RESUMEN
Mitral regurgitation (MR) is a common valvulopathy worldwide increasing in prevalence. Cardiac surgical intervention, preferable repair, is the standard of care, but a relevant number of patients with severe MR do not undergo surgery because of high peri-operative risk. Percutaneous mitral valve repair with the MitraClip System has evolved as a new tool for the treatment of severe MR. The procedure simulates the surgical edge-to-edge technique, developed by Alfieri in 1991, creating a double orifice valve by a permanent approximation of the two mitral valve leaflets. Several preclinical studies, registries and Food and Drug Administration approved clinical trials (EVEREST, ACCESS-EU) are currently available. The percutaneous approach has been recently studied in a randomized controlled trial, concluding that the device is less effective at reducing MR, when compared with surgery, by associated with a lower adverse event rate. The patients enrolled in this trial had a normal surgical risk and mainly degenerative MR with preserved left ventricular function. On the other hand, results derived from the clinical "real life" experience, show that patients actually treated in Europe present a higher surgical risk profile, more complex mitral valve anatomy and functional MR in the most of cases. Thus these data suggest that MitraClip procedure is feasible and safe in this subgroup of patients that should be excluded from the EVEREST trial due to rigid exclusion criteria. Despite the promising results clinical experience is still small, and no data related the durability are currently available. Therefore, MitraClip device should be reserved now to high risk or inoperable patients.
Asunto(s)
Insuficiencia de la Válvula Mitral/cirugía , Cateterismo Cardíaco/instrumentación , Procedimientos Quirúrgicos Cardíacos/métodos , Ensayos Clínicos como Asunto , Diseño de Equipo , Predicción , HumanosRESUMEN
Mitral regurgitation (MR) is the second most common heart valve disease worldwide and the current gold-standard treatment is surgical repair or replacement. Nevertheless, many patients do not undergo surgical intervention due to several comorbidities. Percutaneous "edge-to-edge" mitral valve repair using the MitraClip System is an emerging and effective option to this subset of patients. This device has been used to treat both functional and degenerative mitral valve regurgitation and has been compared to surgery in the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) randomized trial. Although the field of percutaneous management of MR is at an early stage, it has been demonstrated that percutaneous approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.