Three-dimensional printing-guided coaxiality assessment in transcatheter aortic valve replacement for aortic regurgitation

Abstract

Background: Transcatheter aortic valve replacement (TAVR) using the J-Valve system provides a solution for patients with aortic regurgitation (AR). However, it remains unclear whether its coaxiality performance is related to procedural complications. Aim: Our goal was to improve the efficacy and accuracy of TAVR in patients with AR by adjusting J-Valve coaxiality using three-dimensional printing (3DP). Methods: This multicenter, prospective study included 612 patients with AR who underwent transapical TAVR. Of these, 228 patients were assigned to the 3DP group, in which the insertion angle and implantation depth were pre-determined. The coaxiality index was calculated using the distances from the bottom of the bioprosthesis to the base of the three cusps. Results: Compared to the non-3DP group, the 3DP group demonstrated better coaxiality performance (coaxiality index: 3.4 ± 1.7 vs. 4.0 ± 2.1; coaxiality angle: 10.5 ± 3.7° vs. 12 ± 4.2°; both p<0.001). Post-operative coaxiality index showed a strong correlation with the coaxiality angle (correlation coefficients: 0.85 in the 3DP group and 0.88 in the non-3DP group). The procedural success rate was higher in the 3DP group (100% vs. 96.4%; p=0.008). Paravalvular leakage (PVL) occurred less frequently in the 3DP group (mild PVL: 3.51% vs. 18.2%; p<0.001; moderate PVL: 0% vs. 1.04%; p<0.001). Multivariable analysis identified the coaxiality index, coaxiality angle, and horizocardia as independent predictors of PVL. Conclusion: PVL incidence after TAVR can be reduced through pre-operative simulations that adjust coaxiality using 3DP. Relevance for patients: The high incidence of PVL in transapical TAVR with the J-Valve is associated with coaxiality after bioprosthesis implantation. This study suggests that adjusting coaxiality using pre-procedural 3DP simulations may effectively reduce PVL incidence and other procedural complications during transapical TAVR. In the future, randomized clinical trials will be needed to evaluate the efficacy and accuracy of pre-procedural 3DP simulations and the coaxiality index in treating patients with pure AR undergoing transapical TAVR.

Keywords

Aortic regurgitation / Transcatheter aortic valve replacement / Three-dimensional printing / Coaxiality / Clinical outcome

Funding

This work was supported by the Development and Transformation of New Technology and Construction of Precision Diagnosis and Treatment System for Transcatheter Interventional Diagnosis and Treatment of Structural Heart Diseases (2022YFC2503400); National Natural Science Foundation (82370375); Research on Key Techniques of Minimally Invasive Treatment for Valvular Heart Diseases (2023-YBSF-105); Xijing Hospital Booster Foundation (XJZT24LY42); and Safety and Efficacy of 3D Printing in Transcatheter Aortic Valve Replacement: A National Multicenter, Prospective Study Program (XJZT24LY42).

Conflict of interest

The authors declare they have no conflicts of interest.

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