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European Heart Journal 2000 21(24):2056-2062; doi:10.1053/euhj.2000.2467
Copyright © 2000 by the European Society of Cardiology.
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A novel balloon angioplasty catheter impregnated with beta-particle emitting radioisotopes for vascular brachytherapy to prevent restenosis. First in vivo results

C Hehrleina,f1, A Kovacsb, G.K Wolfb, N Yuec and R Nathc

a Department of Cardiology, University of Freiburg and Heidelburg, Germany
b Department of Radiochemistry, University of Freiburg and Heidelburg, Germany
c Department of Therapeutic Radiology, Yale University, New Haven, CT, U.S.A.

revised September 11, 2000; accepted September 18, 2000

Abstract

Background According to early clinical trials, vascular brachytherapy performed prior to or shortly after angioplasty is very effective in reducing restenosis rates. The purpose of this study was to investigate the effects of a novel radioactive catheter that allows simultaneous balloon angioplasty and beta-particle irradiation in the prevention of restenosis.

Material and Methods The balloon surface of an angioplasty catheter was impregnated with the radioisotope32P. Dosimetry calculations using a Monte Carlo method were performed at a radial distance of 0·2mm from the balloon surface. Rabbit iliac arteries were dilated and simultaneously irradiated with a dose of 20Gy delivered to the adventitia. Control arteries were only dilated and not irradiated. Neointimal areas, cell numbers and the perimeter of the arteries were measured by histomorphometry after 6 weeks.

Results Neointima formation was reduced after balloon dilatation and simultaneous beta-particle irradiation using the32P impregnated angioplasty catheter as compared to balloon dilatation alone with a non-impregnated catheter (0·09±0·06 vs 0·27±0·09mm2neointimal area and 168±45 vs 360±133 cells/0·05mm2neointima, P<0·001 vs control, respectively). In addition, balloon dilatation with the32P impregnated angioplasty catheter increased the vessel perimeter as compared to balloon dilatation with a non-impregnated catheter (4·7±0·2 vs 3·9±0·3mm, P<0·001 vs control).

Conclusions Simultaneous balloon dilatation and vascular brachytherapy with a novel32P impregnated angioplasty catheter markedly reduces restenosis in vivo by preventing neointimal hyperplasia and constrictive vascular remodelling.

Key Words: Balloon angioplasty, constrictive remodelling, neointimal hyperplasia, radioisotopes, radiotherapy, restenosis

f1 Correspondence: Christoph Hehrlein, MD, Abteilung für Kardiologie und Angiologie, Medizinische Universitätsklinik III, Hugstetterstr. 55, 79106 Freiburg i. Br., Germany.


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