Original Title: Efectividad y seguridad del cierre de la orejuela izquierda con clip epicárdico por cirugía mínimamente invasiva para la prevención del tromboembolismo sistémico en pacientes con fibrilación auricular

Authors' objectives: To assess the effectiveness and safety of the left atrial appendage closure using epicardia clips by minimally invasive surgery for the thromboembolism prevention in patients with atrial fibrillation who are not candidates for oral anticoagulants.

Authors' results and conclusions: There is very scarce and very poor quality scientific evidence about effectiveness and safety of the left atrial appendage closure through minimally invasive epicardial clipping. Available scientific evidence is composed exclusively of six non-comparative studies (case series), which followed 351 patients. None of the studies evaluated model Atriclip PRO2TM model results. All studies were based on the Atriclip PROTM model. Device implantation peri-operatively evaluated was successful in 99.1% of the concomitant clip interventions and in 94.1% of the clip isolated interventions. After 3 to 6 months follow-up, 6,8% of the concomitant interventions failed because a significant residual neck or flow was observed. This indicator is not possible to be evaluated for the isolated interventions because there were only 10 patients with follow up. There were two cardiovascular events, representing a rate of 0.5/100 patient-year, in 222 patients after a follow-up of 20 months (median). There were few peri-operative complications related with the intervention. Few adverse events with follow-up were reported. It is not possible to determine the effectiveness and safety of these devices in comparison with other procedures used for thromboembolism prevention in patients with atrial fibrillation who are not candidates for oral anticoagulants. Well-designed studies that compare with sufficient follow-up the results of the implementation of this intervention with respect to its alternatives are needed.

Project Status: Completed

Year Published: 2019

URL for published report: https://redets.sanidad.gob.es/productos/buscarProductos.do?metodo=detalle&id=943

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: Agencia de Evaluacion