Systematic brain magnetic resonance imaging and safety evaluation of non-invasive ultrasound therapy for patients with severe symptomatic aortic valve stenosis

Danijela Trifunovic-Zamaklar, Miloš Velinović, Nataša Kovačević-Kostić, Emmanuel Messas, Danijela Trifunovic-Zamaklar, Miloš Velinović, Nataša Kovačević-Kostić, Emmanuel Messas

No abstract available

Keywords: MRI; aortic stenosis; calcification; non-invasive ultrasound therapy; stroke.

Conflict of interest statement

Conflict of interest: D.T.Z., M.V., and N.K.K. were investigators of the study. D.T.Z. reports honoraria for lectures from Astra Zeneca, Boehringer Ingelheim, Pfizer, Hemofarm, and Amicus and received support to attend meetings from Boehringer, participates in DSMBs/advisory boards for Boehringer, and is the president of the Serbian Society of Echocardiography. E.M. is a co-founder and scientific advisory board member of Cardiawave and holds shares in the company and subsequently has royalties/licenses, receives consulting fees, support to attend meetings, and is involved in patents. All other authors declare having nothing to disclose.

Figures

Figure 1

Summary of study outcomes and the mechanism of the Valvosoft device. Valvosoft device (A): during treatment, the applicator, which contains an imaging ultrasound and an independent therapeutic transducer, is positioned against the patient’s chest, the aortic valve is targeted and imaged using 2-D echo live monitoring (B); the treatment aims to soften the valve tissue, improving leaflet mobility and enabling a wider opening of the valve through delivering precise, focused, high-intensity ultrasound (C), resulting in the formation of cavitation bubbles that implode, creating local shock waves that mechanically fracture the calcification embedded in the aortic valve without damaging the leaflets or surrounding tissue; the representative diffusion-weighted imaging MRI (b = 1000 s/mm²) at baseline (D) and post-procedure (E) shows that the treatment did not result in any new ischaemic lesions; furthermore, the Minimental State Examination values did not decrease at one month (F).