Aims To evaluate the impact of Home Monitoring™ (HM) technology on detection and treatment of atrial fibrillation (AF). Methods and results One hundred and sixty-six patients (mean age 73 ± 10 years, 112 males) received HM devices [121 pacemakers, 22 implantable cardioverter defibrillators (ICDs), and 23 ICDs combined with cardiac resynchronization therapy]. A nurse consulted the cardioreports on the website and submitted the alerts for AF (new onset AF, persistent AF, and AF burden of >10% for >5 consecutive days) to the physician. During a mean follow-up of 488 ± 203 days, 42 patients (26%) had alerts for AF. Twenty-two patients had no history of AF before implant. In nine patients, no further action was taken. For the remaining 33 patients, an unscheduled follow-up was performed: in 16, antiarrhythmic drug therapy was introduced/modified; in 15, anticoagulation was started; in 2, antiplatelet drugs were introduced; in 7, an external cardioversion was performed; in 2 patients, the device was reprogrammed to avoid intermittent atrial undersensing during AF; and in 4 patients, no further action was taken. In four cases the arrhythmia was not confirmed (false positive). The median time to the first intervention for AF was 50 days (148 days before the scheduled follow-up). Conclusion The HM technology allowed early detection of AF in paced patients and early reaction to optimize medical treatment.

To evaluate the impact of Home Monitoring™(HM) remote control on patient medical treatment and on health-care resource utilization. One hundred and seventeen patients received HM pacemakers or defibrillators. A pacing expert nurse consulted daily the website and submitted critical cases to physician. During a mean follow-up of 227 ± 128 days, 25 210 messages were received (23 545 daily messages and 1665 alert events) resulting in 90.7% of HM supervised days. Fifty-nine minutes/week for the nurse and 12 min/week for the physician were spent for HM data analysis during 267 web-connections. The mean connection time per patient was 115 ± 60 s. The nurse submitted to the physician 133 critical cases in 56 patients. The diagnosis were atrial fibrillation (47%), ventricular tachyarrhythmias (9%), inappropriate implantable cardioverter defibrillator intervention (4%), unsustained ventricular tachycardia (7%), device suboptimal programming (23%), and impending heart failure (10%). Sixty-six unplanned follow-up in 43 patients led to drug therapy change (44%), device reprogramming (18%), diagnosis confirmation without further intervention (24%), no confirmation (6%), further diagnostic tests (9%). HM technology allowed optimization of medical treatment and device programming with low consumption of health-care resource.

The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management. The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients. Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.

Aims To evaluate patients’ acceptance and satisfaction of the Home Monitoring (HM) remote control system after 1 year of follow-up by a self-made questionnaire (HM Acceptance and Satisfaction Questionnaire, HoMASQ) specifically designed for this purpose.

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 (25th-75th percentile, 1-4) days vs 29 (25th-75th 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).

Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM. The aim of this study was to assess the costs and benefits of RM compared with standard care (SC). We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients. HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group. RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM.