The NCDR Left Atrial Appendage Occlusion Registry.

Area of Science:

• Cardiology
• Medical Devices
• Public Health

Background:

• Limited post-approval clinical data exist for Left Atrial Appendage Occlusion (LAAO) device use in preventing stroke in atrial fibrillation patients.
• Existing data primarily stem from two randomized trials, necessitating real-world evidence.

Purpose of the Study:

• To describe the National Cardiovascular Data Registry (NCDR) LAAO Registry structure and governance.
• To present patient, hospital, and physician characteristics for Watchman procedures.
• To report in-hospital adverse event rates for LAAO procedures in the United States over a three-year period.

Main Methods:

• Analysis of data from the NCDR LAAO Registry, encompassing procedures performed between January 2016 and December 2018.
• Characterization of patient demographics, comorbidities (CHA2DS2-VASc and HAS-BLED scores), and procedural details.
• Adjudication of outcomes and assessment of data quality for collected information.

Main Results:

• 38,158 LAAO procedures were included, performed by 1,318 physicians across 495 hospitals.
• Patients were older (mean age 76.1 years) with high comorbidity scores (CHA2DS2-VASc 4.6, HAS-BLED 3.0).
• Major in-hospital adverse events occurred in 2.16% of patients, with pericardial effusion (1.39%) and bleeding (1.25%) being most common; stroke (0.17%) and death (0.19%) were rare.

Conclusions:

• The NCDR LAAO Registry successfully enrolled over 38,000 patients.
• Patients undergoing LAAO were older and had more comorbidities than those in pivotal trials.
• In-hospital adverse event rates were lower than previously reported in clinical trials, indicating favorable real-world outcomes.