ABSTRACT
BACKGROUND AND AIM OF THE STUDY: Structural valve deterioration (SVD) is the leading failure mode of bioprosthetic heart valves. The Edwards Integrity-Preservation (EIP™) technology was developed to permanently block tissue calcium-binding sites and allow for non-aqueous valve storage. The study aim was to evaluate the efficacy of tissue anti-calcification, valve performance, durability, and safety. METHODS: Bovine pericardial tissue with EIP technology was compared to industry-standard Carpentier-Edwards ThermaFix® and Xenologix® treatments. Anti-calcification efficacy was evaluated in the rabbit model at 60 days, and tissue calcium contents were quantified using atomic absorption spectrophotometry. Valve performance was assessed using an in-vivo 20-week chronic ovine model, and in-vitro hydrodynamic testing (effective orifice area and regurgitation). Valve durability was evaluated by accelerated wear testing at 200 million cycles (equivalent to five years). Valve safety was characterized by biocompatibility testing as per ISO requirements. RESULTS: Calcification results showed that the control and EIP technology tissues had a mean Ca content of 104.95 ± 102.69 and 21.20 ± 38.46 µg/mg dry tissue, respectively; the median Ca contents were 81.15 and 0.43 µg/mg dry tissue, respectively (p < 0.0001). The overall valve performance in the sheep was comparable between control and test. In-vitro hydrodynamics and durability were similar between groups, across all sizes, and met ISO requirements. EIP technology was shown to be biocompatible for use as an implantable device. CONCLUSION: Preclinical in-vitro and in-vivo evaluations showed that EIP technology significantly reduced tissue calcification and preserved valve performance and safety compared to current standards of care. Future studies will determine whether these findings can be replicated in humans.
