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Background: Device follow-up is mandatory in the care of patients with a pacemaker. However, in most cases, device checks appear to be mere technical, time-consuming procedures. The aim of this research is to evaluate whether remote follow-up can replace in-clinic device checks by assessing clinical outcomes for pacemaker patients followed only via remote follow-up., Methods and Results: Consecutive pacemaker patients followed with remote monitoring were prospectively included by 6 Italian cardiology centers in an observational investigation. The workflow for remote monitoring included an initial assessment by nursing staff and, when necessary, by a responsible physician for medical decisions. No in-person visits were scheduled after the start of remote monitoring. One-thousand and two-hundred and fifty one patients (30% female, 75±11years old) were followed for a median observation period of 15months. Out of 4965 remote transmissions, 1882 (38%) had at least one clinically relevant event to be investigated further, but, only after 137 transmissions (2.8%), the patients were contacted for an in-clinic visit or hospitalization. Sixty-nine patients died and 124 were hospitalized for various reasons. Atrial fibrillation episodes were the most common clinical events discovered by remote transmissions, occurring in 1339 (26%) transmissions and 471 (38%) patients., Conclusions: Our experience shows that remote monitoring in a pacemaker population can safely replace in-clinic follow-up, avoiding unnecessary in-hospital device follow-up., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Background: Remote Monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended in management of Atrial Fibrillation (AF), which is a recognized risk factor for thromboembolism. We tried to elucidate whether stroke incidence observed in a large, remotely monitored population was consistent with the CHA2DS2VASc risk profile., Methods: Data from 1650 patients [76% male, age 72 (63-68), CHA2DS2VASc score 3.0 (2.0-4.0)] enrolled during the HomeGuide study and monitored with a daily-transmission RM system providing automatic alerts for AF, were analysed. Of those, 25% had a pacemaker and 75% an implantable cardioverter defibrillator with or without cardiac resynchronization. Estimations of the expected thromboembolic events were based on the population CHA2DS2VASc score profile used in a computer-simulated Markov model., Results: Eight thromboembolic events were observed with a 4-year cumulative stroke rate of 0.8% (confidence interval, 0.4%-1.5%). Simulations returned from 18.7 to 17.1 expected events, depending on the AF duration assumed to trigger anticoagulation (one-sample log-rank p<0.03). During the study period, 681 (84%) AF episodes and 129 (16%) atrial tachycardias were detected in 291 patients (18%): 93% of episodes were detected remotely in 269 patients, 66% of whom had no history of AF. Medical interventions were necessary in 305 episodes, 85% of which were detected remotely. Reaction time was 1 (0-6) days for remotely-detected episodes and 33 (14-121) days for episodes detected in clinic (p<0.0001)., Conclusions: In a large CIED population followed remotely for up to 4years, the incidence of thromboembolic events was less than half the estimations based on the CHA2DS2VASc risk profile., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: Several trials demonstrated the life saving role of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD). The aim was to evaluate the clinical characteristics and 4-year outcome of consecutive patients treated in clinical practice by prophylactic ICD implantation on the basis of class I recommendations and up-to-date ICD programming., Methods and Results: IRIDE multi-center, prospective and observational study enrolled 604 consecutive patients (mean age: 66 ± 10 years) treated by ICD between 01/01/2006 and 30/06/2010. Main characteristics were similarly distributed among the inclusion criteria of MADIT II (24%), SCD-HeFT (24%), COMPANION (26%) and MADIT-CRT (18%) trials, while a small number of patients met the MUSTT and MADIT (7%) inclusion criteria. Single-chamber ICDs were implanted in 168 (28%) patients, dual-chamber in 167 (28%) and biventricular in 269 (43%) patients. ATP programming was activated in 546 (90%) patients. Overall survival and rate of appropriate ICD intervention by ATP and/or shock at 12-24-36-48 months of follow-up were 94%, 89%, 80%, 75% and 16%, 28%, 37% and 50%, respectively. No difference in mortality rate between the groups who received or did not receive appropriate ICD interventions was demonstrated (p=ns)., Conclusions: The IRIDE study confirms the effectiveness in real world practice of ICD implantation in patients at risk of SCD. The life saving role of ICD therapy increases as the duration of follow-up is prolonged and the survival benefit is similar in patients who received or did not receive appropriate device treatment, thus suggesting a beneficial effect of up-to-date device programming., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)