Early Feasibility Study with the SATURN Transapical Mitral Valve Replacement Device.

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Severe functional mitral regurgitation poses a significant risk for high-risk surgical patients.
• Transcatheter mitral valve replacement (TMVR) offers a less invasive alternative for this patient population.

Purpose of the Study:

• To evaluate the early feasibility and 1-year outcomes of transapical TMVR using the SATURN System.
• To assess the safety and efficacy of the SATURN System in patients with severe functional mitral regurgitation.

Main Methods:

• A single-center feasibility study involving five high surgical risk patients.
• Transapical implantation of the SATURN System.
• One-year follow-up including clinical assessment, quality of life questionnaires (Kansas City Cardiomyopathy Questionnaire), and echocardiography.

Main Results:

• Successful valve implantation in all patients without major adverse events.
• All patients were alive at 1-year follow-up.
• Significant improvement in quality of life (median KCCQ score increase from 63.5 to 99.0).
• Stable valve hemodynamics, absence of significant mitral regurgitation, and no left ventricular outflow tract obstruction on echocardiography.

Conclusions:

• Transapical TMVR with the SATURN System is feasible and safe in high-risk patients with severe functional mitral regurgitation.
• The system demonstrates favorable 1-year clinical and hemodynamic outcomes.
• Larger studies are warranted to confirm these promising initial findings.