Remote monitoring heart failure patients with implanted heart devices: a descriptive exploratory qualitative study of nurses' experiences and competences in Italy.

HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.

ORAL PRESENTATION

Can we predict, prevent, and minimize defibrillator shocks? Lessons learned from “remote monitoring”

This editorial refers to ‘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’ by S. Sack et al., published in this issue on pages 1019–1027. Implantable cardioverter–defibrillators (ICDs) have become standard therapy for patients with poor systolic function and low left ventricular ejection fraction, most often due to ischaemic heart disease, and also non-ischaemic cardiomyopathy. These patients are thus protected from life-threatening arrhythmias but remain at risk of deterioration of cardiac function leading to decompensation. Cardiac resynchronization therapy can improve symptoms of heart failure and mortality in advanced heart failure but has more recently been shown to also reduce mortality in milder heart failure patients with broad QRS complexes.1 Implantation rates have been shown to be increasing steadily in Europe2,3 and it is expected that they will increase further after the recent updated guidelines on device therapy in heart failure.4 These devices can increasingly be connected to remote monitoring to assess device function but also heart failure-related parameters. Prospective data on the use of remote monitoring is scarce but is being increasingly used also in the light of recent device-related malfunctions. The use of parameters that can predict heart failure-related complications can be an important add-on to these remote technical device check-ups. As mentioned, prospective data are few but there are numerous trials currently recruiting or in the follow-up phase that should be available within the next few years and these should aid in answering important questions such as if heart failure hospitalizations can be prevented by remote monitoring of cardiac devices. A lot of study designs are not published in peer-reviewed journals but can be looked up at www.clinicaltrials.gov. A comprehensive review was recently published summarizing available systems and reviewing ongoing trials.5 In this issue of the European Journal of Heart Failure, Sack et al.6 present data from the Home-CARE study comparing seven different parameters possibly related to worsening of heart failure with regard to their prospective value in predicting heart failure hospitalization. These parameters, however, did not include changes in thoracic impedance measurements, which are possibly the most sensitive markers of pulmonary fluid accumulation.7,8 The authors found that combination of several predictors showed higher sensitivity and even higher specificity than using a single parameter. The downside is that even if all seven parameters are included, the specificity of alerts was not >65%. One could speculate that in a follow-up study the best parameters could be tested with inclusion of thoracic impedance. Patient activity seemed to have a low predictive value whereas mean and resting heart rates as well as heart rate variability appeared to be more important. The upside of the presented results is, however, that the specificity of combined parameters was very high which cannot be expected from thoracic impedance measurements alone.9 Remote monitoring of ICDs can aid in early detection of technical problems. This includes lead problems such as fracture, but also device problems such as early battery depletion. Even though the event rate is low early after implantation10 this can increase during the lifespan of an implanted device. The occurrence of frequent non-sustained ventricular tachycardias or successful anti-tachycardia pacing can precede shock therapy, which might be prevented by changes in therapy such as intensifying antiarrhythmic treatment. The occurrence of atrial fibrillation (AF) with fast ventricular conduction or other supraventricular tachycardias as well as intermittent T-top oversensing are typical examples of situations where early detection could prevent inadequate ICD therapies. What is the evidence for remote monitoring in the prevention of heart failure events? Non-device telemonitoring of patient parameters such as symptoms and weight showed no benefit over conventional therapy.11,12 Registry data, which can obviously not replace prospective analyses, suggest that mortality is lower in patients with remote monitoring than in a group receiving standard face-to-face follow-up.13 For the use of intrathoracic impedance we eagerly await the report of prospective randomized studies such as DOT-HF (Diagnostic Outcome Trial in Heart Failure)14 and OptiLink HF.15 It is, however, to be expected that in real life specificity will not be higher than suggested by earlier studies. Sack et al. can be heralded to try to combine several parameters to overcome this caveat. If future studies can combine promising parameters with intrathoracic impedance it might be possible to find a combination with reasonable sensitivity and specificity. Cardiac resynchronization devices are actually the theoretical prototype for remote monitoring. Most patients have an ICD function and may benefit from early detection of technical problems and ventricular tachyarrhythmias as discussed in the previous paragraph. New-onset AF may be a marker of worsening heart failure. In patients with cardiac resynchronization it is especially deleterious because of loss of biventricular stimulation especially during exercise16 and it has been demonstrated to be an independent predictor of non-response to CRT17 as well as mortality.18 The effecT study (NCT00811382) was started to prospectively study the early treatment of AF episodes detected via home monitoring. What are the future possibilities for remote monitoring? Patients at high risk of device malfunctions will continue to receive remote monitoring devices. As we await the results from additional randomized trials, prevention of heart failure events is a reasonable target. This might have to be restricted to certain populations until we find additional parameters or technical advances that will improve sensitivity and specificity. Cost effectiveness is an important issue that cannot be left unmentioned. Remote monitoring can be used to reduce face-to-face contacts that could save health-care expenditure as well as costs to the individual patient (travel expenses) and to society (missing time at work). For the issue of cost, prospective trials are also missing but ongoing. Finally, we must not forget patient satisfaction and quality of life. Implantable cardioverter–defibrillators shocks and heart failure hospitalizations can impact on patients’ lives. Heart failure is associated with reduced quality of life. Remote monitoring can aid in patient satisfaction providing an additional sense of security and acceptance of their cardiac device with as a possible downside the continuous reminder of their illness. Conflicts of interest: D.J.V. has received consultancy fees from Medtronic and Biotronik, and is the Principal (Co-) Investigator of the DOT-HF Study. A.H.M. has received lecture fees from Medtronic, Biotronik, Boston Scientific, and Sorin.

Implantable cardioverter-defibrillators (ICDs) have revolutionized the treatment of patients at risk for sudden cardiac death. In the nearly 3 decades since the first human ICD implant,1 millions of devices have been implanted worldwide and innumerable lives have been saved. Successful resuscitation of a potentially lethal ventricular arrhythmia by an ICD system depends on successful arrhythmia detection and timely delivery of therapy. Both the ICD generator and the ICD lead are critical components of this system. The lead, in particular, is literally a lifeline whose purpose is to convey critical information about the heart’s rhythm to the ICD generator and, in turn, to deliver life-sustaining therapy when needed. Failure of an ICD lead may result in significant clinical events, including failure to pace, failure to defibrillate, inappropriate shocks, and even death. Article p 2727 ICD leads, like many medical technologies, have undergone a remarkable transformation. Epicardial leads, which necessitated a thoracotomy for lead placement, have given way to transvenous leads, which are easier to implant, less costly, and associated with decreased morbidity and mortality.2 Important advances in transvenous lead technology, such as the development of steroid elution, smaller diameter leads, novel insulations, and multipolar leads, have translated into meaningful clinical benefits for patients. Although modern ICD leads consist primarily of electrodes, conductors, insulation, and a fixation mechanism to attach the lead to the myocardium, lead design and performance vary from model to model. Indeed, monitoring of performance is critical not only to identify products with increased failure rates but also to provide physicians and patients with realistic expectations of device performance. In the current issue of Circulation , Eckstein et al add to our understanding of ICD lead performance.3 The investigators conducted a retrospective analysis of 1317 consecutive patients who received ICD systems (including 38 different ICD lead …

Heart failure (HF) remains a large medical problem, and prevention of decompensation and HF-related hospitalizations is important not only for the patient, but also from an economic point of view. Close monitoring is crucial and can be done through a whole spectrum of modalities. This monitoring ranges from a (nurse-based) disease management program, to structured telephone support, to remote or telemonitoring with or without the use of an implantable device.1–3 Article see p 2985 Disease management programs, usually with a specialized nurse and in the hospital, are implemented on a large scale, but the optimal level and intensity of care is still unclear.4 Structured telephone support may be useful, and a recent meta-analysis showed a reduction in HF hospitalization, but no effect on mortality.2 Remote, home, or telemonitoring using a number of (relatively simple) noninvasive variables such as heart rate, blood pressure, and body weight was also examined in a number of studies, and the same meta-analysis showed that this method reduced both hospitalizations and mortality.2 However, 2 recent large studies not included in that analysis did not show such a positive effect.5,6 In the American Telemonitoring to improve outcomes in HF (TELE-HF) study5 and in the German Telemedical Intervention Monitoring in HF (TIM-HF) study,6 which together randomly assigned 2362 HF patients, no effect on HF hospitalizations or mortality was observed. In recent years, a number of studies in the field of telemonitoring have been published that measured invasive variables. In the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of HF (COMPASS-HF) study,7 a strategy based on measurement of right-sided intracardiac pressures (with a special transvenous lead: Chronicle, Medtronic) was examined. The primary (composite) end point showed a nonsignificant 21% reduction, but there was a …

More than 4000 patients have been evaluated in randomized controlled trials of cardiac resynchronization therapy (CRT). These studies have demonstrated that CRT with or without an implantable cardioverter-defibrillator (ICD) consistently improves quality of life, functional status, exercise capacity, and cardiac structure and function and reduces morbidity and mortality in heart failure patients with ventricular dyssynchrony. The magnitude of benefit seen with CRT is comparable to or exceeds that seen with evidence-based drug therapies for heart failure but occurs in patients who are already receiving such medications. Thus, CRT has been added to the list of evidence-based therapies that make heart failure patients feel better and live longer (the Table). Consequently, a strong ethical mandate exists for the use of CRT in heart failure. This mandate is reflected in our current practice guidelines for the management of chronic heart failure, which state that all eligible patients should receive CRT unless contraindicated.1,2 End of debate! CRT should be a routine part of any evidence-based treatment regimen for heart failure. View this table: Major Benefits of Evidence-Based Heart Failure Therapies Of course, things are never quite so simple, so let us take a look at the evidence supporting this clinical mandate for CRT and address patient selection, some of the limitations of CRT, and some of the unanswered questions about the use of CRT in heart failure. None of this discussion will lessen the role of CRT in the treatment of heart failure; rather, it will guide the selection of appropriate patients and speculate on the future application of CRT to an even broader group of heart failure patients. Response by Greenberg and Mehra p 2698 Approximately one third of patients with systolic heart failure exhibit ventricular dyssynchrony, defined as a QRS duration >120 ms on the surface ECG.3,4 Ventricular dyssynchrony produces suboptimal ventricular …

Background Non-sustained ventricular tachycardia (NSVT) is commonly found in patients with structural heart disease and was historically obtained from registers of external ambulatory monitoring. The advent of remote patient monitoring (RPM) in Cardiac implantable electronic devices (CIEDs) has made it possible to detect asymptomatic NSVT in Heart Failure (HF) patients more frequently, but its impact in real world is uncertain. Purpose To determine the clinical impact of NSVT detection in RPM in ischemic and non-ischemic chronic heart failure patients with reduced ejection fraction (HFrEF) and CIEDs. Methods We retrospectively enrolled 121 consecutive patients with HFrEF, CIEDs and RPM. Patients were evaluated through routine episodic CIEDs interrogation, routine clinical evaluations and continuous monitoring data obtained from CIEDs and transmitted remotely to the care team and divided into NSVT positive (Group 1) and negative groups (Group 2). Primary endpoint was admissions to the emergency department by HF decompensation and secondary endpoint was the occurrence of arrhythmic events. A sub-analysis of non-ischemic HF was also performed. Results NSVT was detected in 78 (72,2%) patients. The mean number of episodes of NSVT was 611,68±3271,25 during the follow-up period or 2,445±16,688 in 24 hours. Mean age was 62,40±13,218 years, 71,9% were males and mean follow-up period was 56,30±39,37 months. Fifty-eight patients (47,9%) had transvenous implantable cardioverter defibrillator (ICD), 48 (39,7%) implantable cardiac resynchronization therapy (CRT) defibrillator (CRT-D), 14 (11,6%) subcutaneous ICD (S-ICD) and 1 (0,8%) CRT pacemaker (CRT-P). Medium left ventricular ejection fraction (LVEF) was 34,70±12,53%, 25 (23,14%) were in NYHA III-IV and 46 (39,0%) were ischemic (29 (37,7%) in Group 1 and 11 (37,9%) in Group 2). NSVT was associated with the occurrence of sustained ventricular tachycardia (VT) (1,88±0,186episodes of VT in group 1 and 0,03±0,186 in group 2, p=0,012), ventricular fibrillation (VF) (1,44±5,325 episodes of VT in group 1 and 0,03±0,186 in group 2, p=0,011) and admissions to the emergency department by HF decompensation at 5 years (r=0,310, p=0,011). A sub-analysis in non-ischemic HF patients also showed correlation between NSVT and VT (r=0,602, p<0,05) and admissions to the emergency department by HF decompensation at 5 years (r=0,382, p=0,014). Conclusions On remote patient monitoring with CIEDs, NSVT in HF patients was associated with arrhythmic events and may serve as a predictor for HF decompensations. Funding Acknowledgement Type of funding sources: None.

Introduction Remote monitoring (RM) of cardiac implantable electronic devices (CIED) allows rapid detection of clinical and electrical events. Recently, several smartphone applications have been developed with the aim of improving patient compliance and better interpreting and integrating data deriving from remote control for the management of heart failure (HF). Areas covered Studies investigating the role of CIEDs’ RM in HF patients to predict and early treat acute decompensation. The importance of new technologies and applications developed to provide crucial information to clinicians, to better manage HF patients. Expert opinion New medical technologies and smartphone applications for CIEDs’ RM were developed to help clinicians in the management of CIED carriers. Indeed, the accessibility of technological devices (e.g. smartphones) and the improvements in medical technology provide the opportunity to optimize HF patients’ monitoring by the transmission of device-related data, and with direct involvement of patients themselves. Thanks to these advancements, physicians have the possibility to recognize worsening signs of HF and promptly optimize treatments to potentially avoid hospitalization. The great value of this approach is its potential of reducing scheduled in-office visits or unnecessary medical contacts and optimizing healthcare resources management.

Background NYHA functional class (FC) is used for selection of heart failure (HF) patients who are candidates to primary prevention (PP) implantable cardioverter defibrillator (ICD) therapy. However, FC is subjectively estimated and concerns about its real prognostic value are still present in this setting. Purpose To compare whether mortality and arrhythmic risk are different, in a cohort of HF patients undergoing PP ICD-only implant, according to their FC. Methods All HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD-only implant were collected from the UMBRELLA nationwide registry (2006–2015). The sample was divided into three groups: no symptoms (NYHA I), mildly symptomatic patients (NYHA II) and severely symptomatic (NYHA III) patients. Outcomes were studied as follow: all-cause death, cardiovascular mortality and arrhythmia free survival (surrogate marker of sudden cardiac death) defined as survival free of first appropriate ICD therapy delivered in ventricular fibrillation (VF) window. Arrhythmic events were collected by remote monitoring and reviewed by a committee of experts. Results Six hundred and twenty one patients were identified (61.1±11.4 years, 87.3% male). Distribution of study groups was as follow: 101 patients in NYHA I; 411 in NYHA II; and 109 in NYHA III. More symptomatic patients were older and had higher prevalence of atrial fibrillation (AF) and chronic kidney disease (CKD). Higher rates of optimal medical treatment were present among study groups (beta-blockers: 92.1%; ACEI or ARB: 86.8%; aldosterone antagonists: 60.2%). After a median follow-up of 4.2 years (IQR, 2.7–5.7 years) 126 patients died (event rate: 20.3%). All-cause mortality was higher in patients with worse FC (13.9% vs. 18.3% vs. 32.9% for NYHA I, II and III respectively; p<0.001, log-rank test). Seventy-eight out of 126 deaths were related to cardiovascular causes (overall event rate: 12.6%). Cardiovascular mortality risk was also higher in more symptomatic patients (6.9% vs. 11% vs. 23.9% for NYHA I, II and III respectively; p<0.001, log-rank test). One hundred and seventeen patients received afirst appropriate ICD therapy (19.4%). Arrhythmia free survival was not different among study groups (20.8% vs. 18.7% vs. 20.8% for NYHA I, II and III, respectively; p=0.495, log-rank test). Cumulative incidence curves for the three outcomes are shown in Figure 1. After multivariate analysis, worse NYHA class independently predicted cardiovascular mortality but not all-cause death. Moreover, diabetes, AF and CKD strongly predicted both all-cause and cardiovascular mortality. Figure 1 Conclusions In HF patients, prophylactic ICD seems to be useful in preventing death due to life threatening arrhythmias, regardless of the baseline FC. Nevertheless, the combination of NYHA class with other comorbidities may be useful to select those ICD candidates who obtain less survival benefit.

POSTER PRESENTATIONS

Cardiac resynchronization therapy (CRT): Clinical trials, guidelines, and target populations

Disorders of the cardiac muscle or cardiomyopathies are a broad, yet collectively common, group of conditions. Despite the heterogeneous etiologies, mode of death from these conditions is remarkably similar - progressive decline in cardiac function leading to intractable heart failure (HF) and sustained ventricular arrhythmias resulting in sudden cardiac death (SCD). Nearly 50% of patients die within 5 years of a HF diagnosis.1 Indeed, in the United States, HF alone is thought to cause 55,000 deaths per year2 and further contribute to 1 in 9 deaths overall.1 However, while advanced HF and the risk of SCD were once thought to be untreatable, technological advances has seen the emergence of device therapies as viable treatment options. Specifically, implantable cardioverter-defibrillator (ICD) therapy for treatment of ventricular arrhythmias, cardiac resynchronization therapy (CRT) for restoring cardiac synchrony and mechanical efficiency, and ventricular assist device (VAD) therapy to temporarily or permanently replace the function of the failing heart, have all emerged as highly efficacious therapies. The expanding use of device therapies, however, poses many challenges. First, while the indications for these devices are well summarized in clinical guidelines,3,4 considerable hurdles remain in ensuring eligible patients receive these therapies.5 By the same token, establishing the safety and effectiveness of these therapies in populations that are found in clinical practice, yet commonly excluded from trials, such as the elderly6 and uncommon forms of cardiomyopathies,7 is a high priority. Second, rapid dissemination of technologies frequently results in disparities in care. Indeed, age, gender, and racial disparities, in both receipt of these devices and outcomes following implantation, have been well documented. Whether these disparities have persisted, and the potential causative mechanisms underlying these disparities, however, are uncertain.8,9 Third, these devices are not without significant untoward effects; understanding …

Randomized controlled trials demonstrate that remote monitoring (RM) of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds) may improve quality of care and prognosis in heart failure (HF) patients. However, the impact of RM on long-term mortality in a real-world cohort is still not well examined. This study was designed as a matched cohort study based on the COMMIT-HF trial--a single-center, ongoing prospective observational registry (NCT02536443). Complete patient demographics, medical history, in-hospital results, hospitalizations, and mortality data were collected based on institutional registries and healthcare providers' records. Patients were divided into 2 groups based on RM presence and matched by means of propensity scores according to clinical characteristics. The primary endpoint of this study was the long-term all-cause mortality. Out of 1,429 consecutive patients, 822 patients with a first implantation of an ICD/CRT-D were included in the analysis. The final matched study population contained 574 patients in RM and in a control group. Although demographic and echocardiographic parameters as well as pharmacological treatments were similar in both groups, a significantly lower 1-year mortality was detected in the RM group (2.1% vs. 11.5%, P < 0.0001). This was also maintained during a 3-year follow-up (4.9% vs. 22.3%, P < 0.0001). Multivariate analysis showed that RM was associated with an improved prognosis (hazard ratio 0.187, 95% confidence interval 0.075-0.467, P = 0.0003). RM of HF patients with ICDs/CRT-Ds significantly reduced long-term mortality in a real-world clinical condition.

Funding AcknowledgementsType of funding sources: Private hospital(s). Main funding source(s): Mayo ClinicBackground/IntroductionSyncope is a common presentation in heart failure (HF) patients. However, the associations between syncope and prognosis in HF patients with the cardiac implantable electronic device (CIED) have not been demonstrated. It is unclear whether syncope increases all-cause mortality in HF patients with CIED.PurposeWe aimed to examine the association between syncope and all-cause mortality in the largest cohort of HF with reduced ejection fraction (HFrEF), mid-ranged ejection fraction (HFmEF), and preserved ejection fraction (HFpEF) patients with and without CIED.MethodsA retrospective cohort of patients with HF and syncope at our hospital between 2010 and 2015 were identified, and 1:1 propensity was matched with a control group of HF patients without syncope. A chart review was conducted. The multivariate Cox regression model was applied to estimate the association between syncope and the all-cause mortality endpoint.Results3,449 HF patients were diagnosed with syncope (mean age, 72.8±14.5 years; 41.5% women), and the propensity-matched control HF patients without syncope (n=3,449) aged 72.8±14.3 years, and 42.5% women were selected. Cardiac implantable electronic devices were implanted more in HF patients with syncope (32.5% versus 13.7%, p<0.001). Implantable cardioverter defibrillators were implanted more in HF patients with syncope (15.6% versus 8.3%, p<0.001) as well as pacemakers (16.9% versus 7.5%, p<0.001) and cardiac resynchronization therapy devices (6.9% versus 4.8%, p=0.015). Among HF patients with CIED, syncope significantly increased the risk of all-cause mortality in HFrEF patients (hazard ratio [HR]=1.479, 95% confidence interval [CI]: 1.197-1.828, p<0.001) but not in HFpEF (HR=0.980, 95%CI: 0.793-1.210, p=0.849)(Figure 1). Syncope also tended to increase the risk of all-cause mortality in HFmEF patients with CIED but was not significant (HR=1.193, 95%CI: 0.762-1.865, p=0.762)(Figure 1). Among HF patients without CIED, syncope did not increase the risk of all-cause mortality in HFrEF (HR=0.923, 95%CI: 0.806-1.057, p=0.247), HFmEF (HR=1.074, 95%CI: 0.848-1.360, p=0.554), or HFpEF (HR=0.964, 95%CI: 0.883-1.052, p=0.406).ConclusionsSyncope significantly increased the risk of all-cause mortality in HFrEF patients but not in HFmEF or HFpEF patients with CIED. The association of syncope and increased mortality in HFrEF patients with CIED suggests that syncope may be a marker and a factor of mortality and warrants further investigation.