Implantable defibrillator-detected heart failure status predicts ventricular tachyarrhythmias.

INTRODUCTION: The prediction of ventricular tachyarrhythmias among patients with implantable cardioverter defibrillators is difficult with available clinical tools. We sought to assess whether in patients with heart failure (HF) and reduced ejection fraction with defibrillators, physiological sensor-based HF status, as summarized by the HeartLogic index, could predict appropriate device therapies. METHODS: Five hundred and sixty-eight consecutive HF patients with defibrillators (n = 158, 28%) or cardiac resynchronization therapy-defibrillators (n = 410, 72%) were included in this prospective observational multicenter analysis. The association of both HeartLogic index and its physiological components with defibrillator shocks and overall appropriate therapies was assessed in regression and time-dependent Cox models. RESULTS: Over a follow-up of 25 (15-35) months, 122 (21%) patients received an appropriate device therapy (shock, n = 74, 13%), while the HeartLogic index crossed the threshold value (alert, HeartLogic ≥ 16) 1200 times (0.71 alerts/patient-year) in 370 (65%) subjects. The occurrence of ≥1 HeartLogic alert was significantly associated with both appropriate shocks (Hazard ratios [HR]: 2.44, 95% confidence interval [CI]: 1.49-3.97, p = .003), and any appropriate defibrillator therapies. In multivariable time-dependent Cox models, weekly IN-alert state was the strongest predictor of appropriate defibrillator shocks (HR: 2.94, 95% CI: 1.73-5.01, p < .001) and overall therapies. Compared with stable patients, patients with appropriate shocks had significantly higher values of HeartLogic index, third heart sound amplitude, and resting heart rate 30-60 days before device therapy. CONCLUSION: The HeartLogic index is an independent dynamic predictor of appropriate defibrillator therapies. The combined index and its individual physiological components change before the arrhythmic event occurs.

Incidental and anticipated arrhythmic diagnoses in patients with an implantable cardiac monitor.

AIMS: In this study, we investigated a cohort of unselected patients with various indications for an implantable cardiac monitor (ICM). Our main objectives were to determine the incidence of arrhythmic diagnoses, both anticipated and incidental in relation to the ICM indication, and to assess their clinical relevance. METHODS: We examined remote monitoring transmissions from patients with an ICM at four Italian sites to identify occurrences of cardiac arrhythmias. Concurrently, we collected data on medical actions taken in response to arrhythmic findings. RESULTS: The study included 119 patients, with a median follow-up period of 371 days. ICM indications were syncope/presyncope (46.2%), atrial fibrillation management (31.1%), and cryptogenic stroke (22.7%). In the atrial fibrillation management group, atrial fibrillation was the most common finding, with an incidence of 36% [95% confidence interval (CI) 22-55%] at 18 months. Rates of atrial fibrillation were not significantly different between patients with cryptogenic stroke and syncope/presyncope [17% (95% CI 7-40%) vs. 8% (95% CI 3-19%), P  = 0.229].For patients with cryptogenic stroke, the incidence of asystole and bradyarrhythmias at 18 months was 23% (95% CI 11-45%) and 42% (95% CI 24-65%), respectively, similar to estimates obtained for patients implanted for syncope/presyncope ( P  = 0.277 vs. P  = 0.836).Overall, 30 patients (25.2%) required medical intervention following ICM-detected arrhythmias, predominantly involving atrial fibrillation ablation (10.9%) and medication therapy changes (10.1%). CONCLUSION: In a real-life population with heterogeneous insertion indications, approximately 25% of patients received ICM-guided medical interventions within a short timeframe, including treatments for incidental findings. Common incidental arrhythmic diagnoses were bradyarrhythmias in patients with cryptogenic stroke and atrial fibrillation in patients with unexplained syncope.

Daily and automatic remote monitoring of implantable cardiac monitors: A descriptive analysis of transmitted episodes.

BACKGROUND: Remote Monitoring (RM) is recognized for its ability to enhance the clinical management of patients with implantable cardiac monitor (ICM). This study aims to provide a comprehensive description of the arrhythmic episodes transmitted by a daily and automatic RM system from a cohort of ICM patients. METHODS: The study retrospectively analyzed daily transmissions from consecutive patients who had been implanted with a long-sensing vector ICM (BIOMONITOR III/IIIm) at four sites. All transmitted arrhythmic recordings were evaluated to determine whether they were true positive episodes or false positives (FP). RESULTS: A total of 14,136 episodes were transmitted from 119 patients (74.8% male, median age 62 years old) during a median follow-up of 371 days. The rate of arrhythmic episodes was 14.2 per patient-year (interquartile range: 1.8-126), with 97 patients (81.5%) experiencing at least one ICM activation. Fifty-five percent of episodes were identified as FP, and 67 patients (56.3%) had at least one inappropriate activation. The FP rate was 1.4 per patient-year (0-40). The best per-episode predictive positive values were observed for bradycardia and atrial fibrillation (0.595 and 0.553, respectively). Notably, the implementation of an algorithm designed to minimize false detections significantly reduced the prevalence of atrial fibrillation FP episodes (17.6% vs. 43.5%, p = 0.008). CONCLUSION: Daily and automatic RM appears to be a reliable tool for the comprehensive remote management of ICM patients. However, the number of arrhythmic episodes requiring review is high, and further improvements are needed to reduce FP and facilitate accurate interpretation of transmissions.

[Chronic kidney disease prevalence and trends (1998-2008) in an area of southern Italy. The data of the VIP project]. / Prevalenza e trend (1998-2008) dell'insufficienza renale cronica in un'area dell'Italia meridionale: i dati del progetto VIP.

Chronic kidney disease (CKD) is a common disorder whose prevalence is increasing worldwide. In Italy the prevalence of CKD, especially the early stages, is still not exactly known. Our study examines the prevalence and trends in ten years (1200 subjects in 1998-1999 and 1200 subjects in 2008-2009) of the estimated glomerular filtration rate (eGFR) in a population of southern Italy. We analyzed, within the VIP project, the prevalence of CKD (eGFR <60) in our area and its relationship to diabetes and hypertension as well as the trend between the years 1998-1999 and 2008-2009. The estimate of the GFR was obtained with the Cockcroft-Gault formula corrected for body surface area. The prevalence of CKD, stratified by the population of Campania, was about 5.9% in males and 3.9% in females in the years 1998-1999; ten years later (2008-2009) it had increased to 6.2% in males and 4.5% in females. The differences between males and females and between the two decades are not statistically significant although the trend shows a clear increase in subjects affected by CKD among both sexes. Among the male population the prevalence of CKD in persons with hypertension or diabetes, in those with both diseases, and in those free from these diseases was 11.2%, 12%, 13.8% and 6.3% (p=0.018), respectively. The same groups among females showed a CKD prevalence of 8%, 9.2%, 9.7% and 4.4%, respectively (p=0.042). Our work provides a picture of the prevalence of CKD in an area of southern Italy. It highlights the increase in CKD and calls upon a greater use of renal function tests in clinical practice, so that individuals at increased risk of developing cardiovascular complications may be detected as early as possible.

Decongestive treatment adjustments in heart failure patients remotely monitored with a multiparametric implantable defibrillators algorithm.

AIMS: HeartLogic algorithm combines data from multiple implantable defibrillators (ICD)-based sensors to predict impending heart failure (HF) decompensation. A treatment protocol to manage algorithm alerts is not yet known, although decongestive treatment adjustments are the most frequent alert-triggered actions reported in clinical practice. We describe the implementation of HeartLogic for remote monitoring of HF patients, and we evaluate the approach to diuretic dosing and timing of the intervention in patients with device alerts. METHODS: The algorithm was activated in 229 ICD patients at eight centers. The median follow-up was 17 months (25th-75th percentile: 11-24). Remote data reviews and patient phone contacts were undertaken at the time of HeartLogic alerts, to assess the patient's status and to prevent HF worsening. We analyzed alert-triggered augmented HF treatments, consisting of isolated increases in diuretics dosage. RESULTS: We reported 242 alerts (0.8 alerts/patient-year) in 123 patients, 137 (56%) alerts triggered clinical actions to treat HF. The HeartLogic index decreased after the 56 actions consisting of diuretics increase. Specifically, alerts resolved more quickly when the increases in dosing of diuretics were early rather than late: 28 days versus 62 days, p < .001. The need of hospitalization for further treatments to resolve the alert condition was associated with higher HeartLogic index values on the day of the diuretics increase (odds ratio: 1.11, 95% CI: 1.02-1.20, p = .013) and with late interventions (odds ratio: 5.11, 95% CI: 1.09-24.48, p = .041). No complications were reported after drug adjustments. CONCLUSIONS: Decongestive treatment adjustments triggered by alerts seem safe and effective. The early use of decongestive treatment and the use of high doses of diuretics seem to be associated with more favorable outcomes.