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Aims: The number of patients with heart failure (HF) and implantable cardiac electronic devices has been growing steadily. Remote monitoring care (RC) of cardiac implantable electronic devices can facilitate patient-healthcare clinical interactions and prompt preventive activities to improve HF outcomes. However, studies that have investigated the efficacy of remote monitoring have shown mixed findings, with better results for the system including daily verification of transmission. The purpose of the RESULT study was to analyse the impact of remote monitoring on clinical outcomes in HF patients with implantable cardioverter-defibrillator [ICD/cardiac resynchronization therapy-defibrillator (CRT-D)] in real-life conditions., Methods and Results: The RESULT is a prospective, single-centre, randomized trial. Patients with HF and de novo ICD or CRT-D implantation were randomized to undergo RC vs. in-office follow-ups (SC, standard care). The primary endpoint was a composite of all-cause death and hospitalization due to cardiovascular reasons within 12 months after randomization. We randomly assigned 600 eligible patients (299 in RC vs. 301 in SC). Baseline clinical and echocardiographic characteristics were well-balanced and similar in both arms. The incidence of the primary endpoint differed significantly between RC and SC and involved 39.5% and 48.5% of patients, respectively, (P = 0.048) within the 12-month follow-up. The rate of all-cause mortality was similar between the studied groups (6% vs. 6%, P = 0.9), whereas hospitalization rate due to cardiovascular reasons was higher in SC (37.1% vs. 45.5%, P = 0.045)., Conclusion: Remote monitoring of HF patients with implanted ICD or CRT-D significantly reduced the primary endpoint rate, mostly as a result of a lower hospitalization rate in the RC arm (ClinicalTrials.gov Identifier: NCT02409225)., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225)., (© 2016 Wiley Periodicals, Inc.)

Background: Current real-life information from all-comers registries from middle and east Europe about the incidence and type of complications during long-term follow-up of patients with cardioverters-defibrillators (ICD) and cardiac resynchronization devices-defibrillators (CRT-D) is still insufficient. The aim of the study was to assess the incidence and determinants of short- and long-term complications related to implantable ICD and CRT-D., Methods: We studied 1,105 recipients hospitalized in our center in 2009-2013, followed for a mean of 2.4 years (total of 2,652 patient-years). The independent association between ICD and CRT-D recipients' and implantation-procedures' characteristics with the incidence of complications was analyzed using multivariable Cox regression analysis., Results: In 2-month post-procedural period, 124 (11.2%) patients developed complications. Independent predictors of short-term complications (within 2 months) were: atrial fibrillation, dual chamber ICD implantation, and use of antiplatelet therapy or coumarin. Twenty-seven (2.44%) patients experienced complications, mostly lead-related (n = 21). Independent predictors of long-term complications (2-12 months after implantation) were atrial fibrillation and dual chamber ICD implantation., Conclusions: Despite significant technological progress and operators' experience, the occurrence of complications in ICD and CRT-D recipients is still substantial. Majority of complications are recorded in the early post-implantation phase. Analysis of independent predictors of complications seem to be essential in helping to reduce adverse events in the future and strongly supports the need for routine follow-up.