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OBJECTIVE: To observe and characterise vessel injury after stenting using optical coherence tomography (OCT), to propose a systematic OCT classification for periprocedural vessel trauma, to evaluate its frequency in stable versus unstable patients and to assess its clinical impact during the hospitalisation period. SETTING: Stenting causes vessel injury. DESIGN AND INTERVENTIONS: All consecutive patients in whom OCT was performed after stent implantation were included in the study. Qualitative and quantitative assessment of tissue prolapse, intra-stent dissection and edge dissection were performed. RESULTS: Seventy-three patients (80 vessels) were analysed. Tissue prolapse within the stented segment was visible in 78/80 vessels (97.5%). Median number of tissue prolapse sites was 8 (IQR 4-19), mean (SD) area 1.04 (0.9) mm(2). Intra-stent dissection flaps were visible in 69/80 vessels (86.3%) (median number 3 (IQR 1.25-6), maximum flap length 450 (220) microm). Fifty-five out of 80 vessels (68.8%) showed dissection cavities (median number 2 (IQR 0-4.75), maximum depth 340 (170) microm). Edge dissection was visible in 20 vessels (mean (SD) length flap 744 (439) microm). The frequency of tissue prolapse or intra-stent dissection was similar in stable and unstable patients (95.6% vs 100%, p = 0.5 for tissue prolapse; 91.1% vs 82.9%, p = 0.3 for intra-stent dissection). There were no events during the hospitalisation period. CONCLUSIONS: OCT allows a detailed visualisation of vessel injury after stent implantation and enables a systematic classification and quantification in vivo. In this study, frequency of tissue prolapse or intra-stent dissections after stenting was high, irrespective of the clinical presentation of the patients, and was not associated with clinical events during hospitalisation.
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Implante de Prótese Vascular/efeitos adversos , Vasos Coronários/lesões , Infarto do Miocárdio/cirurgia , Stents/efeitos adversos , Angiografia Coronária , Feminino , Seguimentos , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/patologia , Prolapso , Tomografia de Coerência Óptica , Túnica Íntima/patologiaRESUMO
Coronary artery disease is the leading cause of mortality and morbidity in the Western world and an ever-increasing problem in developing countries. Unheralded acute coronary syndromes (ACS) are common initial manifestations of coronary atherosclerosis and are often caused by lesions which have previously not generated symptoms. Histopathological studies have identified several plaque morphologies associated with ACS. However, the natural history of these high-risk or vulnerable lesions remains unknown and the limited knowledge about their eventual prognosis is provided by retrospective histopathological studies. Detection of these vulnerable plaques in vivo is essential to study their natural history and to evaluate potential treatment modalities and, therefore, may ultimately have an important impact on the prevention of acute myocardial infarction and death. Currently, there are several diagnostic imaging tools capable of evaluating determinants of plaque vulnerability. These techniques can provide information on the vessel lumen and wall size, tissue composition and the status of inflammation. This article aims to review the current status of these imaging techniques.
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Doença da Artéria Coronariana/diagnóstico , Humanos , Imageamento por Ressonância Magnética , Tomografia de Coerência Óptica , Ultrassonografia de IntervençãoRESUMO
In this case report, we present the use of intracardiac echocardiography (ICE) for guiding the cardiac catheterization and subsequent hemodynamic investigation in an unusual patient case with multiple congenital abnormalities (bicuspid aortic valve, left cervical aortic arch, two aortic coarctations) and two aortic valve replacement operations in the past. The ICE catheter (AcuNav) permitted us to accurately and safely puncture the interatrial septum and place the Swan-Ganz catheter in the left ventricle; additionally, visualization of the aortic coarctation in the ascending aorta was also achieved.
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Ecocardiografia/normas , Cardiopatias Congênitas/fisiopatologia , Próteses Valvulares Cardíacas , Hemodinâmica/fisiologia , Anormalidades Múltiplas/diagnóstico por imagem , Anormalidades Múltiplas/fisiopatologia , Adulto , Aorta Torácica/anormalidades , Aorta Torácica/diagnóstico por imagem , Aorta Torácica/fisiopatologia , Coartação Aórtica/diagnóstico por imagem , Coartação Aórtica/fisiopatologia , Coartação Aórtica/terapia , Valva Aórtica/anormalidades , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Cateterismo Cardíaco , Ecocardiografia/métodos , Feminino , Cardiopatias Congênitas/diagnóstico por imagem , Cardiopatias Congênitas/cirurgia , Doenças das Valvas Cardíacas/congênito , Doenças das Valvas Cardíacas/fisiopatologia , Doenças das Valvas Cardíacas/terapia , Implante de Prótese de Valva Cardíaca , Humanos , Valva Mitral/anormalidades , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologiaRESUMO
OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the additional one year costs at 166. CONCLUSIONS: The one year data from RAVEL suggest an attractive balance between costs and effects for sirolimus eluting stents in the treatment of single native de novo coronary lesions. The cost effectiveness of drug eluting stents in more complex lesion subsets remains to be determined.
Assuntos
Estenose Coronária/terapia , Imunossupressores/administração & dosagem , Sirolimo/administração & dosagem , Stents/economia , Angiografia Coronária/economia , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/economia , Reestenose Coronária/prevenção & controle , Estenose Coronária/economia , Análise Custo-Benefício , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Humanos , Imunossupressores/uso terapêutico , Masculino , Metais , Países Baixos , Sirolimo/uso terapêutico , Propriedades de SuperfícieAssuntos
Reestenose Coronária/prevenção & controle , Imunossupressores/administração & dosagem , Sirolimo/administração & dosagem , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Reestenose Coronária/economia , Análise Custo-Benefício , Implantes de Medicamento , Feminino , Humanos , Imunossupressores/economia , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Inibidores da Agregação Plaquetária/uso terapêutico , Sirolimo/economia , Stents/economia , Análise de Sobrevida , Resultado do TratamentoRESUMO
OBJECTIVES: Comparison of the in-hospital success rates, procedural costs and short-term clinical outcomes of direct stenting versus stenting after balloon predilatation. METHODS: Altogether, 400 patients with angina pectoris and/or myocardial ischaemia due to coronary stenoses in a single native vessel were randomised to either direct stenting or stenting after predilatation. Baseline characteristics were evenly distributed between the two groups. RESULTS: Procedural success rates were similar (96.0% direct stenting group vs. 94.5% predilatation) as well as final successful stent implantation (98.3 vs. 97.8%), while the primary success rate of direct stenting alone was 88.3%, p=0.01. In multivariate analysis, angiographic lesion calcification was an independent predictor of unsuccessful direct stenting (odds ratio 7.1, 95% confidence interval 2.8-18.2, p<0.0001). Rates of troponin I rises >0.15 µg/l, used as a measure of distal embolisation, were similar in both groups (17.8 vs. 17.1%). Rates of major adverse cardiac events at 30 days were 4.5% in the direct stenting group versus 5.5% in the predilated group (ns). Direct stenting was associated with savings in fluoroscopy time, and angiographic contrast agent use, and a reduction in utilisation of angioplasty balloons (0.4 vs. 1.17 balloons per patient, p<0.001). Mean per patient procedural costs associated with direct stenting versus predilatation were 2545±914 versus 2763±842 (p=0.01), despite the implantation of more stents in the directly stented group. CONCLUSION: Compared with a strategy of stenting preceded by balloon predilatation, direct stenting was equally safe and effective, with similar in-hospital and 30-day clinical outcomes, and modest procedural cost-savings. A calcified lesion predicted unsuccessful direct stenting.
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OBJECTIVES: To review the currently available data from studies assessing feasibility, safety, clinical outcome and cost-effectiveness of direct stenting. BACKGROUND: With technical advances of stent designs and their delivery systems a new strategy has become increasingly popular: direct stent implantation without prior balloon dilatation. METHODS: The Medline database was searched from January 1996 to March 2001 for clinical trials investigating direct stenting using the index terms direct stenting, coronary intervention, percutaneous transluminal coronary angioplasty (PTCA), PCI, angioplasty and ischemic heart disease. Studies were chosen based on the number of patients involved and endpoints mentioned. Data not yet published but presented at recent international meetings were also included. A comparison between direct stenting and stenting with predilatation was performed using for the latter results of the randomized trials supplemented with Benestent II data. RESULTS: At least 26 studies have investigated direct stenting, showing high primary and final success rates with few complications. Direct stenting provides a way to reduce costs, shorten procedural and fluoroscopy times and lower material consumption. Immediate and long-term clinical outcomes appear to be similar to stenting with predilatation. Preliminary results of large randomized trials with angiographic follow-up indicate that restenosis rates are similar to those of conventional stenting strategies. CONCLUSIONS: Direct stenting compared with stenting with predilatation is feasible, safe, faster and more cost-effective. The evidence to date shows similar late outcomes.
Assuntos
Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/economia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/economia , Estenose Coronária/economia , Estenose Coronária/terapia , Análise Custo-Benefício/economia , Avaliação de Resultados em Cuidados de Saúde , Stents/efeitos adversos , Stents/economia , Estudos de Viabilidade , Humanos , Fatores de TempoRESUMO
STUDY OBJECTIVE: To compare the long-term angiographic, clinical and economic outcome of direct stenting vs stenting after balloon predilatation. PATIENT POPULATION AND METHODS: Four hundred patients with coronary stenoses in a single native vessel were randomized to direct stenting vs stenting after predilatation. A major adverse cardiac and cerebral event (MACCE) was defined as death, myocardial infarction, stent thrombosis, target restenosis, repeat target- and non-target vessel-related percutaneous coronary intervention, target lesion revascularization, coronary artery bypass surgery and stroke. RESULTS: Stents were successfully implanted in 98.3% of patients randomized to direct stenting vs 97.8% randomized to stenting preceded by predilatation. The primary success rate of direct stenting was 88.3%, vs 97.8% for stenting preceded by balloon dilatation (P=0.01). The angiographic follow-up at 6 months included 333 of the 400 patients (83%). The binary in-stent restenosis rate was 23.1% of 163 patients randomized to direct stenting vs 18.8% of 166 patients randomized to balloon predilatation (P=0.32). By 185+/-25 days, MACCE had occurred in 31 of 200 (15.5%) patients randomized to direct stenting, vs 33 of 200 (16.5%) randomized to predilatation (P=0.89). At 6 months, costs associated with the direct stenting strategy (Euros 3222/patient) were similar to those associated with predilatation (Euros 3428/patient, P=0.43). However, procedural costs were significantly lower. It is noteworthy that, on multivariate analysis, a baseline C-reactive protein level >10 mg l(-1)was a predictor of restenosis (odds ratio: 2.10, P=0.025) as well as of MACCE (odds ratio: 1.94, P=0.045). CONCLUSIONS: Compared to stenting preceded by balloon predilatation, direct stenting was associated with similar 6-month restenosis and MACCE rates. Procedural, but not overall 6-month costs, were reduced by direct stenting. An increased baseline CRP level was an independent predictor of adverse long-term outcome after coronary stent implantation.
Assuntos
Reestenose Coronária/prevenção & controle , Estenose Coronária/terapia , Stents , Angina Pectoris/economia , Angina Pectoris/terapia , Cateterismo/economia , Cateterismo/métodos , Reestenose Coronária/economia , Estenose Coronária/economia , Análise Custo-Benefício , Falha de Equipamento , Feminino , Seguimentos , Oclusão de Enxerto Vascular/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/economia , Infarto do Miocárdio/prevenção & controle , Stents/economia , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/terapia , Resultado do TratamentoRESUMO
BACKGROUND: Earlier reports have shown that the outcome of balloon angioplasty or bypass surgery in unstable angina is less favorable than in stable angina. Recent improvements in percutaneous treatment (stent implantation) and bypass surgery (arterial grafts) warrant reevaluation of the relative merits of either technique in treatment of unstable angina. Methods and Results- Seven hundred fifty-five patients with stable angina were randomly assigned to coronary stenting (374) or bypass surgery (381), and 450 patients with unstable angina were randomly assigned to coronary stenting (226) or bypass surgery (224). All patients had multivessel disease considered to be equally treatable by either technique. Freedom from major adverse events, including death, myocardial infarction, and cerebrovascular events, at 1 year was not different in unstable patients (91.2% versus 88.9%) and stable patients (90.4% versus 92.6%) treated, respectively, with coronary stenting or bypass surgery. Freedom from repeat revascularization at 1 year was similar in unstable and stable angina treated with stenting (79.2% versus 78.9%) or bypass surgery (96.3% versus 96%) but was significantly higher in both unstable and stable patients treated with stenting (16.8% versus 16.9%) compared with bypass surgery (3.6% versus 3.5%). Neither the difference in costs between stented or bypassed stable or unstable angina ($2594 versus $3627) nor the cost-effectiveness was significantly different at 1 year. CONCLUSIONS: There was no difference in rates of death, myocardial infarction, and cerebrovascular event at 1 year in patients with unstable angina and multivessel disease treated with either stented angioplasty or bypass surgery compared with patients with stable angina. The rate of repeat revascularization of both unstable and stable angina was significantly higher in patients with stents.
Assuntos
Angina Pectoris/cirurgia , Implante de Prótese Vascular , Ponte de Artéria Coronária , Stents , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Angina Instável/cirurgia , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/economia , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/economia , Intervalo Livre de Doença , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Revascularização Miocárdica/economia , Revascularização Miocárdica/métodos , Reoperação , Stents/efeitos adversos , Stents/economia , Taxa de Sobrevida , Resultado do TratamentoRESUMO
We tested whether fractional flow reserve (FFR) discriminates between suboptimally and optimally deployed stents. Latex tubes (diameter solidus in circle = 4 mm) with diameter stenosis 40% (n = 3), 50% (n = 3) and 60% (n = 3) were tested in a pulsatile flow system, using water. Measurements were done at baseline (n = 9; FFR/QCA) and after suboptimal (SOD; 3-mm balloon at 8 atm) and optimal (OD; 4 mm balloon at 16 atm) deployment of a 35-mm stent (n = 6; FFR/QCA/IVUS). Varying Q from 150 to 50 ml/min increased FFR by 2-7%. Conversely, at 100 ml/min, FFR increased by only 0.8% from SOD to OD (P < 0.05). Extrapolating data to blood flow, the gain in FFR from SOD to OD is less than 5% for Q = 100 ml/min, while FFR may increase by 15-20% by changes in blood flow from 50 to 150 ml/min. We conclude that IVUS and QCA are more appropriate for the assessment of optimal stent deployment.
Assuntos
Velocidade do Fluxo Sanguíneo/fisiologia , Angiografia Coronária , Estenose Coronária/fisiopatologia , Estenose Coronária/cirurgia , Stents , Ultrassonografia de Intervenção , Circulação Coronária/fisiologia , Estenose Coronária/diagnóstico , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Desenho de Equipamento , Humanos , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. METHODS AND RESULTS: Patients (n=1205) were randomly assigned to stent implantation (n=600; diabetic, 112) or CABG (n=605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, P<0.001) and nondiabetic patients treated with stents (76.2%, P=0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (P<0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. CONCLUSIONS: Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status.
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Ponte de Artéria Coronária , Doença das Coronárias/cirurgia , Complicações do Diabetes , Stents , Transtornos Cerebrovasculares/etiologia , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/economia , Doença das Coronárias/complicações , Doença das Coronárias/terapia , Vasos Coronários/patologia , Vasos Coronários/cirurgia , Análise Custo-Benefício , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Revascularização Miocárdica , Complicações Pós-Operatórias/mortalidade , Stents/efeitos adversos , Stents/economia , Análise de Sobrevida , Taxa de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: The recent recognition that coronary-artery stenting has improved the short- and long-term outcomes of patients treated with angioplasty has made it necessary to reevaluate the relative benefits of bypass surgery and percutaneous interventions in patients with multivessel disease. METHODS: A total of 1205 patients were randomly assigned to undergo stent implantation or bypass surgery when a cardiac surgeon and an interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. The primary clinical end point was freedom from major adverse cardiac and cerebrovascular events at one year. The costs of hospital resources used were also determined. RESULTS: At one year, there was no significant difference between the two groups in terms of the rates of death, stroke, or myocardial infarction. Among patients who survived without a stroke or a myocardial infarction, 16.8 percent of those in the stenting group underwent a second revascularization, as compared with 3.5 percent of those in the surgery group. The rate of event-free survival at one year was 73.8 percent among the patients who received stents and 87.8 percent among those who underwent bypass surgery (P<0.001 by the log-rank test). The costs for the initial procedure were $4,212 less for patients assigned to stenting than for those assigned to bypass surgery, but this difference was reduced during follow-up because of the increased need for repeated revascularization; after one year, the net difference in favor of stenting was estimated to be $2,973 per patient. CONCLUSION: As measured one year after the procedure, coronary stenting for multivessel disease is less expensive than bypass surgery and offers the same degree of protection against death, stroke, and myocardial infarction. However, stenting is associated with a greater need for repeated revascularization.
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Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença das Coronárias/cirurgia , Doença das Coronárias/terapia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/economia , Transtornos Cerebrovasculares/epidemiologia , Transtornos Cerebrovasculares/prevenção & controle , Ponte de Artéria Coronária/economia , Doença das Coronárias/mortalidade , Análise Custo-Benefício , Creatina Quinase/sangue , Creatina Quinase Forma MB , Complicações do Diabetes , Intervalo Livre de Doença , Feminino , Custos Hospitalares , Humanos , Isoenzimas/sangue , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Qualidade de Vida , Recidiva , Stents/economia , Resultado do TratamentoRESUMO
OBJECTIVE: To assess the mechanism of restenosis after balloon angioplasty. DESIGN: Prospective study. PATIENTS: 13 patients treated with balloon angioplasty. INTERVENTIONS: 111 coronary subsegments (2 mm each) were analysed after balloon angioplasty and at a six month follow up using three dimensional intravascular ultrasound (IVUS). MAIN OUTCOME MEASURES: Qualitative and quantitative IVUS analysis. Total vessel (external elastic membrane), plaque, and lumen volume were measured in each 2 mm subsegment. Delta values were calculated (follow up - postprocedure). Remodelling was defined as any (positive or negative) change in total vessel volume. RESULTS: Positive remodelling was observed in 52 subsegments while negative remodelling occurred in 44. Remodelling, plaque type, and dissection were heterogeneously distributed along the coronary segments. Plaque composition was not associated with changes in IVUS indices, whereas dissected subsegments had a greater increase in total vessel volume than those without dissection (1.7 mm(3) v -0.33 mm(3), p = 0.04). Change in total vessel volume was correlated with changes in lumen (p < 0.05, r = 0.56) and plaque volumes (p < 0.05, r = 0.64). The site with maximum lumen loss was not the same site as the minimum lumen area at follow up in the majority (n = 10) of the vessels. In the multivariate model, residual plaque burden had an influence on negative remodelling (p = 0.001, 95% confidence interval (CI) -0.391 to -0.108), whereas dissection had an effect on total vessel increase (p = 0.002, 95% CI 1.168 to 4.969). CONCLUSIONS: The mechanism of lumen renarrowing after balloon angioplasty appears to be determined by unfavourable remodelling. However, different patterns of remodelling may occur in individual injured coronary segments, which highlights the complexity and influence of local factors in the restenotic process.
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Angioplastia Coronária com Balão/efeitos adversos , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/terapia , Estudos de Coortes , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/lesões , Seguimentos , Humanos , Processamento de Imagem Assistida por Computador , Modelos Cardiovasculares , Análise Multivariada , Estudos Prospectivos , Recidiva , Análise de Regressão , Ultrassonografia de IntervençãoRESUMO
BACKGROUND: The "edge effect," late lumen loss at the margins of the treated segment, has become an important issue in the field of coronary brachytherapy. The aim of the present study was to assess the edge effect in noninjured margins adjacent to the irradiated segments after catheter-based intracoronary beta-irradiation. METHODS AND RESULTS: Fifty-three vessels were assessed by means of 3-dimensional intravascular ultrasound after the procedure and at 6- to 8-month follow-up. Fourteen vessels (placebo group) did not receive radiation (sham source), whereas 39 vessels were irradiated. In the irradiated group, 48 edges (5 mm in length) were identified as noninjured, whereas 18 noninjured edges were selected in the placebo group. We compared the volumetric intravascular ultrasound measurements of the noninjured edges of the irradiated vessels with the fully irradiated nonstented segments (IRS, n=27) (26-mm segments received the prescribed 100% isodose) and the noninjured edges of the vessels of the placebo patients. The lumen decreased (6 mm(3)) in the noninjured edges of the irradiated vessels at follow-up (P:=0. 001). We observed a similar increase in plaque volume in all segments: noninjured edges of the irradiated group (19.6%), noninjured edges of the placebo group (21.5%), and IRS (21.0%). The total vessel volume increased in the IRS in the 3 groups. No edge segment was subject to repeat revascularization. CONCLUSIONS: The edge effect occurs in the noninjured margins of radiation source train in both irradiated and placebo patients. Thus, low-dose radiation may not play an important role in this phenomenon, whereas nonmeasurable device injury may be considered a plausible alternative explanation.
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Angioplastia com Balão , Braquiterapia/métodos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/efeitos da radiação , Partículas beta , Angiografia Coronária , Relação Dose-Resposta à Radiação , Humanos , UltrassonografiaRESUMO
AIMS: Evaluation of angiographical and intracoronary Doppler-derived parameters of coronary stenosis severity. METHODS AND RESULTS: A total of 225 patients with one-vessel disease were studied before PTCA and at 6 months follow-up. Exercise electrocardiography was performed to document presence (n = 157) or absence (n = 138) of an ST segment shift (> or =0.1 mV). Intracoronary blood flow velocity analysis was performed to determine the proximal/distal flow velocity ratio, the distal diastolic/systolic flow velocity ratio and coronary flow velocity reserve. Receiver operator characteristic curves were calculated to assess the predictive value of these variables compared with the exercise test. The distal coronary flow velocity reserve demonstrated the best linear correlation for both percentage diameter stenosis and minimum lumen diameter (r = 0.67 and r = 0.66; P<0.01), compared to the diastolic/systolic flow velocity ratio (r = 0.19 and r = 0.14; P<0.01) and the proximal/distal flow velocity ratio (r = 0.03 and r = 0.07; not significant). The areas under the curve were 0. 84+/-0.02; 0.82+/-0.03 and 0.83+/-0.03 for diameter stenosis, minimum lumen diameter and coronary flow velocity reserve, respectively. Logistic regression analysis revealed that the percentage diameter stenosis or minimum lumen diameter and coronary flow velocity reserve were independent predictors for the result of stress testing. CONCLUSIONS: The distal coronary flow velocity reserve is the best intracoronary Doppler parameter for evaluation of coronary narrowings. Angiographical estimates of coronary lesion severity and distal coronary flow velocity reserve are good and independent predictors for the assessment of functional severity of coronary stenosis, emphasizing the complementary role of these parameters for clinical decision making.
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Angiografia Coronária/normas , Doença das Coronárias/diagnóstico , Doença das Coronárias/fisiopatologia , Fluxometria por Laser-Doppler/normas , Adulto , Angioplastia Coronária com Balão , Velocidade do Fluxo Sanguíneo , Eletrocardiografia , Europa (Continente) , Teste de Esforço , Feminino , Humanos , Modelos Logísticos , Masculino , Valor Preditivo dos Testes , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty.
Assuntos
Angina Pectoris/terapia , Angioplastia com Balão/economia , Stents/economia , Análise de Variância , Velocidade do Fluxo Sanguíneo , Análise Custo-Benefício , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
The rising costs of health care have forced policy makers to make choices, and new treatments are increasingly assessed in terms of the balance between additional costs and additional effects. The recent recognition that stenting has a major and long-lasting effect enhancing balloon PTCA procedure has made it imperative to compare in patients with multivessel disease the standard surgical procedure with multiple stenting in a large scale multinational and multicentre approach (19 countries, 68 sites). Selection and inclusion of patients is based on a consensus of the cardiac surgeon and interventional cardiologist on equal 'treatability' of patients by both techniques with analysis of clinical follow-up (event-free survival) on the short (30 day), medium (1 year), and long-term (3 and 5 year) with analysis of cost-effectiveness and quality of life (EuroQol and SF-36). Of the entire trial, the primary null hypothesis which needs to be rejected is that there will be no difference in event-free survival or effectiveness (E), at 1 year and also that the direct and indirect costs (C) per event-free year are not different between surgery or stenting. For this to become significant with a power of 90% one needs 1200 patients. Between April 97 and June 98, 1205 patients have been randomized with a monthly recruitment of 83 patients. Expected costs, effects and cost-effectiveness ratio (CE ratio) are: Stent high costs 2 VDStent high costs 3 VDStent low costs 2 VDStent low costs 3 VDCABG costs (C)$19.297$24.566$16.638$20.456$21.350 effects (E)81%81%81%81%88% CE ratio$23.876$30.397$20.586$25.322$24.348 Clinically, stenting is not expected to be more effective than CABG, but should be cost effective in both the 2- and 3-VD group when using the lower cost estimate and in the 2 VD group when using the higher cost assumptions.
Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença das Coronárias/terapia , Stents , Angioplastia Coronária com Balão/economia , Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/economia , Doença das Coronárias/cirurgia , Análise Custo-Benefício , Humanos , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Stents/economiaRESUMO
Angioscopy represents a diagnostic tool with the unique ability of assessing the true color of intravascular structures. Current angioscopic interpretation is entirely subjective, however, and the visual interpretation of color has been shown to be marginal at best. The quantitative colorimetric angioscopic analysis system permits the full characterization of angioscopic color using two parameters (C1 and C2), derived from a custom color coordinate system, that are independent of illuminating light intensity. Measurement variability was found to be low (coefficient of variation = 0.06-0.64%), and relatively stable colorimetric values were obtained even at the extremes of illumination power. Variability between different angioscopic catheters was good (maximum difference for C1, 0.022; for C2, 0.015). Catheter flexion did not significantly distort color transmission. Although the fiber optic illumination bundle was found to impart a slight yellow tint to objects in view (deltaC1 = 0.020, deltaC2 = 0.024, P < 0.0001) and the imaging bundle in isolation imparted a slight red tint (deltaC1 = 0.043, deltaC2 = -0.027, P < 0.0001), both of these artifacts could be corrected by proper white balancing. Finally, evaluation of regional chromatic characteristics revealed a radially symmetric and progressive blue shift in measured color when moving from the periphery to the center of an angioscopic image. An algorithm was developed that could automatically correct 93.0-94.3% of this error and provide accurate colorimetric measurements independent of spatial location within the angioscopic field. In summary, quantitative colorimetric angioscopic analysis provides objective and highly reproducible measurements of angioscopic color. This technique can correct for important chromatic distortions present in modern angioscopic systems. It can also help overcome current limitations in angioscopy research and clinical use imposed by the reliance on visual perception of color.