Heart 1999;81:206-211 ( February )
In vitro validation of the luminal measurement of a novel catheter based moulding technique
a Department of
Cardiology, Queen Elizabeth Hospital, Edgbaston, Birmingham B15, UK, b University Department of Cardiovascular
Medicine, University of Birmingham, Birmingham, UK
Correspondence to: Dr Eccleshall.
Accepted for publication 5 October 1998
Objective
To
investigate a modified angioplasty balloon catheter, which uses a
novel balloon polymer to produce luminal moulds.
DesignThe catheter
was tested in polyurethane phantoms of diameter 1.5 to 4.0 mm.
Inflations were to 1.4 atmospheres for 20 seconds at 37°C. The moulds
were viewed by reinflating the balloon to 0.34 atmospheres and
quantified using macrophotography and caliper measurement.
ResultsEvidence of
systematic error was found with lumen diameters 
2.0 mm, accuracy
being 0.32 to 0.80 mm and precision 0.23 to 0.24 mm. However, between
2.5 and 4.0 mm the accuracy of measuring luminal diameters was 0.01 mm,
the precision 0.06 mm, and the absolute mean error 0.05 mm. The results
for percentage diameter stenosis were 
1.15%, 0.86%, and 1.21%,
and for lesion length they were 0.20, 0.60, and 0.41 mm, respectively.
ConclusionsThe
prototype catheter shows a high degree of accuracy and precision in
phantoms of diameter 2.5 to 4.0 mmthe range within which most
interventional work is performed. Further work on this technique as a
method of direct three dimensional moulding of the coronary artery
lumen is warranted.
© 1999 by Heart
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