Abstract
The aim of this study was to adapt patient-specifically a co-registration procedure for image fusion (IF) of a pre-interventional CT dataset with real-time X-ray (XR) fluoroscopy during transfemoral transcatheter aortic valve implantation (TAVI), enabling improved performance of the procedure. The ability to use 3D models of the respective anatomies to complement the anatomic information obtained by XR fluoroscopy and provide a greater degree of real-time anatomical guidance holds great potential for complex cardiac interventions, especially for TAVI procedures with cerebral protection. Initial registration of two datasets was performed during the femoral puncture and sheath introduction using routinely acquired arteriographies. On-time refinement of the co-registration was then performed during the on-going procedure avoiding additional angiograms for the co-registration. Performance of the method was evaluated quantitatively in terms of procedural characteristics and clinical events. Significant reduction of the radiation dose [51 (42-55) vs. 64 (49-81) Gycm2, p = 0.032] and contrast agent (CA) volume [80 (50-95) vs. 100 (80-110)ml, p = 0.010] was achieved with the optimized approach as compared to the control group without IF, with simultaneous decrease of procedural [48 (41-58) vs. 61 (53-67) min, p = 0.002] and fluoroscopy times [14.8 (12.7-18.5) vs. 17.8 (14.3-19.4), p = 0.108]. In this proof-of-concept study we have demonstrated a novel co-registration approach for IF during TAVI not requiring any additional CA or XR scan. We have evaluated its potential benefit with the strong focus on guiding the femoral puncture, placement of the double-filter cerebral embolic protection device, and deployment of the valve prosthesis. We achieved improved performance and safety of the procedure with the introduced approach.
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