Introduction: Patients with atrial fibrillation (AF) and likelihood of bleeding can undergo left atrial appendage occlusion (LAAO) as an alternative method of stroke prophylaxis. A short course of anti-thrombotic drugs is used post-procedure to offset the risk of device-related thrombus, but evidence for this practice is limited.
Methods: Patients with AF and high risk for both stroke and bleeding were advised about their management strategy by a multidisciplinary physician panel. This included the perioperative drug therapy for those patients advised to undergo LAAO. Those deemed to be at unduly high risk of bleeding from anti-thrombotic drugs were assigned to minimal treatment with no anti-thrombotic drugs or aspirin alone. The remaining patients received standard care with a 6–12-week course of dual antiplatelets or anticoagulation following device implant. We compared mortality, device-related thrombus, ischaemic stroke and bleeding events during the 90 days post-implant and long term. Event-free survival was assessed using Kaplan–Meier survival analysis, with log rank testing for statistical significance.
Results: A total of 75 patients underwent LAAO (Amulet™, Abbott Medical) of whom 63 (84%) had a prior serious bleeding event. The 42 patients on minimal treatment were older (74.3 ± 7.7 vs 71.2 ± 7.2) and had higher HASBLED score (3.6 ± 0.9 vs 3.3 ± 1.2) than the 33 patients receiving standard care. There were no device-related thrombi or strokes in either group in the 90 days post-procedure, but patients having standard treatment had more bleeding events (5/33 vs 0/42; p=0.01) with associated deaths (3/33 vs 0/42; p=0.05). During median long-term follow-up of 2.2 years, all patients were transitioned onto no antithrombotic drugs (43 patients [61%]) or a single antiplatelet (29 patients [39%]). There was no evidence of early minimal treatment adversely affecting long-term outcomes.
Conclusions: Short-term anti-thrombotic drugs are not needed after LAAO implant in patients with high bleeding risk and this is the first clinical study to show that they may be harmful. ❑