Percutaneous aortic valve replacement. Part 3: Balloon counterpulsation of a novel temporary aortic valve.

A previously published two-part study described an engineering design of a percutaneous aortic valve (PAV) replacement system, which utilizes a novel temporary aortic valve (TAV) support to improve procedural outcomes and safety. Conceptually, this investigational approach can promote accurate PAV placement, procedural hemodynamic stability, smaller catheter delivery system, reduction in PAV regurgitation, reduction in conduction and vascular complications. The balloon TAV can potentially facilitate the PAV replacement procedure by serving as the patient's surrogate aortic valve while the native valve is pretreated and replaced. The original TAV is designed to function with an effective aortic stenosis and insufficiency in moderate ranges, which lessens from the patient's more critical valve condition, should be well tolerated when the native valve becomes nonfunctional during the replacement process. Further optimization of the TAV's hemodynamic profile could further improve the system's overall performance and enhance the realization of a truly minimally invasive, cath lab-based PAV replacement procedure comparable to that of percutaneous coronary intervention. This study explores design permutations from the original published TAV, including varying the number of balloons and adding balloon counterpulsations, to improve upon its hemodynamic profile to better serve as the patient's surrogate valve and the overall PAV replacement procedure.