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Cardiostat™ – Compared to a Standard ECG Holter Monitoring

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Cardiostat™ – Compared to a Standard ECG Holter Monitoring Journal of Electrocardiology 53 (2019) 57–63 Contents lists available at ScienceDirect Journal of Electrocardiology journal homepage: www.jecgonline.com Validation of a novel single lead ambulatory ECG monitor – Cardiostat™ – Compared to a standard ECG Holter monitoring Isabelle Nault ⁎,1, Philippe André 1,BenoitPlourde1,FrançoisLeclerc1, Jean-François Sarrazin 1, François Philippon 1, Gilles O'Hara 1,FranckMolin1, Christian Steinberg 1,KarineRoy1, Louis Blier 1, Jean Champagne 1 IUCPQ – Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada article info abstract Keywords: Background: Cardiostat™ is a single lead ambulatory ECG monitor. Recording is made through 2 electrodes posi- Ambulatory ECG monitoring tioned in a lead 1-like configuration. We first validated its accuracy for atrial fibrillation detection compared to a fi Atrial brillation 12-lead ECG. In the second phase of the study, arrhythmia detection accuracy was compared between Extended monitoring Cardiostat™ ambulatory ECG and a standard 24 h Holter ECG monitoring. Method/results: Phase one of the study included patients undergoing cardioversion for atrial fibrillation (AF) or atrial flutter. Cardiostat™ tracings were compared with standard 12-lead ECG. In the second phase, patients undergoing 24 h ambulatory Holter ECG monitoring for control or suspicion of atrial fibrillation (AF) were included. Simultaneous Holter monitoring and Cardiostat™ ECG recordings were per- formed. Tracings were analysed and compared. Two hundred twelve monitoring were compared. AF was diagnosed in 73 patients. Agreement between Cardiostat™ ECG and standard Holter monitoring was 99% for AF detection with kappa = 0.99. Kappa correlation for atrial flutter detection was only moderate at 0.51. AF burden was similar in both recordings. Noise hindered analysis in a greater proportion with Cardiostat™ compared to Holter ambulatory ECG (8.5 vs 3.8%). Conclusion: Cardiostat™ ambulatory ECG device showed excellent correlation with the standard Holter ECG monitoring for AF detection. Holter monitoring was however superior to discriminate premature atrial and ven- tricular beats and to qualify the morphology of PVCs since it has more vectors for analysis. Added value of Cardiostat™ includes longer monitoring duration, less cumbersome installation and water resistance. © 2019 Elsevier Inc. All rights reserved. Brief summary Introduction We investigated the performance of Cardiostat™ ambulatory ECG Ambulatory ECG monitoring is indicated to detect asymptomatic ar- patch compared to a standard 24 h ECG Holter monitoring for arrhyth- rhythmias or to establish a diagnosis in the presence of symptoms sug- mia detection. Cardiostat™ device continuously records a single ECG gestive of arrhythmia such as palpitations, dyspnea and dizziness [1,2]. lead for 48 h to 14 days. Excellent correlation was seen between both Many arrhythmias are intermittent, and some are infrequent, therefore devices for detection of atrial fibrillation. The Holter ECG monitoring longer sampling time increases the diagnostic yield of monitoring. was however superior to discriminate premature atrial from ventricular It is of utmost importance to make a timely diagnosis for many ar- beats and was more accurate to assess PVC morphology. Added value of rhythmias since treatment significantly alters the risk of associated the Cardiostat™ patch includes longer monitoring duration, less cum- morbidity, for example in atrial fibrillation (AF). AF is the most frequent bersome installation and water resistance. cardiac arrhythmia affecting 1–2% of the general population [3] and it is associated with an increased risk of stroke, which can be reduced by ad- equate treatment [3–5]. Clinical symptoms attributable to AF include ⁎ Corresponding author at: IUCPQ - Department of Cardiology, 2725 chemin Ste-Foy, dyspnea, reduced exercise tolerance, thrombo-embolic events, palpita- Quebec, Qc G1V 4G5, Canada. tions, and sometimes dizziness [6]. AF can also be silent [7], nonetheless, E-mail address: [email protected] (I. Nault). 1 This author takes responsibility for all aspects of the reliability and freedom from bias asymptomatic patients carry the same stroke risk as symptomatic pa- of the data presented and their discussed interpretation. tients [8]. Approximately 23% of ischemic strokes are related to AF [9]. https://doi.org/10.1016/j.jelectrocard.2018.12.011 0022-0736/© 2019 Elsevier Inc. All rights reserved. 58 I. Nault et al. / Journal of Electrocardiology 53 (2019) 57–63 Recent studies have shown that silent AF is often diagnosed in pa- Phase 2 tients with stroke, and longer recording periods, beyond 24 h, lead to in- creased AF detection [10–12]. However, 24 h Holter ECG monitoring, Phase 2 of the study aimed to validate the accuracy of Cardiostat™ despite its short duration, is still the most widely used technology for ar- ECG montoring in an ambulatory setting, compared to a 24 h-Holter rhythmia detection in patients with symptoms or in search for asymp- ECG monitoring (SEER Light, GE Healthcare). Cardiostat™ was installed tomatic AF in patients with cryptogenic stroke. simultaneously with a 24 h Holter monitor in patients undergoing mon- We investigated the performance of a novel device, Cardiostat™ itoring for the following indications: suspicion of AF, recent stroke, as- (Icentia, Quebec, Canada), to detect arrhythmia (Fig. 1). Cardiostat™ is sessment of rate/rhythm control in patients with documented AF or an ambulatory ECG monitor with continuous recording of a single lead monitoring after AF ablation. Cardiostat™ can monitor continuously tracing. It is less cumbersome than a regular 3 lead Holter monitoring, for up to two weeks, however for the purpose of this study, only 24 h re- it is waterproof and it has a longer recording capacity (up to 14 days). cordings were performed. Electrodes can be replaced by the patient during prolonged monitoring Inclusion criteria were age ≥18 years old and ability to give informed periods. consent. Since AF is the most frequent clinically significant arrhythmia Exclusion criteria were: refusal to consent, allergy to a device com- encountered, we included patients at risk of AF and compared AF detec- ponent, failure to obtain interpretable tracings (improper activation of tion and global arrhythmia detection with 24 h Holter versus 24 h the recording device) and for phase 1, left appendage thrombus pre- Cardiostat™ ambulatory ECG monitoring. cluding cardioversion or spontaneous return in sinus rhythm. The aim of this study was to validate the diagnostic accuracy of The standard 24 h Holter ECG monitor (SEER Light, GE Healthcare) Cardiostat™. The aim of phase 1 was to compare Cardiostat™ ECG re- had 7 electrodes linked to the monitor by cables (Fig. 1A). Electrodes cording to a standard 12 lead ECG in patients with atrial fibrillation or were positioned as recommended by the manufacturer (Fig. 1A). This flutter undergoing cardioversion, in order to test the diagnostic accu- configuration recorded a modified V5 lead on channel 1, a modified racy of Cardiostat™ for atrial arrhythmia. The aim of phase 2 was to V1 on channel 2 and a modified aVF on channel 3. compare diagnostic accuracy of Cardiostat ™ to that of a standard 24 h The Cardiostat™ (Icentia, Quebec Canada) had 2 electrodes attached Holter monitoring for arrhythmia detection in an ambulatory setting. to a microprocessor inside a rubber band. The 2 electrodes were installed each side of the sternum at the second intercostal space (Fig. 1B). This configuration recorded a modified lead 1. Methods Patients were instructed on how to use the notification button lo- cated on the Cardiostat™ if symptoms were felt during the monitoring. This is a single-center study conducted at a tertiary care cardiology They were asked how easy it was to find the event marker button and center. how confident they were of having used it properly. The protocol was reviewed and approved by the institutional Ethical When performing analysis and interpretation of the tracings, techni- review board. All subjects provided written informed consent. cians and electrophysiologists were blinded to the results of the corre- The study was divided in 2 phases. sponding test for the same patient using the other device. An electrophysiology technician screened the 24 h tracings for ar- Phase 1 rhythmic events (Holter: Mars 7.2, GE Healthcare; Cardiostat™: EART™, Icentia). The EART™ analysis software is based on a 2D color Phase 1 evaluated the accuracy of Cardiostat™ compared to a 12- coded ECG representation scheme allowing the user to visualize a lead ECG in patients with AF or atrial flutter referred for an electrical large number of QRS complexes in the tens of thousands representing cardioversion. The study included patients 18 years or older with a diag- several hours of ECG recording in one static view. The number of QRS nosis of AF or atrial flutter presenting for an elective electrical cardiover- and the ECG duration which can be displayed in a single screen view sion. Before and after the cardioversion, each patient had a 10-second vary depending on the heart rate of the recording and the screen reso- rhythm strip with Cardiostat™ and had a standard 12-lead ECG (MAC lution. All tracings with arrhythmia were submitted for validation. The 5500, GE). The four tracings obtained for each patient were then preliminary report contained all rhythm strips with arrhythmia, reviewed by 2 blinded electrophysiologists. Rhythm identification and the percentage of tracing
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