Self-management in Heart Failure: The Importance of Self-regulation but not Complexity of Condition.

Heart failure (HF) is a growing public health problem. Self-management (SM) of HF is an important component of chronic disease management. Guided by the Individual and Family Self-Management Theory (IFSMT), we examined the associations among complexity of condition, self-regulation, and self-efficacy mediation of SM behaviors in a population of HF outpatients. A cross-sectional design was used. Seventy-three outpatients with HF were enrolled. Simple and multiple linear regressions were run for each outcome variable. Only self-regulation was significantly associated with SM behavior. Complexity of condition was not significantly associated with SM behavior. There was no mediation by self-efficacy. Future nursing interventions should explore self-regulation in HF to provide a clearer understanding of the processes used to change health behavior. SM may be particularly useful in HF with preserved ejection fraction (EF), where there is no proven pharmacological treatment.

A Dual-Lumen Percutaneous Cannula for Managing Refractory Right Ventricular Failure.

A right ventricular assist device (RVAD) using a dual-lumen percutaneous cannula inserted through the right internal jugular vein (IJV) might improve weaning in patients with refractory right ventricular (RV) failure. However, the reported experience with this cannula is limited. We reviewed the records of all patients receiving RVAD support with this new dual-lumen cannula at our institution between April 2017 and February 2019. We recorded data on weaning, mortality, and device-specific complications. We compared outcomes among three subgroups based on the indications for RVAD support (postcardiotomy, cardiogenic shock, and primary respiratory failure) and against similar results in the literature. Mean (standard deviation [SD]) age of the 40 patients (29 men) was 53 (15.5) years. Indications for implantation were postcardiotomy support in 18 patients, cardiogenic shock in 12, and respiratory failure in 10. In all, 17 (94%) patients in the postcardiotomy group were weaned from RVAD support, five (42%) in the cardiogenic shock group, and seven (70%) in the respiratory failure group, overall higher than those reported in the literature (49% to 59%) for surgically placed RVADs. Whereas published in-hospital mortality rates range from 42% to 50% for surgically placed RVADs and from 41% to 50% for RVADs with percutaneous cannulas implanted through the right IJV, mortality was 11%, 58%, and 40% in our subgroups, respectively. There were no major device-related complications. This percutaneous dual-lumen cannula appears to be safe and effective for managing refractory RV failure, with improved weaning and mortality profile, and with limited device-specific adverse events.

The Impact of Direct Cardiac Output Determination On Using A Widely Available Direct Continuous Oxygen Consumption Measuring Device On The Hemodynamic Assessment of Aortic Valve.

BACKGROUND: Accurate assessment of cardiac output (CO) is essential for the hemodynamic assessment of aortic valve area (AVA). Estimation of oxygen consumption (VO2) and Thermodilution (TD) is employed in many cardiac catheterization laboratories (CCL) given the historically cumbersome nature of direct continuous VO2 measurement, the "gold standard" for this technique. A portable facemask device simplifies the direct continuous measurement of VO2, allowing for relatively rapid and continuous assessment of CO and AVA. METHODS AND MATERIALS: Seventeen consecutive patients undergoing right heart catheterization had simultaneous determination of CO by both direct continuous and assumed VO2 and TD. Assessments were only made when a plateau of VO2 had occurred. All measurements of direct continuous and assumed VO2, as well as, TD CO were obtained in triplicate. RESULTS: Direct continuous VO2 CO and assumed VO2 CO correlated poorly (R= 0.57; ICC =0.59). Direct continuous VO2 CO and TD CO also correlated poorly (R= 0.51; ICC=0.60). Similarly AVA derived from direct continuous VO2 correlated poorly with those of assumed VO2 (R= 0.68; ICC=0.55) and TD (R=0.66, ICC=0.60). Repeated direct continuous VO2 CO and AVA measurements were extremely correlated and reproducible [(R=0.93; ICC=0.96) and (R=0.99; ICC>0.99) respectively], suggesting that this was the most reliable measurement of CO. CONCLUSIONS: CO calculated from direct continuous VO2 measurement varies substantially from both assumed VO2 and TD based CO, which are widely used in most CCL. These differences may significantly impact the CO and AVA measurements. Furthermore, continuous, rather than average, measurement of VO2 appears to give highly reproducible results.

Cardiac output determination using a widely available direct continuous oxygen consumption measuring device: a practical way to get back to the gold standard.

BACKGROUND: Accurate assessment of cardiac output (CO) is essential for the hemodynamic assessment of valvular heart disease. Estimation of oxygen consumption (VO2) and thermodilution (TD) are employed in many cardiac catheterization laboratories (CCL) given the historically cumbersome nature of direct continuous VO2 measurement, the "gold standard" for this technique. A portable facemask device simplifies the direct continuous measurement of VO2, allowing for relatively rapid and continuous assessment of CO. METHODS AND MATERIALS: Thirty consecutive patients undergoing right heart catheterization had simultaneous determination of CO by both direct continuous and assumed VO2 and TD. Assessments were only made when a plateau of VO2 had occurred. All measurements of direct continuous and assumed VO2, as well as, TD CO were obtained in triplicate. RESULTS: Direct continuous VO2 CO and assumed VO2 CO correlated poorly (R=0.57; ICC=0.59). Direct continuous VO2 CO and TD CO also correlated poorly (R=0.51; ICC=0.60). Repeated direct continuous VO2 CO measurements were extremely correlated and reproducible [(R=0.93; ICC=0.96) suggesting that this was the most reliable measurement of CO. CONCLUSIONS: CO calculated from direct continuous VO2 measurement varies substantially from both assumed VO2 and TD based CO, which are widely used in most CCL. These differences may significantly impact the CO measurements. Furthermore, continuous, rather than average, measurement of VO2 appears to give highly reproducible results.

Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study.

BACKGROUND: Oxidative stress may contribute to heart failure (HF) progression. Inhibiting xanthine oxidase in hyperuricemic HF patients may improve outcomes. METHODS AND RESULTS: We randomly assigned 253 patients with symptomatic HF, left ventricular ejection fraction ≤40%, and serum uric acid levels ≥9.5 mg/dL to receive allopurinol (target dose, 600 mg daily) or placebo in a double-blind, multicenter trial. The primary composite end point at 24 weeks was based on survival, worsening HF, and patient global assessment. Secondary end points included change in quality of life, submaximal exercise capacity, and left ventricular ejection fraction. Uric acid levels were significantly reduced with allopurinol in comparison with placebo (treatment difference, -4.2 [-4.9, -3.5] mg/dL and -3.5 [-4.2, -2.7] mg/dL at 12 and 24 weeks, respectively, both P<0.0001). At 24 weeks, there was no significant difference in clinical status between the allopurinol- and placebo-treated patients (worsened 45% versus 46%, unchanged 42% versus 34%, improved 13% versus 19%, respectively; P=0.68). At 12 and 24 weeks, there was no significant difference in change in Kansas City Cardiomyopathy Questionnaire scores or 6-minute walk distances between the 2 groups. At 24 weeks, left ventricular ejection fraction did not change in either group or between groups. Rash occurred more frequently with allopurinol (10% versus 2%, P=0.01), but there was no difference in serious adverse event rates between the groups (20% versus 15%, P=0.36). CONCLUSIONS: In high-risk HF patients with reduced ejection fraction and elevated uric acid levels, xanthine oxidase inhibition with allopurinol failed to improve clinical status, exercise capacity, quality of life, or left ventricular ejection fraction at 24 weeks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00987415.

Deciding which drugs get onto the formulary: a value-based approach.

OBJECTIVES: Hospitals, physicians, payers, and patients face economic and ethical decisions about the use of biotechnology drugs, commonly called specialty medications. These often target a small population, have data based on smaller clinical trials, are expensive, and may have questionable advantage. This is a result of how the Food and Drug Administration (FDA) approves medications, which is based only on safety and efficacy. Cancer drugs, once approved by the FDA, regardless of cost or value must be covered by Medicare. Some states have laws requiring additional coverage as well. All of this has created an unintended consequence: It has driven up costs with questionable evidence to support the medication's value, placing patients, payers, and providers in an ethical conflict. In this new era of health care transformation, health care leaders must focus on creating value to support a sustainable health system. Christiana Care Health System's Value Institute has designed a new model to evaluate specialty medications, using value as its main criterion. METHODS: This article describes the process and outcomes using a new value model for evaluating specialty medications for a hospital formulary. It also introduces a new criterion of evaluation entitled "Societal Benefit" that provides a rating on quality- of-life issues. With measurable factors of efficacy, risk, cost, and quality-of-life concerns, our methodology provides a more balanced approach in the evaluation of specialty medications. RESULTS: Specialty medications are the fastest growing segment of drug expense, and it is hard to understand how these medications will be sustainable under health care reforms. Unlike other countries, the United States has no national agency providing cost-effectiveness review; review occurs, if at all, at a local level. Laws governing Medicare and most private insurers' coverage of FDA-approved medication and some clinical quality standards conflict with cost-effectiveness, making this type of review difficult. Finally, because these medications affect the health system as a whole, it is a great example to begin to support health care reform. CONCLUSIONS: Hospitals need to challenge the value of specialty medication. Although our model will continue to evolve, value is now our central consideration when selecting specialty medications to be added to the formulary. We share this experience to encourage other hospitals to design their own approach to this vital issue.

Characteristics and outcomes of peripartum versus nonperipartum cardiomyopathy in women using a wearable cardiac defibrillator.

BACKGROUND: Peripartum cardiomyopathy (PPCM) mortality rates vary between 2% and 56%, with half occurring ≤12 weeks'; postpartum. Although risk factors for PPCM have been identified, predicting sudden cardiac death among PPCM patients remains difficult. This study describes the characteristics and outcomes of PPCM patients and controls referred for a wearable cardioverter defibrillator (WCD). METHODS AND RESULTS: Deidentified WCD medical orders between 2003 and 2009 and death index searches were used to characterize women (ages 17-43) with PPCM (n = 107) or matched nonpregnant women with nonischemic dilated cardiomyopathy (NIDCM; n = 159). Demographics were similar. WCD use averaged 124 ± 123 days and 96 ± 83 days among PPCM and NIDCM patients, respectively. No PPCM patients received an appropriate shock for ventricular tachycardia/ventricular fibrillation; 1 NIDCM patient received 2 successful shocks. No PPCM patient died during WCD use versus 11 concurrent NIDCM deaths. After WCD use, 3 PPCM and 13 NIDCM patients died, respectively. CONCLUSIONS: The mortality rate of 2.8% (over 3.0 ± 1.2 years) in PPCM patients is low compared to published data. The role of WCD therapy among PPCM patients deserves further study.

The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial.

BACKGROUND: Many patients with heart failure remain symptomatic and have a poor prognosis despite existing treatments. Decreases in myocardial contractility and shortening of ventricular systole are characteristic of systolic heart failure and might be improved by a new therapeutic class, cardiac myosin activators. We report the first study of the cardiac myosin activator, omecamtiv mecarbil, in patients with systolic heart failure. METHODS: We undertook a double-blind, placebo-controlled, crossover, dose-ranging, phase 2 trial investigating the effects of omecamtiv mecarbil (formerly CK-1827452), given intravenously for 2, 24, or 72 h to patients with stable heart failure and left ventricular systolic dysfunction receiving guideline-indicated treatment. Clinical assessment (including vital signs, echocardiograms, and electrocardiographs) and testing of plasma drug concentrations took place during and after completion of each infusion. The primary aim was to assess safety and tolerability of omecamtiv mecarbil. This study is registered at ClinicalTrials.gov, NCT00624442. FINDINGS: 45 patients received 151 infusions of active drug or placebo. Placebo-corrected, concentration-dependent increases in left ventricular ejection time (up to an 80 ms increase from baseline) and stroke volume (up to 9·7 mL) were recorded, associated with a small reduction in heart rate (up to 2·7 beats per min; p<0·0001 for all three measures). Higher plasma concentrations were also associated with reductions in end-systolic (decrease of 15 mL at >500 ng/mL, p=0·0026) and end-diastolic volumes (16 mL, p=0·0096) that might have been more pronounced with increased duration of infusion. Cardiac ischaemia emerged at high plasma concentrations (two patients, plasma concentrations roughly 1750 ng/mL and 1350 ng/mL). For patients tolerant of all study drug infusions, no consistent pattern of adverse events with either dose or duration emerged. INTERPRETATION: Omecamtiv mecarbil improved cardiac function in patients with heart failure caused by left ventricular dysfunction and could be the first in class of a new therapeutic agent. FUNDING: Cytokinetics Inc.

Burden of sodium abnormalities in patients hospitalized for heart failure.

Hyponatremia presumably is associated with adverse clinical outcomes in patients with congestive heart failure (CHF), but risk thresholds and economic burden are less studied. The authors analyzed 115,969 patients hospitalized for CHF and grouped them by serum sodium levels (severe hyponatremia, ≤130 mEq/L; hyponatremia, 131-135 mEq/L; normonatremia, 136-145 mEq/L; hypernatremia, >145 mEq/L). Univariable and multivariable analyses on the associated clinical and economic outcomes were performed. The most common abnormality was hyponatremia (15.9%), followed by severe hyponatremia (5.3%) and hypernatremia (3.2%). Hospital mortality was highest for severe hyponatremia (7.6%), followed by hypernatremia (6.7%) and hyponatremia (4.9%) (P<.0001). Compared with normonatremia, risk-adjusted mortality was highest for severe hyponatremia (odds ratio [OR], 1.78; 95% confidence interval [CI], 1.59-1.99), followed by hypernatremia (OR, 1.55; 95% CI, 1.34-1.80) and hyponatremia (OR, 1.29; 95% CI, 1.19-1.40; all P<.0001). Risk-adjusted hospital prolongation was greater for each level of sodium abnormality than for normonatremia, ranging from 0.42 (CI, 0.26-0.60) days for hypernatremia to 1.28 (CI, 1.11-1.47) days for severe hyponatremia. Risk-adjusted attributable hospital cost increase was highest for severe hyponatremia ($1132; CI, $856-$1425; all (P<.0001). Sodium abnormalities were common in patients hospitalized for CHF. Adverse outcomes resulted not only from severe hyponatremia, but also from mild hyponatremia and hypernatremia.

Ultrafiltration is associated with fewer rehospitalizations than continuous diuretic infusion in patients with decompensated heart failure: results from UNLOAD.

BACKGROUND: Compare outcomes of ultrafiltration (UF) versus standard intravenous (IV) diuretics by continuous infusion or bolus injection in volume overloaded heart failure (HF) patients. In the Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated heart Failure (UNLOAD) study, UF produced greater fluid reduction and fewer HF rehospitalizations than IV diuretics in 200 hospitalized HF patients. Outcomes may be due to greater fluid removal, but UF removes more sodium/unit volume than diuretics. METHODS AND RESULTS: Outcomes of 100 patients randomized to UF were compared with those of patients randomized to standard IV diuretic therapy with continuous infusion (32) or bolus injections (68). Choice of diuretic therapy was by the treating physician. Forty-eight hour weight loss (kg): 5.0 +/- 3.1 UF, 3.6 +/- 3.5 continuous infusion, and 2.9 +/- 3.5 bolus diuretics (P = .001 UF versus bolus diuretic; P > .05 for the other comparisons). Net fluid loss (L): 4.6 +/- 2.6 UF, 3.9 +/- 2.7 continuous infusion, and 3.1 +/- 2.6 bolus diuretics (P < .001 UF versus bolus diuretic; P > .05 for the other comparisons). At 90 days, rehospitalizations plus unscheduled visits for HF/patient (rehospitalization equivalents) were fewer in UF group (0.65 +/- 1.36) than in continuous infusion (2.29 +/- 3.23; P = .016 versus UF) and bolus diuretics (1.31 +/- 1.87; P = .050 versus UF) groups. No serum creatinine differences occurred between groups up to 90 days. CONCLUSIONS: Despite similar fluid loss with UF and continuous diuretic infusion, fewer HF rehospitalizations equivalents occurred only with UF. Removal of isotonic fluid by UF compared with hypotonic urine by diuretics more effectively reduces total body sodium in congested HF patients.

The safety of intravenous diuretics alone versus diuretics plus parenteral vasoactive therapies in hospitalized patients with acutely decompensated heart failure: a propensity score and instrumental variable analysis using the Acutely Decompensated Heart Failure National Registry (ADHERE) database.

BACKGROUND: The treatment of acute decompensated heart failure remains problematic and most often requires parenteral therapies. Significant concerns have been expressed regarding risks and benefits of individual therapies, especially nesiritide (NES), but few studies have compared the relative safety of varied intravenous therapies on clinical outcomes. METHODS: We compared the safety of intravenous diuretics (DIUR), inotropes (INO), and vasodilators (nitroglycerin [NTG]) on mortality rates and worsening renal function in 99,963 inpatients with acutely decompensated heart failure (ADHF). Patients with a diagnosis of ADHF within 48 hours were grouped by intended primary treatment (intravenous agents administered during the first 2 hours of intravenous therapy). Treatments studied were (a) intended monotherapy (DIUR), (b) intended combination therapy (DIUR + NES, NTG, or INO), and (c) sequential therapy (intended DIUR monotherapy followed by a second agent administered >2 hours later). Propensity-matched cohorts and instrumental analysis were used to adjust for differences among patients in treatment groups. RESULTS: Intended DIUR monotherapy yielded an unadjusted inpatient mortality rate of 3.2%. After intended DIUR monotherapy, inpatient mortality was not higher for sequential use of NES than for sequential use of NTG (3.4% vs 6.2%, P = .0028). In all regimens, INOs were associated with higher inpatient mortality than were diuretics or vasodilators used alone. The rate of worsening renal function was higher with combination of diuretic-based regimens with NES (risk ratio 1.44, P < .0001) or NTG (RR 1.2, P = .012) compared with diuretics alone. CONCLUSIONS: Compared with alternative intravenous regimens, administration of vasodilators, including NES, was not associated with increased inpatient mortality. A large randomized controlled clinical trial is being planned to prospectively address the question of risks and benefits of NES for ADHF.

Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure.

OBJECTIVES: This study was designed to compare the safety and efficacy of veno-venous ultrafiltration and standard intravenous diuretic therapy for hypervolemic heart failure (HF) patients. BACKGROUND: Early ultrafiltration may be an alternative to intravenous diuretics in patients with decompensated HF and volume overload. METHODS: Patients hospitalized for HF with > or =2 signs of hypervolemia were randomized to ultrafiltration or intravenous diuretics. Primary end points were weight loss and dyspnea assessment at 48 h after randomization. Secondary end points included net fluid loss at 48 h, functional capacity, HF rehospitalizations, and unscheduled visits in 90 days. Safety end points included changes in renal function, electrolytes, and blood pressure. RESULTS: Two hundred patients (63 +/- 15 years, 69% men, 71% ejection fraction < or =40%) were randomized to ultrafiltration or intravenous diuretics. At 48 h, weight (5.0 +/- 3.1 kg vs. 3.1 +/- 3.5 kg; p = 0.001) and net fluid loss (4.6 vs. 3.3 l; p = 0.001) were greater in the ultrafiltration group. Dyspnea scores were similar. At 90 days, the ultrafiltration group had fewer patients rehospitalized for HF (16 of 89 [18%] vs. 28 of 87 [32%]; p = 0.037), HF rehospitalizations (0.22 +/- 0.54 vs. 0.46 +/- 0.76; p = 0.022), rehospitalization days (1.4 +/- 4.2 vs. 3.8 +/- 8.5; p = 0.022) per patient, and unscheduled visits (14 of 65 [21%] vs. 29 of 66 [44%]; p = 0.009). No serum creatinine differences occurred between groups. Nine deaths occurred in the ultrafiltration group and 11 in the diuretics group. CONCLUSIONS: In decompensated HF, ultrafiltration safely produces greater weight and fluid loss than intravenous diuretics, reduces 90-day resource utilization for HF, and is an effective alternative therapy. (The UNLOAD trial; http://clinicaltrials.gov/ct/show/NCT00124137?order=1; NCT00124137).

B-type natriuretic peptide (BNP) levels and ethnic disparities in perceived severity of heart failure: results from the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) multicenter study of BNP levels and emergency department decision making in patients presenting with shortness of breath.

BACKGROUND: Previous studies have shown that in patients presenting to the emergency department (ED) with heart failure, there is a disconnect between the perceived severity of congestive heart failure (CHF) by physicians and the severity as determined by B-type natriuretic peptide (BNP) levels. Whether ethnicity plays a role in this discrepancy is unknown. METHODS AND RESULTS: The Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) was a 10-center trial of 464 patients seen in the ED with acute dyspnea and BNP level higher than 100 pg/mL on arrival. Physicians were blinded to BNP levels. Patients were followed for 90 days after discharge. A total of 151 patients identified themselves as white (32.5%) and 294 as black (63.4%). Of these, 90% were hospitalized. African Americans were more likely to be perceived as New York Heart Association class I or II than whites (P = .01). Blacks who were discharged from the ED had higher median BNP levels than whites who were discharged (1293 vs. 533, P = .004). The median BNP of blacks who were discharged was actually higher than the median BNP of blacks who were admitted (1293 vs. 769, P = .04); the same did not hold true for whites. BNP was predictive of 90-day outcome in both blacks and whites; however, perceived severity of CHF, race, and ED disposition did not contribute to the prediction of events. CONCLUSION: In patients presenting to the ED with heart failure, the disconnect between perceived severity of CHF and severity as determined by BNP levels is most pronounced in African Americans.

Gray zone BNP levels in heart failure patients in the emergency department: results from the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT) multicenter study.

OBJECTIVES: The study purpose was to examine "gray zone" B-type natriuretic peptide (BNP) levels (100-500 pg/mL) in terms of associated clinical factors, perceived severity, and outcomes in patients with established congestive heart failure (CHF). BACKGROUND: Although gray zone BNP levels may have diagnostic ambiguity, the implications of these levels in patients with an established diagnosis of CHF have not been examined. METHODS: REDHOT was a national prospective study in which 464 patients seen in the emergency department with dyspnea had BNP levels drawn. Entrance criteria included a BNP > 100 pg/mL; however, physicians were blinded to the actual BNP level. Patients were followed up for 90 days. RESULTS: Thirty-three percent had gray zone BNP levels. There was no difference in perceived New York Heart Association class (P = .32) or admission rates (P = .76) between the gray zone and non-gray zone groups; 62% of patients with a gray zone BNP were identified as class III or IV CHF. Despite this perceived severity, the 90-day event rate was lower in the gray zone group (19.2% vs 32.9%, respectively, P = .002). Although patients in the gray zone had more symptoms of concomitant pulmonary disease, multivariate analysis could not demonstrate any variable that worsened the prognosis of patients with a gray zone BNP level. CONCLUSIONS: In patients with established CHF, those with gray zone BNP levels have a better prognosis than those with non-gray zone levels despite being perceived by physicians as having New York Heart Association class III or IV CHF.

Early ultrafiltration in patients with decompensated heart failure and diuretic resistance.

OBJECTIVES: We sought to determine if ultrafiltration before intravenous (IV) diuretics in patients with decompensated heart failure and diuretic resistance results in euvolemia and early discharge without hypotension or worsening renal function. BACKGROUND: Heart failure patients with renal insufficiency and diuretic resistance have increased hospital mortality and length of stay. Peripheral veno-venous ultrafiltration may re-establish euvolemia and diuretic responsiveness. METHODS: Ultrafiltration was initiated within 4.7 +/- 3.5 h of hospitalization and before IV diuretics in 20 heart failure patients with volume overload and diuretic resistance (age 74.5 +/- 8.2 years; 75% ischemic disease; ejection fraction 31 +/- 15%) and continued until euvolemia. Re-evaluation was each hospital day, at 30 days, and at 90 days. RESULTS: A total of 8,654 +/- 4,205 ml were removed with ultrafiltration. Twelve patients (60%) were discharged in < or =3 days. One patient was readmitted in 30 days. Weight (p = 0.006), Minnesota Living with Heart Failure scores (p = 0.003), and Global Assessment (p = 0.00003) improved after ultrafiltration and at 30 and 90 days. Median B-type natriuretic peptide levels decreased after ultrafiltration (from 1,230 pg/ml to 788 pg/ml) and at 30 days (815 pg/ml) (p = 0.035). Blood pressure, renal function, and medications were unchanged. CONCLUSIONS: In heart failure patients with volume overload and diuretic resistance, ultrafiltration before IV diuretics effectively and safely decreases length of stay and readmissions. Clinical benefits persist at three months.

Strategies to reduce length of stay and costs associated with decompensated heart failure.

Heart failure (HF) is a major medical problem in the United States, imposing significant economic burden on the health care system. Despite therapeutic advances, HF-associated morbidity and mortality continue to increase. Compliance with therapeutic guidelines for the management of chronic HF is far from ideal, increasing the likelihood that patients will experience multiple episodes of acute decompensated heart failure (ADHF) during the course of HF disease. Prevention, streamlined inpatient care, effective vasoactive therapy, and initiation of proven long-term therapies, including angiotensin-converting enzyme (ACE) inhibitors and beta-blockers, are all targets for improvement. Because of the chronic nature of heart failure, a successful disease management program for ADHF must also include effective outpatient care.

Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath.

OBJECTIVES: The purpose of this study was to examine the relationships among B-type natriuretic peptide (BNP) levels within the diagnostic range, perceived congestive heart failure (CHF) severity, clinical decision making, and outcomes of the CHF patients presenting to emergency department (ED). BACKGROUND: Since BNP correlates with the presence of CHF, disease severity, and prognosis, we hypothesized that BNP levels in the diagnostic range offer value independent of physician decision making with regard to critical outcomes in emergency medicine. METHODS: The Rapid Emergency Department Heart failure Outpatient Trial (REDHOT) study was a 10-center trial in which patients seen in the ED with shortness of breath were consented to have BNP levels drawn on arrival. Entrance criteria included a BNP level >100 pg/ml. Physicians were blinded to the actual BNP level and subsequent BNP measurements. Patients were followed up for 90 days after discharge. RESULTS: Of the 464 patients, 90% were hospitalized. Two-thirds of patients were perceived to be New York Heart Association (NYHA) functional class III or IV. The BNP levels did not differ significantly between patients who were discharged home from the ED and those admitted (976 vs. 766, p = 0.6). Using logistic regression analysis, an ED doctor's intention to admit or discharge a patient had no influence on 90-day outcomes, while the BNP level was a strong predictor of 90-day outcome. Of admitted patients, 11% had BNP levels <200 pg/ml (66% of which were perceived NYHA functional class III or IV). The 90-day combined event rate (CHF visits or admissions and mortality) in the group of patients admitted with BNP <200 pg/ml and >200 pg/ml was 9% and 29%, respectively (p = 0.006). CONCLUSIONS: In patients presenting to the ED with heart failure, there is a disconnect between the perceived severity of CHF by ED physicians and severity as determined by BNP levels. The BNP levels can predict future outcomes and thus may aid physicians in making triage decisions about whether to admit or discharge patients. Emerging clinical data will help further refine biomarker-guided outpatient therapeutic and monitoring strategies involving BNP.

Safety and feasibility of using serial infusions of nesiritide for heart failure in an outpatient setting (from the FUSION I trial).

The Follow-Up Serial Infusions of Nesiritide pilot study was designed to assess the safety and tolerability of outpatient serial infusions of nesiritide in 210 patients with decompensated heart failure who were randomly assigned to usual care only or usual care plus weekly infusions of nesiritide at dosages of 0.005 or 0.01 microg/kg/min for 12 weeks. The mean age +/- SD of the entire population was 67 +/- 13 years; 70% were men, and 80% were white. Mean baseline serum creatinine levels were 1.8 +/- 0.7 mg/dl, and mean left ventricular ejection fraction was 0.28 +/- 0.15%. Diabetes mellitus was present in 106 patients (50%), and atrial arrhythmias were present in 100 patients (48%). A totalof 1,645 nesiritide infusions was administered; 11 (< 1%) were discontinued due to an adverse event. All treatment groups had a similar frequency of adverse events and experienced improvements in quality of life. Administration of nesiritide resulted in acute decreases in aldosterone and endothelin-1 concentrations. Although there were no statistically significant differences among groups by outcome, prospectively defined higher risk subgroups demonstrated significant decreases in cardiovascular events. These results demonstrate the safety and feasibility of administering nesiritide in an outpatient setting. Additional studies are needed to determine the effect of outpatient serial infusions of nesiritide on rates of morbidity and mortality in advanced heart failure.