ABC | Volume 113, Nº4, October 2019

Original Article Şahiner et al LAA occlusion with amulet device Arq Bras Cardiol. 2019; 113(4):712-721 anticoagulant treatments, or any life-threatening bleeding risk, such as high risk of falling or idiopathic thrombocytopenic purpura, were evaluated for suitability for LAA occlusion. Individuals who had less than one-year survival, were under critical non-cardiac status, and did not accept any interventional procedure were excluded. This retrospective observational study included 60 patients who had undergone percutaneous LAA occlusion with the Amulet device in the Hacettepe University Hospital Cardiology Clinic between September 2015 and March 2018. All patients signed the informed consent form, and the local ethics committee approved the procedures. Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, retroperitoneal etc.) and bleeding causing a fall in hemoglobin level of 20 g/L or more or leading to transfusion of two or more units of whole blood or red cells were considered a major bleeding, in accordance with International Society on Thrombosis and Haemostasis (ISTH) recommendations. 8 Statistical analysis We performed the statistical analysis using the SPSS statistical software (version 20; SPSS Inc., Chicago, IL, USA). Descriptive and categorical variables were presented as frequencies and percentages. Continuous data with normal distribution were expressed as means ± SD. Quantitative variables without normal distribution were described as median and interquartile range. We evaluated the condition of normality using the Kolmogorov-Smirnov test. The Student’s t-test or Mann-Whitney test compared the numerical variables, as appropriate. P-values < 0.05 were statistically significant. The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder The AMPLATZER™ Amulet™ Left Atrial Appendage Occluder (ST Jude Medical, Minneapolis, Minnesota) was used in all 60 patients for LAA occlusion. The AMPLATZER™ Amulet™ device is a self-expanding nitinol device with two parts (a lobe and a disc) pre-assembled on a single cable. Depending on the size of the device, a 12 to 14 French delivery catheter is used. Measurement of left atrial appendage dimensions Multidetector Computed Tomography (MDCT) was performed in 31 patients who had normal kidney function to evaluate the LAA anatomy. The LAA landing zone was measured with the MDCT in these 31 patients. All patients underwent transesophageal echocardiography (TEE) to guide the device selection and evaluate cardiac function. The device size was selected by using 3D TEE and MDCT when available. All patients had the size of LAA ostium and the device landing zone measured by TEE. TEE results were compared withMDCT ones in patients who had preprocedural MDCT. The relationship between LAA and pulmonary artery was evaluated in patients who had preprocedural MDCT. Left atrial appendage occlusion procedure As a routine preprocedural approach, standard transthoracic echocardiogram and TEE were performed before LAA occlusion in all patients to evaluate the shape and size of LAA and to reveal the presence of thrombus in LAA. TEE was performed after intravenous fluid infusion to avoid undersizing of LAA due to hypovolemia. The intravenous fluid infusion volume was determined according to the patients’ physical examination, B-type natriuretic peptide (BNP) levels, and left ventricular ejection fraction. Left atrial pressure was also measured to determine the optimal intravascular volume status during the procedure. Patients with normal renal function underwent multislice cardiac computed tomography for optimal evaluation of LAA anatomy, size, and the relationship between LAA and related cardiovascular structures. All patients undergoing percutaneous LAAocclusionprocedure were under general anesthesia and intubated for better TEE guidance. Transseptal puncture was conducted with fluoroscopy and 3D TEE guidance at the inferoposterior site of the interatrial septum when the patient had no anatomic variations that could prevent optimum orientation. After a successful transseptal puncture, the delivery catheter was placed in the left atrium. The Amulet™ LAA occlusion device was then advanced to some extent out of the delivery sheath, the lobe of the device formed a ball shape, and the delivery sheath was placed in the LAA with a counterclockwise rotation. After confirming the optimum settlement in the LAAwith TEE, the lobe of the devicewas opened with further advancement. After the proper placement of the lobe in the LAA, the disc was opened at the LAA ostium with the withdrawal of the delivery sheath. Relationships between the occlusion device and the circumflex artery and mitral valve were checked with 3D TEE, and radiopaque contrast was injected in the delivery sheath to evaluate para-device leak. Before being released, the device was pulled back with acceptable strength to check the stability. After all these steps, the occlusion device was released, and the relationships between the device and LAA, circumflex artery, and mitral valve were evaluated by 3D TEE. Periprocedural anticoagulation was maintained by IV heparin infusion with activated clotting time (ACT) control. Postprocedural antiplatelet therapy Postprocedural antiplatelet therapy was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy. This individualized therapy was designed according to patients’ thromboembolism as well as bleeding risk. Postprocedural follow-up The patients were reevaluated with transthoracic echocardiography at the 1 st , 6 th , and 12 th month. TEE was performed at all three visits. The patients were evaluated clinically and with TEE annually after the first year post-procedure. Results Baseline characteristics This study involved 60 patients (mean age was 72.3 ± 20.1 years) who had undergone percutaneous LAA occlusion with the AMPLATZER Amulet device in the Hacettepe University Cardiology Clinic between September 2015 and March 2018. The sample consisted of 35 women (58.3%) and 25 men (41.7%). Table 1 lists all baseline characteristics. 713