Mark L. McBride

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.

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.

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.

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.

Medication Dosing in Outpatients With Heart Failure After Implementation of a Practice-Based Performance Improvement Intervention: Findings From IMPROVE HF

Eligible outpatients with heart failure (HF) and reduced left ventricular ejection fraction (LVEF) frequently do not receive target doses of HF medications. The Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) evaluated the effect of a practice-based performance improvement intervention on treatment of outpatients with LVEF ≤35%. Specific agent and dose were collected at baseline and 24 months for angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), β-blockers, and aldosterone antagonists. Changes in dosing over time were analyzed for each medication class. Data were available for 7605 patients. At baseline, target dose treatment rates were 36.1%, 20.5%, and 74.4%, respectively. Absolute and relative improvements of 9.8% and 47.7% ( P<.001) were achieved for β-blocker dosing at 24 months. The IMPROVE HF intervention was associated with significantly increased treatment of eligible patients with target doses of β-blockers but not ACE inhibitors/ARBs or aldosterone antagonists. Additional research to determine barriers to use of target doses of HF medications may be necessary.

Cardiac resynchronization therapy utilization for heart failure: Findings from IMPROVE HF

BACKGROUND Cardiac resynchronization therapy (CRT) has established efficacy for patients with systolic heart failure (HF). Treatment rates and factors associated with CRT utilization among eligible patients in outpatient cardiology practices have not been well studied. METHODS IMPROVE HF is a prospective cohort study designed to characterize current management of patients with chronic HF and left ventricular ejection fraction <or=35% in a registry of outpatient cardiology practices located throughout the United States. Baseline data were abstracted by trained chart review specialists from May 31, 2005, through June 22, 2007, for 15,381 patients attending 167 outpatient cardiology practices. Multivariable analyses of patient and practice characteristics identified predictors of CRT for eligible patients. RESULTS A total of 1,373 patients were eligible for CRT based on current guideline criteria, and 533 (38.8%) received a CRT device, with 84.1% of these treated with a CRT-defibrillator. Cardiac resynchronization therapy use varied widely among practices, with 11.1% at the 25th percentile and 53.4% at the 75th percentile. Patient age, insurance, longer QRS duration, and practice location were independently associated with higher CRT utilization rates among eligible patients, whereas sex, HF etiology, and other clinical and laboratory parameters were not. CONCLUSIONS Despite being evidence based and guideline recommended, CRT is underutilized in eligible patients with significant variations associated with age, insurance, QRS duration, and geographic location of practices. Practice-specific performance improvement initiatives may be needed to reduce variations in use of CRT for eligible patients.

Comparison of Medical Therapy Dosing in Outpatients Cared for in Cardiology Practices With Heart Failure and Reduced Ejection Fraction With and Without Device Therapy Report From IMPROVE HF

Background—Few data exist to characterize the delivery of evidence-based medical therapy for outpatients with heart failure who have received implantable cardioverter-defibrillators or cardiac resynchronization therapy (CRT) for systolic dysfunction. Methods and Results—IMPROVE HF is a prospective study characterizing the management of 15 381 outpatients with systolic heart failure (left ventricular ejection fraction ⩽35%) enrolled from 167 US cardiology practices. Data were abstracted for dose, type, and daily frequency for angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, &bgr;-blockers, and aldosterone antagonists. Target doses for each medication class were based on current guidelines. Patients with devices (implantable cardioverter-defibrillators, CRT with defibrillators, or CRT with pacemakers) more frequently received evidence-based medical therapy than did those without such devices, although treatment at or above target doses was low for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (implantable cardioverter-defibrillators 32.6%, CRT with pacemaker 30.7%, CRT with defibrillator 32.0%, no device 34.6%) and &bgr;-blockers (20.2%, 17.4%, 20.4%, and 15.3%, respectively). Fewer patients received aldosterone antagonists, although when used, doses were more frequently within the target dosing range (70.1%, 72.1%, 72.7%, and 76.5%, respectively). Multivariable models showed that use of CRT with defibrillators and CRT with pacemakers was significantly associated with delivery of &bgr;-blockers at or above target doses, but no device therapies were associated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker or aldosterone antagonist dosing. Conclusions—Patients treated with heart failure devices received evidence-based medical therapy at similar or greater frequency than did those without such devices. Patients with CRT with defibrillator or CRT with pacemaker devices were more likely to be treated with target doses of &bgr;-blockers than were patients not treated with device therapy. Doses of evidenced-based therapies remain significantly lower in clinical practice than in clinical trials. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00303979.

Evidence of clinical practice heterogeneity in the use of implantable cardioverter-defibrillators in heart failure and post-myocardial infarction left ventricular dysfunction: Findings from IMPROVE HF.

BACKGROUND Clinical guidelines recommend implantable cardioverter-defibrillators (ICDs) for selected patients with chronic left ventricular dysfunction (LVD) to improve survival, yet ICD treatment rates for eligible patients with LVD or heart failure (HF) in cardiology practices remain poorly studied. OBJECTIVE This study sought to determine patient and practice characteristics associated with ICD use in the outpatient setting. METHODS IMPROVE HF (Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting), a prospective cohort study, is designed to characterize management of HF with reduced left ventricular ejection fraction (LVEF < or =35%). Baseline data were collected for 15,381 patients attending 167 outpatient cardiology practices located in the U.S. RESULTS By current guidelines, 7,221 patients met eligibility for ICD implantation (+/- cardiac resynchronization therapy [CRT]), of whom 3,659 (50.7%) received either ICD (63.8%) or CRT with defibrillator (36.2%). Individual practice conformity for guideline-recommended ICD use ranged from 0% to 100% (27.3% to 74.6% at the 10th and 90th percentiles, respectively). Adjusted analyses revealed lack of adherence for ICD use most notably with advancing age (odds ratio: 0.87; 95% confidence interval: 0.82 to 0.93 per 10 years), black race (odds ratio: 0.75; 95% confidence interval: 0.60 to 0.94), and lack of insurance (odds ratio: 0.45; 95% confidence interval: 0.26 to 0.78). Characteristics of increased adherence included male sex, ischemic disease, atrial fibrillation, and wider QRS. Practices in the Northeast U.S. were more likely to adhere to guidelines (P <.001), as were those with a dedicated HF clinic (P = .004) and electrophysiologists on staff (P <.001). CONCLUSION Although a number of patient and practice characteristics are associated with guideline-based ICD use, there is significant unexplained variation in the use of ICD therapy for sudden death prophylaxis across cardiology practices.

Adherence to Guideline-Recommended Adjunctive Heart Failure Therapies Among Outpatient Cardiology Practices (Findings from IMPROVE HF)

Although previous studies have documented adherence with certain established heart failure (HF) quality metrics in outpatient cardiology practices, the extent to which there is conformity with other evidence-based, guideline-driven quality metrics in outpatients with HF is unknown. IMPROVE HF is a prospective cohort study designed to characterize the current management of patients with chronic HF and left ventricular ejection fraction <or=35% in outpatient cardiology practices. We evaluated baseline data for conformity with adjunctive HF therapies including pneumococcal vaccinization, hydralazine/isosorbide dinitrate (HYD/ISDN) for Black patients, statin therapy, antiplatelet therapy, smoking-cessation counseling, low-density lipoprotein cholesterol levels (<100 mg/dl), and systolic blood pressure decrease (all patients <140 mm Hg or [optimal] <130 mm Hg). Baseline data were available for 15,381 patients attending 167 cardiology practices. Patient characteristics included a median age 70 years, 71.0% men, 9.1% Black patients, 65.2% with ischemic HF cause, and 61.7% with a history of hypertension. Mean adherences or documentations of adherence were only 7.3% for HYD/ISDN and 1.0% for pneumococcal vaccination. Adherence to other adjunctive therapies ranged from 27.4% to 82.0% but none of the adjunctive treatment interventions were associated with high levels of adherence. Conformity with guideline-recommended, adjunctive HF therapies is deficient in the management of outpatients with HF. Critical gaps in documentation or delivery of care exist, especially for the use of pneumococcal vaccination and HYD/ISDN. In conclusion, improved processes of care, better documentation, and/or increased measures to promote adherence to all primary and adjunctive therapies for HF are needed.