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

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.

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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 ◽

10.1161/circ.142.suppl_3.16527 ◽

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.

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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 ◽

10.1093/europace/euab116.283 ◽

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

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Left atrial appendage percutaneous closure with a watchman device in patients with a contraindication to long-term oral anticoagulation. One-year follow-up

Archives of Cardiovascular Diseases Supplements ◽

10.1016/j.acvdsp.2017.11.288 ◽

2018 ◽

Vol 10 (1) ◽

pp. 75-76

Author(s):

G. Bonnet ◽

J. Pradier ◽

J. Spychaj ◽

E. Salaun ◽

M. Pankert ◽

...

Keyword(s):

Oral Anticoagulation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Percutaneous Closure ◽

Atrial Appendage ◽

Watchman Device ◽

One Year

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Nine-year, single-centre experience of left atrial appendage occlusion: patient characteristics, procedural outcomes and long-term follow up

CardioVascular Journal of Africa ◽

10.5830/cvja-2020-051 ◽

2021 ◽

Vol 32 (1) ◽

pp. 35-38

Author(s):

Mark Abelson ◽

Andre Phillips ◽

Shirley Middlemost

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Patient Characteristics ◽

Single Centre ◽

Left Atrial Appendage Occlusion ◽

Single Centre Experience ◽

Long Term Follow Up ◽

Procedural Outcomes

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

EP Europace ◽

10.1093/europace/euab116.287 ◽

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

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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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Spontaneously occluded left atrial appendage in a patient with atrial fibrillation and stroke: a case report

European Heart Journal - Case Reports ◽

10.1093/ehjcr/ytaa027 ◽

2020 ◽

Vol 4 (2) ◽

pp. 1-4

Author(s):

Andreas Bugge Tinggaard ◽

Kasper Korsholm ◽

Jesper Møller Jensen ◽

Jens Erik Nielsen-Kudsk

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Transoesophageal Echocardiography ◽

Similar Efficacy ◽

Cardiovascular Death ◽

Atrial Appendage ◽

Left Atrial Appendage Occlusion ◽

All Cause Mortality

Abstract Background The left atrial appendage (LAA) is the main source of thromboembolism in atrial fibrillation (AF). Transcatheter closure is non-inferior to warfarin therapy in preventing stroke. Case summary A patient with two consecutive strokes associated with AF was referred for transcatheter LAA occlusion (LAAO). Preprocedural cardiac CT and transoesophageal echocardiography demonstrated a spontaneously occluded LAA with a smooth left atrial surface, with stationary results at 6- and 12-month imaging follow-up. Warfarin was discontinued, and life-long aspirin instigated. Discussion Left atrial appendage occlusion has shown non-inferiority to warfarin for prevention of stroke, cardiovascular death, and all-cause mortality. No benefits from anticoagulation have been demonstrated in patients with embolic stroke of undetermined source. In the present case, we observed that the LAA was occluded and, therefore, treated with aspirin monotherapy assuming similar efficacy as transcatheter LAAO.

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