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      Oclusão do apêndice atrial esquerdo com o Amplatzer Cardiac Plug em pacientes com fibrilação atrial Translated title: Left atrial appendage closure with the Amplatzer Cardiac Plug in patients with atrial fibrillation

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          Abstract

          FUNDAMENTO: A oclusão percutânea do apêndice atrial esquerdo (OAAE) surgiu como alternativa à anticoagulação oral (AO) para prevenção do acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). OBJETIVO: Relatar os resultados imediatos e o seguimento clínico de pacientes submetidos a OAAE com o Amplatzer Cardiac Plug (ACP) em um único centro de referência. MÉTODOS: Oitenta e seis pacientes consecutivos com FANV, contra-indicação à AO e escore CHADS2= 2,6±1,2 foram submetidos a OAAE com implante de ACP. Realizou-se seguimento clínico e ecocardiográfico no mínimo 4 meses após o implante. RESULTADOS: Todos os implantes foram guiados apenas por angiografia. O sucesso do procedimento foi de 99% (1 insucesso por tamponamento cardíaco e consequente suspensão da OAAE). Houve 4 complicações maiores (o tamponamento já referido, 2 AVCs transitórios e uma embolização com retirada percutânea da prótese) e duas menores (um derrame pericárdico sem tamponamento e uma pequena comunicação interatrial evidenciada no seguimento). Houve 1 óbito hospitalar após 6 dias, não relacionado à intervenção. Todos os outros pacientes receberam alta sem AO. Após seguimento de 25,9 pacientes-ano (69 pacientes) não houve AVCs nem embolizações tardias de próteses. O AAE estava completamente ocluído em 97% dos casos. Seis pacientes apresentaram evidência de trombo sobre a prótese, que desapareceram após reinstituição de AO por 3 meses. CONCLUSÃO: OAAE se associa a um alto índice de sucesso, um índice aceitável de complicações e resultados promissores a médio prazo, podendo ser considerada uma alternativa válida à OA na prevenção do AVC em pacientes com FANV.

          Translated abstract

          BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To describe the immediate results and short- to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. METHODS: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6±1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. RESULTS: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. CONCLUSION: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.

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          Most cited references38

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          Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

          The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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            Apixaban versus Warfarin in Patients with Atrial Fibrillation

            Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
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              Dabigatran versus warfarin in patients with atrial fibrillation.

              Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 2009 Massachusetts Medical Society
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                Author and article information

                Journal
                abc
                Arquivos Brasileiros de Cardiologia
                Arq. Bras. Cardiol.
                Sociedade Brasileira de Cardiologia - SBC (São Paulo, SP, Brazil )
                0066-782X
                1678-4170
                June 2012
                : 98
                : 6
                : 528-536
                Affiliations
                [01] Berna orgnameUniversity Hospital Bern orgdiv1Cardiovascular Department Suíça
                [02] Curitiba PR orgnameCentro de Cardiopatias Congênitas e Estruturais do Paraná Brasil
                Article
                S0066-782X2012000600008 S0066-782X(12)09800608
                fb81f2d1-9f41-4811-aef2-a684140f2414

                This work is licensed under a Creative Commons Attribution 4.0 International License.

                History
                : 17 October 2011
                : 14 October 2011
                : 26 December 2011
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 38, Pages: 9
                Categories
                Artigos Originais

                Apêndice atrial,próteses e implantes,Atrial appendage,arritmias cardíacas,fibrilação atrial,arrhythmias, cardiac,prostheses and implants,atrial fibrillation

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