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Review
. 2023 Mar 9:10:1137827.
doi: 10.3389/fcvm.2023.1137827. eCollection 2023.

Polymeric prosthetic heart valves: A review of current technologies and future directions

Sameer K Singh  1 , Mateusz Kachel  2   3 , Estibaliz Castillero  1 , Yingfei Xue  1 , David Kalfa  1 , Giovanni Ferrari  1 , Isaac George  1
Affiliations
Review

Polymeric prosthetic heart valves: A review of current technologies and future directions

Sameer K Singh et al. Front Cardiovasc Med. .

Abstract

Valvular heart disease is an important source of cardiovascular morbidity and mortality. Current prosthetic valve replacement options, such as bioprosthetic and mechanical heart valves are limited by structural valve degeneration requiring reoperation or the need for lifelong anticoagulation. Several new polymer technologies have been developed in recent years in the hope of creating an ideal polymeric heart valve substitute that overcomes these limitations. These compounds and valve devices are in various stages of research and development and have unique strengths and limitations inherent to their properties. This review summarizes the current literature available for the latest polymer heart valve technologies and compares important characteristics necessary for a successful valve replacement therapy, including hydrodynamic performance, thrombogenicity, hemocompatibility, long-term durability, calcification, and transcatheter application. The latter portion of this review summarizes the currently available clinical outcomes data regarding polymeric heart valves and discusses future directions of research.

Keywords: aortic valve; heart valve; polymer; polymer valve; transcatheter and surgical aortic valve replacement.

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Conflict of interest statement

IG reports the following disclosures: consultant (honoraria)—Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson & Johnson, Boston Scientific, Edwards Lifesciences, Medtronic. Advisory Boards: Edwards Surgical, Medtronic Surgical, Trisol Medical, Abbvie, Johnson & Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific.Equity: Valcare Medical, Durvena, CardioMech, Vdyne, MitreMedical, MITRx.Institutional funding to Columbia University: Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, JenaValve. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Selected polymeric heart prostheses. (A) Foldax Tria TAVR; (B) Foldax Tria SAVR A-M; (C) PoliValve; (D) Polynova TAVR; (E) Inflow TAVR; (F) SAT TAVR; (G) Triskele TAVR; (H) Hastalex; (I) Innovia.
Figure 2
Figure 2
Chemical structures for various polymer compounds used in PHV construction. (A) Polysiloxanes; (B) Polycarbonate urethane; (C) Carbosil TSiPCU; (D) Poly(styrene-b-isobutylene-b-styrene); (E) Poly(styrene-b-isobutylene-b-styrene); (F) Polytetrafluoroethyelene; (G) poly(styrene-b-ethylene/butylene-b-styrene).
Figure 3
Figure 3
Polynova polymer TAVR valve compared with Perimount Magna SAVR and Inovare TAVR tissue valves. Images from in-vitro testing showing valve in peak diastole and systole.
Figure 4
Figure 4
Hydrodynamic performance of fatigued PoliValve prototypes of various iterations. (A) Effective orifice area (EOA); (B) regurgitant fraction (REG). Durability testing performed over 1.3 billion cycles.
Figure 5
Figure 5
Foldax Tria surgical valve early feasibility study in humans—EOA and MPG over 1-year follow-up.
See this image and copyright information in PMC

References

    1. Rosamond W, Flegal K, Friday G, Karen F, Alan G, Greenlund K. Heart disease and stroke statistics--2007 update: a report from the American Heart Association statistics committee and stroke statistics subcommittee. Circulation. (2007) 115:e69–e171. doi: 10.1161/CIRCULATIONAHA.106.179918, PMID: - DOI - PubMed
    1. Davidson LJ, Davidson CJ. Transcatheter treatment of Valvular heart disease: a review. JAMA. (2021) 325:2480–94. doi: 10.1001/jama.2021.2133 - DOI - PubMed
    1. Li RL, Russ J, Paschalides C, Ferrari G, Waisman H, Kysar JW, et al. Mechanical considerations for polymeric heart valve development: biomechanics, materials, design and manufacturing. Biomaterials. (2019) 225:119493. doi: 10.1016/j.biomaterials.2019.119493, PMID: - DOI - PMC - PubMed
    1. Shim HS. The behavior of isotropic pyrolytic carbons under cyclic loading. Biomater Med Devices Artif Organs. (1974) 2:55–64. doi: 10.3109/10731197409118952, PMID: - DOI - PubMed
    1. Rahimtoola SH. Choice of prosthetic heart valve in adults an update. J Am Coll Cardiol. (2010) 55:2413–26. doi: 10.1016/j.jacc.2009.10.085 - DOI - PubMed

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