Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns

Federal health officials warn that the use of certain surgical devices to prevent blood clots appear to carry an increased risk of severe bleeding events and complications among women.

The FDA issued a Letter to Healthcare Providers on September 27, after determining that Left Atrial Appendage Occlusion (LAAO) devices may cause women to face a higher risk of major adverse events and lengthened hospital stays when compared to men.

The warning comes following an analysis of a recent study published in JAMA Cardiology.

LAAO is a surgical procedure performed on patients who suffer from atrial fibrillation, a condition in which the upper chambers of the heart beat either too fast or too slow, causing inadequate blood flow to the lower chamber of the heart. This condition often puts patients at risk blood clots, stroke, heart failure and other heart-related complications.

To treat the condition, cardiologist will often recommend implanting LAAO devices in the heart to mechanically seal the left atrial appendage to prevent blood clots from entering the bloodstream and causing a stroke.

Currently, the only approved and marketed LAAO devices in the U.S. are manufactured by Abbott Medical (Amplatzer Amulet device) and Boston Scientific (Watchman and Watchman FLX devices). However, research published in JAMA Cardiology last month found a statistically significant higher rate of adverse procedural events in women receiving LAAO device implants compared to men.

Researchers reviewed 49,357 patients from the LAAO registry who were treated with the Boston Scientific Watchman device between 2016 and 2019. Of the patients, 41.3% were women and 58.7% were men.

The team of researchers found the overall risk of death or adverse events requiring prolonged hospital stays for women were about twice the rate of male patients. Female patients were assessed with a 4.1% chance of major adverse events compared to 2.0% for men.

Female patients had higher rates of occurrence for experiencing major bleeding events, fluid build-up around the heart (pericardial effusion), and the need for catheters to drain infections.

As a result of the study’s findings, the FDA is recommending medical professionals closely monitor patients who have been treated with LAAO devices,  and to discuss risks and benefits of all available options for stroke prevention in patients with atrial fibrillation.

The FDA announced it will continue reviewing the new study while also evaluating LAAO devices currently approved by Abbott Medical and Boston Scientific. Officials indicated they will investigate several sources of information related to the devices including premarket studies, mandated postmarket studies, and real-world data to provide additional information on this issue.

The agency requests healthcare providers and patients to report any and all adverse events or suspected adverse events involving LAAO devices to the MedWatch, the FDA Safety Information and Adverse Event Reporting program.