Preliminary assessment of an innovative aortic valve decalcification device in ex vivo human model

Aortic valve (AV) stenosis is one of the most prevalent valvular heart diseases in the elderly population. Transcatheter aortic valve implantation (TAVI) has emerged as the gold standard for patients with severe AV stenosis. However, TAVI is not without complications, including periprocedural neurological events and long-term bioprosthetic durability. New strategies for slowing disease progression and delaying prosthetic AV implantation are being developed. With the aim to break up calcium deposits and restore the AV leaflets' flexibility and mobility, a new transcatheter debridement device (TDD) exploiting ultrasonic pulse waves is under development. Preliminary ex vivo investigations on human hearts were carried out to understand if biomechanical modifications in leaflets treated with TDD could influence AV hemodynamic. Four human cadaveric hearts with AV stenosis were incorporated into an ex-vivo beating heart platform. Each heart sample was characterized under pulsatile flow conditions before (baseline) and after TDD treatment (post-treatment). The following parameters were evaluated: transvalvular pressure drop (ΔPsys), backflow volume (BV), and effective orifice area (EOA). Images of the leaflets were captured after the TDD procedure for a macroscopic qualitative examination. The treatment induced a reduction in ΔPsys in all tested samples (19.4±9.5%). An average improvement in EOA of 17.8±6.6% and an average reduction in BV of 16.6±57.5% were obtained. However, no statistically significant changes were observed in ΔPsys (p-value=0.1076), EOA (p-value=0.0649), and BV (p-value=0.8385) values between baseline and post-treatment conditions, probably due to the low number of heart samples used. Furthermore, valve integrity was maintained in all experiments. These tests are a preliminary demonstration of TDD' potential to improve AV hemodynamics without damaging the valve's integrity. TDD may be a promising tool to treat patients with AV stenosis without valve replacement intervention.