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Fourth-generation LAA closure device feasible, safe for nonvalvular AF
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In patients with nonvalvular atrial fibrillation, left atrial appendage closure with the latest generation Watchman device was feasible and safe and has features that could contribute to better performance of the occluder, researchers reported in Catheterization and Cardiovascular Intervention.
“Besides increasing operator experience, new technical features may further decrease the rate of pericardial effusions, which represents one of the major concerns in percutaneous [left atrial appendage] closure,” the researchers wrote.
Jakob Ledwoch, MD, of the CardioVascular Center CVC in Frankfurt, Germany, and colleagues conducted a prospective, nonrandomized, first-in-man study of left atrial appendage (LAA) closure with the fourth-generation device in 36 patients (mean age, 73 ± 6 years; 67% men; mean CHADS2 score, 2.5; mean CHA2DS2-VASc score, 4.5). The team conducted follow-up at 45 days, 6 months and 12 months after implantation.
The researchers sought technical success (considered effective delivery and release of occluder into the LAA) and procedural success (considered effective implantation of the device without serious adverse events) as primary endpoints. For secondary endpoints, the researchers looked for absence of device- or procedure-related adverse events during the index hospitalization, as well as rate of stroke at 1 year and rate of phenprocoumon discontinuation at 45 days and 12 months.
The device was implanted successfully in 34 patients (94%). Patients experienced no serious device- or procedure-related hospital complications. At 12 months, three ischemic strokes (8%), one hemorrhagic stroke (3%), one transient ischemic attack (3%) and three deaths (9%) occurred. At 6 months, thrombus formation associated with the device was detected in one patient (3%) and successfully treated with low–molecular-weight heparin.
“With a technical and procedural success rate of 94%, high feasibility and acute safety of the device were proven,” the researchers wrote. – by Allegra Tiver
Disclosure: Ledwoch reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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