First-in-Human Mechanical Leaflet Modification of Native Aortic Stenosis During TAVR

Coronary obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR). Mechanical leaflet modification (LM) has been developed to mitigate this risk in patients with degenerated bioprostheses. However, their use in native valves has not previously been reported.

We report two cases of mechanical LM performed in patients with severe native aortic stenosis at high risk for coronary obstruction during TAVR. In both cases, successful LM was achieved using a dedicated device (ShortCut, Pi-Cardia), followed by TAVR. Imaging validated leaflet split and preserved coronary flow. Post procedure the patients had optimal valve hemodynamics without neurological adverse events.

These cases demonstrate the technical feasibility of dedicated mechanical LM in native calcific aortic valve disease. This strategy warrants further clinical investigation.

This report describes, to our knowledge, the first-in-human application of mechanical LM for native aortic stenosis at risk for coronary obstruction during TAVR.