Circulation, Vol 80, 1029-1040, Copyright © 1989 by American Heart Association
IJ Sarembock, PJ LaVeau, SL Sigal, I Timms, J Sussman, C Haudenschild and MD Ezekowitz
To evaluate the effect of balloon size and inflation pressure on acute and
subsequent outcome following balloon angioplasty (BA), 70 New Zealand White
rabbits with bilateral femoral atherosclerosis were assigned to four
groups: group 1, oversized balloon, low inflation pressure (n = 35 vessels;
balloon size, 3.0 mm/inflation pressure, 5 atm); group 2, oversized
balloon, high inflation pressure (n = 36; 3.0 mm/10 atm); group 3,
appropriate size, low inflation pressure (n = 17; 2.5 mm/5 atm); and group
4, appropriate size balloon, high inflation pressure (n = 19; 2.5 mm/10
atm). Angiograms were obtained before, 10 minutes after, and 28 days after
BA and read by two blinded observers using electronic calipers. The in vivo
balloon-to-vessel ratio was measured for each group. There were eight
non-BA controls. Rabbits were sacrificed either immediately (n = 34) or at
28 days after BA (n = 36), with the femoral vessels pressure perfused for
histologic and morphometric analysis. The latter was performed at 28 days
only. Absolute angiographic diameters increased in all groups immediately
after BA (p less than 0.01). Acute angiographic success, defined as greater
than 20% increase in luminal diameter, was higher using high inflation
pressure (group 2, 32/36 [89%] and group 4, 16/19 [84%] vs. group 1, 23/35
[66%] and group 3, 9/17 [53%]; p less than 0.05). A 3.0- mm balloon
resulted in significant oversizing irrespective of inflation pressure
(balloon-to-vessel ratio, 1.5 +/- 0.1 vs. 1.1 +/- 0.1 to 1, for the 2.5-mm
balloon). Vessels exposed to high inflation pressure had a significantly
higher incidence of mural thrombus, dissection (p less than 0.01), and
medial necrosis versus low pressure (p less than 0.05). At 28 days, the
rates of restenosis (defined as greater than 50% loss of initial gain) were
14/20 (70%), 11/16 (69%), 5/10 (50%), and 5/10 (50%) for groups 1 through 4
(p = NS; a trend in favor of the groups using an oversized balloon). There
was an increase in the degree of intimal hyperplasia by morphometric
analysis in all groups, being most marked in group 2 (oversized balloon and
high inflation pressure, 1.7 +/- 0.9 vs. 0.5 +/- 0.2 mm for controls, p
less than 0.001). We reached two conclusions. First, all protocols resulted
in a significant increase in luminal diameter immediately after angioplasty
with the highest success rate in vessels subjected to high pressure
dilatation.(ABSTRACT TRUNCATED AT 400 WORDS)
ARTICLES
Influence of inflation pressure and balloon size on the development of intimal hyperplasia after balloon angioplasty. A study in the atherosclerotic rabbit
Yale University School of Medicine, Department of Medicin, New Haven, Ct. 06510.
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