Abstract 16527: Peri-Procedural and 45-Day Outcomes in the Roll-In Cohort of the Amplatzer Amulet Ide Trial of Left Atrial Appendage Occlusion

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rakesh Gopinathannair ◽  
Scott M Koerber ◽  
Krishna Akella ◽  
Dhanunjaya Lakkireddy
Keyword(s):  
Ischemic Stroke ◽  
High Risk ◽  
Adverse Events ◽  
Hospital Discharge ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Watchman Device ◽  
Major Adverse Events

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.

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

Evaluating long-term outcomes of left atrial appendage occlusion: the results of a prospective single-center registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Major Bleeding ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Left Atrial Appendage Occlusion ◽  
Long Term Follow Up

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted grant from Boston Scientific. Boston Scientific was not involved in the design/conduct of the study, data collection/analysis and interpretation of the data and preparation of the manuscript. Background Percutaneous left atrial appendage occlusion is an emerging alternative to anticoagulation in the prevention for stroke in patients with atrial fibrillation, especially in patients with a contra-indication for oral anticoagulation therapy. Long-term results on the efficacy and safety of this treatment remain scarce. Methods In this single-center prospective registry, data of all consecutive patients that underwent percutaneous left atrial appendage closure between 2009 and 2019 were collected. Patients with successful left atrial appendage closure (peri-device leakage ≤5mm) and at least one year of follow-up data were analyzed. The occurrence of thrombo-embolic events (ischemic stroke, TIA and systemic embolism), major bleeding events (BARC >2) and anticoagulation use during long-term follow-up were evaluated. Results A total of 192 patients after left atrial appendage occlusion were included (61 % male, age 69.0 ± 8.4 years, CHA2DS2-VASc 4.0[3.0-5.0], HAS-BLED 3.0[2.0-3.25]) with a mean follow-up duration of 5.7 ± 2.8 years (in total 1087 patient-years). During follow-up 36 patients (19%) died. 49 thrombo-embolic complications were observed in 38 patients. The ischemic stroke rate was 1.9 events per 100 patient-years, accounting for a 70% reduction compared to CHA2DS2-VASc predicted rate. Device-related thrombus (DRT) occurred in 5 patients (2.6%), 3 were observed during routine follow-up and were not associated with thrombo-embolic complications. The other 2 DRT were observed in patients presenting with ischemic stroke more than 3 years after device implantation. Furthermore, 38 non-procedural major bleeding complications occurred in 19 patients, resulting in 3.5 events per 100-patients years, accounting for a reduction of 43% compared to estimated bleeding rates under OAC use. At the end of the study 71% of all patients were on single antiplatelet or no antiplatelet/anticoagulation treatment at all. Conclusions During long-term follow-up thrombo-embolic event rates and non-procedural major bleeding rates were consistently low (ischemic stroke rate reduction 70% and non-procedural major bleeding rate reduction 40% compared to predicted rates). These results confirm the efficacy of left atrial appendage occlusion. Abstract Figure. Ischemic stroke rates

scholarly journals Major Adverse Events With Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation

2019 ◽  
Vol 73 (20) ◽  
pp. 2638-2640 ◽  
Author(s):  
Laurent Fauchier ◽  
Alexandre Cinaud ◽  
François Brigadeau ◽  
Antoine Lepillier ◽  
Bertrand Pierre ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Major Adverse Events

scholarly journals Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Karapet Davtyan ◽  
Georgiy Simonyan ◽  
Arpi Topchyan ◽  
Andrey Kalemberg ◽  
Alexander Romanov ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Primary Efficacy ◽  
Left Atrial Appendage Occlusion ◽  
Safety Endpoint ◽  
Watchman Device ◽  
Comparative Safety ◽  
Major Adverse Events ◽  
Primary Safety Endpoint

Purpose. This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia. Methods. The study included data from 200 consecutive NVAF patients ( 66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( n = 108 ) or ACP ( n = 92 ) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up. Results. Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( p = 0.053 ). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, p = 0.008 ). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( n = 9 ) and 1.1% of patients in the ACP group ( n = 1 ) ( p = 0.016 ). Conclusions. In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.

Outcome of left atrial appendage occlusion in high-risk patients

Heart ◽  
2017 ◽  
Vol 104 (7) ◽  
pp. 594-599 ◽  
Author(s):  
Ahmed Masoud ◽  
Stefano Bartoletti ◽  
Timothy Fairbairn ◽  
Ayush Khurana ◽  
Periaswamy Velavan ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Stroke Prevention ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Complication Rates ◽  
Serious Adverse Events ◽  
Risk Patients

ObjectivePercutaneous left atrial appendage (LAA) occlusion can be an interventional alternative to oral anticoagulation for stroke prevention in patients with atrial fibrillation.MethodsWe delivered LAA occlusion therapy using a standardised approach to patient referral, multidisciplinary team assessment, implant criteria, imaging and follow-up. We analysed patient characteristics, efficacy and safety of the implant procedure, and 12-month outcomes.ResultsOf 143 referrals from October 2014 to December 2016, 83 patients (age 76±8years, 32.5% female, mean CHAD2S2-VASc score 4 ±1) were offered LAA occlusion. Eighty (95.3%) had previous major bleeding (intracranial in 59%). LAA occluder implantation with an Amulet device was successful in 82 (98.8%), with periprocedural major adverse events occurring in 5 (6.0%) patients (2 device embolisations including 1 death, 2 major bleeds). Cardiac imaging in 75 (94%) patients 2months following implant showed device-related thrombus in 1 case (1.3%) and minor (<5mm) device leaks in 13 (17.1%). Over a median 12-month follow-up, 3 (3.8%) ischaemic strokes, 2 (2.5%) haemorrhagic strokes and 5 (6.3%) major extracranial bleeds occurred. All-cause mortality was 10%, with most deaths (7, 87.5%) due to non-cardiovascular causes.ConclusionsLAA occlusion may be a reasonable option for stroke prevention inhigh-risk patients with atrial fibrillation ineligible for anticoagulation. However, procedural complication rates are not insignificant, and patients remain at risk of serious adverse events and death even after successful implant.

scholarly journals Closure of Residual Left Atrial Appendage Communications After a Prior Exclusion Attempt

2021 ◽  
Author(s):  
William Hucker ◽  
Aneesh Bapat ◽  
Alan Hanley ◽  
Samuel Bernard ◽  
Phillippe Bertrand ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Imaging Data ◽  
Maximal Diameter ◽  
Amplatzer Occluder ◽  
Preprocedural Imaging ◽  
Watchman Device ◽  
Laa Closure

Background: Surgical or percutaneous occlusion of the left atrial appendage (LAA) is increasingly used for thromboembolic protection in atrial fibrillation. Incomplete LAA closure may increase risk of thrombosis and thromboembolism, and therefore approaches to address residual communications are needed. Objective: To analyze the technique of closing an incompletely occluded LAA and subsequent patient outcomes. Methods: We performed a retrospective analysis of 5 consecutive patients who presented for completion of LAA closure. Results: Four patients were male, mean age 75, average CHA2DS2-VASc score 5.4, and four had prior surgical LAA ligation. One patient had previously had a WATCHMAN device placed for whom a 3D printed model was created from preprocedural imaging data to guide Amplatzer occluder device selection for closure. The residual LAA communication maximal diameter averaged 6.2 mm (range 5-8mm). In 4 of 5 cases, an ablation catheter was used to enter the LAA. The residual LAA communication was closed with either an Amplatzer occluder (n=3) or a WATCHMAN device (n=2). No procedural complications occurred, and no residual leak remained afterwards. No neurologic events occurred during follow up (average 603 days, range 155-1177 days). Anticoagulation or dual antiplatelet therapy was stopped following a transesophageal echo (TEE) ³ 6 weeks after the procedure demonstrated no residual communication in 4 of 5 patients, and after 20 weeks in the fifth patient without a follow up TEE. Conclusion: Large residual LAA communications after LAA occlusion attempts can be successfully and safely closed percutaneously using either Amplatzer occluder devices or WATCHMAN devices.

Ligation of Left Atrial Appendage during Off-Pump Coronary Surgery

2019 ◽  
Vol 68 (08) ◽  
pp. 695-699 ◽  
Author(s):  
Soslan Enginoev ◽  
Dmitry Koz'min ◽  
Gasan Magomedov ◽  
Sergey Makeev ◽  
Igor Chernov ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Coronary Artery ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Artery Bypass ◽  
Study Groups ◽  
Atrial Appendage ◽  
Off Pump ◽  
Group 2

Abstract Objective The main purpose of this article is to evaluate an impact of epicardial ligation of the left atrial appendage (LAA) in patients with atrial fibrillation (AF) undergoing off-pump coronary artery bypass grafting (OPCAB) on the development of ischemic stroke and mortality. Methods From 2009 to 2013, a total of 125 patients (86.4% men, mean age 64 ± 7 years, 95% confidence interval: 61–65 years) received a combined OPCAB and LAA ligation because of coronary artery disease and AF. All the subjects were divided into two groups: group 1 (n = 57)—LAA ligation during OPCAB, group 2 (n = 68) without LAA ligation during OPCAB. Primary endpoints were postoperative incidence of ischemic stroke and mortality. Results No difference in the number of ischemic stroke (0 vs. 5.9%) and death (0 vs. 4.4%) in both groups during the hospital period (p > 0.05). Median overall follow-up was 41 (22–61) months: without difference for groups (p > 0.05). During follow-up, there was a difference in the number of ischemic stroke (0 vs. 17.6%, p < 0.001), while there was no difference in mortality in two study groups (5.3 vs. 16.2%, p > 0.05). Conclusion Epicardial ligation of LAA during OPCAB in patients with AF may reduce the risk of ischemic stroke in long-term follow-up and does not affect the mortality.

P765 Does detection of thrombus in left atrial appendage increase risk of ischemic stroke and mortality?

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
E Kagawa ◽  
M Kato ◽  
N Oda ◽  
E Kunita ◽  
M Nagai ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Anticoagulation Therapy ◽  
Transoesophageal Echocardiography ◽  
Atrial Appendage ◽  
Increase Risk ◽  
Baseline Characteristics ◽  
Free Rate

Abstract Background Left atrial appendage (LAA) thrombus is one of causes of cardiogenic stroke and detection of LAA thrombus by transoesophageal echocardiography (TOE) strongly suggest cardiogenic stroke. It was reported that cardiogenic stroke patients had higher in-hospital mortality about 19%; however, little is known about LAA thrombus and mortality after indexed detection of LAA thrombus. We investigated LAA thrombus detection and their prognosis including ischemic stroke and survival. Methods The patients who were performed TOE between 2005 and 2016 in our hospital were enrolled in this study. Patients were divided into 2 groups based on thrombus detection in the LAA, and baseline characteristics and outcomes including prevalence of 5-y stroke-free and survival from the indexed TOE were compared. Results Among the 1260 study patients, the follow-up duration was median 971 d (interquartile range 345 d – 2017 d), and 67% of the patients were performing TOE for atrial fibrillation (AF), 20% for cerebral infarction, and 14% for valvular heart disease. Non-valvular AF was seen in 64% of the study patients and rheumatic AF was in 2%. The age (74 y [66 y – 79 y] vs 70 y [62 y – 76 y], p &lt; 0.001), the prevalence of male sex (67% vs 69%, p = 0.63), and hemoglobin level (13.9 g/dl [12.5 – 15.1 g/dl] vs 13.8 g/dl [12.4 – 14.9 g/dl], p = 0.49) were similar between the patients with LAA thrombus and those without. The CHA2DS2-VASc score (p = 0.008), the prevalence of receiving anticoagulation before TOA (34% vs 24%, p = 0.01), those of after TOA (98% vs 66%, p &lt; 0.001), serum creatinine (0.92 mg/dl [0.80 – 1.10 mg/dl] vs 0.85 mg/dl [0.71 – 1.00 mg/dl], p &lt; 0.001), d-dimer level (1.7 mcg/ml [0.9 – 3.5 mcg/ml] vs 0.8 mcg/ml [0.5 – 2.2 mcg/ml], p &lt; 0.001), and plasma brain natriuretic peptide (315 pg/ml [128 – 515 pg/ml] vs 126 pg/ml [47 – 284 pg/ml], p &lt; 0.001) were higher in the patients with LAA thrombus than those without. The 5-y ischemic stroke-free rate was lower in the patients with LAA thrombus than those without (p &lt; 0.001) (Figure, Panel A); however, the 5-y survival was similar between the 2 groups (p = 0.93) (Panel B). Conclusions The patients who were detected thrombus in the LAA had higher incidence of ischemic stroke, but the survival rate were similar. The higher rate of receiving anticoagulation therapy in the patients with LAA thrombus may be the cause of this discrepancy. Further studies are necessary to clarify this issue. Abstract P765 Figure

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