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. Heart failure management using implantable devices for ventricular resynchronization: Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) trial. COMPANION Steering Committee and COMPANION Clinical Investigators. A randomized study of remote monitoring and fluid monitoring for the management of patients with implanted cardiac arrhythmia devices. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. 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. Randomized controlled trial of an implantable continuous hemodynamic monitor in patients with advanced heart failure: the COMPASS-HF study. Treatment of arrhythmias and use of implantable cardioverter-defibrillators to improve survival in elderly patients with cardiac disease. Wireless Pulmonary Artery Pressure Monitoring Guides Management to Reduce Decompensation in Heart Failure With Preserved Ejection Fraction Predictors and treatment response with cardiac resynchronization therapy in patients with heart failure characterized by dyssynchrony: a pre-defined analysis from the CARE-HF trial. INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients with Remotely Monitored Implanted Cardioverter Defibrillators SysTems (InContact) Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings From IMPROVE HF Remote management of heart failure using implantable electronic devices Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study Device monitoring strategies in acute heart failure syndromes A study to improve communication between clinicians and patients with advanced heart failure: methods and challenges behind the working to improve discussions about defibrillator management trial. Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization
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 Although pharmacological therapy has ameliorated symptoms and improved the survival of patients with chronic heart failure ( CHF ) , this chronic syndrome remains a progressive disease causing incremental morbidity and early mortality . A new therapy for the treatment of CHF should ideally decrease mortality , alleviate symptoms , and improve functional capacity . A growing body of evidence suggests that the use of implantable devices to resynchronize ventricular contraction may be a beneficial adjunct in the treatment of CHF . METHODS The Comparison of Medical Therapy , Pacing , and Defibrillation in Chronic Heart Failure ( COMPANION ) trial is a r and omized , open-label , 3-arm study of patients in New York Heart Association class III or IV with an ejection fraction of 35 % or less and a QRS duration of 120 milliseconds or less . The COMPANION study objectives are to determine whether optimal pharmacological therapy used with ( 1 ) ventricular resynchronization therapy alone or ( 2 ) ventricular resynchronization therapy combined with cardioverter-defibrillator capability is superior to optimal pharmacological therapy alone in reducing combined all-cause mortality and hospitalizations ; reducing cardiac morbidity ; improving functional capacity , cardiac performance , and quality of life ; and increasing total survival AIMS Only limited comparative data exist on the benefits of fluid monitoring ( FM ) combined with remote monitoring ( RM ) regarding morbidity and mortality of heart failure ( HF ) patients . This prospect i ve single-centre r and omized pilot study aim ed to estimate the influence of RM in combination with FM on HF hospitalizations as well as ventricular tachyarrhythmias and mortality . METHODS AND RESULTS Patients with st and ard indication for implantable cardioverter defibrillator ( ICD ) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM , and were followed for 15 months . Subjects were r and omly allocated to RM including OptiVol and predefined management of alerts ( remote group ) , or st and ard in-office visits every 3 months ( control group ) . A total of 176 patients ( 77 % male ; 66 ± 12 years ; left ventricular ejection fraction ( LVEF ) 32 ± 11 % ; ischemic cardiomyopathy 50 % ; CRT device 50 % ; primary prevention 85 % ) were analysed . Cox proportional hazard analysis on the time to first HF-related hospitalization showed a hazard ratio of 1.23 [ 0.62 - 2.44 ] ( P = 0.551 ) favouring the control group . In the remote group , 13 patients ( 15 % ) experienced ICD shocks vs. 10 patients ( 11 % ) in the control group ( P = 0.512 ) . The average time to first ICD shock was 212 ± 173 days in the remote arm and 212 ± 143 days in the control arm ( P = 0.994 ) . The Kaplan-Meier estimate of mortality after 1 year was 8.6 % ( eight deaths ) in the remote group vs. 4.6 % in the control group ( six deaths ; P = 0.502 ) . CONCLUSION In a single-centre r and omized pilot study of RM in combination with FM , no significant influence on HF-related hospitalizations , ICD shocks , or mortality was found 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 Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors .  Anticoagulation ameliorates stroke risk , but because these arrhythmias may occur intermittently without symptoms , initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained . The IMPACT study is a multicenter , r and omized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator ( CRT-D ) devices design ed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke , systemic embolism , and major bleeding compared with conventional clinical management . For those in the intervention group , early detection of atrial high-rate episodes ( AHRE ) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification . Subsequently , freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding . Patients in the control arm are managed conventionally , the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up . The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke . In this report , we describe the study design and baseline demographic and clinical features of the initial cohort ( 227 patients ) 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 ) 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 Patients who have left ventricular dysfunction and heart failure ( HF ) are at high risk for ventricular tachyarrhythmias and sudden cardiac death . R and omized clinical trials have demonstrated that pharmacologic management with antiarrhythmic drugs has limited efficacy for the prevention of arrhythmic mortality in this high-risk population , whereas implantation of a defibrillator was shown to be associated with a significant survival benefit . Data on the efficacy of defibrillator therapy  in elderly patients , in whom comorbidities are common , are limited . In this article we outline current information on therapeutic modalities for the prevention of arrhythmic mortality in elderly patients who have left ventricular dysfunction and HF , focusing mainly on data on the benefit of device therapy in the older age group Background —No treatment strategies have been demonstrated to be beneficial for the population for patients with heart failure ( HF ) and preserved ejection fraction ( EF ) . Methods and Results —The CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients ( CHAMPION ) trial was a prospect i ve , single-blinded , r and omized controlled clinical trial testing the hypothesis that hemodynamically guided HF management decreases decompensation leading to hospitalization . Of the 550 patients enrolled in the study , 119 had left ventricular EF ≥40 % ( average , 50.6 % ) , 430 patients had low left ventricular EF ( < 40 % ; average , 23.3 % ) , and 1 patient had no documented left ventricular EF .  A microelectromechanical system pressure sensor was permanently implanted in all participants during right heart catheterization . After implant , subjects were r and omly assigned in single-blind fashion to a treatment group in whom daily uploaded pressures were used in a treatment strategy for HF management or to a control group in whom st and ard HF management included weight-monitoring , and pressures were uploaded but not available for investigator use . The primary efficacy end point of HF hospitalization rate > 6 months for preserved EF patients was 46 % lower in the treatment group compared with control ( incidence rate ratio , 0.54 ; 95 % confidence interval , 0.38–0.70 ; P<0.0001 ) . After an average of 17.6 months of blinded follow-up , the hospitalization rate was 50 % lower ( incidence rate ratio , 0.50 ; 95 % confidence interval , 0.35–0.70 ; P<0.0001 ) . In response to pulmonary artery pressure information , more changes in diuretic and vasodilator therapies were made in the treatment group . Conclusions —Hemodynamically guided management of patients with HF with preserved EF reduced decompensation leading to hospitalization compared with st and ard HF management strategies . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00531661 AIMS The cardiac resynchronization therapy in heart failure trial ( CARE-HF ) demonstrated that cardiac resynchronization therapy ( CRT ) reduces morbidity and mortality in patients with heart failure and cardiac dyssynchrony . The aim of this study was to develop a prognostic model to evaluate the relationship between prospect ively defined patient characteristics and treatment on the trial primary outcome of death from any cause or unplanned hospitalization for a major cardiovascular event . METHODS AND RESULTS A total of 813 patients were enrolled in the CARE-HF study and were followed for a mean of 29.4 months . A Cox Proportional Hazards Model was fitted to identify predictors of the primary outcome and any predictors that modified the effect of CRT . Ischaemic aetiology , more severe mitral regurgitation and increased N-terminal pro-brain natriuretic peptide , were associated with an increased risk of death or unplanned cardiovascular hospitalization irrespective of cardiac resynchronization [ Hazard ratio ( HR ) 1.89 , 95 % CI 1.45 - 2.46 , HR 1.71 , 95 % CI 1.38 - 2.12 and HR 1.31 , 95 % CI 1.17 - 1.47 , respectively ] and increasing systolic blood pressure with a decreasing risk of an event ( HR 0.99 , 95 % CI 0.98 - 1.00 ) . The benefits of cardiac resynchronization were modified by systolic blood pressure and interventricular mechanical delay ( IVMD ) . Patients with increasing systolic blood pressure appear to receive reduced benefit from CRT ( HR 1.02 , 95 % CI 1.00 - 1.03 ) , whereas those patients with more severe IVMD appear to benefit more from treatment ( HR 0.99 , 95 % CI 0.98 - 1.00 ) . CONCLUSION Patients with echocardiographic evidence of more severe cardiac dyssynchrony and low systolic blood pressure obtain greater benefit from CRT , although benefits were substantial across the range of subjects included in the trial Background In heart failure ( HF ) patients with implantable cardioverter defibrillators ( ICD ) or cardiac resynchronisation therapy defibrillators ( CRT-D )  , remote monitoring has been shown to result in at least non-inferior outcomes relative to in-clinic visits . We aim ed to provide further evidence for this effect , and to assess whether adding telephone follow-ups to remote follow-ups influenced outcomes . Methods InContact was a prospect i ve , r and omised , multicentre study . Subjects receiving quarterly automated follow-up only ( telemetry group )  were compared to those receiving personal physician contact .  Personal contact patients were further divided into those receiving automated follow-up plus a telephone call ( remote+phone subgroup ) or in-clinic visits only . Results Two hundred and ten patients underwent r and omisation ( telemetry n = 102 ; personal contact n = 108 [ remote+phone : n = 53 ; visit : n = 55 ] ) . Baseline characteristics were comparable between groups and subgroups . Over 12 months , 34.8 % of patients experienced deterioration of their Packer Clinical Composite Response , with no significant difference between the telemetry group and personal care ( p > 0.999 ) , remote+phone ( p = 0.937 ) or visit ( p = 0.940 ) patients ; predefined non-inferiority criteria were met . Mortality rates ( 5.2 % overall ) were comparable between groups and subgroups ( p = 0.832/p = 0.645 ) , as were HF-hospitalisation rates ( 11.0 % overall ; p = 0.605/p = 0.851 ) . The proportion of patients requiring ≥1 unscheduled follow-up was nominally higher in telemetry and remote+phone groups ( 42.2 and 45.3 % ) compared to the visit group ( 29.1 % ) . Overall , ≥ 1 ICD therapy was delivered to 15.2 % of patients . Conclusion In HF patients with ICDs/CRT-Ds , quarterly remote follow-up only over 12 months was non-inferior to regular personal contact . Addition of quarterly telephone follow-ups to remote monitoring does not appear to offer any clinical advantage . Trial registration clinical trials.gov : NCT01200381 ( retrospectively registered on September 13th 2010 ) Background —Few data exist regarding contemporary care patterns for heart failure ( HF ) in the outpatient setting . IMPROVE HF is a prospect i ve cohort study design ed to characterize current management of patients with chronic HF and ejection fraction ≤35 % in a national registry of 167 US outpatient cardiology practice s. Methods and Results —Baseline patient characteristics and data on care of 15 381 patients with diagnosed HF or prior myocardial infa rct ion and left ventricular dysfunction were collected by chart abstract ion . To quantify use of therapies , 7 individual metrics ( use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker , & bgr;-blocker , aldosterone antagonist , anticoagulation , implantable cardioverter defibrillator , cardiac resynchronization therapy , and HF education ) and composite metrics were assessed . Care metrics include only patients documented to be eligible and without contraindications or intolerance . Among practice s , 69 % were nonteaching . Patients were 71 % male , with a median age of 70 years , and a median ejection fraction of 25 % . Use of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker ( 80 % ) and & bgr;-blocker ( 86 % ) was relatively high in eligible patients in the outpatient cardiology setting ; other metrics , such as aldosterone antagonist ( 36 % ) , device therapy ( implantable cardioverter defibrillator/cardiac resynchronization therapy with defibrillator , 51 % ; cardiac resynchronization therapy , 39 % ) , and education ( 61 % ) , showed lower rates of use . A median 27 % of patients received all HF therapies for which they were potentially eligible on the basis of chart documentation . Use of guideline -recommended therapies by practice s varied widely . Conclusions —These data are among the first to assess treatment in the outpatient setting since the release of the latest national HF guidelines and to demonstrate substantial variation among cardiology practice s in the documented therapies provided to HF patients Abstract Aims Remote management of heart failure using implantable electronic devices ( REM-HF ) aim ed to assess the clinical and cost-effectiveness of remote monitoring ( RM ) of heart failure in patients with cardiac implanted electronic devices ( CIEDs ) . Methods and results Between 29 September 2011 and 31 March 2014 , we r and omly assigned 1650 patients with heart failure and a CIED to active RM or usual care ( UC ) . The active RM pathway included formalized remote follow-up protocol s , and UC was st and ard practice in nine recruiting centres in Engl and . The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons . Secondary endpoints included death from any cause , death from cardiovascular reasons , death from cardiovascular reasons and unplanned cardiovascular hospitalization , unplanned cardiovascular hospitalization , and unplanned hospitalization . REM-HF is registered with IS RCT N ( 96536028 ) . The mean age of the population was 70 years ( range 23–98 ) ; 86 % were male . Patients were followed for a median of 2.8 years ( range 0–4.3 years ) completing on 31 January 2016 . Patient adherence was high with a drop out of 4.3 % over the course of the study . The incidence of the primary endpoint did not differ significantly between active RM and UC groups , which occurred in 42.4 and 40.8 % of patients , respectively [ hazard ratio 1.01 ; 95 % confidence interval ( CI ) 0.87–1.18 ; P = 0.87 ] . There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components . Conclusion Among patients with heart failure and a CIED , RM using weekly downloads and a formalized follow up approach does not improve outcomes Aim To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators ( CRT-Ds ) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death . Methods and results Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option .  Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospect ively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5 % . Seven parameters were included in the algorithm : mean heart rate over 24 h , heart rate at rest , patient activity , frequency of ventricular extrasystoles , atrial – atrial intervals ( heart rate variability ) , right ventricular pacing impedance , and painless shock impedance . The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death . While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0 % , the combination of all parameters was 65.4 % sensitive in detecting cardiovascular hospitalizations and deaths with 99.5 % specificity ( corresponding to 1.83 false-positive detections per patient-year of follow-up ) . The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding . Conclusion We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring . This tool may increase patients ’ quality of life and reduce morbidity , mortality , and health economic burden , it now warrants prospect i ve studies . Clinical Trials.gov NCT00376116 Acute heart failure syndromes ( AHFS ) represent the most common discharge diagnoses in adults over age 65 and translate into dramatically increased heart failure – associated morbidity and mortality . Conventional approaches to the early detection of pulmonary and systemic congestion have been shown to be of limited sensitivity . Despite their proven efficacy , disease management and structured telephone support programs have failed to achieve widespread use in part due to their re source intensiveness and reliance upon motivated patients . While once thought to hold great promise , results from recent prospect i ve studies on telemonitoring strategies have proven disappointing . Implantable devices with their capacity to monitor electrophysiologic and hemodynamic parameters over long periods of time and with minimal reliance on patient participation may provide solutions to some of these problems . Conventional electrophysiologic parameters and intrathoracic impedance data are currently available in the growing population of heart failure patients with equipped devices . A variety of implantable hemodynamic monitors are currently under investigation . How best to integrate these devices into a systematic approach to the management of patients before , during , and after AHFS  is yet to be established We report the challenges of the Working to Improve Discussion s About Defibrillator Management trial , our novel , multicenter trial aim ed at improving communication between cardiology clinicians and their patients with advanced heart failure ( HF ) who have implantable cardioverter defibrillators ( ICDs ) .  The study objectives are ( 1 ) to increase ICD deactivation conversations , ( 2 ) to increase the number of ICDs deactivated , and ( 3 ) to improve psychological outcomes in bereaved caregivers . The unit of r and omization is the hospital , the intervention is aim ed at HF clinicians , and the patient and caregiver are the units of analysis . Three hospitals were r and omized to usual care and three to intervention . The intervention consists of an interactive educational session , clinician reminders , and individualized feedback . We enroll patients with advanced HF and their caregivers , and then we regularly survey them to evaluate whether the intervention has improved communication between them and their HF providers . We encountered three implementation barriers . First , there were institutional review board concerns at two sites because of the palliative nature of the study . Second , we had difficulty in creating entry criteria that accurately identified an HF population at high risk of dying . Third , we had to adapt our entry criteria to the changing l and scape of ventricular assist devices and cardiac transplant eligibility . Here we present our novel solutions to the difficulties we encountered . Our work has the ability to enhance conduct of future studies focusing on improving care for patients with advanced illness Purpose To determine the association between device-determined diagnostic indices , including intrathoracic impedance , and heart failure ( HF ) hospitalization . Methods Clinical and device diagnostic data of 558 HF patients indicated for CRT-D therapy ( In Sync Sentry , Medtronic Inc. ) were prospect ively collected from 34 centers . Device-recorded intrathoracic impedance fluid index threshold crossing event ( TCE ) , mean activity counts , tachyarrhythmia events , night heart rate ( NHR ) and heart rate variability ( HRV ) were compared within patients with vs. without documented HF hospitalization . Results Mean follow-up was 326 ± 216 days . Patients hospitalized for HF had significantly higher rates of TCE , a higher percentage of days with the thoracic impedance fluid index above the programmed threshold , a higher percentage of days with low activity , with low HRV or with high NHR.Multivariate analysis showed that TCE result ed in a 36 % increased probability of HF hospitalization . Both TCE duration and patient activity were also significantly associated with hospitalization . Kaplan Meier analysis indicated that patients with more TCE events were significantly more likely to be hospitalized ( log rank test , p = 0.005 ) . Conclusions Decreased intrathoracic impedance , low patient activity and low HRV were all independently associated with increased risk for HF hospitalization in HF patients treated with resynchronization therapy . Device-derived diagnostic data may provide valuable and reliable indices for the prognostic stratification of HF patients
RESULTS Device diagnostics showed strong correlation with established HF biomarkers and hemodynamic measures .
The findings from this review indicate that device diagnostic parameters predict impending HF much earlier than traditional methods of monitoring do .
Device diagnostics are also more accurate in the early prediction of HF when compared with noninvasive objective measures , particularly when multiple parameters are combined and monitored for trends .
Device diagnostics possess a distinct advantage over traditional methods of monitoring for HF because they allow clinicians to remotely monitor the status of their HF patients without relying on patient compliance for data entry and reporting .
Studies regarding the efficacy of device diagnostic parameters suggest that their integration into clinical practice will provide a more accurate and reliable mechanism for assisting clinicians in risk stratifying and predicting potential episodes of decompensated HF
BACKGROUND Traditional methods of heart failure ( HF ) management are based on reactive strategies to treat late indicators of decompensated HF .
Advances in monitoring methods have become available with the evolution of implantable cardioverter-defibrillators and cardiac-resynchronization therapy devices .
These devices provide new diagnostic data and remote monitoring capabilities that allow clinicians to proactively monitor patients for earlier signs of worsening HF .
The integration of data obtained from implantable cardioverter-defibrillator and cardiac-resynchronization therapy technology could improve outpatient HF care , potentially leading to decreased readmission rates and improved patient outcomes .
OBJECTIVE This review will synthesize the literature regarding the efficacy of device diagnostic data and the usability of the data in the clinical setting .