Rationale and Design of a Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics: the TRENDS Study

Overview

Journal J Interv Card Electrophysiol

Publisher Springer

Date 2006 May 9

PMID 16680544

Citations 9

Authors

Taya V Glotzer

Emile G Daoud

D George Wyse

Daniel E Singer

Reece Holbrook

Khadeeja Pruett

Kenneth Smith

Christopher E Hilker

Affiliations

Soon will be listed here.

Abstract

Background: Sustained atrial fibrillation (AF) is a common risk factor for stroke. While intermittent AF also appears to pose a substantial stroke risk, the quantitative relationship between the percentage of time spent in AF and stroke risk is poorly specified and "intermittent" AF is not the same as paroxysmal AF. Improved assessment of the impact of AF burden on stroke risk will allow more targeted and safer use of antithrombotic therapy.

Methods And Results: The primary objective of this study is to determine if AT/AF (all device detected atrial tachyarrhythmias, including atrial flutter, atrial fibrillation, and atrial tachycardia) burden over a 30 day period is an independent predictor of the occurrence of ischemic stroke, transient ischemic attack (TIA) and/or systemic embolism in subjects not receiving anticoagulation therapy. TRENDS is a prospective, post-market, non-randomized, multicenter study designed to enroll 3100 subjects who have an independent Class I/II indication for cardiac rhythm device implantation and who have demographic features suggestive of an increased risk for thromboembolic complications related to AT/AF. All implanted devices will have the ability to collect long-term AT/AF burden trending data and will be equivalently programmed to ensure consistent data collection. All subjects will be followed with device interrogations every 3 months and clinic visits every 6 months for 1 year. Subjects with a documented history of AT/AF prior to enrollment and those who develop AT/AF during the 12-month follow-up will be followed until the last subject enrolled in the study has completed their 24-month follow-up.

Conclusions: The results of the TRENDS study should help clarify the implications of data retrieved from an implantable device with regard to the risk for thromboembolic complications from atrial arrhythmias, even in the absence of symptoms.

Citing Articles

Mobile Health for Arrhythmia Diagnosis and Management.

Baman J, Mathew D, Jiang M, Passman R J Gen Intern Med. 2021; 37(1):188-197.

PMID: 34282532 PMC: 8288067. DOI: 10.1007/s11606-021-07007-w.

Subclinical and Asymptomatic Atrial Fibrillation: Current Evidence and Unsolved Questions in Clinical Practice.

Ballatore A, Matta M, Saglietto A, Desalvo P, Bocchino P, Gaita F Medicina (Kaunas). 2019; 55(8).

PMID: 31426580 PMC: 6722728. DOI: 10.3390/medicina55080497.

Association of Burden of Atrial Fibrillation With Risk of Ischemic Stroke in Adults With Paroxysmal Atrial Fibrillation: The KP-RHYTHM Study.

Go A, Reynolds K, Yang J, Gupta N, Lenane J, Sung S JAMA Cardiol. 2018; 3(7):601-608.

PMID: 29799942 PMC: 6145663. DOI: 10.1001/jamacardio.2018.1176.

Paroxysmal Atrial Fibrillation: Novel Strategies for Monitoring and Implications for Treatment in Stroke.

Silverman S Curr Treat Options Cardiovasc Med. 2016; 18(8):52.

PMID: 27325256 DOI: 10.1007/s11936-016-0475-5.

Simulation of Daily Snapshot Rhythm Monitoring to Identify Atrial Fibrillation in Continuously Monitored Patients with Stroke Risk Factors.

Yano Y, Greenland P, Lloyd-Jones D, Daoud E, Koehler J, Ziegler P PLoS One. 2016; 11(2):e0148914.

PMID: 26882334 PMC: 4755529. DOI: 10.1371/journal.pone.0148914.

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