Rapid-assay BNP may provide information that helps physicians decide when to pursue more aggressive and invasive therapies.
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evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness escape design and rationale
American Heart Journal, 2001Co-Authors: Monica R Shah, Vic Hasselblad, George Sopko, Robert M. Califf, Christopher M Oconnor, Lynne W. StevensonAbstract:Abstract Background There is little information about how to adjust pharmacologic agents in the treatment of patients with advanced congestive heart failure (CHF). Some studies have suggested that use of Pulmonary Artery Catheterization to guide reductions in filling pressures may improve outcomes for patients with heart failure who are hospitalized with evidence of elevated filling pressures. However, there is no consensus regarding the true utility of this strategy. A randomized clinical trial is needed to test the safety, efficacy, and treatment benefit of Pulmonary Artery Catheterization in patients with advanced CHF. Study Design The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial is a multicenter, randomized trial designed to test the long-term safety and efficacy of treatment guided by hemodynamic monitoring and clinical assessment versus that guided by clinical assessment alone in patients hospitalized with New York Heart Association class IV CHF. Five hundred patients will be randomly assigned to receive either medical therapy guided by a combination of clinical assessment and hemodynamic monitoring (PAC arm) or medical therapy guided by clinical assessment alone (CLIN arm). The primary end point of ESCAPE will be the number of days that patients are hospitalized or die during the 6-month period after randomization. Secondary end points will include changes in mitral regurgitation, peak oxygen consumption, and natriuretic peptide levels. Other secondary end points will be Pulmonary Artery catheter–associated complications, resource utilization, quality of life measures, and patient preferences regarding survival. Implications The primary goal of ESCAPE will be to provide information about the utility of the Pulmonary Artery catheter in patients with advanced heart failure, independent of various treatment approaches used by individual physicians. In addition, this study will define current outcomes for this severely compromised population. (Am Heart J 2001;141:528-35.)
Lynne W. Stevenson - One of the best experts on this subject based on the ideXlab platform.
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triage after hospitalization with advanced heart failure the escape evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness risk model and discharge score
Journal of the American College of Cardiology, 2010Co-Authors: Christopher M Oconnor, Vic Hasselblad, Mona Fiuzat, Gudaye Tasissa, Robert M. Califf, Carl V. Leier, Rajendra H Mehta, Joseph G. Rogers, Lynne W. StevensonAbstract:Objectives Identifying high-risk heart failure (HF) patients at hospital discharge may allow more effective triage to management strategies. Background Heart failure severity at presentation predicts outcomes, but the prognostic importance of clinical status changes due to interventions is less well described. Methods Predictive models using variables obtained during hospitalization were created using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial and internally validated by the bootstrapping method. Model coefficients were converted to an additive risk score. Additionally, data from FIRST (Flolan International Randomized Survival Trial) was used to externally validate this model. Results Patients discharged with complete data (n = 423) had 6-month mortality and death and rehospitalization rates of 18.7% and 64%, respectively. Discharge risk factors for mortality included BNP, per doubling (hazard ratio [HR]: 1.42, 95% confidence interval [CI]: 1.15 to 1.75), cardioPulmonary resuscitation or mechanical ventilation during hospitalization (HR: 2.54, 95% CI: 1.12 to 5.78), blood urea nitrogen, per 20-U increase (HR: 1.22, 95% CI: 0.96 to 1.55), serum sodium, per unit increase (HR: 0.93, 95% CI: 0.87 to 0.99), age >70 years (HR: 1.05, 95% CI: 0.51 to 2.17), daily loop diuretic, furosemide equivalents >240 mg (HR: 1.49, 95% CI: 0.68 to 3.26), lack of beta-blocker (HR: 1.28, 95% CI: 0.68 to 2.41), and 6-min walk, per 100-foot increase (HR: 0.955, 95% CI: 0.99 to 1.00; c-index 0.76). A simplified discharge score discriminated mortality risk from 5% (score = 0) to 94% (score = 8). Bootstrap validation demonstrated good internal validation of the model (c-index 0.78, 95% CI: 0.68 to 0.83). Conclusions The ESCAPE study discharge risk model and score refine risk assessment after in-hospital therapy for advanced decompensated systolic HF, allowing clinicians to focus surveillance and triage for early life-saving interventions in this high-risk population. (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE]; NCT00000619 )
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correlation of impedance cardiography with invasive hemodynamic measurements in patients with advanced heart failure the bioimpedance cardiography big substudy of the evaluation study of congestive heart failure and Pulmonary Artery Catheterization e
American Heart Journal, 2009Co-Authors: Sandeep A Kamath, Gudaye Tasissa, Mark H Drazner, Lynne W. Stevenson, Joseph G. Rogers, Clyde W YancyAbstract:Background Impedance cardiography (ICG) is a noninvasive modality that uses changes in impedance across the thorax to assess hemodynamic parameters, including cardiac output (CO). The utility of ICG in patients hospitalized with heart failure is uncertain. Methods The BioImpedance CardioGraphy in Advanced Heart Failure study was a prospective substudy of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness. A total of 170 subjects underwent blinded ICG measurements using BioZ (CardioDynamics, San Diego, CA); of these, 82 underwent right heart Catheterization. We compared ICG with invasively measured hemodynamics by simple correlation and compared overall ICG hemodynamic profiles ("wet" [thoracic fluid content ≥47/kOhm in men and ≥37/kOhm in women] and "cold" [cardiac index ≤2.2 L min −1 m −2 ) versus those determined by invasive measurements (wet [Pulmonary capillary wedge pressure ≥22 mm Hg] and cold [cardiac index ≤2.2 L min −1 m −2 ). We also determined whether ICG measurements were associated with subsequent death or hospitalization within 6 months. Results There was modest correlation between ICG and invasively measured CO ( r = 0.4 to 0.6 on serial measurement). Thoracic fluid content measured by ICG was not a reliable measure of Pulmonary capillary wedge pressure. There was poor agreement between ICG and invasively measured hemodynamic profiles (κ ≤0.1). No ICG variable alone or in combination was associated with outcome. Conclusions In hospitalized patients with advanced heart failure, ICG provides some information about CO but not left-sided filling pressures. Impedance cardiography did not have prognostic utility in this patient population.
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)–derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson’s correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (−653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)-derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson's correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (-653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP <500 pg/ml. BNP decreased after hospitalization, but correlated modestly with PAC-derived hemodynamics. Rapid-assay BNP may provide information that helps physicians decide when to pursue more aggressive and invasive therapies.
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evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness
JAMA, 2005Co-Authors: James A. Hill, Daniel F Pauly, Debra R Olitsky, Beth Patterson, Uri Elkayam, Salman Khan, Lynne W. Stevenson, Stuart D Russell, Christopher M Oconnor, Kimberly BrooksAbstract:Abstract Pulmonary Artery catheters (PACs) have been used to guide therapy in multiple settings, but recent studies have raised concerns that PACs may lead to increased mortality in hospitalized patients. To determine whether PAC use is safe and improves clinical outcomes in patients hospitalized with severe symptomatic and recurrent heart failure. The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) was a randomized controlled trial of 433 patients at 26 sites conducted from January 18, 2000, to November 17, 2003. Patients were assigned to receive therapy guided by clinical assessment and a PAC or clinical assessment alone. The target in both groups was resolution of clinical congestion, with additional PAC targets of a Pulmonary capillary wedge pressure of 15 mm Hg and a right atrial pressure of 8 mm Hg. Medications were not specified, but inotrope use was explicitly discouraged. The primary end point was days alive out of the hospital during the first 6 months, with secondary end points of exercise, quality of life, biochemical, and echocardiographic changes. Severity of illness was reflected by the following values: average left ventricular ejection fraction, 19%; systolic blood pressure, 106 mm Hg; sodium level, 137 mEq/L; urea nitrogen, 35 mg/dL (12.40 mmol/L); and creatinine, 1.5 mg/dL (132.6 micromol/L). Therapy in both groups led to substantial reduction in symptoms, jugular venous pressure, and edema. Use of the PAC did not significantly affect the primary end point of days alive and out of the hospital during the first 6 months (133 days vs 135 days; hazard ratio [HR], 1.00 [95% confidence interval {CI}, 0.82-1.21]; P = .99), mortality (43 patients [10%] vs 38 patients [9%]; odds ratio [OR], 1.26 [95% CI, 0.78-2.03]; P = .35), or the number of days hospitalized (8.7 vs 8.3; HR, 1.04 [95% CI, 0.86-1.27]; P = .67). In-hospital adverse events were more common among patients in the PAC group (47 [21.9%] vs 25 [11.5%]; P = .04). There were no deaths related to PAC use, and no difference for in-hospital plus 30-day mortality (10 [4.7%] vs 11 [5.0%]; OR, 0.97 [95% CI, 0.38-2.22]; P = .97). Exercise and quality of life end points improved in both groups with a trend toward greater improvement with the PAC, which reached significance for the time trade-off at all time points after randomization. Therapy to reduce volume overload during hospitalization for heart failure led to marked improvement in signs and symptoms of elevated filling pressures with or without the PAC. Addition of the PAC to careful clinical assessment increased anticipated adverse events, but did not affect overall mortality and hospitalization. Future trials should test noninvasive assessments with specific treatment strategies that could be used to better tailor therapy for both survival time and survival quality as valued by patients.
Monica R Shah - One of the best experts on this subject based on the ideXlab platform.
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)–derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson’s correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (−653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)-derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson's correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (-653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP <500 pg/ml. BNP decreased after hospitalization, but correlated modestly with PAC-derived hemodynamics. Rapid-assay BNP may provide information that helps physicians decide when to pursue more aggressive and invasive therapies.
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Pulmonary Artery Catheterization in acute coronary syndromes insights from the gusto iib and gusto iii trials
The American Journal of Medicine, 2005Co-Authors: Mauricio G Cohen, Monica R Shah, Robert V Kelly, David F Kong, Venu Menon, Douglas A Criger, Rosana Poggio, Karen S Pieper, Jorge Ferreira, Magnus E OhmanAbstract:Abstract Purpose To correlate Pulmonary Artery Catheterization (PAC) use and 30-day outcomes and to characterize the use of Pulmonary Artery catheters among patients with acute coronary syndromes (ACS). Subjects and methods We retrospectively studied 26437 ACS patients from two large multicenter, international randomized clinical trials. Multivariable and causal inference analyses were applied to adjust for differences in baseline risk. Results PAC was performed in 735 patients (2.8%), with a median time to insertion of 24 hours. Patients undergoing PAC were older (median, 67 vs. 64 years), more often diabetic (25.7% vs.16.2%), and more likely to present with ST-segment elevation (81.6% vs. 70.2%) or Killip class III or IV (7.9% vs. 1.4%). US patients were 3.8 times more likely than non-US patients to undergo PAC. Patients managed with PAC also underwent more procedures, including percutaneous intervention (40.7% vs. 18.1%), coronary Artery bypass grafting (12.5% vs. 7.7%), and endotracheal intubation (29.3% vs. 2.2%). Mortality at 30 days was substantially higher among patients with PAC for both unadjusted (odds ratio [OR] 8.7; 95% confidence interval [CI] 7.3–10.2) and adjusted analyses (OR 6.4; 95% CI 5.4–7.6) in all groups except in patients with cardiogenic shock (OR 0.99; 95% CI 0.80–1.23). Conclusions PAC was associated with increased mortality, both before and after adjustment for baseline patient differences and subsequent events that may have led to PAC use, except in patients with cardiogenic shock. The definitive role of PAC in managing patients with ACS is still to be determined.
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evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness escape design and rationale
American Heart Journal, 2001Co-Authors: Monica R Shah, Vic Hasselblad, George Sopko, Robert M. Califf, Christopher M Oconnor, Lynne W. StevensonAbstract:Abstract Background There is little information about how to adjust pharmacologic agents in the treatment of patients with advanced congestive heart failure (CHF). Some studies have suggested that use of Pulmonary Artery Catheterization to guide reductions in filling pressures may improve outcomes for patients with heart failure who are hospitalized with evidence of elevated filling pressures. However, there is no consensus regarding the true utility of this strategy. A randomized clinical trial is needed to test the safety, efficacy, and treatment benefit of Pulmonary Artery Catheterization in patients with advanced CHF. Study Design The Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial is a multicenter, randomized trial designed to test the long-term safety and efficacy of treatment guided by hemodynamic monitoring and clinical assessment versus that guided by clinical assessment alone in patients hospitalized with New York Heart Association class IV CHF. Five hundred patients will be randomly assigned to receive either medical therapy guided by a combination of clinical assessment and hemodynamic monitoring (PAC arm) or medical therapy guided by clinical assessment alone (CLIN arm). The primary end point of ESCAPE will be the number of days that patients are hospitalized or die during the 6-month period after randomization. Secondary end points will include changes in mitral regurgitation, peak oxygen consumption, and natriuretic peptide levels. Other secondary end points will be Pulmonary Artery catheter–associated complications, resource utilization, quality of life measures, and patient preferences regarding survival. Implications The primary goal of ESCAPE will be to provide information about the utility of the Pulmonary Artery catheter in patients with advanced heart failure, independent of various treatment approaches used by individual physicians. In addition, this study will define current outcomes for this severely compromised population. (Am Heart J 2001;141:528-35.)
Gudaye Tasissa - One of the best experts on this subject based on the ideXlab platform.
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triage after hospitalization with advanced heart failure the escape evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness risk model and discharge score
Journal of the American College of Cardiology, 2010Co-Authors: Christopher M Oconnor, Vic Hasselblad, Mona Fiuzat, Gudaye Tasissa, Robert M. Califf, Carl V. Leier, Rajendra H Mehta, Joseph G. Rogers, Lynne W. StevensonAbstract:Objectives Identifying high-risk heart failure (HF) patients at hospital discharge may allow more effective triage to management strategies. Background Heart failure severity at presentation predicts outcomes, but the prognostic importance of clinical status changes due to interventions is less well described. Methods Predictive models using variables obtained during hospitalization were created using data from the ESCAPE (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness) trial and internally validated by the bootstrapping method. Model coefficients were converted to an additive risk score. Additionally, data from FIRST (Flolan International Randomized Survival Trial) was used to externally validate this model. Results Patients discharged with complete data (n = 423) had 6-month mortality and death and rehospitalization rates of 18.7% and 64%, respectively. Discharge risk factors for mortality included BNP, per doubling (hazard ratio [HR]: 1.42, 95% confidence interval [CI]: 1.15 to 1.75), cardioPulmonary resuscitation or mechanical ventilation during hospitalization (HR: 2.54, 95% CI: 1.12 to 5.78), blood urea nitrogen, per 20-U increase (HR: 1.22, 95% CI: 0.96 to 1.55), serum sodium, per unit increase (HR: 0.93, 95% CI: 0.87 to 0.99), age >70 years (HR: 1.05, 95% CI: 0.51 to 2.17), daily loop diuretic, furosemide equivalents >240 mg (HR: 1.49, 95% CI: 0.68 to 3.26), lack of beta-blocker (HR: 1.28, 95% CI: 0.68 to 2.41), and 6-min walk, per 100-foot increase (HR: 0.955, 95% CI: 0.99 to 1.00; c-index 0.76). A simplified discharge score discriminated mortality risk from 5% (score = 0) to 94% (score = 8). Bootstrap validation demonstrated good internal validation of the model (c-index 0.78, 95% CI: 0.68 to 0.83). Conclusions The ESCAPE study discharge risk model and score refine risk assessment after in-hospital therapy for advanced decompensated systolic HF, allowing clinicians to focus surveillance and triage for early life-saving interventions in this high-risk population. (Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE]; NCT00000619 )
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correlation of impedance cardiography with invasive hemodynamic measurements in patients with advanced heart failure the bioimpedance cardiography big substudy of the evaluation study of congestive heart failure and Pulmonary Artery Catheterization e
American Heart Journal, 2009Co-Authors: Sandeep A Kamath, Gudaye Tasissa, Mark H Drazner, Lynne W. Stevenson, Joseph G. Rogers, Clyde W YancyAbstract:Background Impedance cardiography (ICG) is a noninvasive modality that uses changes in impedance across the thorax to assess hemodynamic parameters, including cardiac output (CO). The utility of ICG in patients hospitalized with heart failure is uncertain. Methods The BioImpedance CardioGraphy in Advanced Heart Failure study was a prospective substudy of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness. A total of 170 subjects underwent blinded ICG measurements using BioZ (CardioDynamics, San Diego, CA); of these, 82 underwent right heart Catheterization. We compared ICG with invasively measured hemodynamics by simple correlation and compared overall ICG hemodynamic profiles ("wet" [thoracic fluid content ≥47/kOhm in men and ≥37/kOhm in women] and "cold" [cardiac index ≤2.2 L min −1 m −2 ) versus those determined by invasive measurements (wet [Pulmonary capillary wedge pressure ≥22 mm Hg] and cold [cardiac index ≤2.2 L min −1 m −2 ). We also determined whether ICG measurements were associated with subsequent death or hospitalization within 6 months. Results There was modest correlation between ICG and invasively measured CO ( r = 0.4 to 0.6 on serial measurement). Thoracic fluid content measured by ICG was not a reliable measure of Pulmonary capillary wedge pressure. There was poor agreement between ICG and invasively measured hemodynamic profiles (κ ≤0.1). No ICG variable alone or in combination was associated with outcome. Conclusions In hospitalized patients with advanced heart failure, ICG provides some information about CO but not left-sided filling pressures. Impedance cardiography did not have prognostic utility in this patient population.
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effect of Pulmonary hypertension on clinical outcomes in advanced heart failure analysis of the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness escape database
American Heart Journal, 2009Co-Authors: Kiran K Khush, Dana Mcglothlin, Gudaye Tasissa, Javed Butler, Teresa De MarcoAbstract:Background Pulmonary hypertension has been shown to predict hospitalizations and mortality in patients with heart failure. We aimed to define the prevalence of mixed Pulmonary hypertension (MPH; mean Pulmonary Artery pressure ≥25 mm Hg, Pulmonary capillary wedge pressure >15 mm Hg, and Pulmonary vascular resistance ≥3 Wood units), identify clinical predictors of MPH, and determine whether MPH predicts adverse outcomes in patients hospitalized with severe heart failure. Methods This is a subgroup analysis of patients assigned to Pulmonary Artery catheter placement in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) trial. Patients with and without MPH were compared with respect to baseline characteristics and clinical outcomes, including NYHA class, 6-minute walk distance, quality of life, days hospitalized, and 6-month mortality. Results Of the 171 patients studied, 80 (47%) had MPH. Older age was the only significant predictor of MPH. MPH patients had lower cardiac index (1.8 ± 0.5 L/min vs 2.1 ± 0.5 L/min, P = .001) and higher systemic vascular resistance index (3,179 ± 1,454 vs 2,550 ± 927 dynes·s/cm 5 ·m 2 , P 2 /beat) in MPH patients. There were no significant differences in clinical outcomes between the two groups. Conclusions Mixed Pulmonary hypertension is common in patients hospitalized with advanced heart failure and is not associated with adverse short-term clinical outcomes over and above the poor prognosis of ADHF patients without MPH.
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)–derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson’s correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (−653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)-derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson's correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (-653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP <500 pg/ml. BNP decreased after hospitalization, but correlated modestly with PAC-derived hemodynamics. Rapid-assay BNP may provide information that helps physicians decide when to pursue more aggressive and invasive therapies.
Magnus E Ohman - One of the best experts on this subject based on the ideXlab platform.
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)-derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson's correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (-653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP <500 pg/ml. BNP decreased after hospitalization, but correlated modestly with PAC-derived hemodynamics. Rapid-assay BNP may provide information that helps physicians decide when to pursue more aggressive and invasive therapies.
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rapid assay brain natriuretic peptide and troponin i in patients hospitalized with decompensated heart failure from the evaluation study of congestive heart failure and Pulmonary Artery Catheterization effectiveness trial
American Journal of Cardiology, 2007Co-Authors: Monica R Shah, Vic Hasselblad, Magnus E Ohman, Robert H Christenson, Cynthia Binanay, Gudaye Tasissa, Lynne W. Stevenson, Christopher M Oconnor, Robert M. CaliffAbstract:Rapid-assay biomarkers may predict outcomes in patients with decompensated heart failure (HF). This study assessed whether rapid-assay B-type natriuretic peptide (BNP) and troponin I predicts length of stay and mortality and correlates with Pulmonary Artery catheter (PAC)–derived hemodynamics in patients hospitalized with acute HF. There were 141 nonconsecutive patients in this prospective cohort study of the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE), a randomized trial testing PACs in 433 patients with severe decompensated HF. Biomarkers were drawn at baseline and discharge and when the first, second, and final hemodynamics were obtained in 69 patients randomly assigned to PACs. Cox analysis was used to model mortality, length of stay, and rehospitalization, and Pearson’s correlations were used to describe the relation among BNP, troponin I, and PAC-derived hemodynamics. The median (25th percentile, 75th percentile) BNP levels were 783 pg/ml (329, 1,565) at baseline and 468 pg/ml (240, 946) at discharge. After treatment for HF, the median BNP level decreased by 144 pg/ml (−653, 55; p = 0.004). Patients with baseline BNP levels >1,500 pg/ml had greater mortality at 6 months and almost twice the length of stay as patients with BNP levels 1,500 pg/ml had greater mortality and longer length of stay than patients with BNP
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Pulmonary Artery Catheterization in acute coronary syndromes insights from the gusto iib and gusto iii trials
The American Journal of Medicine, 2005Co-Authors: Mauricio G Cohen, Monica R Shah, Robert V Kelly, David F Kong, Venu Menon, Douglas A Criger, Rosana Poggio, Karen S Pieper, Jorge Ferreira, Magnus E OhmanAbstract:Abstract Purpose To correlate Pulmonary Artery Catheterization (PAC) use and 30-day outcomes and to characterize the use of Pulmonary Artery catheters among patients with acute coronary syndromes (ACS). Subjects and methods We retrospectively studied 26437 ACS patients from two large multicenter, international randomized clinical trials. Multivariable and causal inference analyses were applied to adjust for differences in baseline risk. Results PAC was performed in 735 patients (2.8%), with a median time to insertion of 24 hours. Patients undergoing PAC were older (median, 67 vs. 64 years), more often diabetic (25.7% vs.16.2%), and more likely to present with ST-segment elevation (81.6% vs. 70.2%) or Killip class III or IV (7.9% vs. 1.4%). US patients were 3.8 times more likely than non-US patients to undergo PAC. Patients managed with PAC also underwent more procedures, including percutaneous intervention (40.7% vs. 18.1%), coronary Artery bypass grafting (12.5% vs. 7.7%), and endotracheal intubation (29.3% vs. 2.2%). Mortality at 30 days was substantially higher among patients with PAC for both unadjusted (odds ratio [OR] 8.7; 95% confidence interval [CI] 7.3–10.2) and adjusted analyses (OR 6.4; 95% CI 5.4–7.6) in all groups except in patients with cardiogenic shock (OR 0.99; 95% CI 0.80–1.23). Conclusions PAC was associated with increased mortality, both before and after adjustment for baseline patient differences and subsequent events that may have led to PAC use, except in patients with cardiogenic shock. The definitive role of PAC in managing patients with ACS is still to be determined.
