AimsThe purpose of this study is to evaluate the accuracy of the Senbiosys device in measuring blood pressure (BP) by photoplethysmography (PPG) in patients undergoing coronary angiography.Methods This is a substudy within the Senbiosys trial, which is a prospective, single-arm, single-center study, evaluating the accuracy of BP estimation of the Senbiosys device compared to invasive BP. Patients referred for coronary angiography underwent invasive BP measurement and simultaneously wore the Senbiosys ring. SBP and DBP estimations measured by the Senbiosys device were compared with invasive measurements.Results A total of 25 patients were included. Overall, 708 epochs with adequate PPG signal belonging to 17 patients were analyzed. A total of 84% of the SBP estimates and 99% of the DBP estimates have an absolute error of less than 10 mmHg compared with the invasive measurements. Mean difference was 2.3 ± 7.0 mmHg and 0.5 ± 3.5 mmHg for SBP and DBP, respectively.
Background/rationaleAtrial fibrillation (AF) is frequent and causes great morbidity in the aging population. While initial events may be symptomatic, many patients have silent AF and are at risk of ischemic embolic complications. Timely detection of asymptomatic patients is paramount. The HECTO-AF trial aims to investigate the efficacy of an electrocardiogram (ECG) handheld device for the detection of AF in patients in hospital without a prior diagnosis of AF.Methods/designThe “Handheld ECG tracking of in-hospital atrial fibrillation” (HECTO-AF) study is a single-center, open-label, randomized controlled trial. The study population consists of all adult patients admitted to a general medicine ward of the University and Hospital of Fribourg throughout the study period. The study will enroll 1600 patients with 1:1 ratio allocation to either the detection group with one-lead handheld ECG recordings twice daily and extra recordings in the case of palpitations, versus a control group undergoing detection of AF as per routine clinical practice. Recordings will be self-performed after dedicated training, and will be independently adjudicated through a specific web-based interface. All enrolled patients will be followed clinically at 1, 2 and 5 years to assess the occurrence of AF, death, non-fatal stroke, systemic embolism, myocardial infarction and bleeding. The primary outcome is incidence of newly detected AF during the hospital stay. Secondary outcomes are incidence of AF, cardiovascular death, stroke, myocardial infarction and bleeding complications at 1, 2 and 5 years.DiscussionHECTO-AF is an independent randomized study aiming to detect the incidence of silent AF in all-comers hospitalized in general medicine wards.Trial registrationClinicalTrials.gov, NCT03197090. Registered on 23 June 2017. Local ethical Committee (CER-VD) registration number: 2017–01594. There are no conflicts of interest to declare.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3189-7) contains supplementary material, which is available to authorized users.
Background: Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation.Aims: The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients.Methods: The HECTO-AF is a single-center, open label, randomized controlled trial. Patients admitted to the general internal medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. The primary outcome was the prevalence of newly diagnosed AF during the hospital stay. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled.Results: A total of 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65 ± 16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, and 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. The incidence of newly detected AF was 1.4% over a median of 6 hospitalized days. Seven patients (1.8%) were diagnosed with AF in the intervention group vs. 3 (0.7%) in the control group (p = 0.20).Conclusion: There was a trend toward a higher AF detection over a median of 6 hospitalized days in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis.Clinical Trial Registration:ClinicalTrials.gov, identifier [NCT03197090].
Background. Atrial fibrillation (AF) is frequent and causes substantial morbidity through AF-related strokes. Given the increasing prevalence of AF, screening methods are of interest given the potential to initiate timely appropriate anticoagulation. The HECTO-AF trial aims to determine the efficacy of AF screening with a single-lead electrocardiogram (ECG) handheld device in naïve in-hospital patients.Methods. The HECTO-AF is a single-centre, open label, randomized controlled trial. Patients admitted to the general medicine ward of the University and Hospital Fribourg without previous diagnosis of AF were invited to participate in a screening program with a 1:1 allocation to either the screening group with intermittent single-lead handheld ECG recordings vs. a control group undergoing detection of AF as per routine clinical practice. Primary outcome was prevalence of newly diagnosed AF. Enrolment was terminated for poor patient recruitment and apparent futility before a sufficient sample for powered efficacy comparisons was enrolled. Results. A total 804 patients were included of whom 381 were allocated to the intervention and 423 to the control group. Mean age was 65±16 and 464 (58%) were male. Median CHA2DS2-VASc score was 3 (13% heart failure, 57% hypertension, 19% diabetes mellitus, 14% prior stroke/transient ischemic attack, 29% arterial disease) and all CHA2DS2-VASc risk factors were equally distributed between groups. Seven patients (1.8%) were diagnosed with AF in the intervention group versus 3 (0.7%) in the control group (p-value=0.20). Conclusion. There was a trend towards a higher AF detection in the intervention group, but a definitive conclusion cannot be drawn due to the early termination of the present study. Systematic screening for AF in the hospital setting is resource-consuming, and of uncertain clinical benefit. The interpretation of single-lead handheld ECG is challenging and may result in inaccurate AF diagnosis. Trial registration. ClinicalTrials.gov, ID: NCT03197090.
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