Key result
LAAO linked to ~79% lower ischemic stroke rate versus predicted rates in NVAF.
Why the study?
Long-term real-world comparative outcomes of three LAAO devices for stroke prevention in NVAF patients were not well established in a Chinese population.
Do different LAAO devices (WATCHMAN, ACP/Amulet, LAmbre) have comparable safety and efficacy in preventing stroke and major bleeding in patients with non-valvular atrial fibrillation?
Observational (n=161)
No
Do different LAAO devices (WATCHMAN, ACP/Amulet, LAmbre) have comparable safety and efficacy in preventing stroke and major bleeding in patients with non-valvular atrial fibrillation?
Effect estimate: RRR 79.2%
Absolute Event Rate: 1.07% vs 5.14%
Number Needed to Treat: 25
p-value: p=<0.001
WATCHMAN, ACP/Amulet, and LAmbre LAAO devices demonstrated comparable long-term safety and efficacy for stroke prevention in patients with non-valvular atrial fibrillation.
Comparable device outcomes may guide selection in non-valvular AF; leaves open randomized confirmation of stroke reduction.
Aims:We aimed to compare long-term "real-world" outcomes of three left atrial appendage occlusion (LAAO) devices for stroke prevention in a Chinese population with non-valvular atrial fibrillation (NVAF). Methods and results:Consecutive patients who underwent LAAO from June 2009 to October 2016 at a university-affiliated hospital were retrospectively analysed.In-hospital and major adverse events (MAE) including mortality, stroke and major bleeding rates were compared by LAAO device.One hundred and sixty-one (161) patients (mean age 71.4±8.2 years; 67.7% male) with mean CHA 2 DS 2 -VASc score of 4.1±1.6 and HAS-BLED score of 2.9±1.1 underwent 162 LAAO procedures, of which 47.5% (n=77), 41.4% (n=67) and 11.1% (n=18) were AMPLATZER Cardiac Plug (ACP)/Amulet, WATCHMAN and LAmbre, respectively.The procedural success rate was 97.5% (158/162).The in-hospital adverse event rate was 7.4% (12/162) and comparable among devices (p=NS).Mean follow-up duration was 28.3±24.4months (373 patient-years).There were no significant differences in long-term MAE rates among devices (p=NS).Observed annual ischaemic stroke (1.1% vs. 5.1%, p<0.001) and major bleeding rates (2.7% vs. 4.5%, p=NS) were lower compared with the predicted rates, respectively. Conclusions:The WATCHMAN, ACP/Amulet and LAmbre LAAO devices demonstrated similar longterm safety and efficacy in prevention of ischaemic stroke and major bleeding in patients with NVAF.
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A 2019 study conducted an observational in Non-valvular atrial fibrillation (n=161). Left atrial appendage occlusion (LAAO) devices (WATCHMAN, ACP/Amulet, LAmbre) vs. Predicted rates based on CHA2DS2-VASc score was evaluated on Annual ischaemic stroke rate (RRR 79.2%, p=<0.001). Left atrial appendage occlusion devices reduced the observed annual ischaemic stroke rate by 79.2% compared to predicted rates (1.1% vs. 5.1%, p<0.001) in patients with non-valvular atrial fibrillation, with similar long-term safety and efficacy among the WATCHMAN, ACP/Amulet, and LAmbre devices.
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