Polymeric Heart Valves Will Displace Mechanical and Tissue Heart Valves: A New Era for the Medical Devices

Abstract

The development of a novel artificial heart valve with outstanding durability and safety has remained a challenge since the first mechanical heart valve entered the market 65 years ago. Recent progress in high-molecular compounds opened new horizons in overcoming major drawbacks of mechanical and tissue heart valves (dysfunction and failure, tissue degradation, calcification, high immunogenic potential, and high risk of thrombosis), providing new insights into the development of an ideal artificial heart valve. Polymeric heart valves can best mimic the tissue-level mechanical behavior of the native valves. This review summarizes the evolution of polymeric heart valves and the state-of-the-art approaches to their development, fabrication, and manufacturing. The review discusses the biocompatibility and durability testing of previously investigated polymeric materials and presents the most recent developments, including the first human clinical trials of LifePolymer. New promising functional polymers, nanocomposite biomaterials, and valve designs are discussed in terms of their potential application in the development of an ideal polymeric heart valve. The superiority and inferiority of nanocomposite and hybrid materials to non-modified polymers are reported. The review proposes several concepts potentially suitable to address the above-mentioned challenges arising in the R&D of polymeric heart valves from the properties, structure, and surface of polymeric materials. Additive manufacturing, nanotechnology, anisotropy control, machine learning, and advanced modeling tools have given the green light to set new directions for polymeric heart valves.

Removal of Free Liquid Layer from Liquid-Infused Catheters Reduces Silicone Loss into the Environment while Maintaining Adhesion Resistance

“…Silicone material and silicone liquids are widely used in clinical settings, including as heart valves, breast implants, retinal tamponades, and syringe barrel lubricants, [40][41][42][43][44] due to their versatility and relative biocompatibility. Recent findings have shown that when free silicone liquid is infused into silicone catheter materials, there is a remarkable decrease in both fibrinogen and pathogen adhesion levels, both in vivo and in vitro.…”

Preliminary Implantation of a Novel TAVR Device With Polymeric Leaflets for Symptomatic Calcific Aortic Disease

“…The polymeric leaflets have also better durability than pericardium leaflets. 1 Finally, the novel valve was implanted according to patient's wishes.…”

Analysis of the Effect of Thickness on the Performance of Polymeric Heart Valves

“…Materials with good durability and biocompatibility have always been the research focus in the field of PHVs for many years. Polysiloxanes, polytetrafluoroethylene (PTFE) and polyurethane (PUs) are the earliest materials applied for developing PHVs, which have good biocompatibility, hemodynamic properties and viscoelasticity, respectively [ 4 , 5 ]. Still, as time goes on, many PHVs made from them have been tested and failed because of thrombosis, calcification, hydrolysis, etc.…”

“…However, no commercially−viable devices have been developed using macroscopic composite materials so far. Nanocomposites have a better application foreground because of their superior mechanical properties, biocompatibility and simpler valve manufacturing process [ 3 , 4 , 13 ], such materials include polyhedral oligomeric silsesquioxane poly(carbonate–urea) urethane (POSS−PCU), polyvinyl alcohol (PVA) hydrogels reinforced with bacterial cellulose (BC) [ 14 ], the integration of graphene oxide (FGO) nanomaterials and PCUs [ 15 ], and the addition of carbon nanotubes (CNTs) to polymers with acceptable biocompatibility and mechanical properties [ 16 , 17 ]. Except for POSS−PCU that has undergone in vitro testing [ 18 ], the other three nanocomposites are still in the early stages of development.…”

“…Carbothane PC−3585A is a kind of medical−grade thermoplastic polyurethane, it is widely used in the fields of biomedical applications [ 27 ]. xSIBS and SIBS−CNTs are the most promising developments in recent years [ 4 , 17 ]. SIBS−CNTs have enhanced biocompatibility and increased strength compared to neat SIBS [ 17 ], which will contribute to improving long−term durability and fatigue resistance, particularly in high−stress environments such as the cardiac cycle.…”