OBJECTIVE: This study was designed to first evaluate the histological compatibility of the split occluder in preclinical animal models, followed by clinical validation of its procedural feasibility and occlusion effectiveness in a first-in-human trial cohort. METHODS: Eight healthy labrador retrievers were selected for this study. A split-type occluder was introduced to occlude their left atrial appendage. The experimental animals were euthanized at 1, 3, and 6 months, respectively. Prior to being euthanized, transesophageal echocardiogram (TEE) and pulmonary vein computed tomography venography (CTV) were conducted on the subjects. A gross anatomical examination was then conducted on each animal post euthanasia. Additionally, data from 12 patients who underwent LAAO procedures using this device were included in the study. Each patient was monitored over a 3-month follow-up period. RESULTS: The operations to insert split left atrial appendage occluders into each of the eight test dogs were successful. Subsequent TEE and pulmonary vein CTV revealed that occluder surfaces exhibited no thrombus formation and that the occluders exhibited no significant residual flow. The gross anatomical examination indicated satisfactory endothelialization. The occluders were successfully implanted in all 12 patients, with no complications reported in the occlusions during the subsequent 3-month follow-up period. CONCLUSIONS: In both animal and human studies, the split occluder demonstrated a significantly high immediate success rate in the occlusion of the left atrial appendage. This was accompanied by a low occurrence of residual shunts and device-related complications, indicating its reliability and efficacy.
Li et al. (Thu,) studied this question.