Biomedical subjects

Raoul Bonan

Publications and source records attributed to Raoul Bonan.

42 records · Page 3Linked to original sources

PubMed2002

Randomized trial of 90Sr/90Y beta-radiation versus placebo control for treatment of in-stent restenosis.

BACKGROUND: After conventional treatment of in-stent restenosis, the incidence of recurrent clinical restenosis may approach 40%. We report the first multicenter, blinded, and randomized trial of intracoronary radiation with the use of a 90Sr/90Y beta-source for the treatment of in-stent restenosis. METHODS AND RESULTS: After successful catheter-based treatment of in-stent restenosis, 476 patients were randomly assigned to receive an intracoronary catheter containing either 90Sr/90Y (n=244) or placebo (n=232) sources. The prescribed dose 2 mm from the center of the source was 18.4 Gy for vessels between 2.70 and 3.35 mm in diameter and 23.0 Gy for vessels between 3.36 and 4.0 mm. The primary end point, ie, clinically driven target-vessel revascularization by 8 months, was observed in 56 (26.8%) of the patients assigned to placebo and 39 (17.0%) of the patients assigned to radiation (P=0.015). The incidence of the composite including death, myocardial infarction, and target-vessel revascularization was observed in 60 (28.7%) of the patients assigned to placebo and 44 (19.1%) of the patients assigned to radiation (P=0.024). Binary 8-month angiographic restenosis (> or =50% diameter stenosis) within the entire segment treated with radiation was reduced from 45.2% in the placebo-treated patients to 28.8% in the 90Sr/90Y-treated patients (P=0.001). Stent thromboses occurred in 1 patient assigned to placebo <24 hours after the procedure and in 1 patient assigned to 90Sr/90Y at day 244. CONCLUSIONS: The results of this study demonstrated that beta-radiation using 90Sr/90Y is both safe and effective for preventing recurrence in patients with in-stent restenosis.

Beta Particles↗

PubMed2002

Two-year angiographic follow-up of intracoronary Sr90 therapy for restenosis prevention after balloon angioplasty.

BACKGROUND: Postcoronary angioplasty vascular brachytherapy (VBT) has emerged as a successful intervention for restenosis prevention in some clinical scenarios. Longer-term follow-up after VBT in de novo nonstented lesions has not been reported. METHODS AND RESULTS: Thirty patients treated with post-percutaneous transluminal coronary angioplasty (PTCA) VBT with Sr90 underwent clinical and angiographic follow-up at 6 and 24 months. Specific vessel segment quantitative coronary angiographic analyses were performed to identify radiation edge effects. Nineteen patients who had not undergone index procedure stenting or target vessel revascularization (TVR) over the 2-year period were analyzed separately. Of the 30 patients, 3 underwent TVR by 6-month follow-up. An additional 4 patients required TVR between 6 and 24 months. In the total cohort of 26 patients undergoing angiographic follow-up at 6 and 24 months, an increase in minimal lumen diameter of the initial target segment was noted at 6 months compared with postprocedure analysis (2.31+/-0.48 versus 2.04+/-0.43 mm, P<0.05). At 24 months, this was no longer significant (2.19+/-0.61 mm). In the proximal segments of the entire cohort and the nonintervened subgroup, the principal late loss occurred over the first 6 months with no additional late loss at 2-year follow-up. The distal segments remained stable over the entire follow-up period. CONCLUSIONS: Although some late failures of post-PTCA VBT are seen between 6 and 24 months, most treated vessels remain stable with no late loss or additional luminal increase beyond the 6-month period. This suggests that late aneurysm formation and significant late edge restenosis are unlikely in VBT after PTCA of de novo lesions for up to 2 years.

Angioplasty, Balloon, Coronary↗

PubMed2002

Clinical and angiographic outcomes after use of 90Strontium/90Yttrium beta radiation for the treatment of in-stent restenosis: results from the Stents and Radiation Therapy 40 (START 40) registry.

PURPOSE: To evaluate the safety and efficacy of a 40-mm 90Strontium/90Yttrium source train in the management of in-stent restenosis within native coronary arteries. MATERIALS AND METHODS: This multicenter, prospective registry was designed to compare the results of patients with in-stent restenosis treated with a 40-mm source train to the placebo arm of the previously reported randomized Stents and Radiation Trial (START). All patients entered in the registry were treated with repeat balloon angioplasty followed by intravascular brachytherapy. Radiation dose was prescribed based on vessel size. 18 Gy was delivered at 2 mm for vessel diameters between 2.75 and 3.35 mm, and 23 Gy was used for vessels between 3.36 and 4.0 mm. The efficacy endpoints for the START 40 registry included a reduction in the target lesion revascularization (TLR) rate, target vessel revascularization rates, and target vessel failure (TVF) at 8 months. Secondary angiographic efficacy endpoints were binary restenosis at 8 months, in-stent minimum luminal diameter (MLD), and late loss. The safety endpoints included major adverse cardiac events as well as late aneurysm formation. The registry was designed to allow a statistically valid comparison of these results to the placebo group of the START 30 trial. Quantitative angiographic analysis was performed on the 8-month follow-up examination. Rates of restenosis were evaluated for various segments of the treated vessel. A separate analysis was performed to evaluate the relationship between vessel injury length and the radiated segment. RESULTS: A total of 207 patients were entered into the START 40 registry. The postprocedure angiographic results, including the postprocedure MLD and percent diameter stenosis, were similar between the START 40 patients and the placebo group from the START trial in the stented segment of the treated vessel. Eight-month angiographic follow-up was available on 150 patients from the registry. The TLR rate was significantly reduced when compared to the placebo group (11% vs. 22.4% respectively, p = 0.008). A similar reduction was seen in terms of target vessel revascularization (15.9% vs. 24.1%, p = 0.03). The 8-month MLD was found to be significantly larger in the START 40 patients (1.85 mm vs. 1.47 mm, p < 0.0001). The difference seen in the clinical endpoint of TVF (19.3% vs. 25.9%) did not reach statistical significance (p = 0.1). Analysis of the procedural angiograms revealed mismatch between the length of vessel injured and the location of the 90% isodose in 46% of the treated cases. Angiographic analysis revealed that geographic miss was associated with a higher rate of binary restenosis (32% vs. 18% p = 0.04) in the analysis segment. CONCLUSIONS: This multicenter registry demonstrates the safety and efficacy of a 40-mm 90Strontium/90Yttrium source train in the management of patients with in-stent restenosis. Restenosis rates were lowered with the use of this longer source train when compared to the placebo arm of the START trial for lesions with a maximum vessel injury length of 20 mm. Angiographic analysis identified the importance of the accurate delineation of injury length and correct source positioning. These results support the continued use of beta radiation for the treatment of this disease process.

Brachytherapy↗

PubMed2002

Transmyocardial coil implants: a novel approach to transmyocardial revascularization.

BACKGROUND: Transmyocardial laser revascularization (TMLR) has potential benefit for patients with end-stage coronary artery disease and intractable angina not amenable to conventional revascularization techniques. Neovascularization has been proposed to occur around the laser channels. Our aim was to determine the feasibility of a novel nonlaser myocardial revascularization technique and its effect on angiogenesis in a nonischemic porcine model. METHODS: In the first phase, six transmyocardial stainless steel coil implants (TMI) were deployed to the lateral wall of the left ventricle in each of 6 pigs. The animals were sacrificed at 8 and 12 weeks, with a single animal dying prematurely at 4 weeks, and the myocardium was assessed for new vessel growth. In the second phase, 8 implants were deployed in each of 12 pigs with regular fluoroscopic follow-up until sacrifice at 2 weeks to assess implant stability. RESULTS: The deployment procedure was safe and feasible with no complications evident. A significant increase in new vessels at implant sites with 5.43 +/- 3.67, 4.97 +/- 2.44, and 3.57 +/- 2.29 seen per high power field at 12, 8, and 4 weeks, respectively, compared to 1.00 +/- 1.06 (p < 0.0001) in control myocardium. There was no evidence of implant migration in Phase 2. CONCLUSIONS: TMIs can feasibly be deployed in the nonischemic pig model with a high success rate. The presence of angiogenesis at the implant site and the maintenance of this reaction for 3 months implies that TMI may offer an alternative to TMLR while providing a platform for delivery of angiogenic factors.

Animals↗

PubMed2002

Cutting and stenting in a heavily calcified left anterior descending artery lesion.

The significance of heavily calcified proximal left anterior descending coronary artery stenosis in a 57-year-old man was assessed physiologically using a Doppler flow wire. Intravascular ultrasound guidance allowed for adequate dilatation with a cutting balloon and optimization of stent deployment. The cutting balloon offers an effective alternative in this challenging scenario.

Arteries↗

PubMedDate not supplied

Dosimetry for an Sr90/Y90 source train used for intravascular radiation of a hemodialysis graft.

OBJECTIVE: Vascular access for hemodialysis is often achieved with an arterial-venous graft (AVG). Brachytherapy is being explored for prevention of stenosis within these grafts. The objective was to develop treatment planning (TP) capability for dialysis implants. MATERIALS AND METHODS: Fluoroscopic images are used to identify position of sources and irradiated vessel. An Sr(90)/Y(90) beta source, jacketed in a CO(2)-filled balloon, is used to irradiate the AVG. A single-seed Sr(90) dose kernel was generated using Monte Carlo. The single-seed dose kernel was employed to calculate the dose surrounding the implant accounting for the path length of the beta particles through the gas-filled balloon. RESULTS: Dose distributions are displayed superimposed on the fluoroscopic image of the AVG. Dose-area histograms were also generated. CONCLUSION: TP for dialysis implants can be performed using radiographic localization of the graft. The TP tools could be used to correlate clinical outcome with dose delivery.

Algorithms↗