Development of a device for assessment of aortic root parameters and positioning of aortic valve cusps during aortic valve-sparing root replacement

Background. A promising method of surgical treatment of aneurysms of the root and ascending aorta (AA) with unchanged aortic valve (AV) cusps is aortic valve-sparing root replacement (VSRR) with AV reimplantation (David procedure). To date, there are no clear indications to make a choice in favor of valve-replacing or valve-sparing intervention. The result of visual evaluation and the choice of treatment method based on the surgeon’s experience remains the main criteria. Objective . In the experiment to develop a prototype and method of application of the device for positioning of AV cusps, which will simplify and standardize aortic valve-sparing root replacement, improve the results and increase the reproducibility of these operations. Design and methods . Three-dimensional (3D) modeling of the device components was performed in the parametric open-source computer-aided design environment FreeCAD 0.20.1. Two-dimensional sketches were converted into three-dimensional models and exported as stl files for 3D printing. Solid components of the model were made of polylactic acid (PLA-plastic), elastic components were made of rubber-like photopolymer (Dropstil F556 10 shore A) also by 3D printing using SLA technology. Results. The device consists of 2 similar ring-sizers of variable diameter connected by three struts of variable length. In the upper part of each of the struts fastenings to the distal ring represents T-shaped cutouts for temporary locking of the suture-holders passed through the commissures of the AV cusps. For proximal locking of the aortic graft and the proximal ring-sizer, 3 U-shaped sutures are used, passed from inside to outside through the AV ring, the proximal part of the graft and taken in the tourniquets. The diameters of the ring-sizers can be varied between 25–40 mm by rotating a worm drive. A graft is placed on the inner side of the device, the suture-holders attached to the tops of the commissures are locked in the T-shaped notches in the upper parts of the struts. The device will allow changing the position of the coaptation point, coaptation square and performing hydraulic tests in different positions of the cusps, as well as variable diameters at the level of the AV ring and sinotubular junction (25–40 mm). When the target position of the coaptation point, coaptation area and satisfactory hydraulic test result are achieved, the cusps with commissures are locked inside the graft and the device is removed. Conclusion. A new device has been developed to facilitate, reproduce, and standardize VSRR. The results obtained will facilitate and accelerate the performance of VSRR, increase the reproducibility of the technique, and reduce the risks of complications.