Experimental substantiation of the design of a prosthetic heart valve for «valve-in-valve» implantation

The aim of the study was to perform a series of in vitro tests of a prototype of the developing heart valve prosthesis to evaluate its functional characteristics. Materials and methods. In this work we have used the frames and full prototypes of the prosthesis, consisting of a stent-like stainless steel support frame with mounted biological leaflets and cover. The authors evaluated the calculated and experimental forces necessary for the displacement of the sutureless implanted prosthesis using the test machine under uniaxial tension. The risk of defects and damages to the supporting framework as a result of implantation was evaluated by scanning electron microscopy. The hydrodynamic characteristics of the prosthesis were investigated under physiological conditions and «valvein-valve» implantation. Evaluation of the ergonomics and applicability of the proposed construction on the cadaver heart model of cattle was carried out. Results. As a result of the forces assessment, it was found that the force required to shear the prosthesis was 3.12 ± 0.37 N, while the calculated value was 1.7 N, which is significantly lower than the obtained value. The comparison of the images obtained with small and large magnifications demonstrated the absence of critical surface defects. Additional analysis under the super-large magnifications also did not reveal problem areas. During the hydrodynamic study, it was shown that the average transplant gradient increased slightly from 2.8–3.4 to 3.2–4.5 mm Hg for the initial prosthesis and the «valve-in-valve» complex, respectively. The decrease of the effective orifice area was 6–9% relative to the initial one. Evaluation of the implantation technique demonstrated the consistency of the approach: the use of the developed holder in combination with the balloon implantation system made it possible to position the prosthesis throughout the procedure. Conclusion. The series of tests demonstrates the consistency of the developed design, intended for the replacement of a failed prosthetic valve of the heart with the «valve-in-valve» implantation.

prosthesis, heart valve, hydrodynamic, blood flow, implantation

1. Beckmann A, Funkat AK, Lewandowski J, Frie M, Ernst M, Hekmat K, Schiller W et al. Cardiac Surgery in Germany during 2014: A Report on Behalf of the German Society for Thoracic and Cardiovascular Surgery. Thorac. Cardiovasc. Surg. 2015; 63 (4): 258–269. doi: 10.1055/s-0035-1551676. PubMed PMID: 26011675.

2. Brown JM, O’Brien SM, Wu C, Sikora JA, Griffith BP, Gammie JS. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years: changes in risks, valve types, and outcomes in the Society of Thoracic Surgeons National Database. J. Thorac. Cardiovasc. Surg. 2009; 137 (1): 82–90. doi: 10.1016/j.jtcvs.2008.08.015. PubMed PMID: 19154908.

3. Овчаренко ЕА, Клышников КЮ, Глушкова ТВ, Бар­бараш ЛС. Моделирование имплантации биопротеза методом конечных элементов. Комплексные пробле­мы сердечно-сосудистых заболеваний. 2016; 5 (1): 6–11. [In Russ, English abstract]. Ovcharenko EA, Klyshnikov KU, Glushkova TV, Barbarash LS. Modelirovanie implantacii bioproteza metodom konechnyh jelementov. Kompleksnye problemy serdechno-sosudistyh zabolevanij. 2016; 5 (1): 6–11. doi: 10.17802/2306-1278-2016-1-6-11.

4. Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O’Gara PT et al. ACC/AHA Task Force Members. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014; 129 (23): 2440–2492. doi: 10.1161/CIR.0000000000000029. PubMed PMID: 24589852.

5. Клышников КЮ, Овчаренко ЕА, Кудрявцева ЮА, Барбараш ЛС. Репротезирование клапанов сердца по методике «протез-в-протез». Российский кардио­логический журнал. 2016; 11 (139): 73–80. [In Russ, English abstract]. Klyshnikov KU, Ovcharenko EA, Kudrjavceva JuA, Barbarash LS. Reprotezirovanie klapanov serdca po metodike «protez-v-protez». Rossijskij kardiologicheskij zhurnal. 2016; 11 (139): 73–80. doi: 10.15829/1560-4071-2016-11-73-80.

6. David TE, Ivanov J. Is degenerative calcification of the native aortic valve similar to calcification of bioprosthetic heart valves? J. Thorac. Cardiovasc. Surg. 2003; 126 (4): 939–941. doi: 10.1016/S0022. PubMed PMID: 14566227.

7. Nollert G, Miksch J, Kreuzer E, Reichart B. Risk factors for atherosclerosis and the degeneration of pericardial valves after aortic valve replacement. J. Thorac. Cardiovasc. Surg. 2003; 126 (4): 965–968. doi: 10.1016/S0022. PubMed PMID: 14566233.

8. Balsam LB, Grossi EA, Greenhouse DG, Ursomanno P, Deanda A, Ribakove GH, Culliford AT, Galloway AC. Reoperative valve surgery in the elderly: predictors of risk and long-term survival. Ann. Thorac. Surg. 2010; 90 (4): 1195–1200. doi: 10.1016/j.athoracsur.2010.04.057. PubMed PMID: 20868814.

9. Maganti M, Rao V, Armstrong S, Feindel CM, Scully HE, David TE. Redo valvular surgery in elderly patients. Ann. Thorac. Surg. 2009; 87 (2): 521–525. doi: 10.1016/j.athoracsur.2008.09.030. PubMed PMID: 19161771.

10. 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 сердечно-сосудис­тых 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. doi: 10.17802/2306-1278-2015-3-85-90.

11. Рогулина НВ, Одаренко ЮН, Журавлева ИЮ, Бар­бараш ЛС. Отдаленные результаты применения механических и биологических протезов у пациентов различных возрастов. Медицина и образование в Сибири. 2014; 3: 47. Rogulina NV, Odarenko JuN, Zhuravleva IJu, Barbarash LS. Otdalennye rezul’taty primenenija mehanicheskih i biologicheskih protezov u pacientov razlichnyh vozrastov. Medicina i obrazovanie v Sibiri. 2014; 3: 47.

12. Ovcharenko EA, Klyshnikov KU, Yuzhalin AE, Savrasov GV, Kokov AN, Batranin AV, Ganyukov VI, Kudryavtseva YuA. Modeling of transcatheter aortic valve replacement: Patient specific vs general approaches based on finite element analysis. Comput. Biol. Med. 2016; 69: 29–36. doi: 10.1016/j.compbiomed.2015.12.001. PubMed PMID: 26708469.

13. Бокерия ЛА, Гудкова РГ. Сердечно-сосудистая хирургия – 2015. Болезни и врожденные аномалии системы кровообращения. М.: НЦССХ им. А.Н. Бакулева, 2016. 208. Bokerija LA, Gudkova RG. Serdechno-sosudistaja hirurgija – 2015. Bolezni i vrozhdennye anomalii sistemy krovoobrashchenija. M.: NCSSH im. A.N. Bakuleva, 2016. 208.

14. Клышников КЮ, Овчаренко ЕА, Мальцев ДА, Журав­лева ИЮ. Сравнительная характеристика гидродинамических показателей биопротезов клапанов сердца «ЮниЛайн» и «ПериКор». Клиническая физиология кровообращения. 2013; 1: 45–51. [In Russ, English abstract]. Klyshnikov KU, Ovcharenko EA, Mal’cev DA, Zhuravleva IJu. Sravnitel’naja harakteristika gidrodinamicheskih pokazatelej bioprotezov klapanov serdca «JuniLajn» i «PeriKor». Klinicheskaja fiziologija krovoobrashchenija. 2013; 1: 45–51.