Abstract
In the field of congenital heart surgery, tissue-engineered vascular grafts (TEVGs) are a promising alternative to traditionally used synthetic grafts. Our group has pioneered the use of TEVGs as a conduit between the inferior vena cava and the pulmonary arteries in the Fontan operation. The natural history of graft remodeling and its effect on hemodynamic performance has not been well characterized. In this study, we provide a detailed analysis of the first U.S. clinical trial evaluating TEVGs in the treatment of congenital heart disease. We show two distinct phases of graft remodeling: an early phase distinguished by rapid changes in graft geometry and a second phase of sustained growth and decreased graft stiffness. Using clinically informed and patient-specific computational fluid dynamics (CFD) simulations, we demonstrate how changes to TEVG geometry, thickness, and stiffness affect patient hemodynamics. We show that metrics of patient hemodynamics remain within normal ranges despite clinically observed levels of graft narrowing. These insights strengthen the continued clinical evaluation of this technology while supporting recent indications that reversible graft narrowing can be well tolerated, thus suggesting caution before intervening clinically.
Highlights
Improved biomaterials promise to reduce the morbidity and mortality associated with congenital heart disease
The scaffold consisted of a middle layer of poly(glycolic acid) (PGA) fibers that were knitted into a tube and coated on both luminal and abluminal surfaces by a thick porous poly(caprolactone/lactic acid) (PCLA) sponge layers
The reduction of minimum graft diameter at intervention time points ranged from 58 to 77% (Table 1)
Summary
Improved biomaterials promise to reduce the morbidity and mortality associated with congenital heart disease. The common lack of homologous tissue for reconstructive surgery necessitates the use of cadaveric, xenograft, or synthetic materials[1]. These biomaterials have limited durability and, relevant to the pediatric population, they lack growth potential[2]. Their use is associated with the need for repeat operations secondary to somatic overgrowth or deterioration of graft function[3]. Tissue engineering offers an alternative to currently available biomaterials by stimulating the growth of autologous tissue for surgical repair, replacement, or reconstruction[4]. The general approach involves harvesting human cells that are seeded onto a scaffold
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