Valter Correia de Lima

Randomized evaluation of two drug-eluting stents with identical metallic platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial.

Objectives: We tested two novel drug‐eluting stents (DES), covered with a biodegradable‐polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti‐restenosis effects of sirolimus versus paclitaxel (secondary objective). Background: The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel. Methods: Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow‐up was obtained at 9 months and major cardiac adverse events up to 12 months. Results: Both paclitaxel and sirolimus stents reduced the 9‐month in‐stent late loss (0.54–0.44 mm, 0.32–0.43 mm, vs. 0.90–0.45 mm respectively), and 1‐year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1‐year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups. Conclusion: Both novel DES were effective in reducing neointimal hyperplasia and 1‐year re‐intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.© 2009 Wiley‐Liss, Inc.

Percutaneous Mechanical Assistance for the Failing Heart

One of the most challenging situations in contemporary medicine is, doubtlessly, the approach and treatment of patients presenting with severe left ventricle failure. Since its first clinical application in patients with cardiogenic shock in 1968, the intraaortic balloon pump (IABP) has been widely accepted by heart failure physicians. Although IABP therapy has been shown to be effective for the support and stabilization of hemodynamically compromised patients, it has failed to promote any improvements in patient outcomes. For this reason, much attention has been invested in the development of external devices that can collaborate with the treatment of this condition. In this context, the percutaneous left ventricle assist device (pLVAD), like TandemHeart (Cardiac Assist, Inc.; Pittsburgh, PA, USA), and, more recently, the Impella 2.5 (Abiomed Europe, Aachen, Germany) has emerged. The purpose of this review is to describe the history of pLVAD, from its beginning, to the other devices currently available, including those created for right ventricle and biventricular support.

Exeqüibilidade, segurança e acurácia do ecocardiograma sob estresse com dobutamina/ atropina para detecção de doença arterial coronariana em candidatos a transplante renal

OBJECTIVE To evaluate the feasibility, safety and accuracy of dobutamine/atropine stress echocardiography (DASE) for the detection of coronary artery disease (CAD) in renal transplant candidates. METHODS Patients candidates to renal transplant were submitted consecutively to DASE and coronary angiography. The adopted angiographic criteria for CAD were an obstructive lesion of > or = 50% and > or = 70%. RESULTS 148 patients underwent the DASE and the coronary angiography. Mean age was 52 +/- 9 years, 69% of the patients were males; 27% had diabetic nephropathy and 73% had LVH; 63% were asymptomatic; 36% and 22% presented coronary obstructions > or = 50% and 70%, respectively. The DASE performance was 91% and major complication rate was 2.7%. The sensibility, specificity and accuracy for the diagnosis of coronary obstruction > 50% were 53% (CI:45-61), 87% (CI:81-93), and 75% (CI:63-83) respectively. For coronary obstruction > or = 70% these values were, respectively, 71% (CI:64-92), 85% (CI:79-91) and 81% (CI:75-87). The sensibility to detect univessel and multivessel disease was 41% (CI:19-63) and 78% (CI:64-92), respectively. CONCLUSION The DASE was practical and safe; however, it presented a poor result for the detection of CAD regarding obstructions > or = 50%. It can be a useful screening for the detection of CAD in candidates with obstructions > or = 70% and multivessel disease.

Efficacy and safety of oral sirolimus to inhibit in-stent intimal hyperplasia.

Sirolimus systemic administration has shown marked inhibition of neointimal hyperplasia (NIH) after balloon angioplasty in porcine models. In this pilot study, we tested the hypothesis that oral sirolimus is safe and effective to inhibit in‐stent NIH and therefore to prevent and treat in‐stent restenosis (ISR). Twelve patients (18 lesions) with high risk for ISR, including 8 ISR lesions, were admitted. One day before the procedure, patients were given a 15 mg loading dose of oral sirolimus, followed by 5 mg daily for 28 days, with weekly whole blood level measurements. The daily dose was adjusted to keep the concentration at 10–15 ng/ml. Sirolimus was well tolerated by all patients but one, who died at the end of the third week of treatment. The 4‐ and 8‐month follow‐up revealed an angiographic late loss of 0.40 ± 0.24 and 0.67 ± 0.45 mm (P < 0.01), respectively. At the same time points, the intravascular ultrasound in in‐stent relative volumetric obstruction was 14.4% ± 9.1% and 23.2% ± 10.1% (P < 0.01), respectively. At 24‐month clinical follow‐up, adverse events were one (8.3%) death, two (11.1%) target lesion, and four (22.2%) target vessel revascularizations. In conclusion, in this small group of high‐risk ISR patients, oral sirolimus inhibited NIH and therefore may be an effective strategy for the prevention and treatment of ISR. Catheter Cardiovasc Interv 2005;64:413–418.

Hidratação com bicarbonato de sódio não previne a nefropatia de contraste: ensaio clínico multicêntrico

BACKGROUND Radiographic contrast media exposition can cause acute renal function impairment. There is limited and conflicting evidence that hydration with sodium bicarbonate prevents contrast-induced nephropathy (CIN) in patients undergoing cardiac catheterization. OBJECTIVE The present study was aimed at determining whether sodium bicarbonate is superior to hydration with saline to prevent nephropathy in patients at risk undergoing cardiac catheterization. METHODS Three hundred and one patients undergoing coronary angiography or percutaneous coronary intervention with serum creatinine > 1.2mg/dL or glomerular filtration rate (GFR) < 50 ml/min were randomized to receive hydration with sodium bicarbonate starting 1 hour before the procedure and 6 hours after the procedure, or hydration with 0.9% saline. CIN was defined as an increase of 0.5mg/dL in creatinine in 48 h RESULTS Eighteen patients (5.9%) developed contrast induced nephropathy: 9 patients in the bicarbonate group (6.1%) and 9 patients in the saline group (6.0%), p = 0.97. The change in serum creatinine was similar in both groups, 0.01 ± 0.26 mg/dL in the bicarbonate group and 0.01 ± 0.35 mg/dL in the saline group, p = 0.9. No statistical difference was observed between the change in glomerular filtration rate (0.89 ± 9 ml/min vs. 2.29 ± 10 ml/min, p = 0.2 bicarbonate group and saline group, respectively). CONCLUSION Hydration with sodium bicarbonate was not superior to saline to prevent contrast media induced nephropathy in patients at risk undergoing cardiac catheterization.

Effect of systemic immunosuppression on coronary in-stent intimal hyperplasia in renal transplant patients

Cyclosporin, combined with other agents, is an immunosuppressive agent approved for prophylaxis of renal transplant rejection. In experimental studies, cyclosporin has been shown to inhibit smooth muscle cell proliferation in the vascular response to injury. 1,2 Similar experimental results have been observed with systemic use of rapamycin. 3,4 The aim of this clinical investigation was to test the hypothesis that systemic immunosuppression therapy inhibits in-stent restenosis in renal transplant patients with coronary artery disease treated with stenting.

Electrocardiography in the diagnosis of ventricular hypertrophy in patients with chronic renal disease.

BACKGROUND Left ventricular hypertrophy (LVH) is an independent predictor of cardiovascular risk, and its characterization and prevalence in chronic renal disease (CRD) should be further studied. OBJECTIVE To establish the diagnosis of LVH in patients with stage-5 CRD using six different electrocardiographic criteria, and to correlate them with left ventricular mass index (LVMI) as obtained by echocardiography. METHODS Cross-sectional study including 100 patients (58 men and 42 women, mean age 46.2 + or - 14.0 years) with CRD of all causes undergoing hemodialysis (HD) for at least six months. Electrocardiography (ECG) and echocardiography were performed in all patients, always up to one hour after the end of the HD sessions. RESULTS LVH was detected in 83 patients (83%), of whom 56 (67.4%) had the concentric pattern and 27 (32.6%) the eccentric pattern of LVH. Diagnostic sensitivity, specificity and accuracy of all the electrocardiographic methods studied were higher than 50%. Using Pearsons linear correlation for LVMI, only the Sokolow-Lyon voltage criterion did not show a > or = 0.50 coefficient. Calculation of the likelihood ratio, in turn, showed that ECG has a discriminatory power for the diagnosis of LVH in the population studied, with emphasis on the Cornell-product and Romhilt-Estes criteria. No correlation was observed between LVMI and QTc and QTc dispersion. CONCLUSION ECG is a useful, efficient, and highly reproducible method for the diagnosis of LVH in HD patients. In this population, the Cornell-product proved to be the most reliable criterion for the detection of LVH.FUNDAMENTO: La hipertrofia ventricular izquierda (HVI) es un factor predictor independiente de riesgo cardiovascular y su caracterizacion y prevalencia en la enfermedad renal cronica (ERC) carecen de mejor estudio. OBJETIVO: Establecer el diagnostico de HVI en pacientes con ERC en estadio 5 por seis diferentes criterios electrocardiograficos, correlacionandolos al indice de masa del ventriculo izquierdo (IMVI) que se obtuvo mediante el ecocardiograma. METODOS: Estudio transversal que incluyo a 100 pacientes (58 varones y 42 mujeres, edad de 46,2 ± 14,0 anos) con ERC de todas las etiologias, desde hace al menos 6 meses en hemodialisis (HD). Se obtuvieron electrocardiograma (ECG) y ecocardiograma de los pacientes, siempre hasta una hora tras el termino de las sesiones de HD. RESULTADOS: La HVI se detecto en 83 pacientes (83%), de los que 56 (67,4%) presentaban el estandar concentrico y 27 (32,6%) el estandar excentrico de HVI. Todos los metodos electrocardiograficos estudiados tuvieron sensibilidad, especificidad y exactitud diagnosticas superiores al 50%. Mediante la correlacion lineal de Pearson con el IMVI, solamente el criterio de Sokolow-Lyon voltaje no presento coeficiente > 0,50. Sin embargo, el calculo de la razon de verosimilitud evidencio que el ECG tiene poder discriminatorio para diagnostico de HVI en la poblacion estudiada, con enfasis para los criterios de Producto de Cornell y Romhilt-Estes. No hubo correlacion entre IMVI con el QTc y su dispersion. CONCLUSION: El ECG es un metodo util, eficaz y de alta reproductibilidad en el diagnostico de HVI de los pacientes en HD. En esa poblacion, el criterio de Producto de Cornell fue mas fiable para la deteccion de HVI.

Análise de impacto do stent farmacológico no orçamento do sistema único de saúde

BACKGROUND: Drug-eluting stents represent an additional option to treat coronary artery disease. This technology represents a major breakthrough that may require additional funding in the short-term to enable its inclusion in procedures of the Unified Health System. OBJECTIVE: To estimate the impact on the Unified Health System budget in the first year of use of drug-eluting stents. METHODS: A Budget Impact Model was designed to predict the economic impact of the inclusion of drug-eluting stents in the Unified Health System budget. Data about costs and local procedures were collected in multiple sources, specifically procedure volume data, hospital costs, cost of stents, drug costs and number of stents used in single and multi-vessel procedures. RESULTS: The results in the first year indicate that the impact on the Unified Health System is of 12.8% in the best scenario and 24.4% in the worst scenario, representing an increase by R

Uma comparação entre a intervenção coronariana percutânea de resgate e primária realizadas no infarto agudo do miocárdio: relato multicêntrico de 9.371 pacientes

24 to 44 million in the total projected budget. CONCLUSION: Drug-eluting stents have an additional cost compared with standard stents in the first year of use in the Unified Health System.

Cardiopulmonary exercise testing early after catheter-balloon mitral valvuloplasty in patients with mitral stenosis

OBJECTIVE: To perform a comparative analysis of in-hospital results obtained from AMI patients who underwent rescue or primary PTCA. METHODS: From the Brazilian Interventional National Registry (CENIC), we selected all consecutive patients who underwent a percutaneous coronary intervention for myocardial infarction (< 24 hours), between 1997 and 2000, analyzing those undergoing a rescue (n=840) or a primary (n=8,531) procedure, and comparing their in-hospital results. RESULTS: Rescue patients were significantly younger males with anterior wall infarctions, associated with left ventricular dysfunction, but had less multivessel disease, compared with those treated with primary intervention. Coronary stents were implanted in at similar rates (56.9% vs. 54.9%; P=0.283). Procedural success were lower for rescue cases (88.1% vs. 91.2%; P<0.001), with higher mortality (7.4% vs. 5.6%; P=0.034), compared with the primary intervention group; target vessel revascularization (< 0.5%), emergency bypass surgery (< 0.3%) and reinfarction (< 2.6%) rates were similar for both strategies. Multivariate analysis identified the rescue procedure as a predictor of in-hospital death [OR(CI=95%) = 1.60 (1.17-2.19); P=0.003]. CONCLUSION: Patients who underwent a rescue coronary intervention had higher in-hospital death rates compared with those who underwent a primary coronary intervention.