Key result
Pulsed cavitational ultrasound decreases calcified bioprosthesis stenosis by remotely softening leaflets in preclinical models.
Why the study?
Calcified tissue bioprosthetic heart valves eventually fail and surgical or percutaneous valve replacement carries higher complication rates, motivating a non-invasive therapeutic approach.
Does pulsed cavitational ultrasound improve the opening of calcified bioprosthetic valves in preclinical models?
Does pulsed cavitational ultrasound improve the opening of calcified bioprosthetic valves in preclinical models?
Pulsed cavitational ultrasound demonstrates preclinical feasibility as a non-invasive therapy to soften calcified bioprosthetic valves and reduce stenosis.
BACKGROUND: The majority of prosthetic heart valves currently implanted are tissue valves that can be expected to calcify with time and eventually fail. Surgical or percutaneous redux valve replacement is associated with higher rate of complications. We propose a novel non-invasive therapeutic approach based on the use of pulsed cavitational ultrasound (PCU) to improve the valvular function of degenerative calcified bioprosthesis. OBJECTIVES: Our study aims to demonstrate in vitro and in vivo on an ovine model that PCU can significantly improve the bioprosthesis opening by softening remotely the calcified stiff cusps. METHODS: All the experiments were performed on calcified bioprosthetic valves explanted from human patients. PCU was performed in vitro on calcified bioprosthesis mounted on a hydraulic bench with pulsatile flow (n=8) and in vivo on an ovine model with implanted calcified bioprosthesis (n=7). We used 3D echocardiography, pressure and flow sensors, quantitative stiffness evaluation using shear wave elastography, micro-CT imaging and histology to evaluate in vitro and in vivo the effect of PCU. RESULTS: p<0.001). Histology and micro-CT imaging showed modifications of calcification structure without loss of calcification volume or alteration of the leaflet superficial structures. CONCLUSIONS: We have demonstrated in vitro and in vivo that PCU can decrease a calcified bioprosthesis stenosis by softening the leaflets remotely. This new non-invasive approach has the potential to improve the outcome of patients with severe bioprosthesis stenosis.
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Villemain et al. (2017) studied Degenerative calcified bioprosthesis (n=15). Pulsed cavitational ultrasound (PCU) was evaluated on Bioprosthesis opening and stiffness (p=<0.001). Pulsed cavitational ultrasound decreased calcified bioprosthesis stenosis by softening the leaflets remotely in vitro and in an in vivo ovine model (p<0.001).
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