Risk stratification of cardiovascular and heart failure hospitalizations using integrated device diagnostics in patients with a cardiac resynchronization therapy defibrillator.

Aims: Cardiac resynchronization therapy defibrillators (CRT-D) are able to monitor various parameters that may be combined by an automatic algorithm to provide a heart failure risk status (HFRS). We sought to validate the HFRS for stratifying patient risk, evaluate its association with heart failure (HF) symptoms, and investigate its utility for triage of automatic alerts. Methods and results: Data from 722 patients included in the MORE-CARE trial were analysed in a post hoc analysis. A high HFRS was associated with a significantly increased risk of admission over the next 30 days with a relative risk for cardiovascular hospitalization (CVH) of 4.5 (95% CI: 3.1-6.6, P < 0.001), of HF hospitalization of 6.3 (95% CI: 3.9-10.2, P < 0.001) and of non-HF related CVH of 3.5 (95% CI: 2.0-6.9, P < 0.001). The negative predictive value of low or medium HFRS for these admissions was ≥98%. A high HFRS was associated with an increased risk of HF symptoms. Of all the automatic remote monitoring alerts generated during the study, only 10% had a high HFRS. Conclusion: The HFRS is able to risk-stratify CRT-D patients, which is potentially useful for managing automatic remote monitoring alerts, by focusing attention on the minority of high-risk patients. Clinical Trial Registration: The trial was registered at www.clinicaltrials.gov under number NCT00885677.

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring.

BACKGROUND: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. OBJECTIVE: The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. METHODS: In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. RESULTS: The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). CONCLUSIONS: RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).

Innovative solutions for disease management.

The increasing prevalence of chronic diseases is a driver for emerging big data technologies for healthcare including digital platforms for data collection, systems for active patient engagement and education, therapy specific predictive models, optimized patient pathway models. Powerful bioelectronic medicine tools for data collection, analysis and visualization allow for joint processing of large volumes of heterogeneous data, which in turn can produce new insights about patient outcomes and alternative interpretations of clinical patterns that can lead to implementation of optimized clinical decisions and clinical patient pathway by healthcare professionals.With this perspective, we identify innovative solutions for disease management and evaluate their impact on patients, payers and society, by analyzing their impact in terms of clinical outcomes (effectiveness, safety, and quality of life) and economic outcomes (cost-effectiveness, savings, and productivity).As a result, we propose a new approach based on the main pillars of innovation in the disease management area, i.e. progressive patient care models, patient-centric approaches, bioelectronics for precise medicine, and lean management that, combined with an increase in appropriate private-public-citizen-partnership, leads towards Patient-Centric Healthcare.

Detection of new atrial fibrillation in patients with cardiac implanted electronic devices and factors associated with transition to higher device-detected atrial fibrillation burden.

BACKGROUND: In patients with cardiac implanted electronic devices, detection of new atrial fibrillation (AF) is associated with an increased risk of stroke. OBJECTIVE: To characterize daily AF burden at first detection and the rate of temporal transition to higher device-detected AF burden. METHODS: A pooled analysis of data from 3 prospective projects was analyzed, and 6580 patients (mean age 68 ± 12 years, 72% male) with no history of AF and no use of anticoagulants at baseline were identified. Various thresholds of daily AF burden (5 minutes and 1, 6, 12, and 23 hours) were analyzed. RESULTS: Among the study population of 6580 patients, a new AF, with an AF burden of ≥5 minutes, was detected in 2244 patients (34%) during a follow-up period of 2.4 ± 1.7 years. Among these patients, 1091 (49.8%) transitioned to a higher AF-burden threshold during follow-up. A higher duration of daily AF burden manifest at first detection and CHADS2 score ≥2 were associated with faster transition to a subsequent higher burden. Approximately 24% of patients transitioned from a lower threshold to a daily AF burden of ≥23 hours during follow-up. CONCLUSION: More than one-third of patients with no history of AF developed device-detected AF, with attainment of different thresholds of daily AF burden over time. Continuous long-term monitoring, especially when the initial detection corresponds to a higher daily AF burden and the CHADS2 score is ≥2, could support timely clinical decisions on anticoagulation by capturing transitions to higher AF-burden thresholds.

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

AIMS: The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. METHODS AND RESULTS: The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits. CONCLUSIONS: In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. TRIAL REGISTRATION: NCT00885677.