This study was performed to assess the acute intraprocedural effects of transcatheter direct mitral annuloplasty using the Cardioband device on 3-dimensional (3D) anatomy of the mitral annulus. Of 45 patients with functional mitral regurgitation (MR) enrolled in a single arm, multicenter, prospective trial, 22 had complete pre- and post-implant 3D transesophageal echocardiography (TEE) images stored in native data format that allowed off-line 3D reconstruction. Images with the highest volume rate and best image quality were selected for analysis. Multiple measurements of annular geometry were compared from baseline to post-implant using paired t tests with Bonferroni correction to account for multiple comparisons. The device was successfully implanted in all patients, and MR was reduced to moderate in 2 patients, mild in 17 patients, and trace in 3 patients after final device cinching. Compared with preprocedural TEE, postprocedural TEE showed statistically significantly reductions in annular circumference (137 ± 15 vs 128 ± 17 mm; p = 0.042), intercommissural distance (42.4 ± 4.3 vs 38.6 ± 4.4 mm; p = 0.029), anteroposterior distance (40.0 ± 5.4 vs 37.0 ± 5.7 mm; p = 0.025), and aortic-mitral angle (117 ± 8° vs 112 ± 8° p = 0.032). This study demonstrates that transcatheter direct mitral annuloplasty with the Cardioband device results in acute remodeling of the mitral annulus with successful reduction of functional MR.
- Cardiology and Cardiovascular Medicine