FDA monitoring gender differences in outcomes with LAAO devices

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The US Food and Drug Administration (FDA) has informed healthcare providers of recent information about the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device.

The FDA is evaluating an analysis published in the Journal of the American Medical Association (JAMA) Cardiology of real-world data in the National Cardiovascular Data Registry (NCDR) LAAO Registry from patients undergoing LAAO procedures with the Watchman (Boston Scientific) left atrial appendage closure device from 2016 to 2019 indicates that procedural outcomes such as major adverse events and lengthened hospital stay may be more common in women compared to men. The causes for these differences are yet to be determined.

The article by Douglas Darden (University of California, San Diego, La Jolla, USA) et al presented an analysis of 49,357 patients from the LAAO registry (41.3% women and 58.7% men) treated with the Watchman device between 2016 to 2019. The authors found a statistically significant higher rate of adverse procedural events in women compared to men including any adverse events (6.3% vs. 3.9%, p<0.001), any major adverse events (4.1% vs 2.0%, p<0.001), and hospital stay longer than one day (16% vs 11.6%, p<0.001). Among specific procedural adverse events, the rates of pericardial effusion requiring percutaneous drainage was 1.2% vs. 0.5% and major bleeding was 1.7% vs. 0.8% in women compared to men, respectively. Procedure-associated death was 0.3% in women and 0.1% in men.

As well as the Watchman device, Abbott’s Amplatzer Amulet is also approved for use in the USA. The FDA has said that it will work with the manufacturers of approved LAAO devices to evaluate information from several sources, including premarket studies, mandated post-market studies, and real-world data to provide additional information on this issue. Currently, the FDA has said that it believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use.

Current recommendations from the regulator include to continue monitoring patients who have been treated with LAAO devices per the current standard of care, and to discuss the risks and benefits of all available options for stroke prevention in patients with atrial fibrillation (AF) as part of shared clinical decision-making.

Additionally, the FDA has advised healthcare providers to report any adverse events or suspected adverse events experienced with the use of LAAO devices. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting programme.


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