AimsThe ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).Methods and resultsThe trial's primary objective was to randomly compare the proportions of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).ConclusionOur observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery.Clinical trials registrationNCT00989417.
Atrial fibrillation (AF) is the most frequent cardiac rhythm disorder and presents a considerable public health burden that is likely to increase in the next decades due to the ageing population. Current management strategies focus on the heart rate and rhythm control, thromboembolism prevention, and treatment of underlying diseases. The concept of quality of life (QoL) has gained significant importance in recent years as an outcome measure in AF studies evaluating therapeutic interventions and as a relevant component of a comprehensive treatment plan. Quality of life is impaired in the majority of patients with AF, and both rate and rhythm control strategies show significant improvement in QoL measures in highly symptomatic patients. This article reviews generic and specialized instruments for measuring QoL in the context of AF, discusses their applications and limitations to integration in clinical practice, and addresses the potential of early therapy for improving QoL outcomes. The development and validation of new QoL assessment tools will have a central role in the advancement of therapies and treatment guidelines for AF.
AimsThe Effectiveness and Cost of ICD follow-up Schedule with Telecardiology (ECOST) trial evaluated prospectively the economic impact of long-term remote monitoring (RM) of implantable cardioverter defibrillators (ICDs).Methods and resultsThe analysis included 310 patients randomly assigned to RM (active group) vs. ambulatory follow-ups (control group). Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit, while patients in the control group were seen in the ambulatory department every 6 months. The costs of each follow-up strategy were compared, using the actual billing documents issued by the French health insurance system, including costs of (i) (a) ICD-related ambulatory visits and transportation, (b) other ambulatory visits, (c) cardiovascular treatments and procedures, and (ii) hospitalizations for the management of cardiovascular events. The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study. The characteristics of the study groups were similar. Over a follow-up of 27 months, the mean non-hospital costs per patient-year were €1695 ± 1131 in the active, vs. €1952 ± 1023 in the control group (P = 0.04), a €257 difference mainly due to device management. The hospitalization costs per patient-year were €2829 ± 6382 and €3549 ± 9714 in the active and control groups, respectively (P = 0.46). Adding the ICD to the non-hospital costs, the savings were €494 (P = 0.005) or, when the monitoring system was included, €315 (P = 0.05) per patient-year.ConclusionFrom the French health insurance perspective, the remote management of ICD patients is cost saving.Clinical trials registrationNCT00989417,
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