Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry.

Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients.

Treatment satisfaction in cystic fibrosis: early patient experience with tobramycin inhalation powder.

BACKGROUND: This study assessed treatment satisfaction of cystic fibrosis (CF) patients in a routine clinical setting for tobramycin inhalation powder (TIP), the first dry powder-inhaled antibiotic for Pseudomonas aeruginosa infection. METHODS: CF patients aged 6 years or older treated with at least one cycle of TIP completed a web survey on experience with TIP, including the Treatment Satisfaction Questionnaire for Medication (TSQM). Regression analysis determined the factors associated with TSQM global satisfaction. RESULTS: Eighty patients (mean age ± standard deviation: 24.4±9.4 years; 57.5% female; mean forced expiratory volume in 1 second ± standard deviation: 67.1%±27.3% predicted) completed the survey. The majority expressed satisfaction with TIP's administration time (100%), time to clean (97.1%), portability (97.1%), and ease of use (94.3%). Effectiveness was significantly associated with TSQM global satisfaction (regression R-squared: 0.54). CONCLUSION: Patient preferences for TIP were based on administration time and ease of use. Global satisfaction was related to greater patient-perceived effectiveness.

Cost-effectiveness Analysis of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection Fraction.

IMPORTANCE: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan was associated with a reduction in cardiovascular mortality, all-cause mortality, and hospitalizations compared with enalapril. Sacubitril/valsartan has been approved for use in heart failure (HF) with reduced ejection fraction in the United States and cost has been suggested as 1 factor that will influence the use of this agent. OBJECTIVE: To estimate the cost-effectiveness of sacubitril/valsartan vs enalapril in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from US adults (mean [SD] age, 63.8 [11.5] years) with HF with reduced ejection fraction and characteristics similar to those in the PARADIGM-HF trial were used as inputs for a 2-state Markov model simulated HF. Risks of all-cause mortality and hospitalization from HF or other reasons were estimated with a 30-year time horizon. Quality of life was based on trial EQ-5D scores. Hospital costs combined Medicare and private insurance reimbursement rates; medication costs included the wholesale acquisition cost for sacubitril/valsartan and enalapril. A discount rate of 3% was used. Sensitivity analyses were performed on key inputs including: hospital costs, mortality benefit, hazard ratio for hospitalization reduction, drug costs, and quality-of-life estimates. MAIN OUTCOMES AND MEASURES: Hospitalizations, quality-adjusted life-years (QALYs), costs, and incremental costs per QALY gained. RESULTS: The 2-state Markov model of US adult patients (mean age, 63.8 years) calculated that there would be 220 fewer hospital admissions per 1000 patients with HF treated with sacubitril/valsartan vs enalapril over 30 years. The incremental costs and QALYs gained with sacubitril/valsartan treatment were estimated at $35 512 and 0.78, respectively, compared with enalapril, equating to an incremental cost-effectiveness ratio (ICER) of $45 017 per QALY for the base-case. Sensitivity analyses demonstrated ICERs ranging from $35 357 to $75 301 per QALY. CONCLUSIONS AND RELEVANCE: For eligible patients with HF with reduced ejection fraction, the Markov model calculated that sacubitril/valsartan would increase life expectancy at an ICER consistent with other high-value accepted cardiovascular interventions. Sensitivity analyses demonstrated sacubitril/valsartan would remain cost-effective vs enalapril.

Association between cardiac, renal, and hepatic biomarkers and outcomes in patients with acute heart failure.

OBJECTIVES: Myocardial injury, worsening renal function, and hepatic impairment are independent risk factors for poor patient acute heart failure (AHF) outcomes. Biomarkers of organ damage may be useful in identifying patients at risk for poor outcomes. The objective of this analysis was to assess the relationship between abnormal AHF biomarkers and outcomes in AHF patients. METHODS: AHF admissions (N = 104,794) data from the Cerner Health Facts® inpatient database were analyzed retrospectively. Multivariate predictive models determined the impact of biomarkers on mortality, readmission, length of stay (LOS), and cost from index admission through 180 days post discharge. Thirty and 60 day time windows are reported but 180 day results were consistent with 60 day outcomes. Biomarkers evaluated were aspartate transaminase (AST), estimated glomerular filtration rate (eGFR), high sensitivity cardiac troponin, bilirubin, alanine transaminase (ALT), sodium, high sensitivity C-reactive protein (hs-CRP), uric acid, B-type natriuretic peptide (BNP), NT-ProBNP, blood urea nitrogen (BUN), serum creatinine (SCr), and hemoglobin. RESULTS: All biomarkers evaluated except hs-CRP, uric acid, and NT-ProBNP were significant (p < 0.0001) predictors of mortality at all timepoints; non-significance for these 3 biomarkers is likely due to low patient counts (1%-2%). Odds ratios for significant biomarkers of mortality ranged from 1.168-2.076 at index admission, 1.205-1.946 at 30 days post-discharge, and 1.233-1.991 at 60 days post-discharge. AST, eGFR, troponin, ALT, BNP, BUN, SCr, and hemoglobin were significant (p < 0.0001) predictors of readmission risk at all timepoints. AST, eGFR, troponin, bilirubin, BUN, SCr, and hemoglobin were significant (p < 0.0001) predictors of cumulative LOS at all timepoints. AST, eGFR, troponin, ALT, sodium, BUN, and hemoglogin were significant (p < 0.0001) cost predictors at 30 and 60 days post-discharge. CONCLUSIONS: Renal function measures were associated with outcomes in patients hospitalized for AHF. Increased vigilance of renal biomarkers may be warranted to assess risk and promote proactive clinical management to improve outcomes.

Evaluation of mortality and readmissions following hospitalization with heart failure.

OBJECTIVE: To examine the association of patient/clinical characteristics with mortality and readmission following a heart failure (HF)-related hospitalization. RESEARCH DESIGN AND METHODS: Claims data, linked to laboratory, race/ethnicity, and mortality data, from a large US health plan were utilized to identify individuals with ≥1 inpatient claim with a diagnosis code for HF (1 January 2008-30 September 2012). Study variables were analyzed using descriptive and multivariable approaches to identify patient/clinical characteristics associated with post-discharge outcomes. MAIN OUTCOME MEASURES: Primary outcomes included post-discharge mortality and readmission. RESULTS: A total of 126,214 individuals were identified with a HF-related hospitalization; 19.1% with data to calculate chronic kidney disease (CKD) stage. For the overall sample, mortality probability was 4.9% and 13.4% at 1 and 6 months post-discharge, respectively (4.5% and 12.4% for subset with calculated CKD stage), while readmission (all-cause) probability was 14.8% and 39.6% at 1 and 6 months post-discharge, respectively (18.4% and 44.5% for subset with calculated CKD stage). Within the subset with calculated CKD stage, mortality and readmission probabilities differed by CKD stage (p < 0.001), with decreased renal function corresponding with increased risk of mortality and readmission. After multivariable adjustment, increasing age was associated with increased risk of mortality, while advancing CKD stage, various index hospitalization variables (i.e., pre-admission emergency room visit, intensive care unit during hospitalization), and baseline all-cause hospitalization were associated with both increased risk of mortality and all-cause 1 month readmission. CONCLUSIONS: Calculated CKD, various index hospitalization variables, and baseline all-cause hospitalization were associated with increased risk of mortality and all-cause 1 month readmission among patients hospitalized with HF. Risk of post-discharge readmission and mortality increased with worse renal function, suggesting that improved management of this subset may reduce the burden and cost of this disease. Key study limitations include those related to retrospective claims-based studies and that renal function data were available for a subset of study patients.

Comparison of Risk of Re-hospitalization, All-Cause Mortality, and Medical Care Resource Utilization in Patients With Heart Failure and Preserved Versus Reduced Ejection Fraction.

Because heart failure (HF) with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) are different clinical entities with differing demographic characteristics, common HF outcomes may occur at different rates. Comparative outcome studies have been equivocal, and studies comparing resource utilization are scant. We used an observational cohort design to study 6,513 patients hospitalized for HF who had an EF measured during the hospitalization and were discharged alive within 30 days. We excluded 677 patients with borderline EF values (41% to 49%) and categorized the remaining as HFrEF (EF ≤40%, n = 2,205) and HFpEF (EF >50%, n = 3,631). Patients were followed for up to 1 year for all-cause re-hospitalization and mortality and annualized medical resource utilization. Patients with HFrEF and HFpEF experienced similar adjusted incidence rates of re-hospitalization, but those with HFrEF had a 39% increased risk of mortality at 30 days (rate ratio 1.39, 95% confidence interval 1.10 to 1.76) and 25% greater risk at 1 year (rate ratio1.25, 95% confidence interval 1.12 to 1.41). After adjustment for covariates, patients with HFpEF incurred significantly more annualized outpatient visits (21.5 vs 20.1, p = 0.002) and emergency room visits (3.24 vs 2.94, p = 0.002) than those with HFrEF, but absolute differences were small. High inpatient and pharmacy utilization did not differ. Our study suggests that whether a patient has HFrEF or HFpEF has little bearing on risk of re-hospitalization or inpatient resource utilization in the year after an HF hospitalization. Both groups experienced high mortality, but those with HFrEF had greater risk. In conclusion, from the standpoint of resource use, HF can be considered a single entity.

Resource use and patient care associated with chronic kidney disease in a managed care setting.

OBJECTIVE: To describe the resource utilization and care of chronic kidney disease (CKD) patients in a managed care plan. METHODS: This was a retrospective claims analysis of a nationwide managed care medical and pharmacy database from September 1, 1998, to July 31, 2001. Twenty-seven health plans in 19 states distributed across the Northeast, Southeast, Midwest, and Southwest United States were represented in this analysis. CKD patients were identified using ICD-9 CM, CPT-4, and HCPCS codes indicative of dialysis. Patients continuously enrolled for at least 6 months before and 3 months after an initial dialysis event were included in the study. Health care charges and associated clinical information were assessed during 3 time periods: predialysis was from the sixth through the second month before initial dialysis, peridialysis was 30 days before and 30 days after initial dialysis, and postdialysis was the second and third month after initial dialysis. The main outcome measures were total health care charges, primary diagnoses, and diagnosis- related groups (DRGs). RESULTS: The per-patient-per-month charges were 4,265 dollars in the predialysis period (average for 5 months), 35,292 dollars in the peridialysis period (average for 2 months), and 15,399 dollars in the postdialysis period (average for 2 months). The most common primary diagnosis categories during all time periods were chronic renal failure and congestive heart failure. Similarly, the most common DRGs were related to renal and heart failure. A total of 38.2% of patients did not have an initial nephrologist visit until the first dialysis event. Treatments with nutritional supplements and medications such as angiotensin-converting enzyme inhibitors and erythropoietin were found to be suboptimal. CONCLUSION: CKD patients generate significant medical charges during the predialysis period and after initiation of dialysis. Further investigations are warranted to assess the impact of active management of CKD patients on CKD-related health care expenditures in kidney disease.

Examination of resource use and clinical interventions associated with chronic kidney disease in a managed care population.

BACKGROUND: The management of chronic kidney disease (CKD) is multifaceted, including monitoring, early diagnosis, and treatment of comorbidities such as diabetes, hypoalbuminemia, and anemia, and initiating timely procedures in preparation for dialysis such as vascular access placement. Presumably, optimal care provided to patients during the predialysis phase will produce a significant impact on morbidity and mortality outcomes. OBJECTIVE: A retrospective analysis was conducted to assess specific factors that may be associated with optimal quality of care for CKD patients during the predialysis phase. METHODS: Health care resource utilization and the occurrence of interventions associated with optimal predialysis care were evaluated with claims data. Predialysis erythropoietin (EPO) therapy, nephrology referrals, and nutritional supplement administration were all examined during the 12 months prior to dialysis. RESULTS: Medical and pharmacy claims from a managed care database were analyzed for 1,936 incident dialysis patients. Of these, 48.7% did not have any interventions associated with optimal care. Only a minority of patients received prescription iron preparations (6.8%), vitamin D (4.0%), and phosphate binders (7.7%). A total of 20.8% patients had a vascular access placement, and 29.8% were in the care of a nephrologist during this same time period. Only 10.5% received predialysis EPO, yet more than 40% were diagnosed with anemia. Of the EPO users, however, 72.4% were also receiving other interventions to appropriately manage CKD. CONCLUSION: These claims-documented results suggest that the lack of EPO use in predialysis patients in a managed care plan may predict overall suboptimal treatment of these patients. There is an apparent need for the proactive management of CKD in a managed care plan to potentially redistribute or reduce health care resource utilization while improving patient outcomes.