Why the study?
Mechanical leaflet modification was developed to mitigate coronary obstruction during TAVR in degenerated bioprostheses, but its use in native valves had not previously been reported.
Does mechanical leaflet modification prevent coronary obstruction and maintain safety during TAVR in patients with severe native aortic stenosis?
Does mechanical leaflet modification prevent coronary obstruction and maintain safety during TAVR in patients with severe native aortic stenosis?
This first-in-human report demonstrates the technical feasibility and acute safety of mechanical leaflet modification to prevent coronary obstruction during TAVR in patients with native calcific aortic valve disease.
Mechanical LM may be feasible in high-risk native aortic stenosis; leaves open questions on safety and efficacy in larger cohorts.
BACKGROUND: 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. CASE SUMMARY: 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. DISCUSSION: These cases demonstrate the technical feasibility of dedicated mechanical LM in native calcific aortic valve disease. This strategy warrants further clinical investigation. NOVELTY: 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.
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Dvir et al. (2026) studied this question.
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