strontium-radioisotopes and Graft-Occlusion--Vascular

Topics: Angioplasty, Balloon, Coronary; Beta Particles; Blood Platelets; Brachytherapy; CD40 Ligand; Clopidogrel; Coronary Restenosis; Coronary Thrombosis; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Platelet Activation; Platelet Aggregation Inhibitors; Platelet Membrane Glycoprotein IIb; Prospective Studies; Stents; Strontium Radioisotopes; Ticlopidine; Yttrium Radioisotopes

Treatment of in-stent restenosis using intravascular brachytherapy (IVBT) has been demonstrated to be successful and has become the standard of care for native coronary artery disease. Based on the current Food and Drug Administration (FDA) indications for use and the clinical demand to increase the scope of this form of therapy to include saphenous vein grafts for the Beta-Cath System (Novoste Corporation, Norcross, Georgia), we set out to obtain institutional approval for off-label use. Identification of institutional regulatory bodies and related procedures for obtaining off-label device use was performed. Additionally, the IVBT written directive proscription and patient informed consent forms were revised to accurately administer radiation dose and to disclose the regulatory status of using IVBT for this anatomic site. While the specifics are outlined in this report, this process and the resources needed to obtain institutional approval for off-label use are indicative of that to be expected at similar institutions.

Topics: Blood Vessel Prosthesis Implantation; Brachytherapy; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Informed Consent; Radiopharmaceuticals; Risk Management; Saphenous Vein; Stents; Strontium Radioisotopes; Treatment Outcome

The aim of this study was to investigate the time course of angiographic restenosis rate and late loss after successful percutaneous coronary intervention and vascular brachytherapy with beta-irradiation using strontium-90/yttrium-90 in 98 patients who were prospectively enrolled into a quantitative angiographic and clinical follow-up protocol at 6, 12, and 24 months after the index procedure, regardless of their symptom status. Actuarial restenosis rates measured 11.2 +/- 5% at 6 months of follow-up, 24.5 +/- 5% at 12 months, and 28.5 +/- 6% at 24 months, respectively. Late loss of the stent segment during the first 6 months measured 0.38 +/- 0.40 mm (6 to 12 months: 0.25 +/- 0.38 mm; 12 to 24 months: 0.16 +/- 0.32 mm), of the injured segment 0.27 +/- 0.21 mm (6 to 12 months: 0.21 +/- 0.26 mm; 12 to 24 months: 0.13 +/- 0.24 mm), of the irradiated segment 0.18 +/- 0.29 mm (6 to 12 months: 0.19 +/- 0.31 mm; 12 to 24 months: 0.11 +/- 0.27 mm), and of the analysis segment 0.18 +/- 0.36 mm (6 to 12 months: 0.17 +/- 0.29 mm; 12 to 24 months: 0.11 +/- 0.20 mm). Restenosis after angioplasty and beta-irradiation of in-stent restenotic lesions is not complete within 6 months but is sustained with a gradual decrease over 24 months.

Topics: Actuarial Analysis; Aged; Brachytherapy; Coronary Angiography; Endothelium, Vascular; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Prospective Studies; Recurrence; Strontium Radioisotopes; Time Factors; Yttrium Radioisotopes

Beta irradiation has recently been investigated as a possible technique for the prevention of restenosis in intravascular brachytherapy after balloon dilatation or stent implantation. Present methods of beta radiation dosimetry are primarily conducted using radiochromic film. These film dosimeters exhibit limited sensitivity and their characteristics differ from those of tissue, therefore the dose measurement readings require correction factors to be applied. In this work a novel, mini-size (2 mm diameter by 5 mm long) dosimeter element fabricated from Organic Plastic Scintillator (OPS) material was employed. Scintillation photon detection is accomplished using a precision photodiode and innovative signal amplification and processing techniques, rather than traditional photomultiplier tube methods. A significant improvement in signal to noise ratio, dynamic range and stability is achieved using this set-up. In addition, use of the non-saturating organic plastic scintillator material as the detector enables the dosimeter to measure beta radiation at very close distances to the source. In this work the plastic scintillators have been used to measure beta radiation dose at distances of less than 1 mm from an Sr-90 cardiovascular brachytherapy source having an activity of about 2.1 GBq beta radiation levels for both depth-distance and longitudinal profile of the source pellet chain, both in air and in liquid water, are measured using this system. The data obtained is compared with results from Monte Carlo simulation technique (MCNP 4B). Plastic scintillator dosimeter elements, when used in conjunction with photodiode detectors may prove to be useful dosimeters for cardiovascular brachytherapy beta sources, or other applications where precise near-source field dosimetry is required. The system described is particularly useful where measurement of actual dose rate in real time, a high level of stability and repeatability, portability, and immediate access to results are prime requirements.

Topics: Beta Particles; Blood Vessels; Brachytherapy; Electronics, Medical; Equipment Design; Equipment Failure Analysis; Graft Occlusion, Vascular; Plastics; Polymethyl Methacrylate; Radiometry; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Radiotherapy, Computer-Assisted; Reproducibility of Results; Scintillation Counting; Sensitivity and Specificity; Strontium Radioisotopes; Transducers

The radiation treatment of catheter-based beta-emitter sources is being used to prevent restenosis following interventional coronary procedures. We present the results of a Monte Carlo calculation study to assess the dosimetric impact in the vessel tissue due to the presence of the stent. A catheter-based beta-emitter system is modeled using the Monte-Carlo code MCNP4B. Dose distributions are calculated in annular voxels (0.050 x 0.025 mm2 section) along the axis of a 40 mm. 90Sr/90Y source with and without the stent (at a distance of 1.5-3.0 mm from the longitudinal axis of the source). The main results include: (a) a clear difference between the local perturbation just behind the strut and a more general perturbation seen deeper into the vessel tissue; (b) the local perturbations disappears at a depth of 300-400 microm while the more general perturbation affects the tissue in its full thickness including the prescription point; (c) in the local perturbation the maximum impact is determined mainly by the material and the thickness of the strut while the spatial attenuation of this impact is defined mainly by the strut width; (d) in the general perturbation, the most important magnitude is the free-area ratio for the path of the electrons, being the material characteristics and strut thickness of secondary importance; (e) analytical expressions are presented to estimate the magnitude of this perturbation according to the complete characteristics of the expanded strut, i.e., thickness, free-area ratio, and material; and (f) a simple algorithm is presented for estimating the free-area ratio when this information is not available.

Topics: Algorithms; Artifacts; Blood Vessel Prosthesis; Blood Vessels; Brachytherapy; Computer Simulation; Graft Occlusion, Vascular; Humans; Models, Cardiovascular; Models, Statistical; Monte Carlo Method; Radiometry; Radiopharmaceuticals; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Relative Biological Effectiveness; Risk Assessment; Risk Factors; Scattering, Radiation; Stents; Strontium Radioisotopes; Yttrium Radioisotopes

Symptomatic coronary artery disease is routinely treated with angioplasty and stenting. Unfortunately, treatment failure in the form of in-stent restenosis (ISR) occurs relatively frequently. Intravascular brachytherapy (IVBT) is a safe and effective method proven to markedly reduce the rate of ISR in native coronary arteries. The commercially available devices for IVBT are not FDA-approved for treatment of saphenous vein grafts (SVG). This article presents calculated dosimetry for treatment of a wide range of SVG, in addition to further evaluating the dose homogeneity for native coronary arteries.. AAPM Task Group 43 and 60 formalisms permitted dose calculations for a wide range of vessel internal diameters (phi) in both native coronary arteries and SVG. Doses were analytically calculated for the Novoste Beta-Cath 5.0 French (F) treatment devices (30, 40, and 60 mm sourcetrains) when employed for the treatment of native vessels with 2.7

Topics: Brachytherapy; Catheterization; Graft Occlusion, Vascular; Saphenous Vein; Strontium Radioisotopes

This work presents a quantitative dosimetric analysis of the Novoste (90)Sr/(90)Y beta-source cardiovascular brachytherapy treatments using a manual pullback technique for patients with in-stent restenosis.. Based on our previous measurements, a model was developed to estimate the dose in the middle of the junction region for tandem irradiation expressed as fraction of prescription dose (FPD) and dosimetric overlap length (DOL) receiving more/less than a threshold dose. The overlap/gap size was measured using the digital cine images recorded during treatment and then FPD and DOL were quantified.. Statistical analysis of 55 patients showed that the overlap size and the FPD at 2 mm radial distance were in range of 0 to 23 mm and 13-200% of prescription dose (Rx), respectively. Four gaps out of 76 pullback cases were found, but their size was at most 5 mm.. Use of a 5 mm overlap avoided underdosed regions in the vast majority of the cases. These results are the first step towards an analysis of the clinical outcome of these patients.

Topics: Brachytherapy; Coronary Artery Bypass; Coronary Stenosis; Dose Fractionation, Radiation; Graft Occlusion, Vascular; Humans; Iridium Radioisotopes; Radiography; Radiometry; Radiotherapy, Computer-Assisted; Reproducibility of Results; Retrospective Studies; Strontium Radioisotopes