Women seem more likely than men to experience adverse events or extended hospital stays from left atrial appendage occlusion devices (LAAO), the FDA said today.
In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference – and that it is working with device manufacturers to understand the cause.
Currently, FDA officials still believe the benefits outweigh the risks when it comes to using LAAO devices like Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman and Watchman FLX to prevent people with atrial fibrillation from having strokes.
The FDA advised health care providers to continue monitoring people using LAAO devices, discussing risks and benefits, and reporting adverse events.
The letter to healthcare providers comes after an analysis of real data in the National Cardiovascular Data Registry’s LAAO register of 49,357 patients (41.3% women and 58.7% men) who underwent LAAO procedures from 2016 to 2019. Researchers at UC San Diego, Yale University, and other US and Canadian institutions found that 6.3% of women experienced adverse events versus 3.9% of men.
There were also differences between women and men for serious adverse events (4.1% vs. 2.0%) and hospital stays of more than one day (16.0% vs. 11.6%).
FDA officials admitted the limitations of the study, which was published in the August 11th issue JAMA cardiology. The data covered only one device – the first-generation Watchman – and it was not randomized or included longer-term outcomes beyond what was happening in the hospital. But the FDA added, “The analysis provides results from a large registry of patients treated with LAAO implants in the United States.”