Dual Anti-Platelet Therapy Following Percutaneous Left Atrial Appendage Occlusion with the Watchman Device is not Associated with Increased Risk of Thromboembolism Compared with Warfarin

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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Attenuated Postimplant Anticoagulation Regime After Left Atrial Appendage Occlusion With the Watchman Device

Journal of the American College of Cardiology ◽

10.1016/j.jacc.2013.08.087 ◽

2013 ◽

Vol 62 (18) ◽

pp. C29 ◽

Cited By ~ 1

Author(s):

Ömer Sanatci ◽

Anja Schade ◽

Guido Groschup ◽

K. Wehner ◽

Burghard Schumacher ◽

...

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Left Atrial Appendage Occlusion ◽

Watchman Device

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Comparative data on left atrial appendage occlusion efficacy and clinical outcomes by age group in the Amplatzer™ Amulet™ Occluder Observational Study

EP Europace ◽

10.1093/europace/euaa262 ◽

2020 ◽

Author(s):

Xavier Freixa ◽

Boris Schmidt ◽

Patrizio Mazzone ◽

Sergio Berti ◽

Sven Fischer ◽

...

Keyword(s):

Observational Study ◽

Ischaemic Stroke ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Serious Adverse Events ◽

Left Atrial Appendage Occlusion ◽

Increased Risk ◽

The Impact

Abstract Aims Left atrial appendage occlusion (LAAO) may be considered for patients with non-valvular atrial fibrillation (NVAF) and a relative/formal contraindication to anticoagulation. This study aimed to summarize the impact of aging on LAAO outcomes at short and long-term follow-up. Methods and results We compared subjects aged <70, ≥70 and <80, and ≥80 years old in the prospective, multicentre Amplatzer™ Amulet™ Occluder Observational Study (Abbott, Plymouth, MN, USA). Serious adverse events (SAEs) were reported from implant through a 2-year post-LAAO visit and adjudicated by an independent clinical events committee. Overall, 1088 subjects were prospectively enrolled. There were 265 subjects (24.4%) <70 years old, 491 subjects (45.1%) ≥70 and <80 years old, and 332 subjects (30.5%) ≥80 years old, with the majority (≥80%) being contraindicated to anticoagulation. As expected, CHA2DS2-VASc and HAS-BLED Scores increased with age. Implant success was high (≥98.5%) across all groups, and the proportion of subjects with a procedure- or device-related SAE was similar between groups. At follow-up, the observed ischaemic stroke rate was not significantly different between groups, and corresponding risk reductions were 62, 56, and 85% when compared with predicted rates for subjects <70, ≥70 and <80, and ≥80 years old, respectively. Major bleeding and mortality rates increased with age, while the incidence of device-related thrombus tended to increase with age. Conclusions Despite the increased risk for ischaemic stroke with increasing age in AF patients, LAAO reduced the risk for ischaemic stroke compared with the predicted rate across all age groups without differences in procedural SAEs.

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Acute Device-Related Thrombus after Watchman Device Implant

Case Reports in Cardiology ◽

10.1155/2019/8397561 ◽

2019 ◽

Vol 2019 ◽

pp. 1-4

Author(s):

Muhammad Ajmal ◽

Vijendra Swarup

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Blood Clot ◽

Heart Rhythm ◽

Bleeding Risk ◽

Atrial Appendage ◽

Acute Thrombosis ◽

Increased Risk ◽

Watchman Device ◽

Laa Closure

Atrial fibrillation is characterized by irregularly irregular heart rhythm with an increased morbidity and mortality. It is associated with an increased risk of thromboembolism due to formation of blood clot in the left atrium. Most of these blood clots are formed in the left atrial appendage. The risk of blood clot formation is reduced with the use of anticoagulants. The patients who cannot take anticoagulants due to an increased bleeding risk can undergo percutaneous left atrial appendage (LAA) closure. A Watchman device is used for this purpose. LAA closure with the Watchman device is associated with some adverse effects, and one of them is device-related thrombus. Currently, there are no specific guidelines for the management of device-related thrombus. We present a case of Watchman device-related thrombus which developed 16 hours after the device placement. We will also discuss various options for the management of acute thrombosis.

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Left Atrial Appendage: Physiology, Pathology, and Role as a Therapeutic Target

BioMed Research International ◽

10.1155/2015/205013 ◽

2015 ◽

Vol 2015 ◽

pp. 1-13 ◽

Cited By ~ 22

Author(s):

Damiano Regazzoli ◽

Francesco Ancona ◽

Nicola Trevisi ◽

Fabrizio Guarracini ◽

Andrea Radinovic ◽

...

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Oral Anticoagulants ◽

Blood Stasis ◽

Atrial Appendage ◽

Low Flow ◽

Left Atrial Appendage Occlusion ◽

Poor Patient Compliance ◽

Increased Risk ◽

Variable Morphology

Atrial fibrillation (AF) is the most common clinically relevant cardiac arrhythmia. AF poses patients at increased risk of thromboembolism, in particular ischemic stroke. The CHADS2 and CHA2DS2-VASc scores are useful in the assessment of thromboembolic risk in nonvalvular AF and are utilized in decision-making about treatment with oral anticoagulation (OAC). However, OAC is underutilized due to poor patient compliance and contraindications, especially major bleedings. The Virchow triad synthesizes the pathogenesis of thrombogenesis in AF: endocardial dysfunction, abnormal blood stasis, and altered hemostasis. This is especially prominent in the left atrial appendage (LAA), where the low flow reaches its minimum. The LAA is the remnant of the embryonic left atrium, with a complex and variable morphology predisposing to stasis, especially during AF. In patients with nonvalvular AF, 90% of thrombi are located in the LAA. So, left atrial appendage occlusion could be an interesting and effective procedure in thromboembolism prevention in AF. After exclusion of LAA as an embolic source, the remaining risk of thromboembolism does not longer justify the use of oral anticoagulants. Various surgical and catheter-based methods have been developed to exclude the LAA. This paper reviews the physiological and pathophysiological role of the LAA and catheter-based methods of LAA exclusion.

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