Aortic valve: The new challenge for interventional cardiology!
Explore the source record for details and available documents.
Aortic Valve Stenosis↗
Biomedical subjects
Raoul Bonan
Publications and source records attributed to Raoul Bonan.
Reduced pulmonary clearance of endothelin in congestive heart failure: a marker of secondary pulmonary hypertension.
BACKGROUND: Endothelin-1 (ET-1) levels are elevated in congestive heart failure (CHF) in relation with the severity of pulmonary hypertension. We evaluated whether a reduced pulmonary ET-1 clearance could contribute to this elevation. METHODS AND RESULTS: We determined pulmonary ET-1 clearance in 24 patients with CHF in relation with hemodynamics, plasma ET-1, and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. Pulmonary ET-1 extraction, measured by the single bolus indicator-dilution technique, was reduced to 32 +/- 14% in comparison to historic controls (47 +/- 7%). Plasma ET-1 clearance by the lungs (924 +/- 588 mL/min) was also much lower than in controls (1424 +/- 79 mL/min). Clearance correlated inversely with mean pulmonary artery pressure (PAP, r = -.47, P = .017) and pulmonary capillary wedge pressure (r = -.47, P = .017) and positively with the rate of left ventricular (LV) relaxation LV -dP/dt (r = .593, P = .004). After multivariate analysis, only mean PAP and LV -dP/dt were independently correlated with ET-1 clearance (r = -.40, P = .03, and r = .55, P = .005, respectively). Plasma ET-1 levels did not correlate with clearance (r = .038, P = .86), and there was no significant arteriovenous ET-1 gradient. There was a mild nonsignificant correlation between plasma ET-1 and pulmonary artery systolic pressure (r = .38, P = .06), but a strong correlation with right atrial pressure (r = .696, P < .0001) and NT-proBNP levels (r = .51, P = .001), which were maintained after multivariate linear regression (r = .60, P = .001, and r = .32, P = .04, respectively). CONCLUSION: Pulmonary ET-1 clearance is reduced in CHF in relation with the severity of pulmonary hypertension. This reduced clearance does not significantly modulate plasma ET-1 levels. Whether this is only a marker of secondary pulmonary hypertension or could modulate pulmonary vascular tone will require further studies.
Adult↗
Incidence of stent under-deployment as a cause of in-stent restenosis in long stents.
Although stent under-deployment (SU) has been associated with increased risk of in-stent restenosis, little data have been reported on the incidence of SU in patients presenting with clinical in-stent restenosis. In 59 patients referred for vascular brachytherapy and showing angiographic in-stent restenosis, we sought (1) to determine the incidence of SU using standard intravascular ultrasound (IVUS) criteria (2) to evaluate the effects of repeat angioplasty on further stent expansion. Stented length was 32+/-17 mm and diameter stenosis was 75+/-14%. Before re-intervention, the incidence of reduced absolute values of minimal stent cross-sectional area (MSCSA) varied from 69% (< or =8 mm2) to 15% (< or =5 mm2). After re-intervention, the incidence decreased to 24% (< or =8 mm2) (p = 0.0001) and 0% (< or =5 mm2) (p = 0.005). Before re-intervention, SU as assessed by relative criteria varied from 21% (80% mean reference lumen area or 90% minimum distal reference lumen area) to 28% (100% minimum reference lumen area). After re-intervention, the incidence of SU varied from 7% (90% minimum distal reference lumen area) (p = 0.0001 vs. pre) to 24% (55% mean reference EEM area) (p = ns). No change in strut apposition (97% pre vs. 100% post) nor in symmetry index (100% pre vs. post) was noted. From all criteria, the 90 and 100% minimum reference lumen area criteria were the most altered by repeat balloon dilatation, 21% pre vs. 7% post and 28% pre vs. 11% post, respectively. In conclusion, among patients presenting with severe angiographic in-stent restenosis, a significant number showed signs of SU whose incidence varied according to applied criteria. Significant stent re-expansion can be obtained following IVUS-guided repeat angioplasty irrespective of initial SU criteria.
Angioplasty, Balloon↗
The role of brachytherapy and Cutting Balloon angioplasty in the current treatment of stent restenosis.
The Gamma I, START and INHIBIT trials conclusively demonstrate the feasibility, safety and efficacy of intracoronary radiation as the treatment of choice for stent restenosis. Further reports confirm this finding and extend the indications. Vascular brachytherapy should be made available for all patients with diffuse stent restenosis. Specific devices such as cutting balloons may improve the procedure but does not seem to have an impact alone on the evolution.
Angioplasty, Balloon, Coronary↗
New anticoagulation.
Explore the source record for details and available documents.
Angioplasty, Balloon, Coronary↗
Results of intracoronary beta-brachytherapy administered by 60 mm transfer device/radiation source train: a subgroup analysis from the RENO registry.
UNLABELLED: To investigate the safety and efficacy of a 60 mm transfer device, delivering 60 mm radiation source train, in the treatment of coronary lesions by b-brachytherapy employing the BetaCath system (Novoste, Norcross, Georgia). METHODS AND RESULTS: As part of the REgistry NOvoste (RENO), the first large-scale registry of intracoronary beta-radiation applied in routine clinical practice, 46 centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 49 patients with 56 lesions were treated with a 60 mm transfer device/radiation source train (TD/RST) in at least 1 vessel, constituting the study population. With 75.4% in-stent restenosis (ISR), 3.6% graft lesions, long lesions (30.9 +/- 14.7 mm) and 19% diabetes, the cohort had a high-risk for recurrence. The in-hospital major adverse cardiac event (MACE) rate was 4.1%. The 6-month follow-up revealed 2.0% death, 4.1% myocardial infarction, 8.2% target vessel revascularization, 12.2% MACE, 82.6% improved angina, 16.7% binary restenosis and 4.1% late thrombosis. The results were comparable to all other patients in the registry treated with standard source lengths of 30 mm and 40 mm, although much longer lesions were treated by the 60 mm device (18.4 +/- 11.3 mm versus 30.9 +/- 14.7 mm; p < 0.0001). In the ISR subgroup (mean lesion length, 32.03 +/- 14.99 mm), the 6-month MACE rate was 12.8%, while the angiographic restenosis rate was 16.0% and the late thrombosis rate was 2.6%. CONCLUSION: Beta-brachytherapy with 60 mm TD/RST was safe, feasible and effective in this broad population of high-risk patients presenting in day-to-day practice. Its efficacy in long-segment ISR, where conventional interventional strategies have poor outcome rates, is particularly noteworthy.
Angioplasty, Balloon, Coronary↗
Vascular brachytherapy using a beta emitter source in diabetic patients with in-stent restenosis: angiographic and clinical outcomes.
PURPOSE: The management of diabetic patients with restenosis after percutaneous coronary intervention remains a significant challenge. Diabetic patients remain at significant risk of restenosis despite stent implantation. This retrospective analysis was performed to determine the extent to which vascular brachytherapy improves late clinical and angiographic outcomes in diabetic patients compared to conventional therapy and compared to patients' nondiabetic counterparts. METHODS: Pooled data from two studies (START [Stents and Radiation Trial] and START-40 trials) of patients (204 diabetic, 477 nondiabetic) receiving vascular brachytherapy (VBT) with a (90)Sr/(90)Y source after conventional percutaneous coronary intervention for in-stent restenosis comprise the study population. The radiation delivery system used in both studies was the Beta-Cath system. The prescribed dose at 2 mm from the centerline of the source axis was 18.4 Gy or 23 Gy, depending on vessel diameter. The reference vessel diameter, minimal lumen diameter, and percent diameter stenosis were measured before the intervention, at the conclusion of the procedure, and at the 8-month follow-up examination. The Breslow-Day test was used to formally assess the similarity of treatment effect between diabetic and nondiabetic patients. RESULTS: Target lesion and target vessel revascularization rates and angiographic restenosis rates in diabetic and nondiabetic patients treated with beta radiation or placebo were analyzed. Diabetic patients were more likely to have longer and more complex coronary lesions. In-hospital outcomes in diabetic and nondiabetic patients were similar, irrespective of treatment status. At 8 months, patients treated with beta radiation exhibited less target lesion revascularization (diabetic: 10.9% vs. 22.7%, p = 0.02; nondiabetic: 12.8% vs. 22.3%, p = 0.007) and less target vessel revascularization (diabetic: 14.7% vs. 25.3%, p = 0.06; nondiabetic: 16.6% vs. 23.6%, p = 0.06) compared to placebo. In-stent binary angiographic restenosis was lower in irradiated patients (diabetic: 19.4% vs. 37.3% for placebo, p = 0.01; nondiabetic: 12.9% vs. 43% for placebo, p < 0.001). However, restenosis beyond the stent site reduced the impact of VBT, regardless of diabetic status. The magnitude of the treatment effect for target lesion and target vessel revascularization rates was similar between diabetic and nondiabetic patients. CONCLUSIONS: Previously published institutional experiences have suggested that diabetic patients benefit from the use of VBT in the management of in-stent restenosis. This analysis now provides direct evidence to support the role of beta radiation VBT in this patient population. Diabetic patients undergoing this therapy are just as likely to benefit from it as their nondiabetic counterparts.
Beta Particles↗
Intracoronary beta-brachytherapy in chronic total occlusions: a subgroup analysis from the RENO registry.
Conventional interventional therapy has been less rewarding in chronic total occlusion (CTO). Brachytherapy by its antiproliferative and positive remodeling effect may be more efficacious. Forty-six centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 78 patients had 82 lesions (CTO) at presentation-the study population. With 67% in-stent CTO, 8% graft CTO, 4% recurrent CTO, long lesions (27.6 +/- 20.9 mm), and 31% diabetes, the cohort had high risk for recurrence. The in-hospital event rate was 1.3%. Six-month follow-up revealed 1.3% death, 5.1% myocardial infarction, 21.8% target vessel revascularization, 77.8% improved angina, 34.5% binary restenosis, 12.7% reocclusion, and 10.3% late thrombosis. The results were comparable to all other patients in the registry, although late thrombosis rate was higher in the CTO group (10.3% vs. 5.0%; P = 0.047). In the in-stent CTO subgroup (n = 52; 66.7%), there was no in-hospital event, no follow-up death or myocardial infarction, restenosis in 35.1%, and reocclusion in 10.8% of patients. In comparison, death or myocardial infarction was significantly higher in de novo CTO subgroup (P = 0.005). Compared to all other in-stent restenosis patients in the registry, the patients with in-stent CTO had similar clinical and angiographic event rate. Thus, beta-brachytherapy was safe, feasible, and effective in this broad population of high-risk patients with CTO presenting in day-to-day practice. It was particularly effective in in-stent CTO, where conventional interventional strategies are disappointing.
Aged↗
Debulking does not benefit patients undergoing intracoronary beta-radiation therapy for in-stent restenosis: insights from the START trial.
Intracoronary brachytherapy has become the current treatment of choice for patients with in-stent restenosis (ISR). The aim of the present study was to determine whether plaque extraction using debulking techniques prior to brachytherapy would improve the outcomes of patients with ISR. Patients enrolled into the START (n = 476) and START-40 (n = 205) trials were divided into four subgroups according to their treatment assignments: debulking-radiation, debulking-placebo, balloon angioplasty (BA) radiation, and BA placebo. Patients were further divided according to their ISR lesion length: all lesions, > 15 mm, and > 19 mm. Restenosis rates were higher in placebo, nonradiated lesions undergoing debulking (52.7%) vs. BA alone (38.5%; P = 0.04). Postprocedural minimal lumen diameter (MLD) was similar among the subgroups. Outcomes were similar between debulking and BA within each therapeutic arm. MLD after debulking radiation was greater in patients with ISR > 15 mm (post-MLD was 1.9 vs. 1.7 mm; P = 0.06) but not in the placebo. Debulking radiation patients had greater MLD at follow-up, but restenosis (23.5% after debulking vs. 32.7% BA alone) and late loss (0.3 mm in both subgroups) were not statistically different. There was a trend toward higher mortality among debulked patients (3.7%) compared to BA alone (0.8%). In patients with ISR > 19 mm, four patients died following debulking radiation as compared to no death after BA (P = 0.05). Our results do not support the strategy of plaque extraction prior to intracoronary beta-radiation for ISR.
Aged↗
Too much may be too much.
Explore the source record for details and available documents.
Brachytherapy↗
New research in vascular brachytherapy applications beyond coronary artery disease.
Explore the source record for details and available documents.
Biomedical Research↗
Cutting or not cutting: more than 10 years later the cutting balloon is around and still looking for the indication!
Explore the source record for details and available documents.
Angioplasty, Balloon, Coronary↗
Treatment of bifurcation in-stent restenotic lesions with beta radiation using strontium 90 and sequential positioning pullback technique: procedural details and clinical outcomes.
BACKGROUND: In-stent restenotic lesions have been problematic for many patients with the need for multiple repeat percutaneous coronary interventions (PCI). The need for repeat PCI has been significantly reduced in patients since the advent of vascular brachytherapy. In-stent restenosis resulting in bifurcation presents even more of a challenge. The use of radiation therapy for the treatment of this kind of lesion has not yet been reported. The purpose of this paper is to present five cases of radiation therapy in bifurcation in-stent restenotic lesions using the intraluminal beta radiation catheter delivery system (Beta-Cath System, Novoste Corporation, Norcross, Georgia). METHODS: We reviewed the database of patients enrolled in our Compassionate Use Registry between August 1999 and April 2002. The data is reported for 5 patients who received radiation in both branches of bifurcation lesions with the Beta-Cath catheter system. RESULTS: The mean diameter of the vessels was 3.1 mm 0.5 mm. The dose administered was from 18.3 to 23 Gy, with an overlap of 3.3 to 10.3 mm; the hinge angle between the branches went from 43.3 to 65.4 . Angiographic follow-up was obtained at 6 months in 4 patients, with a single patient showing a focal (< 5 mm) edge lesion treated by balloon angioplasty (TVR no TLR). No aneurysms or zones of ectasia were noted. CONCLUSION: Beta radiation with the Beta-Cath catheter system appears to be safe, secure and clinically useful in in-stent restenotic bifurcation lesions.
Angioplasty, Balloon↗
Benefits of cutting balloon before stenting cut and stent.
Explore the source record for details and available documents.
Atherectomy, Coronary↗
Beta radiation in lesions > 15 mm: a START subgroup.
BACKGROUND: Following conventional treatment of in-stent restenosis, clinical restenosis may be as high as 60% in long lesions. Results of the START (Stents and Radiation Therapy) trial indicate that intracoronary beta radiation yields significant reductions in the incidence of recurrent in-stent restenosis as compared with placebo. METHODS AND RESULTS: In a subgroup of the START trial, results in patients with coronary lesions > 15 mm in length (n = 239) were analyzed to assess treatment with a 30 mm, beta radiation source train. Patients received an intracoronary catheter with (90)Strontium/(90)Yttrium (n = 128) or placebo (n = 111). Clinical and angiographic parameters were evaluated at 8 months. Patient demographics and angiographic lesion characteristics were similar between the 2 groups. The mean lesion lengths were comparable in the radiation and placebo groups (21.5 5.2 mm versus 22.1 5.5 mm, respectively; p = 0.3873). A total of 14.1% and 22.5% of patients in the radiation and placebo groups, respectively, received new stents (p = 0.09). At 8 months, radiation therapy yielded significant reductions in major adverse cardiac events (16.4% versus 29.7%; p = 0.014), target vessel revascularization (14.8% versus 28.8%; p = 0.0085) and target lesion revascularization (11.7% versus 27.9%; p = 0.0015). There was no stent thrombosis, and binary restenosis rates were significantly lower in the radiation group compared to placebo. CONCLUSION: Intracoronary beta radiation may prevent early recurrent restenosis in long lesions. Additional study is required to determine if the reduction persists throughout mid- to long-term follow-up.
Aged↗
Clinical outcome following combination of cutting balloon angioplasty and coronary beta-radiation for in-stent restenosis: a report from the RENO registry.
At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary beta-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary beta-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary beta-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27 0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.
Aged↗
Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial.
The cutting balloon (CB) is a specialized device designed to create discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Such controlled dilatation theoretically reduces the force needed to dilate an obstructive lesion compared with standard percutaneous transluminal coronary angioplasty (PTCA). We report a multicenter, randomized trial comparing the incidence of restenosis after CB angioplasty versus conventional balloon angioplasty in 1,238 patients. Six hundred seventeen patients were randomized to CB treatment, and 621 to PTCA. The mean reference vessel diameter was 2.86 +/- 0.49 mm, mean lesion length 8.9 +/- 4.3 mm, and prevalence of diabetes mellitus in patients was 13%. The primary end point, the 6-month binary angiographic restenosis rate, was 31.4% for CB and 30.4% for PTCA (p = 0.75). Acute procedural success, defined as the attainment of <50% diameter stenosis without in-hospital major adverse cardiac events, was 92.9% for CB and 94.7% for PTCA (p = 0.24). Freedom from target vessel revascularization was slightly higher in the CB arm (88.5% vs 84.6%, log-rank p = 0.04). Five coronary perforations occurred in the CB arm only (0.8% vs 0%, p = 0.03). At 270 days, rates of myocardial infarction, death, and total major adverse cardiac events for CB and PTCA were 4.7% versus 2.4% (p = 0.03), 1.3% versus 0.3% (p = 0.06), and 13.6% versus 15.1% (p = 0.34), respectively. In summary, the proposed mechanism of controlled dilatation did not reduce the rate of angiographic restenosis for the CB compared with conventional balloon angioplasty. CB angioplasty should be reserved for difficult lesions in which controlled dilatation is believed to provide a better acute result compared with balloon angioplasty alone.
Acute Disease↗
Delivered dose and vascular response after beta-radiation for in-stent restenosis: retrospective dosimetry and volumetric intravascular ultrasound analysis.
BACKGROUND: Observations from previous intracoronary radiation therapy trials noted a considerable discrepancy between the prescribed radiation dose and the dose actually delivered. The aims of this study were to investigate the effect of actual delivered dose on vascular changes and to test the appropriateness of the current dose prescription. METHODS AND RESULTS: Serial volumetric intravascular ultrasound (IVUS) analysis was performed in 30 in-stent restenosis cases treated with a 40-mm (90)Sr/Y source train. The fixed dose was prescribed at 2 mm from the centerline of the source train (18.4 Gy at 2 mm for reference diameter < or =3.35 mm and 23 Gy for diameter > or =3.36 mm). Only stent segments with full radiation coverage and device injury were enrolled and divided into 2-mm-long subsegments (n=202). D(S90)EEM (the minimum dose absorbed by 90% of the external elastic membrane surface) was calculated as the delivered dose corresponding to each segment, assuming that the radiation catheter occupied the same position in the vessel as the IVUS catheter. Mean D(S90)EEM of 23.5+/-5.82 Gy (range 12.3 to 41.7 Gy) was delivered to these subsegments. Overall, intimal hyperplasia volume remained constant from postintervention to follow-up (2.23+/-1.10 to 2.32+/-1.09 mm3/m; P=NS). Regression analysis revealed there was no correlation between delivered dose intensity and changes in intimal hyperplasia volume. No particular dose-dependent complications were appreciated in this delivered dose range. CONCLUSIONS: The current dose-prescription protocol of (90)Sr/Y radiation to native in-stent restenosis lesions may provide substantial inhibition of neointimal reproliferation regardless of the actual delivered dose intensity.
Beta Particles↗