Crimping may affect the durability of transcatheter valves: an experimental analysis.

Abstract

BACKGROUND: Transcatheter aortic valve implantation has gained widespread acceptance to treat elderly high-risk patients with aortic stenosis. We used a subcutaneous rat model to evaluate whether crimping may affect valve long-term durability. METHODS: Standard Sapien transcatheter valves (Edwards Lifesciences, Irvine, CA) were crimped for different durations (1 hour, 1 day, 1 month) and uncrimped, and leaflet pieces as well as control tissue (Perimount Magna, Edwards) were then implanted subcutaneously in 15 male weanling Sprague-Dawley rats for 12 weeks. Grade of calcification was measured by freeze-dried mass and van Kossa staining. Histologic and electron microscopic examination were performed to investigate potential leaflet-fragmentation caused by crimping. RESULTS: There were no differences in calcification among the groups. The calcium carbonate concentrations in all samples ranged from 0.1 to 100 mg/g dry weight. Leaflet morphology, however, differed from no fragmentation (control group) to highly fragmented tissue (1-month crimped). These differences reached statistical significance between crimped and non-crimped leaflets (p<0.003). CONCLUSIONS: Transcatheter valve crimping does not necessarily affect leaflet calcification. However, the structural changes of the leaflets that were caused by crimping may have clinical significance. Duration of crimping should be as short as possible, and very tight crimping to small diameters should be avoided.