title: Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial. A randomized controlled trial of telephone-supported care coordination in patients with congestive heart failure Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure. Long-Term Prospective, Randomized, Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients: The REMADHE Trial Tele-guidance of chronic heart failure patients enhances knowledge about the disease. A multi-centre, randomised controlled study. A randomized controlled trial of telemonitoring in older adults with multiple chronic conditions: the Tele-ERA study Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. Telemonitoring of heart failure patients and their caregivers: a pilot randomized controlled trial. A heart failure self-management program for patients of all literacy levels: A randomized, controlled trial [ISRCTN11535170] Reducing the Cost of Frequent Hospital Admissions for Congestive Heart Failure: A Randomized Trial of a Home Telecare Intervention Effect of Home-Based Telemonitoring Using Mobile Phone Technology on the Outcome of Heart Failure Patients After an Episode of Acute Decompensation: Randomized Controlled Trial Improving Outcomes for Older Adults With Heart Failure: A Randomized Trial Using a Theory‐Guided Nursing Intervention Randomised controlled trial of specialist nurse intervention in heart failure AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. Heart failure management: multidisciplinary care has intrinsic benefit above the optimization of medical care. Impact of telemonitoring at home on the management of elderly patients with congestive heart failure Influence of Nonfatal Hospitalization for Heart Failure on Subsequent Mortality in Patients With Chronic Heart Failure Continuous Monitoring of Intrathoracic Impedance and Right Ventricular Pressures in Patients With Heart Failure A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. Managing heart failure care using an internet-based telemedicine system. Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. Long-Term Healthcare and Cost Outcomes of Disease Management in a Large, Randomized, Community-Based Population With Heart Failure Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial Effects of Nurse Management on the Quality of Heart Failure Care in Minority Communities Impact of the nursing consultation on the frequency of hospitalizations in patients with heart failure in Curitiba, Parana State. Impact of Remote Telemedical Management on Mortality and Hospitalizations in Ambulatory Patients With Chronic Heart Failure: The Telemedical Interventional Monitoring in Heart Failure Study Telemonitoring with case management for seniors with heart failure. Outcomes of chronic heart failure. Evaluation of a telemedicine system for heart failure patients: feasibility, acceptance rate, satisfaction and changes in patient behavior: results from the CARME (CAtalan Remote Management Evaluation) study Cost of medical services in older patients with heart failure: those receiving enhanced monitoring using a computer-based telephonic monitoring system compared with those in usual care: the Heart Failure Home Care trial. A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial. Randomized trial of a nurse-administered, telephone-based disease management program for patients with heart failure. Relation between modifiable lifestyle factors and lifetime risk of heart failure. Changes in Brain Natriuretic Peptide and Norepinephrine Over Time and Mortality and Morbidity in the Valsartan Heart Failure Trial (Val-HeFT) Randomised trial of telephone intervention in chronic heart failure: DIAL trial Randomized clinical trial of the effectiveness of a home-based intervention in patients with heart failure: the IC-DOM study. A multicenter disease management program for hospitalized patients with heart failure. A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure. [Monitoring multiple cardiovascular paramaters using telemedicine in patients with chronic heart failure]. [Disease management for heart failure patients: role of wireless technologies for telemedicine. The ICAROS project]. An intervention for VA patients with congestive heart failure. Managing heart failure patients after formal homecare. Can monitoring of intrathoracic impedance reduce morbidity and mortality in patients with chronic heart failure? Rationale and design of the Diagnostic Outcome Trial in Heart Failure (DOT-HF). Randomized trial of an education and support intervention to prevent readmission of patients with heart failure. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. Prevalence of left-ventricular systolic dysfunction and heart failure in the Echocardiographic Heart of England Screening study: a population based study Home telemonitoring in heart failure patients: the HHH study (Home or Hospital in Heart Failure) Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: the Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study. Impact of Telemedical Care and Monitoring on Morbidity in Mild to Moderate Chronic Heart Failure Application of implantable hemodynamic monitoring in the management of patients with diastolic heart failure: a subgroup analysis of the COMPASS-HF trial. Using home telehealth to empower patients to monitor and manage long term conditions. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team: results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) Study. A comparison of in-person home care, home care with telephone contact and home care with telemonitoring for disease management Telecardiology for patients with chronic heart failure: the 'SHL' experience in Israel. A Randomized Trial of Telemonitoring Heart Failure Patients Pilot Testing of a Multicomponent Home Care Intervention for Older Adults With Heart Failure: An Academic Clinical Partnership The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. Randomized controlled trial of telephone case management in Hispanics of Mexican origin with heart failure. A randomized clinical trial of the clinical effects of enhanced heart failure monitoring using a computer-based telephonic monitoring system in older minorities and women. Rationale and design of a prospective trial to assess the sensitivity and positive predictive value of implantable intrathoracic impedance monitoring in the prediction of heart failure hospitalizations: the SENSE-HF study. Care Management for Low-Risk Patients with Heart Failure Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study. A randomized trial of home telemonitoring in a typical elderly heart failure population in North West London: results of the Home-HF study. Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial. Home telemonitoring of vital signs and cardiorespiratory signals in heart failure patients: system architecture and feasibility of the HHH model. Utilization of telemedicine by heart disease patients following hospitalization Continuous hemodynamic monitoring in patients with mild to moderate heart failure: results of The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCEhf) trial. Influence of Home Monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study. Mode of Action and Effects of Standardized Collaborative Disease Management on Mortality and Morbidity in Patients With Systolic Heart Failure: The Interdisciplinary Network for Heart Failure (INH) Study Impact of a comprehensive telephone-based disease management programme on quality-of-life in patients with heart failure. Tailored Telemonitoring in patients with heart failure: results from a multicentre randomized controlled trial (the TEHAF-study) Case management in a heterogeneous congestive heart failure population: a randomized controlled trial. [Impact of telemetric management on overall treatment costs and mortality rate among patients with chronic heart failure]. Compliance and effectiveness of 1 year's home telemonitoring. The report of a pilot study of patients with chronic heart failure Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Hospital cost effect of a heart failure disease management program: the Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) trial. Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare via telephone-monitoring. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial Symptomatic and asymptomatic left-ventricular systolic dysfunction in an urban population Telemonitoring in patients with heart failure. Quantifying the heart failure epidemic: prevalence, incidence rate, lifetime risk and prognosis of heart failure The Rotterdam Study. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system. Impact of Home Patient Telemonitoring on Use of β-Blockers in Congestive Heart Failure Impact of Telehealth on Clinical Outcomes in Patients With Heart Failure Telehome monitoring in patients with cardiac disease who are at high risk of readmission. Cost-Effectiveness of Nurse-Led Disease Management for Heart Failure in an Ethnically Diverse Urban Community The effects of an advanced practice nurse led telephone intervention on outcomes of patients with heart failure. Cost-effectiveness of telephonic disease management in heart failure. Framework for design and evaluation of complex interventions to improve health Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Clinical trials update from the European Society of Cardiology Heart Failure meeting 2011: TEHAF, WHICH, CARVIVA, and atrial fibrillation in GISSI-HF and EMPHASIS-HF. Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (TElemonitoring in the MAnagement of Heart Failure) study. Multicenter randomised trial on home-based telemanagement to prevent hospital readmission of patients with chronic heart failure. Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Do heart failure disease management programs make financial sense under a bundled payment system? Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. Automated home telephone self-monitoring reduces hospitalization in patients with advanced heart failure
abstract: BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction < or = 35 % were r and omized to receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the  AlereNet system and 142 received st and ard care .  Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes .  No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P < .003 ) for patients r and omized to the AlereNet group . CONCLUSIONS This is the largest multicenter , r and omized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups An evaluation was undertaken on the effectiveness and efficiency of care coordination as a means of delivering health services to Australian veterans with a diagnosis of congestive heart failure . The veterans participated in a r and omized controlled trial of care coordination that was supported by the Department of Veterans ' Affairs ( DVA ) . Of 490 veterans who were recruited , 409 were surveyed at baseline ( 214 in the intervention group and 195 controls ) . At follow-up , 288 were surveyed ( 155 intervention and 133 controls ) . Information on cost of care and quality of life ( QOL ) was collected before the commencement of coordinated care and at follow-up after 12 months . Cost of care data were obtained from DVA records . Information on QOL was obtained from telephone interviews , using the Short Form ( SF-12 ) Health Survey and the EuroQol Group EQ-5D survey . There were no significant differences in costs of care between the intervention ( coordinated care ) and control groups of veterans . Nor were there significant differences between the intervention and control groups in QOL measurements with either of the evaluation tools that were used . Because evidence of benefit from coordinated care may be slow to emerge in patients with chronic disease , it would be desirable for future work in this area to include long term , good quality comparative studies on selected veteran population s. Such studies should measure QOL and economic outcomes in addition to clinical indicators BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use .  Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized .  Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches Background —The effectiveness of heart failure disease management programs in patients under cardiologists ' care over long-term follow-up is not established . Methods and Results —We investigated the effects of a disease management program with repetitive education and telephone monitoring on primary ( combined death or unplanned first hospitalization and quality -of-life changes ) and secondary end points ( hospitalization , death , and adherence ) . The REMADHE [ Repetitive Education and Monitoring for ADherence for Heart Failure ] trial is a long-term r and omized , prospect i ve , parallel trial design ed to compare intervention with control . One hundred seventeen patients were r and omized to usual care , and 233 to additional intervention . The mean follow-up was 2.47±1.75 years , with 54 % adherence to the program . In the intervention group , the primary end point composite of death or unplanned hospitalization was reduced ( hazard ratio , 0.64 ; confidence interval , 0.43 to 0.88 ; P=0.008 ) , driven by reduction in hospitalization . The quality -of-life question naire score improved only in the intervention group ( P<0.003 ) . Mortality was similar in both groups . Number of hospitalizations ( 1.3±1.7 versus 0.8±1.3 , P<0.0001 ) , total hospital days during the follow-up ( 19.9±51 versus 11.1±24 days , P<0.0001 ) , and the need for emergency visits ( 4.5±10.6 versus 1.6±2.4 , P<0.0001 ) were lower in the intervention group . Beneficial effects were homogeneous for sex , race , diabetes and no diabetes , age , functional class , and etiology . Conclusions —For a longer follow-up period than in previous studies , this heart failure disease management program model of patients under the supervision of a cardiologist is associated with a reduction in unplanned hospitalization , a reduction of total hospital days , and a reduced need for emergency care , as well as improved quality of life , despite modest program adherence over time BACKGROUND New strategies are required to optimize care in increasing numbers of chronic heart failure patients . The aim of this r and omised trial was to evaluate a remote guidance system . METHODS Intervention group patients received a home TV-channel providing educational material s. Tele-guidance was performed by a Medical Service Centre . Control group patients were followed by cardiologists and HF-nurses . Primary endpoints were total days in hospital for all causes and days alive and out of hospital . Secondary endpoints were : quality of life and knowledge of disease and self care . RESULTS 214 patients were enrolled , median age was 66 years , 89 % had systolic LV dysfunction , and 90 % were in NYHA class II or III . The mean LVEF was 31 % . Over a mean follow-up duration of 288 days , there were 199 hospital admissions in 105 patients . Comparison of the groups revealed no differences for the primary outcomes or for QoL or self care behaviour . Knowledge about heart failure however , increased significantly more in the Intervention group ( p<0.001 ) . CONCLUSION Tele-guidance may play a role in the management of heart failure patients since it takes over some of the tasks of HF-nurses . This may facilitate delivery of optimal care to more patients with the same level of experienced staff Background Older adults with multiple chronic illnesses are at risk for worsening functional and medical status and hospitalization . Home telemonitoring may help slow this decline . This protocol of a r and omized controlled trial was design ed to help determine the impact of home telemonitoring on hospitalization . The specific aim of the study reads as follows : to determine the effectiveness of home telemonitoring compared with usual care in reducing the combined outcomes of hospitalization and emergency department visits in an at-risk population 60 years of age or older . Methods / Design Two-hundred patients with the highest 10 % Mayo Clinic Elder Risk Assessment scores will be r and omly assigned to one of two interventions . Home telemonitoring involves the use of a computer device , the Intel Health Guide , which records biometric and symptom data from patients in their homes . This information is monitored by midlevel providers associated with a primary care medical practice . Under the usual care scenario , patients make appointments with their providers as problems arise and use ongoing support such as a 24-hour nurse line . Patients will have initial evaluations of gait and quality of life using instruments such as the SF-12 Health Survey , the Kokmen Short Test of Mental Status , and the PHQ-9 health question naire . Patients will be followed for 1 year for primary outcomes of hospitalizations and emergency department visits . Secondary analysis will include quality of life , compliance with the device , and attitudes about telemonitoring . Sample size is based on an 80 % power to detect a 36 % difference between the two groups . The primary analysis will involve Cox proportional time-to-event analysis . Secondary analysis will use t-test comparisons for continuous variables and the chi square test for proportional analysis . Discussion Patients r and omized to home telemonitoring will have daily assessment s of their health status using the device . Registered nurse monitoring will assess any change in status followed by videoconferencing by a mid-level provider . We obtained trial registration and Institutional Review Board approval . Trial registration Trial registration number through http://www . clinical trials.gov:%20NCT01056640 OBJECTIVES The purpose of this study was to assess the rate of death and hospitalization for heart failure ( HF ) 1 and 3 years after a r and omized trial of telephone intervention aim ed to improve education and compliance in stable patients with HF ended . BACKGROUND The long-term effects of HF programs are not well known . METHODS In all , 1,518 patients with HF were r and omized into the DIAL ( R and omized Trial of Phone Intervention in Chronic Heart Failure ) . After completion of the trial , patients were followed up to 3 years to assess major outcomes . Compliance with diet , weight control , and treatment was evaluated . The effect of the intervention on mortality and HF hospitalizations was assessed using relative risk ( RR ) , relative risk reduction , and Cox proportional hazards model for adjusting by potential confounders . RESULTS The rate of death or hospitalization for HF was lower in the intervention group ( 37.2 % vs. 42.6 % , RR : 0.81 , 95 % confidence interval [ CI ] : 0.69 to 0.96 ; p = 0.013 ) 1 and 3 years ( 55.7 % vs. 57.5 % , RR : 0.88 , 95 % CI : 0.77 to 1.00 ; p = 0.05 ) after the intervention ended . This benefit was mainly caused by a reduction in admission for HF ( 28.5 % vs. 35.1 % after 3 years , RR : 0.72 , 95 % CI : 0.60 to 0.87 ; p = 0.0004 ) . Patients who showed improvement in 1 or more of 3 key compliance indicators ( diet , weight control , and medication ) had lower risks of events . CONCLUSIONS The benefit observed during the intervention period persisted and was sustained 1 and 3 years after the intervention ended . This effect may be explained by the impact of the educational intervention on patients ' behavior and habits Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit Background Self-management programs for patients with heart failure can reduce hospitalizations and mortality . However , no programs have analyzed their usefulness for patients with low literacy . We compared the efficacy of a heart failure self-management program design ed for patients with low literacy versus usual care .  Methods We performed a 12-month r and omized controlled trial . From November 2001 to April 2003 , we enrolled participants aged 30–80 , who had heart failure and took furosemide .  Intervention patients received education on self-care emphasizing daily weight measurement , diuretic dose self-adjustment , and symptom recognition and response . Picture-based educational material s , a digital scale , and scheduled telephone follow-up were provided to reinforce adherence . Control patients received a generic heart failure brochure and usual care . Primary outcomes were combined hospitalization or death , and heart failure-related quality of life . Results 123 patients ( 64 control , 59 intervention ) participated ; 41 % had inadequate literacy . Patients in the intervention group had a lower rate of hospitalization or death ( crude incidence rate ratio ( IRR ) = 0.69 ; CI 0.4 , 1.2 ; adjusted IRR = 0.53 ; CI 0.32 , 0.89 ) . This difference was larger for patients with low literacy ( IRR = 0.39 ; CI 0.16 , 0.91 ) than for higher literacy ( IRR = 0.56 ; CI 0.3 , 1.04 ) , but the interaction was not statistically significant . At 12 months , more patients in the intervention group reported monitoring weights daily ( 79 % vs. 29 % , p < 0.0001 ) . After adjusting for baseline demographic and treatment differences , we found no difference in heart failure-related quality of life at 12 months ( difference = -2 ; CI -5 , + 9 ) . Conclusion A primary care-based heart failure self-management program design ed for patients with low literacy reduces the risk of hospitalizations or death Background .The high cost of caring for patients with congestive heart failure ( CHF ) results primarily from frequent hospital readmissions for exacerbations . Home nurse visits after discharge can reduce readmissions , but the intervention costs are high . Objectives .To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges : 1 ) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope ; 2 ) nurse telephone calls ; and 3 ) usual outpatient care . Research Design . One-year r and omized trial . Subjects . English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF . Measures .Our primary outcome was CHF-related readmission charges during a 6-month period after r and omization . Secondary outcomes included all-cause readmissions , emergency department ( ED ) visits , and associated charges . Results .Thirty-seven subjects were r and omized : 13 to home telecare , 12 each telephone care and 12 to usual care .  Mean CHF-related readmission charges were 86 % lower in the telecare group ( $ 5850 , SD $ 21,094 ) and 84 % lower in the telephone group ( $ 7320 , SD $ 24,440 ) than in the usual care group ( $ 44,479 , SD $ 121,214 ) . However , the between-group difference was not statistically significant . Both intervention groups had significantly fewer CHF-related ED visits ( P = 0.0342 ) and charges ( P = 0.0487 ) than the usual care group . Trends favoring both interventions were noted for all other utilization outcomes . Conclusions .Substantial reductions in hospital readmissions , emergency visits , and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring . Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive Background Telemonitoring of patients with chronic heart failure ( CHF ) is an emerging concept to detect early warning signs of impending acute decompensation in order to prevent hospitalization . Objective The goal of the MOBIle TELemonitoring in Heart Failure Patients Study ( MOBITEL ) was to evaluate the impact of home-based telemonitoring using Internet and mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation . Methods Patients were r and omly allocated to pharmacological treatment ( control group ) or to pharmacological treatment with telemedical surveillance for 6 months ( tele group ) . Patients r and omized into the tele group were equipped with mobile phone – based patient terminals for data acquisition and data transmission to the monitoring center . Study physicians had continuous access to the data via a secure Web portal . If transmitted values went outside individually adjustable borders , study physicians were sent an email alert . Primary endpoint was hospitalization for worsening CHF or death from cardiovascular cause . Results The study was stopped after r and omization of 120 patients ( 85 male , 35 female ) ; median age was 66 years ( IQR 62 - 72 ) . The control group comprised 54 patients ( 39 male , 15 female ) with a median age of 67 years ( IQR 61 - 72 ) , and the tele group included 54 patients ( 40 male , 14 female ) with a median age of 65 years ( IQR 62 - 72 ) . There was no significant difference between groups with regard to baseline characteristics . Twelve tele group patients were unable to begin data transmission due to the inability of these patients to properly operate the mobile phone ( “ never beginners ” ) . Four patients did not finish the study due to personal reasons . Intention-to-treat analysis at study end indicated that 18 control group patients ( 33 % ) reached the primary endpoint ( 1 death , 17 hospitalizations ) , compared with 11 tele group patients ( 17 % , 0 deaths , 11 hospitalizations ; relative risk reduction 50 % , 95 % CI 3 - 74 % , P = .06 ) . Per- protocol analysis revealed that 15 % of tele group patients ( 0 deaths , 8 hospitalizations ) reached the primary endpoint ( relative risk reduction 54 % , 95 % CI 7 - 79 % , P= .04 ) . NYHA class improved by one class in tele group patients only ( P < .001 ) . Tele group patients who were hospitalized for worsening heart failure during the study had a significantly shorter length of stay ( median 6.5 days , IQR 5.5 - 8.3 ) compared with control group patients ( median 10.0 days , IQR 7.0 - 13.0 ; P= .04 ) . The event rate of never beginners was not higher than the event rate of control group patients . Conclusions Telemonitoring using mobile phones as patient terminals has the potential to reduce frequency and duration of heart failure hospitalizations . Providing elderly patients with an adequate user interface for daily data acquisition remains a challenging component of such a concept Newly discharged older adults with heart failure continue to experience frequent hospital readmissions , lower quality of life , and decreased satisfaction with health services .  A theory-guided intervention delivered by home health nurses via the telephone was studied using a r and omized controlled trial to assess its feasibility and inform further studies . Findings generated a profile of older adults with heart failure , utilization by patients and nurses , operational issues , and preliminary data on intended outcomes . Implication s for further study are presented Abstract Objectives : To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure . Design : R and omised controlled trial . Setting : Acute medical admissions unit in a teaching hospital . Participants : 165 patients admitted with heart failure due to left ventricular systolic dysfunction . The intervention started before discharge and continued thereafter with home visits for up to 1 year . Main outcome measures : Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure . Results : 31 patients ( 37 % ) in the intervention group died or were readmitted with heart failure compared with 45 ( 53 % ) in the usual care group ( hazard ratio=0.61 , 95 % confidence interval 0.33 to 0.96).Compared with usual care , patients in the intervention group had fewer readmissions for any reason ( 86 v 114 , P=0.018 ) , fewer admissions for heart failure ( 19 v 45 , P<0.001 ) and spent fewer days in hospital for heart failure ( mean 3.43 v 7.46 days , P=0.0051 ) . Conclusions : Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure . What is already known on this topic Studies have suggested that nurse intervention may reduce readmission in patients with heart failure What this study adds Home based intervention from nurses reduces readmissions for worsening heart failure Regular contact to review treatment and patient education are likely to contribute to this OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess  systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review OBJECTIVES The purpose of this study was to determine whether a heart failure ( HF ) management strategy using continuous intracardiac pressure monitoring could decrease HF morbidity . BACKGROUND Patients with HF may experience frequent decompensations that require hospitalization despite intensive treatment and follow-up . METHODS The COMPASS-HF ( Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure ) study was a prospect i ve , multicenter , r and omized , single-blind , parallel-controlled trial of 274 New York Heart Association functional class III or IV HF patients who received an implantable continuous hemodynamic monitor . Patients were r and omized to a Chronicle ( Medtronic Inc. , Minneapolis , Minnesota ) ( n = 134 ) or control ( n = 140 ) group . All patients received optimal medical therapy , but the hemodynamic information from the monitor was used to guide patient management only in the Chronicle group . Primary end points included freedom from system-related complications , freedom from pressure-sensor failure , and reduction in the rate of HF-related events ( hospitalizations and emergency or urgent care visits requiring intravenous therapy ) . RESULTS The 2 safety end points were met with no pressure-sensor failures and system-related complications in only 8 % of the 277 patients who underwent implantation ( all but 4 complications were successfully resolved ) . The primary efficacy end point was not met because the Chronicle group had a nonsignificant 21 % lower rate of all HF-related events compared with the control group ( p = 0.33 ) . A retrospective analysis of the time to first HF hospitalization showed a 36 % reduction ( p = 0.03 ) in the relative risk of a HF-related hospitalization in the Chronicle group . CONCLUSIONS The implantable continuous hemodynamic monitor-guided care did not significantly reduce total HF-related events compared with optimal medical management . Additional trials will be necessary to establish the clinical benefit of implantable continuous hemodynamic monitor-guided care in patients with advanced HF PURPOSE This work addresses the unanswered question of whether multidisciplinary care ( MDC ) of heart failure ( HF ) can reduce readmissions when optimal medical care is applied in both intervention and control groups . METHODS In a r and omized , controlled study , 98 patients ( mean age , 70.8 + /- 10.5 years ) admitted to hospital with left ventricular failure ( New York Heart Association Class IV ) were assigned to routine care ( RC , n = 47 ) or MDC ( n = 51 ) . All patients received the same components of inpatient , optimal medical care of HF : specialist-led inpatient care ; titration to maximum tolerated dose of angiotensin-converting enzyme inhibitor before discharge ; attainment of predetermined discharge criteria ( weight stable , off all intravenous therapy , and no change in oral regimen for 2 days ) . Only those in the MDC group received inpatient and outpatient education and close telephone and clinic follow-up . The primary study endpoint was rehospitalization or death for a HF-related issue at 3 months . MAIN FINDINGS At 3 months , four people had events in the MDC group ( 7.8 % rate over 3 months ) compared with 12 people ( 25.5 % rate over 3 months ) in the RC group ( P = 0.04 ) . CONCLUSION These data demonstrate for the first time the intrinsic benefit of MDC in the setting of protocol -driven , optimal medical management of HF . Moreover , the event rate of 7.8 % at 3 months , as the lowest reported rate for such a high-risk group , underlines the value of this approach to the management of heart failure We studied the effects of home telemonitoring in elderly patients with congestive heart failure ( CHF ) on mortality and rate of hospitalization , compliance with treatment , quality of life and costs of CHF management , by comparison with a group receiving usual care . Fifty-seven elderly CHF patients were r and omized to st and ard care or to home telemonitoring-based care  and followed for 12 months . In the subjects who were monitored , weekly reports on their clinical status were obtained and their management was modified accordingly . Home telemonitoring was associated with improvements in the composite endpoint of mortality and rate of hospitalizations ( P = 0.006 ) , a better compliance with therapy , more frequent use of beta-blockers and statins , lower total cholesterol level and a better reported health perception score . The improved results with home telemonitoring in CHF were probably due to better compliance and to closer monitoring of the patients Background — Patients with chronic heart failure ( HF ) are at increased risk of both fatal and nonfatal major adverse cardiovascular events . We used data from the C and esartan in Heart failure : Assessment of Reduction in Mortality and morbidity ( CHARM ) trials to assess the influence of nonfatal hospitalizations for HF on subsequent mortality rates in a broad spectrum of HF patients . Methods and Results — In the present study , 7599 patients with New York Heart Association class II to IV HF and reduced or preserved left ventricular ejection fraction were r and omized to placebo or c and esartan . We assessed the risk of death after discharge from a first hospitalization for HF using time-up date d Cox proportional-hazards models on 7572 patients for whom discharge data were available . Of 7572 patients , 1455 ( 19 % ) had at least 1 HF hospitalization , and 586 of 1819 deaths occurred after discharge from an HF hospitalization . The mortality rate was increased after HF hospitalizations , even after adjustment for baseline predictors of death ( hazard ratio , 3.15 ; 95 % confidence interval , 2.83 to 3.50 ) . Longer duration of HF hospitalization enhanced the risk of dying , as did repeat HF hospitalizations . Moreover , risk of death was highest within a month of discharge and then declined progressively over time , particularly for death result ing from HF progression and for sudden cardiac death . We observed a similar pattern of risk associated with all-cause hospitalization , although the magnitude was less than that with HF hospitalization . Conclusions — In patients with chronic HF , the risk of death is greatest in the early period after discharge after a hospitalization for HF and is directly related to the duration and frequency of HF hospitalizations . These findings suggest a role for increased surveillance in the early postdischarge period of greatest vulnerability after an HF admission Background —Hemodynamic monitoring using implantable devices may provide early warning of volume overload in patients with heart failure ( HF ) . This study was design ed to prospect ively compare information from intrathoracic impedance monitoring and continuous right ventricular pressure measurements in patients with HF . Methods and Results —Sixteen patients with HF ( age , 63.5±13.8 years ; left ventricular ejection fraction , 23.2±11.3 % ; New York Heart Association , II and III ) and a previous HF decompensation received both a cardiac resynchronization therapy defibrillator providing a daily average of intrathoracic impedance and an implantable hemodynamic monitor providing an estimate of the pulmonary artery diastolic pressure . At the end of a 6-month investigator-blinded period , baseline reference hemodynamic values were determined over 4 weeks during which the patient was clinical ly stable . A major HF event was defined as HF decompensation requiring hospitalization , IV diuretic treatment , or leading to death . Sixteen major HF events occurred in 10 patients . Within 30 days and 14 days before a major HF event , impedance decreased by 0.12±0.21 & OHgr;/d and 0.20±0.20 & OHgr;/d , respectively , whereas estimated pulmonary arterial diastolic pressure increased by 0.10±0.20 mm Hg/d and 0.16±0.15 mm Hg/d , respectively . During these periods , impedance decreased by 3.8±5.4 & OHgr ; ( P<0.02 ) and 4.9±6.1 & OHgr ; ( P<0.007 ) , respectively , whereas estimated pulmonary arterial diastolic pressure increased by 5.8±5.7 mm Hg ( P<0.002 ) and 6.8±6.1 mm Hg ( P<0.001 ) , respectively , compared with baseline . In all patients , impedance and estimated pulmonary arterial diastolic pressure were inversely correlated ( r=−0.48±0.25 ) . Within 30 days preceding a major HF event , this correlation improved to r=−0.58±0.24 . Conclusions —Decompensated HF develops based on hemodynamic derangements and is preceded by significant changes in intrathoracic impedance and right ventricular pressures during the month prior to a major clinical event . Impedance and pressure changes are moderately correlated . Future research may establish the complementary contribution of both parameters to guide diagnosis and management of patients with HF by implantable devices OBJECTIVES We sought to determine whether a multidisciplinary outpatient management program decreases  chronic heart failure ( CHF )  hospital readmissions and mortality over a six-month period . BACKGROUND Hospital admission for CHF is an important problem amenable to improved outpatient management . METHODS Two hundred patients hospitalized with CHF at increased risk of hospital readmission were r and omized to a multidisciplinary program or usual care . A study cardiologist and a CHF nurse evaluated each patient and made recommendations to the patient 's primary physician before r and omization . The intervention team consisted of a cardiologist , a CHF nurse , a telephone nurse coordinator and the patient 's primary physician . Contact with the patient was on a prespecified schedule . The CHF nurse followed an algorithm to adjust medications . Patients in the nonintervention group were followed as usual . The primary outcome was the composite of the number of CHF hospital admissions and deaths over six months , compared by using a log transformation t test by intention-to-treat analysis . RESULTS The median age of the study patients was 63.5 years , and 39.5 % were women . There were 43 CHF hospital admissions and 7 deaths in the intervention group , as compared with 59 CHF hospital admissions and 13 deaths in the nonintervention group ( p = 0.09 ) . The quality -of-life score , percentage of patients on target vasodilator therapy and percentage of patients compliant with diet recommendations were significantly better in the intervention group . Cost per patient , in 1998 U.S. dollars , was similar in both groups . CONCLUSIONS This study demonstrates that a six-month , multidisciplinary approach to CHF management can improve important clinical outcomes at a similar cost in recently hospitalized high-risk patients with CHF BACKGROUND Managing patients with heart failure ( HF ) is labor intensive , and follow-up is often inadequate to detect day-to-day changes that ultimately lead to decompensation . We tested the effect of an Internet-based telemedicine ( T ) system that provides frequent surveillance and increased communicate between HF patients and their provider on frequency of hospitalization in a cohort of patients with advanced HF . METHODS AND RESULTS HF patients in NYHA Class II-IV were r and omized to usual care ( UC , n = 24 ) or T ( T plus UC , n = 24 ) and followed for 1 year .  Office visits , emergency department visits , hospitalizations , telephone calls , and number of Internet communications were measured over the 1-year period . Left ventricular ejection fraction ( EF ) was assessed by echocardiography in both groups . For T , mean age was 53.2 + /- 2.0 years ( 72 % male , 61 % Caucasian , 39 % African American ) . For UC , mean age was 54.1 + /- 2.6 years ( 76 % male , 72 % Caucasian , 14 % African American , and 14 % Hispanic ) .  HF etiologies and EF were similar in both groups . During the 12-month period , UC had 74 total phone calls to the practice , whereas T had 88 telephone calls plus 1887 telemedicine data messages ( 6.5 messages/patient/month ) . ER visits were lower in the T group ( T 5 , UC 12 ; P < .05 ) . Hospital admissions ( T 24 , C 40 ; P = .025 ) and total hospital days ( T 84 , UC 226 days ; P < .005 ) were lower in T. Unscheduled clinic visits ( T 13 , UC 13 ; P = NS ) and scheduled clinic visits ( T 78 , UC 94 ; P = NS ) were similar in both groups . CONCLUSIONS Frequent monitoring and patient management using a telemedicine system may help to reduce hospitalizations , hospital days , and emergency department visits BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the  control group  ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) < 45 % who could be contacted by telephone after discharge .  HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P < 0.001 ) . Other outcomes were similar . CONCLUSION An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge OBJECTIVES The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinical ly actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation . BACKGROUND Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function . More recently developed remote monitoring technology leverages exp and ed device capabilities , augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation . METHODS The time to first diagnosis of a clinical ly actionable event was compared in patients who were followed by remote interrogation ( Remote )  and those who were followed per st and ard of care with office visits augmented by transtelephonic monitoring ( Control ) . Patients were r and omized 2:1 . Remote arm  patients transmitted pacemaker information at 3-month intervals .  Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals . Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months . All patients were seen in office at 12 months . RESULTS The mean time to first diagnosis of clinical ly actionable events was earlier in the Remote arm ( 5.7 months ) than in the Control arm ( 7.7 months ) . Three ( 2 % ) of the 190 events in the Control arm and 446 ( 66 % ) of 676 events in the Remote arm were identified remotely . CONCLUSIONS The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings . The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations . ( PREFER [ Pacemaker Remote Follow-up Evaluation and Review ] ; NCT00294645 ) Background —Because of the prevalence and expense of congestive heart failure ( CHF ) , significant efforts have been made to develop disease management ( DM ) programs that will improve clinical and financial outcomes . The effectiveness of such programs in a large , heterogeneous population of CHF patients remains unknown . Methods and Results —We r and omized 1069 patients ( aged 70.9±10.3 years ) with systolic ( ejection fraction 35±9 % ) or echocardiographically confirmed diastolic heart failure ( HF ) to assess telephonic DM over an 18-month period . Data were collected at baseline and at 6-month intervals . Survival analysis was performed by Kaplan-Meier and Cox regression methods . Healthcare utilization was defined after extensive record review , with an attempt to account for all inpatient and outpatient visits , medications , and diagnostic tests . We obtained data on 92 % of the patients , from nearly 53 000 health-related encounters . Total cost per patient was defined by adding estimated costs for the observed encounters , excluding the cost of the DM . Kaplan-Meier analysis showed that DM patients had a reduced mortality rate ( P=0.037 ) , with DM patients surviving an average of 76 days longer than controls . Subgroup analysis showed that DM had beneficial outcomes in patients with systolic HF ( hazard ratio 0.62 ; P=0.040 ) , which was more pronounced in NYHA classes III and IV . Although improvements in NYHA class were more likely with DM ( P<0.001 ) , 6-minute walk data from 217 patients in whom data were available at each visit showed no significant benefit from DM ( P=0.08 ) . Total and CHF-related healthcare utilization , including medications , office or emergency department visits , procedures , or hospitalizations , was not decreased by DM . Repeated- measures ANOVA for cost by group showed no significant differences , even in the higher NYHA class groups . Conclusions —Participation in DM result ed in a significant survival benefit , most notably in symptomatic systolic HF patients .  Although DM was associated with improved NYHA class , 6-minute walk test results did not improve . Healthcare utilization was not reduced by DM , and it conferred no cost savings . DM in HF results in improved life expectancy but does not improve objective measures of functional capacity and does not reduce cost Remote monitoring ( RM ) of homebound heart failure ( HF ) patients has previously been shown to reduce hospital admissions . We conducted a pilot trial of ambulatory , non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting . Eligible patients from Massachusetts General Hospital ( n = 150 ) were r and omized to a control group ( n = 68 ) or to a group that was offered RM ( n = 82 ) . The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study . Participants in the RM program had a lower all-cause per person readmission rate ( mean = 0.64 , SD ± 0.87 ) compared to the usual care group ( mean = 0.73 , SD ± 1.51 ; P-value = .75 ) although the difference was not statistically significant . HF-related readmission rate was similarly reduced in participants . This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates Context People with chronic conditions may need tailored , practical help for managing their conditions . Contribution This 12-month trial of assistance with managing systolic- dysfunction heart failure r and omly assigned 406 ethnically diverse adults from Harlem , New York , to usual care or nurse management .  Nurses counseled nurse management patients about sodium intake , fluid buildup , medication adherence , and self-management of symptoms ; served as a bridge between patients and physicians ; and regularly called patients to discuss problems . Compared with usual care patients , nurse management patients had fewer hospitalizations and better functioning . Implication s Nurse management can improve some outcomes in ethnically diverse patients with systolic-dysfunction heart failure in ambulatory practice s. The Editors Heart failure disproportionately affects black and elderly people and is a leading cause of hospitalization among people 65 years of age or older ( 1 , 2 ) . Although effective therapies can improve functioning and survival in patients with systolic dysfunction , many patients may not be receiving the full benefit of existing knowledge ( 35 ) . Patients play a critical role in managing a chronic condition , such as heart failure . Patients may not realize that specific symptoms are related to heart failure or that adhering to medications and diet can reduce symptoms and life-threatening episodes ( 6 ) . Evidence -based guidelines for systolic dysfunction recommend that physicians not only offer patients effective therapies but also teach them the importance of adherence and self-monitoring ( 3 , 4 ) . Clinicians have fallen short in prescribing angiotensin-converting enzyme inhibitors and -blockers for patients with systolic dysfunction ( 5 , 7 , 8) . When prescribed , the doses have often been lower than those proven to convey greater benefits ( 3 , 9 ) . Clinicians have also documented counseling only a fraction of patients with heart failure about self-management ( 10 , 11 ) . System-related factors may also influence patients ' ability to obtain quality care ( 12 , 13 ) . Systematic review s of clinical behavior change have suggested that interventions targeted to specific problems are more likely to be successful ( 14 , 15 ) . On the basis of shortfalls identified in patient self-management and clinical care in Harlem , New York , a predominately nonwhite area , we tailored a nurse management intervention to address documented problems and evaluated its effectiveness in a r and omized , controlled trial . Our trial among primarily minority patients addresses important gaps in the literature . We targeted problems documented among patients with heart failure in Harlem , enrolled patients from ambulatory care practice s , r and omly assigned patients to either nurse management or usual care , and evaluated the patients ' subsequent health-related outcomes . We hypothesized that patients in the  focused nurse management program  would have fewer hospitalizations and report better functioning than patients in usual care . Methods Development of the Intervention During interviews with patients with heart failure at Mount Sinai Hospital , New York , New York , patients reported inadequate underst and ing of heart failure and their role in managing it ( 6 ) . Less than half of patients followed a very-low-salt diet , and only about one quarter weighed themselves daily . Regarding clinical management , medical records noted prescriptions for an angiotensin-converting enzyme inhibitor or hydralazinedinitrate combination in 82 % of 322 consecutive black patients with documented systolic dysfunction who were scheduled for visits at the general medicine clinic at Harlem Hospital from February 1995 through February 1997 . The prescribed doses , however , equaled or exceeded those found to be efficacious in clinical trials in only 26 % of these patients ( 3 ) . In design ing a nurse management intervention to address these problems , we built on a Stanford University program that evaluated primarily privately insured patients at Kaiser Permanente in northern California ( 16 , 17 ) . We adapted their question naire on the frequency of foods eaten to incorporate those that are common among African-American and Hispanic people in Harlem . Setting s and Recruitment All 4 hospitals in Harlem , the area 's major providers , collaborated in the trial : 1 large private academic medical center ( 1171 beds ) , 2 medium-sized municipal hospitals ( 286 beds and 363 beds ) , and 1 smaller private community hospital ( 200 beds ) . In 2000 , these hospitals had 521 , 267 , 218 , and 168 discharges for the heart failure diagnosis-related group ( code 127 ) , respectively . All are not-for-profit institutions . The trial had the following inclusion criteria : adults 18 years of age or older ; systolic dysfunction documented on a cardiac test ( echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization ) ; English- language or Spanish- language speakers ; community-dwelling at enrollment ; and current patient in a general medicine , geriatrics , or cardiology clinic or office at a participating site . Exclusion criteria were medical conditions that prevented interaction with the nurse , including blindness , deafness , or cognitive impairment ; medical conditions requiring individualized management that might differ from st and ard protocol , namely pregnancy , renal dialysis , or terminal illness ; or procedures that corrected systolic dysfunction , such as heart transplantation . Of the 216 clinicians ( 209 physicians and 7 physicians ' assistants or nurse practitioners ) in participating practice s , 1 clinician declined permission to recruit his patients . The institutional review boards for each site approved the study . We identified patients with International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) , and diagnosis-related group codes on outpatient or inpatient billings for heart failure , March 1999 through February 2001 , who had at least 1 clinician visit to a participating practice and impaired systolic dysfunction . We defined impaired systolic dysfunction as a left ventricular ejection fraction less than 0.40 or moderately or severely reduced systolic dysfunction on echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization . We obtained clinicians ' permission to recruit specific patients and sent each approved patient a letter from the site 's physician coordinator . Bilingual recruiters telephoned eligible patients or approached them at scheduled clinician appointments . The recruiter confirmed each patient 's eligibility , obtained written informed consent to participate in the study , conducted the baseline survey , and telephoned the project manager for the treatment group assignment . The recruiter conveyed the assignment to the patient and , for each nurse management patient , scheduled the in-person appointment with a nurse . We provided telephone service for 3 patients who did not have it so we could telephone patients in both treatment groups every 3 months for data on end points and so nurse management patients could participate in the intervention . R and omization and Treatment Groups The project 's statistician used a computer-generated , r and om-number sequence without blocking or stratification to central ly determine r and omization assignments and concealed treatment group assignments in sealed , opaque envelopes . Usual care patients received federal consumer guidelines for managing systolic dysfunction but no other intervention ( 18 ) . In the nurse management intervention , 1 of 3 trained registered nurses met once with each patient ( Table 1 ) . In counseling the patient , the nurse stressed the relationship among sodium intake ; fluid buildup ; and symptoms , such as shortness of breath . Nurses mailed patients the reports from the food-frequency question naire after each administration . The nurse also served as a bridge between the patient and the clinician ( Table 1 ) . A local clinical advisory committee implemented national evidence -based guidelines , and a committee of key clinicians from participating sites approved the protocol ( 3 , 4 ) . Nurses contacted patients ' clinicians to discuss specific medications and arranged any prescription changes and examinations ordered ( Table 1 ) . An internist monitored the nurses ' work , initially in weekly and then in biweekly meetings , and a cardiologist provided oversight and substituted for the internist at regular meetings , as necessary . Table 1 . Components of Nurse Management * One nurse who was bilingual in English and Spanish delivered the intervention primarily at the 2 municipal hospitals , a second bilingual nurse delivered the intervention primarily at the small community hospital , and the second and a third English- language speaking nurse delivered the intervention primarily at the academic center . All 3 nurses covered each other , especially for the follow-up telephone calls . Outcomes and Measurement To measure hospitalizations , we used billing data from the 4 participating hospitals . At quarterly telephone surveys , interviewers who were blinded to treatment assignment asked patients about hospitalizations at nonparticipating hospitals ; however , we present the analysis of billing data because they measure hospitalizations independent of possibly socially acceptable responses or survey nonresponse of the patients . For functional status , we used the generic Short Form-12 ( SF-12 ) physical component score and the condition-specific Minnesota Living with Heart Failure ( MLHF ) Question naire , with both scales administered at the quarterly interviews . We measured deaths recorded in the National Death Index plus deaths reported by patients ' families for patients with no subsequent billings . Since both nurse management and usual care involved only services delivered in routine practice , the study did not monitor adverse effects . As required by the BACKGROUND Heart failure ( HF ) has become a public health problem with increased incidence and prevalence in the last decade , a consequence of the aging of the population and improved pharmacological and interventionist therapies . It has high rates of mortality and morbidity , expressed as high rates of hospitalizations and re-hospitalizations , even in patients su bmi tted to new therapies , especially ACEI and beta-blockers . OBJECTIVE This study is the analysis of the impact that the nursing consultation has on the frequency of hospitalizations in patients with HF living in the city of Curitiba , state of Parana and its metropolitan region . METHOD Patients with a diagnosis of HF and New York Heart Association ( NYHA ) functional classification , with telephone access , living in the city of Curitiba or its metropolitan region , life expectancy > 3 months due to non-cardiac diseases , aged 18 or older , non-users of illicit drugs . The groups were created by simple r and om allocation ( drawing lots ) and one group received the usual medical care , nursing consultation and telephone monitoring every 15 days of educational nature , intervention group ( IG ) , whereas the other group received the usual medical care , monthly telephone monitoring of administrative and epidemiological nature , control group ( CG ) . The follow-up was carried out for 6 months . RESULTS The IG needed 0.25+/-0.79 and the CG needed 1.10 + /-1.41 ; p = 0.037 hospitalizations . CONCLUSION The nursing consultation promotes the decrease in the frequency of hospitalizations in patients with HF undergoing treatment and living in the city of Curitiba and its metropolitan region Background — This study was design ed to determine whether physician-led remote telemedical management ( RTM ) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure ( HF ) . Methods and Results — We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ⩽35 % and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ⩽25 % . Patients were r and omly assigned ( 1:1 ) to RTM or usual care . Remote telemedical management used portable devices for ECG , blood pressure , and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers . The primary end point was death from any cause . The first secondary end point was a composite of cardiovascular death and hospitalization for HF . Baseline characteristics were similar between the RTM ( n=354 ) and control ( n=356 ) groups . Of the patients assigned to RTM , 287 ( 81 % ) were at least 70 % compliant with daily data transfers and no break for > 30 days ( except during hospitalizations ) . The median follow-up was 26 months ( minimum 12 ) , and was 99.9 % complete . Compared with usual care , RTM had no significant effect on all-cause mortality ( hazard ratio , 0.97 ; 95 % confidence interval , 0.67 to 1.41 ; P=0.87 ) or on cardiovascular death or HF hospitalization ( hazard ratio , 0.89 ; 95 % confidence interval , 0.67 to 1.19 ; P=0.44 ) . Conclusions — In ambulatory patients with chronic HF  , RTM compared with usual care was not associated with a reduction in all-cause mortality . Clinical Trial Registration : — URL : http://www . Clinical Trials.gov . Unique identifier : NCT00543881 OBJECTIVE To assess the impact of supplementing nurse case management with Internet-connected telemonitoring on clinical outcomes in an elderly heart failure ( HF ) population . STUDY DESIGN R and omized clinical trial allocating high-risk HF subjects to the telehealth system with case management ( THCM ) versus case management ( CM ) alone . METHODS Medicare Advantage members with HF and recent hospitalization were r and omized to THCM or CM . Consenting participants received THCM for 6 months or the health plan 's usual Medicare specialized CM as long as deemed necessary . The primary outcome measure was a composite of all-cause hospitalization , ED visit , or death . Because only a subset of those who were r and omized consented and participated , the strategies were evaluated as-treated rather than by intention-to-treat , with multivariate adjustment in logistic regression models for confounding introduced by postr and omization exclusions . RESULTS The treated sample size was 164 subjects in THCM and 152 in CM . Treatment arms did not differ significantly for the primary composite outcome ( 45 % for THCM vs 40 % for CM , relative risk 1.18 ; P = .22 ) . Telehealth alerts prompted frequent telephonic contact , increasing THCM case managers ' workload . The participant population overall had 42 % fewer inpatient days during the intervention period compared with the previous year . CONCLUSIONS Despite effective implementation of an Internet-based telehealth intervention in an elderly HF population , there was no discernible impact on overall morbidity or mortality . Notably , limited postr and omization participation decreased power to detect a difference . The reduction in days hospitalized for trial participants overall underscores the benefit of CM for such HF patients BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the  NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P</=.001 ) with shorter lengths of stay ( 49.5 vs 105.0 days ; P</=.001 ) compared with the HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P</=.02 ) . At 6 and 12 months , cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P<.03 ] and $ 541 378 vs $ 677 710 [ P</=.16 ] , respectively ) compared with the HNV group . Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care Background : Telemedicine can be useful for managing heart failure ( HF ) , but patient acceptance of telemedicine and its impact on patient behavior are unclear . Aims : To assess a telemedicine program in a HF Unit . Methods and results : This sub- analysis of the CARME study assessed the use of an interactive telemedicine platform . This prospect i ve intervention study had a before/after design with HF patients r and omized 1:1 into two groups : A ) Motiva system ( educational videos , motivational messages , and question naires ) ; and B ) Motiva system + telemonitoring of blood pressure  , heart rate and weight .  Of 211 patients screened , 44 were excluded , 62 did not consent to participate and 8 withdrew consent prior to installation of the system . The final study population included 97 patients . During 1 year of follow-up , 22 patients voluntarily discontinued use of the system , 5 died ( three after early discontinuation ) and 5 withdrew consent before the last evaluation . A total of 15,017 question naires were sent to patients , with a median response rate of 88 % . Satisfaction with the system and tools was high ( median score 8.4/10 ) , especially with the self-monitoring chart , scale and sphygmomanometer . Positive changes were observed in patient behavior , especially for blood pressure and weight control ( p < 0.001 ) . After the study , 65 % of the patients wished to continue with telemonitoring , particularly those in Group B ( p = 0.004 ) . Conclusion : Less than half of our patients participated in the telemedicine study . However , those who completed the study had confidence in the system , a high degree of satisfaction with the tools and positive behavioral changes BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure . Whether these types of programs can lower health care cost and be adapted to the primary care setting is unknown . This study was design ed to assess the impact of a home-based disease management program , the Alere DayLink HF Monitoring System ( HFMS ) , on the clinical and economic outcomes of Medicare beneficiaries recently hospitalized for heart failure who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care trial was a multicenter , r and omized , controlled trial of sophisticated , monitoring of heart failure patients with an interactive program versus st and ard heart failure care with enhanced patient education and follow-up ( SC ) in Medicare-eligible patients . The study endpoints included cardiovascular death or rehospitalization for heart failure , length of hospital stay , total patient cost , and cost to Medicare at 6 months of enrollment . A total of 315 patients age ≥ 65 years old were r and omized : 160 to the HFMS and 155 to SC . There were no significant statistical differences between the groups in regards to 6-month cardiac mortality , rehospitalizations for heart failure , or length of hospital stay . Of those , 304 patients had their Medicare data available . The information from the Medicare cl aims data was used to determine the cost . Information from the trial was used to determine costs of out-patient drugs and the interventions . The 6-month mean Medicare costs were estimated to be $ 17,837 and $ 13,886 for the HFMS and the SC groups , respectively . We found that overall medical costs of medicare patients were significantly higher for patients who were r and omized to the HFMS arm than they were for the patients r and omized to the SC arm . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients who are elderly and receive the care from a community-based primary care practitioner BACKGROUND We performed a prospect i ve , r and omized investigation assessing the incremental effect of automated health monitoring ( AHM ) technology over and above that of a previously described nurse directed heart failure ( HF ) disease management program . The AHM system measured and transmitted body weight , blood pressure , and heart rate data as well as subjective patient self- assessment s via a st and ard telephone line to a central server . METHODS AND RESULTS A total of 188 consented and eligible patients were r and omized between intervention and control groups in 1:1 ratio . Subjects r and omized to the control arm received the Specialized Primary and Networked Care in Heart Failure ( SPAN-CHF ) heart failure disease management program . Subjects r and omized to the intervention arm received the SPAN-CHF disease management program in conjunction with the AHM system . The primary end point was prespecified as the relative event rate of HF hospitalization between intervention and control groups at 90 days . The relative event rate of HF hospitalization for the intervention group compared with controls was 0.50 ( 95%CI [ 0.25 - 0.99 ] , P = .05 ) . CONCLUSIONS Short-term reductions in the heart failure hospitalization rate were associated with the use of automated home monitoring equipment . Long-term benefits in this model remain to be studied BACKGROUND Heart failure is a common and important cause of morbidity and mortality . Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients , but experimental data on the efficacy of such programs are limited . METHODS AND RESULTS A total of 151 patients hospitalized with heart failure were r and omized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline -based therapy as prescribed by primary physicians . Nurses also screened patients for heart failure exacerbations , which they managed with supplemental diuretics or by contacting the primary physician for instructions . Outcomes included time to hospital encounter , mortality , number and cost of hospitalizations , functional status , and satisfaction with care . Intervention patients had a longer time to encounter ( hazard ratio [ HR ] = 0.67 ; 95 % confidence interval [ CI ] 0.47 - 0.96 ; P = .029 ) , hospital readmission ( HR = 0.67 ; CI 0.46 - 0.99 ; P = .045 ) , and heart failure-specific readmission ( HR = 0.62 ; CI 0.38 - 1.03 ; P = .063 ) . The number of admissions , hospital days , and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year . The intervention had little effect on functional status , mortality , and satisfaction with care . CONCLUSION A nurse-administered , telephone-based disease management program delayed subsequent health care encounters , but had minimal impact on other outcomes CONTEXT The lifetime risk of  heart failure at age 40 years is approximately 1 in 5 in the general population ; however , little is known about the association between modifiable lifestyle factors and the remaining lifetime risk of heart failure . OBJECTIVE To examine the association between modifiable lifestyle factors and the lifetime risk of heart failure in a large cohort of men . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study using data from 20,900 men ( mean age at baseline , 53.6 years ) from the Physicians ' Health Study I ( 1982 - 2008 ) who were apparently healthy at baseline . Six modifiable lifestyle factors were assessed : body weight , smoking , exercise , alcohol intake , consumption of breakfast cereals , and consumption of fruits and vegetables . MAIN OUTCOME MEASURE Lifetime risk of heart failure . RESULTS During a mean follow-up of 22.4 years , 1200 men developed heart failure . Overall , the lifetime risk of heart failure was 13.8 % ( 95 % confidence interval [ CI ] , 12.9%-14.7 % ) at age 40 years . Lifetime risk remained constant in men who survived free of heart failure through age 70 years and reached 10.6 % ( 95 % CI , 9.4%-11.7 % ) at age 80 years . Lifetime risk of heart failure was higher in men with hypertension than in those without hypertension . Healthy lifestyle habits ( normal body weight , not smoking , regular exercise , moderate alcohol intake , consumption of breakfast cereals , and consumption of fruits and vegetables ) were individually and jointly associated with a lower lifetime risk of heart failure , with the highest risk in men adhering to none of the 6 lifestyle factors ( 21.2 % ; 95 % CI , 16.8%-25.6 % ) and the lowest risk in men adhering to 4 or more desirable factors ( 10.1 % ; 95 % CI , 7.9%-12.3 % ) . CONCLUSION In this cohort of apparently healthy men , adherence to healthy lifestyle factors is associated with a lower lifetime risk of heart failure Background —Neurohormones are considered markers of heart failure progression . We examined whether changes in brain natriuretic peptide ( BNP ) and norepinephrine ( NE ) over time are associated with corresponding changes in mortality and morbidity in the Valsartan Heart Failure Trial . Methods and Results —Plasma BNP and NE were measured before r and omization and during follow-up in ≈4300 patients in the Valsartan Heart Failure Trial . The relation between baseline BNP and NE and all-cause mortality and first morbid event ( M&M ) was analyzed in subgroups , with values above and below the median , and by quartiles . The change and percent change from baseline to 4 and 12 months in BNP and NE were also analyzed by quartiles for subsequent M&M. Risk ratios for M&M were calculated using a Cox proportional hazard model . Risk ratio of M&M for patients with baseline BNP or NE above the median was significantly higher than that for patients with values below the median . Baseline BNP and NE in quartiles also showed a quartile-dependent increase in M&M. BNP had a stronger association with M&M than NE . Patients with the greatest percent decrease in BNP and NE from baseline to 4 and 12 months had the lowest whereas patients with greatest percent increase in BNP and NE had the highest M&M. Conclusions —Not only are plasma BNP and NE important predictors of heart failure M&M , but changes in these neurohormones over time are associated with corresponding changes in M&M. These data further reinforce their role as significant surrogate markers in HF and underscore the importance of including their measurement in HF trials Abstract Objective To determine whether a central ised telephone intervention reduces the incidence of death or admission for worsening heart failure in out patients with chronic heart failure . Design Multicentre r and omised controlled trial . Setting 51 centres in Argentina ( public and private hospitals and ambulatory setting s ) . Participants 1518 out patients with stable chronic heart failure and optimal drug treatment r and omised , stratified by attending cardiologist , to telephone intervention or usual care .  Intervention Education , counselling , and monitoring by nurses through frequent telephone follow-up in addition to usual care , delivered from a single centre . Main outcome measure All cause mortality or admission to hospital for worsening heart failure . Results Complete follow-up was available in 99.5 % of patients . The 758 patients in the usual care group were more likely to be admitted for worsening heart failure or to die ( 235 events , 31 % ) than the 760 patients who received the telephone intervention ( 200 events , 26.3 % ) ( relative risk reduction = 20 % , 95 % confidence interval 3 to 34 , P = 0.026 ) . This benefit was mostly due to a significant reduction in admissions for heart failure ( relative risk reduction = 29 % , P = 0.005 ) . Mortality was similar in both groups . At the end of the study the intervention group had a better quality of life than the usual care group ( mean total score on Minnesota living with heart failure question naire 30.6 v 35 , P = 0.001 ) . Conclusions This simple , central ised heart failure programme was effective in reducing the primary end point through a significant reduction in admissions to hospital for heart failure INTRODUCTION AND OBJECTIVES The objective of this study was to determine whether a home-based intervention can reduce mortality and hospital readmissions and improve quality of life in patients with heart failure . METHODS A r and omized clinical trial was carried out between January 2004 and October 2006 . In total , 283 patients admitted to hospital with a diagnosis of heart failure were r and omly allocated to a home-based intervention ( intervention group ) or usual care ( control group ) . The primary end-point was the combination of all-cause mortality and hospital readmission for worsening heart failure at 1-year follow-up . RESULTS The primary end-point was observed in 41.7 % of patients in the intervention group and in 54.3 % in the control group . The hazard ratio was 0.70 ( 95 % confidence interval [ CI ] 0.55 - 0.99 ) . Taking significant clinical variables into account slightly reduced the hazard ratio to 0.62 ( 95 % CI 0.50 - 0.87 ) . At the end of the study , the quality of life of patients in the intervention group was better than in the control group ( 18.57 vs. 31.11 ; P < .001 ) . CONCLUSIONS A home-based intervention for patients with heart failure reduced the aggregate of mortality and hospital readmissions and improved quality of life BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients )  ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P < .0001 ) , and the daily dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P < .0001 ) . In Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes Background It is expected that increased dem and s on services will result from exp and ing numbers of older people with long-term conditions and social care needs . There is significant interest in the potential for technology to reduce utilisation of health services in these patient population s , including telecare ( the remote , automatic and passive monitoring of changes in an individual 's condition or lifestyle ) and telehealth ( the remote exchange of data between a patient and health care professional ) . The potential of telehealth and telecare technology to improve care and reduce costs is limited by a lack of rigorous evidence of actual impact . Methods / Design We are conducting a large scale , multi-site study of the implementation , impact and acceptability of these new technologies . A major part of the evaluation is a cluster-r and omised controlled trial of telehealth and telecare versus usual care in patients with long-term conditions or social care needs . The trial involves a number of outcomes , including health care utilisation and quality of life . We describe the broad evaluation and the methods of the cluster r and omised trial Discussion If telehealth and telecare technology proves effective , it will provide additional options for health services worldwide to deliver care for population s with high levels of need . Trial Registration Current Controlled Trials IS RCT BACKGROUND With the advent of remote monitoring , current models of implantable cardioverter defibrillators ( ICDs ) have the possibility of sending automatic alert messages that allow early diagnosis of events such as lung fluid overload , atrial fibrillation and device integrity issues . Timely treatment of these events has the potential to improve patient outcome , but this has not as yet been proven . METHODS The MORE-CARE study is a multicenter r and omized controlled trial evaluating the efficacy of advanced device diagnostics and remote monitoring in improving the outcome of patients with biventricular ICDs . Up to 1720 patients with a st and ard indication for a biventricular ICD will be r and omized to st and ard in-office follow-up , or to a remote monitoring strategy using the CareLink network and involving automatic alerts for lung fluid overload , atrial fibrillation , and device integrity issues . The first phase aims at evaluating the delay between an alert event , and clinical action to the event . The second phase of the study will evaluate whether the remote monitoring strategy results in a significant reduction of a combined end point of total mortality or cardiovascular and device-related hospitalization . The duration of the study will be event-driven due to its sequential design . CONCLUSION MORE-CARE will evaluate the efficacy of remote monitoring for improving patient outcome in patients implanted with a biventricular ICD BACKGROUND Remote monitoring of heart failure ( HF ) patients may help in the early detection of acute HF decompensation before the onset of symptoms . Appropriate early intervention in these patients may reduce HF-related hospitalizations and costs . METHODS The MUSIC ( Multi-Sensor Monitoring in Congestive Heart Failure ) study comprises 2 multicenter nonr and omized phases ( MUSIC-Development and MUSIC-Validation ) design ed to develop and vali date an algorithm for the prediction of acute HF decompensation using multiple physiologic signals obtained from an external , adherent , multisensor system capable of intermittent transmission of physiologic signals . Data obtained from MUSIC-Development will be used to develop the algorithm to predict HF decompensation . The algorithm will be vali date d in MUSIC-Validation with the objectives of ≥ 60 % sensitivity for correctly predicting an acute HF event , a false-positive patient status signal rate of ≤ 1.0 per patient-year , and a safety endpoint of ≤ 5 % of patients experiencing significant adverse skin conditions related to the prolonged wearing of the adherent device . A total of 542 patients in New York Heart Association functional class III-IV HF , with ejection fraction ≤ 40 % and a recent HF admission , are enrolled in MUSIC-Development ( n = 180 ) and MUSIC-Validation ( n = 362 ) . All patients are remotely monitored for 90 days using the Corventis multisensor system that transmits bioimpedance , electrocardiogram , and accelerometer data . RESULTS The MUSIC study has completed patient enrollment and follow-up in both phases . Once algorithm development is complete from the MUSIC-Development phase , the sequestered data set from the MUSIC-Validation phase will be used for algorithm validation Progression of chronic heart failure depends on various additional pathophysiologic factors like blood pressure , arrhythmias , congestion . Early detection of any alteration using telemonitoring of multiple vital parameters may avoid severe decompensation requiring hospital admission . The feasibility and the clinical outcome using a new telemonitoring device for recording multiple vital parameters and allowing communication on individual state of health is investigated . Twenty-four patients with chronic heart failure ( mean age 65 years , mean LV ejection fraction 35 % ) requiring at least one hospital admission during the past year were investigated . Twice a day , the vital-parameters were measured ( weight , blood pressure , heart rate and rhythm , oxygen saturation , respiration rate ) and patients information on well being , shortness of breath , medication , and request for contact were received . Intra-individual comparison was carried out between the 12 month before inclusion in this study and 12 month under telemonitoring surveillance ( extrapolated , if necessary ) . Performing over 10 500 measurements during 5751 patient days , critical events were diagnosed for 55 events concerning relative weight gain ( 43 episodes ) , blood pressure ( 6 ) , decrease in oxygen saturation ( 3 ) , new onset of atrial fibrillation with tachyarrhymia ( 3 ) . Of these , 45 events were controlled on an outpatient basis by changing medication or external cardioversion . Only 10 patients required re-admission . Thus , the number of admission to the hospital could be reduced by 62 % , those of days spent in hospital by 69 % . Non-invasive telemonitoring of multiple vital parameters combined with patients statements on their health condition and out-patient treatment on the basis of these findings is found to be an effective and reliable approach to avoid hospital readmission for patients with chronic heart failure Healthcare costs for heart failure are increasing . The need for a better care , however , has to be matched with a policy of cost containment . A way to improve the cost-effectiveness of heart failure care is the disease management approach , in which therapy , education and follow-up are tailored for each patient by a multidisciplinary team . Such a complex intervention can be facilitated by the use of telemedicine , which allows the remote control of considerable amounts of clinical data . In Italy , a few studies with telemedicine have been reported . A recent development in this field is represented by the ICAROS project ( Integrated Care vs Conventional Intervention in Cardiac Failure Patients : R and omized Open Label Study ) , whose aim is to improve the clinical and psychological care of heart failure patients employing advanced wireless telecommunication technology . So far , we r and omized 60 patients : 30 in usual ambulatory care , 30 in an intensive treatment group . The latter patients were instructed to use a portable computer to get in touch daily with the heart failure clinic and receive feedback instruction for the management of drug therapy and daily problems .  At the first year of follow-up , the treatment group showed good compliance to drug prescriptions , and could easily h and le the portable computer . The preliminary results of this ongoing study support the feasibility and appropriateness of new technologies for the management of heart failure , even in elderly patients in whom a limited expertise with these appliances could have been anticipated OBJECTIVE To assess the effect of a telephone intervention to improve quality of life among patients with congestive heart failure ( CHF ) . STUDY DESIGN Prospect i ve r and omized study . METHODS Single-site recruitment of 458 patients using Veterans Health Administration care into a r and omized controlled trial with a 1-year preintervention data collection period and a 1-year intervention and follow-up period . To compensate for imbalanced study groups , propensity scores were included in adjusted models of quality of life , satisfaction with care , inpatient utilization , survival , and costs of care . RESULTS Patients aged 45 to 95 years participated in the study ; 22 % were of Hispanic race/ethnicity , and 7 % were African American . All but 5 were male , consistent with the older population among veterans . At baseline , 40 % were in Goldman Specific Activity Scale class I , 42 % were in class III , 6 % were in class II or IV , and 12 % were unclassified . Patients scored a mean ( SD ) of 14 ( 1.5 ) points below the norm on the physical component score . After the yearlong intervention , no differences in clinical outcomes were noted between the intervention group and the control group . The CHF-related costs were higher for the intervention group , as were overall costs that included the cost of the intervention . Intervention group patients reported better compliance with weight monitoring and exercise recommendations . CONCLUSIONS A risk-stratified intervention for patients with CHF result ed in potential behavioral improvements but no survival benefit . A high-cost high-intensity intervention may be required to improve survival for patients with CHF . Inclusion of the costs of interventions is recommended for future research ers The aim of this study was to determine whether using a teleheath system after discharge from formal home health services would improve clinical outcomes and self-management behaviors .  Patients were recruited from 10 home health agencies ( HHAs ) across the United States . All patients used the Health Buddy telehealth system  during formal home health services . Patients were r and omly assigned to either the telehealth group or the control group  upon discharge from the HHA . Patients in the telehealth group used the Health Buddy for an additional 180 days ; patients in the control group received no further telehealth or home health services . Results show that patients who continued using telehealth beyond the formal episode of care showed greater improvements in respiratory status and activities of daily living . None of the patients who used telehealth during this stage had any hospitalizations or Emergency Department ( ED ) events , while 28.3 % of the control group patients required hospitalization and 26.1 % had at least one ED visit . Telehealth patients were more likely to report that they measured their weights daily , and were more likely to report an increase in diuretic dose following sudden weight gain , ankle swelling , or shortness of breath . We conclude that patients with heart failure may benefit from continued use of telehealth following formal home health services . Results of this study will inform managers and clinicians who are responsible for integrating telehealth into chronic disease protocol BACKGROUND Chronic heart failure is associated with frequent hospitalisations which are often due to volume-overload decompensation . Monitoring of intrathoracic impedance , measured from an implanted device , can detect increases in pulmonary fluid retention early and facilitate timely treatment interventions . OBJECTIVE The DOT-HF trial is design ed to investigate if ambulatory monitoring of intrathoracic impedance together with other device-based diagnostic information can reduce morbidity and mortality in patients with chronic heart failure who are treated with cardiac resynchronization therapy ( CRT ) and /or an implantable defibrillator ( ICD ) .  METHODS Approximately 2400 patients will be r and omised in a 1:1 fashion to a management strategy with access to the diagnostic information from the implantable device ( " access arm " ) , or a " control arm " , where this information is not made available . Study subjects fulfil st and ard indications for CRT and /or ICD  as outlined in current guidelines . In the access arm , a fluid alert algorithm is used to give early warning of decreasing intrathoracic impedance indicating a high risk of an impending volume-overload decompensation . The primary endpoint of DOT-HF is the composite of all-cause mortality or heart failure hospitalisation . Secondary and exploratory endpoints include all-cause mortality , the impact on total health care utilization , quality of life and cost effectiveness . The study is expected to close recruitment during 2010 and to report in 2012 OBJECTIVES We determined the effect of a targeted education and support intervention on the rate of readmission or death and hospital costs in patients with heart failure ( HF ) . BACKGROUND Disease management programs for patients with HF including medical components may reduce readmissions by 40 % or more , but the value of an intervention focused on education and support is not known . METHODS We conducted a prospect i ve , r and omized trial of a formal education and support intervention on one-year readmission or mortality and costs of care for patients hospitalized with HF . RESULTS Among the 88 patients ( 44 intervention and 44 control ) in the study , 25 patients ( 56.8 % ) in the intervention group and 36 patients ( 81.8 % ) in the control group had at least one readmission or died during one-year follow-up ( relative risk = 0.69 , 95 % confidence interval [ CI ] : 0.52 , 0.92 ; p = 0.01 ) . The intervention was associated with a 39 % decrease in the total number of readmissions ( intervention group : 49 readmissions ; control group : 80 readmissions , p = 0.06 ) . After adjusting for clinical and demographic characteristics , the intervention group had a significantly lower risk of readmission compared with the control group ( hazard ratio = 0.56 , 95 % CI : 0.32 , 0.96 ; p = 0.03 ) and hospital readmission costs of $ 7,515 less per patient . CONCLUSIONS A formal education and support intervention substantially reduced adverse clinical outcomes and costs for patients with HF INTRODUCTION Remote monitoring is increasingly becoming the new st and ard of care for implantable cardioverter defibrillator ( ICD ) follow-up . We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic . METHODS AND RESULTS In this single-center pilot clinical trial , adult patients with an ICD were r and omly assigned to remote monitoring versus quarterly device interrogations in clinic . The primary endpoint was a composite of cardiovascular hospitalization , emergency room visit for a cardiac cause , and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year . We also examined health-related quality of life , costs , and patient satisfaction with their ICD care . Of 151 patients enrolled in this trial , 76 were r and omized to remote monitoring and 75 to quarterly device  interrogations in clinic . There was no significant difference in the primary endpoint ( 32 % in the remote monitoring arm vs 34 % in the control arm ; P = 0.8 ) , mortality , or cost between the 2 arms . Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months ( 83 [ 25th , 75th percentiles 70 , 90 ] vs 75 [ 50 , 85 ] ; P = 0.002 and 88 [ 75 , 100 ] vs 75 [ 75 , 88 ] ; P = 0.03 , respectively ) , but not at 12 months . CONCLUSION We showed no significant reduction in cardiac-related re source utilization with remote monitoring of ICDs . However , given the small number of patients in our study , the real clinical and health economics impact of remote monitoring needs to be verified by a large , multicenter , r and omized clinical trial BACKGROUND Accurate data for prevalence rates for heart failure due to various causes , and for left-ventricular systolic dysfunction in all adults are unavailable . Our aim was to assess prevalence of left-ventricular systolic dysfunction and heart failure in a large representative adult population in Engl and . METHODS Of 6286 r and omly selected patients aged 45 years and older , 3960 ( 63 % ) participated in the study . They came from 16 r and omly selected general practice s. We assessed patients by  history and examination , electrocardiography , and echocardiography .  Prevalence of left-ventricular systolic dysfunction ( defined as ejection fraction < 40 % ) and heart failure was calculated for the overall population on the basis of strict criteria and , when necessary , adjudication by a panel . FINDINGS Left-ventricular systolic dysfunction was diagnosed in 72 ( 1.8 % [ 95 % CI 1.4 - 2.3 ] ) participants , half of whom had no symptoms . Borderline left-ventricular function ( ejection fraction 40 - 50 % ) was seen in 139 patients ( 3.5 % [ 3.0 - 4.1 ] ) . Definite heart failure was seen in 92 ( 2.3 % , [ 1.9 - 2.8 ] ) and was associated with an ejection fraction of less than 40 % in 38 ( 41 % ) patients , atrial fibrillation in 30 ( 33 % ) , and valve disease in 24 ( 26 % ) . Probable heart failure was seen in a further 32 ( 0.8 % [ 0.6 - 1.1 ] ) patients . In total , 124 ( 3.1 % [ 2.6 - 3.7 ] ) patients aged 45 years or older had definite or probable heart failure . INTERPRETATION Heart failure is often misdiagnosed or underdiagnosed in primary care . Our results suggest that assessment of left-ventricular function in patients with suspected heart failure could lead to more effective diagnosis and treatment of this disorder The Home or Hospital in Heart failure ( HHH ) study was a European Community‐funded , multinational , r and omized controlled clinical trial , conducted in the UK , Pol and , and Italy , to assess the feasibility of a new system of home telemonitoring ( HT ) . The HT system was used to monitor clinical and physiological parameters , and its effectiveness ( compared with usual care ) in reducing cardiac events in heart failure ( HF ) patients was evaluated . Measurements were patient‐managed BACKGROUND Indications for implantable cardioverter defibrillators ( ICDs ) and cardiac resynchronization therapy defibrillators have greatly exp and ed in the last 5 years , encompassing a wider variety of patients with a multitude of comorbidities . To meet the needs of these patients , the managing clinicians need to streamline their follow-up care . New ICD/cardiac resynchronization therapy defibrillators provide enhanced device status and disease progression remote monitoring capabilities that support more comprehensive and efficient follow-ups . In addition , this monitoring between follow-ups is likely to impact health care utilization . METHODS AND RESULTS The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision ( CONNECT ) study will r and omize approximately 2,000 patients implanted with an ICD with or without CRT capabilities from 150 sites in the United States to remote monitoring versus st and ard in-office care .  This study will evaluate the time from clinical event to clinical decision in response to the event , as well as the associated impact on health care utilization and quality of life . Patients monitored remotely will be provided a home monitor for transmitting device diagnostics to the clinician 's office . These devices will use wireless telemetry , allowing the automatic transmission of diagnostics to the office without the need for patient intervention . Patients receiving in-office care will be followed in the office at a fixed schedule and without remote monitoring . All patients will be followed for 15 months postimplant . CONCLUSION The CONNECT study is evaluating the impact of remote monitoring and early notification using wireless telemetry on the time to clinical decisions , the allocation of health care utilization , and quality of life . Results from this study are expected mid-2009 Objective : We investigated in a pilot study whether telemedicine is beneficial in mild to moderate chronic heart failure . Methods : A total of 128 patients with an ejection fraction ≤60 % and NYHA class II or III chronic heart failure were evaluated . Thirty-two patients were enrolled prospect ively in a staged telemedical service program .  Ninety-six controls were matched 3:1 to each telemedicine patient . Results : Median follow-up was 307 days ( range 104–459 ) . All-cause hospitalization duration [ 317 vs. 693 days/100 patient years ; relative risk ( RR ) 0.46 ; 95 % confidence interval ( CI ) 0.37–0.58 ; p < 0.0001 ) and rate ( 38 vs. 77/100 patient years ; RR 0.49 ; 95 % CI 0.25–0.95 ; p = 0.034 ) as well as cardiac hospitalization duration ( 49 vs. 379 days/100 patient years ; RR 0.13 ; 95 % CI 0.08–0.23 ; p < 0.0001 ] were significantly lower , cardiac hospitalization rate ( 11 vs. 35/100 patient years ; RR 0.31 ; 95 % CI 0.11–1.02 ; p = 0.058 ) tended to be lower in the telemedicine compared with the control group . Conclusion : These preliminary data suggest that telemedical care and monitoring may reduce morbidity in patients with NYHA class II and III chronic heart failure BACKGROUND Nearly half of all patients with chronic heart failure ( HF ) have a normal ejection fraction ( EF ) , and abnormal diastolic function ( ie , diastolic heart failure [ DHF ] ) . However , appropriate management of DHF patients remains a difficult and uncertain challenge . METHODS AND RESULTS The Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure ( COMPASS-HF ) trial was design ed to evaluate whether an implantable hemodynamic monitor ( IHM ) was safe and effective in reducing the number of heart failure-related events ( HFRE ) in patients with chronic HF . The current study presents data on a prespecified and planned subgroup analysis from the COMPASS-HF trial : 70 patients with an EF > or = 50 % ( ie , DHF ) . As such , this represents a subgroup analysis of the COMPASS-HF Trial . DHF patients were r and omized  to IHM-guided care ( treatment ) vs. st and ard care ( control ) for 6 months . All 70 patients received optimal medical therapy , but the hemodynamic information from the IHM was used to guide patient management only in the treatment group . The HFRE rate in DHF patients r and omized to treatment was 0.58 events/6 months compared with DHF patients r and omized to control , which was 0.73 events/6 months ; this represented a 20 % nonsignificant reduction in the overall HFRE rate in the treatment group ( 95 % CI = -46 , 56 , P = .66 ) . There was a 29 % nonsignificant reduction in the relative risk of a HF hospitalization in the DHF patients r and omized to treatment compared with DHF patients r and omized to control ( 95 % CI = -69 , 70 , P = .43 ) . CONCLUSIONS The IHM was shown to be safe and was associated with a very low system-related and procedure-related complication rate in DHF patients . However , in this subgroup analysis limited to 70 DHF patients , the addition IHM-guided care did not significantly lower the rate of HFR events . The results of this subgroup analysis in DHF patients , for whom there are currently no proven , effective management strategies , will be used to design future studies defining the effects of IHM-guided care in patients with DHF This article describes a pilot telehealth project in Swansea where patients with heart failure and chronic obstructive pulmonary disease were provided with telehealth monitoring equipment . While early evaluation points to some potential economic benefits , supporting patient empowerment was a significant outcome BACKGROUND The multidisciplinary approach to managing heart failure has been shown to improve outcomes . The role of a clinical pharmacist in treating heart failure has not been evaluated . METHODS One hundred eighty-one patients with heart failure and left ventricular dysfunction ( ejection fraction < 45 ) undergoing evaluation in clinic were r and omized to an intervention or a control group . Patients in the intervention group received clinical pharmacist evaluation , which included medication evaluation , therapeutic recommendations to the attending physician , patient education , and follow-up telemonitoring . The control group received usual care . The primary end point was combined all-cause mortality and heart failure clinical events . All clinical events were adjudicated by a blinded end point committee . RESULTS Baseline characteristics were similar except for slightly higher age in the intervention group . Median follow-up was 6 months . All-cause mortality and heart failure events were significantly lower in the intervention group compared with the control group ( 4 vs 16 ; P= .005 ) . In addition , patients in the intervention group received higher angiotensin-converting enzyme inhibitor doses as reflected by the median fraction of target reached ( 25th and 75th percentiles ) , 1.0 ( 0.5 and 1 ) and 0.5 ( 0.1875 and 1 ) in the intervention and control groups , respectively ( P<.001 ) . The use of other vasodilators in angiotensin-converting enzyme inhibitor-intolerant patients was higher in the intervention group ( 75 % vs 26 % ; P= .02 ) . CONCLUSIONS Outcomes in heart failure can be improved with a clinical pharmacist as a member of the multidisciplinary heart failure team . This observation may be due to higher doses of angiotensin-converting enzyme inhibitors and /or closer follow-up We compared the effects of evidence -based disease management guidelines delivered to patients with heart failure and diabetes using three different modalities : in-person visits alone ( Control ) , in-person visits and a telephone intervention ( Telephone ) , and in-person visits and telemonitoring ( Telemonitoring ) .  Patients were r and omized to the three groups . There were 112 patients in the Control group , 93 in the Telephone group and 98 in the Telemonitoring group . During the first 60 days , 10 % of the Control group were rehospitalized , 17 % of the Telephone group and 16 % of the Telemonitoring group . Having heart failure and receiving more in-person visits were significantly related to readmission and time to readmission . However , after adjusting for diagnosis and visits , the differences between the three groups were non-significant . There was a trend for increased risk of readmission for the Telephone group compared to Control alone ( P = 0.07 , risk ratio 2.2 , 95 % CI : 0.9 to 5.2 ) and for readmission sooner ( P = 0.02 , risk ratio 2.3 , 95 % CI : 1.2 to 4.6 ) . Patient rehospitalization and emergency department visit rates were lower than the national average , making it difficult to detect a difference between groups . Previous rehospitalization was a consistent predictor of those who were rehospitalized , suggesting that it may be a useful indicator for identifying patients likely to need additional attention BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p<0.0001 ) . Although only 38/118 patients were hospitalized , most participants reported a significant subjective improvement in their quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure EXECUTIVE SUMMARY The purpose of this study was to measure the ability of telemonitoring to reduce hospital days and total costs for Medicare managed care enrollees diagnosed with heart failure . Patients were recruited and r and omly assigned for six months to either  telemonitoring or st and ard care . Telemonitoring transmitted vital signs and clinical alerts daily to a central nursing station . Utilization of covered services was analyzed for the six‐month telemonitoring period to test for hypothesized reductions in hospital days and changes in utilization of the emergency department ( ED ) , urgent care , and primary care . Negative binomial regressions adjusted for gender , age , co‐occurring diabetes , co‐occurring chronic obstructive pulmonary disease , and residence neighborhood were used to analyze units of service , and two‐part ( hurdle ) multivariable models were used for expenditures . The main finding was a tendency for lower total number of hospital days for patients assigned to telemonitoring . Results for other covered services were generally consistent with hypothesized direction and magnitude ; however , statistical power was reduced because of lowerthan‐expected recruitment rates into the study . Within a managed‐care environment , telemonitoring appears to facilitate better ambulatory management of heart failure patients  , including fewer ED visits , which were offset by more frequent primary care and urgent care visits Background : Heart failure ( HF ) has clinical ly significant psychological and physical consequences for older persons , and hospitalization for HF is frequent and costly to the Medicare program . As HF is the most common primary Medicare home care diagnosis , there is a critical need to develop home care services that improve heath-related outcomes for this population . The primary aim of this pilot study was to develop , implement , and test the initial feasibility and potential efficacy of the Home-Care Education , Assessment , Remote-Monitoring , and Therapeutic Activities ( HEART ) trial , a nurse-directed multicomponent home care intervention . Observed outcomes were quality of life ( QOL ) , depressive symptoms , and 90-day hospitalization . Methods : Twenty-four patients with a primary diagnosis of HF were assigned to the intervention ( n = 12 ) or control group ( n = 12 ) according to geographical location in a large multibranch Medicare-certified home health agency . Intervention group patients received 8 structured nurse education visits using evidence -based protocol s design ed in previous trials to teach HF self-management and to prevent/reduce depression , as well as a telemonitoring system . Control group patients received usual care and telemonitoring .  Quality of life was assessed using the Minnesota Living With Heart Failure question naire . Depressive symptoms were assed using the Patient Health Question naire 9 at baseline and 90-day study end point . Results : Study protocol s and instrumentation were found to be feasible and effective . Examination of enrollment data led to a reevaluation of eligibility criteria . Patients participating in the HEART intervention demonstrated significantly improved QOL ( F = 8.99 , P = .007 ) and significantly reduced depressive symptoms ( F = 35.10 , P = .001 ) in comparison to control group patients at the study end point . There was a trend toward lower hospital readmission rates in the intervention group ( 16 % vs 25 % ) , but this was not statistically significant . Conclusion : This pilot study suggests that a full-scale trial of the HEART intervention is feasible OBJECTIVES The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias , cardiovascular ( CV ) disease progression , and device issues compared to patients receiving st and ard in-office care . A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms . BACKGROUND In addition to providing life-saving therapy , implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient 's heart disease . Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits . METHODS The CONNECT ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision ) study was a multicenter , prospect i ve , r and omized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator ( including cardiac resynchronization therapy devices ) and were followed up for 15 months . Health care utilization data included all CV-related hospitalizations , emergency department visits , and clinic office visits . RESULTS The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm ( p < 0.001 ) . The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm ( p = 0.002 ) . CONCLUSIONS Wireless remote monitoring with automatic clinician alerts as compared with st and ard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay . ( Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [ CONNECT ] ; NCT00402246 ) BACKGROUND Disease management is effective in the general population , but it has not been tested prospect ively in a sample of solely Hispanics with heart failure ( HF ) . We tested the effectiveness of telephone case management in decreasing hospitalizations and improving health-related quality of life ( HRQL ) and depression in Hispanics of Mexican origin with HF . METHODS AND RESULTS Hospitalized Hispanics with chronic HF ( n = 134 ) were enrolled and r and omized to intervention ( n = 69 ) or usual care ( n = 65 ) . The sample was elderly ( 72 + /- 11 years ) , New York Heart Association class III/IV ( 81.3 % ) , and poorly educated ( 78.4 % less than high school education ) . Most ( 55 % ) were unacculturated into US society . Bilingual/bicultural Mexican-American registered nurses provided 6 months of st and ardized telephone case management . Data on hospitalizations were collected from automated systems at 1 , 3 , and 6 months after the index hospital discharge . Health-related quality of life and depression were measured by self-report at enrollment , 3 , and 6 months . Intention to treat analysis was used . No significant group differences were found in HF hospitalizations , the primary outcome variable ( usual care : 0.49 + /- 0.81 [ CI 0.25 - 0.73 ] ; intervention : 0.55 + /- 1.1 [ CI 0.32 - 0.78 ] at 6 months ) . No significant group differences were found in HF readmission rate , HF days in the hospital , HF cost of care , all-cause hospitalizations or cost , mortality , HRQL , or depression . CONCLUSION These results have important implication s because of the current widespread enthusiasm for disease management . Although disease management is effective in the mainstream HF patient population , in Hispanics this ill , elderly , and poorly educated , a different approach may be needed BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure ( HF ) . However , the use of these programs in setting s with limited sources and among diverse population is not know . Thus the present study was design ed to assess the impact of a computer-based home disease management program ( Alere DayLink HF Monitoring System [ HFMS ] ) on the clinical outcomes of Medicare beneficiaries with HF who were elderly , women , and non-white males who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care ( HFHC ) trial was a multicenter , r and omized , controlled trial of HFMS versus st and ard heart failure care ( SC : enhanced patient education , education to clinicians , and follow-up ) . The primary study end point was treatment failure , defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment . Among patients rehospitalized for HF , length of hospital stay was also considered a primary end point . A total of 315 patients were r and omized : 160 to HFMS and 155 to SC . Although the incidence of the primary outcome was somewhat higher in the SC arm ( 28.8 % versus 21.2 % , P = .15 ) , the difference was not statistically different . The length of hospital stay was also similar in both groups . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly , women and non-Caucasian males and receive the care from a community-based primary care practitioner BACKGROUND Intrathoracic impedance monitoring is a new diagnostic tool for patients with heart failure that may aid early identification of decompensation and pulmonary congestion . METHODS AND RESULTS The Sensitivity of the InSync Sentry feature for the Prediction of Heart Failure ( ie , SENSE-HF ) trial is a prospect i ve multicenter international study design ed to evaluate the sensitivity and positive predictive value ( PPV ) of the intrathoracic impedance diagnostic tool , OptiVol , present in Medtronic implantable devices . A total of 500 patients will be enrolled in the trial , with follow-up for up to 24 months . The study has 3 phases . Phase I is double-blind , and evaluates retrospectively the sensitivity and PPV of the intrathoracic impedance data for the prediction of hospitalization with the signs and /or symptoms of pulmonary congestion . At 6 months , the patient enters Phase II , which evaluates the clinical utility of the nominal " alarm " threshold value for identification of episodes of decompensation . The patient enters the final phase ( Phase III ) after an episode of decompensation correctly identified by the Fluid Trend data ( " true " positive alarm ) , with data collection on how physicians use the Fluid Trend data to influence management . An end point committee adjudicates health care utilizations events ( hospitalizations and doctor visits ) for their association with signs and /or symptoms of pulmonary congestion . CONCLUSIONS The study completed recruitment during 2008 Context Case management by nurses improves outcomes for patients with heart failure , but studies have targeted patients at high risk for poor outcomes because of sociodemographic or clinical factors . Whether such programs benefit low-risk patients with heart failure is unknown . Contribution Among 462 patients in 1 staff-model health maintenance organization who were hospitalized with heart failure , those r and omly assigned to nurse care management  had rates of rehospitalization and death similar to rates in those who received usual care . Implication s Care management for heart failure may offer limited benefit for patients with clinical and sociodemographic characteristics that put them at low risk for hospitalization or death . The Editors The societal and personal burden of heart failure is large and is growing apace with the aging of the population ( 1 ) . Heart failure is the largest Medicare expenditure and is the leading cause of hospitalization for persons 65 years of age or older ( 2 ) . Rates of hospital readmission within 6 months range from 25 % to 50 % ( 3 ) . Moreover , behavioral factors , such as nonadherence to diet and medications , and social factors , such as social isolation and indigence , frequently contribute to early rehospitalizations ( 3 - 4 ) . Previous studies of specialized treatment programs for heart failure have targeted clinical ly high-risk , medically underserved population s. These studies demonstrated reductions in rehospitalization for heart failure and , to a lesser extent , rehospitalization for all causes ( 4 - 6 ) . In a pilot study conducted at a single Kaiser Permanente medical center in 1994 to 1995 , we found a statistically significant reduction in rehospitalization rates during a 3-month period among low-risk patients with heart failure who received nurse care management over a 6-month period ( 7 ) . The present study evaluated nurse care management for heart failure in a low-risk population of patients selected from several medical centers in the same large health maintenance organization ( HMO ) . Methods Design This was a r and omized , controlled trial of a nurse care management system for heart failure . Patient Sample We selected patients who were hospitalized with a provisional diagnosis of heart failure from Kaiser Permanente medical centers located in San Francisco , Vallejo , Walnut Creek , Sacramento , and Roseville , California , between May 1998 and October 2000 .  Hospital-based project nurses review ed hospital charts to screen for patients with new-onset or worsening heart failure on the basis of 1 ) shortness of breath ( dyspnea at rest , including orthopnea or paroxysmal nocturnal dyspnea ) and 2 ) at least 1 corroborating clinical sign ( pulmonary congestion on examination , including rales , crackles , or wheezes ) or radiologic abnormality ( pulmonary congestion on chest radiograph ) consistent with heart failure . We excluded patients who were scheduled for coronary artery bypass or valvular surgery ; had undergone cardiac surgery in the preceding 8 weeks ; had a serum creatinine value of 13.26 mol/L ( 5 mg/dL ) or greater ; were receiving dialysis or awaiting renal transplantation ; had a history of severe pulmonary disease requiring home oxygen ; had 1 or more additional diseases that were expected to result in death within 1 year ; had cognitive mental deficits , substance abuse , or severe psychiatric disorders ; or were expected to move from the area within 1 year . We did not use measurements of left ventricular function by echocardiography , radionuclide angiography , or contrast angiography as selection criteria . Among the 59 % of patients who had left ventricular ejection fraction measured , 28 % had an ejection fraction less than 0.40 and 31 % had an ejection fraction of 0.40 or greater . Study nurses interviewed patients during hospitalization or by telephone within 2 weeks after discharge , explained the purpose of the study , and obtained written informed consent . Research staff who were not associated with delivering the intervention r and omly assigned patients to treatment conditions by using sealed assignments . Equal numbers of patients were allocated to the 2 groups in each medical center by using the Efron procedure ( 8) . Physicians were notified of r and omization assignment by letter . The institutional review boards at Stanford University and Kaiser Permanente approved the study . Baseline Data Collection Baseline data , recorded by staff nurses on st and ardized forms , included sociodemographic characteristics , self-reported illnesses , medications , and results of st and ard diagnostic studies and laboratory tests . Treatment Environment Before the study , the investigators met with the medical staffs of the 5 participating hospitals to present and discuss the research protocol , including detailed descriptions of the planned interactions between the nurse care managers and the medical staff . The medical staffs were multispecialty groups of 20 to 60 physiciansapproximately 480 physicians total . After r and omization , all patients continued to receive usual care , including instruction on diet , drug adherence , physical activity , and response to changing symptoms .  Intervention In addition to usual care , patients in the intervention group received a physician-directed , nurse-managed , home-based program for heart failure developed by the investigators ( 9 ) . Originally design ed for coronary risk factor management , this program was exp and ed to encompass heart failure . It incorporated the features of best practice design ated by Rich ( 10 ) : coordination of care across disciplines , patient and caregiver education , enhancement of self-management skills , effective follow-up , and guidelines -based medications for heart failure . Our system also incorporated the principles of heart failure management developed by the Cardiovascular Nursing Council of the American Heart Association ( 11 ) . The st and ardized , telephone-mediated intervention included the following elements : initial educational session , including a videotape ; baseline telephone counseling session ; nurse-initiated follow-up telephone contacts ; pharmacologic management ; and nurse-initiated communication with physicians . The initial 1-hour educational session with a nurse occurred in the patient 's medical center . Patients received printed educational material s , including methods for self-monitoring of symptoms , body weight , and medications ; a dietary management workbook ; food-frequency question naires ; and instructions on how to access emergency care in case symptoms abruptly worsened . Patients viewed a videotape portraying the treatment process . Two experienced Stanford-based nurse care managers provided a 45-minute baseline telephone counseling session within 1 week of r and omization ; subsequent nurse contacts were tailored to the needs of the individual patients . Nurse-initiated follow-up telephone contacts with patients during daytime weekday hours were scheduled at weekly intervals for 6 weeks ; biweekly for 8 weeks ; monthly for 3 months ; bimonthly for 6 months ; and as needed to monitor patients ' medications , laboratory assessment s , symptoms , and other medical problems . We based pharmacologic management for heart failure on published treatment guidelines ( 12 , 13 ) . The nurse care managers obtained permission from physicians to initiate and regulate pharmacologic therapy for heart failure according to study protocol . Nurse-initiated communication with physicians about patients ' current medical status was maintained and specific management problems were addressed . Nurse care managers spent an average of 9 hours per patient coordinating the treatment plan with patients and physicians during the first year . The intervention did not include consultation with social services to facilitate discharge planning or home visits after discharge . Measurement Research staff who were not associated with , and were blinded to , the intervention conditions measured health outcomes at 12 months . On the basis of review of the Kaiser Permanente medical records , project nurses used st and ardized forms to record the cause , number , and duration of hospitalizations and emergency department visits during the 12-month follow-up period . Kaiser Permanente provided more than 90 % of all care . Two cardiologists who were not associated with implementing the intervention review ed medical records on deaths , rehospitalizations , and emergency department visits to determine whether these events were primarily due to heart failure or due to other causes . They did not use discharge diagnoses recorded in the medical record to make these judgments . Rehospitalizations and emergency department visits were classified as either due to heart failure or due to other causes ; the latter were classified as cardiac or noncardiac . Outcomes The primary outcome of the study was the time to first rehospitalization for heart failure or for any cause . In our analysis , we treated deaths occurring before rehospitalization as censored data . However , analysis in which we classified deaths occurring before rehospitalization as outcome events result ed in similar conclusions , primarily because most observed deaths occurred after a rehospitalization . Secondary outcomes were the time to a composite outcome of death , rehospitalization , or emergency department visits for cardiac cause or for any cause , the proportion of patients receiving recommended pharmacotherapy , and the rate of outpatient clinic and emergency department visits . We based the study 's power on a proposed reduction in the risk for rehospitalization for heart failure from 21 % to 13 % , corresponding to a number needed to treat for benefit of 12.5 . We expected that the actual number needed to treat for benefit would be less than 12.5 . Statistical Analysis We evaluated the effect of care management on rehospitalization rates by using KaplanMeier survival curves and Cox proportional hazards regression models . We compared nominal variables by using chi-square tests , ordered variables by AIMS The aim of this study was to investigate the 12-month incidence , predictive factors , and prognosis of sustained ventricular tachycardia ( VT ) in chronic heart failure patients implanted with biventricular pacemakers without a back-up defibrillator ( CRT-P ) , assessed by continuous intracardiac ventricular electrograms . METHODS AND RESULTS The Mona Lisa study , a prospect i ve , multicentre , cohort study , design ed to determine the incidence of sustained VT and its prognostic impact in CRT-P recipients within the year after implant enrolled 198 patients with moderate or severe chronic heart failure , despite optimal pharmacological therapy .  An independent committee review ed the data from all arrhythmic episodes as well as causes of death according to predefined criteria . During a mean follow-up of 9.8 + /- 3.1 months after implantation , 8 patients experienced at least one episode of sustained VT [ 4.3 % ; 95 % confidence interval ( CI ) , 1.1 - 7.5 ] and 21 deaths occurred , giving a 12-month mortality rate of 11.7 % ( 95 % CI , 6.4 - 16.9 ) . The presence of sustained VT was associated with a high risk of sudden cardiac death ( SCD ) and the lowest 12-month overall survival ( P < 0.0001 ) . CONCLUSION The incidence of sustained VT remains relatively low in the first year after CRT-P implantation , but when present appears closely associated with short-term adverse outcomes , especially SCD . This emphasizes the possible value of remote monitoring to detect high-risk patients for urgent upgrading AIMS Heart failure chiefly affects the elderly , with frequent emergency admissions . Telemonitoring can identify worsening heart failure but previous r and omized trials have enrolled selected patient population s. The Home-HF study examined the impact of home telemonitoring on typical heart failure patients discharged from three acute hospitals in North West London , UK . METHODS AND RESULTS Patients hospitalized with heart failure were r and omized to telemonitoring or usual specialist care . Primary outcome measures were days alive and out of hospital . Secondary outcome measures were number and duration of heart failure hospitalizations , clinic visits , and quality of life .  We recruited 182 patients . There was no difference in the primary outcome measure in the two groups , but there were significantly fewer unplanned hospitalizations for heart failure decompensation , and a reduction in clinic and emergency room visits in the telemonitoring group . There was no statistically significant difference in the mean direct health service costs . CONCLUSION Home telemonitoring in a typical elderly population of heart failure patients produces a similar outcome to ' usual ' specialist care , but reduces clinic and emergency room visits and unplanned heart failure rehospitalizations at little additional cost . This method of disease monitoring may allow specialist services to increase the number of patients under their care BACKGROUND Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure ( HF ) , the incremental impact of an automated home monitoring ( AHM ) system on health-related quality of life ( HRQL ) is unknown . METHODS AND RESULTS We performed a prospect i ve r and omized investigation , examining the additive value of AHM to a previously described nurse-directed HF disease management program ( SPAN-CHF ) , with attention to HRQL , in patients with a recent history of decompensated HF . A total of 188 patients were r and omized to receive the SPAN-CHF intervention for 90 days , either with ( AHM group ) or without ( NAHM , st and ard-care group ) AHM , with a 1:1 r and omization ratio after HF-related hospitalization . HRQL , measured by the Minnesota Living With Heart Failure Question naire ( MLHFQ ) ( Physical , Emotional , and Total scores on MLHFQ ) was assessed at 3 time points : baseline , 45 days , and 90 days . Although both treatments ( AHM and NAHM ) improved HRQL at 45 and 90 days compared with baseline with respect to Physical , Emotional , and Total domain scales , no significant difference emerged between AHM and NAHM groups . CONCLUSIONS AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment . When comparing 2 state-of the-art disease management programs regarding HRQL outcomes , our results did not support the added value of AHM BACKGROUND The Home or Hospital in Heart Failure Study ( HHH ) is a European Community funded trial ( QLGA-CT-2001 - 02424 ) which compares usual care of heart failure ( HF ) with three home-based interventions in a multicenter , multicountry ( Italy , Pol and and UK ) , r and omized controlled clinical trial . Home telemonitoring ( HT ) of clinical parameters represents a potential alternative ( or addition ) to traditional home care models . Nocturnal respiratory disorders ( periodic breathing , sleep apnea ) are very common in HF , and are associated with increased morbidity and mortality . We developed an integrated HT system for monitoring of both vital signs and respiration . All measurements were patient-managed . This paper describes the architecture of this system , and assesses its feasibility . METHODS AND RESULTS 461 clinical ly stable patients were r and omized first to usual vs home-monitored care ; the latter were further r and omized to 3 strategies . Over a 12-month follow-up 2 of these 3 groups ( 195 patients , age : 60+/-11 years , NYHA class II-III : 97 % , LVEF 28+/-7 % ) underwent self-administered home monitoring of vital signs ( weekly--12 parameters using an interactive voice response system ) and respiration ( monthly--24-hour recording ) . Data were transmitted over conventional telephone lines ; 81 % of actually practicable vital signs measurements were completed by the patients ( range : 75 % (PL)-93 % ( UK ) ) , as well as 92 % of practicable respiratory recordings ( range : 85 % (PL)-99 % ( UK ) ) . 87 % of nighttime recordings were eligible for the study ( good quality signals for > or = 2.5 h ) . CONCLUSIONS This study , the largest so far , demonstrates that self-managed home telemonitoring of both vital signs and respiration is feasible in HF patients , with surprisingly high compliance . We found an excellent rate of acceptable nocturnal respiratory recordings , which are those with the greatest clinical relevance Summary NYHA class III and IV chronic heart failure has been established as a potential indication for telemedical care and monitoring already . We conducted a prospect i ve study to assess the utilization of telemedical services by cardiac patients in order to identify further indications . A total of 540 patients ( mean age 59 years ) with various heart diseases participated for at least 30 days in a home-based telemedicine service programme .  The two primary outcome measures were the rates of symptom-driven telephone calls ( A ) and ECG transmissions ( B ) per patient-year . The total follow-up was 68,649 days , with a median of 93 days . Symptomatic patients placed 713 calls and transmitted 221 ECGs . Poisson regression analysis with subset selection yielded four significant ( P < 0.05 ) independent positive predictors of the use of the telemedicine service : ( 1 ) recent repeat ( at least one previous ) percutaneous coronary intervention  ( A , P = 0.010 ; B , P = 0.001 ) ; ( 2 ) recent cardioversion for atrial fibrillation or flutter ( A , P < 0.0001 ; B , P < 0.0001 ) ; ( 3 ) ejection fraction ( A , P = 0.012 ; B , P > 0.05 ) ; and ( 4 ) reciprocal of age ( A , P < 0.0001 ; B , P > 0.05 ) . These data suggest that telemedicine may benefit patients following repeat percutaneous coronary intervention or cardioversion for atrial fibrillation . Since patients availed themselves of telemedicine service less with deteriorating ejection fraction and increasing age , individuals with chronic heart failure will need dedicated programmes , especially when they are older Clinical trial results support the hypothesis that implantable hemodynamic monitoring ( IHM ) systems may reduce hospitalizations among patients with chronic heart failure ( HF ) . The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure ( REDUCE hf ) study was a prospect i ve , r and omized , multicenter , single-blinded trial that enrolled patients with New York Heart Association class II or III symptoms , an indication for an implantable cardioverter-defibrillator ( ICD ) , and a previous HF hospitalization . A combination IHM-ICD was implanted and patients were r and omly assigned to a treatment group in which hemodynamic information was used or a control group in which hemodynamic information was not available . Patients were followed for 12 months to evaluate the primary efficacy end point of HF hospitalizations , emergency department visits , or urgent clinic visits . The trial was design ed to enroll 1300 patients , but stopped at 400 patients because of IHM lead failures experienced from previous trials . A total of 202 treatment patients and 198 controls were r and omized for 12-month follow-up . The primary safety end point was met , but the rate of HF equivalents was not different between groups . REDUCE hf was unable to test clinical efficacy end points adequately . The device combining IHM-ICD technology was safe and functioned appropriately . Patients at high risk for decompensated HF have high baseline filling pressures and demonstrate consistent increases as the process of congestion worsens to the time of hospitalization BACKGROUND Despite optimal drug and device therapy , frequent hospitalisations due to decompensated heart failure remain an issue . Early detection of decompensation could prevent hospitalisation in patients with congestive heart failure . The recently introduced Home Monitoring functionality of implanted devices is a promising new telecardiology technique which provides information on the status of heart failure . Home Monitoring observation of heart failure patients could lead to early detection of pre clinical decompensation , enable early intervention before clinical decompensation , and thus could prevent hospitalisations . OBJECTIVE The IN-TIME study is design ed to assess the impact of Home Monitoring on the early detection of worsening congestive heart failure and the clinical status of heart failure patients . STUDY DESIGN Approximately 620 patients will be prospect ively r and omised to patient management guided by Home Monitoring analysis or st and ard care and followed for 12 months . The endpoints committee will adjudicate events in a blinded fashion . The primary endpoint is a composite of all-cause mortality , unplanned hospitalisation due to worsening heart failure , NYHA class and patient global self assessment ( Packer score ) . The study should complete recruitment during 2009 and report in late 2010 Background — Trials investigating efficacy of disease management programs ( DMP ) in heart failure reported contradictory results . Features rendering specific interventions successful are often ill defined . We evaluated the mode of action and effects of a nurse-coordinated DMP ( HeartNetCare-HF , HNC ) . Methods and Results — Patients hospitalized for systolic heart failure were r and omly assigned to HNC or usual care ( UC ) .  Besides telephone-based monitoring and education , HNC addressed individual problems raised by patients , pursued networking of health care providers and provided training for caregivers . End points were time to death or rehospitalization ( combined primary ) , heart failure symptoms , and quality of life ( SF-36 ) . Of 1007 consecutive patients , 715 were r and omly assigned ( HNC : n=352 ; UC : n=363 ; age , 69±12 years ; 29 % female ; 40 % New York Heart Association class III-IV ) . Within 180 days , 130 HNC and 137 UC patients reached the primary end point ( hazard ratio , 1.02 ; 95 % confidence interval , 0.81–1.30 ; P=0.89 ) , since more HNC patients were readmitted . Overall , 32 HNC and 52 UC patients died ( 1 UC patient and 4 HNC patients after dropout ) ; thus , uncensored hazard ratio was 0.62 ( 0.40–0.96 ; P=0.03 ) . HNC patients improved more regarding New York Heart Association class ( P=0.05 ) , physical functioning ( P=0.03 ) , and physical health component ( P=0.03 ) . Except for HNC , health care utilization was comparable between groups . However , HNC patients requested counseling for noncardiac problems even more frequently than for cardiovascular or heart-failure – related issues . Conclusions — The primary end point of this study was neutral . However , mortality risk and surrogates of well-being improved significantly . Quantitative assessment of patient requirements suggested that besides (tele)monitoring individualized care considering also noncardiac problems should be integrated in efforts to achieve more sustainable improvement in heart failure outcomes . Clinical Trial Registration — URL : http://www.controlled-trials.com . Unique identifier : IS RCT N23325295 BACKGROUND Disease management programmes for patients with heart failure have improving the quality -of-life ( QOL ) of patients with heart failure . METHODS Patients attending the heart failure clinic were r and omized into 2 groups of 25 patients each . The control group was managed in the heart failure clinic and the intervention group underwent the following additional interventions : ( i ) interactive sessions with the patient and spouse informing them about the disease , drugs , and self-management of fluid intake and diuretic dose ; ( ii ) a telephonic helpline was established and regular telephone calls made to reinforce the information and modify drug dosages . The QOL was assessed using the Kansas City Cardiomyopathy question naire . Functional capacity was assessed by the 6-minute walk test . Continuous variables were compared with the Student t-test ( paired or unpaired ) . RESULTS There was significant improvement in the QOL and functional capacity of patients in the intervention group compared with controls over a 6-month period . The mean ( SD ) QOL scores in the intervention group improved from 60.0 ( 23.6 ) to 76.3 ( 17.3 ) but did not change significantly in the control group ( 62.2 [ 22.6 ] to 63.4 [ 21.9 ] ) . There was a similar improvement in the functional capacity measured by the 6-minute walk test in the intervention group ( from 202.2 [ 81.5 ] to 238.1 [ 100.9 ] metres , p < 0.05 ) but not in the control group ( 193.8 [ 81.5 ] to 179.7 [ 112.0 ] metres ) . In the intervention group , the use of beta-blockers and angiotensin-converting enzyme inhibitors was similar but in the intervention group patients were placed on higher doses . There was no significant difference in the number of emergency room visits or admissions in either group . For every 20 patients in the intervention group , 14 patients improved by 1 functional class while in the control group this was observed in only 3 patients for every 20 treated . CONCLUSION This study demonstrates that in the setting of a developing country , improvement in QOL by intensive management of heart failure patients through a heart failure programme with telephonic reinforcement and a helpline is greater than that usually achieved with drug therapy in a routine heart failure clinic Background Recent increasing prevalence of heart failure ( HF ) patients leads to an increasing burden to the health care system . Consequently , there is a need for innovative strategies to reduce HF hospitalizations . Methods We performed a multicentre r and omized controlled trial to test the hypothesis that telemonitoring in patients with HF , by means of the Health Buddy ® system ( HB ) , will reduce HF hospitalizations and number of contacts with caregivers as compared to care as usual ( CAU ) during 1 year follow-up , from October 1 , 2007 , through December 31 , 2008 . Results Among 382 patients —197 in the HB and 185 in the CAU-group—226 ( 59 % ) were male , mean age was 71.5 ( SD 11.2 ) , 45.5 % being ≥75 years of age ; 57 % of the patients were in NYHA HF class 2 , 40 % in class 3 and 3 % in class 4 . Both study groups were similar for demographic and clinical characteristics . Mean time to first heart failure related hospitalization was 161 days for the intervention group and 139 days for the usual-care group ; hospitalizations occurred in 18 ( 9.1 % ) compared to 25 patients ( 13.5 % ) respectively ( Kaplan – Meier p=0.151 , hazard ratio 0.65 , CI 0.35–1.17 ) . Combined endpoint of heart failure admission and all cause mortality was similar for both groups ( Kaplan – Meier p=0.641 hazard ratio 0.89 , CI 0.69–1.83 ) . Cox regression analysis disclosed an important interaction between group assignment and heart failure duration , p=0.007 , OR=0.983 , CI 0.970–0.995 indicating a significant decrease in heart failure hospitalizations in the intervention group if heart failure duration was < 18 months , p=0.026 , hazard ratio 0.26 , CI 0.07–0.94 . Contacts with the heart-failure-nurse were mean 1.36 ( range 0–11 ) in the intervention group vs. 1.74 ( 0–8 ) in the usual-care group ( Mann-Whitney p<0.001 ) . Mortality was 18 ( 9.1 % ) in the intervention-group and 12 ( 6.5 % ) in the usual-care-group ( Mann – Whitney p=0.34 , Cox-regression analysis p=0.82 ) . Conclusion Telemonitoring tends to reduce heart failure admissions and decreases contacts with specialized nurses . If heart failure duration is < 18 months heart failure admissions and readmissions are significantly reduced BACKGROUND Both r and omized and nonr and omized controlled studies have linked congestive heart failure ( CHF ) case management ( CM ) to decreased readmissions and improved outcomes in mostly homogeneous setting s. The objective of this r and omized controlled trial was to test the effect of CHF CM on the 90-day readmission rate in a more heterogeneous setting . METHODS A total of 287 patients admitted to the hospital with the primary or secondary diagnosis of CHF , left ventricular dysfunction of less than 40 % , or radiologic evidence of pulmonary edema for which they underwent diuresis were r and omized . The intervention consisted of 4 major components : early discharge planning , patient and family CHF education , 12 weeks of telephone follow-up , and promotion of optimal CHF medications . RESULTS The 90-day readmission rates were equal for the CM and usual care groups ( 37 % ) . Total inpatient and outpatient median costs and readmission median cost were reduced 14 % and 26 % , respectively , for the intervention group . Patients in the CM group were more likely to be taking CHF medication at target doses , but dosages did not increase significantly throughout 12 weeks . Although both groups took their medications as prescribed equally well , the rest of the adherence to treatment plan was significantly better in the CM group . Subgroup analysis of patients who lived locally and saw a cardiologist showed a significant decrease in CHF readmissions for the intervention group ( P = .03 ) . CONCLUSIONS These results suggest several limitations to the generalizability of the CHF CM-improved outcome link in a heterogeneous setting . One explanation is that the lack of coordinated system supports and varied accessibility to care in an extended , nonnetworked physician setting limits the effectiveness of the CM BACKGROUND AND OBJECTIVE The rising prevalence of chronic heart failure ( CHF ) has led to an increase in total treatment expenditures . A medical care programme of telemetry was developed to reduce the number of patients with decompensated CHF , hospital admissions and overall treatment cost . PATIENTS AND METHODS As part of a prospect i ve controlled study the body weight of 251 patients with CHF was monitored over one year . The supervising center contacted the patients whenever their body weight exceeded a threshold value . Patients were phoned by a design ated personal adviser and received regular informative material and advice by specialist medical personnel . Patients ' general practitioners had been involved in recruiting patients and by regularly sending them follow-up reports . Another group of 251 patients who had not received the described telemetric intervention served as control . RESULTS The mean age of the patients was 71.7 years , lower than the 76.4 years of the control group . More patients in the intervention groups were in NYHA class III and IV than in the control group ( 52 % vs 36 % ) . After an average observation period of 12 months the duration of hospital stay had been reduced by 48 % ( p = 0.01 ) , the hospital costs by EUR 7128 per patient p = 0.01 ) , while drug expenditure had increased by EUR 245 per patient ( not significant ) . The total costs had thus fallen by EUR 6993 per patient ( -39.5 % ; p = 0.05 ) . The mortality rate of 14.7 % in the intervention group was significantly lower than that of the control group of 27.1 % ( p = 0.001 ) . The reduction in costs and mortality rate was clearly greater for men than women . Total expenditure had been highest for patients who had died . CONCLUSION The results indicate that total treatment costs and mortality rate can be reduced by telemetric monitoring of  patients in CHF , especially in men Patients with a diagnosis of heart failure , registered at the study practice , were recruited into the study . First , they had a cardiologist 's assessment . They were then r and omised into telemonitored patients who measured pulse , BP , weight and video consulted , and controls AIMS Remote patient management ( telemonitoring ) may help to detect early signs of cardiac decompensation , allowing optimization of and adherence to treatments in chronic heart failure ( CHF ) . Two meta-analyses have suggested that telemedicine in CHF can reduce mortality by 30 - 35 % . The aim of the TIM-HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients . Methods CHF patients [ New York Heart Association ( NYHA ) II/III , left ventricular ejection fraction (LVEF)≤35 % ] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months ( no decompensation required if LVEF≤25 % ) were r and omized 1:1 to an intervention group of daily remote device monitoring ( electrocardiogram , blood pressure , body weight ) coupled with medical telephone support or to usual care led by the patients ' local physician . In the intervention group , 24/7 physician-led medical support was provided by two central telemedical centres . A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization . The primary endpoint was total mortality . The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure . Other secondary endpoints included cardiovascular mortality , all-cause and cause-specific hospitalizations ( all time to first event ) as well as days lost due to heart failure hospitalization or cardiovascular death ( in % of follow-up time ) , and changes in quality of life and NYHA class . Overall , 710 CHF patients were recruited . The mean follow-up was 21.5±7.2 months , with a minimum of 12 months . Perspective The study will provide important prospect i ve outcome data on the impact of telemedical management in patients with CHF BACKGROUND Determine the effect on hospitalization cost of a heart failure disease management ( HFDM ) program delivered within a diverse provider network as demonstrated in the SPAN-CHF r and omized controlled trial . METHODS The SPAN-CHF trial was a prospect i ve r and omized assessment of the effectiveness of HFDM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients . Baseline clinical and demographic data were obtained on each patient , mortality was monitored , and hospitalizations were tracked for 90 days . Cost estimates for each hospitalization were based on a sub sample of patients seen at Tufts-New Engl and Medical Center for whom hospitalization costs were calculated . Heart failure disease management program costs were estimated using a programmatic budget model . Hospital utilization and cost data were combined to estimate medical costs for intervention and control groups . RESULTS Heart failure disease management had a favorable effect on heart failure hospitalization , which was partially offset by noncardiac hospitalizations . The relative odds of at least one all-cause hospitalization during the intervention period trended less for the intervention group compared with the control group ( 0.76 [ 95 % CI 0.38 - 1.51 ] ) . The point estimate of the differential hospitalization cost between control and intervention groups was a reduction in cost of $ 375 per patient . The net effect including the costs of the program was an increase of $ 488 per patient for the intervention group compared with the control group . The program would have been cost saving if HFDM costs had been 24 % lower . CONCLUSION The HFDM intervention , administered over 90 days to patients hospitalized for heart failure , succeeded in reducing the rate of heart failure hospitalizations , although this effect was partially offset by an increase in non-heart failure hospitalizations . The result ing modest reduction in all-cause hospitalization costs was exceeded by the cost of the intervention . Thus , although the reduction in heart failure may be interpreted as an improvement in health status , it could not be considered cost saving BACKGROUND Although the potential to reduce hospitalisation and mortality in chronic heart failure ( CHF ) is well reported , the feasibility of receiving healthcare by structured telephone support or telemonitoring is not . AIMS To determine ; adherence , adaptation and acceptability to a national nurse-coordinated telephone-monitoring CHF management strategy . The Chronic Heart Failure Assistance by Telephone Study ( CHAT ) . METHODS Triangulation of descriptive statistics , feedback surveys and qualitative analysis of clinical notes . Cohort comprised of st and ard care plus intervention ( SC+I ) participants who completed the first year of the study . RESULTS 30 GPs ( 70 % rural ) r and omised to SC+I recruited 79 eligible participants , of whom 60 ( 76 % ) completed the full 12 month follow-up period . During this time 3619 calls were made into the CHAT system ( mean 45.81 SD+/-79.26 , range 0 - 369 ) , Overall there was an adherence to the study protocol of 65.8 % ( 95 % CI 0.54 - 0.75 ; p=0.001 ) however , of the 60 participants who completed the 12 month follow-up period the adherence was significantly higher at 92.3 % ( 95 % CI 0.82 - 0.97 , p < or=0.001 ) . Only 3 % of this elderly group ( mean age 74.7+/-9.3 years ) were unable to learn or competently use the technology . Participants rated CHAT with a total acceptability rate of 76.45 % . CONCLUSION This study shows that elderly CHF patients can adapt quickly , find telephone-monitoring an acceptable part of their healthcare routine , and are able to maintain good adherence for a least 12 months BACKGROUND Results of previous studies support the hypothesis that implantable haemodynamic monitoring systems might reduce rates of hospitalisation in patients with heart failure . We undertook a single-blind trial to assess this approach . METHODS Patients with New York Heart Association ( NYHA ) class III heart failure , irrespective of the left ventricular ejection fraction , and a previous hospital admission for heart failure were enrolled in 64 centres in the USA . They were r and omly assigned by use of a central ised electronic system to management with a wireless implantable haemodynamic monitoring ( W-IHM ) system ( treatment group ) or to a control group for at least 6 months . Only patients were masked to their assignment group . In the treatment group , clinicians used daily measurement of pulmonary artery pressures in addition to st and ard of care versus st and ard of care alone in the control group . The primary efficacy endpoint was the rate of heart-failure-related hospitalisations at 6 months . The safety endpoints assessed at 6 months were freedom from device-related or system-related complications ( DSRC ) and freedom from pressure-sensor failures . All analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00531661 . FINDINGS In 6 months , 83 heart-failure-related hospitalisations were reported in the treatment group ( n=270 ) compared with 120 in the control group ( n=280 ; rate 0·31 vs 0·44 , hazard ratio [ HR ] 0·70 , 95 % CI 0·60 - 0·84 , p<0·0001 ) . During the entire follow-up ( mean 15 months [ SD 7 ] ) , the treatment group had a 39 % reduction in heart-failure-related hospitalisation compared with the control group ( 153 vs 253 , HR 0·64 , 95 % CI 0·55 - 0·75 ; p<0·0001 ) . Eight patients had DSRC and overall freedom from DSRC was 98·6 % ( 97·3 - 99·4 ) compared with a prespecified performance criterion of 80 % ( p<0·0001 ) ; and overall freedom from pressure-sensor failures was 100 % ( 99·3 - 100·0 ) . INTERPRETATION Our results are consistent with , and extend , previous findings by definitively showing a significant and large reduction in hospitalisation for patients with NYHA class III heart failure who were managed with a wireless implantable haemodynamic monitoring system . The addition of information about pulmonary artery pressure to clinical signs and symptoms allows for improved heart failure management . FUNDING CardioMEMS BACKGROUND In most previous epidemiological studies on the prevalence of chronic heart failure ( CHF ) the disorder has been defined on clinical criteria . In a cross-sectional survey of 2000 men and women aged 25 - 74 , r and omly sample d from one geographical area , we assessed left-ventricular systolic function by echocardiography . METHODS 1640 ( 83 % ) of those invited took part . They completed a question naire on current medication , history , and symptoms of breathlessness . Blood pressure  was measured and electrocardiography ( ECG ) and echocardiography were done .  Left-ventricular ejection fraction was measurable in 1467 ( 89.5 % ) participants by the biplane Simpson 's rate method . FINDINGS The mean left-ventricular ejection fraction was 47.3 % . The prevalence of definite left-ventricular systolic dysfunction ( defined as a left-ventricular ejection fraction < or = 30 % ) was 2.9 % overall ( 43 participants ) ; it increased with age and was higher in men than in women ( 4.0 vs 2.0 % ) . The left-ventricular systolic dysfunction was symptomatic in 1.5 % of participants and asymptomatic in 1.4 % , 83 % of participants with left-ventricular systolic dysfunction had evidence of ischaemic heart disease ( IHD ) from history or ECG criteria compared with 21 % of those without this abnormality ( p < 0.001 ) . Hypertension was also more common in those with left-ventricular systolic dysfunction ( 72 vs 38 % , p < 0.001 ) , but there was no difference between those with and without left-ventricular systolic dysfunction in the rate of hypertension without IHD . INTERPRETATION Left-ventricular systolic dysfunction was at least twice as common as symptomatic heart failure defined by clinical criteria . The main risk factors are IHD and hypertension in the presence of IHD ; screening of such high-risk groups for left-ventricular systolic dysfunction should be considered BACKGROUND Small studies suggest that telemonitoring may improve heart-failure outcomes , but its effect in a large trial has not been established . METHODS We r and omly assigned 1653 patients who had recently been hospitalized for heart failure to undergo either telemonitoring ( 826 patients ) or usual care ( 827 patients ) .  Telemonitoring was accomplished by means of a telephone-based interactive voice-response system that collected daily information about symptoms and weight that was review ed by the patients ' clinicians . The primary end point was readmission for any reason or death from any cause within 180 days after enrollment . Secondary end points included hospitalization for heart failure , number of days in the hospital , and number of hospitalizations . RESULTS The median age of the patients was 61 years ; 42.0 % were female , and 39.0 % were black . The telemonitoring group and the usual-care group did not differ significantly with respect to the primary end point , which occurred in 52.3 % and 51.5 % of patients , respectively ( difference , 0.8 percentage points ; 95 % confidence interval [ CI ] , -4.0 to 5.6 ; P=0.75 by the chi-square test ) . Readmission for any reason occurred in 49.3 % of patients in the telemonitoring group and 47.4 % of patients in the usual-care group ( difference , 1.9 percentage points ; 95 % CI , -3.0 to 6.7 ; P=0.45 by the chi-square test ) . Death occurred in 11.1 % of the telemonitoring group and 11.4 % of the usual care group ( difference , -0.2 percentage points ; 95 % CI , -3.3 to 2.8 ; P=0.88 by the chi-square test ) . There were no significant differences between the two groups with respect to the secondary end points or the time to the primary end point or its components . No adverse events were reported . CONCLUSIONS Among patients recently hospitalized for heart failure , telemonitoring did not improve outcomes . The results indicate the importance of a thorough , independent evaluation of disease-management strategies before their adoption . ( Funded by the National Heart , Lung , and Blood Institute ; Clinical Trials.gov number , NCT00303212 . ) AIMS To determine the prevalence , incidence rate , lifetime risk and prognosis of heart failure . METHODS AND RESULTS The Rotterdam Study is a prospect i ve population -based cohort study in 7983 participants aged > or = 55 .  Heart failure was defined according to criteria of the European Society of Cardiology . Prevalence was higher in men and increased with age from 0.9 % in subjects aged 55 - 64 to 17.4 % in those aged > or = 85 . Incidence rate of heart failure was 14.4/1000 person-years ( 95 % CI 13.4 - 15.5 ) and was higher in men ( 17.6/1000 man-years , 95 % CI 15.8 - 19.5 ) than in women ( 12.5/1000 woman-years , 95 % CI 11.3 - 13.8 ) . Incidence rate increased with age from 1.4/1000 person-years in those aged 55 - 59 to 47.4/1000 person-years in those aged > or = 90 . Lifetime risk was 33 % for men and 29 % for women at the age of 55 . Survival after incident heart failure was 86 % at 30 days , 63 % at 1 year , 51 % at 2 years and 35 % at 5 years of follow-up . CONCLUSION Prevalence and incidence rates of heart failure are high . In individuals aged 55 , almost 1 in 3 will develop heart failure during their remaining lifespan . Heart failure continues to be a fatal disease , with only 35 % surviving 5 years after the first diagnosis Previous studies have found that home-based intervention programs reduce readmission rates for patients with heart failure . Only one previous trial has compared telephone and videophone to traditional care to deliver a home-based heart failure intervention program . The objective of this study was to evaluate the efficacy of a telehealth-facilitated postdischarge support program in reducing re source use in patients with heart failure . Patients at a Midwestern Department of Veterans Affairs Medical Center were r and omized to telephone , videophone , or usual care for follow-up care after hospitalization for heart failure exacerbation . Outcome measures included readmission rates ; time to first readmission ; urgent care clinic visits ; survival ; and quality of life . The intervention result ed in a significantly longer time to readmission but had no effect on readmission rates or mortality . There were no differences in hospital days or urgent care clinic use . All subjects reported higher disease-specific quality of life scores at 1 year . There was evidence of the value of telephone follow-up , but there was no evidence to support the benefit of videophone care over telephone care . Rigorous evaluation is needed to determine which patients may benefit most from specific telehealth applications and which technologies are most cost-effective OBJECTIVES This study examined the characteristics of continuously measured right ventricular ( RV ) hemodynamic information derived from an implantable hemodynamic monitor ( IHM ) in heart failure patients . BACKGROUND Hemodynamic monitoring might improve the day-to-day management of patients with chronic heart failure ( CHF ) . Little is known about the characteristics of long-term hemodynamic information in patients with CHF or how such information relates to meaningful clinical events . METHODS Thirty-two patients with CHF received a permanent RV IHM system similar to a single-lead pacemaker .  Right ventricular systolic and diastolic pressures , heart rate , and pressure derivatives were continuously measured for nine months without using the data for clinical decision-making or management of patients . Data were then made available to clinical providers , and the patients were followed up for 17 months . Pressure characteristics during optimal volume , clinical ly determined volume-overload exacerbations , and volume depletion events were examined . The effect of IHM on hospitalizations was examined using the patients ' historical controls . RESULTS Long-term RV pressure measurements had either marked variability or minimal time-related changes . During 36 volume-overload events , RV systolic pressures increased by 25 + /- 4 % ( p < 0.05 ) and heart rate increased by 11 + /- 2 % ( p < 0.05 ) . Pressure increases occurred in 9 of 12 events 4 + /- 2 days before the exacerbations requiring hospitalization . Hospitalizations before using IHM data for clinical management averaged 1.08 per patient year and decreased to 0.47 per patient-year ( 57 % reduction , p < 0.01 ) after hemodynamic data were used . CONCLUSIONS Long-term ambulatory pressure measurements from an IHM may be helpful in guiding day-to-day clinical management , with a potentially favorable impact on CHF hospitalizations Abstract Introduction Congestive heart failure ( CHF ) , which typically affects older people , is characterized by high short- and mid-term mortality rates . However , despite accumulating evidence showing that administration of β-blockers ( β-adrenoceptor antagonists ) can improve the clinical status of CHF patients , use of these agents in adequate dosages in this setting is not routine . One reason for this appears to be a concern about a possible risk of bradyarrhythmia associated with use of β-blockers . Telecardiology has recently been investigated as a means of constantly monitoring the heart rate of CHF patients in their homes . Its use may allay concerns about the risk of bradyarrhythmia and facilitate a more widespread use of β-blockers in this context . Objectives The primary objectives of this study were to assess the impact of telemonitoring on patients ’ adherence to prescribed therapeutic regimens , particularly β-blockers , and to explore whether use of home telemonitoring reduces mortality and rate of re-admission to hospital in elderly CHF patients compared with normal specialized CHF team care . Methods A total of 57 patients with CHF ( 31 New York Heart Association [ NYHA ] class II , 23 NYHA class III and 3 NYHA class IV ) , with a mean ±SD age of 78.2±7.3 years , were r and omized to a control group who received st and ard care  , based on routinely scheduled clinic visits , from a team specialized in CHF patient management , or to a home telemonitoring group ( TM group )  , managed by the same specialized CHF team . Patients were followed up over 12 months . Results Compared with the control group , the TM group had a significant increase in the use of β-blockers , HMG-CoA reductase inhibitors ( statins ) and aldosterone receptor antagonists . A reduction in nitrate administration compared with baseline was also seen in the TM group . The 12-month occurrence of the primary combined endpoint of mortality and hospital re-admission for CHF was significantly lower in the TM group than in the control group ( p < 0.01 ) . Conclusions This study showed that a home-care model including telemonitoring of relevant clinical parameters may provide useful support in the management of patients with CHF . Home telemonitoring in CHF patients was associated with increased use of β-blockers at appropriate doses , suggesting that this strategy reassured physicians regarding the safety of careful use of these agents in this setting . However , larger studies are required to confirm these findings . Our findings indicate that there is a need to investigate relevant parameters in CHF patients at the point of care ( i.e. in patients ’ daily lives ) , which can in turn optimize β-blocker and other drug therapy The purpose of this r and omized field study was to determine the effects of telehomecare on hospitalization , emergency department ( ED ) use , mortality , and symptoms related to sodium and fluid intake , medication use , and physical activity . The sample consists of 284 patients with heart failure . The authors used logistic regression to study the effects of telehomecare on health services utilization and mortality and a general linear model to analyze changes in self-reported symptoms . On average , patients in the telehomecare groups had a lower probability of hospitalizations and ED visits than did patients in the control group . Differences were statistically significant at 60 days but not 120 days . Results show a greater reduction in symptoms for patients using telehomecare compared to control patients . The technology enables frequent monitoring of clinical indices and permits the home health care nurse to detect changes in cardiac status and intervene when necessary Patients with chronic conditions are heavy users of the health care system . There are opportunities for significant savings and improvements to patient care if patients can be maintained in their homes . A r and omized control trial tested the impact of 3 months of telehome monitoring on hospital readmission , quality of life , and functional status in patients with heart failure or angina . The intervention consisted of video conferencing and phone line transmission of weight , blood pressure , and electrocardiograms . Telehome monitoring significantly reduced the number of hospital readmissions and days spent in the hospital for patients with angina and improved quality of life and functional status in patients with heart failure or angina . Patients found the technology easy to use and expressed high levels of satisfaction .  Telehealth technologies are a viable means of providing home monitoring to patients with heart disease at high risk of hospital readmission to improve their self-care abilities Context Although evidence indicates that nurse-led care management improves clinical outcomes for patients with heart failure , evidence on the economic benefits of these programs is lacking . Contribution Using data on costs from a r and omized trial of 12 months of care management versus usual care for socioeconomically disadvantaged patients with heart failure , the investigators estimated that the cost-effectiveness of case management is less than $ 20000/QALY . Caution The results might not apply to patients in less socioeconomically disadvantaged setting s. The Editors Health care administrators and policymakers are increasingly turning to nurse-led disease management to lessen the economic and health burden of chronic diseases , such as heart failure . Meta-analyses of r and omized , controlled trials ( RCTs ) suggest that nurse management can be effective at reducing rehospitalization and sometimes at improving functioning ( 1 ) . To our knowledge , however , no previous RCT has included a cost-effectiveness analysis sufficient to inform policymakers as to whether nurse management improves quality of life for patients with heart failure at a reasonable cost to society . Studies have not followed recommended cost-effectiveness guidelines or thoroughly calculated intervention costs ( 2 ) . Establishing the cost-effectiveness of nurse management for heart failure may be especially important in minority communities , which have disproportionate rates of hospitalization for heart failure ( 3 ) and shortfalls in the use of proven effective therapies ( 4 ) and in patients ' underst and ing of heart failure ( 5 ) . We aim ed to estimate the cost-effectiveness of a nurse-led disease management intervention that was conducted alongside a r and omized , controlled effectiveness trial . The trial , conducted in Harlem , New York , from 1999 to 2003 , found that patients in the nurse-managed group maintained better physical functioning , as measured by the Short Form-12 ( SF-12 ) physical component score , and had statistically significantly fewer hospitalizations than did patients in the control group ( 6 ) . Methods For the RCT , we recruited patients from outpatient clinics at the 4 hospitals serving East and Central Harlem in New York City . We r and omly assigned 406 patients to usual care ( 203 patients ) or a nurse-led program ( 203 patients ) in which patients had 1 in-person visit with a trained nurse and periodic follow-up telephone calls over 12 months ( 6 ) . The nurses stressed adherence to a low-salt diet and to medications and worked with the patient 's physician to optimize heart failure medications according to published guidelines . Primary outcomes were total hospitalizations and physical functioning as measured by the SF-12 physical component score . Trained surveyors who were blinded to treatment assignment called patients in both groups every 3 months for 18 months to administer the SF-12 and collect information on health care utilization , amount of informal care received , and patients ' estimates of their time engaged in receiving health care over the past 3 months . We measured cost-effectiveness by using the incremental cost-effectiveness ratio ( ICER ) , which is the difference in average costs between the nurse-managed and usual care groups ( CostNCostUC ) divided by the difference in mean quality -adjusted life-years ( QALYs ) ( QALYNQALYUC ) : ICER = (CostNCostUC)/(QALYNQALYUC ) QALYs We estimated QALYs for the 12-month intervention by translating the SF-12 physical and mental component scores into Health Utility Index Mark 3 ( HUI3 ) and EuroQol-5D ( EQ-5D ) quality -of-life scores by using methods described by Franks and colleagues ( 7 ) . We chose these translations over other published methods ( 810 ) because they were vali date d in African-American patients , and most of the patients in our trial were African American or Hispanic . Patients who died were assigned a quality -of-life score of 0 in subsequent periods . We calculated QALYs by connecting the 5 quality -of-life scores for each patient ( baseline and quarterly through 12 months ) by using straight lines and calculating the area of the result ing 4 trapezoids . We estimated adjusted differences in QALYs by the coefficient on treatment from a linear regression of each patient 's QALY on his or her quality -of-life score at baseline and treatment assignment ( 11 ) . Societal Costs We followed guidelines for cost-effectiveness analysis ( 2 ) to estimate costs from a societal perspective and included intervention , medical , and nonmedical costs ( Appendix Table ) . Intervention costs included all intervention material s ( for example , scales ) , telephone service for 2 patients who did not have it , patients ' transportation costs to the initial nurse meeting , nurses ' salaries and fringe benefits , physician time overseeing the nurse activities , and costs for office space and equipment used by the nurses . Appendix Table . Data Sources and Imputations for Cost Items We derived medical costs for inpatient , outpatient , and emergency department use from administrative records from the 4 hospitals that participated in the trial . For inpatient costs , we converted billed charges to costs by using the cost-to-charge ratio for each hospital ( 2 , 12 ) and converted the costs to 2001 U.S. dollars by using the Producer Price Index for general and surgical hospitals ( 13 ) . For outpatient and emergency department cl aims , we applied the 2001 Medicare fee schedule for the New York City region ( 14 ) to billed procedure codes . For medication costs , we obtained medications prescribed from patients ' charts and prices for those medications from the average prices paid by Medicaid ( 15 ) . We used quarterly patient surveys to collect information on inpatient and outpatient utilization at nonparticipating institutions ( to supplement administrative records from participating hospitals ) and information on nonmedical costs , which included nursing home stays ; patient transportation and time costs associated with medical encounters ; and costs of informal care or assistance with household chores provided by friends , family members , or paid housekeepers . Costs are reported in 2001 U.S. dollars . Because of skewed cost data and a high percentage of patients with zero costs for many cost categories , we evaluated the statistical significance of the difference in costs between nurse-managed and usual care groups by using 2-part gamma models ( 16 ) . In the first part , we estimated the probability of costs being greater than 0 by logistic regression , with treatment assignment ; age ; sex ; race ( non-Hispanic black , non-Hispanic white , or other non-Hispanic ) ; Hispanic ethnicity ; recruitment site ; education ; preference for Spanish interview ; New York Heart Association ( NYHA ) heart failure class ; and indicators for diabetes , chronic pulmonary disease , and ischemic heart disease as explanatory variables . In the second part , for patients with costs greater than zero , we modeled costs as a function of the same explanatory variables by using generalized linear models with a gamma distribution and a logarithmic link function . For nursing home costs , which had a very small probability of being greater than 0 , we calculated unadjusted differences in mean costs and bootstrapped SEs by using 500 replicates stratified by treatment . We replaced missing observations for SF-12 scores and self-reported utilization with 10 imputed values found by using imputation by chained equations ( 17 ) as implemented by the ICE comm and in Stata , version 10.0 ( StataCorp , College Station , TX ) ( 18 ) . The previously listed explanatory variables at baseline and administrative data for hospitalizations and outpatient visits at baseline and quarterly follow-up were regressors in these equations . We estimated the 2-part models described previously on each imputed data set and combined the results by using Rubin 's rules ( 19 ) . Uncertainty in the ICER We created 500 bootstrapped replicates ( 50 from each of the 10 imputations ) and plotted the corresponding cost-effectiveness acceptability curves ( 20 ) . We calculated approximate empirical CIs for the ICER by using the bootstrap percentile method ( 21 ) . To explore whether nurse management is more likely to be cost-effective for patients with varying heart failure severity , we computed separate acceptability curves according to baseline NYHA class . Sensitivity Analysis We estimated costs on the basis of national prices for all cost items . We used the national 2001 Medicare fee schedule to calculate costs for outpatient and emergency department use ( 14 ) , deflated costs for hospitalizations and self-reported medical use by the ratio of the United States to New York metropolitan area Consumer Price Index for medical care , and deflated nonmedical costs by the ratio of the United States to New York metropolitan area Consumer Price Index for urban dwellers ( 22 ) . To characterize the cost implication s from the payer 's perspective , we also calculated costs to the Medicare program on the basis of categories and proportions of societal costs that Medicare typically covers . These included intervention costs but excluded costs for nursing home stays , patient time , telephone consultations , nonphysician office visits , and informal care . We decreased payer costs by the deductible and copayment rates for Medicare beneficiaries in 2001 . We included drug costs because Medicare and most insurers now cover medications . We assumed the deductible and copayment rate of the 2006 Medicare prescription drug plan , but no coverage gap . We investigated the influence of imputing missing survey data on the results by reporting the ICER for the observed data only ( available data analysis ) for patients who responded to every quarterly telephone survey until death or 12 months ( complete case analysis ) and for a data set in which a patient 's missing observations were replaced with the mean value of that patient 's observed responses ( patient-specific imputation ) . We conducted all analyses in Stata , version 10 ( 18 ) . The This study sought to determine the effect of an advanced- practice -nurse (APN)-led telephone intervention on hospital readmissions , quality of life , and self-care behaviors ( SCBs ) of patients with heart failure ( HF ) . Twenty participants were r and omly assigned to either an experimental group that received the APN-led telephone intervention ( ALTI ) or a control group that received usual care in this pretest-posttest experimental study . The results of this study support the idea that an ALTI positively impacts outcomes of patient with HF  , particularly by improving SCBs and decreasing hospital readmissions . An ALTI warrants consideration to improve outcomes of patients with HF OBJECTIVE To evaluate the cost-effectiveness of a telephonic disease management ( DM ) intervention in heart failure ( HF ) . STUDY DESIGN R and omized controlled trial of telephonic DM among 1069 community-dwelling patients with systolic HF ( SHF ) and diastolic HF performed between 1999 and 2003 . The enrollment period was 18 months per subject . METHODS Bootstrap-re sample d incremental cost-effectiveness ratios ( ICERs ) were computed and compared across groups . Direct medical costs were obtained from a medical record review that collected records from 92 % of patients ; 66 % of records requested were obtained . RESULTS Disease management produced statistically significant survival advantages among all patients ( 17.4 days , P = .04 ) , among patients with New York Heart Association ( NYHA ) class III/IV symptoms ( 47.7 days , P = .02 ) , and among patients with SHF ( 24.2 days , P = .01 ) . Analyses of direct medical and intervention costs showed no cost savings associated with the intervention . For all patients and considering all-cause medical care , the ICER was $ 146 870 per quality -adjusted life-year ( QALY ) gained , while for patients with NYHA class III/IV symptoms and patients with SHF , the ICERs were $ 67 784 and $ 95 721 per QALY gained , respectively . Costs per QALY gained were $ 101 120 for all patients , $ 72 501 for patients with SHF , and $ 41 348 for patients with NYHA class III/IV symptoms . CONCLUSIONS The intervention was effective but costly to implement and did not reduce utilization . It may not be cost-effective in other broadly representative sample s of patients . However , with program cost reductions and proper targeting , this program may produce life-span increases at costs that are less than $ 100 000 per QALY gained R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the  benefits of specialist stroke units .  Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community PURPOSE Some implantable cardioverter-defibrillators ( ICDs ) are now able to monitor intrathoracic impedance . The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs . METHODS AND RESULTS Five hundred thirty-two heart failure ( HF ) patients implanted with these ICDs  were followed up for 11 + /- 7 months . A clinical event ( CE ) was deemed to have occurred if it result ed in hospitalization or milder manifestations of HF deterioration . Three hundred sixty-two acute decreases in intrathoracic impedance ( Z events ) occurred in 230 patients . Of these episodes , 171 ( 47 % ) were associated with a CE within 2 weeks of the Z event . In another 71 ( 20 % ) Z events , drug therapy was adjusted despite the absence of overt signs of clinical deterioration . The rate of unexplained Z events was 0.25 per patient-year and 25 hospitalizations were not associated with Z events . The audible alert was disabled in a group of 102 patients ( OFF group ) .  HF hospitalizations occurred in 29 ( 7 % ) patients in the ON group and 20 ( 20 % , P < 0.001 ) patients in the OFF group . The rate of combined cardiac death and HF hospitalization was lower in patients with Alert ON ( log-rank test , P = 0.007 ) . CONCLUSIONS The ICD reliably detected CE and yielded low rates of unexplained and undetected events . The alert capability seemed to reduce the number of HF hospitalizations by allowing timely detection and therapeutic intervention AIMS Early recognition of impending decompensation and timely intervention may prevent heart failure ( HF ) hospitalization . We investigated the performance of OptiVol ® intrathoracic fluid monitoring for the prediction of HF events in chronic HF patients newly implanted with a device ( implantable cardioverter-defibrillator with or without cardiac resynchronization therapy ) . METHODS AND RESULTS SENSE-HF was a prospect i ve , multi-centre study that enrolled 501 patients . Phase I ( double blinded , 6 months ) determined the sensitivity and positive predictive value ( PPV ) of the OptiVol data in predicting HF hospitalizations . Of 58 adjudicated HF hospitalizations that occurred during the first 6 months in Phase I , 12 were predicted by OptiVol ( sensitivity = 20.7 % ) . Sensitivity appeared to be dynamic in nature and at the end of Phase I , had increased to 42.1 % . With 253 OptiVol detections , PPV for Phase I was 4.7 % . Phase II/III ( unblinded , 18 months ) determined the PPV of the first OptiVol Patient Alert for detection of worsening HF status with signs and /or symptoms of pulmonary congestion . A total of 233 patients noted such an OptiVol alert and for 210 , HF status was evaluated within 30 days . Heart failure status had worsened for 80 patients ( PPV = 38.1 % ) . CONCLUSIONS An intrathoracic impedance-derived fluid index had low sensitivity and PPV in the early period after implantation of a device in chronic HF patients  . Sensitivity improved within the first 6 months after implant . Further studies are needed to assess the place of this monitoring technology in the clinical management of patients with HF This article provides information and a commentary on key trials relevant to the pathophysiology , prevention , and treatment of heart failure ( HF ) presented at the European Society of Cardiology Heart Failure meeting held in Gothenburg , Sweden in May 2011 . Unpublished reports should be considered as preliminary , since analyses may change in the final publication . In the TEHAF study , use of the Health Buddy ( ® ) monitoring system failed to reduce the number of HF admissions compared with usual care but a subgroup of patients with more recently diagnosed HF may have benefited . In the WHICH study , some reductions in the rate of hospital stay were observed in patients who underwent a  nurse-led home-based intervention programme following a hospital admission for an acute HF exacerbation , compared with patients who were followed in a specialized outpatient clinic . Results from CARVIVA-HF suggest that ivabradine alone or in combination with carvedilol  is safe and effective for improving exercise capacity and quality of life in HF patients on optimized angiotensin-converting enzyme inhibitor therapy . In the GISSI-HF study there was no difference in atrial fibrillation ( AF ) occurrence between the n-3 polyunsaturated fatty acids and placebo groups . In EMPHASIS-HF the incidence of new onset AF or flutter was reduced in patients with mild HF r and omized to eplerenone compared with placebo AIMS Chronic heart failure ( CHF ) patients are frequently rehospitalized within 6 months after an episode of fluid retention . Rehospitalizations are preventable , but this requires an extensive organization of the healthcare system . In this study , we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners ( GPs ) and a heart failure clinic could reduce mortality and rehospitalization rate . METHODS AND RESULTS One hunderd and sixty CHF patients [ mean age 76 ± 10 years , 104 males , mean left ventricular ejection fraction ( LVEF ) 35 ± 15 % ] were block r and omized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring ( TM ) or usual care ( UC ) . The TM group measured body weight , blood pressure , and heart rate on a daily basis with electronic devices that transferred the data automatically to an online data base . Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded . All-cause mortality was significantly lower in the TM group as compared with the UC group ( 5 % vs. 17.5 % , P = 0.01 ) . The total number of follow-up days lost to hospitalization , dialysis , or death was significantly lower in the TM group as compared with the UC group ( 13 vs. 30 days , P = 0.02 ) . The number of hospitalizations for heart failure per patient showed a trend ( 0.24 vs. 0.42 hospitalizations/patient , P = 0.06 ) in favour of TM . CONCLUSION Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization , death , or dialysis in CHF patients . These findings need confirmation in a large trial BACKGROUND Chronic heart failure ( CHF ) remains a common cause of disability , death and hospital admission . Several investigations support the usefulness of programs of disease management for improving clinical outcomes . However , the effect of home-based telemanagement programs on the rate of hospital readmission is still unclear and the cost-effectiveness ratio of such programs is unknown . The aim of the study was to determine whether a home-based telemanagement ( HBT ) programme in CHF patients decreased hospital readmissions and hospital costs in comparison with the usual care ( UC ) follow-up programme over a one-year period . METHODS AND RESULTS Four hundred-sixty CHF patients ( pts ) , aged 57+/-10 years were r and omised to two management strategies : 230 pts to HBT programme and 230 pts to UC programme .  The HBT pts received a portable device , transferring , by telephone , a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation . The UC pts were referred to their primary care physicians and cardiologists . The primary objective of the study was one-year hospital readmission for cardiovascular reasons . During one-year follow-up 55 pts ( 24 % ) in HBT group and 83 pts ( 36 % ) in UC group had at least one readmission ( RR=0.56 ; 95 % CI : 0.38 - 0.82 ; p=0.01 ) . After adjusting for clinical and demographic characteristics , the HBT group had a significantly lower risk of readmission compared with the UC group ( HR=0.50 , 95 % CI : 0.34 - 0.73 ; p=0.01 ) . The intervention was associated with a 36 % decrease in the total number of hospital readmissions ( HBT group : 91 readmissions ; UC group : 142 readmissions ) and a 31 % decrease in the total number of episodes of hemodynamic instability ( 101 in HBT group vs 147 in UC group ) . The rate of hearth failure-related readmission was 19 % ( 43 pts ) in HBT group and 32 % ( 73 pts ) in UC group ( RR=0.49 , 95 % [ CI ] : 0.31 - 0.76 ; p=0.0001 ) . No significant difference was found on cardiovascular mortality between groups . Mean cost for hospital readmission was significantly lower in HBT group ( euro 843+/-1733 ) than in UC group ( euro 1298+/-2322 ) , ( -35 % , p<0.01 ) . CONCLUSIONS This study suggests that one-year HBT programme reduce hospital readmissions and costs in CHF patients BACKGROUND As the prevalence of heart failure ( HF ) rises sharply , the costs related to the care of these patients increases in parallel . Considering the already limited re sources and manpower , in the future the dem and for care may exceed the supply . Therefore , health care systems are encouraged to develop innovative strategies to deal with the burden of HF to improve the quality of care in order to medical outcomes and patients ' quality of life . For that reason new management systems - such as telemonitoring - have to be explored . OBJECTIVES This paper outlines the study protocol of a tailor-made telemonitoring program in ambulant patients with HF . DESIGN AND METHODS A prospect i ve r and omised controlled trial is carried out at 3 hospitals in the South-Limburg area in the Netherl and s. Primary outcome measures are hospital admissions and cost-effectiveness . Secondary outcomes are effects on therapy compliance , level of disease specific knowledge and quality of life . Also determinants are studied of most and less benefited patients in the intervention group . POWER CALCULATION : It is estimated that 390 patients have to be included in the study , with 185 in each arm . RESULTS Inclusion started in September 2007 with a follow-up time of 12 months . First results are expected at the end of 2010 BACKGROUND Policy makers have proposed bundling payments for all heart failure ( HF ) care within 30 days of an HF hospitalization in an effort to reduce costs . Disease management ( DM ) programs can reduce costly HF readmissions but have not been economically attractive for caregivers under existing fee-for-service payment . Whether a bundled payment approach can address the negative financial impact of DM programs is unknown . METHODS Our study determined the cost-neutral point for the typical DM program and examined whether published HF DM programs can be cost saving under bundled payment programs . We used a decision analytic model using data from retrospective cohort studies , meta-analyses , 5 r and omized trials evaluating DM programs , and inpatient cl aims for all Medicare beneficiaries discharged with an HF diagnosis from 2001 to 2004 . We determined the costs of DM programs  and  inpatient care  over 30 and 180 days . RESULTS With a baseline readmission rate of 22.9 % , the average cost for readmissions over 30 days was $ 2,272 per patient . Under base-case assumptions , a DM program that reduced readmissions by 21 % would need to cost $ 477 per patient to be cost neutral . Among evaluated published DM programs , 2 of the 5 would increase provider costs ( + $ 15 to $ 283 per patient ) , whereas 3 programs would be cost saving ( -$241 to $ 347 per patient ) . If bundled payments were broadened to include care over 180 days , then program saving estimates would increase , ranging from $ 419 to $ 1,706 per patient . CONCLUSIONS Proposed bundled payments for HF admissions provide hospitals with a potential financial incentive to implement DM programs that efficiently reduce readmissions OBJECTIVES We sought to determine the utility of combined heart failure ( HF ) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction . BACKGROUND Some implantable devices continuously monitor HF device diagnostic information , but data are limited on the ability of combined HF device diagnostics to predict HF events . METHODS The PARTNERS HF ( Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure ) was a prospect i ve , multicenter observational study in patients receiving cardiac resynchronization therapy ( CRT ) implantable cardioverter-defibrillators .  HF events were independently adjudicated . A combined HF device diagnostic algorithm was developed on an independent data set . The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period : long atrial fibrillation duration , rapid ventricular rate during atrial fibrillation , high ( > or = 60 ) fluid index , low patient activity , abnormal autonomics ( high night heart rate or low heart rate variability ) , or notable device therapy ( low CRT pacing or implantable cardioverter-defibrillator shocks ) , or if they only had a very high ( > or = 100 ) fluid index . We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month . RESULTS We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 + /- 2 months . Ninety patients had 141 adjudicated HF  hospitalizations with pulmonary congestion  at least 60 days after implantation . Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month ( hazard ratio : 5.5 , 95 % confidence interval : 3.4 to 8.8 , p < 0.0001 ) , and the risk remained high after adjusting for clinical variables ( hazard ratio : 4.8 , 95 % confidence interval : 2.9 to 8.1 , p < 0.0001 ) . CONCLUSIONS Monthly review of HF device diagnostic data identifies patients at a higher risk of HF hospitalizations within the subsequent month . ( PARTNERS HF : Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure ; NCT00279955 ) BACKGROUND Decompensated heart failure ( HF ) is associated with unacceptable morbidity and mortality risks . Recent implantable technology advancements allow frequent filling pressure monitoring and provide insight into HF pathophysiology and a new tool for HF management . METHODS The CHAMPION trial is a prospect i ve , multicenter , r and omized , single-blind clinical trial testing the hypothesis that HF management guided by frequently assessed pulmonary artery pressures is superior to traditional methods . A total of 550 subjects with New York Heart Association ( NYHA ) functional class III HF were enrolled at 64 sites in the United States . All subjects received the CardioMEMS HF sensor as a permanent pulmonary artery implant and were r and omized to the treatment or the control group before discharge . The treatment group received traditional HF management guided by hemodynamic information from the sensor . The control group received traditional HF disease management . Safety endpoints include freedom from device/system-related complications and freedom from HF sensor failure at 6 months . The efficacy endpoint is a reduction in the rate of HF-related hospitalizations in the treatment group versus the control group at 6 months . CONCLUSIONS The CHAMPION trial will investigate the safety and clinical efficacy of the CardioMEMS hemodynamic monitoring system and may establish this management strategy as a new paradigm for the medical management of patients with symptomatic HF We studied 138 patients admitted for heart failure ( HF ) . Patients were allocated one of three treatment strategies . Group 1 ( G1 , n = 50 ) were given usual care for HF , Group 2 ( G2 , n = 56 ) received a multi-disciplinary team approach , while Group 3 ( G3 , n = 32 ) had home telephone self-monitoring . Telemonitoring was based on the answers to three simple queries about bodyweight change , dyspnoea and general health . The system stratified the HF severity of each patient once a week , and recommended a prompt medical appointment or simple follow-up . Over a 12-month follow-up period , there were 43 adverse events ( cardiovascular deaths and rehospitalizations for HF : G1 = 22 , G2 = 14 , G3 = 7 ) . There was no difference between G2 and G3 ( P = 0.78 ) but there was significant disadvantage with usual care ( P = 0.02 vs. G2 and P = 0.04 vs. G3 ) . Time to re-admission for HF increased in G2 and G3 compared to G1 ( 188 and 198 days vs. 95 days , P = 0.03 and P = 0.02 respectively ) . Automated home telephone self-monitoring reduced rehospitalization in patients with advanced HF
target: No favourable effect on mortality was observed with STS HM .
  Similar reductions were observed in all-cause hospitalisations for TM interventions , whereas STS interventions had no major effect .
  STS HM was dominated by usual care .
  Similar results were observed in scenario analyses performed using higher costs of usual care , higher costs of STS HH and lower costs of TM during office hours .
  As a result , the economic model developed scenarios for different RM classifications and their costs were estimated using bottom-up costing methods .
  Despite wide variation in usual care and RM strategies , cost-effectiveness analyses suggest that TM during office hours was an optimal strategy ( in most costing scenarios ) .
  However , clarity was lacking among descriptions of the components of RM packages and usual care and there was a lack of robust estimation of costs .
background: BACKGROUND Remote monitoring ( RM ) strategies have the potential to deliver specialised care and management to patients with heart failure ( HF ) .
  OBJECTIVE To determine the clinical effectiveness and cost-effectiveness of home telemonitoring ( TM ) or structured telephone support ( STS ) strategies compared with usual care for adult patients who have been recently discharged ( within 28 days ) from acute care after a recent exacerbation of HF .
  The review included r and omised controlled trials ( RCTs ) or observational cohort studies with a contemporaneous control group that included the following RM interventions : ( 1 ) TM ( including cardiovascular implanted monitoring devices ) with medical support provided during office hours or 24/7 ; ( 2 ) STS programmes delivered by human-to-human contact ( HH ) or human-to-machine interface ( HM ) .