Gender comparison of immediate and medium-term results of Ozaki operation: a Propensity Score Matching Analysis

Highlights. A retrospective analysis of the patients’ data after Ozaki operation in four Russian Medical Centers was carried out. A comparative gender assessment of the immediate and medium-term results of Ozaki operation was performed.

Aim. Gender assessment of Ozaki operation immediate and mid-term results in patients with aortic valve (AV) pathology.

Methods. A retrospective multicenter study enrolled 251 patients (135 women, median age 66 (60–70) years old) who underwent Ozaki operation (2017–2020) was carried out in four centers in Russia. After propensity score matching, 92 patients were selected (mean age 65.8±10.8 years old). Two groups were formed in the gender structure: 46 females (average age 67.8±6.3 years old), 46 males (average age 63.8±15.4 years old). The main cause of AV dysfunction was severe aortic stenosis – in 86 (93.5%) cases. Chronic heart failure of III–IV functional class according to NYHA was observed in 26 (28.3%) patients. A bicuspid AV was in 24 cases (26.1%). The primary endpoint was hospital mortality. Postoperative complications and mid-term results (three-year overall survival and freedom from reoperation on AV) were assessed as secondary endpoints; the median follow-up period was 23 (18–33) months.

Results. There was no statistically significant difference between the groups in the duration of surgery (275 minutes for females and 285 minutes for males, p = 0.4), cardiopulmonary bypass (98 minutes for females and 115 minutes for males, p = 0.3), aortic clamping (80 minutes for females and 93 minutes for males, p = 0.7). Hospital mortality among the studied patients did not differ: in the female group – 2.2% (1 case) and 0 in the male one, p = 0.9. There were no significant differences in postoperative complications: sepsis (2.2% in women and 0 in men, p = 0.9), superficial wound infection (8.7% in women and 6.5% in men, p = 0.9). Acute kidney injury, stroke, pacemaker implantation, resternotomy for bleeding were not observed in any patient. Three-year overall survival was 91.8% in females and 91.6% in males, p = 0.8; three-year freedom from reoperation – 94.4% for females and 100% for males, p = 0.1.

Conclusion. Ozaki operation is equally reproducible with the same hospital mortality, postoperative complications, and medium-term outcomes in both females and males.

1. Baumgartner H., Falk V., Bax J.J., De Bonis M., Hamm C., Holm P.J., Iung B., Lancellotti P., Lansac E., Rodriguez Muñoz D., Rosenhek R., Sjögren J., Tornos Mas P., Vahanian A., Walther T., Wendler O., Windecker S., Zamorano J.L.; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391.

2. 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.

3. Wada T., Miyamoto S., Shibata T., Abe K., Murakami T. Early and Mid-term Results of Aortic Valve Reconstruction with Autologous Pericardium (Ozaki Procedure): A Multicenter Study in Japan Outside of Toho University. Struct Hear 2020;4:136–7. doi:10.1080/24748706.2020.1715139.

4. 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;155:2379–87. doi: 10.1016/j.jtcvs.2018.01.087.

5. Pirola S., Mastroiacovo G., Arlati F.G., Mostardini G., Bonomi A., Penza E., Polvani G. Single Center Five Years' Experience of Ozaki Procedure: Midterm Follow-up. Ann Thorac Surg. 2021 Jun;111(6):1937-1943. doi: 10.1016/j.athoracsur.2020.08.039.

6. Chernov I. I., Enginoev S. T., Komarov R. N., Bazylev V. V., Tarasov D. G., Kadyraliev K. B., Tungusov D. S., Arutyunyan A. V., Chragyan A. V., Batrakov P. A., Ismailbaev A. M., Tlisov B. M., Weymann A., Pompeu M. B. O. Sá, Zhigalov K. Short-term outcomes of Ozaki procedure: a multicenter study. Russian Journal of Cardiology. 2020;25(S4):4157. (In Russian) doi:10.15829/1560-4071-2020-4157

7. Chaker Z., Badhwar V., Alqahtani F., Aljohani S., Zack C.J., Holmes D.R., Rihal C.S., Alkhouli M. Sex Differences in the Utilization and Outcomes of Surgical Aortic Valve Replacement for Severe Aortic Stenosis. J Am Heart Assoc. 2017;6(9):e006370. doi: 10.1161/JAHA.117.006370.

8. Caponcello M.G., Banderas L.M., Ferrero C., Bramlage C., Thoenes M., Bramlage P. Gender differences in aortic valve replacement: Is surgical aortic valve replacement riskier and transcatheter aortic valve replacement safer in women than in men? J Thorac Dis 2020;12:3737–46. doi:10.21037/jtd-20-700.

9. O'Connor S.A., Morice M.C., Gilard M., Leon M.B., Webb J.G., Dvir D., Rodés-Cabau J., Tamburino C., Capodanno D., D'Ascenzo F., Garot P., Chevalier B., Mikhail G.W., Ludman P.F. Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes: A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients. J Am Coll Cardiol. 2015;66(3):221-228. doi: 10.1016/j.jacc.2015.05.024.

10. Sá. M.P., Chernov I., Marchenko A., Chagyan V., Komarov R., Askadinov M., Enginoev S., Kadyraliev B., Ismailbaev A., Tcheglov M., Clavel M.-A., Pibarot P., Ruhparwar A., Weymann A., Zhigalov K. Aortic Valve Neocuspidization (Ozaki Procedure) in Patients with Small Aortic Annulus (≤21mm): A Multicenter Study. Struct Hear 2020. doi:10.1080/24748706.2020.1792595

11. Bière L., Launay M., Pinaud F., Hamel J.F., Eltchaninoff H., Iung B., Laskar M., Leguerrier A., Gilard M., Furber A. Influence of sex on mortality and perioperative outcomes in patients undergoing TAVR: insights from the FRANCE 2 registry. J Am Coll Cardiol. 2015;65(7):755-7. doi: 10.1016/j.jacc.2014.11.044.

12. Chandrasekhar J., Dangas G., Yu J., Vemulapalli S., Suchindran S., Vora A.N., Baber U., Mehran R.; STS/ACC TVT Registry. Sex-Based Differences in Outcomes With Transcatheter Aortic Valve Therapy: TVT Registry From 2011 to 2014. J Am Coll Cardiol. 2016;68(25):2733-2744. doi: 10.1016/j.jacc.2016.10.041.

13. Kodali S., Williams M.R., Doshi D., Hahn R.T., Humphries K.H., Nkomo V.T., Cohen D.J., Douglas P.S., Mack M., Xu K., Svensson L., Thourani V.H., Tuzcu E.M., Weissman N.J., Leon M., Kirtane A.J. Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study. Ann Intern Med. 2016;164(6):377- 84. doi: 10.7326/M15-0121.

14. Czarnecki A., Qiu F., Koh M., Prasad T.J., Cantor W.J., Cheema A.N., Chu M.W.A., Feindel C., Fremes S.E., Kingsbury K., Natarajan M.K., Peterson M.D., Ruel M., Strauss B.H., Wijeysundera H.C., Ko D.T. Clinical outcomes after trans-catheter aoric valve replacement in men and women in Ontario, Canada. Catheter Cardiovasc Interv. 2017;90(3):486-494. doi: 10.1002/ccd.26906.

15. Shames S., Gillam L.D. Sex differences in aortic valve calcification. Circ Cardiovasc Imaging. 2013;6:8–10. doi:10.1161/CIRCIMAGING.112.983288.

16. Pibarot P., Dumesnil J.G. Prosthesis-patient mismatch: Definition, clinical impact, and prevention. Heart. 2006;92:1022– 9. doi:10.1136/hrt.2005.067363.

17. Aranki S.F., Rizzo R.J., Couper G.S., Adams D.H., Collins J.J.J., Gildea J.S., Kinchla N.M., Cohn L.H. Aortic valve replacement in the elderly. Effect of gender and coronary artery disease on operative mortality. Circulation. 1993;88:II17-23.

18. Morris J.J., Schaff H.V., Mullany C.J., Morris P.B., Frye R.L., Orszulak T.A. Gender differences in left ventricular functional response to aortic valve replacement. Circulation. 1994;90:II183-9.

19. Doenst T., Ivanov J., Borger M.A., David T.E., Brister S.J. Sex-specific long-term outcomes after combined valve and coronary artery surgery. Ann Thorac Surg. 2006;81:1632–6. doi:10.1016/j.athoracsur.2005.11.052.

20. Caballero-Borrego J., Gómez-Doblas J.J., ValenciaSerrano F.M., Cabrera-Bueno F., Rodríguez-Bailón I., SánchezEspín G., Such M., Orrit J., Porras C., Melero J.M., OlallaMercadé E., de Teresa-Galván E. Influence of sex on perioperative outcomes in patients undergoing valve replacement for severe aortic stenosis. Rev Esp Cardiol. 2009;62:31–8.

21. Kulik A., Lam B.K., Rubens F.D., Hendry P.J., Masters R.G., Goldstein W., Bédard P., Mesana T.G., Ruel M. Gender differences in the long-term outcomes after valve replacement surgery. Heart. 2009;95(4):318-26. doi: 10.1136/hrt.2008.146688.

22. Elhmidi Y., Piazza N., Mazzitelli D., Wottke M., Lange R., Bleiziffer S. Sex-related differences in 2197 patients undergoing isolated surgical aortic valve replacement. J Card Surg. 2014;29:772–8. doi:/10.1111/jocs.12442.

23. Hayashida K., Morice M.C., Chevalier B., Hovasse T., Romano M., Garot P., Farge A., Donzeau-Gouge P., Bouvier E., Cormier B., Lefèvre T. Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis. J Am Coll Cardiol. 2012;59(6):566-71. doi: 10.1016/j.jacc.2011.10.877.

24. Conrotto F., D'Ascenzo F., Salizzoni S., Presbitero P., Agostoni P., Tamburino C., Tarantini G., Bedogni F., Nijhoff F., Gasparetto V., Napodano M., Ferrante G., Rossi M.L., Stella P., Brambilla N., Barbanti M., Giordana F., Grasso C., Biondi Zoccai G., Moretti C., D'Amico M., Rinaldi M., Gaita F., Marra S. A gender based analysis of predictors of all cause death after transcatheter aortic valve implantation. Am J Cardiol. 2014 15;114(8):1269-74. doi: 10.1016/j.amjcard.2014.07.053..

25. Erez A., Segev A., Medvedofsky D., Fefer P., Raanani E., Goldenberg I., Guetta V. Factors affecting survival in men versus women following transcatheter aortic valve implantation. Am J Cardiol. 2014;113(4):701-5. doi: 10.1016/j.amjcard.2013.10.047.