Compliant Aortic Annulus Sizing With Different Elliptical Ratios Through a Valvuloplasty Balloon Catheter.

OBJECTIVE: Aortic stenos (AS) is a heart valve disease that commonly affects the elderly. Transcatheter aortic valve implantation is a minimally invasive treatment that allows to replace the function of the diseased native valve with a prosthetic device, relying on catheters for device implantation. According to the current clinical guidelines, the choice of the implanted device is based on preoperative sizing determined by image-based technology. However, this assessment faces inherent limitations that can lead to sub-optimal sizing of the prosthesis; in turn, this can cause major post-operative complications like aortic regurgitation or cardiac electrical signal disruption. METHOD: By utilizing balloon pressure and volume data, this article proposes an intra-operative method for determining the dimension of the aortic annulus which takes into account its compliance and geometric irregularity. The intra-balloon pressure-volume curves were obtained using an Automated Balloon Inflation Device operating a commercially available valvuloplasty balloon catheter. A sizing algorithm to estimate the dimensions of the annulus was integrated via a validated analytical model and a numerical model for balloon free-inflation. Tests were performed on circular and elliptical idealised aortic phantoms. RESULTS: Experimental results confirm that the pressure-volume data processed with the sizing algorithm can be used to determine the circular annular diameter for all tissue rigidities. CONCLUSION: The measurement of stiffer elliptical annulus phantoms shows good accuracy and high repeatability. SIGNIFICANCE: This work represents substantial progress toward improving the selection of TAVI devices by using balloon catheters to improve the sizing of compliant aortic annuli with complex geometry.

Computational Analysis of Balloon Catheter Behaviour at Variable Inflation Levels.

Aortic valvuloplasty is a minimally invasive procedure for the dilatation of stenotic aortic valves. Rapid ventricular pacing is an established technique for balloon stabilization during this procedure. However, low cardiac output due to the pacing is one of the inherent risks, which is also associated with several potential complications. This paper proposes a numerical modelling approach to understand the effect of different inflation levels of a valvuloplasty balloon catheter on the positional instability caused by a pulsating blood flow. An unstretched balloon catheter model was crimped into a tri-folded configuration and inflated to several levels. Ten different inflation levels were then tested, and a Fluid-Structure Interaction model was built to solve interactions between the balloon and the blood flow modelled in an idealised aortic arch. Our computational results show that the maximum displacement of the balloon catheter increases with the inflation level, with a small step at around 50% inflation and a sharp increase after reaching 85% inflation. This work represents a substantial progress towards the use of simulations to solve the interactions between a balloon catheter and pulsating blood flow.