TY - JOUR
T1 - The Leaflex™ Catheter System - A viable treatment option alongside valve replacement? Preclinical feasibility of a novel device designed for fracturing aortic valve calcification
AU - Jonas, Michael
AU - Rozenman, Yoseph
AU - Moshkovitz, Yaron
AU - Hamdan, Ashraf
AU - Kislev, Yael
AU - Tirosh, Nitzan
AU - Sax, Sharon
AU - Trumer, Dror
AU - Golan, Erez
AU - Raanani, Ehud
N1 - Publisher Copyright:
© Europa Digital & Publishing 2015. All rights reserved.
PY - 2015/9/1
Y1 - 2015/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84943763972&partnerID=8YFLogxK
U2 - 10.4244/EIJY14M11_10
DO - 10.4244/EIJY14M11_10
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C2 - 25420790
AN - SCOPUS:84943763972
SN - 1774-024X
VL - 11
SP - 582
EP - 590
JO - EuroIntervention
JF - EuroIntervention
IS - 5
ER -