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

Christian Fastner, Johannes Brachmann, Thorsten Lewalter, Uwe Zeymer, Horst Sievert, Martin Borggrefe, Christian Weiß, Volker Geist, Alexander Krapivsky, Matthias Käunicke, Harald Mudra, Matthias Hochadel, Steffen Schneider, Jochen Senges, Ibrahim Akin, Christian Fastner, Johannes Brachmann, Thorsten Lewalter, Uwe Zeymer, Horst Sievert, Martin Borggrefe, Christian Weiß, Volker Geist, Alexander Krapivsky, Matthias Käunicke, Harald Mudra, Matthias Hochadel, Steffen Schneider, Jochen Senges, Ibrahim Akin

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.

Keywords: Atrial fibrillation; Bleeding risk; Depressed left ventricular function; Ischemic stroke; LAA closure; LAARGE.

Conflict of interest statement

Johannes Brachmann reports grants and personal fees from Biotronik (Berlin, Germany), Medtronic (Dublin, Ireland), Pfizer (New York City, NY, USA), and St. Jude Medical (Saint Paul, MN, USA). Horst Sievert reports study honoraria to institution, payment of travel expenses, consulting fees (personal honoraria had not been paid) from Abbott (Chicago, IL, USA), Boston Scientific (Marlborough, MA, USA), Lifetech (Nanshan District, Shenzhen, China), and Occlutech (Jena, Germany). Matthias Käunicke reports personal fees from Boston Scientific (Marlborough, MA, USA). Matthias Hochadel, Steffen Schneider, and Jochen Senges report unrestricted grants from Boston Scientific (Marlborough, MA, USA) for performing statistical analyses. Christian Fastner, Thorsten Lewalter, Uwe Zeymer, Martin Borggrefe, Christian Weiß, Volker Geist, Alexander Krapivsky, Harald Mudra, and Ibrahim Akin do not report any relevant conflicts of interest.

Figures

Fig. 1
Fig. 1
Freedom from all-cause death and non-fatal stroke after left atrial appendage closure

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Source: PubMed

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