Event rates low at 1 year in real-world data from next-generation LAA closure device
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A next-generation left atrial appendage closure device was associated with low rates of poor outcomes and high rates of complete seal at 1 year, researchers reported at Cardiovascular Research Technologies.
As Healio previously reported, in the 45-day results of the SURPASS registry, the next-generation device (Watchman FLX, Boston Scientific) was associated with low rates of adverse events and peri-device leak in patients with atrial fibrillation requiring left atrial appendage (LAA) closure for stroke prevention. Samir R. Kapadia, MD, chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic and professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, presented 1-year results at Cardiovascular Research Technologies (CRT).
“SURPASS was designed to assess outcomes with Watchman FLX in a routine clinical setting,” Kapadia said during the presentation.
The analysis included 18,233 patients with AF (mean age, 76.2 years; 41% women) who underwent LAA closure with the Watchman FLX device for stroke prevention between Aug. 5, 2020, and March 31, 2022, for whom 1-year data were available.
The most common discharge medications after the procedure were a direct oral anticoagulant plus aspirin (48.3%) and a direct oral anticoagulant alone (23.1%), Kapadia said during the presentation.
At 1 year, 8.3% of patients died, 1.6% had a stroke (1.2% ischemic stroke), 0.1% had a systemic embolism and 6.74% had major bleeding, according to the researchers.
The rates of complete seal with no leak were 96.1% after the procedure, 83% at 45 days and 84.4% at 1 years, Kapadia said.
At 1 year, men were more likely than women to die (7.6% vs. 8.7%; P = .003), but women were more likely than men to have major bleeding (7.7% vs. 6.1%; P < .001), he said, noting that there was no difference by sex in stroke or systemic embolism.
“This SURPASS registry showed that Watchman FLX implantation can be accomplished safely with clinical outcomes similar to pivotal trials in a large number of patients at a large number of sites by a large number of operators,” Kapadia said during the presentation. “These data provide benchmarks for success and complications. Although overall outcomes were similar in women and men, mortality was higher in men than women, whereas women experienced more major bleeding and pericardial effusion requiring intervention within 1 year.”
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Kapadia SR, et al. Late-Breaking Trials | Session Three. Presented at: Cardiovascular Research Technologies; Feb. 25-28, 2023; Washington, D.C.
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