Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial

IntroductionIt is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysisThe ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT03821883.

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Abstract 18516: Regional Dysfunction of Left Atrial Appendage and its Association with Stroke in Atrial Fibrillation

Circulation ◽

10.1161/circ.130.suppl_2.18516 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Abdullah A Alissa ◽

Yuko Inoue ◽

Jochen Cammin ◽

Qiulin Tang ◽

Elliot Fishman ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Control Group ◽

Prior History ◽

Area Change ◽

Increased Risk ◽

History Of ◽

Regional Dysfunction

Background: Atrial Fibrillation (AF) is associated with an increased risk of cardioembolic stroke. Previous studies demonstrate that the Left atrial appendage (LAA) is the most common site of intracardiac thrombus, and the LAA morphology alone may determine the risk of stroke. We aimed to determine the association between LAA regional dysfunction using novel, noninvasive, image-based motion-estimation CT (iME) and prior history of stroke in patients with AF. Methods: Among the patients with history of AF referred for ablation who underwent pre-ablation CT with retrospective ECG gating, we identified 18 patients with a prior history of stroke or TIA, and 18 age- and gender-matched controls. The patients in AF at the time of CT were excluded. Four-dimensional motion vector field was estimated from reconstructed CT images using iME at every 5% RR interval. To assess myocardial deformation, area change ratio and area change rate were calculated over the endocardial surface of the LA and LAA. Univariate and multivariate comparisons were made by using binary logistic regression model. Results: A total of 36 patients (mean age 67.6 ± 8.1 years, 66.7% male, 16.7% persistent AF) were included in the study. Univariate analysis showed that the LA pre-atrial contraction area change ratio and LAA maximum area change ratio were significantly lower (P= 0.02 and 0.04, respectively) in the stroke/TIA group compared to the control group. These changes remained statistically significant in multivariate analysis (P=0.03 and 0.04, respectively) after adjusting for age, sex, body mass index, LV ejection fraction, type of AF, and CHADS score. Conclusions: LAA regional dysfunction is associated with stroke/TIA in patients with AF. LAA regional dysfunction detected by iME could represent a marker for stroke and a possible therapeutic target.

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Safety of Percutaneous Left Atrial Appendage Occlusion in Patients with Atrial Fibrillation after Acute Coronary Syndrome: A Single Center Experience

International Journal of Cardiovascular Research ◽

10.4172/2324-8602.1000302 ◽

2017 ◽

Vol 06 (02) ◽

Author(s):

Giovanni Ciccarelli ◽

Chiara D Amico ◽

Mattia Izzo ◽

Giovanni Cimmino ◽

Alberto Morello ◽

...

Keyword(s):

Atrial Fibrillation ◽

Acute Coronary Syndrome ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Single Center ◽

Coronary Syndrome ◽

Single Center Experience ◽

Left Atrial Appendage Occlusion

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Predictive Value of Left Atrial Appendage Functional Parameters on Left Atrial Thrombus or Spontaneous Echo Contrast in Patients with Nonvalvular Atrial Fibrillation

10.21203/rs.3.rs-1223232/v1 ◽

2022 ◽

Author(s):

Changsheng Ma ◽

Li Wang ◽

Yuzhu Miao ◽

Jiali Fan ◽

Bingyuan Zhou ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Thrombus Formation ◽

Atrial Appendage ◽

Control Group ◽

Nonvalvular Atrial Fibrillation ◽

Increased Risk ◽

High Incidence ◽

Echocardiographic Parameters

Abstract Background: Left atrial appendage (LAA) spontaneous echocardiographic contrast (SEC), sludge and thrombus were associated with a high incidence of thrombus formation and thromboembolic events in patients with non-valvular atrial fibrillation (AF). We aim to identify the main echocardiographic parameters associated with LAA SEC or LAA sludge/thrombus in nonvalvular AF patients.Methods and results: 298 patients with nonvalvular atrial fibrillation were included in the current study between September 2019 and January 2021. Transthoracic echocardiography and transesophageal echocardiography were performed before scheduled electrical cardioversion. LA diameter and maximum left atrial appendage area were increased in the LAA SEC group than control group, and were further increased in patients with LAA sludge or thrombus. LAA-EV, LAA-FV, anterior mitral annular plane systolic excursion (MAPSE) and LAA FAC were lower in the group with LAA SEC than control group, and were further reduced in LAA sludge or thrombus group. Lower LAA FAC and anterior MAPSE were associated with an increased risk of LAA SEC or LAA sludge/thrombus, and LAA FAC and anterior MAPSE showed high accuracy on predicting LAA SEC or LAA sludge/thrombus.Conclusion: Left atrial appendage FAC and anterior MAPSE improves left atrial appendage stasis in patients with nonvalvular atrial fibrillation.

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A new approach: Left atrial appendage occlusion, as an alternative to anticoagulant, to treat patient who suffered of atrial fibrillation, acute coronary syndrome and clopidogrel resistance

International Journal of Cardiology ◽

10.1016/j.ijcard.2015.10.067 ◽

2016 ◽

Vol 202 ◽

pp. 900-903

Author(s):

Mathieu Pankert ◽

Erwan Salaun ◽

Thomas Cuisset ◽

Jean-Louis Bonnet

Keyword(s):

Atrial Fibrillation ◽

Acute Coronary Syndrome ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

New Approach ◽

Clopidogrel Resistance ◽

Coronary Syndrome ◽

Left Atrial Appendage Occlusion ◽

Treat Patient

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Impact of Thrombocytopenia in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion: A Propensity-Matched Comparison of 190 Consecutive Watchman Implantations

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.603501 ◽

2021 ◽

Vol 8 ◽

Author(s):

Xiaochun Zhang ◽

Qinchun Jin ◽

Jialu Hu ◽

Dehong Kong ◽

Cuizhen Pan ◽

...

Keyword(s):

Atrial Fibrillation ◽

Platelet Count ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Bleeding Complications ◽

Control Group ◽

Minor Bleeding ◽

Left Atrial Appendage Occlusion

Objectives: The purpose of this study was to provide data on the long-term efficacy and safety of left atrial appendage occlusion (LAAO) in patients with atrial fibrillation (AF) and chronic thrombocytopenia (cTCP).Methods: Between January 2016 and December 2018, a total of 32 AF patients with thrombocytopenia (platelet count <100*10∧9/L) undergoing LAAO at our center were identified and their outcomes were compared with a propensity-matched cohort (match ratio 1:5) of patients without cTCP who had also been indicated for LAAO.Results: Between the cTCP patients and the control group, no difference was found on the incidence of stroke (0 vs. 3.13%, p = 0.592), systematic thromboembolisation (0 vs. 0.63%, p > 0.9) and device-related thrombus (DRT) (3.13 vs. 2.50%, p > 0.9). Major (12.50 vs. 3.75%, p = 0.065) and minor bleeding (15.63 vs. 1.25%, p = 0.002) was more frequent in cTCP patients but no statistical difference was reached in major bleeding. Moreover, thrombocytopenia was also identified as an independent predictor of any bleeding events (OR: 8.150, 95% CI: 2.579–25.757, p < 0.001), while an inverse relationship between higher absolute platelet count and stroke events was revealed (OR: 1.015; 95% CI: 1.002~1.029, p = 0.022). However, in both groups we saw a significant reduction in observed annualized rates of non-procedural complications compared with the predicted values. In the cTCP and control groups, clinical thromboembolism was reduced by 100 and 74.32%, and major bleeding by 42.47 and 71.67%, respectively.Conclusion: Our preliminary results indicate that LAAO using the Watchman device could be a safe and effective means of preventing stroke in AF patients with or without thrombocytopenia, but bleeding complications should be monitored intensively in cTCP patients.

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Effect of the Alterations in Contractility and Morphology Produced by Atrial Fibrillation on the Thrombosis Potential of the Left Atrial Appendage

Frontiers in Bioengineering and Biotechnology ◽

10.3389/fbioe.2021.586041 ◽

2021 ◽

Vol 9 ◽

Author(s):

Danila Vella ◽

Alessandra Monteleone ◽

Giulio Musotto ◽

Giorgia Maria Bosi ◽

Gaetano Burriesci

Keyword(s):

Atrial Fibrillation ◽

Left Atrium ◽

Left Atrial ◽

Left Atrial Appendage ◽

Thrombus Formation ◽

Fluid Dynamic ◽

Atrial Appendage ◽

Primary Role ◽

Shear Strain Rate ◽

Increased Risk

Atrial fibrillation (AF) is a common arrhythmia mainly affecting the elderly population, which can lead to serious complications such as stroke, ischaemic attack and vascular dementia. These problems are caused by thrombi which mostly originate in the left atrial appendage (LAA), a small muscular sac protruding from left atrium. The abnormal heart rhythm associated with AF results in alterations in the heart muscle contractions and in some reshaping of the cardiac chambers. This study aims to verify if and how these physiological changes can establish hemodynamic conditions in the LAA promoting thrombus formation, by means of computational fluid dynamic (CFD) analyses. In particular, sinus and fibrillation contractility was replicated by applying wall velocity/motion to models based on healthy and dilated idealized shapes of the left atrium with a common LAA morphology. The models were analyzed and compared in terms of shear strain rate (SSR) and vorticity, which are hemodynamic parameters directly associated with thrombogenicity. The study clearly indicates that the alterations in contractility and morphology associated with AF pathologies play a primary role in establishing hemodynamic conditions which promote higher incidence of ischaemic events, consistently with the clinical evidence. In particular, in the analyzed models, the impairment in contractility determined a decrease in SSR of about 50%, whilst the chamber pathological dilatation contributed to a 30% reduction, indicating increased risk of clot formation. The equivalent rigid wall model was characterized by SSR values about one order of magnitude smaller than in the contractile models, and substantially different vortical behavior, suggesting that analyses based on rigid chambers, although common in the literature, are inadequate to provide realistic results on the LAA hemodynamics.

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