Synchronous Inflation of a Valvuloplasty Balloon Catheter With Heart Rate: In-Vitro Evaluation in Terms of Dilatation Performance

Balloon aortic valvuloplasty (BAV), a minimally invasive procedure to alleviate aortic valve stenosis, commonly employs rapid ventricular pacing (RVP) for balloon stabilization. However, the repeated and extended operation time associated with this technique poses potential complications. This paper introduces a novel approach to mitigate these concerns by employing a dilatation mechanism that is synchronized with the cardiac frequency, wherein the balloon catheter is fully inflated and deflated to a safe, low volume during the decrement of the ventricular pressure. The synchronized pacing was tested at a heart rate of 60bpm. To experimentally validate the performance of this new approach, mock aortic roots reproducing different calcification patterns were used to compare the leaflets' mobility after the dilatation test with traditional BAV. Results confirm successful balloon pacing, maintaining low volume before the ventricular pressure increases. The dilatation performance assessment underscores that the proposed methodology resulted in a higher improvement in terms of the transvalvular pressure gradient and opening area. Optimal performance occurs at 60bpm, yielding a 30.28% gradient decrease and a 21.35% opening area increase. This research represents a notable step forward toward the development of BAV devices capable of autonomous stabilization, eliminating the need for RVP and its related complications. Furthermore, the use of calcified aortic root (AR) phantoms contributes to an enhanced understanding of hemodynamic implications during BAV procedures.