scholarly journals Screening for atrial fibrillation: predicted sensitivity of short, intermittent electrocardiogram recordings in an asymptomatic at-risk population

EP Europace ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. 1781-1787 ◽  
Author(s):  
Giorgio Quer ◽  
Ben Freedman ◽  
Steven R Steinhubl

Abstract Aims Screening for asymptomatic atrial fibrillation (AF) could prevent strokes and save lives, but the AF burden of those detected can impact prognosis. New technologies enable continuous monitoring or intermittent electrocardiogram (ECG) snapshots, however, the relationship between AF detection rates and the burden of AF found with intermittent strategies is unknown. We simulated the likelihood of detecting AF using real-world 2-week continuous ECG recordings and developed a generalizable model for AF detection strategies. Methods and results From 1738 asymptomatic screened individuals, ECG data of 69 individuals (mean age 76.3, median burden 1.9%) with new AF found during 14 days continuous monitoring were used to simulate 30 seconds ECG snapshots one to four times daily for 14 days. Based on this simulation, 35–66% of individuals with AF would be detected using intermittent screening. Twice-daily snapshots for 2 weeks missed 48% of those detected by continuous monitoring, but mean burden was 0.68% vs. 4% in those detected (P < 0.001). In a cohort of 6235 patients (mean age 69.2, median burden 4.6%) with paroxysmal AF during clinically indicated monitoring, simulated detection rates were 53–76%. The Markovian model of AF detection using mean episode duration and mean burden simulated actual AF detection with ≤9% error across the range of screening frequencies and durations. Conclusion Using twice-daily ECG snapshots over 2 weeks would detect only half of individuals discovered to have AF by continuous recordings, but AF burden of those missed was low. A model predicting AF detection, validated using real-world data, could assist development of optimized AF screening programmes.

2016 ◽  
Vol 116 (10) ◽  
pp. 587-589 ◽  
Author(s):  
Gregory Y. H. Lip ◽  
Ben Freedman

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.


2017 ◽  
Vol 5 (1) ◽  
pp. 7-22
Author(s):  
Katarina Steen Carlsson ◽  
Bengt Jönsson

What is the actual value of new medicines? The answer to this question is the key to rational use of new technologies in health care and for design of appropriate incentives for innovation. In this paper we present methods, data and study results for valuing new medical technologies in a life cycle perspective, relevant for development of a new approach to contract and payment for innovation that can replace present systems for pricing and reimbursement.   Focus is on value in clinical practice, and on the data needs and methods needed for the development of outcome-based payment systems that balances risks and rewards for innovation in health care. We provide an overview of studies from the Swedish context on the value of new medicines introduced in the treatment of diabetes, cancer, cardiovascular disease and rheumatoid arthritis. These studies using national health data and quality registers emphasise the importance of continuing efforts to collect relevant data for assessment of value after a medicine reaches the market and starts to be used in clinical practice. It is only when medicines are used in clinical practice that the benefits for real-world patient populations can be identified, measured and valued. Analyses of real-world data will also assist further development and tailoring of treatment strategies to optimize the value of the new technology. While an effective patent system rewards innovation for a limited period of time, many innovations may continue to provide value to society long after patent protection, and these values must be included in the assessment of value of innovation.


Stroke ◽  
2019 ◽  
Vol 50 (Suppl_1) ◽  
Author(s):  
Woo-Keun Seo ◽  
Joon-Tae Kim ◽  
Jong-Won Chung ◽  
Tae-Jin Song ◽  
Yong-Jae Kim ◽  
...  

2015 ◽  
Vol 114 (08) ◽  
pp. 403-409 ◽  
Author(s):  
Lars Rasmussen ◽  
Torben Larsen ◽  
Andrew Blann ◽  
Flemming Skjøth ◽  
Gregory Lip

SummaryAs non-valvular atrial fibrillation (AF) brings a risk of stroke, oral anticoagulants (OAC) are recommended. In ‘real world’ clinical practice, many patients (who may be, or perceived to be, intolerant of OACs) are either untreated or are treated with anti-platelet agents. We hypothesised that edoxaban has a better net clinical benefit (NCB, balancing the reduction in stroke risk vs increased risk of haemorrhage) than no treatment or anti-platelet agents. We performed a network meta-analysis of published data from 24 studies of 203,394 AF patients to indirectly compare edoxaban with aspirin alone, aspirin plus clopidogrel, and placebo. Edoxaban 30 mg once daily significantly reduced the risk of all stroke, ischaemic stroke and mortality compared to placebo and aspirin. Compared to aspirin plus clopidogrel, there was a lower risk of intra-cranial haemorrhage (ICH). Edoxaban 60 mg once-daily had a reduced risk of any stroke and systemic embolism compared to placebo, aspirin, and aspirin plus clopidogrel. Mortality rates for both edoxaban doses were estimated to be lower compared to any anti-platelet, and significantly lower compared to placebo. With overall reduced risk of ischemic stroke and ICH, both edoxaban doses bring a NCB of mean (SD) 1.68 (0.15) saved events per 100 patients per year compared to anti-platelet drugs in a clinical trial population. The NCB was demonstrated to be lower, at 0.77 (0.12) events saved (p< 0.01) when modeled to data from a ‘real world’ cohort of AF patients. In conclusion, edoxaban is likely to provide even better protection from stroke and ICH than placebo, aspirin alone, or aspirin plus clopidogrel in both clinical trial populations and unselected community populations. Both edoxaban doses would also bring a positive NCB compared to anti-platelet drugs or placebo/non-treatment based on ‘real world’ data.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.


2021 ◽  
Vol 3 (1) ◽  
pp. e000089
Author(s):  
Sanket S Dhruva ◽  
Guoqian Jiang ◽  
Amit A Doshi ◽  
Daniel J Friedman ◽  
Eric Brandt ◽  
...  

ObjectivesTo determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.DesignRetrospective cohort.SettingThree health systems in the USA.ParticipantsPatients receiving ablation with the two ablation catheters of interest at any of the three health systems.Main outcome measuresFeasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.ResultsOverall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.ConclusionsIt is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.


2021 ◽  
Author(s):  
Peng Zhang ◽  
Fan Lin ◽  
Fei Ma ◽  
Yuting Chen ◽  
Daowen Wang ◽  
...  

SummaryBackgroundWith the increasing demand for atrial fibrillation (AF) screening, clinicians spend a significant amount of time in identifying the AF signals from massive electrocardiogram (ECG) data in long-term dynamic ECG monitoring. In this study, we aim to reduce clinicians’ workload and promote AF screening by using artificial intelligence (AI) to automatically detect AF episodes and identify AF patients in 24 h Holter recording.MethodsWe used a total of 22 979 Holter recordings (24 h) from 22 757 adult patients and established accurate annotations for AF by cardiologists. First, a randomized clinical cohort of 3 000 recordings (1 500 AF and 1 500 non-AF) from 3000 patients recorded between April 2012 and May 2020 was collected and randomly divided into training, validation and test sets (10:1:4). Then, a deep-learning-based AI model was developed to automatically detect AF episode using RR intervals and was tested with the test set. Based on AF episode detection results, AF patients were automatically identified by using a criterion of at least one AF episode of 6 min or longer. Finally, the clinical effectiveness of the model was verified with an independent real-world test set including 19 979 recordings (1 006 AF and 18 973 non-AF) from 19 757 consecutive patients recorded between June 2020 and January 2021.FindingsOur model achieved high performance for AF episode detection in both test sets (sensitivity: 0.992 and 0.972; specificity: 0.997 and 0.997, respectively). It also achieved high performance for AF patient identification in both test sets (sensitivity:0.993 and 0.994; specificity: 0.990 and 0.973, respectively). Moreover, it obtained superior and consistent performance in an external public database.InterpretationOur AI model can automatically identify AF in long-term ECG recording with high accuracy. This cost-effective strategy may promote AF screening by improving diagnostic effectiveness and reducing clinical workload.Research in contextEvidence before this studyWe searched Google Scholar and PubMed for research articles on artificial intelligence-based diagnosis of atrial fibrillation (AF) published in English between Jan 1, 2016 and Aug 1, 2021, using the search terms “deep learning” OR “deep neural network” OR “machine learning” OR “artificial intelligence” AND “atrial fibrillation”. We found that most of the previous deep learning models in AF detection were trained and validated on benchmark datasets (such as the PhysioNet database, the Massachusetts Institute of Technology Beth Israel Hospital AF database or Long-Term AF database), in which there were less than 100 patients or the recordings contained only short ECG segments (30-60s). Our search did not identify any articles that explored deep neural networks for AF detection in large real-world dataset of 24 h Holter recording, nor did we find articles that can automatically identify patients with AF in 24 h Holter recording.Added value of this studyFirst, long-term Holter monitoring is the main method of AF screening, however, most previous studies of automatic AF detection mainly tested on short ECG recordings. This work focused on 24 h Holter recording data and achieved high accuracy in detecting AF episodes. Second, AF episodes detection did not automatically transform to AF patient identification in 24 h Holter recording, since at present, there is no well-recognized criterion for automatically identifying AF patient. Therefore, we established a criterion to identify AF patients by use of at least one AF episode of 6 min or longer, as this condition led to significantly increased risk of thromboembolism. Using this criterion, our method identified AF patients with high accuracy. Finally, and more importantly, our model was trained on a randomized clinical dataset and tested on an independent real-world clinical dataset to show great potential in clinical application. We did not exclude rare or special cases in the real-world dataset so as not to inflate our AF detection performance. To the best of our knowledge, this is the first study to automatically identifies both AF episodes and AF patients in 24 h Holter recording of large real-world clinical dataset.Implications of all the available evidenceOur deep learning model automatically identified AF patient with high accuracy in 24 h Holter recording and was verified in real-world data, therefore, it can be embedded into the Holter analysis system and deployed at the clinical level to assist the decision making of Holter analysis system and clinicians. This approach can help improve the efficiency of AF screening and reduce the cost for AF diagnosis. In addition, our RR-interval-based model achieved comparable or better performance than the raw-ECG-based method, and can be widely applied to medical devices that can collect heartbeat information, including not only the multi-lead and single-lead Holter devices, but also other wearable devices that can reliably measure the heartbeat signals.


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