This article evaluates a new compliant balloon catheter for sizing of Atria
l Septal Defects (ASDs) in vitro and in vivo using X-ray and echo measureme
nts. A phantom consisting of a plastic plate with 17 circular holes varying
from 8 to 30 mm was used to determine the accuracy of the measurements. Th
e catheter has a 7 Fr shaft with a double lumen. The balloon is made from a
0.002 " plastic membrane. Four platinum marker bands on the shaft of the c
atheter allow radiographic measurements. The balloon catheter was placed th
rough Various holes of the phantom and inflated with 38% contrast medium. X
-ray measurement by video and cine recording were performed and compared wi
th the true measurement of the model. The study was carried out in a double
blind fashion. For echo measurements, the plastic model was immersed in a
water bath. The balloon was inflated with water and measured in a long-axis
view. The actual diameters were compared with the measurements obtained by
video, cine, and echo recordings. One young pig with a surgically created
ASD was used for in vivo measurement. The balloon catheter was passed throu
gh the ASD over an exchange wire, inflated with diluted contrast medium unt
il a waist was observed, which was measured by video and cine techniques. T
he animal was euthanized, and the defect was measured by a tapered measurin
g probe. The difference between the actual size and measurements obtained b
y video recordings was 0.54 +/- 0.30 mm, by cine 0.62 +/- 0.20mm, and by ec
ho measurements 0.60 +/- 0.43 mm. All measurements were less than 1 mm in e
rror except for four measurements (<1.5 mm). A strong correlation was prese
nt between each two groups (r = 0.99, P < 0.0001), In the in vivo study, th
e size of the video and cine recordings (14.2 and 13.9 mm, respectively) we
re very closer to the actual size (14 mm) as measured by a probe in the pos
tmortem specimen. The new balloon catheter provides a more rapid and precis
e determination of the stretched diameter of atrial septal defects. It elim
inates the error of pulling a catheter through the communication. This new
technique should be of benefit to all investigators using septal occlusion
devices and will facilitate the selection of the properly sized Amplatzer s
eptal occluder. (C) 1999 Wiley-Liss, Inc.