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(Circulation. 2002;106:725.)
© 2002 American Heart Association, Inc.

Basic Science Reports

Radioactive 133-Xenon Gas-Filled Balloon to Prevent Restenosis

Dosimetry, Efficacy, and Safety Considerations

Marc Apple, MD; Ron Waksman, MD; Rosanna C. Chan, PhD; Yoram Vodovotz, PhD; Jana Fournadjiev, PhD; Bill G. Bass, PhD

From Parkview Radiation Oncology Center (M.A.), Fort Wayne, Ind, and Cardiovascular Research Institute, Division of Cardiology, Washington Hospital Center, Washington, DC.

Correspondence to Ron Waksman, MD, Washington Hospital Center, Cardiovascular Research Institute, 110 Irving St NW, Suite 4B-1, Washington, DC 20010. E-mail ron.waksman{at}medstar.net

Background— Ionizing radiation administered intraluminally via catheter-based systems using solid ß and sources or liquid-filled balloons has shown reduction in the neointima formation after injury in the porcine model. We propose a novel system that uses a 133-Xenon (¹³³Xe) radioactive gas-filled balloon catheter system.

Methods and Results— Overstretch balloon injury was performed in the coronary arteries of 33 domestic pigs. A novel ¹³³Xe radioactive gas–filled balloon (3.5/45 mm) was positioned to overlap the injured segment with margins. After vacuum was obtained in the balloon catheter, 2.5 cc of ¹³³Xe gas was injected to fill the balloon. Doses of 0, 7.5, 15, and 30 Gy were delivered to a distance of 0.25 mm from the balloon surface. The dwell time ranged from 1.0 to 4.0 minutes, depending on the dose. Localization of ¹³³Xe in the balloon was verified by a camera. The average activity in a 3.5/45-mm balloon was measured at 67.7±12.1 mCi, and the total diffusion loss of the injected dose was 0.26% per minute of the injected dose. Bedside radiation exposure measured between 2 and 6 mR/h, and the shallow dose equivalent was calculated as 0.037 mrem per treatment. Histomorphometric analysis at 2 weeks showed inhibition of the intimal area (intimal area corrected for medial fracture length [IA/FL]) in the irradiated segments of 0.26±0.08 with 30 Gy, 0.07±0.24 with 15 Gy, and 0.12±0.89 with 7.5 Gy versus 0.76±0.08 with control P<0.001.

Conclusions— ¹³³Xe gas–filled balloon is feasible and effective in the reduction of neointima formation in the porcine model and safe for use in coronary arteries.

Key Words: restenosis • balloon • catheters