UniLine RetroFit: a multicenter observational cohort study on the effectiveness, safety, and durability of UniLine (an epoxy-treated xenopericardial valve) in patients with isolated aortic and mitral valve disease: rationale, objectives, and study design

Aim. To evaluate the effectiveness, safety, durability, and long-term outcomes of UniLine prosthetic valve application in patients with isolated mitral or aortic valve disease who have undergone a surgical valve replacement.

Materials and Meth­ods. The study aims to include at least 2,000 patients from seven Russian research centers who have undergone surgical mitral valve replacement or surgical aortic valve replacement using an epoxy-treated, xenopericardial bioprosthetic valve Uni­Line. The multicenter design of the study enhances patient re­cruitment, ensures a representative sample, minimises selec­tion bias, and improves the generalisability of findings to the population. Currently, 989 patients have been enrolled, with ongoing recruitment, telephone follow-ups, and clinical as­sessments.

Results. The primary endpoint is long-term safety and durability of UniLine valve in patients with isolated mi­tral or aortic valve disease, with the follow-up period up to 12 years postimplantation. The long-term safety will be assessed by the rates of valve-related complications including mortal­ity, chronic heart failure, life-threatening bleeding, valve mi­gration, valve thrombosis, any other valve-related compli­cation requiring re-intervention, access site-related compli­cations, acute coronary syndrome or progression of chronic coronary syndrome to the state requiring percutaneous coro­nary intervention or coronary artery bypass graft surgery, and stroke. Long-term durability will be evaluated via hemody­namic valve performance (maximum and mean pressure gra­dient across the atrioventricular prosthesis and effective orifice area, per manufacturer specifications) measured by echocardi­ography. Secondary endpoints are incidence of adverse event, major adverse events, device-related adverse events, proce­dure-related adverse events, and all-cause mortality.

Conclu­sion. The UniLine RetroFit multicenter observational cohort study is a valuable initiative for obtaining real-world clinical data on the effectiveness, safety, durability, and long-term out­comes of UniLine valve in patients with isolated mitral and aortic valve disease.

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