PNNL

Abstract

Background: Percutaneous mitral valve (MV) dilatation is performed with either a single balloon (SB) or double balloon (DB) technique. The aim of this study was to compare the two balloon system results using the finite element (FE) method. Methods and Results: An established FE model of the MV was modified by fusing the MV leaflet edges at commissure level to simulate a stenotic valve (orifice area=180mm2). A FE model of a 30mm SB (low-pressure, elastomeric balloon) and an 18mm DB system (high-pressure, non-elastic balloon) was created. Both SB and DB simulations resulted in splitting of the commissures and subsequent stenosis dilatation (final MV area=610mm2 and 560mm2 respectively). Stresses induced by the two balloon systems varied across the valve. At the end of inflation, SB showed higher stresses in the central part of the leaflets and at the commissures compared to DB simulation, which demonstrated a more uniform stress distribution. The higher stresses in the SB analysis were due to the mismatch of the round balloon shape with the oval mitral orifice. The commissural split was not easily accomplished with the SB due to its high compliance. The high pressure applied to the DB guaranteed the commissural split even when high forces were required to break the commissure welds. Conclusions: The FE model demonstrated that MV dilatation can be accomplished by both SB and DB techniques. However, the DB method resulted in higher probability of splitting of the fused commissures and less damage caused to the MV leaflets by overstretching.