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Balloon Sizing for Post TAVR Dilatation
Bulbous balloon segments and waist segment inflation diameters must be carefully considered
in selecting a particular catheter size for any patient. 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.
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.
1204-001 Revision C.2
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