Left atrial appendage (LAA) closure with use of a novel, disc-like occluder (the Leftear device [Pulse Scientific]) has demonstrated a high rate of procedural success, and satisfactory safety and efficacy for stroke prevention among patients with nonvalvular atrial fibrillation (NVAF). These findings were published in the journal JACC: Asia.
Researchers sought to explore the effectiveness and safety of LAA closure with use of the novel, disc-like device in patients with NVAF. They conducted a prospective, multicenter, registry-based study in 200 patients with NVAF and a CHA2DS2-VASc risk score of 2 or higher.
The primary study endpoint was defined as any serious adverse events (SAEs). Efficacy was evaluated with use of a primary composite endpoint that comprised hemorrhagic or ischemic stroke, systemic embolism, and cardiac or unexplained death at 1 year of follow-up.
A total of 200 patients who fulfilled all inclusion and exclusion criteria were enrolled from 9 hospitals in China between 2018 and 2019. Overall, 56.5% of the participants were men. The mean patient age was 68.3 years (range, 38-89 years). Among the participants, the most common risk factor for stroke was hypertension, which was reported in 63.5% of individuals. In all, 35% of patients had experienced a prior ischemic stroke or transient ischemic attack.
Of the participants, 31.0%, 68.0%, and 1.0% had New York Heart Association (NYHA) functional classes I, II, and III, respectively. Patients’ average CHA2DS2-VASc risk score was 3.5. The average HAS-BLED score was 2.5.
The novel, disc-like device was implanted in 98.0% of the patients, with a simple LAA closure procedure, a 1-stop LAA closure combined with atrial fibrillation ablation procedure, and other procedures implemented in 31.5%, 66.5%, and 2.0% of the participants, respectively. All of the 196 patients were implanted with 1 occluder; the remaining 4 patients did not receive implants. The immediate success rate of occlusion was 100% (peridevice leak ≤3 mm) and 90.8% had no residual flow.
Overall, SAEs were reported in 4.5% of the patients (95% CI, 1.6%-7.4%), which occurred mainly in those receiving 1-stop LAA closure. Pericardial tamponade was clinically documented in 6 participants, all of whom had received 1-stop LAA closure. None of the participants experienced a major bleeding event or acute device-related thrombus.
Over the 12-month follow-up, the risk for the primary composite endpoint was 1.6% (95% CI, 0.3%-4.5%), with statistical noninferiority being attained (upper bound of 95% CI: 4.5% < the prespecified maximum annual incidence of 8.0%). Ischemic stroke was reported in 1 participant and incomplete LAA sealing was reported in 3 individuals. No delayed device-related thrombus was observed.
Study limitations include that this is the first-in-human study of this novel, disc-like occluder and most operators were not familiar with this new device. This might enhance the difficulty of implantation and the risk for SEAs. Additionally, no control group is included in the study.
“LAA closure with the novel disc-like device shows high procedural success, satisfactory safety, and encouraging efficacy for stroke prevention in patients with NVAF,” the study authors wrote. “Compared with 1-stop operation of LAA closure combined with AF ablation, single LAA closure may be more tolerable.”
Zhang X, Hou S, Liu W, et al. Percutaneous left atrial appendage closure with a novel
LAA occluder for stroke prevention in atrial fibrillation. JACC: Asia. Published online
September 6, 2022. doi:10.1016/j.jacasi.2022.04.009