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Prediction of readmissions and mortality in patients with heart failure: lessons from the IMPEDANCE-HF extended trial.

ABSTRACT: AIMS:Readmissions for heart failure (HF) are a major burden. We aimed to assess whether the extent of improvement in pulmonary fluid content (?PC) during HF hospitalization evaluated by lung impedance (LI), or indirectly by other clinical and laboratory parameters, predicts readmissions. METHODS AND RESULTS:The present study is based on pre-defined secondary analysis of the IMPEDANCE-HF extended trial comprising 266 HF patients at New York Heart Association Class II-IV and left ventricular ejection fraction ? 35% randomized to LI-guided or conventional therapy during long-term follow-up. Lung impedance-guided patients were followed for 58 ± 36 months and the control patients for 46 ± 34 months (P < 0.01) accounting for 253 and 478 HF hospitalizations, respectively (P < 0.01). Lung impedance, N-terminal pro-brain natriuretic peptide, weight, radiological score, New York Heart Association class, lung rales, leg oedema, or jugular venous pressure were measured at admission and discharge on each hospitalization in both groups with the difference defined as ?PC. Average LI-assessed ?PC was 12.1% vs. 9.2%, and time to HF readmission was 659 vs. 306 days in the LI-guided and control groups, respectively (P < 0.01). Lung impedance-based ?PC predicted 30 and 90 day HF readmission better than ?PC assessed by the other variables (P < 0.01). The readmission rate for HF was lower if ?PC > median compared with ?PC ? median for all parameters evaluated in both study groups with the most pronounced difference predicted by LI (P < 0.01). Net reclassification improvement analysis showed that adding LI to the traditional clinical and laboratory parameters improved the predictive power significantly. CONCLUSIONS:The extent of ?PC improvement, primarily the LI based, during HF-hospitalization, and study group allocation strongly predicted readmission and event-free survival time.

SUBMITTER: Kleiner Shochat M

PROVIDER: S-EPMC6165944 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Prediction of readmissions and mortality in patients with heart failure: lessons from the IMPEDANCE-HF extended trial.

Kleiner Shochat Michael M Fudim Marat M Shotan Avraham A Blondheim David S DS Kazatsker Mark M Dahan Iris I Asif Aya A Rozenman Yoseph Y Kleiner Ilia I Weinstein Jean Marc JM Panjrath Gurusher G Sobotka Paul A PA Meisel Simcha R SR

ESC heart failure 20180810 5

<h4>Aims</h4>Readmissions for heart failure (HF) are a major burden. We aimed to assess whether the extent of improvement in pulmonary fluid content (ΔPC) during HF hospitalization evaluated by lung impedance (LI), or indirectly by other clinical and laboratory parameters, predicts readmissions.<h4>Methods and results</h4>The present study is based on pre-defined secondary analysis of the IMPEDANCE-HF extended trial comprising 266 HF patients at New York Heart Association Class II-IV and left ve ...[more]

PMID: 30094959

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Project description:BackgroundHeart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.Methods/designA multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.DiscussionBEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.Trial registrationClinicalTrials.gov # NCT01360203.

Project description:AimsHeart failure (HF) burden is displaying significant inter-regional differences within Europe and within countries. Due to limited data focusing on regional differences, our aim was to evaluate HF hospitalizations, readmissions, and mortality burden in Slovenian statistical regions.Methods and resultsThe Slovenian National Hospitalization Discharge Registry was searched for HF hospitalizations in patients 20 years or over in the period 2004-12. Annual sex and age-standardized HF hospitalizations, mortality, and HF readmissions rates were calculated for Slovenia and for each Slovenian statistical region. Trends were evaluated using ANOVA. Multiple mixed effect logistic regression models, which included statistical region, admission year, sex, age, intensive care unit treatment, and co-morbidities as a fixed effect and hospital identifier as a random effect, were calculated for mortality and readmissions. Overall, 156 859 HF hospitalizations (55 522 where HF was coded as a main diagnosis and 43 606 as first HF hospitalizations) were recorded. Annual standardized rates varied considerably between statistical regions for main (220-511) and first HF hospitalization (392-721), 30 day (12.6-27.1) and 1 year mortality (66-117), and 30 day (31-80.8) and 1 year readmission (99-24) (per 100 000 patient years in 2012). Yearly decline in HF hospitalization rates was seen for national main (3.6; 0.001) and first (8.4; 0.083) HF hospitalizations, while individual regional main and first HF hospitalization trends mostly did not reach statistical significance. No relevant differences in mortality and readmission endpoints for statistical regions were seen when adjusted for patient demographics and specific co-morbidities.ConclusionsSignificant regional differences in standardized HF hospitalization, mortality, and readmissions between the regions were seen. There were no differences in mortality and readmissions between statistical regions for individual similar patients.

Project description:ObjectivesThis study sought to determine the degree to which U.S. patients enrolled in a heart failure (HF) trial represent patients in routine U.S. clinical practice according to race and sex.BackgroundBlack patients and women are frequently under-represented in HF clinical trials. However, the degree to which black patients and women enrolled in trials represent such patients in routine practice is unclear.MethodsThe ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure) trial randomized patients hospitalized for HF to receive nesiritide or placebo from May 2007 to August 2010 and was neutral for clinical endpoints. This analysis compared non-Hispanic white (n = 1,494) and black (n = 1,012) patients enrolled in ASCEND-HF from the U.S. versus non-Hispanic white and black patients included in a U.S. hospitalized HF registry (i.e., Get With The Guidelines-Heart Failure [GWTG-HF]) during the ASCEND-HF enrollment period and meeting trial eligibility criteria.ResultsAmong 79,291 white and black registry patients, 49,063 (62%) met trial eligibility criteria (white, n = 37,883 [77.2%]; black, n = 11,180 [22.8%]). Women represented 35% and 49% of the ASCEND-HF and trial-eligible GWTG-HF cohorts, respectively. Compared with trial-enrolled patients, trial-eligible GWTG-HF patients tended to be older with higher blood pressure and higher ejection fraction. Trial-eligible patients had higher in-hospital mortality (2.3% vs. 1.3%), 30-day readmission (20.2% vs. 16.8%), and 180-day mortality (21.2% vs. 18.6%) than those enrolled in the trial (all p < 0.02), with consistent mortality findings by race and sex. After propensity score matching, mortality rates were similar; however, trial-eligible patients continued to have higher rates of 30-day readmission (23.1% vs. 17.3%; p < 0.01), driven by differences among black patients and women (all p for interaction ≤0.02).ConclusionsPatients with HF seen in U.S. practice and eligible for the ASCEND-HF trial had worse clinical outcomes than those enrolled in the trial. After accounting for clinical characteristics, trial-eligible real-world patients continued to have higher rates of 30-day readmission, driven by differences among black patients and women. Social, behavioral, and other unmeasured factors may impair representativeness of patients enrolled in HF trials, particularly among racial/ethnic minorities and women. (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure [ASCEND-HF]; NCT00475852).

Project description:AimsOptiVol fluid index was developed as a transthoracic impedance-based indicator of short-term risk for heart failure hospitalization (HFH). OptiVol is calculated as the accumulating difference between daily impedance (measured impedance) and long-term average impedance (reference impedance). Measured impedance alone was thought to have limited prognostic utility; however, measured impedance has the advantage of being simple, direct, and possibly additive to OptiVol fluid index in establishing long-term HFH risk. We tested the hypothesis that directly measured impedance has independent prognostic value in predicting long-term HFH risk and that changes in measured impedance result in a change in predicted long-term HFH risk.Methods and resultsA retrospective analysis of 1719 patients studied in PARTNERS-HF, FAST, and RAFT studies was performed. Baseline measured impedance was determined using daily values averaged over 1 month, from Month 6 to 7 post implant; change in measured impedance was determined from values averaged over 1 month, from Month 7 to 8 post implant compared with baseline. The predictive value of baseline measured impedance for HFHs was assessed beginning 7 months post implant. The predictive value of a change in measured impedance for a change in HFHs was assessed beginning 8 months post implant. Baseline measured impedance successfully predicted HFHs. For example, 3 year HFH rate for low baseline impedance < 70 Ω was 23%; for high baseline impedance ≥ 70 Ω was 15% (P < 0.001). Changes in measured impedance resulted in changes in predicted HFHs. For example, when a baseline impedance of ≥70 fell during follow-up to <70 Ω, the subsequent HFHs were 15% compared with 4% in patients with measured impedance that remained >70 Ω (P = 0.004). In addition, when baseline measured impedance fell during follow-up by >1%, 2%, or 3%, subsequent HFHs increased to 13%, 17%, or 18%, respectively. Finally, the prognostic value of measured impedance was additive to the prognostic value of the OptiVol fluid index.ConclusionsDirect measurements of intrathoracic impedance using an implanted device can be used to stratify patients at varying risk of long-term HFH. These direct measurements of impedance have practical clinical appeal because they are simple, continuous, and ambulatory.

Project description:BACKGROUND:Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life. OBJECTIVES:The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes. METHODS:The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality. RESULTS:Patients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality. CONCLUSIONS:An interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart Failure [PAL-HF]; NCT01589601).

Project description:AimsHeart failure (HF) readmission commonly arises owing to insufficient patient knowledge and failure of recognition of the early stages of recurrent fluid congestion. In previous work, we developed a score to predict short-term hospital readmission and showed that higher-risk patients benefit most from a disease management programme (DMP) that included enhancing knowledge and education by a nurse. We aim to evaluate the effectiveness of a novel, nurse-led HF DMP in selected patients at high risk of short-term hospital readmission, using ultrasound-guided diuretic management and artificial intelligence to enhance HF knowledge in an outpatient setting.Methods and resultsRisk-HF is a prospective multisite randomized controlled trial that will allocate 404 patients hospitalized with acute decompensated HF, and ≥33% risk of readmission and/or death at 30 days, into risk-guided nurse intervention (DMP-Plus group) compared with usual care. Intervention elements include (i) fluid management with a handheld ultrasound (HHU) device at point of care; (ii) post-discharge follow-up; (iii) optimal programmed drug titration; (iv) better transition of care; (v) intensive self-care education via an avatar-based 'digital health coach'; and (vi) exercise guidance through the digital coach. Usual care involves standard post-discharge hospital care. The primary outcome is reduced death and/or hospital readmissions at 30 days post-discharge, and secondary outcomes include quality of life, fluid management efficacy, and feasibility and patient engagement. Assuming that our intervention will reduce readmissions and/or deaths by 50%, with a 1:1 ratio of intervention vs. usual care, we plan to randomize 404 patients to show a difference at a statistical power of 80%, using a two-sided alpha of 0.05. We anticipate this recruitment will be achieved by screening 2020 hospitalized HF patients for eligibility. An 8 week pilot programme of our digital health coach in 21 HF patients, age > 75 years, showed overall improvements in quality of life (13 of 21), self-care (12 of 21), and HF knowledge (13 of 21). A pilot of the use of HHU by nurses showed that it was feasible and accurate.ConclusionsThe Risk-HF trial will evaluate the effectiveness of a risk-guided intervention to improve HF outcomes and will evaluate the efficacy of trained HF nurses delivering a fluid management protocol that is guided by lung ultrasound with an HHU at point of care.

Project description:Imaging has become a routine part of heart failure (HF) investigation. Echocardiography is a first-line test in HF given its availability and it provides valuable diagnostic and prognostic information. Cardiac magnetic resonance (CMR) is an emerging clinical tool in the management of patients with non-ischemic heart failure. Current ACC/AHA/CCS/ESC guidelines advocate its role in the detection of a variety of cardiomyopathies but there is a paucity of high quality evidence to support these recommendations.The primary objective of this study is to compare the diagnostic yield of routine cardiac magnetic resonance versus standard care (that is, echocardiography with only selective use of CMR) in patients with non-ischemic heart failure. The primary hypothesisis that the routine use of CMR will lead to a more specific diagnostic characterization of the underlying etiology of non-ischemic heart failure. This will lead to a reduction in the non-specific diagnoses of idiopathic dilated cardiomyopathy and HF with preserved ejection fraction.Tertiary care sites in Canada and Finland, with dedicated HF and CMR programs, will randomize consecutive patients with new or deteriorating HF to routine CMR or selective CMR. All patients will undergo a standard clinical echocardiogram and the interpreter will assign the most likely HF etiology. Those undergoing CMR will also have a standard examination and will be assigned a HF etiology based upon the findings. The treating physician's impression about non-ischemic HF etiology will be collected following all baseline testing (including echo ± CMR). Patients will be followed annually for 4 years to ascertain clinical outcomes, quality of life and cost. The expected outcome is that the routine CMR arm will have a significantly higher rate of infiltrative, inflammatory, hypertrophic, ischemic and 'other' cardiomyopathy than the selective CMR group.This study will be the first multicenter randomized, controlled trial evaluating the role of CMR in non-ischemic HF. Non-ischemic HF patients will be randomized to routine CMR in order to determine whether there are any gains over management strategies employing selective CMR utilization. The insight gained from this study should improve appropriate CMR use in HF.NCT01281384.

Dataset Information

Prediction of readmissions and mortality in patients with heart failure: lessons from the IMPEDANCE-HF extended trial.

Publications

Prediction of readmissions and mortality in patients with heart failure: lessons from the IMPEDANCE-HF extended trial.

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