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Balloon Sizing
Bulbous balloon segments and waist segment inflation diameters must be carefully
considered in selecting a particular catheter size for any patient. Initially, the nominal
balloon waist diameter is recommended to be equal to, or smaller than, the aortic
annulus as measured at the base of the leaflets. The corresponding balloon bulbous
segment should be at least 4mm smaller in diameter than the aortic sinus.
Aortic Valve Structure Guideline
If moderate to severe calcium is observed in the subannular/LVOT region, balloon
undersizing or underfilling should be considered.
Increasing the inflation volume or exchanging for a larger balloon size may be
considered if the initial balloon does not produce desired results.
In the event that post-implant balloon dilatation of a bioprosthetic valve is required, refer to
the specific valve manufacturer's instructions for use for instructions on the proper sizing and
use of post-implant balloon dilatation, treating the V8 bulb diameter as equivalent to the
recommended diameter of the post-implant balloon diameter. For example, if a 22mm
diameter balloon is recommended for post implantation dilatation, an equivalent would be a
17mm V8, which has a 22mm bulb at nominal inflation volume. If the V8 bulbous segment
diameter selected is greater than the diameter of the native annulus, the V8 waist should be
centered on the native annulus before inflating. The V8 has been tested only with a
self-expanding valve design. Post-implant V8 balloon dilatation of other types of prosthetic
valve design is currently not recommended.
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