Lille, France - Recently, the Transcatheter Mitral Valve Replacement System ("TMVR System") of MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as " MicroPort^® CardioFlow ") has successfully completed its first overseas clinical application under compassionate use at Lille University Center Hospital in France. The procedure, led by Prof. Thomas Modine's team at the hospital, resulted in a stable recovery for the patient, with good hemodynamic improvement, and the patient was discharged after recovery. The 30-day follow-up results showed complete disappearance of mitral regurgitation, no perivalvular leakage, and the valve was in good working order and stable position.

Mitral valve replacement procedure is still in the exploratory stage globally, and the TMVR system developed by MicroPort^® CardioFlow has already been used in many humanitarian clinical applications, with excellent immediate surgical outcomes and follow-up results at 30-day, 3-month, and 1-year. The success of this first overseas humanitarian clinical application signifies that the product has emerged in the field of mitral valve interventional therapy for structural heart disease, and marks another steady step in the exploration of international cutting-edge technology..

Patient Basic Information

The patient, a 70-year-old woman, was admitted due to decompensation of heart compensation caused by ischemic mitral regurgitation and prolapse of the posterior leaflet P3 area of the bicuspid aortic valve, leading to cardiac decompensation. Echocardiography indicated left ventricular dilation with eccentric left ventricular hypertrophy, segmental motion abnormalities, and basal/mid-basal layer arterial aneurysms. The patient had an EF of 55%, moderate tricuspid regurgitation, and right ventricular dilation. Considering the high risk of surgical intervention and unsuitability for transcatheter edge-to-edge mitral valve repair, the hospital's cardiac team decided to perform a transcatheter mitral valve replacement using MicroPort^® CardioFlow’s TMVR system.

Surgical Strategy and Operation

Before the procedure, Professor Thomas Modine's team and MicroPort^® CardioFlow TMVR team engaged in extensive discussions, conducting measurements and analyses based on CT imaging to assess intraoperative risks and plan the strategy. The patient's anatomical structure of the apical puncture site was deemed ideal with a low risk of left ventricular outflow tract obstruction.

The procedure involved a minimally invasive incision at the left fifth intercostal space for apical access, placement of the delivery system under fluoroscopy, and gradual release of the valve after adjusting for circumferential alignment. The valve position was confirmed satisfactory through fluoroscopy and TEE before removing the delivery system. The entire procedure, from insertion to removal of the surgical instruments, took only 20 minutes.

Postoperative Recovery

Postoperatively, the patient's bicuspid aortic valve showed excellent morphology and functioning. Immediate ultrasound indicated complete disappearance of mitral regurgitation, no perivalvular leak, ideal implantation position of the prosthetic valve, and good left ventricular outflow tract (LVOT) blood flow spectrum. There was no risk of left ventricular outflow tract obstruction, and significant hemodynamic improvement was observed. The procedure was highly successful.

Expert Evaluation

After the operation, Professor Thomas Modine gave full recognition to the TMVR system. Professor Thomas Modine stated:

It's gratifying to see that mitral valve interventional therapy is gradually becoming a reality, providing patients with a good prognosis and improving their quality of life. Among the TMVR products I am familiar with, the MicroPort^® CardioFlow’s TMVR system has a unique design concept that effectively avoids LVOT obstruction, provides stable anchoring without perivalvular leak, and offers ample effective valve orifice area for the patient's recovery. The implantation in this case was straightforward, with excellent immediate results and ideal outcomes at the 30-day follow-up, bringing new hope for the treatment of high-risk patients with mitral regurgitation.

In the future, MicroPortc CardioFlow will prioritize meeting patient needs, accelerate independent innovation based on clinical pain points, and continue to explore the optimal solutions for transcatheter mitral valve treatment, benefiting more patients globally.