Vol. 26 No. 2 (2022)
EXPERIMENTAL STUDIES

The results of the application of a new technique of open implantation of self-opening transcatheter aortic valves in an experiment

M.O. Zhulkov
Meshalkin National Medical Research Center, Novosibirsk
Bio
K.V. Kozyr
Meshalkin National Medical Research Center, Novosibirsk
I.S. Zykov
Meshalkin National Medical Research Center, Novosibirsk
A.R. Tarkova
Meshalkin National Medical Research Center, Novosibirsk
H.A. Agaeva
Meshalkin National Medical Research Center, Novosibirsk
A.K. Sabetov
Meshalkin National Medical Research Center, Novosibirsk
D.A. Sirota
Meshalkin National Medical Research Center, Novosibirsk
D.S. Sergeevichev
Meshalkin National Medical Research Center, Novosibirsk
A.M. Chernyavskiy
Meshalkin National Medical Research Center, Novosibirsk
Этап укрепления аортального фиброзного кольца

Published 2022-06-30

Keywords

  • aortic valve,
  • aortic valve stenosis,
  • heart valve prosthesis,
  • minimally invasive surgery,
  • transcatheter aortic valve replacement

How to Cite

Zhulkov, M., Kozyr, K., Zykov, I., Tarkova, A., Agaeva, H., Sabetov, A., Sirota, D., Sergeevichev, D., & Chernyavskiy, A. (2022). The results of the application of a new technique of open implantation of self-opening transcatheter aortic valves in an experiment. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 26(2), 49–57. https://doi.org/10.21688/1681-3472-2022-2-49-57

Abstract

Background. In recent years, transcatheter implantation of the aortic valve has become increasingly performed as an alternative to "open" prosthetics. The undoubted advantage of this technology is its minimally invasive nature, which in most cases provides a favorable clinical outcome of the intervention. The transcatheter method of aortic valve prosthetics does not require sternotomy and connection of an artificial circulation device, which significantly reduces the risk of postoperative mortality and complications. However, despite all the advantages of the existing models, they are not without drawbacks that force researchers to develop and test new transcatheter valves. The problem of experimental studies of new models of self-opening transcatheter aortic valves is mainly determined by the anatomical features of the aortic root of animals. In this regard, the development of a reliable method of implantation of valve prostheses in the experiment is an urgent problem of preclinical testing.
Aim. Development of a protocol for open implantation of a transcatheter aortic valve in experiment and evaluation of long-term results.
Methods. To develop an experimental model, pigs of the "Landras" breed, females weighing 129.83 ± 9 kg were used. Transcatheter aortic valve implantation was performed under conditions of artificial circulation and moderate hypothermia (33-34°C) through a transverse aortotomy under the control of vision. During the experiment, invasive monitoring of blood pressure, central venous pressure, heart rhythm, body temperature, blood gas composition, activated clotting time was performed. The correct positioning and hemodynamic parameters after implantation were evaluated using transesophageal echocardiography.
Results. In a series of chronic experiments, 18 open implantations of self-opening transcatheter aortic valves were performed. Successful positioning was achieved in 100% of cases. The developed protocol of open implantation made it possible to achieve reliable fixation of the prosthesis in the orthotopic position, as well as to prevent the migration of the prosthesis, the development of mitral regurgitation, paraaortic fistulas and coronary circulation disorders.
Conclusion. In the course of the study, a simple and effective method of open implantation of a transcatheter aortic heart valve prosthesis was developed in an experiment.

Received 1 October 2021. Revised 1 November 2021. Accepted 12 November 2021.

Funding: This work was carried out within the framework of the state task of Ministry of Health of Russian Federation No. 121032300337-5.

Conflict of interest: Authors declare no conflict of interest.

Contribution of the authors
Conception and study design: M.O. Zhulkov, D.A. Sirota, K.V. Kozyr, D.S. Sergeevichev
Data collection and analysis: M.O. Zhulkov
Drafting the article: M.O. Zhulkov
Critical revision of the article: D.A. Sirota, A.M. Chernyavskiy
Experimental part: M.O. Zhulkov, H.A. Agaeva, A.K. Sabetov, I.S. Zykov, A.R. Tarkova
Final approval of the version to be published: M.O. Zhulkov, K.V. Kozyr, I.S. Zykov, A.R. Tarkova, H.A. Agaeva, A.K. Sabetov, D.A. Sirota, D.S. Sergeevichev, A.M. Chernyavski

References

  1. Otto C.M., Kumbhani D.J., Alexander K.P., Calhoon J.H., Desai M.Y., Kaul S., Lee J.C., Ruiz C.E., Vassileva C.M. 2017 ACC expert consensus decision pathway for transcatheter aortic valve replacement in the management of adults with aortic stenosis: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2017;69(10):1313-1346. PMID: 28063810. https://doi.org/10.1016/j.jacc.2016.12.006
  2. Артющик В.В., Пристром М.С., Семененков И.И., Олихвер Ю.А., Чечко Р.Ю., Курсевич В.В. Сенильный кальцинированный аортальный стеноз: современный взгляд на проблему. Лечебное дело. 2015;43(3):54-58. Artyushchik V.V., Pristrom M.S., Semenenkov I.I., Olikhver Yu.A., Chechko R.Yu., Kursevich V.V. Senile calcified aortic stenosis: a modern view of the problem. Lechebnoe Delo. 2015;43(3):54-58. (In Russ.)
  3. Кранин Д.Л., Стец В.В., Пестовская О.Р., Дунаев Э.П., Назаров Д.А., Гайдуков А.В., Маштанов Г.В., Замский К.С., Федоров А.Ю., Варочкин К.А., Курносов С.А. Контраст-индуцированная нефропатия после выполнения транскатетерной имплантации аортального клапана. Альманах клинической медицины. 2017;45(3):242-246. https://doi.org/10.18786/2072-0505-2017-45-3-242-246 Kranin D.L., Stets V.V., Pestovskaya O.R., Dunaev E.P., Nazarov D.A., Gaydukov A.V., Mashtanov G.V., Zamskiy K.S., Fedorov A.Yu., Varochkin K.A., Kurnosov S.A. Contrast induced nephropathy after transcatheter aortic valve implantation. Almanac of Clinical Medicine. 2017;45(3):242-246. (In Russ.) https://doi.org/10.18786/2072-0505-2017-45-3-242-246
  4. Cribier A., Eltchaninoff H., Bash A., Borenstein N., Tron C., Bauer F., Derumeaux G., Anselme F., Laborde F., Leon M.B. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-3008. PMID: 12473543. https://doi.org/10.1161/01.cir.0000047200.36165.b8
  5. Карпова Н.Ю., Рашид М.А., Казакова Т.В., Шостак Н.А. Аортальный стеноз. Русский медицинский журнал. 2014;22(2):162-165. Karpova N.Yu., Rashid M.A., Kazakova T.V., Shostak N.A. Aortic stenosis. Russkii meditsinskii zhurnal = Russian Medical Journal. 2014;22(2):162-165. (In Russ.)
  6. Бокерия Л.А., Скопин И.И., Муратов Р.М., Олофинская И.Е., Нерсисян М.М. Изучение результатов хирургического лечения критического аортального стеноза в условиях искусственного кровообращения у больных старше 80 лет. Грудная и сердечно-сосудистая хирургия. 2016;58(1):41-47. Boсkeria L.A., Skopin I.I., Muratov R.M., Olofinskaya I.E., Nersisyan M.M. The results of open heart surgery in very elderly patients aged 80 years and older with severe aortic stenosis. Russian Journal of Thoracic and Cardiovascular Surgery. 2016;58(1):41-47. (In Russ.)
  7. Котовская Ю.В., Курашев Д.Х., Темненко Н.А., Гароян В.О., Хабибуллои Н.Н., Щербакова В.Л., Рунихина Н.К., Ткачева О.Н. Стеноз аортального клапана у пациентов пожилого и старческого возраста. Русский медицинский журнал. 2017;25(25):1833-1836. Kotovskaya Yu.V., Kurashev D.Kh., Temnenko N.A., Garoyan V.O., Khabibulloi N.N., Shcherbakova V.L., Runikhina N.K., Tkacheva O.N. Stenosis of the aortic valve in patients of elderly and senile age. Russkii meditsinskii zhurnal = Russian Medical Journal. 2017;25(25):1833-1836. (In Russ.)
  8. Синьков А.В. Современные подходы к диагностике аортального стеноза. Сибирский медицинский журнал. 2017;151(4):53-57. Sinkov A.V. Modern approaches to aortic stenosis diagnostics. Sibirskij Medicinskij Zurnal (Irkutsk) = Siberian Medical Journal (Irkutsk). 2017;151(4):53-57. (In Russ.)
  9. Cribier A., Litzler P.-Y., Eltchaninoff H., Godin M., Tron C., Bauer F., Bessou J.-P. Technique of transcatheter aortic valve implantation with the Edwards–Sapien heart valve using the transfemoral approach. Herz. 2009;34(5):347-356. PMID: 19711030. https://doi.org/10.1007/s00059-009-3264-z
  10. Кретов Е.И., Козырь К.В., Таркова А.Р., Сергеевичев Д.С., Коробейников А.А., Тимченко Т.П., Зубарев Д.Д., Зыков И.С., Байструков В.И. Первый опыт транскатетерной имплантации прототипа нового самораскрывающегося протеза аортального клапана в эксперименте. Патология кровообращения и кардиохирургия. 2016;20(4):83-87. https://dx.doi.org/10.21688/1681-3472-2016-4-83-87 Kretov E.I., Kozyr K.V., Tarkova A.R., Sergeevichev D.S., Korobeynikov A.A., Timchenko T.P., Zubarev D.D., Zykov I.S., Baystrukov V.I. Transcatheter implantation of a new prototype of self-expanding aortic valve prosthesis: first experience. Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2016;20(4):83-87. (In Russ.) https://dx.doi.org/10.21688/1681-3472-2016-4-83-87
  11. Toggweiler S., Humphries K.H., Lee M., Binder R.K., Moss R.R., Freeman M., Ye J., Cheung A., Wood D.A., Webb J.G. 5-year outcome after transcatheter aortic valve implantation. J Am Coll Cardiol. 2013;61(4):413-419. PMID: 23265333. https://doi.org/10.1016/j.jacc.2012.11.010
  12. Achenbach S., Delgado V., Hausleiter J., Schoenhagen P., Min J.K., Leipsic J.A. SCCT expert consensus document on computed tomography imaging before transcatheter aortic valve implantation (TAVI)/transcatheter aortic valve replacement (TAVR). J Cardiovasc Comput Tomogr. 2012;6(6):366-380. PMID: 23217460. https://doi.org/10.1016/j.jcct.2012.11.002
  13. Имаев Т.Э., Комлев А.Е., Акчурин Р.С. Прогноз при транскатетерной имплантации аортального клапана. Рациональная фармакотерапия в кардиологии. 2016;12(6):718-724. https://doi.org/10.20996/1819-6446-2016-12-6-718-724 Imaev T.E., Komlev A.E., Akchurin R.S. The prognosis in transcatheter aortic valve implantation. Ratsional'naya farmakoterapiya v kardiologii = Rational Pharmacotherapy in Cardiology. 2016;12(6):718-724. (In Russ.) https://doi.org/10.20996/1819-6446-2016-12-6-718-724
  14. Carney J.P., Schappa Faustich J., Lahti M.T., Ashworth P.E., Dalmasso A.P., Moklyak Y., Bianco R.W. New model for the assessment of transcatheter aortic valve replacement devices in sheep. J Invest Surg. 2020;35(2):371-377. https://doi.org/10.1080/08941939.2020.1864796
  15. Carney J.P., Zhang L.M., Larson J.J., Lahti M.T., Robinson N.A., Dalmasso A.P., Bianco R.W. The Hancock® valved conduit for right ventricular outflow tract reconstruction in sheep for assessing new devices. J Heart Valve Dis. 2017;26(4):472-480. PMID: 29302948.
  16. Dewey T.M., Walther T., Doss M., Brown D., Ryan W.H., Svensson L., Mihaljevic T., Hambrecht R., Schuler G., Wimmer-Greinecker G., Mohr F.W., Mack M.J. Transapical aortic valve implantation: an animal feasibility study. Ann Thorac Surg. 2006;82(1):110-116. PMID: 16798200. https://doi.org/10.1016/j.athoracsur.2006.02.035
  17. Wendt D., Pasa S., Kahlert P., Delaloye S., Al-Rashid F., Price V., Jánosi R.-A., Borenstein N., Behr L., Konorza T., Erbel R., Jakob H., Thielmann M. A new self-expandable transcatheter aortic valve for transapical implantation: feasibility in acute and chronic animal experiments. Scand Cardiovasc J. 2013;47(3):145-153. PMID: 23098267. https://doi.org/10.3109/14017431.2012.743675
  18. Nakatsuma K., Saito N., Watanabe H., Bao B., Yamamoto E., Watanabe S., Kimura T., Inoue K. Antegrade transcatheter aortic valve implantation using the looped Inoue balloon technique: a pilot study in a swine model. J Cardiol. 2017;69(1):260-263. PMID: 27169357. https://doi.org/10.1016/j.jjcc.2016.04.008
  19. Kappetein A.-P., Piazza N., Laborde J.-C., de Jaegere P.P., Serruys P.W. Transapical implantation of a self-expanding aortic valve bioprosthesis — animal feasibility study. Eur J Cardiothorac Surg. 2009;36(5):813-817. PMID: 19682918. https://doi.org/10.1016/j.ejcts.2009.04.064
  20. Бургомистрова О.Н., Абрамова Н.И., Хромова О.Л. Оптимальные параметры развития высокопродуктивных коров черно-пестрой породы. Генетика и разведение животных. 2018;(3):57-63. Burgomistrova O.N., Abramova N.I., Khromova O.L. The optimal parameters of development highly productive cows of black-and-white breed. Genetics and breeding of animals. 2018;(3):57-63. (In Russ.)
  21. Piermattei D.L., Swan 2nd H. Techniques for general anesthesia in miniature pigs. J Surg Res. 1970;10(12):587-592. PMID: 4924212. https://doi.org/10.1016/0022-4804(70)90085-5
  22. Swan H., Piermattei D.L. Technical aspects of cardiac transplantation in the pig. J Thorac Cardiovasc Surg. 1971;61(5):710-723. PMID: 4931084.
  23. Hasenkam J.M., Pedesen E.M., Ostergaard J.H., Nygaard H., Paulsen P.K., Johannsen G., Schurizek B.A. Velocity fields and turbulent stresses downstream of biological and mechanical aortic valve prostheses implanted in pigs. Cardiovasc Res. 1988;22(7):472-483. PMID: 3252971. https://doi.org/10.1093/cvr/22.7.472
  24. Grehan J.F., Hilbert S.L., Ferrans V.J., Droel J.S., Salerno C.T., Bianco R.W. Development and evaluation of a swine model to assess the preclinical safety of mechanical heart valves. J Heart Valve Dis. 2000;9(5):710-719; discussion 719-720. PMID: 11041189.
  25. Dewey T.M., Brown D., Ryan W.H., Herbert M.A., Prince S.L., Mack M.J. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. J Thorac Cardiovasc Surg. 2008;135(1):180-187. PMID: 18179938. https://doi.org/10.1016/j.jtcvs.2007.09.011