In vitro test of the prototype of the mitral biological prosthesis for transcatheter implantation according to the method of “valve-in-valve”
Abstract
The trend of exponential growth in the volume of surgical interventions with the use of prosthetic heart valves in recent years creates prerequisites to seek solutions for groups of patients
at high and prohibitive surgical risk. Similarly, the question of the treatment of patients with
pathology of the previously implanted valve remains unsolved. The aim of our study is the
evaluation in vitro of the prototype of the transcatheter mitral biological prosthesis.
Materials and methods. There was developed a concept of the self-expanding nitinol frame
transcatheter mitral biological prosthesis. Leaflets, coating frame and cuffs are made of a xenopericardial pigs and assembled manually. We performed tests of the radial forces of the frame.
The implantation of transcatheter valve was performed positioned at the heart of healthy domestic swine to the frame of the xenopericardial biological prosthesis, pre-sewn into the mitral
position according to traditional methods.
Results. The optimal ratio was selected of the frames bioprostheses for implantation by the
“valve-in-valve” technique. The implantation of the prosthesis with the transcatheter delivery system in in vitro experiment demonstrated the viability of the technique. The concept
of a manufactured product complies with all the requirements.
Conclusion. Prototype of the first domestic transcatheter mitral biological prosthesis in vitro
model of isolated porcine hearts showed satisfactory performance. There is a need of further
preclinical studies and series of acute experiments.
Keywords:mitral valve disease, biological prosthesis, transcatheter implantation, heart failure
Clin. Experiment. Surg. Petrovsky J. 2018; 1 (19): 77–83.
DOI: 10.24411/2308-1198-2018-00011
Received: 30.07.2017. Accepted: 25.01.2018.
References
1. Bokeriya L.A., Gudkova R.G. Cardiovascular Surgery-2014. Diseases and congenital anomalies of the circulatory system. Moscow, 2015: 48–67.
2. Schoen F.J., Levy R.J. Calcification of tissue heart valve substitutes: progress toward understanding and prevention. Ann Thorac Surg. 2005; 79: 80.
3. Barnett S.D., Ad N. Surgery for aortic and mitral valve disease in the United States: A trend of change in surgical practice between 1998 and 2005. J Thorac Cardiovasc Surg. 2009; 137: 9.
4. Coffey S., Cairns B.J., Iung B. The modern epidemiology of heart valve disease. Heart. 2016; 102: 75–85.
5. Nkomo V.T., Gardin J.M., Skelton T.N., Gottdiener J.S., et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006; 368: 1005–11.
6. Mirabel M., Iung B., Baron G., et al. What are the characteristics of patients with severe, symptomatic, mitral regurgitation who are denied surgery? Eur Heart J. 2007; 28: 1358–65.
7. Goel S.S., Bajaj N., Aggarwal B., et al. Prevalence and outcomes of unoperated patients with severe symptomatic mitral regurgitation and heart failure: comprehensive analysis to determine the potential role of MitraClip for this unmet need. JACC. 2014; 63: 185–6.
8. Levine R.A., Schwammenthal E. Ischemic mitral regurgitation on the threshold of a solution: from paradoxes to unifying concepts. Circulation. 2005; 112 (5): 745–8.
9. Nishimura R.A., Vahanian A., Eleid M.F., Mack M.J. Mitral valve disease — current management and future challenges. Lancet. 2016; 387: 1324–34.
10. Paradis J.-M., Del Trigo M., Puri R., Rodes-Cabau J. Transcatheter valve-in-valve and valve-in-ring for treating aortic and mitral surgical prosthetic dysfunction. JACC. 2015; 66 (18): 2019–37. doi: 10.1016/j.jacc.2015.09.015.
11. Kempfert J., Blumenstein J., Chu M.W.A., Pritzwald- Stegmann P., et al. Minimally invasive off-pump valve-in- a-ring implantation: the atrial transcatheter approach for re-operative mitral valve replacement after failed repair. Eur J Cardiothorac Surg. 2009; 35: 965–9. doi: 10.1016/j.ejcts.2009.02.018.
12. Verheye S., Cheung A., Schwartz M., Marko A., et al. Transapical mitral implantation of the tiara bioprosthesis. JACC Cardiovasc Interv. 2014; 7 (2): 154–62.
13. Wang D.D., Eng M., Myers E., Forbes M., et al. Predicting LVOT obstruction after TMVR. JACC Cardiovasc Imaging. 2016; 9 (11): 1349–52. doi: 10.1016/j.jcmg.2016.01.017.
14. Khan J.M., Rogers T., Schenke W.H., Mazal J.R., et al. Intentional laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction during transcatheter mi- tral valve replacement. JACC Cardiovasc Intervent. 2016; 9 (17): 1835–43.
15. 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. doi: 10.1080/17434440.2017.1305267.