J. Thomas Heywood

Improving Evidence-Based Care for Heart Failure in Outpatient Cardiology Practices Primary Results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)

Background— A treatment gap exists between heart failure (HF) guidelines and the clinical care of patients. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) prospectively tested a multidimensional practice-specific performance improvement intervention on the use of guideline-recommended therapies for HF in outpatient cardiology practices. Methods and Results— Performance data were collected in a random sample of HF patients from 167 US outpatient cardiology practices at baseline, longitudinally after intervention at 12 and 24 months, and in single-point-in-time patient cohorts at 6 and 18 months. Participants included 34 810 patients with reduced left ventricular ejection fraction (≤35%) and chronic HF or previous myocardial infarction. To quantify guideline adherence, 7 quality measures were assessed. Interventions included clinical decision support tools, structured improvement strategies, and chart audits with feedback. The performance improvement intervention resulted in significant improvements in 5 of 7 quality measures at the 24-month assessment compared with baseline: &bgr;-blocker (92.2% versus 86.0%, +6.2%), aldosterone antagonist (60.3% versus 34.5%, +25.1%), cardiac resynchronization therapy (66.3% versus 37.2%, +29.9%), implantable cardioverter-defibrillator (77.5% versus 50.1%, +27.4%), and HF education (72.1% versus 59.5%, +12.6%) (each P<0.001). There were no statistically significant improvements in angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use or anticoagulation for atrial fibrillation. Sensitivity analyses at the patient level and limited to patients with both baseline and 24-month quality measure data yielded similar results. Improvements in the single-point-in-time cohorts were smaller, and there were no concurrent control practices. Conclusions— The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting, a defined and scalable practice-specific performance improvement intervention, was associated with substantial improvements in the use of guideline-recommended therapies in eligible patients with HF in outpatient cardiology practices. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00303979.

Physician-Directed Patient Self-Management of Left Atrial Pressure in Advanced Chronic Heart Failure

Background— Previous studies suggest that management of ambulatory hemodynamics may improve outcomes in chronic heart failure. We conducted a prospective, observational, first-in-human study of a physician-directed patient self-management system targeting left atrial pressure. Methods and Results— Forty patients with reduced or preserved left ventricular ejection fraction and a history of New York Heart Association class III or IV heart failure and acute decompensation were implanted with an investigational left atrial pressure monitor, and readings were acquired twice daily. For the first 3 months, patients and clinicians were blinded as to these readings, and treatment continued per usual clinical assessment. Thereafter, left atrial pressure and individualized therapy instructions guided by these pressures were disclosed to the patient. Event-free survival was determined over a median follow-up of 25 months (range 3 to 38 months). Survival without decompensation was 61% at 3 years, and events tended to be less frequent after the first 3 months (hazard ratio 0.16 [95% confidence interval 0.04 to 0.68], P=0.012). Mean daily left atrial pressure fell from 17.6 mm Hg (95% confidence interval 15.8 to 19.4 mm Hg) in the first 3 months to 14.8 mm Hg (95% confidence interval 13.0 to 16.6 mm Hg; P=0.003) during pressure-guided therapy. The frequency of elevated readings (>25 mm Hg) was reduced by 67% (P<0.001). There were improvements in New York Heart Association class (−0.7±0.8, P<0.001) and left ventricular ejection fraction (7±10%, P<0.001). Doses of angiotensin-converting enzyme/angiotensin-receptor blockers and &bgr;-blockers were uptitrated by 37% (P<0.001) and 40% (P<0.001), respectively, whereas doses of loop diuretics fell by 27% (P=0.15). Conclusions— Physician-directed patient self-management of left atrial pressure has the potential to improve hemodynamics, symptoms, and outcomes in advanced heart failure. Clinical Trial Registration Information— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00547729.

Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings from IMPROVE HF

Background—Few data exist regarding contemporary care patterns for heart failure (HF) in the outpatient setting. IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and ejection fraction ≤35% in a national registry of 167 US outpatient cardiology practices. Methods and Results—Baseline patient characteristics and data on care of 15 381 patients with diagnosed HF or prior myocardial infarction and left ventricular dysfunction were collected by chart abstraction. To quantify use of therapies, 7 individual metrics (use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, &bgr;-blocker, aldosterone antagonist, anticoagulation, implantable cardioverter defibrillator, cardiac resynchronization therapy, and HF education) and composite metrics were assessed. Care metrics include only patients documented to be eligible and without contraindications or intolerance. Among practices, 69% were nonteaching. Patients were 71% male, with a median age of 70 years, and a median ejection fraction of 25%. Use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (80%) and &bgr;-blocker (86%) was relatively high in eligible patients in the outpatient cardiology setting; other metrics, such as aldosterone antagonist (36%), device therapy (implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator, 51%; cardiac resynchronization therapy, 39%), and education (61%), showed lower rates of use. A median 27% of patients received all HF therapies for which they were potentially eligible on the basis of chart documentation. Use of guideline-recommended therapies by practices varied widely. Conclusions—These data are among the first to assess treatment in the outpatient setting since the release of the latest national HF guidelines and to demonstrate substantial variation among cardiology practices in the documented therapies provided to HF patients.

THE CARDIORENAL SYNDROME: LESSONS FROM THE ADHERE DATABASE AND TREATMENT OPTIONS

Significant renal dysfunction is common in patients hospitalized for heart failure and carries a grim prognosis. Patients with heart failure who have or develop renal dysfunction while being treated for heart failure are said to have the cardiorenal syndrome. The Acute Decompensated Heart Failure National Registry (ADHERE®) database, which enrolled nonselected patients admitted to the hospital for acute decompensated heart failure (ADHF), was used to determine the causes for this renal dysfunction and whether treatment can optimize outcomes. Results show that the average patient admitted for ADHF is older than those typically enrolled in clinical trials and has at least moderate kidney damage, with significantly impaired glomerular filtration rates. Renal dysfunction in patients with heart failure is complex and often multifactorial in origin, but the syndrome may be reversible in some patients. Reduction of angiotensin II levels with angiotensin-converting enzyme (ACE) inhibitors may prevent glomerular hyperfiltration and ultimately preserve renal function; however, patients who are volume-depleted may be especially sensitive to ACE inhibitor–induced efferent arteriolar dilation, so ACE inhibitor therapy in patients with renal dysfunction should be initiated when the patient is volume replete. In conclusion, impaired renal function is common in heart failure patients and may be a key cause of the cascade involving fluid retention, decompensation, and eventual hospital admission. Future pharmacologic research should focus on therapies aimed at maintaining or improving renal function in heart failure patients to reduce the high mortality associated with the cardiorenal syndrome.

Influence of patient age and sex on delivery of guideline-recommended heart failure care in the outpatient cardiology practice setting: Findings from IMPROVE HF

BACKGROUND The influence of patient age and sex on delivery of guideline-recommended heart failure (HF) therapies in contemporary outpatient settings has not been well studied. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) is a prospective cohort study designed to characterize current management of outpatients with chronic HF and left ventricular ejection fraction < or =35%. METHODS Baseline data for eligible patients with systolic HF in a national registry of 167 US outpatient cardiology practices were collected by trained chart abstractors. Data were stratified and analyzed as male/female and by age tertiles with generalized estimating equation models constructed for 7 care measures. RESULTS A total of 15,381 patients were enrolled, with 8,770 (71.1%) of these male. Median age of female patients was 72.0 and 70.0 for males. Use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone inhibitors, and cardiac resynchronization therapy was not significantly different between male and female patients, but rates for implantable cardioverter defibrillators, anticoagulation therapy for atrial fibrillation, and HF education were significantly lower for females. After adjusting for patient and practice characteristics, 3 of 7 measures significantly differed by patient sex, and 6 of 7 measures by age. Older patients, particularly older women, were significantly less likely to receive guideline-indicated HF therapies. CONCLUSIONS Patient age and sex were independently associated with reduced rates of some, but not all, HF therapies in outpatient cardiology practices. Older women are especially at risk. Further research is needed to understand the causes and consequences of these age- and sex-related differences in care.

Heart Failure Care in the Outpatient Cardiology Practice SettingCLINICAL PERSPECTIVE

Background—Few data exist regarding contemporary care patterns for heart failure (HF) in the outpatient setting. IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and ejection fraction ≤35% in a national registry of 167 US outpatient cardiology practices. Methods and Results—Baseline patient characteristics and data on care of 15 381 patients with diagnosed HF or prior myocardial infarction and left ventricular dysfunction were collected by chart abstraction. To quantify use of therapies, 7 individual metrics (use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, &bgr;-blocker, aldosterone antagonist, anticoagulation, implantable cardioverter defibrillator, cardiac resynchronization therapy, and HF education) and composite metrics were assessed. Care metrics include only patients documented to be eligible and without contraindications or intolerance. Among practices, 69% were nonteaching. Patients were 71% male, with a median age of 70 years, and a median ejection fraction of 25%. Use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (80%) and &bgr;-blocker (86%) was relatively high in eligible patients in the outpatient cardiology setting; other metrics, such as aldosterone antagonist (36%), device therapy (implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator, 51%; cardiac resynchronization therapy, 39%), and education (61%), showed lower rates of use. A median 27% of patients received all HF therapies for which they were potentially eligible on the basis of chart documentation. Use of guideline-recommended therapies by practices varied widely. Conclusions—These data are among the first to assess treatment in the outpatient setting since the release of the latest national HF guidelines and to demonstrate substantial variation among cardiology practices in the documented therapies provided to HF patients.

Intravenous diltiazem for the treatment of patients with atrial fibrillation or flutter and moderate to severe congestive heart failure

The objective of this multicenter, randomized, double-blind, placebo-controlled study was to determine the safety and efficacy of intravenous diltiazem in the treatment of 37 patients with rapid (ventricular rate, mean +/- SD 142 +/- 17 beats/min) atrial fibrillation or flutter and moderate to severe congestive heart failure (ejection fraction, mean +/- SD 36 +/- 14%; New York Heart Association class III [23 patients], class IV [14 patients]). During the double-blind portion of the study, patients received either intravenous diltiazem, 0.25 mg/kg over 2 minutes, or placebo followed 15 minutes later by diltiazem or placebo, 0.35 mg/kg over 2 minutes, if the first dose was tolerated but ineffective. Placebo nonresponders were given open-label intravenous diltiazem in a similar fashion as in the double-blind portion of the study. In the double-blind part of the study, 21 (18 with 0.25 mg/kg, 3 with an additional 0.35 mg/kg) of the 22 patients (95%) responded to diltiazem, and 0 of 15 patients (0%) responded to placebo (p < 0.001). All 15 patients (13 with 0.25 mg/kg and 2 with an additional 0.35 mg/kg) who received placebo during the double-blind period had a therapeutic response to diltiazem during open-label therapy. Overall, 36 of 37 patients (97%) had a therapeutic response to intravenous diltiazem. Heart rate response to diltiazem after the 2-minute bolus infusions consisted of a > or = 20% decrease in heart rate from baseline in 36 patients; in addition, 17 patients also had heart rates decreased to < 100 beats/min, whereas no patient had conversion to sinus rhythm.(ABSTRACT TRUNCATED AT 250 WORDS)

Factors associated with improvement in ejection fraction in clinical practice among patients with heart failure: Findings from IMPROVE HF

BACKGROUND Available data suggest that improvement in left ventricular ejection fraction (LVEF) is a major predictor of improved survival in heart failure (HF). Although certain factors are associated with improvements in LVEF in select patients with HF enrolled in clinical trials, relatively little is known about such factors among patients in clinical practice. This study evaluated changes in LVEF and associated factors in outpatients with systolic HF or post-myocardial infarction with reduced LVEF during 24 months of follow-up. METHODS IMPROVE HF is a prospective evaluation of a practice-based performance improvement intervention implemented at outpatient cardiology/multispecialty practices to increase use of guideline-recommended care for eligible patients. Data were analyzed by patient groups based on absolute improvement in LVEF (<0%, 0-≤10%, and >10%) from baseline to 24 months and by change in LVEF as a continuous variable. RESULTS A total of 3,994 patients from 155 of 167 practices were eligible for analysis. The overall mean LVEF increased from 25.8% at baseline to 32.3% (+6.4%) at 24 months (P < .001), and 28.6% of patients had a >10% improvement in ejection fraction (from 24.5% to 46.2%, 92% relative improvement). Age, race, and practice setting were similar between the 3 LVEF improvement groups. Multivariate analysis revealed female sex, no prior myocardial infarction, nonischemic HF etiology, and no digoxin use were associated with >10% improvement in LVEF. CONCLUSIONS Among patients with HF receiving care in cardiology/multispecialty practices participating in a performance measure intervention, surviving, and having repeat LVEF assessment, close to one third of patients had a >10% improvement in LVEF at 24 months. These findings indicate that HF is not always a progressive disease and that differentiation of the heterogeneous HF phenotypes may set the stage for future research and therapeutic targets.

Associations Between Outpatient Heart Failure Process-of-Care Measures and Mortality

Background— Assessment of the quality of care for outpatients with heart failure (HF) has focused on the development and use of process-based performance measures, with the supposition that these care process measures are associated with clinical outcomes. However, this association has not been evaluated for current and emerging outpatient HF measures. Methods and Results— Performance on 7 HF process measures (4 current and 3 emerging) and 2 summary measures was assessed at baseline in patients from 167 US outpatient cardiology practices with patients prospectively followed up for 24 months. Participants included 15 177 patients with reduced left ventricular ejection fraction (⩽35%) and chronic HF or post–myocardial infarction. Multivariable analyses were performed to assess the process-outcome relationship for each measure in eligible patients. Vital status was available for 11 621 patients. The mortality rate at 24 months was 22.1%. Angiotensin-converting enzyme inhibitor or angiotensin receptor blocker use, &bgr;-blocker use, anticoagulant therapy for atrial fibrillation, cardiac resynchronization therapy, implantable cardioverter-defibrillators, and HF education for eligible patients were each independently associated with improved 24-month survival, whereas aldosterone antagonist use was not. The all-or-none and composite care summary measures were also independently associated with improved survival. Each 10% improvement in composite care was associated with a 13% lower odds of 24-month mortality (adjusted odds ratio, 0.87; 95% confidence interval, 0.84 to 0.90; P<0.0001). Conclusions— Current and emerging outpatient HF process measures are positively associated with patient survival. These HF measures may be useful for assessing and improving HF care. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00303979.

Continuous Hemodynamic Monitoring in Patients With Mild to Moderate Heart Failure: Results of the Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCEhf) Trial

Clinical trial results support the hypothesis that implantable hemodynamic monitoring (IHM) systems may reduce hospitalizations among patients with chronic heart failure (HF). The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCE hf  ) study was a prospective, randomized, multicenter, single-blinded trial that enrolled patients with New York Heart Association class II or III symptoms, an indication for an implantable cardioverter-defibrillator (ICD), and a previous HF hospitalization. A combination IHM-ICD was implanted and patients were randomly assigned to a treatment group in which hemodynamic information was used or a control group in which hemodynamic information was not available. Patients were followed for 12 months to evaluate the primary efficacy end point of HF hospitalizations, emergency department visits, or urgent clinic visits. The trial was designed to enroll 1300 patients, but stopped at 400 patients because of IHM lead failures experienced from previous trials. A total of 202 treatment patients and 198 controls were randomized for 12-month follow-up. The primary safety end point was met, but the rate of HF equivalents was not different between groups. REDUCE hf was unable to test clinical efficacy end points adequately. The device combining IHM-ICD technology was safe and functioned appropriately. Patients at high risk for decompensated HF have high baseline filling pressures and demonstrate consistent increases as the process of congestion worsens to the time of hospitalization.