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

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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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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Long-term follow-up after left atrial appendage occlusion with comparison of transesophageal echocardiography versus computed tomography to guide medical therapy and data about postclosure cardioversion

Journal of Cardiovascular Electrophysiology ◽

10.1111/jce.13289 ◽

2017 ◽

Vol 28 (10) ◽

pp. 1140-1150 ◽

Cited By ~ 8

Author(s):

Benjamin Berte ◽

Christine Attenhofer Jost ◽

Dominik Maurer ◽

Anja Fäh-Gunz ◽

Xavier Pillois ◽

...

Keyword(s):

Computed Tomography ◽

Transesophageal Echocardiography ◽

Medical Therapy ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Left Atrial Appendage Occlusion ◽

Long Term Follow Up

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Long-term follow up of 3 T MRI-detected brain lesions after percutaneous catheter-based left atrial appendage closure

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.27611 ◽

2018 ◽

Vol 92 (2) ◽

pp. 327-333 ◽

Cited By ~ 1

Author(s):

Barbara Bellmann ◽

Andreas Rillig ◽

Carsten Skurk ◽

David Manuel Leistner ◽

Karl Georg Haeusler ◽

...

Keyword(s):

Left Atrial ◽

Left Atrial Appendage ◽

Brain Lesions ◽

Atrial Appendage ◽

Left Atrial Appendage Closure ◽

Percutaneous Catheter ◽

Long Term Follow Up

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240 Left atrial appendage occlusion: safety, efficacy, and antiplatelet therapy in a single-centre experience

European Heart Journal Supplements ◽

10.1093/eurheartj/suab134.002 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Luigi Vignali ◽

Federico Barocelli ◽

Filippo Luca Gurgoglione ◽

Maria Alberta Cattabiani ◽

Arianna Maini ◽

...

Keyword(s):

Antiplatelet Therapy ◽

Major Bleeding ◽

Left Atrial ◽

Left Atrial Appendage ◽

Atrial Appendage ◽

Bleeding Events ◽

Left Atrial Appendage Occlusion ◽

Clinical Events

Abstract Aims Oral anticoagulation (OAC) is the cornerstone therapy for stroke prevention in patients with atrial fibrillation (AF). However, a not negligible proportion of AF patients experiences major bleeding events or is affected by concomitant disorders that represent a contraindication for OAC. Left atrial appendage occlusion (LAAO) has emerged as an effective strategy to minimize the risk of thromboembolism in AF patients (without moderate/severe mitral stenosis or mechanical prosthetic heart valves) that are poor candidates for OAC. After the procedure variable regimens of antithrombotic therapy are prescribed, in order to provide protection and prevent device-related thrombus (DRT). The optimal post-procedural antithrombotic strategy remains to be assessed. Therefore, we aim to evaluate the safety and efficacy of LAAO procedure and the relationship between antiplatelet therapy and outcomes at long-term follow-up. Methods and results We conducted a retrospective observational study including consecutive AF patients who underwent LAAO at Azienda Ospedaliero-Universitaria of Parma from October 2010 to June 2021. The incidence of major ischaemic events [DRT, ischaemic stroke, transient ischaemic attack (TIA) and systemic embolism], Bleeding Academic Research Consortium major bleeding events and net adverse clinical events (major ischaemic + bleeding events) were assessed at follow-up. We enrolled 130 patients [median age 77 years (73; 81)] characterized by both high ischaemic (mean CHA2DS2-VASc 4.48) and bleeding risk (mean HAS-BLED 3.24). Technical procedure success was achieved in 123 (94.6%). Thirty-nine (31.7%) patients were discharged on short (≤1 month)-dual antiplatelet therapy (DAPT); 35 (28.5%) on long-DAPT (1–12 months) and 49 (39.8%) on single antiplatelet therapy (SAPT). Antiplatelet therapy was chosen after multidisciplinary discussion on the basis on the hemorrhagic risk [mean HAS-BLED 3.55; 3.11; 2.97 (P = 0.038) in SAPT, short-DAPT and long-DAPT groups respectively], while no differences were observed in ischaemic risk between the three groups. Clinical follow-up was completed in 119 (98.2%) of successfully implanted patients. After a median follow-up of 31 ± 16 months, 24 (20.2%) patients had a major adverse event: 11 (9.2%) ischaemic events [8 (6.7%) strokes and 3 (2.5%) TIA] and 13 (10.9%) major bleedings. Patients on short-DAPT had a significantly lower occurrence of major bleedings [0 vs. 4 (11.4%) on long-DAPT vs. 9 (18.4%) on SAPT; P = 0.033] and net adverse clinical events [3 (7.7%) vs. 7 (20.0%) on long-DAPT vs. 14 (28.6%) on SAPT; P = 0.005] compared to the other two groups, while no difference was observed in the incidence of major ischaemic events [3 (7.7%) on short-DAPT vs. 3 (8.6%) on long-DAPT vs. 5 (10.2%) on SAPT; P = 0.340]. Conclusions In our cohort of AF patients with a contraindication for OAC therapy, LAAO showed high procedural success; however, long-term major ischaemic and bleeding events were not negligible. Short-DAPT therapy turned out to be the best antiplatelet regimen regarding net ischaemic-hemorrhagic balance. Evidence from well-designed randomized trials would be desirable to guide a tailored approach in the selection of post-procedural antithrombotic regimens.

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