Left atrial appendage occlusion using the ACP or Amulet with aspirin monotherapy resulted in a 1.9% rate of device-related thrombosis and a 61% reduction in stroke risk compared to predicted rates.
Cohort (n=107)
No
Does left atrial appendage occlusion with aspirin monotherapy post-implantation prevent device-related thrombosis and stroke in patients with atrial fibrillation and high bleeding risk?
LAAO with the ACP or Amulet followed by aspirin monotherapy appears safe and effective in high bleeding risk AF patients, with low rates of device-related thrombosis and stroke.
AIMS: The aim of the study was to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) or Amulet using aspirin alone (ASA) as post-implantation antithrombotic treatment. METHODS AND RESULTS: This was a single-centre, prospective, non-randomised study on LAAO with the ACP or Amulet in a consecutive cohort (n=110) treated by ASA alone post implantation. The primary outcome was device-related thrombosis, while secondary outcomes were ischaemic stroke or major bleeding. Clinical follow-up was conducted after six weeks and 12 months with TEE and cardiac CT. One hundred and seven patients were included in the analysis. Three patients were excluded due to a mechanical valve prosthesis. CHA2DS2-VASc score was 4.4±1.6 and HAS-BLED 4.1±1.1. Successful implantation was obtained in all patients with a periprocedural complication rate of 4.6%. Median follow-up was 2.3 years, with a total of 265 patient-years. Device-related thrombosis was detected in 2/107 (1.9%) cases. Stroke occurred in 6/107 patients, with an annualised rate of 2.3%, which is a 61% risk reduction compared to the predicted rate. Annual risk of major bleeding was reduced by 57%. CONCLUSIONS: LAAO with the ACP or Amulet was safely performed with ASA monotherapy after implantation without an increased risk of device-related thrombosis or stroke.
Korsholm et al. (Sat,) conducted a cohort in Atrial fibrillation with high bleeding risk (n=107). Left atrial appendage occlusion (LAAO) with AMPLATZER Cardiac Plug (ACP) or Amulet plus aspirin alone was evaluated on Device-related thrombosis. Left atrial appendage occlusion using the ACP or Amulet with aspirin monotherapy resulted in a 1.9% rate of device-related thrombosis and a 61% reduction in stroke risk compared to predicted rates.