Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry
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Key result
LAAC shows similar death or stroke rates in severe versus preserved LVEF.
- HR 1.09
- 95% CI 0.53-2.27
- P=0.690
- n=619
Why the study?
The benefit of left atrial appendage closure in patients with impaired left ventricular ejection fraction has yet to be investigated.
Does left atrial appendage closure maintain procedural success and stroke prevention efficacy in atrial fibrillation patients with reduced LVEF?
Population
Atrial fibrillation patients with documented LVEF undergoing LAAC in the multicenter German LAARGE registry
Comparison
Patients with different levels of LVEF undergoing LAAC
Design
Prospective non-randomized registry
Follow-up
1 year
Authors
Discussion
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Member takes
Implication
Supports LAA closure in reduced-LVEF AF; extends observational data but leaves open randomized confirmation of efficacy.
Study Design
Type
Observational (n=619)
Multicenter
Yes
Structured PICO
Does left atrial appendage closure maintain procedural success and stroke prevention efficacy in atrial fibrillation patients with reduced LVEF?
P
Population
619 patients with atrial fibrillation undergoing left atrial appendage closure, categorized by left ventricular ejection fraction, followed for 1 year.
E
Exposure
Left atrial appendage closure (LAAC) with standard commercial devices
O
Outcome
Survival free of stroke at one-year follow-uphard clinical
Main Result
Hazard Ratio: 1.09 (95% CI 0.53–2.27)
Absolute Event Rate: 79.8% vs 89.3%
p-value: p=0.690
LVEF reduction does not significantly impact the procedural success, effectiveness, or safety of stroke prevention by left atrial appendage closure.
Limitations
- Observational character of the registry
- Conduction of the intervention was not influenced by the study investigators and was based on operators' discretions
- No information about the implantation volume per center and per operator
- Adverse events during follow-up were partly self-reported
- Individual reason for maintained anticoagulation after the procedure could not be extracted
- Follow-up was limited to one year
Cite This Study
Fastner et al. (2020) conducted an observational in Atrial fibrillation (n=619). Severe reduction in left ventricular ejection fraction (≤ 35%) vs. Preserved left ventricular ejection fraction (> 55%) was evaluated on Absence of all-cause death and non-fatal stroke (HR 1.09, 95% CI 0.53-2.27, p=0.690). Severe reduction in left ventricular ejection fraction did not significantly impact the effectiveness of stroke prevention by left atrial appendage closure, with an adjusted hazard ratio of 1.09 for all-cause death or non-fatal stroke compared to preserved ejection fraction.
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