Canadian Registry of Electronic Device Outcomes: remote monitoring outcomes in the Abbott battery performance alert—a multicentre cohort

EP Europace ◽  
2021 ◽  
Author(s):  
Sharath Kumar ◽  
Jason Davis ◽  
Bernard Thibault ◽  
Iqwal Mangat ◽  
Benoit Coutu ◽  
...  

Abstract Aims Cardiac implantable electronic devices with device advisories have the potential of device malfunction. Remote monitoring (RM) of devices has been suggested to allow the identification of abnormal device performance and permit early intervention. We sought to describe the outcomes of patients with and without RM in devices subject to the Abbott Premature Battery Depletion (PBD) advisory with data from a Canadian registry. Methods and results Patients with an Abbott device subject to the PBD advisory from nine implantable cardioverter defibrillator (ICD) implanting centres in Canada were included in the registry. The use of RM was identified from baseline and follow-up data in the registry. The primary outcome was detection of PBD and all-cause mortality. A total of 2666 patients were identified with a device subject to the advisory. In all, 1687 patients (63.2%) had RM at baseline. There were 487 deaths during follow-up. At a mean follow-up of 5.7 ± 0.7 years, mortality was higher in those without a remote monitor compared with RM at baseline (24.7% vs. 14.5%; P < 0.001). Pre-mature battery depletion was identified in 36 patients (2.1%) with RM vs. 7 (0.7%) without RM (P = 0.004). Time to battery replacement was significantly reduced in patients on RM (median 5 vs. 13 days, P = 0.001). Conclusion The use of RM in patients with ICD and cardiac resynchronization therapy under advisory improved detection of PBD, time to device replacement, and was associated with a reduction in all-cause mortality. The factors influencing the association with mortality are unknown and deserve further study.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Davis ◽  
B Thibault ◽  
I Mangat ◽  
B Coutu ◽  
M Bennett ◽  
...  

Abstract Background Cardiac implantable electronic devices have been known to have lead and device malfunctions leading to advisories. Increased use of remote monitoring of devices has been suggested to allow the identification of abnormal device performance and allow early intervention. We sought to describe the outcomes of patients with and without remote monitoring of in devices in the Abbott Premature Battery Depletion advisory with data from a Canadian registry Methods Patients with an Abbott device subject to the Battery Performance Alert Advisory from nine ICD implanting centres in Canada were included in the registry. The use of remote monitoring was identified from baseline and followup data in the registry. The primary outcome was detection of premature battery depletion and all cause mortality. Results 2679 patents were identified with a device subject to the advisory. Devices were implanted between 2010 and 2017. 1716 patients (64%) had remote monitoring at baseline with this increasing to 83.7% at followup at 12 months. Premature battery depletion occurred in 43 patients (1.6%). Discovery of premature battery depletion was detected by remote monitoring in 70% of patients. There were 492 deaths during the follow up. Mortality was higher in those without a remote monitor compared to those with a remote monitor at follow-up and remote monitor at baseline and follow-up (11.3%, 2.6% versus 6.1% respectively; p=0.0186). There were no deaths attributed to premature battery depletion Conclusion The use of remote monitoring in patients with ICD and CRT under advisory reliably detected device failure and was associated with a reduction in all-cause mortality.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
HDS Ferreira ◽  
F Ferrer ◽  
N Cabanelas ◽  
T Nelumba ◽  
AR Ferreira ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Artificial intelligence (AI) through machine learning (ML) refers to the simulation of human intelligence with the capacity for achieving goals within computers. In electrophysiology, ML has many applications in electrocardiography, intracardiac mapping and cardiac implantable electronic devices (CIEDs). Remote monitoring (RM) of patients equipped with CIEDs associates the analysis of event reports and calendar-based remote follow-ups (FU). ML applications have allowed for risk stratification, improved arrhythmia localisation and streamlined remote monitoring which may significantly reduce the workload faced by electrophysiologists. Aim To develop a system that automates cardiac implantable electronic devices remote follow-up. Methods and Results We created a Java software application, that uses the latest optical character recognition techniques combined with artificial intelligence and natural language processing to extract information from PDF reports of RM of CIEDs from different manufacturers. The current version is HIPAA (Health Insurance Portability and Accountability Act) complaint and runs on local computers only. Using the current system, we were able to run and extract data from 30 remote follow-up PDF reports of Cardiac Implantable Defibrillators (ICDs) and Cardiac Resynchronization Therapy with Defibrillator (CRT-Ds). Time taken from data extraction to conversion of all 30 device PDFs was under 5 minutes. Process and data extracted are presented in the figure below. (Figure 1) Conclusion This machine learning algorithm proved that it is possible to facilitate and automate remote follow-up of cardiac implantable electronic devices. In a near future this will allow to us to efficiently increase productivity, by speeding and facilitating interpretation of remote device follow-ups, leading to improvements in patientcare and precision cardiovascular medicine. Furthermore, in the current and future pandemics it may help prevent unnecessary in-person medical visits, avoiding additional, unnecessary strain on an already overburdened and overwhelmed healthcare system, and saving costs. Abstract Figure 1


2017 ◽  
Vol 6 (3) ◽  
pp. 109 ◽  
Author(s):  
Haran Burri ◽  

In the era of communication technology, remote monitoring has been a paradigm shift in the way patients with cardiac implantable electronic devices are managed. It has been endorsed by scientific societies and is being increasingly adopted in the clinical setting. Despite the various advantages associated with this strategy, data on improved clinical outcome are still sparse. The recently published study on the remote management of heart failure using implanted devices and formalised follow-up procedures, which turned out to be negative, has cast doubt on whether remote monitoring should still be used. This article provides a critical appraisal of the study, and discusses the issue of remote data management.


2015 ◽  
Vol 26 (1) ◽  
pp. 53-60 ◽  
Author(s):  
Massimo S. Silvetti ◽  
Fabio A. Saputo ◽  
Rosalinda Palmieri ◽  
Silvia Placidi ◽  
Lorenzo Santucci ◽  
...  

AbstractBackgroundRemote monitoring is increasingly used in the follow-up of patients with cardiac implantable electronic devices. Data on paediatric populations are still lacking. The aim of our study was to follow-up young patients both in-hospital and remotely to enhance device surveillance.MethodsThis is an observational registry collecting data on consecutive patients followed-up with the CareLink system. Inclusion criteria were a Medtronic device implanted and patient’s willingness to receive CareLink. Patients were stratified according to age and presence of congenital/structural heart defects (CHD).ResultsA total of 221 patients with a device – 200 pacemakers, 19 implantable cardioverter defibrillators, and two loop recorders – were enrolled (median age of 17 years, range 1–40); 58% of patients were younger than 18 years of age and 73% had CHD. During a follow-up of 12 months (range 4–18), 1361 transmissions (8.9% unscheduled) were reviewed by technicians. Time for review was 6±2 minutes (mean±standard deviation). Missed transmissions were 10.1%. Events were documented in 45% of transmissions, with 2.7% yellow alerts and 0.6% red alerts sent by wireless devices. No significant differences were found in transmission results according to age or presence of CHD. Physicians reviewed 6.3% of transmissions, 29 patients were contacted by phone, and 12 patients underwent unscheduled in-hospital visits. The event recognition with remote monitoring occurred 76 days (range 16–150) earlier than the next scheduled in-office follow-up.ConclusionsRemote follow-up/monitoring with the CareLink system is useful to enhance device surveillance in young patients. The majority of events were not clinically relevant, and the remaining led to timely management of problems.


2020 ◽  
Vol 16 (5) ◽  
pp. 447-456
Author(s):  
Franco Zoppo ◽  
Antonio Lupo ◽  
Giacomo Mugnai ◽  
Francesca Zerbo

Aim: The remote monitoring (RM) of cardiac implantable electronic devices (CIED) is standard of care. We describe an organizational and projection RM workload model. Methods: At the time of the analysis (2015), 3995 CIED patients were followed-up; 1582 (40.5%) with RM. All RM transmissions (Tx) have been gathered in five event types. Results: We received 10,406 Tx, classified as: 128 (1.2%) red alerts, 141 (1.3%) atrial fibrillation episodes, 1944 (18.6%) yellow alerts, 403 (3.9%) lost Tx (disconnected/noncompliant patients) and 7790 (75.0%) Tx ‘OK' (un-eventful Tx). At the time of 100% of remote CIED managed, we can expect a total of 25,990 Tx/year. Conclusion: We provide a descriptive analysis of remote monitoring management and workload estimation in a large cohort of CIED patients.


Heart Rhythm ◽  
2021 ◽  
Vol 18 (8) ◽  
pp. S98-S99
Author(s):  
Kyle Heath ◽  
Catherine O'Shea ◽  
Gijo Thomas ◽  
Curtis Harper ◽  
Kevin R. Campbell ◽  
...  

JMIR Cardio ◽  
2019 ◽  
Vol 3 (2) ◽  
pp. e9815
Author(s):  
Gabriele Giannola ◽  
Riccardo Torcivia ◽  
Riccardo Airò Farulla ◽  
Tommaso Cipolla

Background Remote management is partially replacing routine follow-up in patients implanted with cardiac implantable electronic devices (CIEDs). Although it reduces clinical staff time compared with standard in-office follow-up, a new definition of roles and responsibilities may be needed to review remote transmissions in an effective, efficient, and timely manner. Whether remote triage may be outsourced to an external remote monitoring center (ERMC) is still unclear. Objective The aim of this health care quality improvement project was to evaluate the feasibility of outsourcing remote triage to an ERMC to improve patient care and health care resource utilization. Methods Patients (N=153) with implanted CIEDs were followed up for 8 months. An ERMC composed of nurses and physicians reviewed remote transmissions daily following a specific remote monitoring (RM) protocol. A 6-month benchmarking phase where patients’ transmissions were managed directly by hospital staff was evaluated as a term of comparison. Results A total of 654 transmissions were recorded in the RM system and managed by the ERMC team within 2 working days, showing a significant time reduction compared with standard RM management (100% vs 11%, respectively, within 2 days; P<.001). A total of 84.3% (551/654) of the transmissions did not include a prioritized event and did not require escalation to the hospital clinician. High priority was assigned to 2.3% (15/654) of transmissions, which were communicated to the hospital team by email within 1 working day. Nonurgent device status events occurred in 88 cases and were communicated to the hospital within 2 working days. Of these, 11% (10/88) were followed by a hospitalization. Conclusions The outsourcing of RM management to an ERMC safely provides efficacy and efficiency gains in patients’ care compared with a standard in-hospital management. Moreover, the externalization of RM management could be a key tool for saving dedicated staff and facility time with possible positive economic impact. Trial Registration ClinicalTrials.gov NCT01007474; http://clinicaltrials.gov/ct2/show/NCT01007474


Heart Rhythm ◽  
2017 ◽  
Vol 14 (1) ◽  
pp. 50-57 ◽  
Author(s):  
Renato Pietro Ricci ◽  
Alfredo Vicentini ◽  
Antonio D’Onofrio ◽  
Antonio Sagone ◽  
Giovanni Rovaris ◽  
...  

2014 ◽  
Vol 3 (2) ◽  
pp. 123 ◽  
Author(s):  
Renato Pietro Ricci ◽  
Loredana Morichelli ◽  
Niraj Varma ◽  
◽  
◽  
...  

Follow-up of patients with cardiac implantable electronic devices is challenging due to the increasing number and technical complexity of devices coupled to increasing clinical complexity of patients. Remote monitoring (RM) offers the opportunity to optimise clinic workflow and to improve device monitoring and patient management. Several randomised clinical trials and registries have demonstrated that RM may reduce number of hospital visits, time required for patient follow-up, physician and nurse time, hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events requiring clinical reaction, such as atrial fibrillation, ventricular arrhythmias and heart failure. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. To this purpose, new organisational models have been introduced. In spite of a favourable cost:benefit ratio, RM reimbursement still represents an issue in several European countries.


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