Transcatheter closure of a sinus venosus atrial septal defect using 3D printing and image fusion guidance

Figure 1. Process map for development of patient‐centered structural heart interventions. A, Problem, objectives, and boundaries defined with candidate solutions and pitfalls identified from literature review. B, Software based measurements of 3D anatomic structures based on high‐resolution cross‐sectional imaging. Candidate devices selected based upon these measurements. C, After 3D segmentation of CT, 3D model is printed and candidate device is deployed to simulate procedure and identify any potential sources of failure. D, Procedure performed in patient using 3D guidance from CT data imported into fluoroscopy system. Post‐procedure imaging using high‐resolution CT to critically evaluate deployment and procedure. E, Complete process reported publicly including candid critique of process and procedure. [Color figure can be viewed at http://wileyonlinelibrary.com]

Figure 2. Objectives for transcatheter repair of sinus venosus ASD with PAPVR and measures required for candidate device. A, 3D reconstruction of gated cardiac CTA with regions of interest outlined. Objectives were to exclude the ASD and anomalous RUPV (>4 cm) while avoiding extending into the RA or covering the azygos vein (<9 cm) with a device at least the diameter of the SVC near the RA (>26 mm). B, One candidate device demonstrating measures identified in (A); additional important features such as active fixation barbs and stent flexibility to conform to the SVC. [Color figure can be viewed at http://wileyonlinelibrary.com]

Figure 3. Simulation of device implantation in 3D printed model and implantation in patient using 3D image guidance. 3D segmentation of gated cardiac CTA in MIMICS (A) followed by 3D print of segmented structures of interest (B). Implantation of candidate stent graft in 3D printed model under fluoroscopy (C) and cone‐beam CT of results (D) demonstrated successful exclusion of ASD and RUPV. 3D guidance of implant in patient after importing gated cardiac CTA and registration with cone‐beam CT of patient on table (E) followed by overlay of ROIs onto fluoroscopy (F). G, Implant of stent graft guided by 3D ROIs demarcating the ASD and RUPV with proximal and distal ends of SVC outlined in orthogonal planes. H, Post‐procedure gated CTA demonstrated successful exclusion of ASD and RUPV without obstruction. [Color figure can be viewed at http://wileyonlinelibrary.com]