New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract: A Multi-centre Clinical Research

Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients after surgical repair of TOF with pulmonary valve regurgitation, a progressive need is underway for valved conduits. Meanwhile, biological valved conduits used in foreign countries are lacked in China, with the disadvantage that a high failure rate of biological conduits increasing the chances of reoperation which greatly reduce the long-term survival rate. Thus, a new, low failure rate valved conduit with effective performance is urgently needed.

Our team manufactured a new valved conduit with 0.1mm expanded polytetrafluoroethylene and blood vessels. This valved conduit exhibited a fine anti-regurgitation effect and a relatively low failure rate through in vitro fluid test and animal model. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Our team have already applied a patent for inventing and a utility model patent for this technique. Several papers have also been published.

Till now, over 70 cases have been involved with this valved conduit with positive early and mid-term follow-up results. Our team have promoted this technique to several heart center such as Zhongshan Hospital affiliated to Fudan University, Shanghai Children's Medical Center and Nanjing Children's Hospital and all department have achieved satisfactory effects.

Despite the progress which have been made, there are still problems remained to be solved to prove the superiority of valved conduits. First, systematic prospective comparative study is required. Second, 70 cases are not enough and currently this is just a single-center study. Third, follow-up time is too short to evaluate the long-term effect. Last but not least, imaging data are blank for evaluating the function of the conduit and right ventricle.

In this prospective comparative research, the new designed PTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed PTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.