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Subclinical Atrial Tachyarrhythmias:Implantable Devices and Remote Monitoring.

ABSTRACT: Atrial fibrillation (AF) and Atrial Tachyarrhythmias (AT) are the most common clinical arrhythmias and their worst issue is a well-recognized correlation with ischemic stroke. High incidence of "subclinical" AF/ATs has been demonstrated in several trials (TRENDS, ASSERT, CRYSTAL AF, EMBRACE) in patients with both cardiac implantable electronic devices (CIEDS) and external loop recorders. Moreover, a relationship between device-detected AF/ATs and stroke risk has been observed in the same studies. However, while the net clinical benefit of the antithrombotic treatment is well established in patients with "clinical" atrial fibrillation, there may be a lower benefit in patients with device-detected arrhythmias. Subclinical AF/ATs may be considered as a marker of stroke risk rather than the proximate cause and their burden may be used in combination with CHA2DS2-VASC and HAS-BLED scores to identify high-risk population who deserves anticoagulation. Today the remote monitoring associated with the CIEDs is effective in the early detecting of AF/ATs by avoiding delays in the therapy evaluation, as demonstrated by several trials (TRUST, CONNECT, COMPAS). However clinical evidence for stroke risk reduction by remote monitoring is still awaited; the recent trial IMPACT failed to demonstrate that the handling of the anticoagulation therapy guided by device-detected ATs and remote monitoring improves the patients' outcome. The challenges for clinicians are to deal with the huge data entry, to define new organizational models, to improve device patient management and to continuously update AF guidelines in according to the great amount of data offered by the new technology.

SUBMITTER: Maria E

PROVIDER: S-EPMC5135181 | biostudies-other | 2015 Dec

REPOSITORIES: biostudies-other

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Subclinical Atrial Tachyarrhythmias:Implantable Devices and Remote Monitoring.

Maria Elia De E Giacopelli Daniele D

Journal of atrial fibrillation 20151231 4

Atrial fibrillation (AF) and Atrial Tachyarrhythmias (AT) are the most common clinical arrhythmias and their worst issue is a well-recognized correlation with ischemic stroke. High incidence of "subclinical" AF/ATs has been demonstrated in several trials (TRENDS, ASSERT, CRYSTAL AF, EMBRACE) in patients with both cardiac implantable electronic devices (CIEDS) and external loop recorders. Moreover, a relationship between device-detected AF/ATs and stroke risk has been observed in the same studies ...[more]

PMID: 27957222

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Project description:BackgroundRemote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity.MethodsAfter a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics.ResultsA total of 186 patients (77% male) with a mean age of 66.03 (SD = 13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's α = 0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p < 0.01). The second order factor solution yielded good goodness-of-fit indexes (χ2/df = 1.44, CFI = 0.96, TLI = 0.95, RMSEA = 0.05). Satisfaction with remote monitoring was not related to HRQoL (r < 0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r = 0.263, p < 0.001).ConclusionsThe 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.

Project description:BackgroundOutcomes for patients with cardiac implantable electronic devices are better when follow-up incorporates remote monitoring technology in addition to in-clinic visits. For patients with implantable devices, we sought to determine the feasibility, safety and associated health care utilization of remote-only follow-up, along with its effects on patients' quality of life and costs.MethodsThis multicentre before-and-after pilot study involved patients with new or existing pacemakers or implantable cardioverter defibrillators. The "before" phase of the study spanned the period October 2015 to February 2017; the "after" phase spanned the period October 2016 to February 2018. The exposure was remote-only follow-up in combination with Remote View, a service that facilitates access to device data, allowing device settings to be viewed remotely to facilitate remote programming. Outcomes at 12 months were feasibility (adherence to remote monitoring), safety (rate of adverse events) and health care utilization (remote and in-clinic appointments). We also assessed quality of life, using 3 validated scales, and costs, taking into account both health care system and patient costs.ResultsA total of 176 patients were enrolled. Adherence (defined as at least 1 successful remote transmission during follow-up) was 87% over a mean follow-up of 11.7 (standard deviation 2.2) months. There was a reduction in in-clinic visits at specialized sites among patients with both implantable defibrillators (26 v. 5, p < 0.001, n = 48) and pacemakers (42 v. 10, p < 0.001, n = 51). There was no significant change in visits to community sites for patients with defibrillators (13 v. 17, p = 0.3, n = 48). The composite rate of death, stroke, cardiovascular hospitalization and device-related hospitalization was 7% (n = 164). No adverse events were linked to the intervention. There was no change in quality-of-life scales between baseline and 12 months. Health care costs were reduced by 31% for patients with defibrillators and by 44% for those with pacemakers.InterpretationThis pilot study showed the feasibility of remote-only follow-up, with no increase in adverse clinical outcomes and no effect on quality of life, but with reductions in costs and health care utilization. These results support progression to a larger-scale study of whether superior effectiveness and reduced cost can be achieved, with preservation of safety, through use of remote-only follow-up.Trial registrationClinicalTrials.gov, no. NCT02585817.

Dataset Information

Subclinical Atrial Tachyarrhythmias:Implantable Devices and Remote Monitoring.

Publications

Subclinical Atrial Tachyarrhythmias:Implantable Devices and Remote Monitoring.

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