ABC | Volume 113, Nº4, October 2019

Original Article Left Atrial Appendage Transcatheter Occlusion with AMPLATZER™ Amulet™ Device: Real Life Data with Mid‑Term Follow-Up Results Mehmet Levent Şahiner, Ergun Baris Kaya, Cem Çöteli, Kudret Aytemir Hacettepe Universitesi Tip Fakultesi - Department of Cardiogly, Ankara – Turkey Mailing Address: Cem Çöteli • Hacettepe Universitesi Tip Fakultesi - Department of Cardiogly, Ankara 06100 – Turkey E-mail: cemcoteli@hacettepe.edu.tr Manuscript received June 24, 2018, revised manuscript December 12, 2018, accepted January 23, 2019 DOI: 10.5935/abc.20190138 Abstract Background: Left atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy. Objective: To evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device‑related thrombosis. Methods: Sixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15 months (median – 20 months, interquartile range – 9 to 27 months). The postprocedural assessment was done at the 1 st , 6 th , and 12 th month. Patients were clinically evaluated, and transesophageal echocardiography was performed at each visit. We evaluated the condition of normality of variables using the Kolmogorov-Smirnov test. P-values < 0.05 were statistically significant. Results: The most common indication for the procedure was major bleeding with anticoagulants (n: 53, 88.3%). The procedure was completed successfully in 59 (98.3%) patients. Periprocedural mortality was observed in one patient. Postprocedural antiplatelet treatment was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy in 52 (88.1%), 2 (3.4%), and 5 (8.5%) patients, respectively. We found no clinically significant cerebrovascular events, device-related thrombus, or embolization in any patient during the follow-up. Two (3.4 %) patients presented significant peri-device leak (>3 mm) at the 1 st month evaluation, which disappeared at the 12 th month follow-up. Conclusion: We concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes. (Arq Bras Cardiol. 2019; 113(4):712-721) Keywords: Atrial Fibrillation; Atrial Appendage; Mortality; Echocardiography/methods; Cardiac Catheterization; Anticoagulants/therapeutic use. Introduction Atrial fibrillation (AF) is the most common type of sustained cardiac arrhythmia, especially in older adults. 1 AF is associated with increased all-cause mortality and morbidity. The most significant AF morbidity is thromboembolic cerebrovascular events (CVEs). CVEs result in decreased quality of life and increased health care costs. 2 Oral anticoagulants (OACs) are effective therapeutic options to prevent thromboembolic events. 2 Randomized controlled studies and real-life studies showed that OAC drugs raise the risk of bleeding. 3 The major bleeding risk with vitamin K antagonists and direct OACs should not be ignored, especially in patients with high bleeding risk. 4-6 The balance between the protection from thromboembolic events and bleeding risk may be overbalanced towards bleeding. In this scenario, left atrial appendage (LAA) occlusion should be an alternative therapeutic option for some specific patient groups. 2 According to current AF guidelines from the American College of Cardiology/American Heart Association (ACC/AHA) and the European Society of Cardiology (ESC), LAA occlusion (surgical or percutaneous) may be considered for stroke prevention in patients with AF and contraindications to long-termanticoagulant treatment with Class IIb and Level B recommendation. 2,7 Due to the lack of large randomized controlled trials on LAA occlusion with the Amulet device, there are some gaps on clinical approaches for perioperative preparation, appropriate treatments for possible complications, and postoperative follow-up, including post-implant antithrombotic therapy. In this retrospective observational study, we aimed to emphasize challenges to LAA occlusion, evaluate possible perioperative complications, and how to deal with them. In addition, we intended to reveal real-life mid-term outcomes in our patient group and share our postprocedural antiplatelet regimen as an alternative option for patients who have very high stroke risk despite the LAA occlusion. Methods Population Patients who had a major bleeding event with anticoagulant treatment, recurrent minor bleeding with at least two different 712