Clinical validation of a low-power and wearable ECG patch for long term full-disclosure monitoring.

BACKGROUND Detection of intermittent atrial fibrillation (AF) is done using a 24-h Holter. Holter recordings are powerful but lack the comfort and have limited recording times resulting in under diagnosing of intermittent AF. OBJECTIVE Within this work we evaluated and compared a novel miniaturized three-channel ECG monitoring patch versus a 24-h Holter system. METHODS Both patients with a chronic AF rhythm (n=5) as well as patients with an AF rhythm that underwent electrical reconversion (n = 5) were equipped with both a 24-h Holter and ECG patch. RESULTS Alignment of raw data of both ECG systems allowed cross-correlation analysis. Overall good correlations of up to 85% were obtained. RR-interval analysis of both systems resulted in very high correlations of 99% and higher. AF analysis showed correct identification of AF on both ECG systems. CONCLUSIONS The performance of our ECG patch matches that of the 24-h Holter and could provide a suitable tool for long-term monitoring applications.

[1]  A. Skanes,et al.  The Utility of Holter Monitoring Compared to Loop Recorders in the Evaluation of Syncope and Presyncope , 2000 .

[2]  Matthew Reynolds,et al.  Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. , 2006, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[3]  E. Topol,et al.  Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. , 2014, The American journal of medicine.

[4]  R. Wachter,et al.  Letter by Wachter et al regarding article, "occult atrial fibrillation in cryptogenic stroke: detection by 7-day electrocardiogram versus implantable cardiac monitors". , 2013, Stroke.

[5]  A. Skanes,et al.  A prospective randomized comparison of loop recorders versus Holter monitors in patients with syncope or presyncope. , 2003, The American journal of medicine.

[6]  Michael M Laks,et al.  New devices for very long-term ECG monitoring. , 2012, Cardiology journal.

[7]  M. Turakhia,et al.  Diagnostic utility of a novel leadless arrhythmia monitoring device. , 2013, The American journal of cardiology.

[8]  Ary Goldberger,et al.  Diagnostic Yield and Optimal Duration of Continuous-Loop Event Monitoring for the Diagnosis of Palpitations: A Cost-Effectiveness Analysis , 1998, Annals of Internal Medicine.

[9]  A. Waldo,et al.  The Diagnosis of Cardiac Arrhythmias: A Prospective Multi-Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event Monitoring , 2008 .

[10]  T. Gibson,et al.  Diagnostic efficacy of 24-hour electrocardiographic monitoring for syncope. , 1984, The American journal of cardiology.

[11]  Rahul Mehra,et al.  Comparison of continuous versus intermittent monitoring of atrial arrhythmias. , 2006, Heart rhythm.

[12]  Mark Josephson,et al.  The Evolving Role of Ambulatory Arrhythmia Monitoring in General Clinical Practice , 1999, Annals of Internal Medicine.

[13]  B. Hanusa,et al.  The duration of Holter monitoring in patients with syncope. Is 24 hours enough? , 1990, Archives of internal medicine.

[14]  S Suave Lobodzinski,et al.  ECG patch monitors for assessment of cardiac rhythm abnormalities. , 2013, Progress in cardiovascular diseases.

[15]  Amanda Neil,et al.  Cardiac Event Recorders Yield More Diagnoses and Are More Cost-effective than 48-Hour Holter Monitoring in Patients with Palpitations: A Controlled Clinical Trial , 1996, Annals of Internal Medicine.

[16]  E. Prystowsky,et al.  Utility of Mobile Cardiac Outpatient Telemetry for the Diagnosis of Palpitations, Presyncope, Syncope, and the Assessment of Therapy Efficacy , 2007, Journal of cardiovascular electrophysiology.

[17]  B. Hanusa,et al.  The duration of Holter monitoring in patients with syncope. Is 24 hours enough , 1990 .

[18]  Michael A Rosenberg,et al.  Use of a Noninvasive Continuous Monitoring Device in the Management of Atrial Fibrillation: A Pilot Study , 2012, Pacing and clinical electrophysiology : PACE.

[19]  I. Romero,et al.  Comparative study of algorithms for Atrial Fibrillation detection , 2011, 2011 Computing in Cardiology.

[20]  T. Torfs,et al.  Wireless 3-lead ECG system with on-board digital signal processing for ambulatory monitoring , 2012, 2012 IEEE Biomedical Circuits and Systems Conference (BioCAS).

[21]  Jonathan H Seltzer,et al.  The Diagnosis of Cardiac Arrhythmias: A Prospective Multi‐Center Randomized Study Comparing Mobile Cardiac Outpatient Telemetry Versus Standard Loop Event Monitoring , 2007, Journal of cardiovascular electrophysiology.