OBJECTIVES: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using theMitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population. BACKGROUND: The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair. METHODS: The study population included 264 patients withmoderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses. RESULTS: Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF. CONCLUSIONS: Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
RCT Entities:
OBJECTIVES: The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population. BACKGROUND: The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair. METHODS: The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses. RESULTS: Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AFpatients (64%) and for no-AFpatients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF. CONCLUSIONS:Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Authors: Tomás Benito-González; Rodrigo Estévez-Loureiro; Armando Pérez de Prado; Carlos Minguito-Carazo; Samuel Del Castillo García; Carmen Garrote-Coloma; Ignacio Iglesias-Gárriz; David Alonso-Rodríguez; Javier Gualis Cardona; Carlos Cuellas Ramón; María López Benito; Julia Vidán Estévez; Felipe Fernández-Vázquez Journal: Int J Cardiol Heart Vasc Date: 2018-09-19
Authors: Christian Waechter; Felix Ausbuettel; Georgios Chatzis; Dieter Fischer; Holger Nef; Sebastian Barth; Philipp Halbfaß; Thomas Deneke; Sebastian Kerber; Dimitar Divchev; Bernhard Schieffer; Ulrich Luesebrink Journal: J Interv Cardiol Date: 2020-08-28 Impact factor: 2.279