In:
Clinical Research in Cardiology, Springer Science and Business Media LLC, Vol. 109, No. 11 ( 2020-11), p. 1333-1341
Abstract:
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). CHA 2 DS 2 -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 Graphic abstract
Type of Medium:
Online Resource
ISSN:
1861-0684
,
1861-0692
DOI:
10.1007/s00392-020-01627-8
Language:
English
Publisher:
Springer Science and Business Media LLC
Publication Date:
2020
detail.hit.zdb_id:
2218331-0
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