Key result
Left atrial appendage occlusion resulted in an actual annual stroke rate of 1.2%, representing a 70% reduction compared to the expected stroke risk of 4%.
Why the study?
Does transcatheter left atrial appendage occlusion prevent stroke and bleeding in patients with atrial fibrillation in a real-world setting?
Observational (n=457)
Yes
Does transcatheter left atrial appendage occlusion prevent stroke and bleeding in patients with atrial fibrillation in a real-world setting?
In a real-world Belgian registry, LAAO was associated with lower-than-expected rates of stroke and bleeding in patients with atrial fibrillation, with acceptable periprocedural safety.
Answers are grounded in this paper and cite their sources.
LAAO associated with lower stroke rates than expected in real-world AF; leaves open causal benefit without randomized controls.
AIMS: This study aimed to assess the safety and efficacy at midterm follow-up of left atrial appendage occlusion (LAAO) using different devices, in real life in Belgium. METHODS AND RESULTS: Between June 2009 and November 2016, 457 consecutive patients (63% male, 75±12 yrs, CHA2DS2-VASc 4±0.6, HAS-BLED 3.5±0.7) undergoing LAAO were included. Technical success was 97.1%. There were 19 periprocedural major adverse events (4.1%) including three deaths (0.6%), nine tamponades (1.9%), four major bleedings (0.8%) and two device embolisations (0.4%). Among patients successfully implanted having a complete follow-up (672 patient-years, median follow-up 370 days), the actual annual stroke rate was 1.2%, lower than the expected stroke risk of 4% (70% reduction). The observed bleeding rate was 2%, while the calculated risk was 3.7% (46% reduction). Kaplan-Meier analysis showed a similar overall survival (93±2% and 87±3% versus 91±3% and 87±4%; p=0.35) and event-free survival (92±2% and 84±3% versus 88±3% and 80±5%; p=0.17) at one and two years, for the ACP/Amulet versus the WATCHMAN groups of patients, respectively. CONCLUSIONS: The data from the Belgian left atrial appendage occlusion registry suggest that the procedure is effective and relatively safe in a real-world setting, using either the WATCHMAN or the ACP/Amulet device.
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Kefer et al. (2018) conducted an observational in Atrial fibrillation (n=457). Left atrial appendage occlusion vs. Expected risk based on CHA2DS2-VASc score was evaluated on Annual stroke rate (70% reduction). Left atrial appendage occlusion resulted in an actual annual stroke rate of 1.2%, representing a 70% reduction compared to the expected stroke risk of 4%.
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