Mitral valved stent implantation.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomedical Engineering

Background:

• Current transfemoral and trans-apical valved stent techniques are limited to pulmonary and aortic valves in select patients.
• Transcatheter mitral valve replacement is an evolving field with unmet needs.

Purpose of the Study:

• To evaluate the short-term safety and efficacy of a novel self-expanding, repositionable mitral valved stent.
• To assess the feasibility of trans-apical implantation of this mitral valved stent in an off-pump technique.

Main Methods:

• A self-expanding, repositionable mitral valved stent was developed for trans-apical implantation.
• Five pigs underwent successful transcatheter implantation, with hemodynamic stability assessed at baseline, 6 hours, and 1 week.
• Valved stent function was evaluated using trans-esophageal echocardiography and ventriculography; positioning was confirmed by cardiac CT.

Main Results:

• Precise deployment resulted in reduced paravalvular leakage and accurate intra-annular positioning in most animals.
• Mean transvalvular gradients and left ventricular outflow tract (LVOT) gradients remained minimal throughout the follow-up period.
• Mild regurgitation was observed in a small number of animals, and no stent migration, embolization, systolic anterior movement, or LVOT obstruction occurred in the surviving animals.

Conclusions:

• The novel mitral valved stent can be reproducibly deployed with reliable stability.
• The procedure achieved minimal LVOT gradients and adequate valved stent function in the short-term follow-up.
• This trans-apical approach shows promise for future mitral valve interventions.