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This document describes an in vitro test method for characterizing the expansion resistance of a flexible surgical heart valve prosthesis against an outward radial force and provides examples for how this design limit should be communicated in the product’s Instructions for Use (IFU). This document represents a consensus reached among manufacturers, independent bioengineers, and clinicians, and is underpinned by interlaboratory studies.
This document relates to flexible surgical heart valve prostheses and is intended to be used in conjunction with ISO 5840-1:2021 and ISO 5840-2:2021. In addition to rigid (mechanical) valves, sutureless valves, stentless valves, valved conduits, and size-adjustable valves that are intended to operate across a range of expanded diameters are also not included.
Transcatheter valve-in-valve replacement is a known treatment of failing surgical bioprostheses for selected patients after heart team evaluation. Bioprosthetic valve fracture has emerged as a technique to intentionally fracture the frame of a surgical valve using a high-pressure balloon (HPB) to facilitate expansion of the transcatheter valve in a ViV procedure. The clinical safety and efficacy of this practice have not been evaluated. Because bioprosthetic valve fracture and expansion are increasingly used in selected cases to mitigate constrained transcatheter valve expansion and residual PPM, it is important for manufacturers to understand failure modes of surgical valves. Manufacturers should characterize, before commercial release, the pressure at which a surgical valve will be damaged or, if the surgical valve is not damaged, state the pressure limit of the test. It is the goal of this ISO Technical Specification (TS) to provide a standardized procedure for manufacturers to establish the point of failure of a new surgical valve, prior to commercialization. Understanding the behaviour of the surgical valve will allow the manufacturer to provide precautions or warnings to the user identifying the point where the surgical valve may no longer perform its intended use.
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