title: The Leaflex™ Catheter System - a viable treatment option alongside valve replacement? Preclinical feasibility of a novel device designed for fracturing aortic valve.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Kaplan Medical Center, Rehovot, Israel.
authors.forename: Michael
authors.initials: M
authors.lastname: Jonas
authors.forename: Yoseph
authors.initials: Y
authors.lastname: Rozenman
authors.forename: Yaron
authors.initials: Y
authors.lastname: Moshkovitz
authors.forename: Ashraf
authors.initials: A
authors.lastname: Hamdan
authors.forename: Yael
authors.initials: Y
authors.lastname: Kislev
authors.forename: Nitzan
authors.initials: N
authors.lastname: Tirosh
authors.forename: Sharon
authors.initials: S
authors.lastname: Sax
authors.forename: Dror
authors.initials: D
authors.lastname: Trumer
authors.forename: Erez
authors.initials: E
authors.lastname: Golan
authors.forename: Ehud
authors.initials: E
authors.lastname: Raanani
mesh_terms: D001021:Aortic Valve / Q000473:pathology* / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002114:Calcinosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D004867:Equipment Design; D006801:Humans; D008953:Models, Anatomic; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000379:methods