CHAMPION-AF: A Win for Watchman FLX, but With Caveats

Key Points:

• The CHAMPION-AF trial found that left atrial appendage occlusion (LAAO) with the Watchman FLX device is noninferior to direct oral anticoagulants (DOACs) in preventing cardiovascular death, stroke, and systemic embolism over 3 years in patients with atrial fibrillation (AF) eligible for anticoagulation, with lower non-procedure-related bleeding risk.
• Despite meeting noninferiority criteria, experts raised concerns about the trial’s limitations, including lower-than-expected event rates, more ischemic strokes in the LAAO group, and selective focus on non-procedural bleeding, questioning whether LAAO should be considered equal to DOACs for all patients.
• Physicians emphasize that LAAO remains a valuable option primarily for patients with contraindications to anticoagulation, and recommend shared decision-making to weigh the risks and benefits, especially since long-term impacts and certain procedural risks remain uncertain.
• The trial’s results contrast with the prior CLOSURE-AF study, which showed worse outcomes with LAAO, fueling ongoing debate about the device’s role; further data from ongoing trials like LAAOS-4 and CATALYST are awaited to clarify efficacy in higher-risk populations.
• Experts caution against widespread use of LAAO in all AF patients eligible for anticoagulation, highlighting the importance of individualized patient selection and the need for objective discussions about treatment options given the procedure’s upfront risks and unclear long-term benefits.