Key result
CardiAQ TMVR achieves 100% procedural success with marked functional improvement in survivors.
Why the study?
Does transcatheter mitral valve replacement with the CardiAQ valve provide a feasible and safe treatment for patients with severe mitral regurgitation not eligible for surgery?
Case Report (n=4)
Does transcatheter mitral valve replacement with the CardiAQ valve provide a feasible and safe treatment for patients with severe mitral regurgitation not eligible for surgery?
Transcatheter mitral valve replacement with the CardiAQ valve demonstrates procedural feasibility in high-risk patients with severe mitral regurgitation, though safety remains a concern.
Supports feasibility in high-risk severe MR; leaves open safety, durability, and need for larger prospective trials.
AIMS: We report our experience with the CardiAQ prosthetic valve using both transapical and transseptal access. Aim of our study was proving the feasibility, safety and effectiveness of a novel transcatheter mitral valve bioprosthesis. METHODS: Four patients with severe mitral regurgitation, not eligible for mitral valve surgery, were treated with the CardiAQ valve. The procedures were performed under general anaesthesia, fluoroscopic and transesophageal echocardiographic guidance. We used a transapical approach in two patients and transseptal access in the others. RESULTS: Procedural success was obtained in all patients without extracorporeal circulation support. Mean procedure time was 128 min (range 90-180) and mean hospitalization duration was 12 days (range 4-24). The transseptal approach resulted in significantly shorter in-hospital stay with quick recovery. One patient died on day 35 from septicaemia and another one died after 5 months from major bleeding. The survival patients are presently in New York Heart Association I-II with improved left ventricular ejection fraction and normal quality of life. CONCLUSION: CardiAQ valve placement is safe using a transapical or transseptal approach. Following valve replacement, there was a marked functional improvement in survivors. Transcatheter mitral valve replacement is a promising therapy for mitral regurgitation in a selected patient population.
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Ussia et al. (2017) conducted a case report in Severe mitral regurgitation (n=4). CardiAQ prosthetic valve was evaluated on Procedural success. Transcatheter mitral valve replacement using the CardiAQ valve achieved procedural success in 100% of patients (4/4), with marked functional improvement in the 2 survivors.