A 3D Printing-Based Transcatheter Pulmonary Valve Replacement Simulator: Development and Validation

Severe pulmonary regurgitation (PR) often occurs after treatment of tetralogy of Fallot with a valve ring patch, leading to enlargement and diverse morphological characteristics of the native right ventricular outflow tract (nRVOT), which increases the difficulty of transcatheter pulmonary valve replacement (TPVR). The purpose of this study was to use the TPVR simulator to help doctors improve their surgical skills by simulating the surgical process in vitro.

The TPVR simulator was developed using three-dimensional (3D) printing technology under computer-aided design. In this study, the TPVR simulator was used for preoperative simulation training and teaching. First, 10 specialists were equally divided into a 3D-printed group and a non-3D-printed group, each performing one TPVR; then, another six specialists and six young surgeons were selected to complete three TPVR simulations.

For the 3D-printed simulation group, the over-flap time (5.22 min (range: 4.85-5.87 min) vs. 6.72 min (range: 6.12-7.70 min), p = 0.016), fluoroscopy time (15.00 min (range: 13.50-16.50 min) vs. 19.00 min (range: 17.50-21.50 min), p = 0.012), and total operative time for the five surgeons (57.00 min (range: 54.00-62.50 min) vs. 67.00 min (range: 62.00-69.50 min), p = 0.036) were shorter. In addition, the results showed significant reductions in the median over-flap time and total time required in both the expert panel and young surgeon groups (all p < 0.05).

The reliability and validity of the TPVR simulator was initially demonstrated and has the potential to be a teaching and training tool for surgeons.