Download PDF
Thorac Cardiovasc Surg 2021; 69(01): 043-048
DOI: 10.1055/s-0039-3400538
Original Cardiovascular

Further Evolution of a New Nonbiological Transcatheter Valvular Prosthesis

Filip Schröter 
1   Department of Cardiovascular Surgery, Heart Center Brandenburg, Brandenburg Medical School, Bernau bei Berlin, Brandenburg, Germany
,
Martin Hartrumpf
1   Department of Cardiovascular Surgery, Heart Center Brandenburg, Brandenburg Medical School, Bernau bei Berlin, Brandenburg, Germany
,
Ralf-Uwe Kuehnel
1   Department of Cardiovascular Surgery, Heart Center Brandenburg, Brandenburg Medical School, Bernau bei Berlin, Brandenburg, Germany
,
Roya Ostovar
1   Department of Cardiovascular Surgery, Heart Center Brandenburg, Brandenburg Medical School, Bernau bei Berlin, Brandenburg, Germany
,
Johannes M. Albes
1   Department of Cardiovascular Surgery, Heart Center Brandenburg, Brandenburg Medical School, Bernau bei Berlin, Brandenburg, Germany
› Author Affiliations Funding Statement This work was supported by funding of the Brandenburg State Ministry of Science, Research, and Culture. Project Name: INNOVALVE, Germany 2017–2018.
› Further Information
    Permissions and Reprints All articles of this category

Abstract

Background Polymeric heart valves are constructed from flexible synthetic materials, therefore aiming to combine the advantageous hemodynamic of biological and the longevity of mechanical valve prostheses. One such valve prototype in development is the PIZZA valve constructed of flexible triangular silicone leaflets on a foldable metal base for perspective transcatheter implantation. Here we present further improvements in its performance through structural modifications.

Methods Structurally modified prototypes were constructed from silicone sheets and stainless-steel wires. Their performance was then tested in a hemodynamic testing device of the type HKP 2.0.

Results Shift from a planar to a cone shape as well as overlapping of the leaflets significantly improved the valves performance, reducing regurgitation as well as systolic pressure gradients.

Conclusions The results of the modified prototypes expressed superior performance and represented a step forward on the road to an easily producible, polymeric transcatheter valvular prosthesis.

Keywords

heart valve surgery - aortic valve and root - heart valve - transapical - percutaneous (TAVI)


Publication History

Received: 06 June 2019

Accepted: 13 October 2019

Article published online:
13 December 2019

© 2019. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Braunwald NS, Cooper T, Morrow AG. Complete replacement of the mitral valve. Successful clinical application of a flexible polyurethane prosthesis. J Thorac Cardiovasc Surg 1960; 40: 1-11
    CrossrefPubMedSearch in Google Scholar
  • 2 Gott VL, Daggett RL, Young WP. Development of a carbon-coated, central-hinging, bileaflet valve. Ann Thorac Surg 1989; 48 (3, Suppl): S28-S30
    CrossrefPubMedSearch in Google Scholar
  • 3 Bezuidenhout D, Zilla P. Flexible leaflet polymeric heart valves. In: Franz T. ed. Cardiovascular and Cardiac Therapeutic Devices. Luxembourg: Springer Science & Business; 2014
    Search in Google Scholar
  • 4 Ghanbari H, Viatge H, Kidane AG, Burriesci G, Tavakoli M, Seifalian AM. Polymeric heart valves: new materials, emerging hopes. Trends Biotechnol 2009; 27 (06) 359-367
    CrossrefPubMedSearch in Google Scholar
  • 5 Rahmani B, Tzamtzis S, Ghanbari H, Burriesci G, Seifalian AM. Manufacturing and hydrodynamic assessment of a novel aortic valve made of a new nanocomposite polymer. J Biomech 2012; 45 (07) 1205-1211
    CrossrefPubMedSearch in Google Scholar
  • 6 Jiang H, Campbell G, Boughner D, Wan WK, Quantz M. Design and manufacture of a polyvinyl alcohol (PVA) cryogel tri-leaflet heart valve prosthesis. Med Eng Phys 2004; 26 (04) 269-277
    CrossrefPubMedSearch in Google Scholar
  • 7 Albes JM. inventor. Deutschland patent DE 10 2008 012 438 B4. 2008
    PubMedSearch in Google Scholar
  • 8 Schichl K, Affeld K. A computer controlled versatile pulse duplicator for precision testing of artificial heart valves. Int J Artif Organs 1993; 16 (10) 722-728
    CrossrefPubMedSearch in Google Scholar
  • 9 Kühnel RU, Wendt MO, Jainski U, Hartrumpf M, Pohl M, Albes JM. Suboptimal Geometrical Implantation of Biological Aortic Valves Provokes Functional Deficits. Interact Cardiovasc Thoracic Surg; 2010: 971-975
    Search in Google Scholar
  • 10 Kuehnel RU, Pohl A, Puchner R. et al. Opening and closure characteristics of different types of stented biological valves. Thorac Cardiovasc Surg 2006; 54 (02) 85-90
    Thieme ConnectPubMedSearch in Google Scholar
  • 11 Kuehnel RU, Puchner R, Pohl A. et al. Characteristic resistance curves of aortic valve substitutes facilitate individualized decision for a particular type. Eur J Cardiothorac Surg 2005; 27 (03) 450-455 , discussion 455
    CrossrefPubMedSearch in Google Scholar
  • 12 R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing; 2017
    Search in Google Scholar
  • 13 Holm S. A simple sequentially rejective multiple test procedure. Scand J Stat 1979; 6 (02) 65-70
    PubMedSearch in Google Scholar
  • 14 Shabalovskaya SA. Surface, corrosion and biocompatibility aspects of Nitinol as an implant material. Biomed Mater Eng 2002; 12 (01) 69-109
    PubMedSearch in Google Scholar
  • 15 Ghanbari H, de Mel A, Seifalian AM. Cardiovascular application of polyhedral oligomeric silsesquioxane nanomaterials: a glimpse into prospective horizons. Int J Nanomedicine 2011; 6: 775-786
    PubMedSearch in Google Scholar