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Remote monitoring of pulmonary artery (PA) pressures and serial N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurements guide heart failure (HF) treatment, but their association has yet to be described. In the Empagliflozin Evaluation by Measuring the Impact on Hemodynamics in Patients with Heart Failure (EMBRACE-HF) trial, patients with HF and a remote PA pressure monitoring device were randomized to empagliflozin vs placebo. PA diastolic pressures (PADP) and NT-proBNP levels were obtained at baseline and 6 and 12 weeks. We used linear mixed models to examine the association between change in PADP and change in NT-proBNP, adjusting for baseline covariates. Of 62 patients, the mean patient age was 66.2 years, and 63% were male. The mean baseline PADP was 21.8 ± 6.4 mm Hg, and the mean NT-proBNP was 1844.6 ± 2767.7 pg/mL. The mean change between baseline and averaged 6- and 12-week PADP was –0.4 ± 3.1 mm Hg, and the mean change between baseline and averaged 6- and 12-week NT-proBNP was –81.5 ± 878.6 pg/mL. In adjusted analyses, every 2-mm Hg decrease in PADP was associated with an NT-proBNP reduction of 108.9 pg/mL (95% confidence interval –4.3 to 222.0, P =.06). We observed that short-term decreases in ambulatory PADP seem to be associated with decreases in NT-proBNP. This finding may provide additional clinical context when tailoring treatment for patients with HF. [ABSTRACT FROM AUTHOR]

Aims: Improving the health status (symptoms, function, and quality of life) of patients with heart failure with reduced ejection fraction (HFrEF) is a primary treatment goal. Angiotensin receptor neprilysin inhibitors (ARNI) improve short‐term health status in clinical practice, but the sustainability of these improvements is unknown. Methods and results: In CHAMP‐HF, a multicentre observational study of outpatients with HFrEF, patients initiated on ARNI were propensity score matched 1:2 to patients not using ARNI with Cox regression modelling time to ARNI initiation, adjusted for sociodemographic and clinical variables, medical history, medications, and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Repeated measures models for the overall KCCQ score and each domain compared the health status trajectories of patients initiated on ARNI vs. not. Among 3930 participants, 746 (19.0%) began ARNI, of whom 576 were matched to 1152 non‐ARNI patients. Prior to matching, participants initiated on ARNI were younger, non‐Hispanic, had lower EFs, more commonly had a history of ventricular arrhythmia, were less likely to be taking an ACEI/ARB, and more likely to be treated with beta‐blockers and mineralocorticoid receptor antagonists. There were no differences after matching. In the matched cohort, participants initiated on ARNI experienced improved health status by 3 months that persisted through 12 months [KCCQ Overall Summary Score (OSS) = 73.4 vs. 70.8; P < 0.001], with the largest benefit observed in the KCCQ Quality of Life domain (68.7 vs. 64.7; P < 0.001). Similar health status benefits were noted through 18 months (KCCQ‐OSS = 73.9 vs. 71.3; P < 0.001). A responder analysis showed that 12 patients would need to be initiated on ARNI for one to experience at least a large improvement (≥10 points) in health status benefit at 12 months. Conclusions: In outpatient practice, ARNI therapy was associated with improved health status by 3 months and continued to 18 months after initiating therapy. [ABSTRACT FROM AUTHOR]

Sodium‐glucose cotransporter‐2 (SGLT2) inhibitors have been shown to reduce the risk of cardiovascular death or worsening heart failure (HF), and improve symptom burden, physical function and quality of life in patients with HF and reduced ejection fraction. The mechanisms of the HF benefits of SGLT2 inhibitors, however, remain unclear. In this substudy of the DEFINE‐HF trial, patients randomized to dapagliflozin or placebo had lung fluid volumes (LFVs) measured by remote dieletric sensing at baseline and after 12 weeks of therapy. A significantly greater proportion of dapagliflozin‐treated patients (as compared with placebo) experienced improvement in LFVs and fewer dapagliflozin‐treated patients had no change or deterioration in LFVs after 12 weeks of treatment. To our knowledge, this is the first study to suggest a direct effect of dapagliflozin (or any SGLT2 inhibitor) on more effective "decongestion", contributing in a meaningful way to the ongoing debate regarding the mechanisms of SGLT2 inhibitor HF benefits. [ABSTRACT FROM AUTHOR]

Aims: The aim of our study was to investigate heterogeneity of health status treatment response of sacubitril/valsartan in patients with heart failure with reduced ejection fraction (HFrEF). Methods and results: We leveraged data from CHAMP‐HF, an observational registry of 140 US clinics and 5026 outpatients with chronic HFrEF, where health status was serially assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ)‐12 Overall Summary Scale (range from 0 to 100; ≥20‐point improvement is a very large improvement). In 334 patients newly initiated on sacubitril/valsartan, we used hierarchical multivariable logistic regression (13 patient‐level characteristics as well as baseline KCCQ‐12 score) to calculate the odds ratio (OR) of any characteristic being associated with a very large health status improvement. A total of 104/334 (31.1%) of patients achieved the primary endpoint, where only worse baseline health status [KCCQ‐12 score of 0–60 points had an OR = 0.86/5‐point higher score (CI 0.79, 0.93)], and those with a KCCQ‐12 score of 60–80 points had an OR = 0.61/5‐point higher score (0.45–0.82), which was associated with a very large benefit. No other patient characteristic was associated with a very large health status improvement (P > 0.05). Conclusions: We found that, after initiation of sacubitril/valsartan, only worse baseline health status was associated with very large health status improvement. Accordingly, a trial of therapy—particularly in those with worse symptoms, function, and quality of life—and assessing treatment response are likely to be the best prospective strategy. [ABSTRACT FROM AUTHOR]

Background: Although a key treatment goal for patients with heart failure with reduced ejection fraction is to optimize their health status (their symptoms, function, and quality of life), the variability across outpatient practices in achieving this goal is unknown.Methods and Results: In the CHAMP-HF (Change the Management of Patients With Heart Failure) registry, associations between baseline practice characteristics and Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary (OS) and Symptom Frequency (SF) scores were assessed in 3494 patients across 140 US practices using hierarchical regression after accounting for 23 patient and 11 treatment characteristics. We then calculated an adjusted median odds ratio to quantify the average difference in likelihood that a patient would have excellent (KCCQ-OS, ≥75) health status or minimal (monthly or fewer) symptoms (KCCQ-SF, ≥75) when treated at one practice versus another, at random. The mean (±SD) KCCQ-OS and KCCQ-SF were 64.2±24 and 68.9±25.6, with 40% (n=1380) and 50% (n=1760) having KCCQ scores ≥75, respectively. The adjusted median odds ratio across practices, for KCCQ-OS ≥75, was 1.70 (95% confidence interval, 1.54-1.99; P<0.001) indicating a median 70% higher odds of a patient having good-to-excellent health status when treated at one random practice versus another. In regard to KCCQ-SF, the adjusted median odds ratio for KCCQ-SF ≥75 was 1.54 (95% confidence interval, 1.41-1.76; P=0.001).Conclusions: In a large, contemporary registry of outpatients with chronic heart failure with reduced ejection fraction, we observed significant practice-level variability in patients' health status. Quantifying patients' health status as a measure of quality should be explored as a foundation for improving care.Clinical Trial Registration: URL: https://www.centerwatch.com. Unique identifier: TX144901. [ABSTRACT FROM AUTHOR]

Background: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure.Methods and Results: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03).Conclusions: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies.Clinical Trial Registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212. [ABSTRACT FROM AUTHOR]

Use of implantable pulmonary artery pressure monitoring in select patients with heart failure (HF) has been associated with reduction in HF-related admissions and improved HF-specific health status. We sought to analyze real world data from a large tertiary referral center after three years of implants, to inform future patient selection and management. Using retrospective chart abstraction, we collected data on baseline demographics and outcomes of interest for all patients implanted from 1/1/2017 through 12/31/2019 at a single center. Using paired t-tests, we compared frequency of relevant health system encounters in the year before and the year after implant. The study cohort (n=63) was comprised of 33% (n=21) females, mean (±SD) age of 72.7 (±10.7) yrs, 49% HFpEF (EF>50%; n=31), 5% HFmrEF (EF=40-50%; n=3), and 46% HFrEF (EF<40%, n=29). Mean (±SD) eGFR at implant was 45.7 (±16.9) ml/min: 16% CKD Stage 2 (eGFR 60-89 ml/min; n=10), 71% Stage 3 (eGFR 30-59 ml/min; n=45), and 13% Stage 4 (eGFR 15-30 ml/min; n=8). HF readmission within 30 dys after implant occurred in 8% of patients (n=5). In comparison of the year before vs the year after implant, patients experienced significant reductions in the frequency of nearly all health system encounters. (Table) In the first year post-implant, 3% of patients (n=2) underwent LVAD implant, 3% (n=2) had progression of CKD requiring initiation of dialysis, 8% (n=5) required device recalibration due to discordant pressure readings, and 20% (n=13) did not survive to one year post-implant. In sensitivity analysis with these 13 patients removed, results remained similar. Among the subset of patients with no HF ED visits/admissions in the year before implant who lived at least one year post-implant (n=11), frequency of HF clinic visits decreased significantly (mean [±SD] visits pre = 6.1 [±3.0] vs post = 2.6 [±1.4]; p=0.0054). In this three-year, single-center experience using implantable pulmonary artery pressure monitoring to guide treatment of patients with HF, the study population experienced significant reductions in encounters with the health system, even in the absence of HF admissions in the year before implant, and despite event rates in the year post-implant implying a high acuity, highly morbid population. [ABSTRACT FROM AUTHOR]

Improving the health status—symptoms, function, and quality of life - of patients with HFrEF is a primary goal of treatment. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor (ARNI), improves short-term health status in clinical practice, but whether these improvements are sustained has not been assessed. Using data from CHAMP-HF, a multicenter observational study of outpatients with HFrEF (EF ≤40%), patients initiated on ARNI were matched 1:2 to patients not started on ARNI using propensity score Cox models that included sociodemographic and clinical variables, medical history, medications, and baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Frequency and Quality of Life scores. Five repeated measures models, one for the overall KCCQ score and one for each domain, were used to compare the health status trajectories of patients initiated on ARNI vs not. Among 3,930 patients, 746 (19.0%) were initiated on ARNI and 576 were matched to 1,152 patients not started on ARNI. Prior to matching, patients initiated on ARNI were more likely to be younger, non-Hispanic, have lower EF and a history of ventricular arrhythmia, and were less likely to be taking an ACEI or ARB, but were more likely to be on beta-blockers and mineralocorticoid receptor antagonists. Patients initiated on ARNI experienced improved quality of life by 3 months that persisted to 12 months, with the largest benefit observed in the KCCQ Quality of Life domain (Figure 1). In a real-world setting, the health status benefits of ARNI therapy occur within 3 months and persists up to 12-months after initiating therapy. [ABSTRACT FROM AUTHOR]

Three large cardiovascular outcome trials of patients with type 2 diabetes (T2D) found a reduction in hospitalizations for heart failure (HF) in patients treated with SGLT2i. However, a majority of patients in these trials did not have manifest HF, and those that did were not well characterized. Consequently, the effects of SGLT-2i in patients with established HF, specifically HF with reduced ejection fraction (HFrEF), including those with and without T2DM, have not been examined in a dedicated trial. The effects of dapagliflozin on biomarkers, symptoms, and functional status in patients with HFrEF (DEFINE-HF) is a 12-week multi-center, randomized, double-blind, placebo-controlled trial. From March 2016 to March 2019, 263 patients from 26 US centers were randomized 1:1 to dapagliflozin 10 mg or matching placebo. Patients with or without T2D, with LVEF ≤40%, EGFR ≥30 mL/min/m2, and NTproBNP ≥400 pg/mL were eligible for inclusion. Co-primary end points were (1) change in NTproBNP and (2) composite of proportion of patients with ≥ 5point increase in the HF disease-specific health status (assessed using KCCQ) or ≥ 20% decrease in NTproBNP over 12 weeks. Key secondary endpoints included functional status based on 6-minute walk test, and change in KCCQ. Exploratory endpoints included hospitalizations for HF and urgent HF visits. Enrollment in DEFINE-HF was completed in March 2019, with last visit scheduled in June. Baseline characteristics are consistent with other trials of high risk HFrEF patients, and are shown in the Table. Topline study results will be available in July 2019, in time for presentation at HFSA 2019. DEFINE-HF is the first dedicated multi-center randomized double-blind placebo-controlled trial of SGLT-2i in patients with established HFrEF with and without T2D. It will assess whether the SGLT2i dapagliflozin improves HF biomarkers, symptoms and functional status in this high-risk patient population. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. [ABSTRACT FROM AUTHOR]