Feasibility and performance of a device for automatic self-detection of symptomatic acute coronary artery occlusion in outpatients with coronary artery disease : a multicentre observational study

Background Time delay between onset of symptoms and seeking medical attention is a major determinant of mortality and morbidity in patients with acute coronary artery occlusion. Response time might be reduced by reliable self-detection. We aimed to formally assess the proof-of-concept and accuracy of self-detection of acute coronary artery occlusion by patients during daily life situations and during the very early stages of acute coronary artery occlusion. Methods In this multicentre, observational study, we tested the operational feasibility, specificity, and sensitivity of our RELF method, a three-lead detection system with an automatic algorithm built into a mobile handheld device, for detection of acute coronary artery occlusion. Patients were recruited continuously by physician referrals from three Belgian hospitals until the desired sample size was achieved, had been discharged with planned elective percutaneous coronary intervention, and were able to use a smartphone; they were asked to perform random ambulatory selfrecordings for at least 1 week. A similar self-recording was made before percutaneous coronary intervention and at 60 s of balloon occlusion. Patients were clinically followed up until 1 month after discharge. We quantitatively assessed the operational feasibility with an automated dichotomous quality check of self-recordings. Performance was assessed by analysing the receiver operator characteristics of the ST difference vector magnitude. This trial is registered with ClinicalTrials.gov, number NCT02983396. Findings From Nov 18, 2016, to April 25, 2018, we enrolled 64 patients into the study, of whom 59 (92%) were eligible for self-applications. 58 (91%) of 64 (95% CI 81.0-95.6) patients were able to perform ambulatory self-recordings. Of all 5011 self-recordings, 4567 (91%) were automatically classified as successful within 1 min. In 65 balloon occlusions, 63 index tests at 60 s of occlusion in 55 patients were available. The mean specificity of daily life recordings was 0.96 (0.95-0.97). The mean false positive rate during daily life conditions was 4.19% (95% CI 3.29-5.10). The sensitivity for the target conditions was 0.87 (55 of 63; 95% CI 0.77-0.93) for acute coronary artery occlusion, 0.95 (54 of 57; 0.86-0.98) for acute coronary artery occlusion with electrocardiogram (ECG) changes, and 1.00 (35 of 35) for acute coronary artery occlusion with ECG changes and ST-segment elevation myocardial infarction criteria (STEMI). The index test was more sensitive to detect a 60 s balloon occlusion than the STEMI criteria on 12-lead ECG (87% vs 56%; p<0.0001). The proportion of total variation in study estimates due to heterogeneity between patients (I-2) was low (12.6%). The area under the receiver operator characteristics curve was 0.973 (95% CI 0.956-0.990) for acute coronary artery occlusion at different cutoff values of the magnitude of the ST difference vector. No patients died during the study. Interpretation Self-recording with our RELF device is feasible for most patients with coronary artery disease. The sensitivity and specificity for automatic detection of the earliest phase of acute coronary artery occlusion support the concept of our RELF device for patient empowerment to reduce delay and increase Survival without overloading emergency services. Copyright (C) 2019 The Author(s). Published by Elsevier Ltd

Impact of different anticoagulation management strategies on outcomes in atrial fibrillation: Dutch and Belgian results from the GARFIELD-AF registry.

The uptake rate of non-vitamin K oral anticoagulants (NOAC) for the treatment of non-valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. To explore the effect of these differences on thromboembolism (TE) and bleeding. Data from the GARFIELD-AF registry was used. Patients with new-onset AF and ≥1 investigator-determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow-up were used. In NL and BE, 1186 and 1705 patients were included, respectively. Female sex (42.3% vs 42.2%), mean age (70.7 vs 71.3 years), CHA DS -VASc (3.1 vs 3.1), and HAS-BLED score (1.4 vs 1.5) were comparable between NL and BE. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (±1.0) and 2.4 (±1.0) in NL and BE, respectively. Event rates per 100 patient-years in NL and BE, respectively, of all-cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62-2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89-1.99) did not differ significantly. In GARFIELD-AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant

Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF

BACKGROUND: Many patients with atrial fibrillation have concomitant coronary artery disease with or without acute coronary syndromes and are in need of additional antithrombotic therapy. There are few data on the long-term clinical outcome of atrial fibrillation patients with a history of acute coronary syndrome. This is a 2-year study of atrial fibrillation patients with or without a history of acute coronary syndromes

Treatment patterns in anticoagulant therapy in patients with newly diagnosed atrial fibrillation in Belgium: results from the GARFIELD-AF registry

Background: AF, anticoagulation, NOACs, changing patterns of prescription. Methods: We describe baseline data and treatment patterns of patients recruited in Belgium in the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF). Recruitment began when novel oral anticoagulants (NOACs) were introduced and provides a unique picture of changing treatment patterns over time. 1713 patients with a new (= 2), anticoagulants were used in 84.3%, leaving 15.7% unprotected. In low risk patients (CHA(2)DS(2)-VASc 0-1) anticoagulants were overused (58.7%). Factor Xa inhibitors were used more frequently than direct thrombin inhibitors. Conclusion: Guideline adherence on stroke prevention was higher in Belgium than in the rest of Europe, and increased over time. NOAC use in Belgium was the highest of Europe at the study start, with many countries catching up later. Possible reasons are discussed