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      Seguridad y eficacia a corto plazo del cierre de orejuela izquierda con dispositivo WATCHMAN ® en fibrilación auricular no valvular en pacientes con alto riesgo de sangrado Translated title: Short-term safety and efficacy of left atrial appendage closure using WATCHMAN ® device for non-valvular atrial fibrillation in patients with a high risk of bleeding

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          Abstract

          Resumen Objetivo: Evaluar la seguridad y eficacia del cierre percutáneo de la orejuela izquierda en pacientes con fibrilación auricular no valvular con alto riesgo de sangrado o con contraindicación para anticoagulación oral. Métodos: Estudio prospectivo no aleatorizado en una cohorte de pacientes con fibrilación auricular con contraindicación o dificultades con anticoagulación oral y puntaje de CHA2DS2-VASc ≥ 2 y de HASBLED ≥ 2, elegibles para doble antiagregación con aspirina y clopidogrel. Resultados: Se incluyeron 53 pacientes, con edad promedio de 72,24 ± 9,22 años, de los cuales 54,72% eran hombres; 20,75% tenían fibrilación auricular paroxística, 15,1% persistente y 64,15% permanente. Además, 18,9% tenían insuficiencia cardíaca, 22,64% enfermedad coronaria, 92,45% hipertensión arterial, 41,51% eran mayores de 75 años, 18,9% eran diabéticos y 37,7% tenían enfermedad cerebrovascular previa. El promedio del puntaje de CHADS2 y CHA2DS2-VASc fue de 2,73 ± 1,34 y 4,24 ± 1,54, respectivamente. El procedimiento fue exitoso en un 98% (52/53). Sólo en un caso no fue posible implantar el dispositivo por causas anatómicas. No hubo eventos adversos serios relacionados con la implantación; durante el procedimiento se registró un episodio de derrame pericárdico leve que no requirió drenaje. En los 45 días de seguimiento, 2 pacientes (3,77%) desarrollaron enfermedad cerebrovascular y se registró un deceso por causa no cardíaca (1,89%). Conclusiones: El cierre percutáneo de la orejuela izquierda con dispositivo WATCHMAN® es un procedimiento seguro y eficaz en pacientes de alto riesgo con fibrilación auricular no valvular y contraindicación o dificultades para la anticoagulación oral.

          Translated abstract

          Abstract Motivation: To assess the safety and efficacy of percutaneous left atrial appendage closure in patients with non-valvular atrial fibrillation with a high risk of bleeding or a contraindication to oral anticoagulation drugs. Methods: Prospective non-randomised study of a cohort of patients with atrial fibrillation who had a contraindication to or difficulties with oral anticoagulation, CHA2DS2-VASc ≥ 2 and HASBLED ≥ 2 scores, and who were eligible for dual antiaggregation therapy with aspirin and clopidogrel. Results: 53 patients with an average age of 72.24 ± 9.22 years were included, out of whom 54.72% were men, 20.75% had paroxysmal, 15.1% persistent and 64.15% permanent atrial fibrillation, respectively. Besides, 18.9% suffered from heart failure, 22.64% from coronary disease, 92.45% from arterial hypertension, 41.51% were over 75 years old, 18.9% were diabetic and 37.7% had a history of cerebrovascular disease. Average CHADS= y CHA=DS2-VASc scores were of 2.73 ± 1.34 and 4.24 ± 1.54 respectively. Procedure was successful in 98% of the cases (52/53). It was not possible to implant the device in only one case due to anatomical reasons. There were no severe adverse events related to the insertion; during the procedure an episode of mild pericardial effusion that did not require drainage was registered. DUring the 45-day follow up period, 2 patients (3.77%) developed a cerebrovascular disease, and there was one noncardiac death (1.89%). Conclusions: The percutaneous left atrial appendage closure with device is a safe and efficient procedure in high-risk patients with non-valvular atrial fibrillation and contraindications to or difficulties for oral anticoagulation therapy.

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          Most cited references 34

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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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            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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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                rcca
                Revista Colombiana de Cardiología
                Rev. Colomb. Cardiol.
                Sociedad Colombiana de Cardiologia. Oficina de Publicaciones (Bogota, Cundinamarca, Colombia )
                0120-5633
                February 2017
                : 24
                : 4
                : 369-375
                Affiliations
                Medellín Antioquía orgnameUniversidad de Antioquia Colombia
                Medellín Antioquía orgnameUniversidad de Antioquia Colombia
                Medellín orgnameHospital Universitario San Vicente Fundación Colombia
                Article
                S0120-56332017000400369
                10.1016/j.rccar.2016.10.048

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

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                Figures: 0, Tables: 0, Equations: 0, References: 34, Pages: 7
                Product
                Product Information: SciELO Colombia

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