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Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

ABSTRACT: BACKGROUND:There's scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. OBJECTIVE:The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. METHODS:In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (<40%) and no immediate indication for device implant received an implantable loop recorder (ILR) before hospital discharge. Follow-up visits were scheduled at 3 and 6 months, and at every 6 months until study closure; device data were remotely reviewed monthly. CV mortality, unplanned CV hospitalization, and major arrhythmic events during follow-up were analyzed. RESULTS:During a median follow-up of 593 days, major CV occurred in 13 patients (72%); of those, 7 patients had at least 1 cardiac arrhythmic event, 2 had at least a clinical event (CV hospitalization or CV death), and 4 had both an arrhythmic and a CV event. Six (33%) patients experienced 10 major clinical events, 5 of them (50%) were HF related. During follow-up, 2 (11%) patients died due to a CV cause and 3 (16%) patients received a permanent cardiac device. CONCLUSIONS:After an acute HF hospitalization, patients with LVEF<40% and who are not readily eligible for permanent cardiac device implant have a known high incidence of major CV event. In these patients, ILR allows early detection of major cardiac arrhythmias and the ability to react appropriately in a timely manner. TRIAL REGISTRATION:ClinicalTrials.gov NCT01216670; https://clinicaltrials.gov/ct2/show/NCT01216670.

SUBMITTER: Vanoli E

PROVIDER: S-EPMC4863131 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

Vanoli Emilio E Mortara Andrea A Diotallevi Paolo P Gallone Giuseppe G Mariconti Barbara B Gronda Edoardo E Gentili Alessandra A Bisetti Silvia S Botto Giovanni Luca GL

JMIR research protocols 20160426 2

<h4>Background</h4>There's scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant.<h4>Objective</h4>The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population.<h4>Methods</h4>In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who we ...[more]

PMID: 27118481

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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:BACKGROUND:Recurrent hospital admissions are common among patients admitted for acute decompensated heart failure (ADHF), but identification of patients at risk for rehospitalization remains challenging. Contemporary heart failure (HF) management programs have shown modest ability to reduce readmissions, partly because they monitor signs or symptoms of HF worsening that appear late during decompensation. Detecting early stages of HF decompensation might allow for immediate application of effective HF therapies, thereby potentially reducing HF readmissions. One of the earliest indicators of HF decompensation is intrathoracic fluid accumulation, which can be assessed using transthoracic bioimpedance. OBJECTIVE:The SENTINEL-HF study is a prospective observational study designed to test a novel, wearable HF monitoring system as a predictor of HF decompensation among patients discharged after hospitalization for ADHF. METHODS:SENTINEL-HF tests the hypothesis that a decline in transthoracic bioimpedance, as assessed daily with the Philips fluid accumulation vest (FAV) and transmitted using a mobile phone, is associated with HF worsening and rehospitalization. According to pre-specified power calculations, 180 patients admitted with ADHF are enrolled. Participants transmit daily self-assessments using the FAV-mobile phone dyad for 45 days post-discharge. The primary predictor is the deviation of transthoracic bioimpedance for 3 consecutive days from a patient-specific normal variability range. The ADHF detection algorithm is evaluated in relation with a composite outcome of HF readmission, diuretic up-titration, and self-reported HF worsening (Kansas City Cardiomyopathy Questionnaire) during a 90-day follow-up period. Here, we provide the details and rationale of SENTINEL-HF. RESULTS:Enrollment in the SENTINEL-HF study is complete and the 90-days follow-up is currently under way. Once data collection is complete, the study dataset will be used to evaluate our ADHF detection algorithm and the results submitted for publication. CONCLUSION:SENTINEL-HF emerged from our long-term vision that advanced home monitoring technology can improve the management of chronic HF by extending clinical care into patients' homes. Monitoring transthoracic bioimpedance with the FAV may identify patients at risk of recurrent HF decompensation and enable timely preventive measures. TRIAL REGISTRATION:Clinicaltrials.gov NCT01877369: https://clinicaltrials.gov/ct2/show/NCT01877369 (Archived by WebCite at http://www.webcitation.org/6bDYl0dGy).

Project description:AimsHeart failure (HF) patients have a high risk of mortality due to sudden cardiac death (SCD) and non-SCD, including pump failure death (PFD). Anaemia predicts more severe symptomatic burden and higher morbidity, as noted by markedly increased hospitalizations and readmission rates, and mortality, underscoring its importance in HF management. Herein, we aimed to determine whether haemoglobin (Hb) level at discharge affects the mode of death and influences SCD risk prediction.MethodsWe evaluated the data of 3020 consecutive acute HF patients from a Japanese prospective multicentre registry. Patients were divided into four groups based on discharge Hb levels. SCD was defined as an unexpected and otherwise unexplained death in a previously stable patient or death due to documented or presumed cardiac arrhythmia without a clear non-cardiovascular cause. The mode of death (SCD, PFD or other cause) was adjudicated by a central committee. Finally, we investigated whether adding Hb level to the Seattle Proportional Risk Model (SPRM; established risk score utilized to estimate 'proportion' of SCD among death events) would affect its performance.ResultsThe mean age of studied patients was 74.3 ± 12.9 years, and 59.8% were male. The mean Hb level was 12.0 ± 2.1 g/dL (61.3% of patients had anaemia defined by World Health Organization criteria). During the 2-year follow-up, 474 deaths (15.7%) occurred, including 93 SCDs (3.1%), 171 PFDs (5.7%) and 210 other deaths (7.0%; predominantly non-cardiac death). Absolute risk of PFD (P < 0.001) or other death (P < 0.001) increased along with the severity of anaemia, whereas the incidence of SCD was low but remained consistent across all four groups (P = 0.440). As a proportion of total deaths in each Hb level group, the contributions from non-SCD increased and from SCD decreased along with anaemia severity (P = 0.007). Adding Hb level to the SPRM improved the overall discrimination (c-index: 0.62 [95% confidence interval (CI) 0.56-0.69] to 0.65 [95% CI 0.59-0.71]), regardless of the baseline ejection fraction (EF) (c-index: 0.64 [95% CI 0.55-0.73] to 0.67 [95% CI 0.58-0.75] for reduced EF and 0.55 [95% CI 0.45-0.66] to 0.61 [95% CI 0.52-0.70] for preserved EF).ConclusionsThe discharge Hb level provides information about both absolute and proportional risks for each mode of death in acute HF patients, and the addition of Hb level improves the performance of SPRM by identifying more non-SCD cases. Future 'proportional' SCD risk models should incorporate Hb level as a covariate to meet this high performance.

Project description:AimsIdentifying heart failure (HF) patients in general practice is challenging, and little is known about the current quality of care. We implemented an extended audit from the electronic health records (EHRs) of general practitioners (GPs) to identify HF patients and investigate patient characteristics and quality of care.Methods and resultsThis study describes the baseline results of the OSCAR-HF pilot study in eight general practices (51 GPs) in Flanders, Belgium. This prospective trial ran for 6 months. Interventions included an extended audit, an N-terminal pro-B-type natriuretic peptide point-of-care test, and assistance of a specialist HF nurse. The extended audit searched on risk factors for HF, HF symptoms, signs, and medication in the GPs' EHR to generate a list of possible HF patients. GPs determined which patients had HF. Those HF patients constituted the OSCAR-HF study population. Each patient file was manually revised to extract biomarker measurements, echocardiography data, and quality indicators. An independent panel of experts assessed the validity of GPs' HF diagnoses. Feedback about the validity of the HF diagnosis was given to the GP. Out of 18 011 patients ? 40 years, we identified 310 patients with a registered HF diagnosis before the study start (HF prevalence: 1.7%). The extended audit led to a 74% increase in identified HF patients (n = 538, HF prevalence: 3.0%) with a mean age of 79 ± 11 years. The prevalence of HF with reduced ejection fraction (HFrEF) was 20% (n = 110). A high proportion of patients underwent echocardiography in the past 5 years (86%, n = 462). Natriuretic peptides were rarely available in patients' files (19%, n = 100). Medical specialists should improve communication about the HF diagnosis because a specialist diagnosis was present in only 225 patients (42%) while 67% (n = 359) of the HF diagnoses were judged objectified by a panel of experts. Assigning a diagnosis of HF was particularly difficult in HF patients with preserved EF (HFpEF). HFrEF treatment rates with renin-angiotensin-aldosterone system blockers (84%, n = 92) and beta-blockers (86%, n = 94) were very good; however, target doses were hardly reached (34% and 14%, respectively).ConclusionsThis study highlighted the need to improve case finding for HF in general practice and showed that an extended audit in the GPs' EHR was a successful strategy to do so. To improve the quality of HF care in general practice, specific strategies are needed to diagnose HFpEF and to reach target doses of disease-modifying drugs in HFrEF patients.

Dataset Information

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

Publications

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

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