@article{ACS17110,
author = {Changfu Wu and Chad Green and Salvador Marquez and Paolo Monelli and Craig Weinberg and Matthew Weston and Patricia Lawford and Duke Cameron and Ajit Yoganathan and Ulrich Steinseifer},
title = {Effective orifice diameter: a new sizing parameter of surgical valve prostheses to inform valve selection},
journal = {Annals of Cardiothoracic Surgery},
volume = {13},
number = {3},
year = {2024},
keywords = {},
abstract = {Background: The labeled sizes of surgical valve prostheses and their discordance with the physical internal valve orifice sizes has long been a controversy in the cardiac surgery community, leading many to believe it to be a contributing factor in prosthesis-patient mismatch following valvular replacement surgery. In an attempt to address this issue, the International Organization for Standardization (ISO) 5840-2:2021 standard for surgical valve prostheses recommends that a new sizing parameter, namely, the effective orifice diameter, be provided in labeling by all manufacturers as an indicator of the true flow-passing capacity of a prosthetic valve.
Methods: The ISO Cardiac Valves Working Group conducted a multi-laboratory round-robin study to investigate whether the effective orifice diameter of a prosthetic surgical valve could be derived repeatably and reproducibly through steady forward-flow testing. A total of 7 valve models, each with multiple sizes, were tested, including a mechanical heart valve and multiple biological heart valves.
Results: The round-robin study confirmed that the steady forward-flow test had good intra-laboratory repeatability and inter-laboratory reproducibility in deriving the effective orifice diameters of surgical valve prostheses. On average, among the participating laboratories, the experimentally derived effective orifice diameter of a prosthetic heart valve was 3–12 mm smaller than its labeled size.
Conclusions: The effective orifice diameter provides better characterization of the hydrodynamic characteristics of a surgical valve prosthesis and can be derived using a validated steady forward-flow test method. This new sizing parameter will soon be adopted by surgical valve manufacturers and provided in device labeling to inform valve selection by surgeons.},
issn = {2304-1021}, url = {https://www.annalscts.com/article/view/17110}
}