The FDA has announced that it is investigating why left atrial appendage occlusion (LAAO) with the first-generation Watchman device may be associated with better outcomes for men than women.
A recent study published in JAMA Cardiology appears to have caught the agency’s attention. The team behind that analysis tracked data from more than 49,000 LAAO patients, noting that adverse events were seen in 6.3% of women and just 3.9% of men.
Specific complications, including major bleeding events and pericardial effusion requiring drainage, were also more likely to occur when the patient was female.
“The FDA 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,” according to the agency. “Currently, the FDA believes the benefits continue to outweigh the risks for approved LAAO devices when used in accordance with their instructions for use.”
The JAMA Cardiology study in question did have certain limitations, the FDA noted. It didn’t examine long-term outcomes, for instance, and the data all came from a single type of LAAO device, Boston Scientific’s first-generation Watchman.
Even with these limitations in mind, however, the FDA emphasized that this situation was under investigation. The agency said it would work with manufacturers to gain a better understanding of these potential differences between male and female patients, providing updates to the public whenever possible.
Read the full FDA advisory here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.