@platinumstandard, thanks for explaining. I had missed the link...

@platinumstandard, thanks for explaining. I had missed the link to the full publication which comprehensively answered these questions.

https://api.eurointervention.com/v1/articles/17355/download/pdf

My last sentence wasn’t meant to be funny… I was recalling that some procedures were done surgically but may have been thinking back to the animal trials. For the FIH study it appears that the first 5 patients were tested with a modified procedure: “The first cohort of five (5) patients enrolled in November The first cohort of five (5) patients enrolled in November 2021 underwent TAVI procedure with direct aortic approach. 2021 underwent TAVI procedure with direct aortic approach.”

There is some more detail about the other complications, too: “Several challenging anatomies were treated in this FIH study, including patients with severe annular calcium, extreme leaflet calcium, type 1 bicuspid, and severe left ventricular outflow tract (LVOT) calcium”

As you say, the sort of things that go with the territory.

cheers,

exee