None listed
Conditions
Brief summary
The primary purpose of this study is to assess the burden of AF episodes in patients with a cardiac device in situ, and the relationship between AF episode duration and rates of anticoagulation for stroke prevention. AF is associated with a significant risk of ischaemic stroke. Cardiac device-detected AF has now been correlated with elevated stroke risk regardless of the presence or absence of clinical AF symptoms. Anticoagulation reduces both stroke risk and mortality in AF patients. The CHA2DS2-VASc scoring system correlates risk factors to predict the annual stroke risk in AF patients, and guidelines recommend commencing anticoagulation in non-valvular AF patients with a score of at least 2. Over the past decade, remote monitoring (RM) has evolved as a tool in the management of cardiac implantable electronic devices, and is now a standard component in device follow-up. RM provides physician access to patient/device information in between clinic visits, in the form of both routine transmissions, which act as a surrogate for an in-person device check; and alerts, which may indicate a patient event, programming concern, or device malfunction. RM alerts facilitate early detection of device-detected arrhythmias, including AF, compared with in-clinic follow-up alone. In the absence of RM, AF would be detected only in the event of a routine follow-up, or an unscheduled encountered pertaining to AF symptoms, heart failure, or an embolic event such as a stroke. Early recognition of device-detected AF via RM presents an opportunity to implement anticoagulation, as well as a rhythm or rate control strategy, in both the asymptomatic patient, and the symptomatic patient who has not yet sought medical attention. Institution of such therapies likely has implications for the associated risks of stroke and heart failure in AF patients. Using a large clinical cohort of patients undergoing RM via an automated system (Pacemate), we aim to characterize the burden of AF alerts in a cardiac device population undergoing remote monitoring. Specifically, we aim to determine the impact of AF alerts on rates of anticoagulation, in accordance with CHA2DS2-VASc scoring.
Interventions
We aim to assess the burden of atrial fibrillation (AF) episodes in patients with a cardiac implantable electronic device in situ, including permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs). Further, we aim to correlate the duration of AF episodes with rates of anticoagulation (for the purpose of stroke prevention) in patients deemed to be at significant risk of ischaemic stroke in the setting of AF.
All patients with a PPM, ICD,
We aim to assess the burden of atrial fibrillation (AF) episodes in patients with a cardiac implantable electronic device in situ, including permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs). Further, we aim to correlate the duration of AF episodes with rates of anticoagulation (for the purpose of stroke prevention) in patients deemed to be at significant risk of ischaemic stroke in the setting of AF. All patients with a PPM, ICD, or ILR in situ who were connected to the PaceMate remote monitoring service, and transmitted at least one AF episode during the 12-month study period, will be included. Data from these patients is automatically collected routinely as part of the PaceMate remote monitoring database. The data will be sourced from the PaceMate patient registry database into a spreadsheet. Patient demographics collected will be age, device type, and anticoagulation status (Yes or No) at the close of the 12-month remote-monitoring period. All AF episodes transmitted during the 12-month study period will be analysed. All AF episodes will be classified according to duration. Episodes occurring within a 24-hour period will be pooled to create a total duration of AF within a 24-hour period. Pooled episodes will then re-classified into one of four pre-specified AF duration windows: (1) less than 6 minutes during a 24-hour period, (2) between 6 minutes and 5 hours 59 minutes during a 24-hour period, (3) between 6 hours and 23 hours 59 minutes during a 24-hour period, or (4) over 24 hours. Patients will then be categorised into one of the four AF duration categories, according to the longest duration of all their episodes. Anticoagulation rates in each AF duration category will be calculated. Patients who are deemed to be at significant risk of stroke in the setting of AF will then be identified. These patients will be those aged 75 years or older, and those aged 65 to 74 years with a cardiac device in situ suggestive of left ventricular dysfunction (an ICD or cardiac resynchronisation device). Anticoagulation rates in these patient subgroups will be calculated within each of the AF episode duration category.
Sponsors
The University of Adelaide
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with a cardiac implantable electronic device (PPM, ICD, or ILR), who were undergoing remote monitoring via the PaceMate remote monitoring service, from November 2018 until November 2019, who transmitted at least one AF episode during the monitoring period.
Exclusion criteria
None
Outcome results
None listed