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.

1. Khubulava GG, Marchenko SP, Starchik DA, et al. Geometric and morphological features of the aortic root in norm and aortic regurgitation. Xirurgiya. Zhurnal im. N. I. Pirogova=Pirogov Russian Journal of Surgery. 2018; 5:4– 12. In Russian. DOI: 10.17116/hirurgia201854-12.

2. Mazzolai L, Teixido-Tura G, Lanzi S, et al. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. European heart journal. 2024; 45:36: 3538–3700. DOI: 10.1093/eurheartj/ehae179.

3. Le Polain de Waroux JB, Pouleur AC, Goffinet C, et al. Functional anatomy of aortic regurgitation: accuracy, prediction of surgical repairability, and outcome implications of transesophageal echocardiography. Circulation. 2007; 116(11 Suppl):I264–9. DOI: 10.1161/CIRCULATIONAHA.106.680074.

4. El Khoury G, de Kerchove L. Principles of aortic valve repair. The Journal of thoracic and cardiovascular surgery. 2013; 145(3 Suppl): S26–9. DOI: 10.1016/j.jtcvs.2012.11.071.

5. Bentall H, De Bono A. A technique for complete replacement of the ascending aorta. Thorax. 1968; 23:4:338– 9. DOI: 10.1136/thx.23.4.338.

6. De Paulis R, Scaffa R, Salica A, et al. Biological solutions to aortic root replacement: valve-sparing versus bioprosthetic conduit. Journal of visualized surgery. 2018; 4:94. DOI: 10.21037/jovs.2018.04.12.

7. David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. The Journal of thoracic and cardiovascular surgery. 1992; 103:4:617–21; discussion 622. DOI: 10.1016/s0003-4975(02)04135-8.

8. Fagan A, Pillai R, Radleysmith R, et al. Results of new valve conserving operation for treatment of aneurysms or acute dissection of aortic root. Br Heart J. 1983;49:302.

9. Hess PJ, Jr., Klodell CT, Beaver TM, et al. The Florida sleeve: a new technique for aortic root remodeling with preservation of the aortic valve and sinuses. The Annals of thoracic surgery. 2005; 80:2:748–50. DOI: 10.1016/j.athoracsur.2004.02.092.

10. Ross DN. Replacement of aortic and mitral valves with a pulmonary autograft. Lancet (London, England). 1967; 2:7523:956–8. DOI: 10.1016/s0140-6736(67)90794-5.

11. Chernyavsky AM, Khvan DS, Alsov SA, et al. Quality of life of patients with the ascending aorta aneurism after valve-sparing surgery. Cardiology. 2017; 57:9:47–52. In Russian DOI: 10.18087/cardio.2017.9.10017.

12. Arabkhani B, Klautz RJM, de Heer F, et al. A multicentre, propensity score matched analysis comparing a valve-sparing approach to valve replacement in aortic root aneurysm: Insight from the AVIATOR database. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2023; 63:2:ezac514. DOI: 10.1093/ejcts/ezac514.

13. Charchian ÉR, Belov IuV, Stepanenko AB, et al. Valve-sparing technique for type A aortic dissection with insufficiency of aortic valve. Cardiology. 2014; 6:91–6. In Russian DOI: 10.18565/cardio.2014.6.91-96.

14. Mastrobuoni S, Govers PJ, Veen KM, et al. Valve-sparing aortic root replacement using the reimplantation (David) technique: a systematic review and meta-analysis on survival and clinical outcome. Annals of cardiothoracic surgery. 2023; 12:3: 149–58. DOI: 10.21037/acs-2023-avs1-0038.

15. Khvan DS, Sirota DA, Zhul’kov MO, et al. Remote results of Florida Sleeve technique in patients with ascending aortic aneurysms and aortic insufficiency. Angiology and Vascular Surgery. 2020; 26:4:108–118. In Russian DOI: 10.33529/ANGIO2020411.

16. Bokeria LA, Milievskaya EB, Pryanishnikov VV, et al. Cardiovascular surgery–2022. Diseases and congenitalanomalies of the circulatory system. Moscow: Bakoulev NMRC of CVS of the Ministry of Health of Russia. 2023: 344. In Russian

17. Schafers HJ. Aortic valve repair: easy and reproducible? The Journal of thoracic and cardiovascular surgery. 2015; 149:1:129–30. DOI: 10.1016/j.jtcvs.2014.09.022.

18. Schafers HJ, Schmied W, Marom G, et al. Cusp height in aortic valves. The Journal of thoracic and cardiovascular surgery. 2013; 146:2:269–74. DOI: 10.1016/j.jtcvs.2012.06.053.

19. Gordeev ML, Uspenskiĭ VE, Ibragimov AN, et al. Surgical treatment of ascending aortic aneurysms. Kardiologiya i serdechno-sosudistaya xirurgiya =Russian Journal of Cardiology and Cardiovascular Surgery. 2016; 9:3:42–50. In Russian DOI: 10.17116/kardio20169342-50.

20. Boldyrev SIu, Man’kov DR, Rossokha OA, et al. New device for forming of the proximal part of vascular graft for the aortic root reconstruction in patients with ascending aorta aneurysm and bundle. Kardiologiya i serdechno-sosudistaya xirurgiya=Russian Journal of Cardiology and Cardiovascular Surgery. 2014; 7:1:41–43. In Russian

21. David TE. Aortic valve-sparing operations. Ann Thorac Surg. 2024; 117:1:45–53. DOI: 10.1016/j.athoracsur.2023.09.027.

22. Elibol A. A novel device for technical standardization of valve-sparing aortic root reimplantation. Turk Gogus Kalp Damar Cerrahisi Derg. 2020; 28:1:43–52. DOI: 10.5606/tgkdc.dergisi.2020.19182.

23. Love JW, Hanlon JG. Device and method for assessing the geometry of a heart valve. Patent #US 6598307 B2, 29.06.2003.

24. Paolitto A, Paquette J, Valentini V. Surgical tool for measurement of valve annulus and cusp geometry. Patent #US 8317696 B2, 27.11.2012.

25. Dobrilovich N. Heart valve sizing ring for valvesparing aortic root remodeling procedures. Patent #US 10182913 B2, 22.01.2019.

26. Tyler B, Gullotti D, Mangraviti A, et al. Polylactic acid (PLA) controlled delivery carriers for biomedical applications. Advanced drug delivery reviews. 2016; 107:163–75. DOI: 10.1016/j.addr.2016.06.018.

27. Yu C, Schimelman J, Wang P, et al. Photopolymerizable biomaterials and light-based 3D printing strategies for biomedical applications. Chemical reviews. 2020; 120:19:10695–10743. DOI: 10.1021/acs.chemrev.9b00810.

28. Akimoto H, Tsuru Y, Yokoyama H, et al. Commissure holder: an innovative device for aortic valvesparing technique. The Annals of thoracic surgery. 2001; 71:4:1380–1. DOI: 10.1016/s0003-4975(00)02451-6.

29. Jelenc M, Jelenc B, Kneževic I, et al. New graft sizing rings for aortic valve reimplantation procedures. Interactive cardiovascular and thoracic surgery. 2018; 26:1:1–3. DOI: 10.1093/icvts/ivx257.