Nonvalvular atrial fibrillation (AF) is a major risk factor for stroke, and it is a condition that affects at least 12 million individuals in the US, according to data cited in the new guidelines. Oral anticoagulation is a first-line strategy for reducing stroke risk in patients with the arrhythmia, but the benefit is potentially compromised in people at high risk for bleeding.
More Than 100K Implants Per Year and Growing
Clots associated with nonvalvular AF commonly form in the left atrial appendage. The FDA has approved two LAAO systems for the prevention of stroke: the Amplatzer Amulet (Abbott) and the Watchman (Boston Scientific). Earlier this month, the FDA announced that Boston Scientific is recalling Watchman systems that were performed without the use of positive pressure-controlled ventilation. The agency said at least 120 people have been seriously injured, and 17 have died, after undergoing the procedure.
For both systems, the current indication remains limited to people with contraindications to oral anticoagulation; however, the consensus expressed in the new guidelines is that this restriction is “outdated” in the wake of evidence that has become available since the publication of pivotal trials that preceded approval of both available devices.
How often devices are being implanted outside current FDA labeling is unclear, but LAAO has become “one of the most frequent procedures” in cardiology, with an estimated 100,000 performed in 2024, according to data cited by Goldsweig.
Eight evidence-based recommendations, covering patient selection, how imaging should be employed to assess and follow patients, and whether adjunctive oral anticoagulation should be considered in those with peridevice leak or device-related thrombus, were outlined in the new guidelines, which were simultaneously published in the Journal of the Society for Cardiovascular Angiography & Interventions and Heart Rhythm.
Two address patient selection. The first reiterates the current indication, which is that LAAO should be considered in patients with nonvalvular AF with a contraindication to oral anticoagulation.
The second identifies LAAO and oral anticoagulation as treatment options for patients with nonvalvular AF who do not necessarily have a contraindication to oral anticoagulation. Specifically, the guideline includes LAAO as an option for those “with strong preferences to avoid long-term oral anticoagulation.”
https://www.medscape.com/viewarticle/first-major-guidelines-issued-left-atrial-appendage-2025a1000lak
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