Author + information
- Kasper Korsholm1,
- Kirsten Melgaard Nielsen1,
- Jesper Møller Jensen1,
- Henrik Kjærulf Jensen1,
- Grethe Andersen2 and
- Jens Erik Nielsen-Kudsk1
LAAO to prevent thromboembolism in atrial fibrillation is particularly used in patients with a high bleeding risk or prior serious bleeding during anticoagulation. Thus, post-implant antithrombotic treatment to prevent device related thrombosis should be chosen such that the bleeding risk is as low as possible. Current recommendations are 1-3 months of dual antiplatelet therapy after LAAO with the AmplatzerTM devices (St. Jude Medical, MN, USA), followed by aspirin alone for a total period of at least 6 months. The incidence of device-related thrombosis ranges from 2.9-17.6% in different LAAO registries. The objective was to evaluate safety and efficacy of AmplatzerTM LAAO devices and aspirin monotherapy after implantation.
Single-center, prospective, non-randomized study on LAAO with the AmplatzerTM Cardiac Plug or Amulet devices in consecutive patients (n=110) with atrial fibrillation. Aspirin was given as monotherapy for at least 6 months after LAAO. Primary endpoint was device-related thrombosis, while secondary endpoints were ischemic stroke or major bleeding events. Clinical follow-up was conducted after 6 weeks and 12 months with both TEE and cardiac CT.
A total of 107 patients were included for analysis. 3 patients were excluded due to mechanical valve prosthesis. Successful implantation was obtained in all patients. The periprocedural complication rate was 4.6%, and none of these were fatal. The mean CHA2DS2-VASc score was 4.4 ± 1.6 and HAS-BLED 4.1 ± 1.1. Median follow-up was 2.3 years (IQR: 1.6-3.2), with a total of 265.5 patient-years. Device-related thrombus was found in only 2/107 (1.9%) cases. Stroke occurred in 6/107 patients, with an annualized rate of 2.3%, which is a 60.8% risk reduction from the predicted annual stroke rate calculated from the CHA2DS2-VASc score. Annual risk of major bleeding events was reduced with 57.4% from the predicted annual rate.
LAAO with the Amplatzer Cardiac Plug or Amulet can be safely performed with aspirin monotherapy after implantation without increased risk of device-related thrombosis or stroke.
STRUCTURAL: Left Atrial Appendage Exclusion