TY - JOUR
T1 - Early prolonged ambulatory cardiac monitoring in stroke (EPACS)
T2 - An open-label randomised controlled trial
AU - Kaura, Amit
AU - Sztriha, Laszlo
AU - Chan, Fong Kum
AU - Aeron-Thomas, John
AU - Gall, Nicholas
AU - Piechowski-Jozwiak, Bartlomiej
AU - Teo, James T.
PY - 2019/7/26
Y1 - 2019/7/26
N2 - Background: Cardioembolism in paroxysmal atrial fibrillation (PAF) is a preventable cause of transient ischaemic attack (TIA) or ischaemic stroke; however, due to its transient nature, a short-duration Holter monitor may miss a significant proportion of events. Methods: We conducted an open-label randomised controlled trial of cardiac monitoring after a TIA or ischaemic stroke comparing a 14-day ECG monitoring patch (Zio® Patch, iRhythm Technologies) with short-duration Holter monitoring for the detection of PAF. The primary outcome was the detection of one or more episodes of ECG-documented PAF lasting at least 30 s within 90 days in each of the study arms. A budget impact analysis from the healthcare perspective was performed. Results: From February 2016 through February 2017, 43 (76.8%) of the 56 patients assigned to the patch-based monitoring group and 47 (78.3%) of the 60 patients assigned to short-duration Holter monitoring group had successful monitor placement with 90 days of follow-up. Of the 26 protocol failures between the two groups, 23 (88.5%) were due to patient refusal for outpatient short-duration ECG monitor placement, whilst only 1 (3.8%) was due unsuccessful ZioPatch placement. The rate of detection of PAF at 90 days was 16.3% in the patch-based monitoring group (seven patients) compared to 2.1% in the short-duration Holter monitoring group (1 patient), with an odds ratio of 8.9 (95% CI 1.1-76.0; P = 0.026). An economic model demonstrated that implementation of the Zio Patch service would result in 10.8 more strokes avoided per year compared to current practice with Holter monitoring with an associated yearly saving in direct medical costs of £113,630, increasing to £162,491 over 5 years. Conclusions: Early, prolonged, patch-based monitoring after an index stroke or TIA is superior to short-duration Holter monitoring in the detection of PAF and likely cost-effective for preventing recurrent strokes.
AB - Background: Cardioembolism in paroxysmal atrial fibrillation (PAF) is a preventable cause of transient ischaemic attack (TIA) or ischaemic stroke; however, due to its transient nature, a short-duration Holter monitor may miss a significant proportion of events. Methods: We conducted an open-label randomised controlled trial of cardiac monitoring after a TIA or ischaemic stroke comparing a 14-day ECG monitoring patch (Zio® Patch, iRhythm Technologies) with short-duration Holter monitoring for the detection of PAF. The primary outcome was the detection of one or more episodes of ECG-documented PAF lasting at least 30 s within 90 days in each of the study arms. A budget impact analysis from the healthcare perspective was performed. Results: From February 2016 through February 2017, 43 (76.8%) of the 56 patients assigned to the patch-based monitoring group and 47 (78.3%) of the 60 patients assigned to short-duration Holter monitoring group had successful monitor placement with 90 days of follow-up. Of the 26 protocol failures between the two groups, 23 (88.5%) were due to patient refusal for outpatient short-duration ECG monitor placement, whilst only 1 (3.8%) was due unsuccessful ZioPatch placement. The rate of detection of PAF at 90 days was 16.3% in the patch-based monitoring group (seven patients) compared to 2.1% in the short-duration Holter monitoring group (1 patient), with an odds ratio of 8.9 (95% CI 1.1-76.0; P = 0.026). An economic model demonstrated that implementation of the Zio Patch service would result in 10.8 more strokes avoided per year compared to current practice with Holter monitoring with an associated yearly saving in direct medical costs of £113,630, increasing to £162,491 over 5 years. Conclusions: Early, prolonged, patch-based monitoring after an index stroke or TIA is superior to short-duration Holter monitoring in the detection of PAF and likely cost-effective for preventing recurrent strokes.
KW - Atrial fibrillation
KW - Cardiac monitoring
KW - Electrocardiography
KW - Ischaemic stroke
KW - Medical devices
UR - http://www.scopus.com/inward/record.url?scp=85069957913&partnerID=8YFLogxK
U2 - 10.1186/s40001-019-0383-8
DO - 10.1186/s40001-019-0383-8
M3 - Article
AN - SCOPUS:85069957913
SN - 0949-2321
VL - 24
JO - European Journal of Medical Research
JF - European Journal of Medical Research
IS - 1
M1 - 25
ER -