Major Breakthrough: DragonFly-T™ First Transcatheter Tricuspid Valve Repair Surgery in China

HANGZHOU,China,Dec.21,2020 -- On December 15,2020,Professor Wang Jian'an's team from the Second Hospital of Zhejiang University School of Medicine successfully applied the DragonFly-T™ Transcatheter Tricuspid Valve Clamping System to perform the first human clinical application in mainland China. This is the first self-developed product for trans-femoral tricuspid regurgitation repair in China,and the first transcatheter tricuspid valve repair in China,marking a major breakthrough in the field of tricuspid valve intervention in China.

The patient was a 79-year-old woman who was admitted with "recurrent chest tightness for more than 1 year" and was diagnosed with atrial fibrillation,functional tricuspid regurgitation,class IV cardiac function,and ascites. Preoperative transthoracic echocardiography (TTE) revealed extremely severe tricuspid regurgitation,bilateral atrial enlargement,tricuspid regurgitant width about 0.84 cm,effective tricuspid regurgitant orifice area 0.84 cm2,pulmonary artery systolic pressure 39 mmHg. Although the patient had undergone adequate and optimal medication,she still had recurrent heart failure episodes,and the risk of surgical open-heart surgery was extremely high,and she could not be effectively treated in several hospitals. Prof. Wang Jian'an's team decided to perform a minimally invasive tricuspid valve repair via the femoral vein route using the DragonFly-T™ Transcatheter Tricuspid Valve Clamping System.

The operation was performed under general anesthesia with a femoral vein approach. The clip was delivered to the right ventricle under transesophageal echocardiography and X-ray guidance to capture and clamp the anterior and septum tricuspid valve leaflets and close the valve clip. A total of three valve clips were implanted,and the clips were in good position and function. The tricuspid regurgitation grade decreased from 5+ preoperatively (Figure 2) to 1+ immediately postoperatively (Figure 3),and the hepatic venous flow improved significantly (Figure 4). The operation was completed successfully.

The patient was able to move around on her own the day after operation,and her existing discomfort was significantly reduced. She was discharged from the hospital two days after the operation,and a transthoracic ultrasound examination before discharge showed mild tricuspid regurgitation with a regurgitation grade of 1+ (Figure 5).

Professor Wang Jian'an said after the operation: "The population of tricuspid regurgitation patients in China is wide and often with many comorbidities,the current clinical medication treatment is less effective,and the surgical treatment of tricuspid regurgitation remain high risky,and the recommendation of tricuspid regurgitation in clinical guidelines still absence. In this patient,we achieved a very promising result with the DragonFly-T™ device and look forward to further studies to demonstrate the effectiveness and safety of DragonFly-T™."

Valgen Medtech is located in Binjiang,Hangzhou,China. The company focuses on the development of treatment technologies related to structural heart disease,especially mitral and tricuspid valves,and provides systemic solutions for mitral and tricuspid valve lesions (Tool Box Concept).

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