The Leaflex™ Catheter System - A viable treatment option alongside valve replacement? Preclinical feasibility of a novel device designed for fracturing aortic valve calcification

Michael Jonas, Yoseph Rozenman, Yaron Moshkovitz, Ashraf Hamdan, Yael Kislev, Nitzan Tirosh, Sharon Sax*, Dror Trumer, Erez Golan, Ehud Raanani

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

Aims: To demonstrate the feasibility of the Leaflex™ Catheter System, a novel percutaneous device for fracturing valve calcification using mechanical impact in order to regain leaflet mobility. Methods and results: Radiographic analysis of calcium patterns in 90 ex vivo human aortic valve leaflets demonstrated that 82% of leaflets had a typical "bridge" or "half-bridge" pattern, which formed the basis for the catheter design. The therapeutic effect was quantified in 13 leaflets showing a reduction of 49±16% in leaflet resistance to folding after treatment. A pulsatile flow simulator was then used with 11 ex vivo valves demonstrating an increase in aortic valve area of 35±12%. Using gross pathology and histology on fresh calcified leaflets, we then verified that mechanical impacts do not entail excessive risk of embolisation. In vivo safety and usability were then confirmed in the ovine model. Conclusions: We demonstrated preclinically that it is feasible to improve valve function using the Leaflex™ technology. Once demonstrated clinically, such an approach may have an important role as preparation for or bridging to TAVI, as destination treatment for patients where TAVI is clinically or economically questionable and, in the future, maybe even as a means to slow disease progression in asymptomatic patients.

Original languageEnglish
Pages (from-to)582-590
Number of pages9
JournalEuroIntervention
Volume11
Issue number5
DOIs
StatePublished - 1 Sep 2015
Externally publishedYes

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