Valvular Heart Disease
Acute and Midterm Outcome After MitraClip Therapy in Patients With Severe Mitral Regurgitation and Left Ventricular Dysfunction

https://doi.org/10.1016/j.amjcard.2015.05.048Get rights and content

The clinical outcome of patients with severe primary and secondary mitral regurgitation (MR) and heart failure or significantly reduced left ventricular ejection fraction (LVEF) who underwent percutaneous mitral valve repair (pMVR) is yet not well known. This study compares midterm outcome of patients with severe left ventricular dysfunction (EF ≤30%) versus patients with slightly or moderately reduced or normal LVEF (EF >30%) after pMVR. One hundred thirty-six consecutive patients were enrolled: 42 patients displayed severe left ventricular dysfunction, group 1 (logistic EuroSCORE I 27.7 ± 21.8%; secondary MR in 37 patients), and 94 patients displayed slightly or moderately reduced or normal LVEF, group 2 (logistic EuroSCORE I 17 ± 18.2%; secondary MR in 21 patients). The primary efficacy endpoint was death of any cause, repeat mitral valve intervention, and/or New York Heart Association class ≥III, which was reached in 31% of patients in group 1 versus 40% in group 2 (p = 0.719) at a median follow-up of 371 days. MR, graded by transthoracic echocardiography, was reduced in both groups (p <0.001) and New York Heart Association class improved in each group (p <0.001), with no differences between groups (p >0.05). In conclusion, at midterm follow-up, the pMVR provided significant clinical benefits with comparable results achieved both in patients with significantly reduced and in patients with moderately reduced to normal LVEF. Thus, pMVR represents a feasible and effective treatment in high-risk patients who otherwise have limited therapeutic options and no safe option to reduce MR.

Section snippets

Methods

This observational cohort study complies with the Declaration of Helsinki and was approved by the institutional ethics committee. It was conducted in a prospective manner from September 2009 to July 2012, and all patients gave written informed consent before entering the study. Patients with symptomatic MR were included after discussion in the heart team, if eligible for clip placement and unsuitable for cardiac surgery or refusing surgical treatment. Surgical risk was based on the European

Results

One hundred forty-seven consecutive patients were intended to be treated by pMVR from September 2009 to June 2012. In 11 of these patients (7.5%), a clip could not be placed (for further details, see Figure 1). In the remaining 136 patients, at least 1 clip was placed, but in 6 of these patients (4.4%), a sufficient MR reduction of ≥I grade could not be achieved. Therefore, the acute success rate in this patient population was 88.4%. The patient population with at least 1 clip placed was

Discussion

This single-center study demonstrates a significant reduction of MR severity with a primary success rate of 88.4% and an improvement of hemodynamic measurements immediately after pMVR using the MitraClip, regardless of the LVEF, and although 56% of the treated patients did not meet the established morphologic inclusion criteria of the EVEREST trials.11, 16, 18 The first patient treated with the MitraClip in our center was enrolled in September 2009. Since then, we gained a lot of experience and

Disclosures

Drs. Sonne, Mehilli, and Hausleiter received speaker honoraria from Abbott Vascular. Dr. Orban received speaker honoraria from Roche. There is no conflict of interest for the other authors.

References (29)

Cited by (0)

Drs. Lesevic and Sonne contributed equally to this work.

See page 755 for disclosure information.

View full text