Novel thoughts on patient-prosthesis mismatch in aortic valve replacement: the rationale for the PAR I trial.

The hemodynamic performance of prosthetic tissue valves is influenced by valve design and valve-specific sizing strategies. Design determines the actual geometric opening area (GOA) of the prosthetic valve and sizing strategy its actual chosen size. Currently, hemodynamic performance is assessed by determining the effective orifice area (EOA; derived from the continuity equation by relating flow velocities with the area of the left ventricular outflow tract [LVOTA]). The question whether a valve is too small (patient-prosthesis mismatch [PPM]) is currently addressed by relating EOA to body surface area (EOA index [EOAi]). However, this relation may not be appropriate because the EOAi relates flow velocity to patient-specific anatomic parameters twice (i.e., LVOTA and body surface area). This potential confounder may explain the controversies regarding PPM. However, intuitively, leaving a gradient behind after aortic valve replacement cannot be irrelevant. PPM becomes even more relevant with transcatheter valve-in-valve implantation, where a second prosthesis is taking up inner space of a valve that may have already been too small initially. Thus, a reliable method to determine the presence of PPM is needed. The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing the relation between the prosthetic GOA and the LVOTA as a potentially new parameter for the prediction of hemodynamic outcome. The results may possibly guide future valve size selection and may allow prediction of functionally relevant PPM. Here, we will demonstrate the shortcomings of the currently applied EOAi for the assessment of hemodynamic relevance and present the rationale for the PARI trial, which recently started recruiting patients.