Clinical Improvement and Prevention • 201 16th Ave. E, CWB-3 • Seattle, WA 98112 • 206-326-3938 Study Rosenberg et al, 2013. Study Population Inclusion criteria: Patients referred for Holter monitoring for the evaluation of paroxysmal AF and to document a response to therapy and potentially diagnose other arrhythmias. Treatment/ intervention All patients were ® given a Zio Patch and instructed to Study type: wear the device and Comparison of press the trigger diagnostic tests. button when they felt symptoms. They Aim: were instructed to ® To compare Zio wear the patch for as Patch with a 24long as possible with Patients hour Holter the goal of obtaining characteristics: monitor. 14 days of recording. All patients had The rhythm data Endpoints: paroxysmal AF, their were collected on the mean age was 64.5 Correlation device which was years, 54.7% males, then sent back to the between Holter ® and 93.9% were monitor and Zio manufacturer to Caucasians. 48% had analyze the data Patch for hypertension, 8% identifying AF using proprietary diabetes, 5.3% CHF, algorithm. events and and 4% CAD. 50.7% estimating AF were receiving BAll patients were also burden. blockers, 21.3% given a 24-hour calcium channel N of patients: Holter monitor to N=74 consecutive blockers, 32% were on wear simultaneously ® antiarrhythmic patients. with the Zio Patch, medication. 67.1% with the same had symptomatic AF, instructions to record Blinding: 21.3% underwent Yes, the any symptoms during previous investigators this period. Holter ® cardioversion, and reading the Zio rhythm data were Patch were blinded 10.3% prior pulmonary analyzed by an vein isolation. to the reports of independent clinical the 24-hour Holter cardiologist. monitor. Gold standard: Holter monitoring. Results •Significant arrhythmias were defined as atrial fibrillation or flutter (grouped as one category), other supraventricular tachycardias for >4 beats, sustained ventricular tachycardia >4 beats, junctional rhythm, sinus bradycardia (<50 beats/min), and complete or high grade heart block. •Mean monitoring time for Holter monitor 22.5 +1.8 hours ® •Mean monitoring time for Zio Patch 10.8 +2.8 days (range 4-14) Validity /Conclusion Advantages/ limitations: The pilot study had the advantage of ® comparing the Zio Patch to 24-hour ® •During the first 24 hours, when patients wore both the Zio Patch and Holter monitor Holter monitor. simultaneously, 25 AF episodes were recorded on both. However, it was a ® Holter monitor Zio Patch r* p small single center Mean AF burden study that included AF detected in first 24 hours 58.4 + 42.7% 54.7 + 41.2% 0.96 <0.001 patients with *Correlation symptomatic AF which Change in classification of AF based on Zio Patch findings ® does not allow Zio Patch studying the device in None Paroxysmal Persistent Total patients with silent AF. H None 32 17 0 49 O The device was L 12* Paroxysmal 0 12 0 compared to 24-hour T Holter monitor and not E 9* Persistent 0 4 5 to other longer-term R outpatient ambulatory Total 32 33 5 70 cardiac rhythm monitors. ® *Clinical classification of AF pattern changed as a result of Zio Patch in 21 patients The results of the •In patients without AF on clinic ECG or 24-hour Holter, the median time to detection was study show that the 3.7+3.0 days. 90% of first AF events were detected by day 7. ® Zio Patch was able to ® detect more AF •AF was detected with Zio Patch in 18 more patients compared to Holter (p<0.0001) ® episodes than Holter •Estimated AF burden was available for all 43 patients with detected AF with Zio Patch: monitor, and had a 28.4% comparable ability to •Estimated AF burden was available for 21/25 patients with detected AF on Holter 58.4% ® quantify AF burden It •In addition to AF episodes, the Zio Patch also identified ventricular and was able to identify supraventricular tachycardia in 18 and 25 patients respectively. AV block was other arrhythmias due recorded in one patient. to the longer duration ® Clinical utility: Management was changed in 21 patients as a result of the Zio Patch of recording. The study: Antiarrhythmic medication was changed in 13 patients, anticoagulant therapy author recommended that larger studies are (initiated or stopped) in 4 patients. 2 patients received pacemakers, recommendations for AV junction ablation was for one patient, pulmonary ablation in necessary to determine the efficacy one patient, and cardioversion in 2 patients. ® of Zio Patch in overall ® arrhythmia detection Reasons for discontinuing use of Zio Patch: and its cost effectives Study completion 49 patients (66.2%) compared to other Device falling off 16 patients (21.6%) after a mean of 7.9 days ambulatory monitors. Patients decision 6 patients (8.1%) Battery malfunction, unknown, or need for intervention: 1 patient for each
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