(Circulation. 1995;92:2463-2472.)
© 1995 American Heart Association, Inc.
Articles |
From the Cardiac Catheterization Laboratory and Intracoronary Imaging Laboratory, Thoraxcenter, University Hospital Dijkzigt, Rotterdam, Netherlands.
Correspondence to P.W. Serruys, MD, PhD, Catheterization Laboratory, Thoraxcenter Room Bd 416, University Hospital Dijkzigt, Erasmus University Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, Netherlands.
Background Inefficacy of systemic drug administration for restenosis prevention may partially relate to insufficient local drug concentration. This study aimed to evaluate the acute feasibility and long-term outcome of using an infusion-perfusion coil balloon, Dispatch.
Methods and Results In 22 patients after balloon angioplasty, the
coil balloon was studied for (1) feasibility of local heparin delivery,
(2) symptoms and signs of ischemia during prolonged deployment
compared with angioplasty balloon occlusion, (3) coronary
pressure and flow distal to the inflated device, and (4) long-term
clinical and angiographic results. During prolonged
intracoronary deployment of the coil balloon (29±8
minutes), 5 of 22 patients developed mild chest pain versus 20 of 22
during angioplasty (275±283 seconds). Neither
hemodynamic nor vectorcardiographic signs of
ischemia were detected, in contrast to angioplasty balloon
occlusion. Baseline flow across the coil balloon was 44±31 mL/min,
increasing by a factor of 1.8±0.7 during pharmacologically induced
hyperemia. A mean volume of 14.2±6.1 mL containing 1416±608
IU of heparin was infused locally at a pressure of 122±54 mm Hg. At
7±1-month follow-up, 1 asymptomatic patient had
died, and of the remaining 21, 17 (81%) were
asymptomatic. Angiographic follow-up was obtained
in 15 of 21 patients (71%), including all 4 symptomatic
patients. Mean minimal luminal diameter after the procedure was
2.16±0.49 mm and at follow-up, 1.89±0.45 mm, which corresponds
to
a restenosis rate (diameter stenosis
50%) of 7%
(1/15).
Conclusions Intracoronary use of the coil balloon after balloon angioplasty proved to be feasible and subjectively as well as objectively well tolerated during prolonged deployment by virtue of its perfusion properties. High volumes of heparin solution can be infused locally at very low pressure. No unfavorable clinical or angiographic long-term effects were observed.
Key Words: angioplasty heparin restenosis hemodynamics perfusion
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