ABC | Volume 113, Nº4, October 2019

Original Article Şahiner et al LAA occlusion with amulet device Arq Bras Cardiol. 2019; 113(4):712-721 The most common reason for LAA occlusion was major bleeding with OAC treatment (n: 53, 88.3%). The most common type of major bleeding was gastrointestinal bleeding (n:26, 57,8%). Fifty-seven patients took OACs before LAA occlusion. The most common preprocedural anticoagulant used was rivaroxaban, in 30 (50.0%) patients. Warfarin, dabigatran, and apixaban were used by 4 (6.6%), 10 (16.7%), and 13 (21.7%) patients, respectively. Thromboembolic events and bleeding risk scores CHADS 2 , CHA 2 DS 2 -VASc, HAS-BLED, and ORBIT bleeding scores were calculated for all patients, and the average values of these scores were 2.75 ± 2.25, 4.61 ± 2.61, 4.32 ± 3.32, and 4.8 ± 2.8, respectively. Table 1 lists bleeding and thromboembolic event risk scores separately. Device dimensions The smallest implanted device had 16 mm and the biggest, 31 mm. Devices of 20 mm were implanted in 11 patients and of 25 mm in 16 patients. Procedural Outcomes The LAA occlusion device was implanted successfully in all 60 patients. No patient showed device embolization. One patient presented postprocedural major complication and mortality. Fifty-nine patients were discharged without any disabling complication. Six patients had periprocedural bleeding. All of them were associated with an access point, and only one of these patients needed a postprocedural blood transfusion. Periprocedural stroke, transient ischemic attack (TIA), and systemic embolization were not observed in any patient during hospital follow-up. The mean postprocedural hospital length of stay was 1.33 days (median of 2 days, interquartile range of 1 to 3 days). Periprocedural complications The percutaneous LAA transcatheter occlusion device was implanted successfully in all 60 patients. However, one patient presented a postprocedural major complication. This patient had been referred to emergency surgery due to pulmonary artery rupture. Despite the surgical repair of the pulmonary artery injury, the patient did not survive. Two patients had postprocedural pericardial effusion, both self-limited and not requiring pericardiocentesis. Two patients started postprocedural ibuprofen and colchicine therapy. Some clinical and anatomic patient features created problems for the procedural approach, but none of them prevented successful implantation. Five patients had a thrombus formation at the bottom of the LAA. The thrombus was attached to the LAA occlusion device in these patients. One patient had an atrial septal defect (ASD) closure device at the interatrial septum, which had been previously implanted. Generally, an ASD closure device in place is considered challenging for the transseptal puncture, but this patient had the transseptal puncture performed at the inferoposterior side of the interatrial septum, which is the most suitable puncture location for LAA occlusion. The LAA occlusion procedure was performed successfully in this patient without any damage to the ASD closure device (Figure 1). Patients’ postprocedural antiplatelet therapy In most patients, postprocedural antiplatelet therapy consisted of acetylsalicylic acid (100 mg qd) and clopidogrel (75 mg qd). Dual antiplatelet therapy (DAPT) continued for 6 months after the procedure in 53 patients. DAPT was modified to the single antiplatelet therapy (acetylsalicylic acid or clopidogrel) if the absence of thrombus formation over the device was confirmed and peri-device leak was not found. Fifty-three patients under DAPT showed no device‑related thrombus (DRT) or peri-device leak at the 6 th  month follow‑up TEE. Accordingly, these patients continued with single antiplatelet therapy thereafter. Two patients under DAPT after the procedure had TIA during follow-up, which extended the DAPT for 12 months. Single antiplatelet therapy with acetylsalicylic acid was considered in only two patients due to the high bleeding risk. They continued to use single antiplatelet during their entire follow-up. Five patients used a low-dose OAC agent after the procedure. Four of them used apixaban 2.5 mg BID, and one took dabigatran 110mg BID until their 6 th month evaluation. None of them had thrombus over the device or peri-device leak at the 6 th month TEE. Thus, they continued their antithrombotic treatment with single antiplatelet therapy after their 6 th month visit (Figure 2). Follow-up outcomes The patients were evaluated at the 1 st , 6 th , and 12 th month after discharge, undergoing annual assessments afterward. Two patients died during the follow-up. Median follow‑up duration was 20 months (interquartile range of 9 to 27 months). The first patient died due to decompensated heart failure six months after the LAA occlusion. The second patient died from a non-cardiac condition. Clinically manifested stroke did not occur during the follow-up period. Two patients presented TIA-like symptoms and underwent cerebrovascular scanning and TEE. The exams showed no significant findings. These patients had a neurology consultation, and TIA was considered. Their DAPT was extended to 12 months. Both patients were discharged without neurological deficit, and brain imaging showed no evidence of new ischemic lesions. Besides these two cases, themost important thromboembolic clinical event was pulmonary embolism in one patient two months after LAA occlusion. Four patients had bleeding. One required hospitalization and blood transfusion three months after the procedure. This patient had melena. Gastrointestinal bleeding was confirmed with endoscopy and colonoscopy. DAPT was switched to single clopidogrel therapy, and the patient was discharged five days after hospitalization. The bleeding was not significant in the other three patients, and they did not require hospitalization or blood transfusion. Two of them had epistaxis, and one had epidermal petechiae. Routine TEE was performed at the end of the 1 st , 6 th , and 12 th month after the procedure. In 10 patients, the follow up-duration was shorter than 12 months, and they were 714