Key result
Treatment with the Leaflex Catheter System reduced leaflet resistance to folding by 49±16% and increased aortic valve area by 35±12% in ex vivo models, with in vivo safety confirmed in sheep.
Why the study?
Does the Leaflex Catheter System improve valve function in ex vivo calcified human aortic valves and demonstrate safety in an in vivo ovine model?
Does the Leaflex Catheter System improve valve function in ex vivo calcified human aortic valves and demonstrate safety in an in vivo ovine model?
The Leaflex Catheter System demonstrates preclinical feasibility in improving aortic valve function by fracturing calcification, suggesting potential as a standalone or bridging therapy for aortic stenosis.
Early feasibility supports device iteration for aortic stenosis; prospective in-human trials needed before clinical consideration.
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.
No takes yet. Share an insight, caveat, or question.
Jonas et al. (2015) studied Aortic valve calcification (n=90). Leaflex Catheter System was evaluated on Leaflet resistance to folding and aortic valve area. Treatment with the Leaflex Catheter System reduced leaflet resistance to folding by 49±16% and increased aortic valve area by 35±12% in ex vivo models, with in vivo safety confirmed in sheep.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: