Why the study?
High anatomical screen failure rates limit the applicability of transcatheter mitral valve replacement devices due to risks such as LV outflow tract obstruction, large mitral annulus size, and calcification.
Does transcatheter mitral valve replacement using an atrial fixation technology reduce mitral regurgitation in patients with severe functional MR?
Does transcatheter mitral valve replacement using an atrial fixation technology reduce mitral regurgitation in patients with severe functional MR?
Transcatheter mitral valve replacement using an atrial fixation technology is technically feasible and effectively reduces mitral regurgitation in an initial small case series.
BACKGROUND: Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. METHODS: Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. RESULTS: Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. CONCLUSIONS: Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. SHORT ABSTRACT: We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits.
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Ninios et al. (2023) studied this question.
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