Atrial fibrillation burden estimates derived from intermittent rhythm monitoring should not be used for patient follow-up or as endpoints in clinical trials

2014 ◽  
Vol 62 (S 01) ◽  
Author(s):  
E. Charitos ◽  
P. Ziegler ◽  
U. Stierle ◽  
B. Graf ◽  
S. Klotz ◽  
...  
2019 ◽  
Vol 4 (2) ◽  
pp. 172-180 ◽  
Author(s):  
Barbara Ratajczak-Tretel ◽  
Anna Tancin Lambert ◽  
Henriette Johansen ◽  
Bente Halvorsen ◽  
Vigdis Bjerkeli ◽  
...  

Purpose Paroxysmal atrial fibrillation is often suspected as a probable cause of cryptogenic stroke. Continuous long-term ECG monitoring using insertable cardiac monitors is a clinically effective technique to screen for atrial fibrillation and superior to conventional follow-up in cryptogenic stroke. However, more studies are needed to identify factors which can help selecting patients with the highest possibility of detecting atrial fibrillation with prolonged rhythm monitoring. The clinical relevance of short-term atrial fibrillation, the need for medical intervention and the evaluation as to whether intervention results in improved clinical outcomes should be assessed. Method The Nordic Atrial Fibrillation and Stroke Study is an international, multicentre, prospective, observational trial evaluating the occurrence of occult atrial fibrillation in cryptogenic stroke and transient ischaemic attack. Patients with cryptogenic stroke or transient ischaemic attack from the Nordic countries are included and will have the Reveal LINQ® Insertable cardiac monitor system implanted for 12 months for atrial fibrillation detection. Biomarkers which can be used as predictors for atrial fibrillation and may identify patients, who could derive the most clinical benefit from the detection of atrial fibrillation by prolonged monitoring, are being studied. Conclusion The primary endpoint is atrial fibrillation burden within 12 months of continuous rhythm monitoring. Secondary endpoints are atrial fibrillation burden within six months, levels of biomarkers predicting atrial fibrillation, CHA2DS2-VASc score, incidence of recurrent stroke or transient ischaemic attack, use of anticoagulation and antiarrhythmic drugs, and quality of life measurements. The clinical follow-up period is 12 months. The study started in 2017 and the completion is expected at the end of 2020.


EP Europace ◽  
2009 ◽  
Vol 11 (8) ◽  
pp. 1041-1047 ◽  
Author(s):  
A. M. Gillis ◽  
M. Morck ◽  
D. V. Exner ◽  
R. S. Sheldon ◽  
H. J. Duff ◽  
...  

Heart Rhythm ◽  
2012 ◽  
Vol 9 (9) ◽  
pp. 1375-1379 ◽  
Author(s):  
Evgeny Pokushalov ◽  
Alexander Romanov ◽  
Giorgio Corbucci ◽  
Sevda Bairamova ◽  
Denis Losik ◽  
...  

2019 ◽  
Author(s):  
Emily Guhl ◽  
Andrew D Althouse ◽  
Alexandra M Pusateri ◽  
Everlyne Kimani ◽  
Michael K Paasche-Orlow ◽  
...  

BACKGROUND Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. OBJECTIVE This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. METHODS Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. RESULTS A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; <i>P</i>=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; <i>P</i>=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; <i>P</i>&lt;.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Naga Venkata K Pothineni ◽  
Uyanga Batnyam ◽  
Jeffrey Arkles ◽  
John Bullinga ◽  
Brett L CUCCHIARA ◽  
...  

Introduction: Long-term monitoring for atrial fibrillation (AF) is recommended in patients, who have experienced a cryptogenic stroke (CS). Clinical trials have identified AF in ~30% of patients after 3 years of continuous monitoring with insertable cardiac monitors (ICMs). Hypothesis: In a real-world analysis from a large academic healthcare system, we sought to evaluate a CS population with ICMs and a) determine the yield of AF and subsequent initiation of anticoagulation; and b) identify the presence of other arrhythmias. Methods: We evaluated all CS patients who had received an ICM between October 2014 and April 2020. We manually reviewed all stored electrocardiograms that were automatically labeled as AF by the ICM and adjudicated them as either a) AF or b) other cardiac arrhythmia including premature atrial contractions (PAC), premature ventricular contractions (PVC), supraventricular tachycardia (SVT), or nonsustained ventricular tachycardia (NSVT). Results: A total of 84 CS patients with ICMs were included: 51% men, mean age 63 years, and mean CHA 2 DS 2 -VASc 4.1. Over a median follow-up duration of 15.7 months, there were 34 patients (40% of the cohort) who did not have any AF alerts. In the remaining 50 patients, there were 960 stored electrograms that were adjudicated. Only 154 recordings from 16 patients (19% of the entire cohort) were adjudicated as AF. Oral anticoagulation was initiated in all these patients with adjudicated AF. The remaining tracings, which had been automatically categorized by the ICM as AF alerts, represented 34 patients (40% of the cohort). These patients had other arrhythmias including frequent PACs or PVCs, SVT, or NSVT. Conclusions: Compared to clinical trials, our real-world assessment suggests that the yield of AF following CS is lower - approximately 20%. Our findings highlight the importance for reviewing device tracings given the high rates of false positive for AF. Further research to refine AF detection algorithms in ICMs is needed.


2021 ◽  
Vol 1 (58) ◽  
pp. 4-7
Author(s):  
Adam Wojtaszczyk ◽  
Paweł Ptaszyński ◽  
Krzysztof Kaczmarek

Atrial fibrillation (AF) is one of the most important problems in cardiology. Thermal ablation therapies are “gold standard” to treat symptomatic patients. Despite the improvements, both success rate and safety are limited by their thermal nature. Pulsed filed ablation is a new non-thermal ablation method. It is based on the phenomenon of unrecoverable permeabilization of cell membranes caused by pulses of high voltage (irreversible electroporation). Several preclinical studies suggest its safety. Clinical trials published so far have showed high efficacy. Further studies especially with longer follow-up period are needed.


2014 ◽  
Vol 37 (9) ◽  
pp. 1210-1218 ◽  
Author(s):  
EFSTRATIOS I. CHARITOS ◽  
PAUL D. ZIEGLER ◽  
ULRICH STIERLE ◽  
DEREK R. ROBINSON ◽  
BERNHARD GRAF ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.R Grubler ◽  
N.D Verheyen ◽  
A Meinitzer ◽  
L Fiedler ◽  
M Tscharre ◽  
...  

Abstract Background/Introduction Atrial fibrillation (AF) is a common heart rhythm disturbance, associated with an increased risk of stroke, hospital admissions and mortality, especially in patients with reduced ejection fraction. Among the oldest medications used for heart-rate control is digitalis, but largely due to observational studies showing an increased risk of death it has fallen out of favour. Recently newer clinical trials reported that the treatment with digitalis in permanent AF might be superior to beta blocker therapy in regard to functional status and symptom burden. Given this diverging results we attempt to analysis a large cohort of patients facilitating a propensity score matching algorithm. Purpose To assess the associations of digitalis treatment with mortality in patients with increased cardiovascular risk. Methods Patients were derived from a large cohort study including participants from a tertiary care centre who were referred to coronary angiography. The propensity score matching is based on a predefined list of variables, with digitalis as treatment. Matching strategy is nearest neighbour matching and to prove consistency, radius matching (radius = 0.1). For survival analysis we used a Cox proportional hazard regression comparing patients with and without digitalis for all-cause mortality. The analysis is conducted using STATA 13 MP. All patients provided written informed consent and the study was approved by the ethics committee. Results A total of 2457 patients (median age: 63.5 [IQR = 56.3–70.6] years, 30.1% women) referred to coronary angiography, with a median follow up of 9.9 (IQR = 8.5–10.7) years were included. The matching process and the resulting propensity score fulfilled all statistical assumptions and resulted in a balanced cohort. The risk for all-cause mortality was higher among propensity score matched participants not treated with digitalis compared to patients on treatment (n=514) HR 3.03 (95% CI 2.5 to 3.7). Total mortality in patients with AF on digitalis after a median follow-up of 9.9 years was 27.6%. At baseline, only 42.4% of patients with AF were on oral anticoagulation. Conclusions In the present cohort treatment with digitalis was associated with a lower risk of all-cause mortality after long-term follow-up. The patient population has a clinically significant 10-year mortality risk. The results may not apply to other cohorts but may help inform future clinical trials. FUNDunding Acknowledgement Type of funding sources: None.


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