Michael Schwager

Feasibility of intracoronary β-irradiation to reduce restenosis after balloon angioplasty: a clinical pilot study

Background With the aim of decreasing the incidence of restenosis after coronary balloon angioplasty, we developed a technique of intracoronary β-irradiation using an endoluminally centered pure metallic 90Y source. The purpose of the present study was to evaluate the clinical feasibility and safety profile of this approach with a dose of 18 Gy delivered to the inner arterial surface. Methods and Results Between June 21 and November 15, 1995, fifteen patients (6 women and 9 men; mean age, 71±5 years) underwent intracoronary β-irradiation immediately after a conventional percutaneous transluminal coronary angioplasty (PTCA) procedure. The PTCA/irradiation procedure was technically feasible in all attempted cases, and the delivery of the 18 Gy dose was accomplished without complications. In 4 patients, the intervention was completed through intra-arterial stent implantation because of dissection induced by the initial PTCA. During the follow-up period of 178±17 days (range, 150 to 225 days), no complication...

High dose rate brachytherapy for prevention of restenosis after percutaneous transluminal coronary angioplasty: preliminary dosimetric tests of a new source presentation

PURPOSE Balloon dilatation of coronary artery stenosis has become a standard treatment of atherosclerotic heart disease. Restenosis due to excessive intimal cell proliferation, which subsequently occurs in 20-50% of patients, represents one of the major clinical problems in contemporary cardiology, and no satisfactory method for its prevention has thus far been found. Because modest doses of radiation have proved effective in preventing certain types of abnormal cellular proliferation resulting from surgical trauma, and brachytherapy has already been used successfully after dilation of peripheral arteries, development of a radioactive source suitable for coronary artery applications would be of great interest. METHODS AND MATERIALS Nonradioactive flexible yttrium-89 wires (diameter of 0.15 and 0.26 mm) were activated within the thermal neutron flux of an experimental reactor. Standard angioplasty balloons (2 cm long, 2.5 mm in diameter when inflated) were inserted for dosimetry into a specially manufactured tissue equivalent phantom. Four wells, drilled perpendicular to the axis of the balloon, allowed for the insertion of thermal luminescent dosimeters (TLDs; 2 mm of diameter) and spacers. The angioplasty balloon was inflated with air or with contrast media. Radioactive yttrium-90 wires were left in the central lumen of the balloon for 2 min. Doses at the surface of the balloon, and at 1, 2, and 3 mm were determined from TLD readings. RESULTS Doses obtained at the surface of the balloon, for a 2-min exposure for the 0.26 mm wire (balloon inflated with air) and the 0.15 mm wire (air or contrast), were 56.5 Gy, 17.8 Gy, 5.4 Gy, respectively. As expected for a beta emitter, the fall-off in dose as a function of depth was rapid. External irradiation from the beta source was negligible. CONCLUSIONS Our experiments indicate that the dose rates attainable at the surface of the angioplasty balloon using this technique allow the doses necessary for the inhibition of intimal cell proliferation to be reached within a relatively short period of time. The thin yttrium-90 wires are very easy to handle, and their mechanical and radioactive properties are well suited to the requirements of the catheterization procedure.

A novel system for intracoronary β-irradiation: Description and dosimetric results

PURPOSE A dosimetric evaluation of a new device dedicated to intravascular irradiation, associating a beta source and a centering device, was carried out before initiation of a clinical pilot study. METHODS AND MATERIALS A 29-mm-long 90Y coil, coated with titanium and fixed to the end of a thrust wire, was introduced into the inner lumen of purpose-built centering balloons of different diameters (2.5, 3, 3.5, and 4 mm). Dose homogeneity was evaluated by studying both axial and circumferential dose variations, based on readings from thermoluminescent dosimeters (TLDs) placed on the balloon surface. Axial homogeneity was determined by comparing the readout values of dosimeters located on peripheral balloon segments with those located on segments adjacent to the midpoint of the source. The centering ability of the device was studied by comparing measurements on opposing surfaces of the balloon. The dose attenuation by water and contrast medium was evaluated and compared with that in air. The balloon contamination was studied using a contamination counter. The total 90Y coil activity was measured by liquid scintillation to relate activity to surface dose. RESULTS Activity-surface dose correlation showed that for a linear coil activity of 1 mCi/mm, the mean dose rate at the surface of a 2.5-mm balloon filled with contrast medium was 8.29 Gy/min. The doses at the surface of larger balloons (3, 3.5, and 4 mm) filled with contrast were 78%, 59%, and 47%, respectively, of the dose measured at the surface of the 2.5-mm balloon. The coefficient of variation (CV) in surface dose for 2.5-, 3-, 3.5-, and 4-mm centering devices filled with contrast medium were 9%, 8%, 9%, and 12%, respectively. There was no statistically significant difference between readouts from central and peripheral balloon segments or among rows of dosimeters facing each other. For a 2.5-mm balloon, compared with air the dose attenuation by water and contrast medium was similar (0.70 and 0.69, respectively), but a significant difference was seen between the readouts of water- and contrast-filled balloons when the diameter was larger than 3 mm (p < 0.001). No contamination was found in the balloon shaft after source retrieval. CONCLUSION The dosimetric tests showed very good surface dose homogeneity, demonstrating satisfactory centering of the source within the centering balloons. The achievable dose rates will permit intravascular irradiation within a short time interval. The absence of residual balloon contamination after source retrieval meets the requirements for a sealed source used in a clinical setting.