Elevated Mitral Valve Pressure Gradient After MitraClip Implantation Deteriorates Long-Term Outcome in Patients With Severe Mitral Regurgitation and Severe Heart Failure

Abstract Objectives This single-center study was performed to analyze the effect of an increased transvalvular gradient after the MitraClip (MC) (Abbott Laboratories, Abbott Park, Illinois) procedure on patient outcome during follow-up. Background Percutaneous transcatheter repair of the mitral valve with the MC device has been established as a novel technique for patients with severe mitral regurgitation and high surgical risk. This study investigated the influence of an increased pressure gradient after MC implantation on the long-term outcome of patients. Methods A total of 268 patients were enrolled, who received MC implantation between April 2009 and July 2014 in our institution (75 ± 9 years of age, 68% men, weight 76 ± 15 kg, median N-terminal pro–B-type natriuretic peptide 3,696 [interquartile range: 1,989 to 7,711] pg/ml, left ventricular ejection fraction 39 ± 16%, log European System for Cardiac Operative Risk Evaluation score 20% [interquartile range: 12% to 33%]). Pressure in the left atrium and left ventricle were measured during the procedure using fluid-filled catheters. The pressure gradients over the mitral valve were determined simultaneously invasively and echocardiographically directly after MC deployment. A Kaplan-Meier analysis was performed and correlated with the pressure gradients. We used a combined primary endpoint: all-cause-mortality, left ventricular assist device, mitral valve replacement, and redo procedure. Results The Kaplan-Meier-analysis showed a significantly poorer long-term-outcome in the case of an invasively determined mitral valve pressure gradient (MVPG) in excess of 5 mm Hg at implantation for the combined endpoint (p = 0.001) and for all-cause mortality (p = 0.018). For the echocardiographically determined MVPG the cutoff value was 4.4 mm Hg. Propensity score matching was used to balance baseline differences between the groups. In a Cox model the increased residual MVPG >5 mm Hg was a significant outcome predictor in univariate and multivariate analysis (hazard ratio: 2.3; 95% confidence interval: 1.4 to 3.8; p = 0.002, multivariate after adjustment for N-terminal pro–B-type natriuretic peptide, age, and remaining mitral regurgitation). Conclusions It is recommended that the quality of the implantation result be analyzed carefully and repositioning of the MC be considered in the case of an elevated pressure gradient over the mitral valve.