Sustained Reduction in Pulmonary Artery Pressures and Hospitalizations During 2 Years of Ambulatory Monitoring.

BACKGROUND: Therapy guided by pulmonary artery (PA) pressure monitoring reduces PA pressures and heart failure hospitalizations (HFH) during the first year, but the durability of efficacy and safety through 2 years is not known. METHODS AND RESULTS: The CardioMEMS Post-Approval Study investigated whether benefit and safety were generalized and sustained. Enrollment at 104 centers in the United States included 1200 patients with NYHA Class III symptoms on recommended HF therapies with prior HFH. Therapy was adjusted toward PA diastolic pressure 8-20 mmHg. Intervention frequency and PA pressure reduction were most intense during first 90 days, with sustained reduction of PA diastolic pressure from baseline 24.7 mmHg to 21.0 at 1 year and 20.8 at 2 years for all patients. Patients completing two year follow-up (n = 710) showed similar 2-year reduction (23.9 to 20.8 mmHg), with reduction in PA mean pressure (33.7 to 29.4 mmHg) in patients with reduced left ventricular ejection. The HFH rate was 1.25 events/patient/year prior to sensor implant, 0.54 at 1 year, and 0.37 at 2 years, with 59% of patients free of HFH during follow-up. CONCLUSIONS: Reduction in PA pressures and hospitalizations were early and sustained during 2 years of PA pressure-guided management, with no signal of safety concerns regarding the implanted sensor.

Sleep Outcomes From AWAKE-HF: A Randomized Clinical Trial of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection Fraction.

BACKGROUND: Heart failure and sleep-disordered breathing have been increasingly recognized as co-occurring conditions. Their bidirectional relationship warrants investigation into whether heart failure therapy improves sleep and sleep-disordered breathing. We sought to explore the effect of treatment with sacubitril/valsartan on sleep-related endpoints from the AWAKE-HF study. METHODS AND RESULTS: AWAKE-HF was a randomized, double-blind study conducted in 23 centers in the United States. Study participants with heart failure with reduced rejection fraction and New York Heart Association class II or III symptoms were randomly assigned to receive treatment with either sacubitril/valsartan or enalapril. All endpoints were assessed at baseline and after 8 weeks of treatment. Portable sleep-monitoring equipment was used to measure the apnea-hypopnea index, including obstructive and central events. Total sleep time, wake after sleep onset and sleep efficiency were exploratory measures assessed using wrist actigraphy. THE RESULTS WERE AS FOLLOWS: 140 patients received treatment in the double-blind phase (sacubitril/valsartan, n = 70; enalapril, n = 70). At baseline, 39% and 40% of patients randomly assigned to receive sacubitril/valsartan or enalapril, respectively, presented with undiagnosed, untreated, moderate-to-severe sleep-disordered breathing (≥ 15 events/h), and nearly all had obstructive sleep apnea. After 8 weeks of treatment, the mean 4% apnea-hypopnea index changed minimally from 16.3/h to 15.2/h in the sacubitril/valsartan group and from 16.8/h to 17.6/h in the enalapril group. Mean total sleep time was long at baseline and decreased only slightly in both treatment groups at week 8 (-14 and -11 minutes for sacubitril/valsartan and enalapril, respectively), with small changes in wake after sleep onset and sleep efficiency in both groups. CONCLUSIONS: In a cohort of patients with heart failure with reduced rejection fraction who met prescribing guidelines for sacubitril/valsartan, one-third had undiagnosed moderate-to-severe obstructive sleep apnea. The addition of sacubitril/valsartan therapy did not significantly improve sleep-disordered breathing or sleep duration or efficiency. Patients who meet indications for treatment with sacubitril/valsartan should be evaluated for sleep-disordered breathing.

Impact of Practice-Based Management of Pulmonary Artery Pressures in 2000 Patients Implanted With the CardioMEMS Sensor.

BACKGROUND: Elevated pulmonary artery (PA) pressures in patients with heart failure are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and heart failure hospitalization risk reduction with a novel implantable PA pressure monitoring system (CardioMEMS HF System, St. Jude Medical). This study examines PA pressure changes in the first 2000 US patients implanted in general practice use. METHODS: Deidentified data from the remote monitoring Merlin.net (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated with an area under the curve methodology to estimate the total sum increase or decrease in pressures (mm Hg-day) during the follow-up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION clinical trial (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association [NYHA] Functional Class III Heart Failure Patients). The area under the curve results are presented as mean±2 SE, and P values comparing the area under the curve of the general-use cohort with outcomes in the CHAMPION trial were computed by the t test with equal variance. RESULTS: Patients were on average 70±12 years old; 60% were male; 34% had preserved ejection fraction; and patients were followed up for an average of 333±125 days. At implantation, the mean PA pressure for the general-use patients was 34.9±10.2 mm Hg compared with 31.3±10.9 mm Hg for CHAMPION treatment and 32.0±10.5 mm Hg for CHAMPION control groups. The general-use patients had an area under the curve of -32.8 mm Hg-day at the 1-month time mark, -156.2 mm Hg-day at the 3-month time mark, and -434.0 mm Hg-day after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. CONCLUSIONS: The first 2000 general-use patients managed with hemodynamic-guided heart failure care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared with the pivotal CHAMPION clinical trial. These data demonstrate that general use of implantable hemodynamic technology in a nontrial setting leads to significant lowering of PA pressures.

Rationale and design of the Aquapheresis Versus Intravenous Diuretics and Hospitalization for Heart Failure (AVOID-HF) trial.

BACKGROUND: In patients hospitalized with acutely decompensated heart failure, unresolved signs and symptoms of fluid overload have been consistently associated with poor outcomes. Regardless of dosing and type of administration, intravenous loop diuretics have not reduced heart failure events or mortality in patients with acutely decompensated heart failure. The results of trials comparing intravenous loop diuretics to mechanical fluid removal by isolated venovenous ultrafiltration have yielded conflicting results. Studies evaluating early decongestive strategies have shown that ultrafiltration removed more fluid and was associated with fewer heart failure-related rehospitalization than intravenous loop diuretics. In contrast, when used in the setting of worsening renal function, ultrafiltration was associated with poorer renal outcomes and no reduction in heart failure events. METHODS: The AVOID-HF trial seeks to determine if an early strategy of ultrafiltration in patients with acutely decompensated heart failure is associated with fewer heart failure events at 90 days compared with a strategy based on intravenous loop diuretics. Study subjects from 40 highly experienced institutions are randomized to either early ultrafiltration or intravenous loop diuretics. In both treatment arms, fluid removal therapies are adjusted according to the patients' hemodynamic condition and renal function. The study was unilaterally terminated by the sponsor in the absence of futility and safety concerns after the enrollment of 221 subjects, or 27% of the originally planned sample size of 810 patients. CONCLUSIONS: The AVOID-HF trial's principal aim is to compare the safety and efficacy of ultrafiltration vs that of intravenous loop diuretics in patients hospitalized with acutely decompensated heart failure. Because stepped treatment approaches are applied in both ultrafiltration and intravenous loop diuretics groups and the primary end point is time to first heart failure event within 90 days, it is hoped that the AVOID-HF trial, despite its untimely termination by the sponsor, will provide further insight on how to optimally decongest patients with fluid-overloaded heart failure.

Clinical pharmacy services in heart failure: an opinion paper from the Heart Failure Society of America and American College of Clinical Pharmacy Cardiology Practice and Research Network.

BACKGROUND: Heart failure (HF) care takes place in multiple settings, with a variety of providers, and generally involves patients who have multiple comorbidities. This situation is a "perfect storm" of factors that predispose patients to medication errors. METHODS AND RESULTS: The goals of this paper are to outline potential roles for clinical pharmacists in a multidisciplinary HF team, to document outcomes associated with interventions by clinical pharmacists, to recommend minimum training for clinical pharmacists engaged in HF care, and to suggest financial strategies to support clinical pharmacy services within a multidisciplinary team. As patients transition from inpatient to outpatient settings and between multiple caregivers, pharmacists can positively affect medication reconciliation and education, assure consistency in management that results in improvements in patient satisfaction and medication adherence, and reduce medication errors. For mechanical circulatory support and heart transplant teams, the Centers for Medicare and Medicaid Services considers the participation of a transplant pharmacology expert (e.g., clinical pharmacist) to be a requirement for accreditation, given the highly specialized and complex drug regimens used. Although reports of outcomes from pharmacist interventions have been mixed owing to differences in study design, benefits such as increased use of evidence-based therapies, decreases in HF hospitalizations and emergency department visits, and decreases in all-cause readmissions have been demonstrated. Clinical pharmacists participating in HF or heart transplant teams should have completed specialized postdoctoral training in the form of residencies and/or fellowships in cardiovascular and/or transplant pharmacotherapy, and board certification is recommended. Financial mechanisms to support pharmacist participation in the HF teams are variable. CONCLUSIONS: Positive outcomes associated with clinical pharmacist activities support the value of making this resource available to HF teams.

An implantable left atrial pressure sensor lead designed for percutaneous extraction using standard techniques.

BACKGROUND: An implantable left atrial pressure (LAP) monitoring system for guiding the management of patients with advanced heart failure has the potential to require extraction, particularly in the setting of infection. The LAP sensor lead was designed to be suitable for ease of percutaneous extraction using standard techniques for extracting pacemaker and defibrillator leads. The clinical experience, to date, with percutaneous extraction of the LAP sensor lead is presented. METHODS: A total of 82 patients underwent successful implantation of the LAP sensor lead using transseptal catheterization. Five patients of the 82 patients during a cumulative follow-up period of 267 patient-years (median of 2.9 years/patient) underwent percutaneous extraction using manual traction with a locking stylet and/or an excimer laser sheath to bore through adhesions. The distal fixation anchors of the LAP sensor lead are designed to fold forward during extraction so that the sensor module can easily separate from the interatrial septum. RESULTS: Percutaneous extraction of the LAP sensor lead was accomplished successfully in all five patients with no embolic events, vascular tears, perforations, or other complications requiring surgical intervention. Manual traction alone was sufficient to detach the LAP sensor lead from the interatrial septum in all cases. Use of the excimer laser sheath was needed in selected cases to bore through scar tissue within the venous insertion site, but not within the heart. CONCLUSIONS: The extraction of the LAP sensor lead was accomplished safely using standard techniques and equipment for percutaneously extracting pacemaker and defibrillator leads.

Factors associated with improvement in utilization of cardiac resynchronization therapy in eligible heart failure patients: findings from IMPROVE HF.

BACKGROUND: There is a well-recognized gap between the number of patients in whom cardiac resynchronization therapy (CRT) is indicated based on current guidelines and its actual utilization. In the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) study, there was a significant increase in the use of CRT at 24 months in patients with heart failure (HF) in comparison to baseline. This study evaluated patient, physician, and practice factors associated with this increase in CRT utilization. METHODS: Patients with reduced left ventricular ejection fraction and chronic HF who met the eligibility criteria for CRT at baseline and 24 months were analyzed. Multivariate analyses using patient, physician, and practice characteristics were performed to evaluate factors associated with increased CRT utilization at 24 months. RESULTS: There were 440 patients eligible for CRT both at baseline and 24 months, with 217 (49.3%) treated at baseline and 374 (85%) treated at 24 months, leading to an absolute increase in use of CRT of 35.7%, P < 0.001. Although serum sodium and the absence of rales had modest associations, none of the patient, physician, or practice characteristics had any significant association with the extent of increase in CRT utilization. There was a significant reduction in the variation of CRT utilization across practice sites after the implementation of the performance improvement initiative. CONCLUSIONS: The performance improvement initiative in IMPROVE HF was the most important factor associated with an increase in guideline-recommended CRT utilization. This improvement in CRT utilization and reduced practice variability was found across a variety of cardiology and multispecialty practice sites.

Impact of exercise on pulmonary artery pressure in patients with heart failure using an ambulatory pulmonary artery pressure monitor.

Background: In this multicenter prospective study, we explored the relationship between pulmonary artery pressure (PAP) at rest and in response to a 6-min walk test (6MWT) in ambulatory patients with heart failure (HF) with an implantable PAP sensor (CardioMEMS, Abbott). Methods: Between 5/2019 and 2/2021, HF patients with a CardioMEMS sensor were recruited from seven sites. PAP was recorded in the supine and seated position at rest and in the seated position immediately post-exercise. Results: In our cohort of 66 patients, mean age was 70 ± 12 years, 67% male, left ventricular ejection fraction (LVEF) < 50% in 53%, mean 6MWT distance was 277 ± 95 meters. Resting seated PAPs were 31 ± 15 mmHg (systolic), 13 ± 8 mmHg (diastolic), and 20 ± 11 mmHg (mean). The pressures were lower in the seated rather than the supine position. After 6MWT, the pressures increased to PAP systolic 37 ± 19 mmHg (p < 0.0001), diastolic 15 ± 10 mmHg (p = 0.006), and mean 24 ± 13 mmHg (p < 0.0001). Patients with elevated PAP diastolic at rest (>15 mmHg) demonstrated a greater increase in post-exercise PAP. Conclusion: The measurement of PAP with CardioMEMS is feasible immediately post-exercise. Despite being well-managed, patients had severely limited functional capacity. We observed a significant increase in PAP with ambulation which was greater in patients with higher baseline pressures.

Multicenter registry and test bed for extended outpatient hemodynamic monitoring: the hemodynamic frontiers in heart failure (HF2) initiative.

Background: Hemodynamic Frontiers in Heart Failure (HF2) is a multicenter academic research consortium comprised of 14 US institutions with mature remote monitoring programs for ambulatory patients with heart failure (HF). The consortium developed a retrospective and prospective registry of patients implanted with a wireless pulmonary artery pressure (PAP) sensor. Goals/aims: HF2 registry collects demographic, clinical, laboratory, echocardiographic (ECHO), and hemodynamic data from patients with PAP sensors. The aims of HF2 are to advance understanding of HF and to accelerate development of novel diagnostic and therapeutic innovations. Methods: HF2 includes adult patients implanted with a PAP sensor as per FDA indications (New York Heart Association (NYHA) Class III HF functional class with a prior hospitalization, or patients with NYHA Class II or brain natriuretic peptide (BNP) elevation without hospitalization) at a HF2 member site between 1/1/19 to present. HF2 registry is maintained at University of Kansas Medical Center (KUMC). The registry was approved by the institutional review board (IRB) at all participating institutions with required data use agreements. Institutions report data into the electronic registry database using REDCap, housed at KUMC. Results: This initial data set includes 254 patients implanted from the start of 2019 until May 2023. At time of device implant, the cohort average age is 73 years old, 59.8% are male, 72% have NYHA Class III HF, 40% have left ventricular ejection fraction (LVEF) < 40%, 35% have LVEF > 50%, mean BNP is 560 pg/ml, mean N-Terminal pro-BNP (NTproBNP) is 5,490 pg/ml, mean creatinine is 1.65 mg/dl. Average baseline hemodynamics at device implant are right atrial pressure (RAP) of 11 mmHg, pulmonary artery systolic pressure (PASP) of 47 mmHg, pulmonary artery diastolic pressure (PADP) 21 mmHg, mean pulmonary artery pressure (mPAP) of 20 mmHg, pulmonary capillary wedge pressure (PCWP) of 19 mmHg, cardiac output (CO) of 5.3 L/min, and cardiac index (CI) of 2.5 L/min/m2. Conclusion: A real-world registry of patients implanted with a PAP sensor enables long-term evaluation of hemodynamic and clinic outcomes in highly-phenotyped ambulatory HF patients, and creates a unique opportunity to validate and test novel diagnostic and therapeutic approaches to HF.

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, ß-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.

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.

The worst symptom as defined by patients during heart failure hospitalization: implications for response to therapy.

BACKGROUND: Patients perceive different symptoms of heart failure decompensation. It is not known whether the nature of the worst symptom relates to hemodynamic profile, response to therapy, or improvement in clinical trials. METHODS AND RESULTS: Patients in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness trial were hospitalized with advanced heart failure, ejection fraction ≤30%, and at least 1 sign and 1 symptom of elevated filling pressures. Visual analog scales (VAS) for symptoms were completed by 371 patients, who selected their worst symptom as difficulty breathing, fatigue, abdominal discomfort, or body swelling and also scored breathing and global condition at baseline and discharge. The dominant symptom identified was difficulty breathing by 193 (52%) patients, fatigue by 118 (32%), and abdominal discomfort and swelling each by 30 (8%) patients, combined as right-sided congestion for analysis. Clinical and hemodynamic assessments were not different between groups except that right-sided congestion was associated with more hepatomegaly, ascites, third heart sounds, and jugular venous distention. This group also had greater reduction in jugular venous distention and trend toward higher blood urea nitrogen after therapy. By discharge, average improvements in worst symptom and global score were 28 points and 24 points. For those with ≥10 points in improvement in worst symptom, 84% also improved global assessment ≥10 points. Initial fatigue was associated with less improvement (P = .002) during and after hospitalization, but improvements in symptom scores were sustained when re-measured during 6 months after discharge. CONCLUSION: In most patients hospitalized with clinical congestion, therapy will improve symptoms regardless of the worst symptom perceived, with more evidence of baseline fluid retention and reduction during therapy for worst symptoms of abdominal discomfort or edema. Improvement in trials should be similar when tracking worst symptom, dyspnea, or global assessment.

Factors associated with improvement in guideline-based use of ICDs in eligible heart failure patients.

BACKGROUND: IMPROVE HF, a 24-month performance improvement initiative for outpatient cardiology and multispecialty practices, demonstrated significant improvement in guideline-based use of implantable cardioverter-defibrillators (ICDs) for patients with heart failure (HF). We investigated patient, physician, and practice factors associated with improvements in ICD use. METHODS: Patients with HF or postmyocardial infarction (MI) left ventricular systolic dysfunction who met eligibility criteria for ICDs at baseline and 24 months were analyzed. Multivariate analyses were performed to identify patient, physician, and practice characteristics associated with greater improvement in ICD therapy rates from baseline to 24 months. RESULTS: There were 4,058 patients eligible for ICD therapy at baseline and 24 months, with 2,600 (64.1%) treated at baseline and 3,361 (82.8%) treated at 24 months (+18.7%, P < 0.001). Practice heterogeneity in ICD use was significantly decreased after implementation of the performance improvement initiative. Characteristics independently associated with improvement in use of ICD therapy included race, history of MI, presence of edema, QRS duration, months since last measured left ventricular ejection fraction, and number of physicians in the practice. Improvement in ICD use was independent of other patient, physician, and practice characteristics, including age and sex. CONCLUSIONS: The IMPROVE HF performance improvement initiative was associated with substantially improved adherence to guideline-recommended ICD therapy. Certain patient and practice characteristics, including race, history of MI, edema, QRS duration, and number of physicians in the practice, were independently associated with improvement in ICD use. These findings highlight the need for ongoing quality improvement monitoring and performance improvement activities.

Race and improvements in the use of guideline-recommended therapies for patients with heart failure: findings from IMPROVE HF.

BACKGROUND: Race is associated with differences in use of guideline-recommended therapies for patients with heart failure (HF). OBJECTIVE: To evaluate whether a practice-based performance improvement intervention is associated with similar improvements in evidence-based care for black, white, and race-undocumented patients. METHODS: IMPROVE HF is a longitudinal evaluation of a performance improvement intervention on use of evidence-based therapies for outpatients with HF or prior myocardial infarction and left ventricular ejection fraction less than or equal to 35%. Data were available for 7605 patients. Changes in use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, aldosterone antagonist, cardiac resynchronization therapy, implantable cardioverter-defibrillator therapy, anticoagulant for atrial fibrillation, and HF education were analyzed by patient race (black, white, or undocumented/missing). Multivariate analyses identified variables independently associated with changes in each therapy. RESULTS: There were 686 black patients (9.0%) and 3238 white patients (42.6%), and race was undocumented for 3537 (46.5%). Baseline use of B-blockers and aldosterone antagonists was significantly higher in black patients than in the other 2 groups, and use of aldosterone antagonists and HF education was higher among black patients at 24 months. Postintervention use of 4 of 7 therapies increased equitably for the 3 groups, and treatment rates were similar between black and white patients for 5 of 7 individual quality measures. Improvements in care were independent of race. CONCLUSIONS: These findings offer some indication that race-based differences in delivery of evidence-based HF care may be decreasing in outpatient cardiology practices. Application of clinical decision support and performance feedback may facilitate equitable improvements in HF care in outpatient settings regardless of patient race. TRIAL REGISTRATION: NCT00303979, wwwv.clinicaltrials.gov.

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 (< or =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: beta-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 beta-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.

Renal function and neurohormonal changes following intravenous infusions of nitroglycerin versus nesiritide in patients with acute decompensated heart failure.

BACKGROUND: Rises in serum creatinine and efficacy have been reported as dose-related effects of nesiritide and nitroglycerin in acute decompensated heart failure (ADHF). However, no study has evaluated the comparative safety, efficacy, and biomarkers of optimally dosed nesiritide versus nitroglycerin in ADHF. METHODS AND RESULTS: Eighty-nine ADHF patients were prospectively randomized to receive either nesiritide (0.01 µg kg(-1) min(-1) ± bolus) or nitroglycerin (maximally tolerated doses by standard protocol). Blood urea nitrogen (BUN), and creatinine were obtained during 48 hours of intravenous infusion. B-Type natriuretic peptide (BNP) and N-terminal (NT) proBNP concentrations were measured during hospitalization. There were no significant differences in BUN, serum creatinine, creatinine clearance, or hospitalization and mortality. Although concentrations of BNP and NT-proBNP were significantly decreased over time, the comparative reductions between the 2 vasodilators were similar. CONCLUSIONS: Nesiritide and nitroglycerin produce similar hemodynamic effects, do not worsen markers of renal function, and produce significant, yet similar, reductions in neurohormones over time. Both nitroglycerin at maximally titrated doses and nesiritide at standard doses are safe and effective in patients with ADHF who require vasodilator therapy.

The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure.

BACKGROUND: AWAKE-HF evaluated the effect of the initiation of sacubitril/valsartan versus enalapril on activity and sleep using actigraphy in patients who have heart failure with reduced ejection fraction (HFrEF). METHODS: In this randomized, double-blind study, patients with HFrEF (n = 140) were randomly assigned to sacubitril/valsartan or enalapril for 8 weeks, followed by an 8-week open-label phase with sacubitril/valsartan. Primary endpoint was change from baseline in mean activity counts during the most active 30 min/day at week 8. The key secondary endpoint was change in mean nightly activity counts/minute from baseline to week 8. Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) was an exploratory endpoint. RESULTS: There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:enalapril]; 95% confidence interval [CI] 0.8863-1.0088; P = 0.0895) or in mean change from baseline in activity during sleep (difference: 2.038 counts/min; 95% CI - 0.062 to 4.138; P = 0.0570). Change from baseline to week 8 in KCCQ-23 was 2.89 for sacubitril/valsartan and 4.19 for enalapril, both nonsignificant. CONCLUSIONS: In AWAKE-HF, no detectable differences in activity and sleep were observed when comparing sacubitril/valsartan with enalapril in patients with HFrEF using a wearable biosensor. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02970669.

Influence of dedicated heart failure clinics on delivery of recommended therapies in outpatient cardiology practices: findings from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF).

BACKGROUND: National guidelines recommend heart failure (HF) disease management programs to facilitate adherence to evidence-based practices. This study examined the influence of dedicated HF clinics on delivery of guideline-recommended therapies for cardiology practice outpatients with HF and reduced left ventricular ejection fraction. METHODS: IMPROVE HF, a prospective cohort study, enrolled 167 cardiology practices to characterize outpatient management of 15,381 patients with chronic systolic HF. Adherence to guideline-recommended HF therapies was recorded, and the presence of a dedicated HF clinic was assessed by survey. Multivariate models identified contributions to delivery of guideline-recommended HF therapies. RESULTS: Of practices, 41.3% had a dedicated HF clinic. Practices with a dedicated HF clinic had greater adherence to 3 of 7 guideline-recommended HF therapy measures: angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (P = .02), beta-blocker (P = .025), and HF education (P = .009). After adjustment, use of a dedicated HF clinic was associated with greater conformity in 2 of 7 measures: cardiac resynchronization therapy (P = .036) and HF education (P = .005) but not angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, aldosterone antagonist, implantable cardioverter-defibrillator therapy, and anticoagulation for atrial fibrillation. CONCLUSIONS: Use of dedicated HF clinics varied in cardiology outpatient practices and was associated with greater use of cardiac resynchronization therapy and HF education but not other guideline-recommended therapies.

Electronic health records and quality of care for heart failure.

BACKGROUND: Electronic health records (EHRs) are considered an important technology to improve the quality of health care, yet few data exist regarding their effect on delivery of evidence-based care in the outpatient setting. METHODS: IMPROVE HF is a prospective cohort study of 15,381 patients with HF or post myocardial infarction and left ventricular ejection fraction < or =35% cared for in 167 US outpatient cardiology practices. Baseline patient characteristics and quality data were collected by chart abstraction. To quantify care, 7 HF quality measures were assessed; practices with and without EHR were compared. RESULTS: Among practices, 52% had EHR systems (30% EHR-only; 22% both EHR and paper) and 48% paper-only systems. Conformity with indicated care for practices with EHR systems was modestly higher for 2 of 7 quality measures compared to those without. After controlling for patient and site characteristics, use of EHR was associated with improved delivery of 3 of 7 quality measures (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, aldosterone antagonist, and HF education), similar care for 3 measures (beta-blocker, anticoagulation for atrial fibrillation, and cardiac resynchronization therapy), and worse for 1 measure (implantable cardioverter-defibrillator). CONCLUSIONS: These data are among the first to assess the potential influence of EHR on conformity with HF guidelines in the outpatient setting and suggest that EHR systems as currently deployed are associated with only modest differences in some, but not other, quality measures provided to HF patients compared with use of paper-only systems.