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      First results of the Brazilian Registry of Percutaneous Left Atrial Appendage Closure

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          Abstract

          Background

          Left atrial appendage closure (LAAC) is an effective alternative to oral anticoagulation (OA) for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF).

          Objective

          To present the immediate results and late outcomes of patients submitted to LAAC and included in the Brazilian Registry of Percutaneous Left Atrial Appendage Closure.

          Methods

          91 patients with NVAF, high stroke risk (CHA 2DS 2VASc score = 4.5 ± 1.5) and restrictions to OAC (HAS-BLED score = 3.6 ± 1.0) underwent 92 LAAC procedures using either the Amplatzer cardiac plug or the Watchman device in 11 centers in Brazil, between late 2010 and mid 2016.

          Results

          Ninety-six devices were used (1.04 device/procedure, including an additional non-dedicated device), with a procedural success rate of 97.8%. Associated procedures were performed in 8.7% of the patients. Complete LAAC was obtained in 93.3% of the successful cases. In cases of incomplete closure, no residual leak was larger than 2.5 mm. One patient needed simultaneous implantation of 2 devices. There were 7 periprocedural major (5 pericardial effusions requiring pericardiocentesis, 1 non-dedicated device embolization and 1 coronary air embolism without sequelae) and 4 minor complications. After 128.6 patient-years of follow-up there were 3 deaths unrelated to the procedure, 2 major bleedings (one of them in a patient with an unsuccessful LAAC), thrombus formation over the device in 2 cases (both resolved after resuming OAC for 3 months) and 2 strokes (2.2%).

          Conclusions

          In this multicenter, real world registry, that included patients with NVAF and high thromboembolic and bleeding risks, LAAC effectively prevented stroke and bleeding when compared to the expected rates based on CHA 2DS 2VASc and HASBLED scores for this population. Complications rate of the procedure was acceptable considering the beginning of the learning curve of most of the involved operators.

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          Most cited references 28

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          Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation.

          Left atrial appendage obliteration was historically ineffective for the prevention of postoperative stroke in patients with rheumatic atrial fibrillation who underwent operative mitral valvotomy. It is, however, a routine part of modern "curative" operations for nonrheumatic atrial fibrillation, such as the maze and corridor procedures. To assess the potential of left atrial appendage obliteration to prevent stroke in nonrheumatic atrial fibrillation patients, we reviewed previous reports that identified the etiology of atrial fibrillation and evaluated the presence and location of left atrial thrombus by transesophageal echocardiography, autopsy, or operation. Twenty-three separate studies were reviewed, and 446 of 3,504 (13%) rheumatic atrial fibrillation patients, and 222 of 1,288 (17%) nonrheumatic atrial fibrillation patients had a documented left atrial thrombus. Anticoagulation status was variable and not controlled for. Thrombi were localized to, or were present in the left atrial appendage and extended into the left atrial cavity in 254 of 446 (57%) of patients with rheumatic atrial fibrillation. In contrast, 201 of 222 (91%) of nonrheumatic atrial fibrillation-related left atrial thrombi were isolated to, or originated in the left atrial appendage (p < 0.0001). These data suggest that left atrial appendage obliteration is a strategy of potential value for stroke prophylaxis in nonrheumatic atrial fibrillation.
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            Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry.

            The Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) randomized trial compared left atrial appendage closure against warfarin in atrial fibrillation (AF) patients with CHADS₂ ≥1. Although the study met the primary efficacy end point of being noninferior to warfarin therapy for the prevention of stroke/systemic embolism/cardiovascular death, there was a significantly higher risk of complications, predominantly pericardial effusion and procedural stroke related to air embolism. Here, we report the influence of experience on the safety of percutaneous left atrial appendage closure. The study cohort for this analysis included patients in the PROTECT AF trial who underwent attempted device left atrial appendage closure (n=542 patients) and those from a subsequent nonrandomized registry of patients undergoing Watchman implantation (Continued Access Protocol [CAP] Registry; n=460 patients). The safety end point included bleeding- and procedure-related events (pericardial effusion, stroke, device embolization). There was a significant decline in the rate of procedure- or device-related safety events within 7 days of the procedure across the 2 studies, with 7.7% and 3.7% of patients, respectively, experiencing events (P=0.007), and between the first and second halves of PROTECT AF and CAP, with 10.0%, 5.5%, and 3.7% of patients, respectively, experiencing events (P=0.006). The rate of serious pericardial effusion within 7 days of implantation, which had made up >50% of the safety events in PROTECT AF, was lower in the CAP Registry (5.0% versus 2.2%, respectively; P=0.019). There was a similar experience-related improvement in procedure-related stroke (0.9% versus 0%, respectively; P=0.039). Finally, the functional impact of these safety events, as defined by significant disability or death, was statistically superior in the Watchman group compared with the warfarin group in PROTECT AF. This remained true whether significance was defined as a change in the modified Rankin score of ≥1, ≥2, or ≥3 (1.8 versus 4.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.24 to 0.82; 1.5 versus 3.7 events per 100 patient-years; relative risk, 0.41; 95% confidence interval, 0.22 to 0.82; and 1.4 versus 3.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.22 to 0.88, respectively). As with all interventional procedures, there is a significant improvement in the safety of Watchman left atrial appendage closure with increased operator experience. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00129545.
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              • Record: found
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              Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.

              While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions.
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                Author and article information

                Journal
                Arq Bras Cardiol
                Arq. Bras. Cardiol
                abc
                Arquivos Brasileiros de Cardiologia
                Sociedade Brasileira de Cardiologia - SBC
                0066-782X
                1678-4170
                November 2017
                November 2017
                : 109
                : 5
                : 440-447
                Affiliations
                [1 ] Hospital Pilar, Curitiba, PR - Brasil
                [2 ] Hospital dos Servidores do Estado do Rio de Janeiro, Rio de Janeiro, RJ - Brasil
                [3 ] Instituto Estadual de Cardiologia Aloysio de Castro (IECAC), Rio de Janeiro, RJ - Brasil
                [4 ] Hospital Pró-Cardíaco, Rio de Janeiro, RJ - Brasil
                [5 ] Instituto Nacional de Cardiologia (INC - MS), Rio de Janeiro, RJ - Brasil
                [6 ] Hospital São Vicente de Paulo, Rio de Janeiro, RJ - Brasil
                [7 ] Rede D'Or, Rio de Janeiro, RJ - Brasil
                [8 ] Hospital Israelita Albert Einstein, São Paulo, SP - Brasil
                [9 ] Centro de Pesquisa Cardiovasculares do Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS), Porto Alegre, RS - Brasil
                [10 ] Instituto de Medicina Integral Prof. Fernando Figueira, Recife, PE - Brasil
                [11 ] SOS Cardio Serviços Hospitalares, Florianópolis, SC - Brasil
                Author notes
                Mailing Address: Ênio Eduardo Guérios, Rua Hugo Simas, 322. Postal Code 80520-250, Pilarzinho, Curitiba, PR - Brazil. E-mail: eguerios@ 123456cardiol.br , eguerios@ 123456terra.com.br
                Article
                10.5935/abc.20170150
                5729780
                29069203

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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