Splitter – a novel device for leaflet modification in transcatheter aortic valve-in-valve implantation procedures

More than 12% of Americans ≥65 years old suffer from aortic stenosis (AS)1. Transcatheter aortic valve (TAV) implantation (TAVI) has become an established treatment for severe AS and is performed in growing numbers of patients. It is estimated that >300,000 TAVI procedures are performed globally each year. Nowadays, low-risk patients who undergo TAVI have a longer life expectancy than the implanted valve’s lifespan. Therefore, more and more valve deterioration cases are expected to be seen, in which redo-TAVI will be required.

A high percentage (35-71%) of patients are unable to undergo a valve-in-valve TAVI procedure due to the high associated risks of sinus sequestration, coronary occlusion, or prevention of future coronary reaccess2. If the orifice of the two coronaries is located behind the leaflets of the aortic valve, there is an immediate risk of obstruction of the blood flow into the coronaries when the cusps of the replaced valve are pushed by the new implant34.

The projection for the next 10 years is for the number of valve-in-valve procedures to increase by 400% (courtesy of P. Généreux, et...