First “post-marketing” implantation in Western China for the TAVI procedure with VitaFlow® was performed by Professor Tao Lin on September 23, 2019

The patient was a 58-year-old male patient who was treated at another hospital for repeated heart failures, but the medication worked not well. The patient was unable to lie flat and his lower limbs were swollen when he was transferred to Xijing Hospital. The presurgical ultrasonic assessment showed the EF value as 18%, the orifice area as 0.8cm2, the regurgitant flow as 23ml, and the left ventricular length as 102/110mm. The CT scan showed that the patient had Type 1 bicuspid aortic valve, horizocardia, right ridgeless calcified fusion that formed into a calcified lump, but the opposite side was not calcified at all, indicating difficult anchoring. Besides, the ECG showed combined intermittent left bundle branch block (LBBB).

A TAVR team led by Director Tao Ling had presurgical discussions and considered that the patient was in a critical condition and at high risk of aortic stenosis with regurgitation; and according to previous experiences, the patient was prone to failure of circulation at the time of rapid pacing and balloon dilatation during surgery, thus leading to catastrophic consequences. After in-hospital multidisciplinary consultations and with the agreement of the patient’s family, the team decided to use ECMO to ensure the success of the surgery.

During surgery, Director Tao Ling successfully completed the transvalvular process within a short time and used Alwide® Balloon for pre-dilation to implant the VitaFlow® valve. As predicted before surgery, it’s difficult for anchoring, and the ECG indicated that the patient’s valvular regurgitation was moderate and severe. For a better prognosis, Director Tao Ling and Director Li Fei agreed after discussions to apply the valve-in-valve technology, implanting another VitaFlow™ valve with the first valve as the reference and anchor point. The postsurgical ECG assessment showed no PVL, no regurgitation, and no pressure gradient, meeting the surgical expectations. The patient was awake and extubated immediately after surgery, and is able to lie flat.

This was domestic first TAVR surgery supported by ECMO after the VitaFlow® Valve System was put onto the market, demonstrating the safety and effectiveness of the VitaFlow® Valve System in patients with severe and complex aortic stenosis combined with regurgitation.