Dataset Information

Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry.

ABSTRACT:

Background

Interventional left atrial appendage closure (LAAC) effectively prevents thromboembolic events in atrial fibrillation patients. Impaired left ventricular ejection fraction (LVEF) increases not only the thromboembolic risk but also the complication rates of cardiac interventions. The LAAC procedure's benefit in patients with an impaired LVEF, therefore, has yet to be investigated.

Methods

LAARGE is a prospective, non-randomized registry depicting the clinical reality of LAAC in Germany. Procedure was conducted with different standard commercial devices, and follow-up period was one year. In the sense of an as-treated analysis, patients with started procedure and documented LVEF were selected from the whole database.

Results

619 patients from 37 centers were categorized into one of three groups: LVEF > 55% (56%), 36-55% (36%), and ≤ 35% (8%). Prevalence of cardiovascular comorbidity increased with LVEF reduction (p < 0.001 for trend). CHA₂DS₂-VASc score was 4.3, 4.8, and 5.1 (p < 0.001), and HAS-BLED score was 3.7, 4.1, and 4.2 (p < 0.001). Implantation success was consistently high (97.9%), rates of intra-hospital MACCE (0.5%), and other major complications (4.2%) were low (each p = NS). Kaplan-Meier estimation showed a decrease in survival free of stroke with LVEF reduction during one-year follow-up (89.3 vs. 87.0 vs. 79.8%; p = 0.067), a trend which was no longer evident after adjustment for relevant confounding factors. Rates of non-fatal strokes (0.4 vs. 1.1 vs. 0%) and severe bleedings (0.7 vs. 0.0 vs. 3.1%) were consistently low across all groups (each p = NS).

Conclusions

LVEF reduction neither influenced the procedural success nor the effectiveness and safety of stroke prevention by LAAC.

Trial registration

ClinicalTrials.gov Identifier: NCT02230748.

SUBMITTER: Fastner C

PROVIDER: S-EPMC7588387 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry.

Fastner Christian C Brachmann Johannes J Lewalter Thorsten T Zeymer Uwe U Sievert Horst H Borggrefe Martin M Weiß Christian C Geist Volker V Krapivsky Alexander A Käunicke Matthias M Mudra Harald H Hochadel Matthias M Schneider Steffen S Senges Jochen J Akin Ibrahim I

Clinical research in cardiology : official journal of the German Cardiac Society 20200331 11

<h4>Background</h4>Interventional left atrial appendage closure (LAAC) effectively prevents thromboembolic events in atrial fibrillation patients. Impaired left ventricular ejection fraction (LVEF) increases not only the thromboembolic risk but also the complication rates of cardiac interventions. The LAAC procedure's benefit in patients with an impaired LVEF, therefore, has yet to be investigated.<h4>Methods</h4>LAARGE is a prospective, non-randomized registry depicting the clinical reality of ...[more]

PMID: 32236717

Similar Datasets

Project description:BackgroundInterventional left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for prophylaxis of thromboembolic events (TEs) in nonvalvular atrial fibrillation patients, predominantly in those with high bleeding risk and contraindications for long-term OAC. Although spontaneous echo contrast (SEC) is a well-known risk factor for atrial thrombus formation, little is known about whether this means an increased risk of device-related thrombus (DRT) or TEs following LAAO.MethodsThis substudy of the prospective, multicenter German LAARGE registry assessed two groups according to absence (SEC -) or presence of SEC (SEC +) in preprocedural cardiac imaging. Clinical and echocardiographic parameters were registered up to 1 year after LAAO.ResultsFive hundred eighty-eight patients (SEC - 85.5 vs. SEC + 14.5%) were included. More SEC + patients were implanted for OAC non-compliance (11.8 vs. 4.6%, p = 0.008) and a higher proportion received only antiplatelet therapy without OAC at hospital discharge (96.5 vs. 86.0%, p = 0.007). The SEC + patients had larger LA diameters (50 (47; 54) vs. 47 (43; 51) mm, p < 0.001), wider LAA ostia (21 (19; 23) vs. 20 (17; 22) mm at 45°, p = 0.011), and lower left ventricular ejection fraction (50 (45; 60) vs. 60 (50; 60) %, p < 0.001) on admission. Procedural success was very high in both groups (98.1%, p = 1.00). Periprocedural major adverse cardiac and cerebrovascular events and other major complications were rare in both groups (3.8 vs. 4.7%, p = 0.76). At follow-up, DRT was only detected in the SEC - group (3.8 vs. 0%, p = 1.00). The rates of TEs (SEC - 1.2 vs. SEC + 0%, p = 1.00) after hospital discharge and 1-year mortality (SEC - 12.0 vs. SEC + 11.8%, p = 0.96) were not significantly different between the two groups.ConclusionsPresence of SEC at baseline was not associated with an increased rate of DRT or TEs at 1-year follow-up after LAAO in LAARGE.

Dataset Information

Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry.

Background

Methods

Results

Conclusions

Trial registration

Publications

Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry.

Similar Datasets

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