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Journal of the American College of... Jun 2020The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest.
OBJECTIVES
The purpose of this study was to assess recurrence of AF in the CABANA trial.
METHODS
The authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post-90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach.
RESULTS
Median age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF.
CONCLUSIONS
Catheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).
Topics: Aged; Anti-Arrhythmia Agents; Atrial Fibrillation; Catheter Ablation; Electrocardiography, Ambulatory; Female; Humans; Intention to Treat Analysis; Male; Outcome and Process Assessment, Health Care; Recurrence; Stroke; Time
PubMed: 32586583
DOI: 10.1016/j.jacc.2020.04.065 -
JAMA Jun 2021Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in... (Comparative Study)
Comparative Study Randomized Controlled Trial
Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial.
IMPORTANCE
Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown.
OBJECTIVES
To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up.
DESIGN, SETTING, AND PARTICIPANTS
The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion.
INTERVENTIONS
Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders.
MAIN OUTCOMES AND MEASURES
Incident AF lasting more than 30 seconds through 12 months.
RESULTS
Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain).
CONCLUSIONS AND RELEVANCE
Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02700945.
Topics: Aged; Atrial Fibrillation; Electrocardiography; Electrocardiography, Ambulatory; Electrodes, Implanted; Female; Humans; Intracranial Arterial Diseases; Ischemic Attack, Transient; Male; Middle Aged; Risk Factors; Stroke
PubMed: 34061145
DOI: 10.1001/jama.2021.6470 -
European Review For Medical and... Sep 2022With the help of metrology, we can identify research hotspots and development trends in dynamic electrocardiography, and thereby provide corresponding reference material...
OBJECTIVE
With the help of metrology, we can identify research hotspots and development trends in dynamic electrocardiography, and thereby provide corresponding reference material to aid further theoretical research.
MATERIALS AND METHODS
All research data derived from the core collection of Web of Science, and all searches were completed on the same day (February 6, 2022). The obtained data were stored in plain text format and imported into CiteSpace for subsequent analysis. Citation analysis and visualization technology were used to draw a visual map of the research elements, using factors such as annual literature volume, country, journal, author, abstract, keywords, and citation.
RESULTS
After screening, 2,937 papers were obtained. Research on ambulatory electrocardiography is increasing worldwide every year. Using research hotspots, keyword-clustering time-zone maps, and high-frequency emerging words, the research in this field was roughly divided into two stages, with 2017 as the divider. The first stage primarily focuses on areas such as atrial fibrillation, stroke, autonomic nerve function, catheter ablation, and T-wave alternation. The second stage saw the focus shift to wearable devices, sudden cardiac death, obstructive sleep apnea, feature extraction, cryptogenic stroke, and similar topics.
CONCLUSIONS
With the development of various wearable technologies, the daily monitoring of healthy people engaged in sporting activities and the development of innovative analysis algorithms providing more accurate data may represent the hotspots and direction of future research.
Topics: Bibliometrics; Cluster Analysis; Electrocardiography; Electrocardiography, Ambulatory; Humans; Publications
PubMed: 36111902
DOI: 10.26355/eurrev_202209_29617 -
Journal of the American College of... Oct 2017Atrial fibrillation (AF) and left ventricular systolic dysfunction (LVSD) frequently co-exist despite adequate rate control. Existing randomized studies of AF and LVSD... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Atrial fibrillation (AF) and left ventricular systolic dysfunction (LVSD) frequently co-exist despite adequate rate control. Existing randomized studies of AF and LVSD of varying etiologies have reported modest benefits with a rhythm control strategy.
OBJECTIVES
The goal of this study was to determine whether catheter ablation (CA) for AF could improve LVSD compared with medical rate control (MRC) where the etiology of the LVSD was unexplained, apart from the presence of AF.
METHODS
This multicenter, randomized clinical trial enrolled patients with persistent AF and idiopathic cardiomyopathy (left ventricular ejection fraction [LVEF] ≤45%). After optimization of rate control, patients underwent cardiac magnetic resonance (CMR) to assess LVEF and late gadolinium enhancement, indicative of ventricular fibrosis, before randomization to either CA or ongoing MRC. CA included pulmonary vein isolation and posterior wall isolation. AF burden post-CA was assessed by using an implanted loop recorder, and adequacy of MRC was assessed by using serial Holter monitoring. The primary endpoint was change in LVEF on repeat CMR at 6 months.
RESULTS
A total of 301 patients were screened; 68 patients were enrolled between November 2013 and October 2016 and randomized with 33 in each arm (accounting for 2 dropouts). The average AF burden post-CA was 1.6 ± 5.0% at 6 months. In the intention-to-treat analysis, absolute LVEF improved by 18 ± 13% in the CA group compared with 4.4 ± 13% in the MRC group (p < 0.0001) and normalized (LVEF ≥50%) in 58% versus 9% (p = 0.0002). In those undergoing CA, the absence of late gadolinium enhancement predicted greater improvements in absolute LVEF (10.7%; p = 0.0069) and normalization at 6 months (73% vs. 29%; p = 0.0093).
CONCLUSIONS
AF is an underappreciated reversible cause of LVSD in this population despite adequate rate control. The restoration of sinus rhythm with CA results in significant improvements in ventricular function, particularly in the absence of ventricular fibrosis on CMR. This outcome challenges the current treatment paradigm that rate control is the appropriate strategy in patients with AF and LVSD. (Catheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction [CAMERA-MRI]; ACTRN12613000880741).
Topics: Aged; Atrial Fibrillation; Catheter Ablation; Electrocardiography, Ambulatory; Female; Gadolinium; Humans; Magnetic Resonance Imaging, Cine; Male; Middle Aged; Prospective Studies; Single-Blind Method; Ventricular Dysfunction, Left
PubMed: 28855115
DOI: 10.1016/j.jacc.2017.08.041 -
Heart (British Cardiac Society) Jan 2019This manuscript focuses on the broad aviation medicine considerations that are required to optimally manage aircrew with suspected or confirmed heart muscle disease... (Review)
Review
This manuscript focuses on the broad aviation medicine considerations that are required to optimally manage aircrew with suspected or confirmed heart muscle disease (both pilots and non-pilot aviation professionals). ECG abnormalities on aircrew periodic medical examination or presentation of a family member with a confirmed cardiomyopathy are the most common reason for investigation of heart muscle disease in aircrew. Holter monitoring and imaging, including cardiac MRI is recommended to confirm or exclude the presence of heart muscle disease and, if confirmed, management should be led by a subspecialist. Confirmed heart muscle disease often requires restriction toflying duties due to concerns regarding arrhythmia. Pericarditis and myocarditis usually require temporary restriction and return to flying duties is usually dependent on a lack of recurrent symptoms and acceptable imaging and electrophysiological investigations.
Topics: Aerospace Medicine; Cardiomyopathies; Disease Management; Electrocardiography, Ambulatory; Humans; Military Personnel
PubMed: 30425086
DOI: 10.1136/heartjnl-2018-313058 -
International Heart Journal 2023The relationship between Holter electrocardiography (ECG) and atrial fibrillation (AF) diagnosis in the real world has not been widely evaluated in Japan.This is a...
The relationship between Holter electrocardiography (ECG) and atrial fibrillation (AF) diagnosis in the real world has not been widely evaluated in Japan.This is a claims-based retrospective study using a health insurance claims database provided by DeSC Healthcare Corporation. We identified patients with at least one Holter for any purpose during the data period from April 2015 to November 2020 and without diagnosis of AF before the tests (n = 19,739). We obtained a whole picture of Holter and AF diagnosis after correcting for population distribution bias in the dataset. Based on this picture and the assumption that the patient had AF at the 1 Holter whose AF was detected for the first time at the second or subsequent Holter, we estimated the number of diagnosis with AF and overlooked AF by initial Holter. We conducted sensitivity analyses changing the definition of AF, the potential detection period, and the washout period (a period required to avoid including patients who have already been diagnosed with AF or who have already undergone several Holters) to confirm the validity of the base scenario.Among patients for analysis, 88.4% had only one Holter. The percentage of AF diagnosis by initial Holter was 7.6%. The percentage of AF overlooked by initial Holter was estimated to be 31.4% and this value did not change much by sensitivity analyses.It was estimated that approximately 30% of AF patients were overlooked by initial Holter, and reducing the overlooked rate will be a clinical challenge.
Topics: Humans; Atrial Fibrillation; Electrocardiography, Ambulatory; Japan; Retrospective Studies; Electrocardiography
PubMed: 37005314
DOI: 10.1536/ihj.22-436 -
The Journal of Thoracic and... Jan 2014
Topics: Animals; Blood Pressure Monitoring, Ambulatory; Electrocardiography, Ambulatory; Female; Heart-Assist Devices; Pulsatile Flow; Telemetry; Ventricular Function, Left; Wireless Technology
PubMed: 24176276
DOI: 10.1016/j.jtcvs.2013.09.015 -
Scientific Reports Jul 2022While various QRS detection and classification methods were developed in the past, the Holter ECG data acquired during daily activities by wearable devices represent new...
While various QRS detection and classification methods were developed in the past, the Holter ECG data acquired during daily activities by wearable devices represent new challenges such as increased noise and artefacts due to patient movements. Here, we present a deep-learning model to detect and classify QRS complexes in single-lead Holter ECG. We introduce a novel approach, delivering QRS detection and classification in one inference step. We used a private dataset (12,111 Holter ECG recordings, length of 30 s) for training, validation, and testing the method. Twelve public databases were used to further test method performance. We built a software tool to rapidly annotate QRS complexes in a private dataset, and we annotated 619,681 QRS complexes. The standardised and down-sampled ECG signal forms a 30-s long input for the deep-learning model. The model consists of five ResNet blocks and a gated recurrent unit layer. The model's output is a 30-s long 4-channel probability vector (no-QRS, normal QRS, premature ventricular contraction, premature atrial contraction). Output probabilities are post-processed to receive predicted QRS annotation marks. For the QRS detection task, the proposed method achieved the F1 score of 0.99 on the private test set. An overall mean F1 cross-database score through twelve external public databases was 0.96 ± 0.06. In terms of QRS classification, the presented method showed micro and macro F1 scores of 0.96 and 0.74 on the private test set, respectively. Cross-database results using four external public datasets showed micro and macro F1 scores of 0.95 ± 0.03 and 0.73 ± 0.06, respectively. Presented results showed that QRS detection and classification could be reliably computed in one inference step. The cross-database tests showed higher overall QRS detection performance than any of compared methods.
Topics: Algorithms; Artifacts; Electrocardiography; Electrocardiography, Ambulatory; Humans; Signal Processing, Computer-Assisted; Ventricular Premature Complexes; Wearable Electronic Devices
PubMed: 35879331
DOI: 10.1038/s41598-022-16517-4 -
Annals of Noninvasive Electrocardiology... Nov 2022
Topics: Humans; Electrocardiography; Electrocardiography, Ambulatory; Societies, Medical
PubMed: 36401342
DOI: 10.1111/anec.13019 -
Open Veterinary Journal 2022A patch Holter electrocardiograph (P-Holter) is cordless, making it lightweight, unlike the conventional Holter electrocardiograph (C-Holter). A P-Holter can also take...
BACKGROUND
A patch Holter electrocardiograph (P-Holter) is cordless, making it lightweight, unlike the conventional Holter electrocardiograph (C-Holter). A P-Holter can also take continuous measurements for up to 14 days without replacing the battery or SD card.
AIM
To compare the performance of the P-Holter and the C-Holter in healthy cats. Additionally, we aimed to investigate whether multiday recordings with the P-Holter decrease sympathetic nerve activity or improve the accuracy of arrhythmia detection.
METHODS
Five healthy domestic short-haired cats were used for this study. Both a P-Holter and C-Holter were used on the first day, but only the P-Holter was used on days 2-6. The evaluated variables were the analyzable time of both Holter types, heart rate (HR), HR variability (HRV), and the number of arrhythmia occurrences.
RESULTS
For two out of the five cats, measurement of P-Holter was interrupted. Eventually, continuous recordings using the P-Holters were able to be collected from all individuals for 6 days. The 24 hours analyzable time from the P-Holter and C-Holter was almost identical ( = 0.94). The 24 hours mean HR did not differ across Holter types ( = 0.67). In addition, the timing of the occurrences of arrhythmias was almost identical to the P-Holter and C-Holter. Results of HRV suggested that sympathetic nerve activity was likely to decrease and vagal nerve activity was likely to increase after 4-5 days of measurement, compared to the second day of measurement ( < 0.05). When only the P-Holter was installed, the number of arrhythmia occurrences was similar on days 2-6.
CONCLUSION
In this study, the P-Holter may be as useful as the C-Holter in cats with suspected intermittent arrhythmias, although the P-Holters were placed on cats without a clinical indication. However, cats may have individual differences in their adaptation to the device. P-Holter recordings taken for more than 4-5 days may allow the cat to acclimate to the device and reduce sympathetic nerve activity. The accuracy of arrhythmia detection across multiday P-Holter recordings requires further investigation using clinical cases.
Topics: Animals; Arrhythmias, Cardiac; Cat Diseases; Cats; Electrocardiography, Ambulatory; Heart Rate; Pilot Projects
PubMed: 36118727
DOI: 10.5455/OVJ.2022.v12.i4.10