Moscow, Russia- On December 18, 2023, MicroPort^® CardioFlow completed the first implantation of its VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®) in Russia, marking the completion of a highly complex Type 0 bicuspid aortic valve implantation with an extremely horizontally positioned heart via Transcatheter Aortic Valve Implantation (TAVI). Led by Professor Imaev Timur of the Russian National Medical Research Center for Cardiovascular Surgery, with guidance from Chinese experts, the team achieved precise deploy and successful release of the valve without the need for post-dilation. Post-operative echocardiography showed good valve shape and position, with no paravalvular leakage or conduction abnormalities, confirming the success of the procedure.

Patient Baseline Information

The patient, 65 years old, had a preoperative CT showing a Type 0 bicuspid aortic valve with severe stenosis, thickened leaflets, a valve annulus perimeter of 78.4 mm, a valve annulus horizontal angle of 80°, and an extremely horizontally positioned aorta. After thorough examination and multidisciplinary assessment, the surgical team, following in-depth communication with the patient and family, decided to use the VitaFlow Liberty^® for TAVI treatment.

Surgical Strategy and Operation

Given the patient's condition, the procedure required high demands on guidewire shaping and operational techniques. During the procedure, the surgical team switched to a shaped guidewire and then introduced a 20mm balloon for pre-dilation. The valve selection was determined after angiographic imaging during balloon pre-dilation, ultimately choosing the 24mm VitaFlow Liberty^® for high-position release. When the valve was released to 2/3 of its working position, angiography showed ideal depth of the valve implantation, and the surgeon proceeded to fully release it. Angiography demonstrated that the valve was anchored 2mm below the annulus, with good valve shape and position, with no paravalvular leakage, unaffected mitral valve, and no conduction abnormalities.

Expert Evaluation

The novel interventional experience brought by VitaFlow Liberty^® has left a profound impression on the surgeon and the entire team. Professor Imaev Timur commented:

The success of this surgery was not only due to the surgical team's exceptional medical skills and seamless collaboration but also benefited from the groundbreaking upgrades in the VitaFlow Liberty^®'s electrically retrievable delivery system, featuring a unique double reinforced spiral design and reinforced inner and outer tubes, which achieved a 1:1 response throughout the valve release process, ensuring stable release without microdislogment and precise anchoring at the optimal implantation depth. Given the excellent interventional experience during this surgery, I will support the promotion of this product to more hospitals in Russia, which providing local physicians and patients with better interventional choices.

In October of this year, VitaFlow Liberty^® obtained market approval from the Russian National Food and Drug Administration (RZN). The successful completion of the first implantation in Russia signifies a new phase in the local commercialization process of VitaFlow Liberty^®. In the future, MicroPort^® CardioFlow will continue to actively promote global market expansion and innovative research and development, aiming to provide high-quality and accessible total solutions for structural heart disease to more patients.