Sérgio Almeida de Oliveira

The Medicine, Angioplasty or Surgery Study (MASS): A prospective, randomized trial of medical therapy, balloon angioplasty or bypass surgery for single proximal left anterior descending artery stenoses

OBJECTIVES This study sought to evaluate, in a prospective and randomized trial, the relative efficacies of three possible therapeutic strategies for patients with a single severe proximal stenosis of the left anterior descending coronary artery and stable angina. BACKGROUND Although percutaneous transluminal coronary angioplasty and coronary artery bypass surgery are often performed in patients with a single proximal stenosis of the left anterior descending coronary artery, it is unclear whether revascularization offers greater clinical benefit than medical therapy alone. METHODS At a single center, 214 patients with stable angina, normal ventricular function and a proximal stenosis of the left anterior descending coronary artery > 80% were randomly assigned to undergo mammary bypass surgery (n = 70), balloon angioplasty (n = 72) or medical therapy alone (n = 72). Angioplasty had to be considered technically feasible in every case. The predefined primary study end point was the combined incidence of cardiac death, myocardial infarction or refractory angina requiring revascularization. RESULTS At an average follow-up period of 3 years, a primary end point had occurred in only 2 patients (3%) assigned to bypass surgery compared with 17 assigned to angioplasty (24%) and 12 assigned to medical therapy (17%) (p = 0.0002, angioplasty vs. bypass surgery; p = 0.006, bypass surgery vs. medical treatment; p = 0.28, angioplasty vs. medical treatment, all by log-rank test). There was no difference in mortality or infarction rates among the groups. However, no patient allocated to bypass surgery needed revascularization, compared with eight and seven patients assigned, respectively, to coronary angioplasty and medical treatment (p = 0.019). Both revascularization techniques resulted in greater symptomatic relief and a lower incidence of ischemia on the treadmill test; however, all three strategies eventually resulted in the abolition of limiting angina. CONCLUSIONS The more aggressive therapeutic approach with initial bypass surgery for patients with a single severe proximal stenosis of the left anterior descending coronary artery is associated with a lower incidence of medium-term adverse events than coronary angioplasty or medical treatment. However, all three strategies resulted in a similar incidence of death and infarction during an average follow-up period of 3 years. This information should be taken into consideration when physicians and patients make therapeutic choices in this setting.

Assessment of the pulmonary vascular blood supply in patients with pulmonary atresia, ventricular septal defect, and aortopulmonary collateral arteries

OBJECTIVE: To study the morphometric characteristics of the central pulmonary arteries and aortopulmonary collateral arteries by assessing the morphology of the pulmonary vascular blood supply, to determine their significance in surgical treatment. METHOD: From January 1990 to June 2001, 40 patients were studied. Those who had the complete cineangiocardiographic study prior to the first surgical intervention were included in the study. The morphometric characteristics of the central pulmonary arteries (PPAA) and aortopulmonary collateral arteries (APCA) were analyzed, as was the distribution of blood irrigation to the lungs. The following indices were calculated: pulmonary arterial index (PPAAI), aortopulmonary collateral arterial index (APCAI), and total neopulmonary arterial index (TNPAI = PPAAI + APCAI). The surgical treatment was considered palliative (PT), palliative definitive (PDT), and definitive (DT). RESULTS: The palliative treatment predominated. No statistically significant differences were observed in the patients undergoing PT, PDT, and DT, in regard to PPAAI, APCAI, and TNPAI. Comparing PPAAI and APCAI, no difference was observed for DT (P=0.4309); APCAI was greater than PPAAI for PT (P=0.0176); and APCAI was descriptively greater for PDT. The TNPAI of patients undergoing DT was greater than that of patients undergoing PT (P=0.0959). Five morphologically similar subgroups were identified and designated as B1, B2, B3, B4, and B5. Overall mortality was 17.5%. CONCLUSION: The morphometric characteristics are important, but the morphology of the pulmonary vascular blood supply of the PPAA and APCA proved to be better for guiding the surgical treatment. Independently of the didactical division into subgroups, PT predominated. Mortality was not correlated with the morphometric characteristics.

Effectiveness of the Maze Procedure Using Cooled-Tip Radiofrequency Ablation in Patients With Permanent Atrial Fibrillation and Rheumatic Mitral Valve Disease

Background—Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation (AF), its high complexity limits its use. The Saline-Irrigated Cooled-tip Radiofrequency Ablation (SICTRA) System is an alternative source of energy used to ablate AF. The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve (MV) disease. Methods and Results—Between February 2002 and April 2003, 70 patients with permanent AF and rheumatic MV disease were randomly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery (group A) or MV surgery alone (group B). Groups A and B were similar in terms of baseline characteristics. The in-hospital mortality rate was 2.3% (1 death) in group A versus 0% (no deaths) in group B (P>0.99). The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes. The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months, respectively, in groups A and B. The overall mid-term survival rate was 95.1% in group A and 92.8% in group B (P>0.99). The cumulative rates of sinus rhythm were 79.4% in group A and 26.9% in group B (P=0.001). Doppler echocardiography documented biatrial transport function in 90.3% of group A patients in sinus rhythm. Conclusions—The SICTRA is effective for treating permanent AF associated with rheumatic MV disease.

The body mass index and level of resection: predictive factors for compensatory sweating after sympathectomy.

ObjectiveCompensatory sweating (CS) is the most common adverse event and the main cause of dissatisfaction among patients undergoing a VATS sympathectomy for the treatment of primary hyperhidrosis. It has been described that obese individuals experience more sweating than thinner ones. The aim of this study is to identify the Body Mass Index (BMI) and the level of resection as predictive factors for CS and its relation to levels of patient satisfaction following the procedure.MethodsFrom October 1998 to June 2003, 102 patients undergoing VATS sympathectomies (51 for palmar hyperhidrosis, PH, and 51 for axillary hyperhidrosis, AH) were prospectively surveyed. They were divided into three groups according to their BMI: Group I was composed of 19 patients with BMI<20 (9 patients with PH and 10 with AH); Group II was composed of 52 patients with 20 ≤BMI<25 (25 with PH and 27 with AH); and Group III was composed of 31 patients with BMI ≥ 25 (17 with PH and 14 with AH). Each procedure was simultaneously and bilaterally performed under general anesthesia using two 5.5mm trocars and a 30° optic system.ResultsPatients treated for PH (resection of T2-T3) had more severe CS than those with AH (resection of T3-T4) (p=0.007) and the greater the BMI, the greater the severity of the CS (p<0.001). No statistically significant difference was found between the BMI bands in relation to the degree of satisfaction (p=0.644), nor when we compared the degree of satisfaction to the degree of CS (p=0.316).ConclusionsThe greater the BMI, the more severe the CS, but this did not correlate with the patients’ level of satisfaction. Avoiding the resection of T2 sympathetic ganglia is also important in reducing the intensity of CS.

Surgical Ventricular Restoration: The RESTORE Group Experience

Congestive heart failure may be caused by late left ventricular (LV) dilation following anterior infarction. Early reperfusion prevents transmural necrosis, and makes the infarcted segment akinetic rather than dyskinetic. Surgical ventricular restoration (SVR) reduces LV volume and creates a more elliptical chamber by excluding scar in either akinetic or dyskinetic segments.The international RESTORE group applied SVR in a registry of 1198 post-infarction patients between 1998 and 2003. Early and late outcomes were examined and risk factors identified.Concomitant procedures included coronary artery bypass grafting in 95%, mitral valve repair in 22%, and mitral valve replacement in 1%. Overall 30-day mortality after SVR was 5.3% (8.7% with mitral repair vs. 4.0% without repair, p < .001) Perioperative mechanical support was uncommon (< 9%).Global systolic function improved postoperatively, as ejection fraction increased from 29.6 ± 11.0% to 39.5 ± 12.3% (p < .001) and left ventricular end systolic volume index decreased from 80.4 ± 51.4 ml/m2 to 56.6 ± 34.3 ml/m2 (p < .001). Overall 5-year survival was 68.6 ± 2.8%, Logistic regression analysis identified EF ≤ 30%, LVESVI ≥ 80 ml/m2, advanced NYHA functional class, and age ≥75 years as risk factors for death. Five-year freedom from hospital readmission for CHF was 78%. Preoperatively, 67% of patients were class III or IV, and postoperatively 85% were class I or II.SVR improves ventricular function and is highly effective therapy in the treatment of ischemic cardiomyopathy with excellent 5-year outcome.

Coronary Revascularization (Surgical or Percutaneous) Decreases Mortality After the First Year in Diabetic Subjects but not in Nondiabetic Subjects With Multivessel Disease An Analysis From the Medicine, Angioplasty, or Surgery Study (MASS II)

Background— It is currently unknown whether revascularization procedures are associated with an improvement in mortality among diabetic subjects, as compared with a more conservative medical treatment. Methods and Results— In MASS II, a total of 611 patients with stable multivessel coronary disease were randomly assigned to medical treatment, surgery, or angioplasty. From these, 190 patients had diabetes (medical, 75 patients; angioplasty, 56 patients; surgery, 59 patients) and comprised the present study population. Mortality rates were analyzed for the entire 5 years of follow-up. Separate analyzes were also performed for mortality at 2 time intervals: during the first year and after the first year of follow-up. We calculated the probability of death conditional on surviving to the start of the interval analyzed. The cumulative 5-year mortality as well as the mortality during the first year of follow-up was not significantly different among treatment groups, both for diabetic and for nondiabetic subjects. Also, during years 2 to 5, the mortality of the 3 treatment groups was not different for nondiabetic subjects. Among diabetic subjects, however, patients randomized to angioplasty or surgery had a significantly lower mortality between years 2 and 5 than those allocated to medical treatment (P=0.039). Conclusion— Surgery, angioplasty, and medical treatment appear to be associated with similar mortality rates for non-diabetic subjects. For diabetic subjects, however, coronary revascularization (percutaneous or surgical) significantly decreased the risk of death after the first year and up to 5 years, compared with medical treatment alone.

Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

BackgroundCardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials.Method/DesignWe have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpsons rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group.DiscussionMany phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies.The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT00333827), acute myocardial infarction (NCT00350766) and Chronic Ischemic Heart Disease (NCT00362388).

New lead for in utero pacing for fetal congenital heart block

Complete heart block occurs in 4% to 15% of cases of fetal arrhythmia. Although it is usually well tolerated in the absence of complicating cardiac anomalies, as many as 25% of these fetuses have hydrops and die in utero. The pathophysiologic arguments for fetal ventricular pacing are compelling. We describe the case of a fetus presenting with complete heart block, hydrops, and associated structural heart defects, the mother of whom consented to attempts at in utero pacing. The purpose of this article is to describe a new lead for percutaneous implantation that minimizes surgical trauma to both the fetus and the mother.

Relative Cost Comparison of Treatments for Coronary Artery Disease: The First Year Follow-Up of MASS II Study

Background—Prior comparisons of costs following CABG and PTCA have demonstrated higher initial costs after CABG but following PTCA, recurrent symptoms and repeat revascularization result in increased late costs and over time their costs equilibrate. The MASS II trial provides an opportunity to compare the costs of CABG and PTCA in addition to a strategy of medical therapy. Methods—We studied the 611 patients of MASS II [Medical (203), Angioplasty (205), or Surgery (203) Study], a randomized study to compare treatments for multivessel CAD and preserved left ventricle function. The costs were: CABG US

Multivariate analysis of risk factors for hospital mortality in valvular reoperations for prosthetic valve dysfunction

10 650.00; PTCA US