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. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Heart Failure Care in the Outpatient Cardiology Practice Setting: Findings From IMPROVE HF 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). 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. 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. Clinical utility of intrathoracic impedance monitoring to alert patients with an implanted device of deteriorating chronic heart failure. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. 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. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias. Treatment of arrhythmias and use of implantable cardioverter-defibrillators to improve survival in elderly patients with cardiac disease. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. Continuous Monitoring of Intrathoracic Impedance and Right Ventricular Pressures in Patients With Heart Failure Frequency and causes of implantable cardioverter-defibrillator therapies: is device therapy proarrhythmic? 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. CHAMPION trial rationale and design: the long-term safety and clinical efficacy of a wireless pulmonary artery pressure monitoring system. 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. Monitoring intrathoracic impedance with an implantable defibrillator reduces hospitalizations in patients with heart failure. Clinical characteristics and outcomes of elderly patients treated with an implantable cardioverter-defibrillator or cardiac resynchronization therapy in a real-world setting: data from the Israeli ICD Registry. Seasonal variation of daily physical activity in individuals with heart failure Insights from internet-based remote intrathoracic impedance monitoring as part of a heart failure disease management program.
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 ) 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 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 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 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 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 AIMS To evaluate the utility of intrathoracic impedance monitoring for detecting  heart failure ( HF ) deterioration in patients with an implanted cardiac resynchronization/defibrillation device . METHODS AND RESULTS Patients enrolled in the European InSync Sentry Observational Study were audibly alerted by a device algorithm if a decrease in intrathoracic impedance suggested fluid accumulation . Clinical HF status and device data were assessed at enrolment , during regular follow-up , and if patients presented with an alert or HF deterioration .  Data from 373 subjects were analysed . Fifty-three alert events and a total of 53 clinical events ( HF deterioration defined by worsening of HF signs and symptoms ) were reported during a median of 4.2 months . Adjusted for multiple events per patient , the alert detected clinical HF deterioration with 60 % sensitivity ( 95 % CI 46 - 73 ) and with a positive predictive value of 60 % ( 95 % CI 46 - 73 ) . Higher NYHA class at baseline was predictive for adequate alert events during follow-up ( P < 0.05 ) . In 11 of 20 HF deteriorations without preceding alert , an upstroke of the fluid index occurred without reaching the programmed alert threshold . CONCLUSION A device-based algorithm that alerts patients in case of decreasing intrathoracic impedance facilitates the detection of HF deterioration . Future r and omized , controlled trials are needed to test whether the tailored use of intrathoracic impedance monitoring can improve the ambulatory management of patients with chronic HF and an implanted device The relative sensitivity and unexplained detection rate of changes in intrathoracic impedance has not been compared with st and ard heart failure ( HF ) monitoring using daily weight changes . The Fluid Accumulation Status Trial ( FAST ) prospect ively followed 156 HF patients with implanted cardioverter-defibrillator or cardiac resynchronization therapy defibrillator devices modified to record daily changes in intrathoracic impedance in a blinded fashion for 537±312 days .  Daily impedance changes were used to calculate a fluid index that could be compared with a prespecified threshold . True positives were defined as adjudicated episodes of worsening HF occurring within 30 days of a fluid index above threshold or an acute weight gain . Unexplained detections were defined as threshold crossings or acute weight gains not associated with worsening HF . Impedance measurements were performed on > 99 % of follow-up days , compared with only 76 % of days for weight measurements . Sixty-five HF events occurred during follow-up ( 0.32/patient-year ) . Forty HF events were detected by impedance but not weight , whereas 5 were detected by weight but not impedance . Sensitivity was greater ( 76 % vs 23 % ; P<.0001 ) and unexplained detection rate was lower ( 1.9 vs 4.3/patient-year ; P<.0001 ) for intrathoracic impedance monitoring at the threshold of 60Ω days compared with acute weight increases of 3 lbs in 1 day or 5 lbs in 3 days and also over a wide range of fluid index and weight thresholds . The sensitivity and unexplained detection rate  of intrathoracic  impedance monitoring was superior to that seen for acute weight changes . Intrathoracic impedance monitoring represents a useful adjunctive clinical tool for managing HF in patients with implanted devices 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 ) 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 OBJECTIVES This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy ( CRT ) when combined with an implantable cardioverter defibrillator ( ICD ) . BACKGROUND Long-term outcome of CRT was measured in patients with symptomatic heart failure ( HF ) , intraventricular conduction delay , and malignant ventricular tachyarrhythmias ( ventricular tachycardia/ventricular fibrillation [ VT/VF ] ) requiring therapy from an ICD . METHODS Patients ( n = 490 ) were implanted with a device capable of providing both CRT and ICD therapy and r and omized to CRT ( n = 245 ) or control ( no CRT , n = 245 ) for up to six months . The primary end point was progression of HF , defined as all-cause mortality , hospitalization for HF , and VT/VF requiring device intervention . Secondary end points included peak oxygen consumption ( VO(2 ) ) , 6-min walk ( 6 MW ) , New York Heart Association ( NYHA ) class , quality of life ( QOL ) , and echocardiographic analysis . RESULTS A 15 % reduction in HF progression was observed , but this was statistically insignificant ( p = 0.35 ) . The CRT , however , significantly improved peak VO(2 ) ( 0.8 ml/kg/min vs. 0.0 ml/kg/min , p = 0.030 ) and 6 MW ( 35 m vs. 15 m , p = 0.043 ) . Changes in NYHA class ( p = 0.10 ) and QOL ( p = 0.40 ) were not statistically significant . The CRT demonstrated significant reductions in ventricular dimensions ( left ventricular internal diameter in diastole = -3.4 mm vs. -0.3 mm , p < 0.001 and left ventricular internal diameter in systole = -4.0 mm vs. -0.7 mm , p < 0.001 ) and improvement in left ventricular ejection fraction ( 5.1 % vs. 2.8 % , p = 0.020 ) . A subgroup of patients with advanced HF ( NYHA class III/IV ) consistently demonstrated improvement across all functional status end points . CONCLUSIONS The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay 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 CONTEXT Cardiac resynchronization therapy ( CRT ) through biventricular pacing is an effective treatment for heart failure ( HF ) with a wide QRS ; however , the outcomes of patients requiring CRT and implantable cardioverter defibrillator ( ICD ) therapy are unknown . OBJECTIVE To examine the efficacy and safety of combined CRT and ICD therapy in patients with New York Heart Association ( NYHA ) class III or IV congestive HF despite appropriate medical management . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , parallel-controlled trial conducted from October 1 , 1999 , to August 31 , 2001 , of 369 patients with left ventricular ejection fraction of 35 % or less , QRS duration of 130 ms , at high risk of life-threatening ventricular arrhythmias , and in NYHA class III ( n = 328 ) or IV ( n = 41 ) despite optimized medical treatment . INTERVENTIONS Of 369 r and omized patients who received devices with combined CRT and ICD capabilities , 182 were controls ( ICD activated , CRT off ) and 187 were in the CRT group ( ICD activated , CRT on ) . MAIN OUTCOME MEASURES The primary double-blind study end points were changes between baseline and 6 months in quality of life , functional class , and distance covered during a 6-minute walk . Additional outcome measures included changes in exercise capacity , plasma neurohormones , left ventricular function , and overall HF status . Survival , incidence of ventricular arrhythmias , and rates of hospitalization were also compared . RESULTS At 6 months , patients assigned to CRT had a greater improvement in median ( 95 % confidence interval ) quality of life score ( -17.5 [ -21 to -14 ] vs -11.0 [ -16 to -7 ] , P = .02 ) and functional class ( -1 [ -1 to -1 ] vs 0 [ -1 to 0 ] , P = .007 ) than controls but were no different in the change in distance walked in 6 minutes ( 55 m [ 44 - 79 ] vs 53 m [ 43 - 75 ] , P = .36 ) . Peak oxygen consumption increased by 1.1 mL/kg per minute ( 0.7 - 1.6 ) in the CRT group vs 0.1 mL/kg per minute ( -0.1 to 0.8 ) in controls ( P = .04 ) , although treadmill exercise duration increased by 56 seconds ( 30 - 79 ) in the CRT group and decreased by 11 seconds ( -55 to 12 ) in controls ( P<.001 ) . No significant differences were observed in changes in left ventricular size or function , overall HF status , survival , and rates of hospitalization . No proarrhythmia was observed and arrhythmia termination capabilities were not impaired . CONCLUSIONS Cardiac resynchronization improved quality of life , functional status , and exercise capacity in patients with moderate to severe HF , a wide QRS interval , and life-threatening arrhythmias . These improvements occurred in the context of underlying appropriate medical management without proarrhythmia or compromised ICD function 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 Implantable cardioverter-defibrillator ( ICD ) shocks diminish patients ' quality of life , increase health care re source utilization , and may lead to other adverse sequelae . Better underst and ing of the factors that lead to ICD therapies , and better strategies to avoid unnecessary therapies , are needed to optimize patient outcomes . Data from major r and omized clinical trials involving the use of  ICDs and cardiac resynchronization therapy-defibrillator devices  were review ed to determine control group mortality rates  , control group sudden death rates  , and the frequency of appropriate and inappropriate ICD therapies . In all studies that classified deaths , appropriate ICD therapies outnumbered control group sudden cardiac deaths by a factor of 2 to 3 . Some of these episodes can be explained by device programming , by the treatment of potentially unsustained tachycardias , and by errors of episode classification . Another underexplored possibility is that device therapy is proarrhythmic . Reasons for frequent therapies and methods to prevent them are discussed , as well as the notion of device proarrhythmia and the potentially detrimental effects of ICD shocks . These issues clearly affect the overall benefit of device therapy and have important implication s for patient management and health care delivery 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 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 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 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 BACKGROUND Elderly patients are underrepresented in clinical trials of device therapy . OBJECTIVE To provide real-world data regarding outcomes associated with device-based therapy in a large cohort of elderly patients enrolled in the Israeli ICD Registry . METHODS Between July 2010 and June 2012 , a total of 2807 consecutive patients undergoing implanted cardioverter-defibrillator/cardiac resynchronization therapy-defibrillator ( ICD/CRT-D ) implantation were prospect ively enrolled in the Israeli ICD Registry . For the present analysis , patients were categorized into 3 age groups : ≤60 years ( n = 1378 [ 49 % ] ) , 61 - 75 years ( n = 863 [ 31 % ] ) , and > 75 years ( n = 566 [ 20 % ] ) . RESULTS Elderly patients ( > 75 years of age ) had more comorbid conditions and were more likely to undergo CRT-D implantation ( all P < .01 ) . However , the rate of device-related complications associated with surgical re interventions at 1 year was <3 % regardless of age ( P = .70 for the comparison among the 3 age groups ) . Multivariate analysis showed that the risk of heart failure or death and of appropriate ICD therapy for ventricular arrhythmias was significantly increased with increasing age among patients who received an ICD . In contrast , the age-related increase in the risk of all end points was attenuated among patients who received CRT-D devices ( all P values for age-by-device-type interactions are < .05 ) . CONCLUSIONS In a real-world scenario , elderly patients ( > 75 years of age ) comprise approximately 20 % of the ICD/CRT-D recipients and experience a device reintervention rate similar to that of their younger counterparts . Our data suggest that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices Background Previous studies indicate that seasonal variation affects daily physical activity ( PA ) , but none have investigated this relationship in individuals with heart failure ( HF ) who also have implanted cardioverter defibrillators and cardiac resynchronization therapy ( ICD/CRT ) devices . The purpose of the present study was to determine if seasonal variation in temperature affects daily PA in patients with HF and ICD/CRTs . Patients and methods Secondary analysis of data from 16 subjects with HF and Medtronic ® ICD/CRT devices enrolled in a r and omized trial investigating interventions to improve daily PA . Due to the rolling study enrollment , daily PA data for all subjects were not available for the entire time frame and were divided into two groups . Determination of seasonal variation of daily PA was determined using visual analysis of daily PA plotted with average temperature , autocorrelation , visual analysis of seasonal subseries plots and boxplot analysis , as well as Wilcoxon signed-rank tests . Results Subjects 1 - 8 demonstrated the greatest differences in daily PA during periods of seasonal transition whereas subjects 9 - 16 demonstrated the greatest variation in daily PA with greatest seasonal temperature difference . Wilcoxon signed-rank testing of the lowest and highest months for daily PA revealed median differences of 0.30 ( p = 0.050 ) and 0.36 hours ( p = 0.036 ) for subjects 1 - 8 and 9 - 16 , with effect sizes of 0.69 and 0.74 , respectively . Conclusions Seasonal variation in mean temperature appears to affect daily PA in individuals with HF and ICD/CRT devices by a magnitude of 0.30 - 0.36 hours , which may need to be accounted for in future research investigating interventions to improve daily PA Changes in intrathoracic impedance ( Z ) leading to crossing of a derived fluid index ( FI ) threshold has been associated with heart failure ( HF ) hospitalization . The authors developed a remote monitoring program as part of HF disease management and prospect ively examined the feasibility and re source utilization of monitoring individuals with an implanted device capable of measuring Z. An HF nurse analyzed all transmitted data daily , as they were routinely uploaded as part of quarterly remote device monitoring , and called the patient if the FI crossed the threshold ( arbitrarily defined at 60 Omega ) to identify clinical ly relevant events ( CREs ) that occurred during this period ( eg , worsening dyspnea or increase in edema or weight ) . A total of 400 uploads were completed during the 4-month study period . During this period , 34 patients ( 18 % ) had an FI threshold crossing , averaging 0.52 FI threshold crossings per patient-year . Thirty-two of 34 patients contacted by telephone ( 94 % ) with FI threshold crossing had evidence of CREs during this period . However , only 6 ( 18 % ) had HF hospitalizations , 19 ( 56 % ) had reported changes in HF therapy , and 13 ( 38 % ) reported drug and /or dietary plan nonadherence . The average data analysis time required was 30 min daily when focusing on those with FI threshold crossing , averaging 8 uploads for review per working day and 5 telephone follow-ups per week . Our pilot observations suggested that Internet-based remote monitoring of Z trends from existing device interrogation uploads is feasible as part of a daily routine of HF disease management
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 .