In vitro study of a biological prosthetic valve for seamless fixation
https://doi.org/10.15825/1995-1191-2017-4-61-69
Abstract
Aim: to evaluate the manipulative properties of the system being developed for cardiac valve re-operation on an in vitro bovine heart model.
Material and methods. The prototype of the prosthesis being developed, mounted on the implant holder, as well as the dilatation balloon of its own design, were used as the objects of the study. The bioprosthesis «UniLine» of 21 mm size for the aortic position was chosen as the target site of implantation, which was established by the «classical» suture method. After that, the implantation of the tested device was carried out as a «valve in valve» and the quality of the installation and the combined operation of all the components of the re-prosthesis system were evaluated.
Results. The test implantation demonstrated the consistency of the proposed method on the basis of balloon seamless fi xation, as well as high ergonomic characteristics: the average time of seamless implantation of the developed prototype on an in vitro animal heart model was 3 minutes versus the implantation of the «UniLine» bioprosthesis – 11 min, Implantation provided a reliable prosthesis The breaking force was 12.9 N, which is equivalent to a pressure of 279 mm Hg.
About the Authors
K. U. KlyshnikovRussian Federation
Kemerovo.
E. A. Ovcharenko
Russian Federation
Kemerovo.
A. N. Stasev
Russian Federation
Kemerovo.
N. A. Scheglova
Russian Federation
Kemerovo.
Yu. N. Odarenko
Russian Federation
Kemerovo.
I. K. Khalivopulo
Russian Federation
Kemerovo.
Yu. A. Kudravtseva
Russian Federation
Kemerovo.
L. S. Barbarash
Russian Federation
Kemerovo.
References
1. Gummert JF, Funkat A, Beckmann A, Schiller W, Hekmat K, Ernst M et al. Cardiac surgery in Germany during 2007: a report on behalf of the german society for thoracic and cardiovascular surgery. Thorac. Cardiovasc. Surg. 2008; 56: 328–336. doi: 10.1055/s-2008-1038756
2. Brown JM, O’Brien SM, Wu C, Sikora JA, Griffi th BP, Gammie JS. Isolated aortic valve replacements in North America comprising 108,687 patients in 10 years: changes in risk, valve types, and outcomes in the society of thoracic surgeons national database. J. Thorac. Cardiovasc. Surg. 2009; 137: 82–90. doi: 10.1016/j.jtcvs.2008.08.015.
3. Бокерия ЛА, Гудкова РГ. Сердечно-сосудистая хирургия – 2015. Болезни и врожденные аномалии системы кровообращения. М.: НЦССХ им. А.Н. Бакулева; 2016. Bokerija LA, Gudkova RG. Serdechno-sosudistaja hirurgija – 2015. Bolezni i vrozhdennye anomalii sistemy krovoobrashhenija. M.: NCSSH im. A.N. Bakuleva. 2016.
4. Ruel M, Chan V, Bédard P, Kulik A, Ressler L, Lam BK et al. Very long-term survival implications of heart valve replacement with tissue versus mechanical prostheses in adults <60 years of age. Circulation. 2007; 116: 294– 300. doi: 10.1161/CIRCULATIONAHA.106.681429
5. Maganti M, Rao V, Armstrong S, Feindel CM, Scully HE, David TE. Redo valvular surgery in elderly patients. Ann. Thorac. Surg. 2008; 87: 521–525. doi: 10.1016/j.athoracsur.2008.09.030.
6. Стасев АН, Шукевич ДЛ, Рутковская НВ, Левадин ЮВ, Рубцов МС, Одаренко ЮН. Использование современных высокотехнологичных методов при выполнении повторных хирургических вмешательств у тяжелой категории пациентов. Клиническое наблюдение. Комплексные проблемы сердечнососудистых заболеваний. 2015; 3: 85–90. Stasev AN, Shukevich DL, Rutkovskaja NV, Levadin JuV, Rubcov MS, Odarenko JuN. Ispol’zovanie sovremennyh vysokotehnologichnyh metodov pri vypolnenii povtornyh hirurgicheskih vmeshatel’stv u tjazheloj kategorii pacientov. Klinicheskoe nabljudenie. Kompleksnye problemy serdechno-sosudistyh zabolevanij. 2015; 3: 85–90.
7. Kaneko T, Vassileva CM, Englum B, Kim S, Yammine M, Brennan M et al. Contemporary Outcomes of Repeat Aortic Valve Replacement: A Benchmark for Transcatheter Valve-in-Valve Procedures. Ann. Thorac. Surg. 2015; 100 (4): 1298–1304. doi: 10.1016/j.athoracsur.2015.04.062.
8. Christiansen S, Schmid M, Autschbach R. Perioperative risk of redo aortic valve replacement. Ann. Thorac. Cardiovasc. Surg. 2009; 15: 105–110. PMID: 19471224
9. Balsam Balsam LB, Grossi EA, Greenhouse DG, Ursomanno P, Deanda A, Ribakove GH et al. Reoperative valve surgery in the elderly: predictors of risk and longterm survival. Ann. Thorac. Surg. 2010; 90: 1195–1200. doi: 10.1016/j.athoracsur.2010.04.057
10. Одаренко ЮН, Рутковская НВ, Рогулина НВ, Стасев АН, Кокорин СГ, Каган ЕС и др. Анализ 23-летнего опыта использования ксеноаортальных эпоксиобработанных биопротезов в хирургии митральных пороков сердца. Исследование факторов реципиента с позиций влияния на развитие кальциевой дегенерации. Комплексные проблемы сердечно-сосудистых заболеваний. 2015; 4: 17–25. Odarenko JuN, Rutkovskaja NV, Rogulina NV, Stasev AN, Kokorin SG, Kagan ES et al. Analiz 23-letnego opyta ispol’zovanija ksenoaortal’nyh jepoksiobrabotannyh bioprotezov v hirurgii mitral’nyh porokov serdca. Issledovanie faktorov recipienta s pozicij vlijanija na razvitie kal’cievoj degeneracii. Kompleksnye problemy serdechno-sosudistyh zabolevanij. 2015; 4: 17–25.
11. Walther T, Falk V, Dewey T, Kempfert J, Emrich F, Pfannmüller B et al. Valve-in-valve concept for transcatheter minimally invasive repeat xenograft implantation. J. Am. Coll. Cardiol. 2007; 50: 56–60. doi: 10.1016/j. jacc.2007.03.030
12. Wenaweser P, Buellesfeld L, Gerckens U, Grube E. Percutaneous aortic valve replacement for severe aortic regurgitation in degenerated bioprosthesis: the fi rst valve in valve procedure using the Core Valve revalving system. Catheter Cardiovasc. Interv. 2007; 70: 760–764. doi: 10.1002/ccd.21300
13. Garatti A, Nano G, Bruschi G, Canziani A, Colombo T, Frigiola A et al. Twenty-fi ve year outcomes of tricuspid valve replacement comparing mechanical and biologic prostheses. Ann. Thorac. Surg. 2012; 93: 1146–1153. doi: 10.1016/j.athoracsur.2011.12.031
14. Патент РФ на полезную модель «Биологический протез для репротезирования клапанов сердца» № 156774 (приоритет от 19.01.15, патентообладатель: Федеральное государственное бюджетное научное учреждение «Научно-исследовательский институт комплексных проблем сердечно-сосудистых заболеваний»). Patent RF na poleznuyu model’ «Biologicheskij protez dlya reprotezirovaniya klapanov serdca» № 156774 (prioritet ot 19.01.15, patentoobladatel’: Federal’noe gosudarstvennoe byudzhetnoe nauchnoe uchrezhdenie «Nauchno-issledovatel’skij institut kompleksnyh problem serdechno-sosudistyh zabolevanij»).
15. Патент РФ на полезную модель «Устройство для имплантации биологических расширяемых протезов клапанов сердца» № 169559 (приоритет от 11.06.16, патентообладатель: Федеральное государственное бюджетное научное учреждение «Научно-исследовательский институт комплексных проблем сердечно-сосудистых заболеваний»). Patent RF na poleznuyu model‘ «Ustrojstvo dlya implantacii biologicheskih rasshiryaemyh protezov klapanov serdca» № 169559 (prioritet ot 11.06.16, patentoobladatel‘: Federal‘noe gosudarstvennoe byudzhetnoe nauchnoe uchrezhdenie «Nauchno-issledovatel‘skij institut kompleksnyh problem serdechno-sosudistyh zabolevanij»).
Review
For citations:
Klyshnikov K.U., Ovcharenko E.A., Stasev A.N., Scheglova N.A., Odarenko Yu.N., Khalivopulo I.K., Kudravtseva Yu.A., Barbarash L.S. In vitro study of a biological prosthetic valve for seamless fixation. Russian Journal of Transplantology and Artificial Organs. 2017;19(4):61-69. (In Russ.) https://doi.org/10.15825/1995-1191-2017-4-61-69