scholarly journals AMPLATZER™ AMULET™ LEFT ATRIAL APPENDAGE OCCLUDER VERSUS WATCHMAN™ DEVICE FOR STROKE PROPHYLAXIS (AMULET IDE): A RANDOMIZED CONTROLLED TRIAL

Circulation ◽  
2021 ◽  
Author(s):  
Dhanunjaya Lakkireddy ◽  
David Thaler ◽  
Christopher R. Ellis ◽  
Vijendra Swarup ◽  
Lars Sondergaard ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Controlled Trial ◽  
Atrial Appendage ◽  
Systemic Embolism ◽  
Unexplained Death ◽  
Primary Endpoints ◽  
Increased Risk ◽  
Watchman Device

Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF). The Amplatzer™ Amulet™ LAA Occluder IDE Trial (Amulet IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman™ device. Methods: Patients with NVAF at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary endpoints included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion at 45 days. Pre-specified secondary endpoints included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the three primary endpoints. Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% vs. 14.7%; difference=-0.14, 95% CI, -3.42-3.13; p<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% vs 10.0% and 3.9% vs 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% vs. 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness endpoint (2.8% vs. 2.8%; difference=0.00, 95% CI, -1.55-1.55; p<0.001 for non-inferiority), and the composite of stroke, systemic embolism or cardiovascular/unexplained death (5.6% vs 7.7%, difference=-2.12, 95% CI, -4.45-0.21; p<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% vs. 12.3%; difference=-0.71, 95% CI -3.72-2.31; p=0.32 for superiority). LAA occlusion was higher for the Amulet occluder compared with the Watchman device (98.9% vs. 96.8%; difference=2.03, 95% confidence interval [CI], 0.41-3.66; p<0.001 for noninferiority; p=0.003 for superiority). Conclusions: The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion. Procedure-related complications were higher with the Amulet device and decreased with operator experience. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02879448

scholarly journals Acute Device-Related Thrombus after Watchman Device Implant

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.

scholarly journals 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

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044695
Author(s):  
Mu Chen ◽  
Qunshan Wang ◽  
Jian Sun ◽  
Peng-Pai Zhang ◽  
Wei Li ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Ethics Committee ◽  
Aspirin Therapy ◽  
Atrial Appendage ◽  
Control Group ◽  
Coronary Syndrome ◽  
Left Atrial Appendage Occlusion ◽  
Increased Risk

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.

scholarly journals PERIDEVICE LEAK AND DEVICE SIZING IN PATIENTS RECEIVING LEFT ATRIAL APPENDAGE CLOSURE WITH THE WATCHMAN DEVICE

2021 ◽  
Vol 77 (18) ◽  
pp. 955
Author(s):  
Lauren Sharan Ranard ◽  
Elena Donald ◽  
Shmuel Chen ◽  
Omar Khalique ◽  
Nadira Hamid ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Watchman Device

Long-term outcomes in patients with non-valvular atrial fibrillation and left atrial appendage closure in a large UK tertiary centre: 10-year experience

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Briosa E Gala ◽  
MTB Pope ◽  
C Monteiro ◽  
M Leo ◽  
TR Betts
Keyword(s):  
High Risk ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Bleeding Risk ◽  
Atrial Appendage ◽  
Tertiary Centre ◽  
Left Atrial Appendage Occlusion

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Left atrial appendage occlusion (LAAO) is a well-established stroke prevention strategy in patients with non-valvular atrial fibrillation (AF) and high risk of bleeding or contra-indication to oral anticoagulation (OAC). Despite encouraging randomised control trial and international registry safety and efficacy data, long-term outcome data remains sparce. Purpose This study sought to evaluate the long-term outcomes in ‘real-world’ AF patients undergoing left atrial appendage occlusion in a large UK tertiary centre. Methods This retrospective study included all patients that had a LAAO device implanted in our institution from January 2010 to December 2020. Medical notes, electronic patient records, procedural and imaging reports were reviewed. Annual bleeding risk was extrapolated from the Swedish National Cohort study according to CHA2DS2-VASc and HASBLED score. Results During the study period a total of 225 patients underwent LAAO device implant. Seventy-two percent were male, age 74 ± 8 years, BMI 27 ± 6 kg/m2, CHA2DS2-VASc score 4.4 ± 1.2, HASBLED score 3.2 ± 0.8 and at high risk of stroke (98 ischaemic strokes and 129 haemorrhagic strokes) and bleeding (151 life-threatening bleeding episodes). Three different LAAO devices were used: 136 Watchman, 54 Watchman FLX and 35 Amplatzer Cardiac plugs. Three patients (1.3%) had fatal complications related to the procedure. At discharge, 10% were taking single antiplatelet (ATP), 79% dual-antiplatelet (DAPT), 1.4% OAC, 3.6% ATP and OAC, 3.1% DAPT and OAC, 1.3% were not taking any anti-thrombotic. Nine (4%) patients had device-related thrombus on follow-up transoesophageal echocardiography with no significant difference between devices (5.0%, 2.8% and 6.7% p = 0.8, respectively) and anticoagulation strategy (p = 0.7). Over a total follow-up of 889 patient-years (mean follow-up 3.9 ± 3.7 years), 24 (10.4%) patients died, 55 patients (6.2/100 patient-years) suffered an adverse event, 15 ischaemic strokes (1.7/100 patient-years) and 20 non-procedural major bleeding episodes (2.3/100 patient-years) occurred. Compared to estimated annual stroke and bleeding risk adjusted for CHA2DS2-VASc and HASBLED score, our cohort had a 79% and 65% relative risk reduction in ischaemic stroke and major bleeding, respectively. Conclusion In this cohort of "real-world" high-risk patients, major bleeding and thromboembolic rate remained low on long-term follow-up. Abstract Figure 1

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial)

2019 ◽  
Vol 211 ◽  
pp. 45-53 ◽  
Author(s):  
Dhanunjaya Lakkireddy ◽  
Stephan Windecker ◽  
David Thaler ◽  
Lars Søndergaard ◽  
John Carroll ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Controlled Trial ◽  
Atrial Appendage ◽  
Randomized Controlled
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