Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study

Waks, Jonathan W.; Passman, Rod; Matos, Jason; Reynolds, Matthew W.; Thosani, Amit J.; Mela, Theofanie; Pederson, David N.; Glotzer, Taya V.; Zimetbaum, Peter

doi:10.1016/j.hrthm.2018.06.027

Cited by 45 publications

(37 citation statements)

References 21 publications

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“…Pilot studies involving daily review of arrhythmia burden to inform the use of anticoagulation management have demonstrated potential clinical benefits from more frequent data review than would be typically performed in routine care. 33,34 Similar studies have used intensive review of remote monitoring data in heart failure patients to improve clinical outcomes. 35 A key barrier to widespread implementation, however, is the need for clinician review of device data.…”

Section: Ethical Considerations For Patient Access To Datamentioning

confidence: 99%

Ethical and Legal Implications of Remote Monitoring of Medical Devices

Cohen

Gerke

Kramer³

2020

Milbank Quarterly

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r Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. r Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. r Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Context: Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. Methods: Using pacemakers and implantable cardioverter-defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and

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Section: Ethical Considerations For Patient Access To Datamentioning

confidence: 99%

Ethical and Legal Implications of Remote Monitoring of Medical Devices

Cohen

Gerke

Kramer³

2020

Milbank Quarterly

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“…The IMPACT trial was prematurely stopped for futility, the strategy of early initiation and interruption of anticoagulation based on remotely detected AT did neither prevent thromboembolism events nor bleeding 33 . The TACTIC trial 34 tested intermittent anticoagulation in patients with continuous AF burden monitoring in low to moderate risk patients with rare episodes of AF. Pacemaker (PM)/Implantable cardioverter-defibrillator (ICD)-guided DOAC administration has been shown to be feasible and reduced the use of anticoagulation therapy by 75%.…”

Section: What Is the Stroke Risk?mentioning

confidence: 99%

Subclinical atrial fibrillation - what is the risk of stroke?

Plášek¹,

Táborský²

2019

BIOMED PAP

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Atrial fibrillation is the most common arrhythmia and as such, it has become a significant public health issue due to its impact on patient morbidity and mortality. The prevalence of atrial fibrillation (AF) almost doubled in the last decade, being currently 2% in unselected patient populations. Its occurrence varies with age (present in almost 20% of octogenarians) and concomitant diseases. The most prevalent concomitant diseases are hypertension, diabetes, heart failure, renal failure, and cognitive decline. Cognitive decline or stroke may be actually the first manifestation of undiagnosed atrial fibrillation. In the majority of cases, atrial fibrillation is more of a syndrome than a disease in itself, with a multitude of etiologic factors and mechanisms. The risk of cardioembolic stroke increases with the number of comorbidities and age. The overall age-adjusted risk of stroke in patients with atrial fibrillation is 5 times higher than in the general population. Nowadays, the detection of asymptomatic episodes of atrial fibrillation by cardiac electronic implantable devices (CIED), referred to as device detected or subclinical atrial fibrillation, has opened new frontiers in AF management. The risk of stroke and subsequent need for anticoagulation treatment in this group of patients with device detected AF is however not clear. Here, we will review the literature to determine the association of subclinical atrial fibrillation with the risk of stroke.

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“…One such method could be intermittent OAC use associated with a prompt diagnosis. The TACTIC-AF study 9 presented during the late breaking clinical trials introduced listeners to the concept of ''tailored anticoagulation,'' which takes advantage of the rapid onset of non-vitamin-K oral anticoagulants (NOACs). This was a prospective, randomized controlled trial in patients with implanted CIEDs with a primary endpoint of days on OAC therapy.…”

Section: Timing Of Anticoagulant Therapy For Afmentioning

confidence: 99%

Highlights from Heart Rhythm Society 2017: Atrial Fibrillation

Doshi¹

2017

J Innov Cardiac Rhythm Manage

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Intermittent anticoagulation guided by continuous atrial fibrillation burden monitoring using dual-chamber pacemakers and implantable cardioverter-defibrillators: Results from the Tailored Anticoagulation for Non-Continuous Atrial Fibrillation (TACTIC-AF) pilot study

Cited by 45 publications

References 21 publications

Ethical and Legal Implications of Remote Monitoring of Medical Devices

Ethical and Legal Implications of Remote Monitoring of Medical Devices

Subclinical atrial fibrillation - what is the risk of stroke?

Highlights from Heart Rhythm Society 2017: Atrial Fibrillation

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