Abstract
BackgroundInterventional 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.MethodsLAARGE 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.Results619 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).ConclusionsLVEF reduction neither influenced the procedural success nor the effectiveness and safety of stroke prevention by LAAC.Trial RegistrationClinicalTrials.gov Identifier: NCT02230748Graphic abstract
Highlights
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, with stroke and systemic embolization as prognostically relevant complications [1]
In this study, patients with an left ventricular ejection fraction (LVEF) < 30% were excluded by protocol, and the authors stated that this was due to the fact that the intervention in the LAA was naturally insufficient to prevent thromboembolism from the highly impaired left ventricle (LV)
619 patients with documented LVEF were included in this subanalysis. 344 (55.6%) revealed a preserved (p) LVEF, 225 (36.3%) an mrLVEF, and 50 (8.1%) an srLVEF (Table 1)
Summary
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, with stroke and systemic embolization as prognostically relevant complications [1]. In some patients, these drugs are contraindicated for different reasons [1,2,3] For these cases, the interventional left atrial appendage closure (LAAC) has evolved as the therapy of choice [1]. AF patients with a severely reduced LVEF have a markedly increased risk for thromboembolic complications [6]. In this study, patients with an LVEF < 30% were excluded by protocol, and the authors stated that this was due to the fact that the intervention in the LAA was naturally insufficient to prevent thromboembolism from the highly impaired left ventricle (LV). Interventional left atrial appendage closure (LAAC) effectively prevents thromboembolic events in atrial fibrillation patients. Impaired left ventricular ejection fraction (LVEF) increases the thromboembolic risk and the complication rates of cardiac interventions.
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