The Centers for Medicare & Medicaid Services (CMS) approved the left atrial appendage (LAA) occlusion registry on Aug. 17 to assess patients undergoing percutaneous and epicardial based LAA occlusion procedures to reduce the risk of stroke.
Hospitals participating in the registry submit data each quarter to the American College of Cardiology (ACC) Foundation’s National Cardiovascular Data Registry (NCDR). The NCDR consists of eight hospital-based registries and two outpatient registries aimed at measuring outcomes and increasing the quality of care.
The registry enrolls adults with atrial fibrillation who undergo LAA occlusion. The ACC expects to complete the study in 2026.
The primary outcome measures are the proportion of patients with a major complication and the proportion of patients experiencing any of the following: Procedure aborted, conversion to open heart, hemorrhagic, ischemic or undetermined stroke, any effusion requiring drainage or surgery, device embolization, systemic embolism or major bleeding event.
In February, CMS released the final national coverage determination for percutaneous LAA closure for non-valvular atrial fibrillation.
As of now, the Watchman (Boston Scientific) is the only FDA-approved LAA closure device. The ACC launched the LAA occlusion registry in December 2015, less than a week after the ACC, Society for Cardiovascular Angiography and the Heart Rhythm Society released a consensus statement on LAA occlusion procedures and devices.