Vol. 22 No. 1 (2018)
ACQUIRED HEART DISEASES

In vitro implantation of a new transcatheter prosthesis in mitral valve position

A. Bogachev-Prokophiv
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
I. Ghuravleva
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
R. Sharifulin
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
Bio
S. Zeleznev
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
D. Demidov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
E. Kliver
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation
A. Karaskov
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, Novosibirsk, Russian Federation

Published 2018-04-02

Keywords

  • mitral valve,
  • bioprosthesis,
  • transcatheter mitral valve implantation

How to Cite

Bogachev-Prokophiv, A., Ghuravleva, I., Sharifulin, R., Zeleznev, S., Demidov, D., Kliver, E., & Karaskov, A. (2018). In vitro implantation of a new transcatheter prosthesis in mitral valve position. Patologiya Krovoobrashcheniya I Kardiokhirurgiya, 22(1), 22–28. https://doi.org/10.21688/1681-3472-2018-1-22-28

Abstract

Aim. The study was designed to focus on the evaluation of in vitro implantation of a new transcatheter mitral bioprosthesis.
Methods. A prototype of the first domestic self-expanding transcatheter bioprosthesis “Solertis” was tested by implanting it in the position of a native mitral valve of isolated pig heart by using transatrial access.
Results. A correct orientation of the atrial and ventricular elements of the bioprosthesis and reliable circular coverage/adaptation of the annular part of the stent, which provide stable fixation of the prosthesis in a mitral position without left ventricular outflow tract obstruction, were determined. The function of the prosthesis during saline load test was adequate and without paraprosthetic regurgitation.
Conclusion. The prototype of “Solertis” self-expanding transcatheter bioprosthesis demonstrated its efficiency for the native mitral valve replacement in vitro. The study results allow for proceeding to the next stage of preclinical testing—in vivo investigation.

Received 5 December 2017. Accepted 20 December 2017. Published online 28 December 2017.

Funding: The study was carried out with the support of a grant of the Russian Science Foundation (16-15-10315).

Conflict of interest: The authors declare no conflict of interest.

Author contributions
Conception and study design: I.Yu. Zhuravleva
Data collection and analysis: D.P. Demidov
Drafting the article: R.M. Sharifulin
Article editing: A.V. Bogachev-Prokophiev, A.M. Karaskov
Final approval of the version to be published: A.V. Bogachev-Prokophiev, I.Yu. Zhuravleva, R.M. Sharifulin, D.P. Demidov, A.M. Karaskov

References

  1. Бокерия Л.А., Гудкова Р.Г. Сердечно-сосудистая хирургия — 2015. Болезни и врожденные аномалии системы кровообращения. М.: НЦССХ им. А.Н. Бакулева, 2016. 208 c. [Bockeria L.A., Gudkova R.G. Cardiovascular surgery — 2015. Diseases and congenital anomalies of the circulatory system. Moscow: A.N. Bakoulev Scientific Center for Cardiovascular Surgery; 2016. 208 p. (In Russ.)]
  2. Железнев С.И., Богачев-Прокофьев А.В., Афанасьев А.В., Назаров В.М., Демин И.И., Караськов А.М. Среднеотдаленные результаты реконструктивных операций на митральном клапане при дисплазии соединительной ткани с помощью опорных колец D ring и C flex. Патология кровообращения и кардиохирургия. 2015;19(3):36-49. http://dx.doi.org/10.21688/1681-3472-2015-3-36-49 [Zheleznev S.I., Bogachev-Prokophiev A.V., Afanasyev A.V., Nazarov V.M., Demin I.I., Karaskov A.M. Mid-term results of mitral valve reconstruction by using D-ring and C-flex systems in patients with degenerative mitral valve disease. Patologiya krovoobrashcheniya i kardiokhirurgiya = Circulation Pathology and Cardiac Surgery. 2015;19(3):36-49. (In Russ.) http://dx.doi.org/10.21688/1681-3472-2015-3-36-49]
  3. Журавлева И.Ю., Богачев-Прокофьев А.В., Демидов Д.П., Караськов А.М. Транскатетерное протезирование митрального клапана: современное состояние проблемы. Кардиология. 2017;57(8):51-59. http://dx.doi.org/10.18087/cardio.2017.8.10018 [Zhuravleva I.Y., Bogachev-Prokophiev A.V., Demidov D.P., Karaskov A.M. Transcatheter implantation of mitral valve prostheses: current status of the problem. Kardiologiya = Cardiology. 2017;57(8):51-59. (In Russ.) http://dx.doi.org/10.18087/cardio.2017.8.10018]
  4. Baumgartner H., Falk V., Bax J.J., De Bonis M., Hamm C., Holm P.J., Iung B., Lancellotti P., Lansac E., Muñoz D.R., Rosenhek R., Sjögren J., Tornos Mas P., Vahanian A., Walther T., Wendler O., Windecker S., Zamorano J.L. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739-2791. PMID: 28886619. http://dx.doi.org/10.1093/eurheartj/ehx391
  5. Nishimura R.A., Vahanian A., Eleid M.F., Mack M.J. Mitral valve disease-current management and future challenges. Lancet. 2016;387(10025):1324-34. PMID: 27025438. http://dx.doi.org/10.1016/S0140-6736(16)00558-4
  6. Jeevan R.R., Murari B.M. Engineering challenges and the future prospects of transcatheter mitral valve replacement technologies: a comprehensive review of case studies. Expert Rev Med Devices. 2017;14(4):297-307. PMID: 28281857. http://dx.doi.org/10.1080/17434440.2017.1305267
  7. Maisano F., Alfieri O., Banai S., Buchbinder M., Colombo A., Falk V., Feldman T., Franzen O., Herrmann H., Kar S., Kuck K.H., Lutter G., Mack M., Nickenig G., Piazza N., Reisman M., Ruiz C.E., Schofer J., Søndergaard L., Stone G.W., Taramasso M., Thomas M., Vahanian A., Webb J., Windecker S., Leon M.B. The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement? Eur Heart J. 2015;36(26):1651-9. PMID: 25870204. http://dx.doi.org/10.1093/eurheartj/ehv123
  8. Preston-Maher G.L.М., Torii R., Burriesci G. A technical review of minimally invasive mitral valve replacements. Cardiovasc Eng Technol. 2015;6(2):174-84. PMID: 25984249; PMCID: PMC4427651. http://dx.doi.org/10.1007/s13239-014-0203-9
  9. De Backer O., Piazza N., Banai S., Lutter G., Maisano F., Herrmann H.C., Franzen O.W., Søndergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014;7(3):400-9. PMID: 24944303. http://dx.doi.org/10.1161/CIRCINTERVENTIONS.114.001607
  10. Ussia G.P., Quadri A., Cammalleri V., De Vico P., Muscoli S., Marchei M., Ruvolo G., Sondergaard L., Romeo F. Percutaneous transfemoral-transseptal implantation of a second-generation CardiAQ mitral valve bioprosthesis: first procedure description and 30-day follow-up. EuroIntervention. 2016;11(10):1126-31. http://dx.doi.org/10.4244/ EIJY15M09_01
  11. Barbanti M., Tamburino C. Transcatheter mitral valve implantation: CardiAQ. EuroIntervention. 2016;12(Y):Y73-4. PMID: 27640041. http://dx.doi.org/10.4244/EIJV12SYA19
  12. Moat N.E., Duncan A., Quarto C. Transcatheter mitral valve implantation: Tendyne. EuroIntervention. 2016;12(Y):Y75-7. PMID: 27640042. http://dx.doi.org/10.4244/EIJV12SYA20
  13. Cheung A., Banai S. Transcatheter mitral valve implantation: Tiara. EuroIntervention. 2016;12(Y):Y70-2. PMID: 27640040. http://dx.doi.org/10.4244/ EIJV12SYA18
  14. Lange R., Piazza N. HighLife transcatheter mitral valve replacement. EuroIntervention. 2016;12(Y):Y81-3. PMID: 27640044. http://dx.doi.org/10.4244/ EIJV12SYA22
  15. Bapat V., Lim Z.Y., Boix R., Pirone F. The Edwards Fortis transcatheter mitral valve implantation system. EuroIntervention. 2015;11(W):W73-5. PMID: 26384198. http://dx.doi.org/10.4244/EIJV11SWA21
  16. Abdul-Jawad Altisent O., Dumont E., Dagenais F., Sénéchal M., Bernier M., O'Connor K., Paradis J.M., Bilodeau S., Pasian S., Rodés-Cabau J. Transcatheter mitral valve implantation with the FORTIS device: insights into the evaluation of device success. JACC: Cardiovasc Interv. 2015;8(7):994-5. PMID: 26003029. http://dx.doi.org/10.1016/j.jcin.2015.01.036
  17. Testa L., Latib A., Montone R.A., Bedogni F. Transcatheter mitral valve regurgitation treatment: State of the art and a glimpse to the future. J Thorac Cardiovasc Surg. 2016;152(2):319-27. PMID: 27239007. http://dx.doi.org/10.1016/j.jtcvs.2016.04.055
  18. Piazza N., Treede H., Moat N., Sorajja P., Popma J., Grube E., Bolling S., Adams D. The Medtronic transcatheter mitral valve implantation system. EuroIntervention. 2015;11(W):W80-1. PMID: 26384201. http://dx.doi.org/10.4244/EIJV11SWA24
  19. Abdelghani M., Onuma Y., Zeng Y., Soliman O.I., Ma J., Huo Y., Guidotti A., Nietlispach F., Maisano F., Serruys P.W. The Sino Medical AccuFit transcatheter mitral valve implantation system. EuroIntervention. 2015;11(W):W84-5. PMID: 26384203. http://dx.doi.org/10.4244/EIJV11SWA26
  20. Журавлева И.Ю., Нуштаев Д.В., Тимченко Т.В., Требушат Д.В., Майоров А.П., Железнев С.И., Демидов Д.П., Богачев-Прокофьев А.В. Модель устройства для транскатетерной замены митрального биопротеза при его дисфункции. Современные технологии в медицине. 2017;9(3):7-14. http://dx.doi.org/10.17691/stm2017.9.3.01 [Zhuravleva I., Nushtaev D., Timchenko T., Trebushat D., Mayorov A., Zheleznev S., Demidov D., Bogachev-Prokophiev A. The concept of a device for the redo transcatheter mitral valve implantation. Sovremennye Tehnologii v Medicine = Modern Technologies in Medicine. 2017;9(3):7-14. http://dx.doi.org/10.17691/stm2017.9.3.01]