A new device that aims to close the left atrial appendage (LAA) in a different way from existing commercial devices showed promising preclinical and early clinical results, according to a new report. Gordon X. Wong, MD, MBA, of the University of California, Davis Medical Center, Sacramento, and colleagues, presented these findings in a manuscript published online Wednesday in JACC: Cardiovascular Interventions. The senior author of this manuscript, Jason H. Rogers, MD, also of UC-Davis Medical Center, is scheduled to discuss these results Thursday at the Transcatheter Valve Therapeutics (TVT) conference in Phoenix. Both commercially available LAA occlusion devices, Watchman FLX (Boston Scientific) and Amplatzer Amulet (Abbott), have demonstrated safety and effectiveness in preventing stroke, thromboembolism and mortality in patients with non-valvular atrial fibrillation (AF). Unlike the commercially available devices, which use either a plug or a hub-and-disk design to close the LAA, the Laminar left atrial appendage exclusion (LAAX) system uses a rotational ball to exclude the LAA from the left atrium, which substantially reduces LAA volume. Laminar, the manufacturer of the new device, funded the study. The preclinical study reported by the authors implanted the Laminar device into 10 canine and 15 human subjects. All implants were successful. In the animals, no peridevice leak (PDL) or device-related thrombus (DRT) was found at 45 and 150 days, and histological examination showed fully closed LAAs covered with neo-endocardium. In the human subjects, no safety events were reported through 1 year, and all had successful LAA closure without DRT at 45 days by both transesophageal echocardiography and computed tomography, and these results held through 1 year. In an accompanying editorial, Apostolos Tzikas, MD, PhD, of the European Interbalkan Medical Center, Thessaloniki, Greece, asked why, if the LAA can be eliminated with rotation, it had not been tried surgically. He said the answer may lie in the combination of the Laminar device’s dedicated lock mechanism and rotation but that data from longer follow-up are needed. One possible complication, he wrote, is that “tissue folding may lead to the formation of pleats, which theoretically may become thrombogenic in the long term in certain left atrial anatomies.” He noted that two registered studies of Laminar have numerous exclusion criteria, including prior cardiac surgery and a history of pericarditis. “Novel technologies and device designs are definitely needed in the rapidly growing field of transcatheter LAA occlusion, a procedure that might eventually become the primary option for the prevention of thromboembolism in patients with AF,” Tzikas wrote. He added that while the Laminar device has potentially advantageous design features over others, “more experience and data are needed to understand possible limitations of the device design, its use by an average operator, LAA anatomical characteristics, and long-term tissue remodeling and healing.” “It is conceivable that proper patient selection, careful preprocedural planning with advanced cardiovascular imaging, and adequate device surveillance will be the key factors for success,” he concluded. Sources: Wong GX, Kar S, Smith TW, et al. Transcatheter Exclusion of the Left Atrial Appendage: Preclinical and Early Clinical Results With the Laminar Device. JACC Cardiovasc Interv. 2023 Jun 7 (Article in press). Tzikas A. Left Atrial Appendage: The Ex-Clusion Factor. JACC Cardiovasc Interv. 2023 Jun 7 (Article in press). What’s Next: The findings will be discussed at 11:45 a.m. EDT (8:45 a.m. MST) Thursday during an Innovation session at the TVT conference in Phoenix. Image Credit: freshidea – stock.adobe.com