EVALUATION OF THE RESULTS OF AORTIC VALVE NEOCUSPIDIZATION WITH AUTOLOGOUS PERICARDIUM USING THE OZAKI TECHNIQUE IN AORTIC ROOT SURGERY

Highlights

The main surgical interventions for aortic valve pathology at the aortic root site are aortic valve replacement and redo replacement. The Ozaki procedure emerged in the last decade; it involves replacement of the aortic valve using autologous pericardium. Despite the fact that many centers perform the Ozaki procedure frequently, there are few studies on the comparative evaluation of its efficacy. This necessitated the present study, which compares three groups of patients operated on using different techniques.

Aim. To compare the short- and medium-term results of the Ozaki procedure and aortic valve replacements using mechanical and biological valves.

Methods. The retrospective study included 189 patients operated on for aortic malformation at the Cardiac Surgery Department of Sechenov University from 2017 to 2022. Three groups of patients were formed: patients undergoing Ozaki procedure were included in the Ozaki group (70 patients), patients undergoing aortic valve replacement using mechanical prosthesis were included in the Mechanical valve group (62 patients), and patients undergoing aortic valve replacement using biological prosthesis were included in the Biovalve group (57 patients). The Ozaki procedure was performed in case the diameter of the aortic annulus was ≤ 25 mm. All mid-term outcomes were assessed after at least 6 months (mean follow up period was 20 months). The primary end points were mean and peak aortic valve gradient, 30-day mortality in the short-term postoperative period, and midterm mortality (≥ 6 months).

Results. The mean gradient in the Ozaki, Biovalve, and Mechanical valve groups were 10.67 ± 7.15, 15.94 ± 21, and 17.87 ± 7.52 mm Hg. The peak gradient in the Ozaki group decreased from 81.7 ± 32.5 to 21.01 ± 13.22 mm Hg (in the in-hospital setting). 6 months after surgery, the peak gradient values were 18.98 ± 16.17 mm Hg. The in-hospital mortality rates in the Ozaki, Mechanical valve and Biovalve groups were 2.86, 5.26, and 6.45%, respectively. The overall mid-term mortality in three groups was 6/189, 3.17% (95% CI: 1.5–6.07), p = 0.172.

Conclusion. In the short- and mid-term period, Ozaki procedure is superior to aortic valve replacement techniques in terms of aortic valve pressure gradient and comparable in terms of mortality.

1. Joseph J., Naqvi S.Y., Giri J., Goldberg S. Aortic Stenosis: Pathophysiology, Diagnosis, and Therapy. Am J Med. 2017;130(3):253-263. doi: 10.1016/j.amjmed.2016.10.005.

2. Araque J.C., Greason K.L., Suri R.M., Holmes D.R., Rihal C.S., Reeder G.S., Bresnahan J.F., Nkomo V.T., Mathew V. The Role of Balloon Aortic Valvuloplasty in Patients With Aortic Valve Stenosis and Society of Thoracic Surgeons Risk of 15% or Higher. Ann Thorac Surg. 2016;101(2):592-7; discussion 597-8. doi: 10.1016/j.athoracsur.2015.07.030.

3. Klein A., Lee K., Gera A., Ports T.A., Michaels A.D. Long-term mortality, cause of death, and temporal trends in complications after percutaneous aortic balloon valvuloplasty for calcific aortic stenosis. J Interv Cardiol. 2006;19(3):269-75. doi: 10.1111/j.1540-8183.2006.00142.x.

4. Mazine A., El-Hamamsy I. Procedures and Outcomes of Surgical Aortic Valve Replacement in Adults. Cardiol Clin. 2020;38(1):89-102. doi: 10.1016/j.ccl.2019.09.012.

5. Mittal C.M., Talwar S., Devagourou V., Kothari S.S., Sampath Kumar A. Early results of aortic valve reconstruction with stentless glutaraldehyde treated autologous pericardial valve. Indian J Thorac Cardiovasc Surg. 2009;25:178–182 (). doi: 10.1007/s12055-009-0055-3.

6. Mourad F., Shehada S.E., Lubarski J., Serrano M., Demircioglu E., Wendt D., Jakob H., Benedik J. Aortic valve construction using pericardial tissue: short-term single-centre outcomes. Interact Cardiovasc Thorac Surg. 2019;28(2):183-190. doi: 10.1093/icvts/ivy230.

7. Sá M.P.B.O., Chernov I.I., Marchenko A.V., Chagyan V., Komarov R.N., Askadinov M., Enginoev S.T., Kadyraliev B.K., Ismailbaev A.M., Tcheglov M., Clavel M., Pibarot P., Ruhparwar A., Weymann A., Zhigalov K. Aortic Valve Neocuspidization (Ozaki Procedure) in Patients with Small Aortic Annulus (≤21 mm): A Multicenter Study. Structural Heart. 2020;4(5):413–419. doi: 10.1080/24748706.2020.1792595.

8. Ozaki S., Kawase I., Yamashita H., Uchida S., Nozawa Y., Matsuyama T., Takatoh M., Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011;12(4):550-3. doi: 10.1510/icvts.2010.253682.

9. Ozaki S., Kawase I., Yamashita H., Uchida S., Nozawa Y., Takatoh M., Hagiwara S., Kiyohara N. Aortic valve reconstruction using autologous pericardium for ages over 80 years. Asian Cardiovasc Thorac Ann. 2014;22(8):903-8. doi: 10.1177/0218492314520748.

10. Sá M.P.B.O., Perazzo Á.M., Zhigalov K., Komarov R., Kadyraliev B., Enginoev S., Ennker J., Popov A.F., Quarto C., Weymann A., Lima R.C. Aortic Valve Neocuspidization with Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure) - A Promising Surgical Technique. Braz J Cardiovasc Surg. 2019;34(5):610-614. doi: 10.21470/1678-9741-2019-0304.

11. Ozaki S., Kawase I., Yamashita H., Uchida S., Nozawa Y., Takatoh M., Hagiwara S. A total of 404 cases of aortic valve reconstruction with glutaraldehyde-treated autologous pericardium. J Thorac Cardiovasc Surg. 2014;147(1):301-6. doi: 10.1016/j.jtcvs.2012.11.012.

12. Enginoev S.T., Ziankou A.A., Chernov I.I., Dzhambieva M.N., Ramazanova N.E., Baev D.Yu., Hassan M.M., Bolurova A.M., Kolesnikov V.N. Immediate and mid-term results of implanting a MedInzh-2 mechanical prosthesis in the aortic position: ten-year experience of one center. Creative surgery and oncology. 2024;14(1):20-28. doi: 10.24060/2076-3093-2024-14-1-20-28. (In Russian)

13. Komarov R.N., Katkov A.I., Puzenko D.P., Odinokova S.N., Nikolenko V.N. Aortic root and aortic valve surgery: History and modernity. Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2019;23(4):9-25. doi: 10.21688/1681-3472-2019-4-9-25. (In Russian)

14. Reuthebuch O., Koechlin L., Schurr U., Grapow M., Fassl J., Eckstein F.S. Aortic valve replacement using autologous pericardium: single centre experience with the Ozaki technique. Swiss Med Wkly. 2018;148:w14591. doi: 10.4414/smw.2018.14591.

15. Ozaki S., Kawase I., Yamashita H., Uchida S., Takatoh M., Kiyohara N. Midterm outcomes after aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium. J Thorac Cardiovasc Surg. 2018;155(6):2379-2387. doi: 10.1016/j.jtcvs.2018.01.087.

16. Rosseikin E.V., Kobzev E.E., Bazylev V.V. Minimally invasive Ozaki technique. Angiol Sosud Khir. 2019;25(3):142-55. doi: 10.33529/ANGI02019319. (In Russian)

17. Nguyen D.H., Vo A.T., Le K.M., Vu T.T., Nguyen T.T., Vu T.T., Pham C.V.T, Truong B.Q. Minimally Invasive Ozaki Procedure in Aortic Valve Disease: The Preliminary Results. Innovations (Phila). 2018;13(5):332-337. doi: 10.1097/IMI.0000000000000556.

18. Ozaki S., Kawase I., Yamashita H., Uchida S., Nozawa Y., Takatoh M., Hagiwara S., Kiyohara N. Reconstruction of bicuspid aortic valve with autologous pericardium--usefulness of tricuspidization. Circ J. 2014;78(5):1144-51. doi: 10.1253/circj.cj-13-1335.

19. Kawase I., Ozaki S., Yamashita H., Uchida S., Nozawa Y., Matsuyama T., Takatoh M., Hagiwara S. Aortic valve reconstruction of unicuspid aortic valve by tricuspidization using autologous pericardium. Ann Thorac Surg. 2012;94(4):1180-4. doi: 10.1016/j.athoracsur.2012.05.016.

20. Rosseykin E., Bazylev V., Batrakov P., Karnakhin V., Rastorguev A. Immediate results of aortic valve reconstruction by using autologous pericardium (Ozaki procedure). Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2016;20(2):44-48. doi: 10.21688-1681-3472-2016-2-44-48. (In Russian)

21. Marathe S.P., Chávez M., Sleeper L.A., Marx G., Del Nido P.J., Baird C.W. Modified Ozaki Procedure Including Annular Enlargement for Small Aortic Annuli in Young Patients. Ann Thorac Surg. 2020;110(4):1364-1371. doi: 10.1016/j.athoracsur.2020.04.025.

22. Bazylev V.V., Mikulyak A.I., Slastin Ya.S. Possibility of the aortic root expansion combined with the Ozaki procedure. Russian Journal of Thoracic and Cardiovascular Surgery. 2018; 60 (4): 337–41. doi: 10.24022/0236-2791-2018-60-4-337-341. (In Russian)

23. Iida Y., Fujii S., Akiyama S., Sawa S. Early and mid-term results of isolated aortic valve neocuspidization in patients with aortic stenosis. Gen Thorac Cardiovasc Surg. 2018;66(11):648-652. doi: 10.1007/s11748-018-0976-0.

24. Krane M., Boehm J., Prinzing A., Ziegelmueller J., Holfeld J., Lange R. Excellent Hemodynamic Performance After Aortic Valve Neocuspidization Using Autologous Pericardium. Ann Thorac Surg. 2021;111(1):126-133. doi: 10.1016/j.athoracsur.2020.04.108.

25. Enginoev S.T., Chernov I.I., Komarov R.N., Belov V.A., Arutyunyan V.B., Kadyraliev B.K., Semagin A.P., Kuznetsov D.V., Zybin A.A., Ismailbaev A.M., Abdulmedzhidova U.K., Tlisov B.M., Gamzaev A.B. Aortic Valve Reinterventions after Ozaki: Clinical Case Series from Four Centers. Creative surgery and oncology. 2023;13(1):87-92. doi: 10.24060/2076-3093-2023-13-1-87-92. (In Russan)

26. Yamamoto Y., Iino K., Shintani Y., Kato H., Kimura K., Watanabe G., Takemura H. Comparison of Aortic Annulus Dimension After Aortic Valve Neocuspidization With Valve Replacement and Normal Valve. Semin Thorac Cardiovasc Surg. 2017;29(2):143-149. doi: 10.1053/j.semtcvs.2016.11.002.

27. Saisho H., Scharfschwerdt M., Schaller T., Sadat N., Aboud A., Ensminger S., Fujita B. Ex vivo evaluation of the Ozaki procedure in comparison with the native aortic valve and prosthetic valves. Interact Cardiovasc Thorac Surg. 2022;35(3):ivac199. doi: 10.1093/icvts/ivac199.

28. Koechlin L., Schurr U., Miazza J., Imhof S., Maurer M., Erb J., Gahl B., Santer D., Berdajs D., Eckstein F.S., Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.