Key result
Novel cusp-positioning device achieves ~80% aortic valve competence during David procedures in porcine models.
Why the study?
The David procedure is operator-dependent and prolonged, prompting the development and experimental evaluation of a device for intraoperative positioning of aortic valve cusps to improve reproducibility and speed.
The preclinical testing of a novel device for positioning aortic valve cusps demonstrates early feasibility and could potentially simplify and standardize the technically demanding David procedure.
Preclinical feasibility in porcine models is hypothesis-generating; leaves open human trials before any David procedure adoption.
Introduction . Valve-sparing aortic root replacement with aortic valve (AV) reimplantation (David procedure) is associated with low risks of thromboembolic and infectious complications. Its negative features are prolonged duration, risks of hemorrhage, and operator-dependence. To increase the speed of performance, improve reproducibility and reduce operator-dependence we have developed a device for intraoperative positioning of AV cusps. It consists of 2 identical rings-measuring devices of variable diameter, connected with each other by three struts with detachable connections with zones of temporary anchoring of sutures during the test positioning of cusps. The actual task was to study the application of the device in the experiment. Aim : To evaluate the possibility and convenience of valve-sparing aortic root replacement with AV reimplantation using the developed device for positioning of AV cusps in experiment. Material and Methods . 10 cadaveric porcine hearts were used as models. The standard David technique was used for AV reimplantation. After measurement of aortic root parameters, dissection of the sinuses of Valsalva, isolation of the AV cusps with the commissures, proximal anchoring of the aortic graft, positioning of the cusps was performed to achieve the maximum area of coaptation and optimal position of the coaptation point. A static hydraulic test was performed and if it was satisfactory, the cusps were sutured to the inner side of the graft wall. Results . At baseline measurements, the medians (Q1; Q3) of sinotubular junction and aortic ring diameters were 21 (19; 21.3) and 20 (19; 21) mm, respectively. The static hydraulic test was unsatisfactory in two cases: due to asymmetric cusp prolapse and a coaptation defect. We noted loose anchoring of the proximal annulus in the area of aortic ring, difficulties in moving the sliding struts and anchoring of the sutures. Conclusion . The study assessed the device for positioning of AV cusps during David procedure. Standardization of this surgery type will improve the results, increase reproducibility and the number of performed operations. The areas of further work are the improvement of the device anchoring in the area of aortic annulus, some constructive modifications, as well as the improvement of the possibility to perform accurate measurements of the aortic root parameters.
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Uspenskiy et al. (2025) studied Aortic valve reimplantation model (n=10). Device for intraoperative positioning of aortic valve cusps was evaluated on Competence of the reimplanted aortic valve assessed by a static hydraulic test. The developed device for intraoperative positioning of aortic valve cusps during the David procedure resulted in a satisfactory static hydraulic test in 8 out of 10 cadaveric porcine heart models.
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