P015. A Novel 3-Dimensional Reinforced Graft for Valve-Sparing Aortic Root Replacement: Hemodynamic Comparison with Conventional Root Reimplantation and Remodeling Using Ex-Vivo Heart Simulator

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Background
Valve-sparing aortic root replacement (VSARR) is an effective technique to treat aortic root aneurysm or aortic regurgitation (AR) in cases with pliable cusps. However, it remains underutilized due to perceived procedural complexity and difficulty in standardization. To address these concerns, we developed a novel device consisting of a rigid three-dimensional (3D) coronet-shaped aortic annular skeleton assembled with a woven polyester graft (Figure A). This reinforcing 3D frame is designed to attach to the basal ring of the aortic valve (AV) by a single-layer hemostatic line (Figure-B, C) to obviate the need for basal layer stitches typically required in conventional root reimplantation. In this study, we studied the hemodynamic profiles of VSARR performed by this novel device as compared to conventional reimplantation and remodeling techniques.
Methods
Using 5 normal porcine aortic roots (median annular diameter=25mm), the novel (Novel), reimplantation (David) and remodeling (Yacoub) techniques were implemented in each of the 5 roots in a randomized fashion. A 28mm-straight graft was used for all. Hemodynamic data were acquired using a custom 3D-printed ex-vivo left heart simulator. AR fraction was the primary endpoint. Secondary endpoints included other hemodynamic parameters and procedural times.
Results
AR fraction was 1.6±0.8%, 3.3±2.6% and 7.1±3.1% in the Novel, David and Yacoub groups, respectively (P=0.006), with Novel and David groups being significantly lower than Yacoub group (Figure-D). Trans-AV mean pressure gradient was 6.0±2.2mmHg, 9.4±4.0mmHg and 4.2±1.3mmHg in the Novel, David and Yacoub groups, respectively (P=0.032), with David group being higher than other two groups (Figure-E). Energy losses across the AV demonstrated the Novel group having significantly less forward energy loss than the David group (P=0.033), and significantly less closing (P=0.025) and regurgitation (P=0.023) energy losses than the Yacoub group. Finally, the mean procedural times were 23.2±6.2min, 37.8±8.5min and 15.2±2.3min in the Novel, David and Yacoub groups, respectively (P<0.001) with the Novel and Yacoub groups being significantly shorter than the David group (P=0.008 and <0.001, respectively).
Conclusion
VSARR performed using the novel 3D reinforced graft showed short procedural time and favorable hemodynamic profiles that are non-inferior to conventional VSARR techniques suggesting its potential clinical utilities.

Authors
Joon Bum Kim (1), Matthew Park (2), Yuanjia Zhu (2), SHIN YAJIMA (2), Stefan Elde (2), Perry Choi (2), Michael Paulsen (2), Y. Joseph Woo (2)
Institutions
(1) Asan Medical Center, Stanford University School of Medicine, Seoul, Korea; Stanford, CA, (2) Stanford University School of Medicine, Stanford, CA

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