Background: We previously pioneered a negatively ionized polyethylene terephthalate membrane method (the SMART technique) with the LAMax (test) occluder to reduce platelet adhesion and promote endothelialization.
Objectives: This study aimed to compare the safety and efficacy of the test occluder with the Watchman 2.5 device (control) in patients with nonvalvular atrial fibrillation to reduce stroke risk.
Methods: Overall, 236 patients were randomly assigned (1:1) (open-label) to the test or control device for left atrial appendage occlusion (LAAO). The effectiveness endpoints included 12-month successful left atrial appendage (LAA) sealing with residual flow ≤5 mm and clinical success (composite of ischemic stroke, transient ischemic attack, and systemic embolism). Safety endpoints were also studied. A noninferiority margin of -7% was set between the devices.
Results: The test device was noninferior to the control device for the effectiveness endpoints of successful LAA sealing (test 93.2% vs control 89.8%; P < 0.05) and clinical success (test 93.2% vs control 89.8%; P < 0.05). The 12-month safety endpoints were similar between the 2 devices. The device-related thrombus rates for the control device at the 3- and 12-month visits were 5.7% and 4.6%, respectively; no cases of device-related thrombus occurred with the test device.
Conclusions: This study suggests that transcatheter LAAO using the SMART technique may effectively and safely prevent stroke in patients with nonvalvular atrial fibrillation. Although further studies with larger sample sizes are needed, this novel technique may prevent device-related thrombus formation and has high potential for application in interventional therapies. (LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke; NCT04429646).
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