Left ventricular outflow tract diameter variability and prosthesis-patient mismatch: a simulation study

Abstract A recent discussion that highlighted the differences between the reported effective orifice area and corresponding incidence of prosthesis-patient mismatch within the 1- and 7-year results of the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Trial of the Avalus valve has once again emphasized the instability of such measurements. The effective orifice area, calculated using the continuity equation through measurements of the left ventricular outflow tract diameter, is highly susceptible to measurement variability, as previously demonstrated in literature through both intra- and interobserver variability. To illustrate this problem a simulation was performed in which the left ventricular outflow tract diameter was systematically altered by -2 mm, -1 mm, 0 mm, +1 mm, and +2 mm. Subsequently, the proportion of severe prosthesis-patient mismatch was recalculated and varied between 13.3%, 6.2%, 3.1% (original), 1.2%, and 0.3%, respectively. These findings demonstrate that small but clinically realistic variability in left ventricular outflow tract measurements can significantly affect the presence of prosthesis-patient mismatch. A measurement variability of 1 mm can nearly double or halve the prevalence of severe prosthesis-patient mismatch. This illustrates that prosthesis-patient mismatch, in its current form, is highly unstable and that indexed effective orifice area-based prosthesis-patient mismatch should not be used in isolation.