Prevención del stroke en fibrilación auricular. Hallazgos del registro GLORIA-AF / Stroke Prevention In Atrial Fibrillation. Findings From The Gloria-Af Registry

RESUMEN Introducción: El GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) es un registro internacional, prospectivo, en tres fases, para determinar la seguridad y eficacia del dabigatrán en pacientes con fibrilación auricular no valvular recientemente diagnosticada, en riesgo de stroke. La fase II empezó cuando el dabigatrán, el primer anticoagulante oral no antagonista de la vitamina K (NOAC) estuvo disponible. Objetivos: Describir los datos clínicos basales de la fase II en la población general y el seguimiento a 2 años de aquellos que recibieron dabigatrán. Material y Métodos: Se reclutaron un total de 15 644 pacientes, de los cuales 15 308 fueron elegibles y 4873 recibieron dabigatrán. Se analizaron las características de la fibrilación auricular, los hallazgos en el seguimiento y las enfermedades concomitantes. Los datos fueron analizados usando estadísticas descriptivas. Resultados: Del total de pacientes elegibles, el 45,5% eran mujeres, con una edad promedio de 71 (rango intercuartilo: 64-78) años. Los pacientes eran de Europa (47,9%), América del Norte (22,2%), Asia (20,1%), América Latina (6,0%) y Medio Oriente/ África (3,9%). La mayoría se encontraba en alto riesgo de stroke (CHA2DS2-VASc score >2; 86,1%); un 13,9% tuvieron riesgo moderado (CHA2DS2-VASc score >1). El 80,3% recibieron anticoagulantes orales; de ellos, el 47,9% recibieron NOAC y el 32,4%, antagonistas de la vitamina K (VKA); 12,0% recibieron agentes antiagregantes plaquetarios y el 7,6% no recibieron tratamiento antitrombótico. A 2 años de seguimiento, el 70,5% permanecieron en dabigatrán. Conclusiones: Los datos de la fase II del registro GLORIA-AF demostraron que, en FA no valvular, los NOAC han sido ampliamente adoptados en la práctica clínica y fueron más frecuentemente prescriptos que los VKA. No obstante, una gran proporción de pacientes en todo el mundo permanecieron sin tratamiento.

ABSTRACT Background: GLORIA-AF is a prospective, global, 3-phase registry program to determine the safety and effectiveness of dabigatran in patients with newly diagnosed non-valvular atrial fibrillation at risk of stroke. Phase II began when dabigatran, the first non-vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives: To describe phase II baseline clinical data in the general population and 2-year follow-up of those patients treated with dabigatran. Methods: A total of 15,644 patients were enrolled, 15,308 of whom were eligible and 4,873 received dabigatran. Atrial fibrillation disease characteristics, follow-up findings and concomitant diseases were collected. Data were analyzed using descriptive statistics. Results: Of the total eligible patients, 45.5% were female; median age was 71.0 (interquartile range: 64, 78) years. Patients were from Europe (47.9%), North America (22.2%), Asia (20.1%), Latin America (6.0%), and the Middle East/Africa (3.9%). Most had high stroke risk (CHA2DS2-VASc score ≥2; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc =1). Overall, 80.3% received oral anticoagulants, of whom 47.9% received NOACs and 32.4% vitamin K antagonists (VKA); 12.0% received anti-platelet agents; and 7.6% received no antithrombotic treatment. At 2-year follow-up, 70.5% remained on dabigatran. Conclusions: Data from GLORIA-AF phase II showed that in non-valvular AF, NOACs have been highly adopted in clinical practice, becoming more frequently prescribed than VKAs. Worldwide, however, a large proportion of patients remain undertreated.

The Role of Patent Foramen Ovale Closure in the Secondary Prevention of Cryptogenic Stroke: a Meta-Analysis Report

Abstract Background: Patent foramen ovale (PFO) closure has been compared to medical therapy for secondary prevention of recurrent cryptogenic stroke. Objectives: To produce an updated meta-analysis including only data from the primary analyses of clinical trials and to evaluate the role of PFO closure in the secondary prevention of recurrent stroke. Methods: Search in Medline (PubMed) and in ISI Web of Knowledge. Parameters under analysis and meta-analyses were: stroke, transient ischemic attack (TIA) and atrial fibrillation (AF). Comprehensive Meta-analysis Software V.2.0 (Biostat) was used. Random-effects analyses were carried out. A level of significance of 5% was used. Results: In this study six, randomized trials enrolling 3,750 patients were included. Unlike other published meta-analyses on the same topic, in this case, only clinical trial data, and not follow-up data, were used. PFO closure, as compared with medical therapy alone, demonstrated superiority in reducing the rate of recurrent stroke (risk ratio with PFO closure vs. medical therapy, 0.37; 95% confidence interval [CI], 0.17 to 0.78; p = 0.01). PFO closure did not offer a significant benefit in prevention of TIA (risk ratio with PFO closure vs. medical therapy, 0.96; 95% CI, 0.64 to 1.44; p = 0.85). Among patients assigned to closure group, an increased risk of atrial fibrillation was seen (risk ratio with PFO closure vs. medical therapy, 4.64; 95% CI, 2.38 to 9.01; p < 0.01). Conclusions: In patients with cryptogenic stroke who had a patent foramen ovale, a protective effect of closure was seen concerning the risk of recurrent stroke, but not regarding the prevention of TIA.

Endovascular closure of patent foramen ovale: a critical appraisal of published trials / Fechamento endovascular do forame oval patente: análise crítica dos estudos publicados

ABSTRACT The treatment of cryptogenic stroke patients with a patent foramen ovale (PFO) is controversial. A critical review of these studies is presented. Methods A description of all trials comparing medical and endovascular treatment with closing devices is given. Additional pertinent studies are discussed to help construct a rational basis for treatment decisions. Results Initial negative trials evaluating PFO closure were followed by positive studies published in 2017 and 2018. All trials evaluated young patients (up to 60 years). Methodological problems are present in all trials including their open label construction. Most positive trials developed strategies to increase the percentage of patients with interatrial septal aneurysms or hypermobility and large right-to-left shunts. Even in these positive trials, large numbers of patients need to be treated to avoid one stroke. Atrial fibrillation occurred in 2-6% and other adverse effects related to the procedure and to the devices occurred in a substantial number of patients. Incomplete occlusion of the PFO is also frequent. Anticoagulant treatment has not been adequately studied as a therapeutic option. Conclusion Young patients with cryptogenic strokes seem to benefit from endovascular closure of a PFO in the presence of a large right-to-left shunt or an associated atrial septum aneurysm. For most other patients, a highly-individualized decision must be made, taking into account the low risk of recurrence in patients with a cryptogenic stroke attributable to a PFO, the high numbers needed to treat and the risks related to the procedure.

RESUMO O tratamento de pacientes com infarto cerebral criptogênico e forame oval patente (FOP) é controverso. Uma revisão crítica destes estudos é apresentada. Métodos São descritos em detalhes os estudos comparando tratamento médico com o uso de próteses de oclusão do FOP após infarto cerebral. Discutem-se outros estudos pertinentes para ajudar na tomada racional de decisões terapêuticas individualizadas. Resultados Estudos iniciais avaliando fechamento endovascular com próteses foram negativos, porém seguidos de outros estudos com resultados positivos em 2017 e 2018. Somente pacientes até 60 anos foram estudados. Os estudos apresentam vários problemas metodológicos, incluindo sua natureza aberta. A maioria dos estudos positivos desenvolveu estratégias para aumentar o percentual de pacientes com risco aumentado de recorrência, especificamente grandes shunts direita-esquerda e aneurismas/hipermobilidade do septo interatrial. Mesmo estes estudos positivos revelaram um alto NNT (número de pacientes tratados para evitar um evento de desfecho). Fibrilação atrial ocorreu em 2-6 % dos pacientes tratados. Outras complicações relacionadas ao procedimento e às endopróteses e ainda fechamento incompleto do FOP foram também frequentes. Anticoagulantes poderiam constituir estratégia alternativa de tratamento clínico, mas não foram adequadamente estudados. Conclusão Pacientes jovens com infartos criptogênicos parecem beneficiar-se de oclusão endovascular do FOP na presença de grandes shunts e principalmente aneurismas ou hipermobilidade de septo interatrial. Para a maioria dos outros pacientes, uma decisão altamente individualizada deve ser tomada, considerando o baixo risco de recorrência dos infartos atribuíveis ao FOP, o ato NNT e os riscos inerentes ao procedimento.

Construction of national stroke center network system / 国际生物医学工程杂志

Stroke is one of the main causes of mortality, long-term physical and cognitive impairment in China. In order to meet the challenge, Stroke Prevention and Treatment Project of the National Health Commission (SPTPC) was established in April 2011 in the Ministry of Health. In 2016, SPTPC issued a work plan of stroke center hospital. In order to shorten the time of pre-hospital, the SPTPC established the stroke center network, stroke map and stroke green channel to create "the three 1-hour gold rescue circle" to form a hierarchical stroke diagnosis and treatment system. The current construction of the Chinese Stroke Center is divided into two levels and four layers. As of December 31, 2018, SPTPC has certified a total of 310 advanced stroke centers, including 30 demonstration advanced stroke centers and 280 advanced stroke centers, and 127 stroke prevention centers, including 85 demonstration stroke prevention centers and 42 stroke prevention centers. The median time from admission to intravenous thrombolysis (DNT) at the advanced stroke center was decreased by 13.2％ (53 min vs. 46 min) in the fourth quarter of 2018 as compared with that in the first quarter of 2017.The national thrombolytic rate of acute ischemic stroke was increased 3.24 times (1.78％ vs. 0.42％) in 2017 compared that in 2010. In the next step, SPTPC will vigorously promote the construction of stroke centers and graded diagnosis and treatment mechanisms, consolidate quality control and standardization, increase the scope of influence of mobile stroke and remote diagnosis and treatment, and further improve the construction of stroke center systems with Chinese characteristics.

Construction of national stroke center network system / 国际生物医学工程杂志

Stroke is one of the main causes of mortality, long-term physical and cognitive impairment in China. In order to meet the challenge, Stroke Prevention and Treatment Project of the National Health Commission(SPTPC) was established in April 2011 in the Ministry of Health. In 2016, SPTPC issued a work plan of stroke center hospital. In order to shorten the time of pre-hospital, the SPTPC established the stroke center network, stroke map and stroke green channel to create "the three 1-hour gold rescue circle" to form a hierarchical stroke diagnosis and treatment system. The current construction of the Chinese Stroke Center is divided into two levels and four layers. As of December 31, 2018, SPTPC has certified a total of 310 advanced stroke centers, including 30 demonstration advanced stroke centers and 280 advanced stroke centers, and 127 stroke prevention centers, including 85 demonstration stroke prevention centers and 42 stroke prevention centers. The median time from admission to intravenous thrombolysis (DNT) at the advanced stroke center was decreased by 13.2% (53 min vs. 46 min) in the fourth quarter of 2018 as compared with that in the first quarter of 2017.The national thrombolytic rate of acute ischemic stroke was increased 3.24 times (1.78% vs. 0.42%) in 2017 compared that in 2010. In the next step, SPTPC will vigorously promote the construction of stroke centers and graded diagnosis and treatment mechanisms, consolidate quality control and standardization, increase the scope of influence of mobile stroke and remote diagnosis and treatment, and further improve the construction of stroke center systems with Chinese characteristics.

Percutaneous left atrial appendage Closure for Thromboembolic Prevention in atrial Fibrillation / Cierre percutáneo de la orejuela izquierda para prevención tromboembólica en fibrilación auricular

Background: Atrial fibrillation (AF) produces a five-fold increase in the risk of stroke, and the exclusion of the left atrial appendage (LAA), the main source of thrombi, is an interesting therapeutic option in patients with contraindication for oral anticoagulation. Objectives: The goal of this study was to evaluate the initial experience, immediate results and outcome at 45 days of percutaneous closure of the LAA in patients with AF and high risk of thromboembolic events, in whom chronic oral anticoagulation was contrain-dicated. Methods: Twenty-two patients with non-valvular AF and a CHA2DS2-Vasc ≥2 in whom there was contraindication or impossibility of long-term oral anticoagulation underwent percutaneous closure of the LAA with the WATCHMANT device. The patients were evaluated 45 days after the procedure by clinical assessment and transesophageal echocardiography. Results: The implant was successful in 21 of 22 patients (95.4%). Median (interquartile range) age and CHA2DS2-VASc and HAS-BLED scores were 76 years (IQR 14.5), 5 (IQR 1.5) and 4 (IQR 1), respectively. Three (13.6%) periprocedural complications were observed: one cardiac tamponade requiring surgery, one concealed major bleeding and one pseudoaneurysm of the femoral artery. No device-related complications or thromboembolic events were observed during the 45-day follow-up. The LAA was adequately excluded in 95% of the cases. Conclusions: In our initial experience, the procedure is feasible, with an acceptable risk, and can be considered a therapeutic option in patients with AF and high thromboembolic risk who cannot receive oral anticoagulation.

Introducción: La fibrilación auricular (FA) incrementa cinco veces el riesgo de accidente cerebrovascular y la orejuela auricular izquierda (OI) es la principal fuente de formación de trombos, por lo que su exclusión se presenta como una alternativa terapéutica interesante en pacientes con contraindicación para la anticoagulación oral. Objetivos: Evaluar la experiencia inicial, los resultados del implante y la evolución a los 45 días del cierre percutáneo de la OI en pacientes con FA de riesgo tromboembólico alto en los cuales no podía emplearse la anticoagulación oral crónica. Material y métodos: Veintidós pacientes con FA no valvular y CHA2DS2-Vasc ≥2 en los que la anticoagulación a largo plazo estaba contraindicada o era impracticable fueron sometidos al cierre percutáneo de la OI con el dispositivo WATCHMAN®. Los pacientes fueron evaluados a los 45 días mediante control clínico y con ecocardiografía transesofágica. Resultados: El implante fue exitoso en 21 de los 22 pacientes (95,4%). Las medianas (rango intercuartil) de edad, CHA2DS2-VASc y HAS-BLED fueron 76 años (RIC 14,5), 5 (RIC 1,5) y 4 (RIC 1), respectivamente. Se observaron 3 (13,6%) complicaciones periprocedimiento: un taponamiento que requirió revisión quirúrgica, un sangrado mayor oculto y un seudoaneurisma femoral. Durante el seguimiento a 45 días no se observaron complicaciones relacionadas con el dispositivo ni eventos tromboembólicos. En el 95% de los casos, la OI se encontraba adecuadamente excluida. Conclusiones: En nuestra experiencia inicial, el procedimiento es factible con un riesgo aceptable, constituyéndose en una alternativa terapéutica en pacientes con FA de riesgo tromboembólico alto que no pueden recibir anticoagulantes orales.