Shanghai, China, 03 June 2021 — MicroPort CardioFlow Medtech Corporation (CardioFlow) recently held a satellite session on ‘Innovative Design and Four-year Clinical Results of VitaFlow® at The 19th China Interventional Therapeutics Congress (CIT 2021), announcing the four-year follow-up results of the clinical study of the VitaFlow® Transcatheter Aortic Valve and Delivery System (VitaFlow®).
During the sesssion, Prof. Daxin Zhou, from Zhongshan Hospital Affiliated to Fudan University, presented the innovative design of the VitaFlow® and the four-year follow-up results of the clinical study – a prospective, multi-centre, single-arm study, which enrolled 110 patients with severe aortic stenosis not suitable for open-heart intervention. Encouragingly, results of the four-year follow-up also demonstrate the high safety and efficacy of VitaFlow® in the treatment of elderly patients with severe aortic stenosis, proving the effectiveness of long-term use.
Prof. Yongjian Wu, from Fuwai Hospital of Chinese Academy of Medical Sciences, commented on the four-year follow-up results of the VitaFlow®, noting that the follow-up data from this study is very reliable due to well defined research population and study procedure that aims to reflect the real-life situation of the valve when used in-vivo over time. In the first few years, the study focused more on patient survival time, such as all-cause mortality rate and cardiovascular mortality rate, amongst others, as the TAVR therapies were mainly aimed at the elderly population over 70 years old. With the increasing application of TAVR therapies to younger patients, valve durability will become an increasingly important topic, in this respect future studies should place greater emphasis on valve properties (i.e., valve functionality over five years).
Academician Junbo Ge, from Zhongshan Hospital Affiliated to Fudan University, was invited to serve as the guest chairperson. During his address to the congress, Academician Ge said, “After more than a decade of efforts and many breakthroughs, signs of progress have been made in the field of interventional therapy of aortic valve disease in China. TAVR technology, which has been termed as the ‘fourth revolution’ in the cardiovascular field, is now being rapidly adopted in major hospitals across China. As population aging intensifies in China, the number of patients with heart valve disease will increase, which will further expand the clinical application of TAVR technology. Against this context, it is crucial to encourage our colleagues to exchange information, share knowledge and discuss the latest issues.”
CardioFlow presented a wealth of discussions and exciting case studies relevant to clinical practices at CIT 2021, providing experts with insights and inspirations on TAVR strategies for patients with different types of valve disease. In the future, CardioFlow will organize more academic exchange activities in the field of valvular heart disease, enabling better clinical application of therapeutic solutions for the benefit of patients.
About VitaFlow®Transcatheter Aortic Valve and Delivery System (VitaFlow®) Clinical Study
The clinical study of the VitaFlow® Transcatheter Valve System was a prospective, multi-centre, single-arm study, which enrolled 110 patients with severe aortic stenosis not suitable for open-heart intervention. The patients underwent TAVR procedure with the VitaFlow® at 11 hospitals across China from September 2014 to November 2016. According to the results, the mean age of enrolled patients was (77.7 ± 4.8 ) years with a mean Society of Thoracic Surgeons (STS) score of (8.8 ± 5.6)%. At two-year follow-up, the all-cause mortality rate was 4.5%, while the rates of major stroke, major vascular complication and new pacemaker implantation were 7.3%, 2.7% and 19.1%, respectively. At three-year follow-up, the all-cause mortality rate was 10.9%, while the rates of major stroke, major vascular complication and new pacemaker implantation were 11.8%, 2.7% and 20.0%, respectively. At four-year follow-up, the all-cause mortality rate was 12.7%, and the rates of major stroke, major vascular complication and new pacemaker implantation were 12.7%, 2.7% and 20.0%, respectively, showing that VitaFlow® is safe and effective for long-term clinical use.
About MicroPort CardioFlow Medtech Corporation
MicroPort CardioFlow Medtech Corporation (CardioFlow) is a subsidiary of MicroPort Scientific Corporation (00853.HK), focused on the research, development and commercialization of innovative transcatheter and surgical solutions for valvular heart diseases.