RESUMEN
BACKGROUND: Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions. METHODS: A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study. RESULTS: Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II. CONCLUSIONS: In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/terapia , Stents , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/métodos , Cateterismo , Reestenosis Coronaria/prevención & control , Stents Liberadores de Fármacos , Diseño de Equipo , Seguridad de Equipos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Medición de Riesgo , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Since its earlier days, procedural and technical difficulties allied topoor immediate and long-term outcomes have turned the percutaneoustreatment of bifurcated coronary lesions into one of the mostchallenging scenarios of interventional cardiology1,2.In the mid 1980s, when balloon angioplasty was the standardpercutaneous approach, the treatment of bifurcation lesions wasconsidered a procedure of exception for carrying a high risk of acuteischaemic complications (e.g. acute coronary thrombosis) andrestenosis. Usually, kissing-balloon was the preferred technique tominimise plaque shift to the side branch and improve immediateoutcomes3,4.In the early 1990s, the use athero-ablative techniques (rotationaland directional atherectomy) decreased the need for repeat lesionrevascularisation but increased the procedural complications afterpercutaneous approach of bifurcations5-7.In the mid 1990s, coronary stenting, through its scaffolding properties,became the treatment of choice for bifurcated lesions, mainlybecause of its impact in reducing acute complications. However, itwas yet to be determined which was the best technical approach toreduce restenosis and improve long term outcomes in that specificpopulation. Basically, the remaining issue was how to achieve thebest results in the main branch while preserving the side branch. Inthe bare metal stent era, several reports investigating the outcomeof stenting solely the main vessel versus stenting main vessel andside branches, reported dissimilar results; although both techniquesproved to be safe and feasible, substantial restenosis ratesof up to 40% were observed8,9. Of note, among those receivingstents in both branches, T-stenting was superior to Y-stenting inreducing adverse events (86.3% vs. 30.4%, p=0.004).
Asunto(s)
Reestenosis Coronaria , Stents , Lesiones CardíacasRESUMEN
OBJECTIVE: This study aimed at evaluating reduction in intimal hyperplasia volume following angioplasty using sirolimus-eluting stents (Cypher) compared with thin-strut bare-metal stents (Pixel) in patients with small vessels. METHODS: Eighty patients with coronary artery disease were prospectively included in two consecutive series, the first using sirolimus-eluting stents (50) and the second using bare-metal stents (30). RESULTS: The use of sirolimus-eluting stents reduced: in-stent net volume obstruction [5.0% (SE = 0.77) x 39.0% (SE = 4.72), p < 0.001], in-stent late loss [0.25 mm (SE = 0.03) x 1,11 mm (SE = 0.13), p < 0.001], in-segment late loss [0.30 mm (SE = 0.04) x 0.83 mm (SE = 0.11), p < 0.001], in-stent restenosis (0% x 33.3%, p < 0.001) and in-segment restenosis (4% x 36.7%, p < 0.001). The event-free survival rate was 96% in the sirolimus-eluting stent group versus 86.7% in the bare-metal stent group (BMS) (p = 0.190). CONCLUSION: Sirolimus-eluting stents are superior to thin-strut bare-metal stents in reducing intimal hyperplasia (less in-stent obstruction and less late lumen loss) in patients with small vessels. The use of these stents significantly reduced angiographic restenosis at eight months.
Asunto(s)
Angioplastia Coronaria con Balón/métodos , Antibióticos Antineoplásicos/administración & dosificación , Estenosis Coronaria/tratamiento farmacológico , Sirolimus/administración & dosificación , Stents , Túnica Íntima/patología , Adolescente , Adulto , Angioplastia Coronaria con Balón/normas , Reestenosis Coronaria/prevención & control , Estenosis Coronaria/patología , Implantes de Medicamentos , Femenino , Estudios de Seguimiento , Humanos , Hiperplasia/tratamiento farmacológico , Hiperplasia/patología , Masculino , Metales , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
OBJETIVO: Avaliar a redução do volume de hiperplasia intimal após angioplastia com stents com sirolimus (Cypher®) comparados com os stents não-recobertos de estrutura metálica fina (Pixel®) em pacientes com vasos pequenos. MÉTODOS: Oitenta pacientes com doença arterial coronariana foram prospectivamente incluídos em duas séries consecutivas de tratamento, sendo a primeira empregando stents com sirolimus (50) e a segunda stents não-recobertos de estrutura metálica fina (30). RESULTADOS: Os resultados foram: menor porcentual de obstrução da prótese através do ultra-som intracoronário [5,0 por cento (EP = 0,77) x 39,0 por cento (EP = 4,72), p < 0,001], menor perda tardia intra-stent [0,25 mm (EP = 0,03) x 1,11 mm (EP = 0,13), p < 0,001] e no segmento do vaso [0,30 mm (EP = 0,04) x 0,83 mm (EP = 0,11), p < 0,001], e também menor reestenose intra-stent (0 por cento x 33,3 por cento, p < 0,001) e no segmento do vaso (4 por cento x 36,7 por cento, p < 0,001) com os stents com sirolimus. A sobrevivência livre de eventos foi de 96 por cento com os stents com sirolimus x 86,7 por cento com os stents não-recobertos (p = 0,190). CONCLUSÃO: Os pacientes com vasos de pequeno calibre após o implante de stents com sirolimus evoluem com menor hiperplasia intimal (menor porcentual de obstrução intra-stent e menor perda tardia) do que quando são utilizados stents não-recobertos de estrutura metálica fina. Isto resultou em redução significativa da reestenose angiográfica aos oito meses de evolução.
Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Stents , Angioplastia Coronaria con Balón/métodos , Antibióticos Antineoplásicos/administración & dosificación , Estenosis Coronaria/tratamiento farmacológico , Sirolimus/administración & dosificación , Túnica Íntima/patología , Angioplastia Coronaria con Balón/normas , Estenosis Coronaria/patología , Estudios Prospectivos , Hiperplasia/tratamiento farmacológico , Hiperplasia/patología , Implantes de Medicamentos , Metales , Reestenosis Coronaria/prevención & control , Estudios de SeguimientoRESUMEN
Objetivo - Avaliar os resultados hemodinâmicos e angiográficos tardios da valvoplastia mitral por duplo cateter-baläo, para tratamento da estenose mitral reumática. Métodos - Cinquenta e dois pacientes foram submetidos à avaliaçäo, sendo 84,6// do sexo feminino, com idade média de 21,9 anos. Oitenta e um por cento estavam na classe funcional I (NYHA), e 5,7// exibiam fibrilaçäo atrial, 18 meses após dilataçäo. Todos foram submetidos a estudo ecocardiográfico e cateterismo cardíaco com angiografia, 1 ano após o procedimento. Resultados - quarenta e seis pacientes (88,5//) exibiram, imediatamente após a valvoplastia, áerea valvar > 1,50cm². Em 6(11,5//), a área da valva mitral foi ó 1,50cm². Os casos em que se obteve área valvar ò 1,50cm², tiveram boa evoluçäo clínica, sem perda dos bons resultados hemodinâmicos e ecocardiográficos iniciais, incluindo o gradiente de pressäo diastólica mitral, as pressöes médias do átrio esquerdo e da artéria pulmonar e a área valvar mitral. Nos 6 casos em ques e obteve area valvar ó 1,50cm², 2 tiveram evoluçäo favorável, 2 foram redilatados, 1 aguarda tratamento cirúrgico e outro mantém-se em tratamento clínico a despeito do resultado hemodinâmico insatisfarório. Em 3 dos 52 casos (5,7), demonstrou-se, após o procedimento, a existência de comunicaçäo interatrial, em 2 sem repercussäo hemodinâmica, e, no 3º, com repercussäo, foi indicada a correçäo cirúrgica do defeito. A insuficiência mitral ocorreu em 16 casos (30,7//), sendo de grau + em 8 e de + a ++, nos demais, sem nenhum agravamento neste período evolutivo. Conclusäo - A valvoplastia mitral por duplo cateter-baläo é método eficaz para tratamento da estenose mitral reumática, havendo boa evoluçäo tardia, nos casos que apresentam área ò 1,50cm² imediatamente após a dilataçäo
Purpose - To evaluate the late hemodynamic and angiographic results of 52 patients who underwent mitral valvoplasty by the double balloon technique in the treatment of the rheumatic mitral stenosis. Methods - The mean follow-up was of 18 months and the patients had a Doppler-echocardiogram and cardiac catheterization one year after dilatation. Of the 52 patients 84.6% were femule and the mean age was 21.9% years. Eighty one percent were in NYHA class I whereas 5.7% had atrial fibrillation at the end of 18 months. Results Immediatly after valvoplasty 46 patients (88.5%) had a valvar area larger, and 6 (11.5%) smaller than 1.5 cm2 . The first group had a good clinical outcome with maintenance of the clinical, echocardiographic and angiographic results in the late followup, including the dyastolic gradient and the valvar area. Of the 6 cases with mitral area smaller than 1.5 cm2, 2 had a good clinical evolation, 2 were redilated, I was scheduled for surgery and the last one is under clinical management but with poor hemodynamic results. Three (5.7%) cases developed an atrial septal defect after the procedure, with hemodynamic repercussion in 1. Mitral regurgitation developed in 16 cases (+ in 8, +/++ in 8) without changes during the follow-up period. Conclusion - Double balloon mitral valvoplasty is a safe effective method in the treatment of the rheumathic mitral stenosis, and offers a better evolution in patients with a valvar area larger than 1.5 cm2 after the dilatation
Asunto(s)
Humanos , Masculino , Femenino , Embarazo , Adolescente , Adulto , Persona de Mediana Edad , Cateterismo , Estenosis de la Válvula Mitral/terapia , Cardiopatía Reumática/terapia , Angiografía , Ecocardiografía Doppler , Estudios de Seguimiento , Estenosis de la Válvula Mitral/fisiopatología , Cardiopatía Reumática/fisiopatología , Estudio de Evaluación , Hemodinámica , Índice de Severidad de la EnfermedadRESUMEN
Avaliar a incidência de oclusäo de ramos secundários em pacientes com lesäo única da artéria descendente anterior, em que a angioplastia coronária foi aplicada pela primeira vez e com sucesso. Duzentos e treze casos com ramos secundários em pacientes com lesäo única da ar considerados " em risco" por estarem envolvidos na lesäo (grupo I - GI; 85 casos - 39,9%); ou por terem sido atingidos pela insuflaçäo do baläo (grupo II - GII, 128 casos - 61,5%). Corresponderam a: GI - 54 ramos septais (S) e 31 ramos diaggonais (Dg), sendo que 36% tinham evidência angiográfica de doença ostial; GII - 77 S e 51 Dg, com 7,8% de doença ostial. Oclusäo de 7 (3,3%) ramos secundários " em "em risco", 4 (4,7%) do GI e 3 (2,3%) do GII. Na evoluçäo clínica destes 7 casos observaram-se angina de peito em 57% e alteraçöes isquêmicas discretas ao eletrocardiograma em 28.6%. Näo houve qualquer alteraçäo enzímica. A oclusäo foi clinicamente silenciosa em 43% dos casos. A oclusäo de ramos secundários é de baixa incidência, ocorre com maior freqüência nos septais, que nascem da lesäo e nos que têm doença ostial, sendo silenciosa em quase metade dos pacientes ou acompanhada de alteraçeos isquêmicas.
Purpose: To evaluate the incidence and clinical presentation of the occlusion of such secondary branches in patients with single vessel coronary artery disease in the left anterior descending artery, who underwent a first elective and successful PTCA. Material and Methods: Two hundred and thirteen side branches of 121 patients considered to be at risk. They were divided into group I (GI85 side branches, 39.9%), if they originated from the atherosclerotic site; and group II (GII120 side branches, 61.5%), if their origin would be involved during the balloon inflation. In the GI there were 54 septal branches and 3.1 diagonal branches, and 36& had angiographic evidence of ostium disease. GII was constituted by 77 septal and 51 diagonal branches, and 7.8% of them had evidence of ostium disease. Results: Seven side branches (3.3%) at risk occluded, 4 from GI (4.7%) and 3 (2.3%) from GII. As for the clinical presentation, 57% of them had angina, where as 28.6% showed minor abnormalities in the ECG. No patient elevated its serum CK-MB, and silent occlusion cccurred in 43% if them. Conclusion: Occlusion of side branches is a low incidence phenomenon, which happens more often in septal branches with ostium disease that originates from the atherosclerotic site; that about half of the patient had silent occlusion (43%) or mild ischemic manifestations