Key result
Transcatheter Debridement Device reduces systolic pressure drop and increases orifice area in ex-vivo AS hearts.
Why the study?
Bioprosthetic aortic valve replacement is prone to structural degeneration, creating a need for therapies that postpone replacement by fragmenting calcifications and restoring leaflet flexibility.
Does a transcatheter debridement device using ultrasound improve hemodynamics in ex-vivo human hearts with aortic valve stenosis?
Does a transcatheter debridement device using ultrasound improve hemodynamics in ex-vivo human hearts with aortic valve stenosis?
An experimental transcatheter debridement device using ultrasound improved aortic valve fluid-dynamics in an ex-vivo model of calcific aortic stenosis, though it increased backflow volume.
PURPOSE: Aortic valve stenosis (AVS) is the most common valvular disease in developed countries. Surgical or transcatheter bioprosthetic aortic valve (AV) replacement is the standard treatment for severe AVS. However, bioprostheses are prone to structural degeneration. Hence, in terms of lifetime management, there is a need for therapies that can postpone AV replacement. With the aim of fragmenting calcifications and restoring AV leaflets flexibility, a new transcatheter debridement device (TDD) exploiting ultrasound is under development. We performed an ex-vivo study on human hearts to quantify how TDD treatment affects stenotic AVs hemodynamic. Additionally, a qualitative histological analysis was performed to assess TDD's impact on AV leaflets. METHODS: Three human hearts affected by AVS were characterized pre- and post-treatment in an ex-vivo beating heart simulator. To replicate physiological flowrates, a pulsatile pump was connected to the left ventricle, while a systemic impedance simulator connected to the aortic root and a reservoir connected to the left atrium closed the hydraulic circuit. Transvalvular pressure drop (ΔPsys), backflow volume, and effective orifice area (EOA) were evaluated. For histological analysis, AV leaflets sections were stained with Haematoxylin/Eosin and AlizarineRedS to highlight calcifications. RESULTS: The treatment induced a reduction in ΔPsys in all tested samples, improving EOA, but caused an increase in backflow volume. Moreover, histology suggested AV leaflets integrity. CONCLUSIONS: The TDD procedure improved AV fluid-dynamics during systole in all tested samples, without evidence of damage to tissues. This suggests TDD could be a promising option to postpone AV replacement for patients with AVS.
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Perico et al. (2025) studied Calcific aortic valve stenosis (n=3). Transcatheter Debridement Device (TDD) vs. Baseline (pre-treatment) was evaluated on Mean systolic pressure drop across aortic valve (ΔPsys). The Transcatheter Debridement Device reduced systolic transvalvular pressure drop and increased effective orifice area in all three ex-vivo human hearts with aortic stenosis.
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