For the in vivo functional efficacy evaluation, we assessed the following parameters: 3D balloon spacer adjustment and 3D balloon spacer patency in surviving pigs. Procedures were performed under fluoroscopy guidance [6 (link)]. The pivot system was delivered using the 0.035” guidewire (Terumo Corporation, Tokyo 151-0072, Japan) until the collapsed 3D leaflet crossed the tricuspid valve, and the distal end of the device was directed towards the right lower pulmonary artery. To assess the spacer, we injected a fluid (saline and dye mixture) through the injection tube while monitoring the size and position of the spacer using fluoroscopy and echocardiography. Once the inflation was confirmed, the injection tube was simply removed by pulling it out. At the end of the procedure, a spiral anchor was deployed in the inferior vena cava (IVC). Sixteen pigs were used to evaluate the expansion ability, size control ability, and patency via X-ray fluoroscopy (Integris H5000F; Philips Medical Systems, Amsterdam, The Netherlands).
Free full text: Click here
