Key result
Inspiris Resilia valve shows no major complications or early degeneration at 5 years.
Why the study?
The Inspiris Resilia tissue valve was recently introduced into clinical practice, prompting a review of the pre-clinical and clinical studies leading to this new bioprosthesis.
Does the Inspiris Resilia tissue valve provide safe and efficacious outcomes for aortic valve replacement?
Does the Inspiris Resilia tissue valve provide safe and efficacious outcomes for aortic valve replacement?
The Inspiris Resilia valve demonstrates safety and efficacy up to 5 years with no signs of early degeneration, featuring a design that mitigates calcification and facilitates future valve-in-valve procedures.
Supports short-term safety of Inspiris Resilia in AVR; leaves open durability beyond 5 years and comparative RCTs.
INTRODUCTION: The Inspiris Resilia tissue valve was recently introduced into clinical practice. This review summarizes the pre-clinical and clinical studies leading to this new bioprosthesis. AREAS COVERED: The novel Resilia tissue was tested extensively in a large animal model. The clinical use of the tissue started in 2011 with the European Feasibility study, followed by a North-American multi-center study. Since 2017, the Inspiris Resilia valve has been in full commercial use. Further prospective evaluations and registries are ongoing. EXPERT OPINION: The Inspiris Resilia valve was clinically introduced after pre-clinical tests revealed superiority compared to contemporary therapy such as the Perimount valve. Prospective long-term follow-up studies on Resilia are ongoing since 2011 and reveal no major complications. Full 5-year data show no signs of early degeneration, but longer follow-up is certainly still needed. Several prospective registries are actively monitoring the outcome with the Inspiris Resilia valve now. The novel tissue, designed to mitigate calcification and increase durability, together with the expandable stent, facilitating potential future valve-in-valve (ViV) procedures, are the cutting-edge aspects. Clinical use in younger patients is currently ongoing: their follow-up and outcome will determine the added value of this valve.
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Tamagnini et al. (2021) conducted a review in Aortic valve replacement. Inspiris Resilia tissue valve vs. Contemporary therapy (e.g., Perimount valve) was evaluated. The Inspiris Resilia valve demonstrated no major complications and no signs of early degeneration at 5 years of follow-up.
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