Exploring Technical Insights into the Mechanical Adaptation Behavior of the Intuity Elite Bioprosthesis: A Single-Center Experience

Abstract: Objectives: Sutureless aortic valve replacement (Su-AVR) is gaining popularity due to its simplified implantation technique and advantages such as shorter operative time. We evaluated the Intuity aortic bioprosthesis and investigated the mechanical adaptation of its prosthetic stent and its susceptibility to cusp fibrosis, dysfunction, flutter, and obstruction after implantation, if any. Methods: N=19 patients received a Su-AVR with the Intuity bioprosthesis at our institution between 2018 and 2020. We analysed the clinical outcomes, anatomical and stereotactical features using the OSIRIX DICOM Pixmeo software CT images, and the radial force (RF) profile using the RX Machine apparatus (Machine Solutions Inc., located in Flagstaff, AZ), for evaluating the valve’s stent according to ISO standards. Results: In all three-dimensional reconstructions, the Intuity stent showed no degree of deformation or ovalisation. Annulus ovality was 0 and 10.4%, respectively, and ovality of the skirt at its open edge was 2 and 19.9%, respectively. Intuity's RF was significantly higher than other transcatheter aortic devices, exceeding the tester's measurement range. Conclusions: The Intuity Elite bio-prosthesis demonstrates remarkable ovality, RFs, and rigidity that could relate to a potential for dynamic adjustment to the hemodynamic patterns in the aortic root postoperatively. Its high RFs at the annulus may explain the resistance to deformation, ensuring harmonious, natural-like cusp mobility. This may reduce the risk of turbulence-induced fibrosis and increased transvalvular pressure gradients, and may clinically translate into less hemolysis. To validate the clinical impact of our findings, if any, additional research with larger sample and extended follow-up is essential.