Key result
Leftear LAA closure achieves noninferiority for major events with a ~2% incidence.
Why the study?
More than 90% of thromboses originate from the left atrial appendage in nonvalvular AF, prompting investigation of the safety and efficacy of LAA closure with the Leftear device.
Does left atrial appendage closure with the Leftear device safely and effectively prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
RCT (n=196)
Yes
Does left atrial appendage closure with the Leftear device safely and effectively prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation?
Absolute Event Rate: 1.6% vs 8%
LAA closure with the novel Leftear device demonstrated high procedural success and met noninferiority criteria for stroke prevention in NVAF patients, though combining it with AF ablation increased the risk of pericardial tamponade.
Should not yet change practice for LAA closure in NVAF; leaves open randomized confirmation of Leftear efficacy.
Background: More than 90% of thromboses originate from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation (NVAF). Objectives: This study was designed to investigate the safety and efficacy of LAA closure with the Leftear device (Pulse Scientific) in NVAF patients. Methods: -VASc (congestive heart failure, hypertension, age, diabetes, previous stroke/transient ischemic attack, vascular disease, female sex) scores ≥2. The primary safety endpoint was defined as any serious adverse events. Efficacy was assessed by a primary composite endpoint of hemorrhagic or ischemic stroke, systemic embolism, and cardiac or unexplained death at 1 year of follow-up. Results: The device was implanted in 196 patients, with 1-stop LAA closure combined with atrial fibrillation ablation implemented in 133 patients. The immediate success rate was 100%. There were serious adverse events in 9 patients (4.5%; 95% CI: 1.6%-7.4%), which mainly occurred in 1-stop LAA closure. All pericardial tamponades occurred in 6 patients with 1-stop LAA closure. No patient experienced a major bleeding event or acute device-related thrombus. During the 12-month follow-up period, the risk of the primary composite endpoint was 1.6% (95% CI: 0.3%-4.5%), and statistical noninferiority was achieved (the upper bound of 95% CI: 4.5% < the prespecified maximum annual incidence of 8.0%). Ischemic stroke occurred in 1 patient, 3 patients had incomplete LAA sealing, and no delayed device-related thrombus was found. Conclusions: LAA closure with the novel disc-like occluder shows high procedural success, satisfactory safety, and encouraging efficacy for stroke prevention in patients with NVAF. Compared with 1-stop LAA closure, single LAA closure may be more tolerable. (A multicenter, single-arm clinical trial to evaluate the efficacy and safety of left atrial appendage system for left atrial appendage occlusion in patients with non-valvular atrial fibrillation; ChiCTR1900023035).
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Zhang et al. (2022) conducted an RCT in nonvalvular atrial fibrillation (n=196). Left atrial appendage closure with the Leftear device vs. Prespecified maximum annual incidence was evaluated on Composite of hemorrhagic or ischemic stroke, systemic embolism, and cardiac or unexplained death (95% CI 0.3-4.5). Left atrial appendage closure with the Leftear device was noninferior to a prespecified 8.0% incidence for the primary composite endpoint, occurring in 1.6% of patients (95% CI 0.3-4.5%).
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