Transcatheter Mitral Annuloplasty in Mitral Regurgitation
What is the safety and efficacy of the Cardioband percutaneous mitral annuloplasty system for treatment of functional mitral regurgitation (MR)?
This study was a nonrandomized, single-arm, multicenter, prospective trial performed in five European centers, which recruited high-risk adults with functional MR despite optimal medical therapy and, where indicated, cardiac resynchronization therapy. Preprocedural computed tomography and transesophageal echocardiography (TEE) were performed for treatment planning. The device was deployed on the left atrial surface of the mitral valve via a transseptal catheter inserted through a femoral vein under TEE guidance. Follow-up echocardiograms and clinical events were independently evaluated.
The procedure was completed in 31 patients, of which 29 (94%) were technically successful, defined as complete device implantation and reduction in the septolateral dimension of the mitral annulus. The proportion of patients with 3-4+ MR was 77.4% at baseline, 10.7% at 1 month, and 13.6% at 6 months. Vena contracta width and radius of the proximal isovolumic surface area (PISA) were reduced. Distance on 6-minute walking test improved from 250 ± 107 m at baseline to 332 ± 118 m after 6 months (p = 0.002). Quality-of-life scores also significantly improved (p < 0.001). However, left ventricular ejection fraction (LVEF) decreased from 35% at baseline to 30% at 6 months (p = 0.03).
Transcatheter mitral annuloplasty is feasible in patients with symptomatic MR, and appears to reduce MR and improve functional capacity and symptoms.
There continues to be tremendous interest in the development of transcatheter therapies for MR. The Cardioband appears to be feasible and reduces both patient symptoms, as assessed by the Minnesota Living With Heart Failure Questionnaire, as well as functional capacity, as measured by the 6-minute walking test. This study was not randomized, so it is challenging to evaluate the impact of this intervention on hospitalization and mortality. Importantly, a modest reduction in LVEF was observed. Finally, the procedure was not technically successful in approximately 6% of patients, and significant MR remained in approximately 13.6% of patients after 6 months. Larger studies will be necessary to evaluate clinical outcomes and whether technical issues can be surmounted with increasing procedural experience.
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