Vol. 25 No. 4 (2021)
ACQUIRED HEART DISEASES

Three-year results of Ozaki surgery in patients aged ≥65 years: a multicentre study

I.I. Chernov
Federal Center for Cardiovascular Surgery (Astrakhan), Astrakhan
S.T. Enginoev
Federal Center for Cardiovascular Surgery (Astrakhan), Astrakhan; Astrakhan State Medical University, Astrakhan
Bio
R.N. Komarov
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow
D.G. Tarasov
Federal Center for Cardiovascular Surgery (Astrakhan), Astrakhan
Yu.S. Sinelnikov
Sukhanov Federal Center of Cardiovascular Surgery, Perm
A.V. Marchenko
Sukhanov Federal Center of Cardiovascular Surgery, Perm
V.B. Arutyunayan
Sukhanov Federal Center of Cardiovascular Surgery, Perm
B.K. Kadyraliev
Sukhanov Federal Center of Cardiovascular Surgery, Perm
A.M. Ismailbaev
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow
B.M. Tlisov
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow
D.A. Zorin
Astrakhan State Medical University, Astrakhan
M.I. Tcheglov
I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow
K.Yu. Zhigalov
St. Vincent’s Hospital, Karlsruhe

Published 2021-12-28

Keywords

  • acquired heart disease,
  • aortic stenosis,
  • Ozaki operation,
  • neocuspidization

How to Cite

Chernov, I., Enginoev, S., Komarov, R., Tarasov, D., Sinelnikov, Y., Marchenko, A., Arutyunayan, V., Kadyraliev, B., Ismailbaev, A., Tlisov, B., Zorin, D., Tcheglov, M., & Zhigalov, K. (2021). Three-year results of Ozaki surgery in patients aged ≥65 years: a multicentre study. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 25(4), 53–63. https://doi.org/10.21688/1681-3472-2021-4-53-63

Abstract

Background. Currently, aortic valve stenosis is the most common disease of the native valve, which affects 5% of the elderly population. In symptomatic patients, aortic valve replacement is the ‘gold standard’. For patients aged ≥65 years, the use of biological prostheses is recommended. The Ozaki operation is an alternative to bioprostheses.
Aim. The aim of this study was to evaluate the immediate and 3-year results of Ozaki surgery in patients aged ≥65 years.
Methods. This was a prospective multicentre study conducted on 107 patients aged ≥65 years, who underwent the Ozaki procedure at three centres during 2016–2019. There were 46 (43%) men. The median age of the patients was 69 [67–74] years. Severe aortic stenosis was the major cause of aortic valve dysfunction (106 patients [99.1%]). Chronic heart failure III–IV functional class according to NYHA was diagnosed in 47 (43.9%) patients. The following complications were also registered: atrial fibrillation in 30 (28%) patients, a history of diabetes mellitus in 16 (15%) patients, chronic obstructive pulmonary disease in 14 (13.1%) patients and coronary artery disease in 42 (39.2%) patients. Bicuspid aortic valve was detected in 36 (34.6%) patients. There were 72 (67.2%) patients with a small annulus (≤21 mm) and 59 (55.14%) patients with a left ventricular ejection fraction of 64%. The median follow-up period was 23 [18–33] months. This study included all patients who underwent Ozaki surgery from 2016 to 2019.
Results. No patient had any conversions. A total of 45 (42.1%) patients underwent combined interventions. The operation duration was 240 [214–300] min, cardiopulmonary bypass duration was 104 [93–120] min and aortic cross-clamp duration was 82 [72–95] min. The rate of hospital mortality was 1.9%, and the incidence rates of acute renal failure requiring haemodialysis, stroke, pacemaker implantation, sepsis and reoperation for bleeding were 1.9%, 0.9%, 1.9%, 0.9% and 0.9%, respectively. The hospitalisation duration was 14 [11–16] days. The gradients of peak and mean pressure on the aortic valve after surgery were 9 [7–13] and 4 [3–6] mmHg, respectively, and the effective valve opening area was 2.6 [2.3–2.9] cm2. None of the patients had moderate and severe aortic regurgitation. The 3-year overall survival and freedom from reoperation were 88.6% and 97%, respectively.
Conclusion. The Ozaki operation in patients aged ≥65 years has good immediate results, with a hospital mortality rate of 1.9%, excellent haemodynamic parameters with an average pressure gradient across the aortic valve of 4 [3–6] mmHg and a valve opening area of 2.6 [2.3–2.9] cm2. The 3-year overall survival and freedom from reoperation were 88.6% and 97%, respectively. Further monitoring of these patients is required to evaluate long-term results, and there is also a need for randomised clinical trials comparing Ozaki operation with bioprostheses.

Received 4 February 2021. Revised 21 June 2021. Accepted 23 June 2021.

Funding: The study did not have sponsorship.

Conflict of interest: Authors declare no conflict of interest.

Contribution of the authors
Conception and study design: I.I. Chernov, R.N. Komarov, D.G. Tarasov, Yu.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, K.Yu. Zhigalov
Data collection and analysis: B.K. Kadyraliev, A.M. Ismailbaev, B.M. Tlisov, D.A. Zorin, M.I. Tcheglov
Statistical analysis: S.T. Enginoev
Drafting the article: I.I. Chernov, S.T. Enginoev
Critical revision of the article: I.I. Chernov, R.N. Komarov, D.G. Tarasov, Yu.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, K.Yu. Zhigalov
Final approval of the version to be published: I.I. Chernov, S.T. Enginoev, R.N. Komarov, D.G. Tarasov, Yu.S. Sinelnikov, A.V. Marchenko, V.B. Arutyunayan, B.K. Kadyraliev, A.M. Ismailbaev, B.M. Tlisov, D.A. Zorin, M.I. Tcheglov, K.Yu. Zhigalov

References

  1. Nkomo V.T., Gardin J.M., Skelton T.N., Gottdiener J.S., Scott C.G., Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011. PMID: 16980116. https://doi.org/10.1016/S0140-6736(06)69208-8
  2. Di Eusanio M., Fortuna D., De Palma R., Dell’Amore A., Lamarra M., Contini G.A., Gherli T., Gabbieri D., Ghidoni I., Cristell D., Zussa C., Pigini F., Pugliese P., Pacini D., Di Bartolomeo R. Aortic valve replacement: results and predictors of mortality from a contemporary series of 2256 patients. J Thorac Cardiovasc Surg. 2011;141(4):940-947. PMID: 20599229. https://doi.org/10.1016/j.jtcvs.2010.05.044
  3. 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. PMID: 28886619. https://doi.org/10.1093/eurheartj/ehx391
  4. Writing Committee Members, Otto C.M., Nishimura R.A., Bonow R.O., Carabello B.A., Erwin J.P. 3rd, Gentile F., Jneid H., Krieger E.V., Mack M., McLeod C., O'Gara P.T., Rigolin V.H., Sundt T.M. 3rd, Thompson A., Toly C. 2020 ACC / AHA Guideline for the management of patients with valvular heart disease: A report of the American College of Cardiology / American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021;77(4):450-500. PMID: 33342587. https://doi.org/10.1016/j.jacc.2020.11.018
  5. Salazar E., Torres J., Barragán R., López M., Lasses L.A. Aortic valve replacement in patients 70 years and older. Clin Cardiol. 2004;27(10):565-570. PMID: 15553309; PMCID: PMC6654741. https://doi.org/10.1002/clc.4960271009
  6. Wang T.K.M., Sathananthan J., Chieng N., Gamble G.D., Haydock D.A., Ruygrok P.N. Aortic valve replacement in over 70- and over 80-year olds: 5-year cohort study. Asian Cardiovasc Thorac Ann. 2014;22(5):526-533. PMID: 24867025. https://doi.org/10.1177/0218492313497950
  7. Ashikhmina E.A., Schaff H.V., Dearani J.A., Sundt T.M. 3rd, Suri R.M., Park S.J., Burkhart H.M., Li Zh., Daly R.C. Aortic valve replacement in the elderly: determinants of late outcome. Circulation. 2011;124(9):1070-1078. PMID: 21824918. https://doi.org/10.1161/CIRCULATIONAHA.110.987560
  8. 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):301-306. PMID: 23228404. https://doi.org/10.1016/j.jtcvs.2012.11.012
  9. Arutyunyan V., Chernov I., Komarov R., Sinelnikov Yu., Kadyraliev B., Enginoev S., Tcheglov M., Ismailbaev A., Baranov A., Ashurov F., Clavel M.-A., Pibarot P., Pompeu B.O. Sá M., Weymann A., Zhigalov K. Immediate outcomes of aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium: A multicenter study. Brazilian J Cardiovasc Surg. 2020;35(3):241-248. PMID: 32549094; PMCID: PMC7299575. https://doi.org/10.21470/1678-9741-2020-0019
  10. Чернов И.И., Энгиноев С.Т., Комаров Р.Н., Базылев В.В., Тарасов Д.Г., Кадыралиев Б.К., Тунгусов Д.С., Арутюнян В.Б., Чрагян В.А., Батраков П.А., Исмаилбаев А.М., Тлисов Б.М., Вайман А., Помпеу М., Жигалов К. Непосредственные результаты операции Ozaki: многоцентровое исследование. Российский кардиологический журнал. 2020;25(4S):4157. [Chernov I.I., Enginoev S.T., Komarov R.N., Bazylev V.V., Tarasov D.G., Kadyraliev B.K., Tungusov D.S., Arutyunyan V.B., Chragyan V.A., Batrakov P.A., Ismailbaev A.M., Tlisov B.M., Weymann А., Pompeu M., Zhigalov K. Short-term outcomes of Ozaki procedure: a multicenter study. Russian Journal of Cardiology. 2020;25(4S):4157. (In Russ.)] https://doi.org/10.15829/1560-4071-2020-4157
  11. 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. PMID: 29567131. https://doi.org/10.1016/j.jtcvs.2018.01.087
  12. Lancellotti P., Pibarot P., Chambers J., Edvardsen T., Delgado V., Dulgheru R., Pepi M., Cosyns B., Dweck M.R., Garbi M., Magne J., Nieman K., Rosenhek R., Bernard A., Lowenstein J., Campos Vieira M.L., Rabischoffsky A., Vyhmeister R.H., Zhou X., Zhang Y., Zamorano J.-L., Habib G. Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016;17(6):589-590. PMID: 27143783. https://doi.org/10.1093/ehjci/jew025
  13. Sá M.P.B.O., Chernov I., Marchenko A., Chagyan V., Komarov R., Askadinov M., Enginoev S., Kadyraliev B., Ismailbaev A., Tcheglov M., Clavel M.-A., Pibarot Ph., Ruhparwar A., Weymann A., Zhigalov K. Aortic valve neocuspidization (Ozaki procedure) in patients with small aortic annulus (≤ 21 mm): a multicenter study. Struct Heart. 2020;4(5):413-419. https://doi.org/10.1080/24748706.2020.1792595
  14. Frank S., Johnson A., Ross J. Jr. Natural history of valvular aortic stenosis. Br Heart J. 1973;35(1):41-46. PMID: 4685905; PMCID: PMC458562. https://doi.org/10.1136/hrt.35.1.41
  15. Kang D.-H., Park S.-J., Lee S.-A., Lee S., Kim D.-H., Kim H.-K., Yun S.-Ch., Hong G.-R., Song J.-M., Chung Ch.-H., Song J.-K., Lee J.-W., Park S.-W. Early surgery or conservative care for asymptomatic aortic stenosis. N Engl J Med. 2020;382(2):111-119. PMID: 31733181. https://doi.org/10.1056/nejmoa1912846
  16. D'Agostino R.S., Jacobs J.P., Badhwar V., Fernandez F.G., Paone G., Wormuth D.W., Shahian D.M. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2019 Update on Outcomes and Quality. Ann Thorac Surg. 2019;107(1):24-32. PMID: 30423335. https://doi.org/10.1016/j.athoracsur.2018.10.004
  17. Vohra H.A., Whistance R.N., de Kerchove L., Glineur D., Noirhomme Ph., El Khoury G. Influence of higher valve gradient on long-term outcome after aortic valve repair. Ann Cardiothorac Surg. 2013;2(1):30-39. PMID: 23977556; PMCID: PMC3741824. https://doi.org/10.3978/j.issn.2225-319X.2012.12.02
  18. Pibarot P., Dumesnil J.G. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart. 2006;92(8):1022-1029. PMID: 16251232; PMCID: PMC1861088. https://doi.org/10.1136/hrt.2005.067363