Ronaldo da Rocha Loures Bueno

Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study).

AIMS Pre-clinical and few clinical studies suggest that transplantation of autologous bone marrow mononuclear cells (BMNC) improves heart function in dilated cardiomyopathies. Our objective was to determine if intracoronary injection of autologous BMNC improves the left ventricular ejection fraction (LVEF) of patients with non-ischaemic dilated cardiomyopathy (NIDCM). METHODS AND RESULTS This study was a multicentre, randomized, double-blind, placebo controlled trial with a follow-up of 12 months. Patients with NIDCM and LVEF <35% were recruited at heart failure ambulatories in specialized hospitals around Brazil. One hundred and sixty subjects were randomized to intracoronary injection of BMNC or placebo (1:1). The primary endpoint was the difference in change of LVEF between BMNC and placebo groups as determined by echocardiography. One hundred and fifteen patients completed the study. Left ventricular ejection fraction decreased from 24.0% (21.6-26.3) to 19.9% (15.4-24.4) in the BMNC group and from 24.3% (22.1-26.5) to 22.1% (17.4-26.8) in the placebo group. There were no significant differences in changes between cell and placebo groups for left ventricular systolic and diastolic volumes and ejection fraction. Mortality rate was 20.37% in placebo and 21.31% in BMNC. CONCLUSION Intracoronary injection of autologous BMNC does not improve left ventricular function in patients with NIDCM. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.

Percutaneous mitral balloon valvuloplasty in pregnant women with mitral stenosis

Forty‐four consecutive pregnant patients with mitral stenosis were submitted to percutaneous mitral valvuloplasty (PMV) over a period of 12 years. The mean age was 28 ± 6 years and the mean gestational age was 23 ± 6 weeks. The mean mitral valve area had a significant increase from 1.17 ± 0.26 to 2.06 ± 0.41 cm2 (P = 0.0000). The mean mitral valve gradient decreased from 16.22 ± 5.55 to 7.94 ± 3.75 mm Hg (P = 0.0001). The procedure was performed successfully in 95% of the patients and there were no major complications. Concerning labor and delivery, we evaluated 37 patients. Thirty patients (81%) reached term and delivered normal infants. Seven patients (18.9%) delivered prematurely, resulting in two fetal death; one patient delivered a stillborn. We concluded that PMV is a safe procedure for the treatment of mitral stenosis in pregnant patients, providing significant symptomatic relief and better clinical conditions for labor and delivery. Cathet Cardiovasc Intervent 2002;57:318–322.

Obesidade e intervenção coronariana: devemos continuar valorizando o Índice de Massa Corpórea?

BACKGROUND Central anthropometric indexes are better than the body mass index to discriminate elevated coronary risk. However, the Body Mass Index (BMI) is still the most frequently studied anthropometric index on outcomes of patients undergoing percutaneous coronary angioplasty (PCI). OBJECTIVE To recognize, among several anthropometric indexes of obesity, which one best discriminates MACE (Major Adverse Cardiac Events) after PCI. METHODS Subjects were 308 patients (mean age 61.92+/-11.06 years, 60.7% of them men) who had undergone successful coronary angioplasties. Six months after the procedure, patients were contacted for clinical follow-up. Major Adverse Cardiac Events included death, acute myocardial infarction, cardiac surgery, reintervention, angina, or evidence of myocardial ischemia on a non-invasive test. Patients were divided into 2 groups: Group 1 (with MACE, n=91, 29.5%), Group 2 (with no MACE, n= 217; 70.45%). For men and women, the anthropometric indexes studied and their respective cut-off points were waist circumference >90/80 cm, Waist-Hip Ratio > 0.90/0.80 cm, Conicity Index > 1.25/1.18, and Body Mass Index > or =30. RESULTS There were more cases of familial history and previous infarct in Group 2. For men, waist circumference >90 cm (p=0.0498) in multivariate analyses was an independent predictor of MACE. BMI was not related to MACE. In Group 1, the prevalence of an elevated BMI was significantly different compared to the other anthropometric indexes studied (p<0.0001). CONCLUSION Waist circumference was an independent predictor of MACE in men. Body Mass Index was not related to MACE and was the least frequent anthropometric index in the MACE group.

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

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.

Aneurysm of the left main coronary artery

Aneurysm of the left main coronary artery is a rare angiographic finding, with few cases described in the international literature. We report the case of a 42-year-old male with a previous history of acute myocardial infarction, whose coronary angiography indicated triple vessel coronary disease and an aneurysm of the left main coronary artery. A review of the etiology, clinical aspects, and surgical management of coronary arterial aneurysm is presented.

Consenso de especialistas (SBC/SBHCI) sobre o uso de stents farmacológicos: recomendações da sociedade brasileira de cardiologia/sociedade brasileira de hemodinâmica e cardiologia intervencionista ao sistema único de saúde

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare Systems participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA). During this stage the interested company submits to the regulatory agency, results from clinical studies that demonstrate the efficacy and safety of the new device or pharmaceutical product. Frequently, in addition to clinical studies, approval records for clinical use from the regulatory agencies of other countries, mainly the United States of America and the European Community are also submitted. The successful completion of this stage means that the medication or device may be prescribed or used by the physicians in Brazil. The second stage in the incorporation of new healthcare technology involves the reimbursement or financing of the treatment that was approved in the previous stage based on its efficacy and safety. This stage can be more complex than the first one since the new technology, whether a substitution for established treatment methods or the introduction of a new treatment concept, are usually more expensive. The incorporation of new technology requires a cost-effectiveness analysis so that fund administrators can make decisions based on the universal scenario of limited resources to finance healthcare with treatments that are more and more burdensome. The difficulties of funding management are aggravated by medical and social ethical implications that arise when a treatment is approved based on its efficacy and safety but is not made available to patients who could benefit greatly from it. In Brazil, assessment methods for the incorporation of new technology based on reimbursement or financing have not been fully developed for either the private healthcare plans or the Brazilian Public Healthcare System (SUS). The implementation of new technology in both healthcare systems is a slow process and frequently the implementation is a result of the requirements of patients or the organizations that represent them and at times is the result of legal proceedings or political pressure imposed by physicians and their respective scientific societies. Our objective is to review the evolution of percutaneous coronary intervention (PCI) in Brazil and its current status in view of the advent of drug-eluting stents, the growing participation of drug-eluting stents in myocardial revascularization to treat patients with coronary heart disease, as well as, to compare the regulatory standards from Brazil and other countries regarding the incorporation and recommendations for the use of this new technology.

Influência do diabete melito nos resultados imediatos do implante de stent coronário: uma análise dos dados da Central Nacional de Intervenções Cardiovasculares (CENIC)

OBJECTIVE: This study sought to investigate the influence of Diabetes Mellitus (DM) on immediate results after coronary stenting implantation (CSI) according to clinical presentation. METHODS: Between January, 1997 and December, 2003, 11,874 diabetic patients underwent CSI, as recorded by CENIC database: 7,386 (62.3%) had chronic coronary disease (CCD); 3,142 (26.4%) acute coronary syndrome with non-ST segment elevation (ACSNST); and 1,346 (11.3%), reported acute myocardial infarction (AMI), with ST Segment elevation. Those groups were compared with 48,103 non-diabetics: 30,980 (64.5%) with CCD; 10,938 (22.7%), with non-elevated ST segments and unstable angina; and 6,185 (12.8%), with AMI. RESULTS: Diabetic patients presented worse clinical and angiographic characteristics. Diabetics with CCD showed similar incidence of MACE as compared to non-diabetics (0.98% x 0.91%, p=0.5971); however, diabetics with ACSNST and AMI reported higher incidence of events: 2.76% x 1.46% (p<0.0001) and 7.87% x 4.1% (p<0.0001), respectively. Multivariate analysis showed DM to act as independent risk predictor for larger adverse events under non-elevated ST segment and unstable angina (ACSNST) (OR: 1.92 CI: 1.46-2.52 p<0.0001) and with AMI (OR: 2.0 CI: 1.57-2.54 p<=0.0001) and no influence for CCD (OR: 1.08 CI: 0.83-1.42 p=0.5470 CONCLUSION: Diabetic patients with CCD reported similar outcome as compared to the non-diabetics; however, those with ACSNST and AMI presented higher incidence of major adverse cardiac events during hospital stay.

Changes in P-wave after percutaneous mitral valvuloplasty in patients with mitral stenosis and left atrial enlargement.

OBJECTIVE: To investigate potential clinical, echocardiographic and/or hemodynamic predictors of the regression of electrocardiographic (ECG) signs of left atrial enlargement (LAE) after successful percutaneous mitral valvuloplasty (PMV). METHODS: We studied 24 patients (75% female, mean age =37.1 ± 11.9 years) with moderate to severe mitral stenosis (MS), sinus rhythm (SR) and ECG signs of LAE who underwent successful PMV between 2002 and 2004. At least 6 months after the procedure (388.2 ± 192.9 days), the patients returned for clinical, ECG and echocardiographic follow-up. They were then divided in 2 groups: patients of group 1 (n = 8; 33.3%) still had ECG signs of LAE, and patients of group 2 (n = 16; 66.6%), had normal P wave. A multivariate analysis of clinical, ECG, echocardiographic and hemodynamic variables was performed. RESULTS: The mitral valve area (MVA) increased from 1.12 ± 0.15 cm2 to 1.9 ± 0.35 cm2 immediately after the procedure (p 1.7 cm2 at follow-up was the only independent predictor of a normal P-wave after PMV (p=0.02). CONCLUSION: ECG changes suggestive of LAE regress in the majority of patients with MS and sinus rhythm that undergo a successful PMV. An MVA>1.7 cm2 at late follow-up was found to be an independent predictor of such normalization.OBJECTIVE To investigate potential clinical, echocardiographic and/or hemodynamic predictors of the regression of electrocardiographic (ECG) signs of left atrial enlargement (LAE) after successful percutaneous mitral valvuloplasty (PMV). METHODS We studied 24 patients (75% female, mean age =37.1 +/- 11.9 years) with moderate to severe mitral stenosis (MS), sinus rhythm (SR) and ECG signs of LAE who underwent successful PMV between 2002 and 2004. At least 6 months after the procedure (388.2 +/- 192.9 days), the patients returned for clinical, ECG and echocardiographic follow-up. They were then divided in 2 groups: patients of group 1 (n = 8; 33.3%) still had ECG signs of LAE, and patients of group 2 (n = 16; 66.6%), had normal P wave. A multivariate analysis of clinical, ECG, echocardiographic and hemodynamic variables was performed. RESULTS The mitral valve area (MVA) increased from 1.12 +/- 0.15 cm2 to 1.9 +/- 0.35 cm2 immediately after the procedure (p < 0.0001) and decreased to 1.89 +/- 0.41 cm2 at follow-up (p = NS). Left atrium diameter decreased from 48 +/- 2.9 mm pre-procedure to 43 +/- 4.8 mm at follow-up (p = 0.0001). P-wave duration decreased from 0.12 +/- 0.01 sec pre-PMV to 0.09 +/- 0.02 sec at follow-up (p = 0.0001). An MVA > or = 1.7 cm2 at follow-up was the only independent predictor of a normal P-wave after PMV (p=0.02). CONCLUSION ECG changes suggestive of LAE regress in the majority of patients with MS and sinus rhythm that undergo a successful PMV. An MVA > or = 1.7 cm2 at late follow-up was found to be an independent predictor of such normalization.

Randomized comparison between Inoue balloon and metallic commissurotome in the treatment of rheumatic mitral stenosis: immediate results and 6-month and 3-year follow-up.

The metallic commissurotome (MC) technique is a cheaper alternative to the Inoue balloon (IB) technique for percutaneous mitral valvuloplasty (PMV). There are no randomized trials comparing these techniques with longer follow‐up of the patients. The objective of this study was to compare the immediate results and short‐ and medium‐term follow‐up of PMV using either the IB or the MC technique. Fifty patients with rheumatic mitral stenosis were randomly assigned to PMV using the IB (n = 27) or the MC (n = 23) technique. There were no significant differences between the groups regarding baseline clinical, echocardiographic, and hemodynamic data. Clinical and echocardiographic follow‐up were done 6 months and 3 years after the procedure. The success rate was 100% in the IB group and 91.3% in the MC group (P = 0.15); two patients in the latter group developed mitral regurgitation grade 3/4, requiring elective surgery. The mean final mitral valve area was bigger in the MC group (2.17 ± 0.13 vs. 2.00 ± 0.36 cm2; P = 0.04), but after 6‐month and 3‐year follow‐up, this difference was no longer significant (2.06 ± 0.27 vs. 1.98 ± 0.38 cm2, P = 0.22, and 1.86 ± 0.32 vs. 1.87 ± 0.34 cm2, P = 0.89, respectively). This finding suggests valve stretching as an important mechanism of valve dilation with the MC. Three patients in the MC group and two patients in the IB group (P = 0.65) developed mitral valve restenosis; one of them underwent repeat PMV and the other four, all asymptomatic, were clinically followed. PMV performed either with the IB or the MC technique is effective and provides excellent short‐ and medium‐term outcomes regardless of the technique employed. Catheter Cardiovasc Interv 2005;64:301–311.

Autologous Transplantation of Bone Marrow Adult Stem Cells for the Treatment of Idiopathic Dilated Cardiomyopathy

Background Morbimortality in patients with dilated idiopathic cardiomyopathy is high, even under optimal medical treatment. Autologous infusion of bone marrow adult stem cells has shown promising preliminary results in these patients. Objective Determine the effectiveness of autologous transplantation of bone marrow adult stem cells on systolic and diastolic left ventricular function, and on the degree of mitral regurgitation in patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. Methods We administered 4,54 x 108 ± 0,89 x 108 bone marrow adult stem cells into the coronary arteries of 24 patients with dilated idiopathic cardiomyopathy in functional classes NYHA II and III. Changes in functional class, systolic and diastolic left ventricular function and degree of mitral regurgitation were assessed after 3 months, 6 months and 1 year. Results During follow-up, six patients (25%) improved functional class and eight (33.3%) kept stable. Left ventricular ejection fraction improved 8.9%, 9.7% e 13.6%, after 3, 6 and 12 months (p = 0.024; 0.017 and 0.018), respectively. There were no significant changes neither in diastolic left ventricular function nor in mitral regurgitation degree. A combined cardiac resynchronization and implantable cardioversion defibrillation was implanted in two patients (8.3%). Four patients (16.6%) had sudden death and four patients died due to terminal cardiac failure. Average survival of these eight patients was 2.6 years. Conclusion Intracoronary infusion of bone marrow adult stem cells was associated with an improvement or stabilization of functional class and an improvement in left ventricular ejection fraction, suggesting the efficacy of this intervention. There were no significant changes neither in left ventricular diastolic function nor in the degree of mitral regurgitation.