IJCS | Volume 31, Nº6, November / December 2018

572 Table 1 - General characteristics of the study group (n = 16) Age, years 71 ± 9 Male sex 10/16 (63%) Atrial fibrillation Permanent 12/16 (75%) Persistent 1/16 (6%) Paroxysmal 3/16 (19%) CHA 2 DS 2 -VASc score 5 [4 - 5] HAS-BLED score 3 [2 - 3] Indication for LAA closure Major bleeding 10/16 (63%) Labile INR 3/16 (19%) Embolic event despite anticoagulation 2/16 (13%) Poor compliance with anticoagulation 1/16 (6%) Cardiac plug device size, mm 24 ± 2 Left ventricular ejection fraction Normal range 13/16 (81%) Mildly abnormal 3/16 (19%) LAA: left atrial appendage; INR: international normalized ratio. Data expressed as mean and standard deviation, percentage or median and interquartile range. Madeira et al. Atrial appendage closure and atrial performance Int J Cardiovasc Sci. 2018;31(6)569-577 Original Article through an appropriate sheath depending on the size of the selected occluder through a puncture in the femoral vein. Deployment and position of the device were controlled by uoroscopy, and by periprocedural transesophageal or intracardiac echocardiography. LAA was reached through a transseptal puncture. Decision on device size was made upon anatomical morphology, and measurements in echocardiography and uoroscopy. Oral anticoagulation, if present, was discontinued 48 hours prior to the procedure. During procedure, heparinwas administeredwith an activated clotting time of 250s. Dual antiplatelet therapy with aspirin 100 mg and clopidogrel 75 mg was recommended for 1 month, followed by long-term antiplatelet therapy with aspirin 100mg daily. No oral anticoagulationwas recommended after device implantation. Statistical analysis The Kolmogorov-Smirnov test was used to evaluate the distribution of the continuous variables. In the overall sample, all variables were normally distributed, except for Ɛ R and follow-up time; and when patients were separated by group (no change and decrease of Ɛ R and SR R ), the variables were not normally distributed. According to distribution normality, continuous data were presented as mean and standard deviation or as median and interquartile range. Quantitative variables with normal distributionwere compared by the t-test and quantitative variables without normal distribution by the Mann-Whitney test. Qualitative variables were compared using the chi-square test. Differences between baseline and post-implantation of the LAA occlusion device were analysed by the paired sample t-test. Statistical analysis was carried out with SPSS ® 15 and GraphPad Prism ® 6.05. A two-tailed p value < 0.05 was considered statistically significant. Results Population characteristics Mean age of our sample was 71 ± 9 years, with male predominance (63%). Seventy-five percent of patients had permanent atrial fibrillation. There was no history of percutaneous atrial fibrillation ablation attempt or surgical Maze procedure. Our population had a high embolic and bleeding risk, expressed by a median CHA 2 DS 2 -VASc score of 5 [4-5] and HAS-BLED score of 3 [2-3]. Major bleeding (62%) was the most common indication for the procedure, followed by labile INR (19%), embolic events despite anticoagulation (13%), and poor compliance with anticoagulation medication (6%). Percutaneous LAA closure was performed successfully in all patients using the cardiac plug device (size, 24 ± 2 mm), without any major complications during or after the procedure. Characteristics of the studypopulationare summarized in Table 1. LA volume and emptying fraction Maximum and minimum values of left atrial volume and the left atrial emptying fraction before and after the procedure are represented in Figure 2 and Figure 3, respectively. No differences were found in maximum left atrial volume (44 ± 11 vs. 46 ± 13 mL/m 2 ; p = 0.54), minimum left atrial volume (32 ± 8 vs. 37 ± 14 mL/m 2 ; p = 0.09), or the left atrial emptying fraction (26 ± 17%