Copenhagen, Denmark - MicroPort^® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort^® CardioFlow, stock code: 02160.HK) announced that its self-developed VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") has completed five pre-market implantations at Rigshospitalet (Copenhagen University Hospital) in Denmark. The surgery was conducted by cardiologist Dr. Ole De Backer and his team from Rigshospitalet, with Dr. Darren Mylotte, an Irish cardiology expert, serving as a special invited consultant. During the surgery, The valves of all five patients were released to the ideal position, and immediate postoperative imaging showed good valve morphology and position, with no perivalvular leakage or regurgitation, indicating the successful completion of the surgery. All patients recovered well and were discharged the following day.

As China's first and the world's only motorized retrievable transcatheter aortic valve system, Since being approved for listing in China in 2021, VitaFlow Liberty^® has entered four overseas countries, namely Argentina, Colombia, Thailand and Russia. The CE registration process is currently making progress and is expected to receive approval in the near future.

The VitaFlow Liberty^® has inherited the advantages of VitaFlow^® transcatheter aortic valve and delivery system in valve design, using a hybrid cell density frame, self-expanding stent, bovine pericardial leaflets, and a high double-layer PET skirt, which provides high radial force excellent coaxial release, and a reduced incidence of perivalvular leakage and regurgitation in the postoperative period. In addition, its groundbreaking breakthrough upgraded delivery system has a unique double reinforced spiral capsule, which achieves the flexibility and 360°range of motion, while ensuring fast, stable and precise release and recapture.

Case Presentation

The patient is an 85-year-old female diagnosed with moderate aortic valve regurgitation with severe stenosis, moderate mitral valve regurgitation, and moderate tricuspid valve regurgitation. Preoperative echocardiography assessment revealed an average transvalvular pressure gradient of 54.9 mmHg and a peak flow velocity of 4.38 m/s across the aortic valve. The left ventricular ejection fraction (LVEF) was measured at 50%; The NYHA(functional classification) score was Grade III, and the EuroSCORE II (European System for Cardiac Operative Risk Evaluation) score was 3.91%.

Patient Information

The patient has a tricuspid aortic valve with a valve annulus circumference of 75.3mm and an average diameter of 24.0mm. The left ventricular outflow tract (LVOT) has a circumference of 74.0mm and an average diameter of 21.8mm. The heights of the left and right coronary artery ostia are 13.4mm and 19.1mm, respectively. The valve commissure angle is 45°. There is a possibility of aortic root aneurysm during systole with mild aortic valve calcification. The surgical risk factors include difficulty in placing a stiff guidewire due to the small size of the left ventricular cavity, and the possibility of the guidewire dislodging from the left ventricle during devices exchange. Following thorough discussions, The surgical team and expert practitioners decided to use the VitaFlow Liberty^® from MicroPort^® CardioFlow, employing the TAVI 27mm valve in conjunction with the DSR27 motorized retrievable delivery system for the TAVI procedure.

Surgical Procedure

The procedure was performed under local anesthesia, with the right femoral artery as the primary access route. After introducing an 18Fr sheath, the AL-2 catheter was advanced across the valve into the left ventricle. Subsequently, a stiff guidewire and a 21mm balloon were delivered. With the heart pacing at 180bpm, the systolic blood pressure dropped to 60mmHg. The balloon was rapidly inflated and a contrast dye was injected into the aortic root for angiography. The angiography revealed no significant waist sign or regurgitation. The TAV27 valve was selected and assembled into the DSR27 electrically retrievable delivery system. Stabilizing the stiff guidewire smoothly across the aortic arch, the delivery system demonstrated good vascular compliance, allowing easy crossing of the valve. The valve was gradually released to the retrievable limit, and under fluoroscopy, the position of the valve was assessed to be optimal with good coaxiality. The skirt did not impact the coronary arteries. The valve was slowly released until the stent was fully expanded, and the delivery system was smoothly withdrawn. Postoperative angiography revealed a well-shaped and positioned valve with no paravalvular leakage or regurgitation. The delivery system did not cause any significant vascular complications. The surgery was successfully completed.

Postoperative Condition

The patient was discharged on the second day after surgery and recovered well. Follow-up cardiac ultrasound showed an improvement in left ventricular ejection fraction (LVEF) to 60%. The valve function was normal, with a flow velocity of 1.85 m/s, and the average transvalvular pressure gradient reduced to approximately 6.4 mmHg.

Expert Evaluation

Cardiologist Dr. Ole De Backer commented: "The entire release process of VitaFlow Liberty^® was particularly stable, and the release position was very precise. Especially for patients with a small ventricle, stable and precise release can still be achieved, fully demonstrating the advantages of the VitaFlow Liberty^® product. We look forward to its CE certification and benefiting more patients.

The successful completion of 5 clinical implants using VitaFlow Liberty^® in Denmark marks a new stage in the pre-market clinical phase of the product in Europe. It is another important milestone for MicroPort^® CardioFlow in the process of expanding into the international market. In the future, MicroPort^® CardioFlow will further strengthen in-depth cooperation with clinical experts at home and abroad, closely interact with the terminal market, rapidly understand and grasp the feedback and trends of the international market, and fully leverage its technological leadership in the field of structural heart disease, which will bring well-being and hope to patients worldwide.