Next-generation LAA closure device ‘promising alternative’ for adults with nonvalvular AF
Among patients with nonvalvular atrial fibrillation, left atrial appendage closure with a second‐generation device was associated with high success rates and a low risk for procedure‐related adverse events, researchers reported.
Data show left atrial appendage (LAA) closure with the first‐generation Ultraseal device (Cardia Inc.) is a “feasible therapeutic option” in patients with nonvalvular AF, Carlo Andrea Pivato, MD, a resident in advanced heart failure and transplant cardiology at Humanitas University in Milan, and colleagues wrote in Catheterization and Cardiovascular Interventions. The second‐generation Ultraseal consists of a distal bulb to anchor the device and a larger proximal sail, connected by an articulating joint, offering several advantages, they wrote.
“Although both generations of the Ultraseal device can be recaptured up to five times, the second‐ generation device incorporates some iterations that may increase device success rate: The articulating joint has a lesser degree of movement to facilitate the deployment and retrieval, while the distal center post has been removed so that the bulb is more flexible with a lower radial force allowing for less dependence on oversizing and a safer deep implant,” the researchers wrote. “These two modifications reduce the overall length of the device (from 15 to 21 mm of the first generation to 10 to 18 mm of the second generation) and therefore the minimum required length of the LAA (from 16 to 12 mm).”
For the LIGATE study, Pivato and colleagues analyzed data from 52 adults with nonvalvular AF undergoing second‐generation Ultraseal device implantation from February 2018 to September 2020 as part of an international registry. The mean age of patients was 76 years; 30.8% were women and the mean HAS-BLED score was 3. Researchers assessed periprocedural and post‐discharge events through 6 months of follow‐up. The co‐primary efficacy endpoints were device success and technical success; the primary safety endpoint was in‐hospital major adverse events.
All patients received the device implant; technical success was achieved in 96.1% of patients.
In‐hospital major adverse events occurred in 5.8% of patients. The incidence of 6‐month all‐cause death and major bleeding was 11.6% and 2.1%, respectively. There were no strokes, transient ischemic attacks, systemic embolisms or device embolization after discharge.
“This novel device might be a promising alternative to other left atrial appendage occluders,” Pivato told Healio. “Larger studies with longer follow‐up are warranted to further evaluate the safety and the efficacy of this device, especially in comparison with other left atrial appendage occluders.”
For more information:
Carlo Andrea Pivato, MD, can be reached at carloandreapivato@gmail.com; Twitter: @capivato.
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