Five-year follow-up of angiographic disease progression after medicine, angioplasty, or surgery.

BACKGROUND: Progression of atherosclerosis in coronary artery disease is observed through consecutive angiograms. Prognosis of this progression in patients randomized to different treatments has not been established. This study compared progression of coronary artery disease in native coronary arteries in patients undergoing surgery, angioplasty, or medical treatment. METHODS: Patients (611) with stable multivessel coronary artery disease and preserved ventricular function were randomly assigned to CABG, PCI, or medical treatment alone (MT). After 5-year follow-up, 392 patients (64%) underwent new angiography. Progression was considered a new stenosis of ≥ 50% in an arterial segment previously considered normal or an increased grade of previous stenosis > 20% in nontreated vessels. RESULTS: Of the 392 patients, 136 underwent CABG, 146 PCI, and 110 MT. Baseline characteristics were similar among treatment groups, except for more smokers and statin users in the MT group, more hypertensives and lower LDL-cholesterol levels in the CABG group, and more angina in the PCI group at study entry. Analysis showed greater progression in at least one native vessel in PCI patients (84%) compared with CABG (57%) and MT (74%) patients (p < 0.001). LAD coronary territory had higher progression compared with LCX and RCA (P < 0.001). PCI treatment, hypertension, male sex, and previous MI were independent risk factors for progression. No statistical difference existed between coronary events and the development of progression. CONCLUSION: The angioplasty treatment conferred greater progression in native coronary arteries, especially in the left anterior descending territories and treated vessels. The progression was independently associated with hypertension, male sex, and previous myocardial infarction.

Clinical profile of patients enroled in a cell therapy trial for severe coronary artery disease.

AIMS AND OBJECTIVES: To compare the clinical profile of patients included in a clinical trial of autologous bone marrow cells as an adjunctive therapy to coronary artery bypass grafting with that of patients undergoing routine coronary artery bypass grafting. BACKGROUND: The therapeutic potential of autologous bone marrow cells has been explored in the treatment of severe coronary artery disease. There are few data regarding the clinical and socio-economic profile of patients included in clinical trials using bone marrow cell. DESIGN: Case-control study. METHOD: Sixty-seven patients (61 SD 9) years, 82% men) with multivessel coronary artery disease were divided into two groups: patients in the bone marrow cell group (n = 34) underwent incomplete coronary artery bypass grafting + intramyocardial injection of autologous bone marrow cells (lymphomonocytic fraction -2.0 (SD 0.2 x 10(8)) cells/patient) in the ischaemic, non-revascularised myocardium, whereas patients in the coronary artery bypass grafting group (n = 33) underwent routine bypass surgery. Demographics, socio-economic status, clinical and echocardiographic data were collected. Statistical analysis included the Fisher's exact test (categorical variables) and the Student's t-test (continuous variables). RESULTS: There were no significant differences between groups regarding age, gender, BMI, heart rate, blood pressure and echo data. There was a greater prevalence of obesity (65 vs. 33%; OR = 3.7 [1.3-10.1]), of previous myocardial infarction (68 vs. 39%; OR = 3.2 [1.2-8.8]) and prior revascularisation procedures (59 vs. 24%; OR = 4.5 [1.6-12.7]) in the autologous bone marrow cells group and of smokers in the coronary artery bypass grafting group (51 vs. 23%; OR = 3.5 [1.2-10.4]). CONCLUSIONS: Patients included in this clinical trial of autologous bone marrow cells for severe coronary artery disease presented a greater prevalence of myocardial revascularisation procedures, indicating a more severe clinical presentation of the disease. Fewer smokers in this group could be attributable to life style changes after previous cardiovascular events and/or interventions. RELEVANCE TO CLINICAL PRACTICE: The knowledge of the clinical profile of patients included in cell therapy trials may help researchers in the identification of patients that may be enroled in future clinical trials of this new therapeutic strategy.

Intraoperative transesophageal echocardiography in septal hypertrophic cardiomyopathy.

We report the case of a patient with septal hypertrophic cardiomyopathy undergoing surgical correction in which the use of intraoperative transesophageal echocardiography permitted the planning of the surgical approach and an immediate knowledge of the surgical outcome.

Ecocardiografia transesofágica intraoperatória na cardiomiopatia hipertrófica septal / Ecocardiografía transesofágica intraoperatoria en miocardiopatía hipertrófica septal / Intraoperative transesophageal echocardiography in septal hypertrophic cardiomyopathy

Relatamos caso de paciente portador de cardiomiopatia hipertrófica septal submetido a correção cirúrgica em que o emprego da ecocardiografia transesofágica intraoperatória proporcionou o planejamento da abordagem cirúrgica e o reconhecimento imediato do resultado operatório.

We report the case of a patient with septal hypertrophic cardiomyopathy undergoing surgical correction in which the use of intraoperative transesophageal echocardiography permitted the planning of the surgical approach and an immediate knowledge of the surgical outcome.

Relatamos caso de paciente portador de cardiomiopatia hipertrófica septal submetido a correção cirúrgica em que o emprego da ecocardiografia transesofágica intraoperatória proporcionou o planejamento da abordagem cirúrgica e o reconhecimento imediato do resultado operatório.

Keratinocyte growth factor: a new mesothelial targeted therapy to reduce postoperative pericardial adhesions.

BACKGROUND: Several methods have been utilized to prevent pericardial and retrosternal adhesions, but none of them evaluated the mesothelial regenerative hypothesis. There are evidences that the mesothelial trauma reduces pericardial fibrinolytic capability and induces an adhesion process. Keratinocyte growth factor (KGF) has proven to improve mesothelial cells proliferation. This study investigated the influence of keratinocyte growth factor in reducing post-surgical adhesions. METHODS: Twelve pigs were operated and an adhesion protocol was employed. Following a stratified randomization, the animals received a topical application of KGF or saline. At 8 weeks, intrapericardial adhesions were evaluated and a severity score was established. The time spent to dissect the adhesions and the amount of sharp dissection used, were recorded. Histological sections were stained with sirius red and morphometric analyses were assessed with a computer-assisted image analysis system. RESULTS: The severity score was lower in the KGF group than in the control group (11.5 vs 17, p=0.005). The dissection time was lower in the KGF group (9.2+/-1.4 min vs 33.9+/-9.2 min, p=0.004) and presented a significant correlation with the severity score (r=0.83, p=0.001). A significantly less sharp dissection was also required in the KGF group. Also, adhesion area and adhesion collagen were significantly lower in the KGF group than in the control group. CONCLUSION: The stimulation of pericardial cells with KGF reduced the intensity of postoperative adhesions and facilitated the re-operation. This study suggests that the mesothelial regeneration is the new horizon in anti-adhesion therapies.

A randomized comparative study of patients undergoing myocardial revascularization with or without cardiopulmonary bypass surgery: The MASS III Trial.

UNLABELLED: The MASS III Trial is a large project from a single institution, The Heart Institute of the University of Sao Paulo, Brazil (InCor), enrolling patients with coronary artery disease and preserved ventricular function. The aim of the MASS III Trial is to compare medical effectiveness, cerebral injury, quality of life, and the cost-effectiveness of coronary surgery with and without of cardiopulmonary bypass in patients with multivessel coronary disease referred for both strategies. The primary endpoint should be a composite of cardiovascular mortality, cerebrovascular accident, nonfatal myocardial infarction, and refractory angina requiring revascularization. The secondary end points in this trial include noncardiac mortality, presence and severity of angina, quality of life based on the SF-36 Questionnaire, and cost-effectiveness at discharge and at 5-year follow-up. In this scenario, we will analyze the cost of the initial procedure, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events during the follow-up. Exercise capacity will be assessed at 6-months, 12-months, and the end of follow-up. A neurocognitive evaluation will be assessed in a subset of subjects using the Brain Resource Center computerized neurocognitive battery. Furthermore, magnetic resonance imaging will be made to detect any cerebral injury before and after procedures in patients who undergo coronary artery surgery with and without cardiopulmonary bypass. TRIALS REGISTRATION: Clinical Trial registration information ISRCTN59539154 Off-pump vs. on-pump surgery in patients with Stable CAD MASS III.

Intramyocardial injection of autologous bone marrow cells as an adjunctive therapy to incomplete myocardial revascularization--safety issues.

OBJECTIVES: To determine the safety of intramyocardial injection of autologous bone marrow cells in patients undergoing surgical myocardial revascularization (CABG) for severe coronary artery disease. INTRODUCTION: There is little data available regarding the safety profile of autologous bone marrow cells injected during surgical myocardial revascularization. Potential risks include arrythmias, fibrosis in the injected sites and growth of non-cardiac tissues. METHODS: Ten patients (eight men) were enrolled; they were 59+/-5 years old with limiting angina and were non-optimal candidates for complete CABG. Bone marrow cells (1.3+/-0.3x10(8)) were obtained prior to surgery, and the lymphomonocytic fraction (CD34+ =1.8+/-0.3%) was separated by density gradient centrifugation. During surgery, bone marrow cells were injected in non-grafted areas of ischemic myocardium. During the first year after surgery, the patients underwent laboratory tests, cardiac imaging, and 24-hour ECG monitoring. RESULTS: Injected segments: inferior (n=7), anterior (n=2), septal (n=1), apical (n=1), and lateral (n=1) walls. Except for a transient elevation of C-reactive protein at one month post-surgery (P=0.01), laboratory tests results were within normal ranges; neither complex arrhythmias nor structural abnormalities were detected during follow-up. There was a reduction in functional class of angina from 3.6+/-0.8 (baseline) to 1.2+/-0.4 (one year) (P<0.0001). Also, patients had a significant decrease in the ischemic score assessed by magnetic resonance, not only globally from 0.65+/-0.14 (baseline) to 0.17+/-0.05 (one year) (P=0.002), but also in the injected areas from 1.11+/-0.20 (baseline) to 0.34+/-0.13 (one year) (P=0.0009). CONCLUSIONS: Intramyocardial injection of bone marrow cells combined with CABG appears to be safe. Theoretical concerns with arrhythmias and/or structural abnormalities after cell therapy were not confirmed in this safety trial.

Transmyocardial laser revascularization plus cell therapy for refractory angina.

We report that the use of transmyocardial laser revascularization combined with intramyocardial injection is a therapeutic option for patients with severe ischemic heart disease (IHD) not amenable to conventional myocardial revascularization. Recently, cell therapy with autologous bone marrow cells (BMC) has been tested in clinical trials for severe IHD. We tested the hypothesis that TMLR combined with intramyocardial injection of BMC is safe, and may help increase the functional capacity and myocardial perfusion in patients with refractory angina. We enrolled 8 patients (7 men), 64+/-4 years old, with refractory angina, non-candidates for another procedure. TMLR (8+/-2 laser drills) was performed via a limited thoracotomy. BMC were obtained prior to surgery, and the lymphomonocytic fraction was separated by density gradient centrifugation. During surgery, 5 mL containing approximately 1.6+/-0.2 x 10(8) BMC (CD34+=1.7+/-0.4%) was delivered by multiple injections in the ischemic myocardium. We observed a reduction in the ischemic score as assessed by MRI from 1.56+/-0.09 (B) to 0.93+/-0.10 (6M) (P=0.01), as well as a reduction in functional class of angina from 3.6+/-0.2 (B) to 1.4+/-0.2 (6M) (P<0.0001). We concluded that, in this early experience, the combined strategy of TMLR plus cell therapy appeared to be safe, and may have synergistically acted to reduce myocardial ischemia, with clinically relevant improvement in functional capacity.

Intramyocardial injection of autologous bone marrow cells as an adjunctive therapy to incomplete myocardial revascularization: safety issues

OBJECTIVES: To determine the safety of intramyocardial injection of autologous bone marrow cells in patients undergoing surgical myocardial revascularization (CABG) for severe coronary artery disease. INTRODUCTION: There is little data available regarding the safety profile of autologous bone marrow cells injected during surgical myocardial revascularization. Potential risks include arrythmias, fibrosis in the injected sites and growth of non-cardiac tissues. METHODS: Ten patients (eight men) were enrolled; they were 59±5 years old with limiting angina and were non-optimal candidates for complete CABG. Bone marrow cells (1.3±0.3x10(8)) were obtained prior to surgery, and the lymphomonocytic fraction (CD34+=1.8±0.3 percent) was separated by density gradient centrifugation. During surgery, bone marrow cells were injected in non-grafted areas of ischemic myocardium. During the first year after surgery, the patients underwent laboratory tests, cardiac imaging, and 24-hour ECG monitoring. RESULTS: Injected segments: inferior (n=7), anterior (n=2), septal (n=1), apical (n=1), and lateral (n=1) walls. Except for a transient elevation of C-reactive protein at one month post-surgery (P=0.01), laboratory tests results were within normal ranges; neither complex arrhythmias nor structural abnormalities were detected during follow-up. There was a reduction in functional class of angina from 3.6±0.8 (baseline) to 1.2±0.4 (one year) (P<0.0001). Also, patients had a significant decrease in the ischemic score assessed by magnetic resonance, not only globally from 0.65±0.14 (baseline) to 0.17±0.05 (one year) (P=0.002), but also in the injected areas from 1.11±0.20 (baseline) to 0.34±0.13 (one year) (P=0.0009). CONCLUSIONS: Intramyocardial injection of bone marrow cells combined with CABG appears to be safe. Theoretical concerns with arrhythmias and/or structural abnormalities after cell therapy...

Dynamic regulation of MTHFR mRNA expression and C677T genotype modulate mortality in coronary artery disease patients after revascularization.

INTRODUCTION: A large body of evidence links plasma homocysteine (Hcy) concentrations and cardiovascular disease. A common MTHFR polymorphism (C677T) leads to a variant with reduced activity and associated with increased Hcy levels. Coronary surgery precipitates a significant and sustained increase in the blood concentrations of Hcy and elevated levels of plasma Hcy have been associated to saphenous vein (SV) graft disease after CABG. However, the effects of MTHFR genotypes in the incidence of cardiovascular events after CABG have not been investigated prospectively. Here, we investigate whether MTHFR gene variants are associated with an increased cardiovascular risk in individuals submitted to CABG. We also propose a molecular mechanism to explain our findings. METHODS: We performed MTHFR C677T genotypes in 558 patients with two or three vessel-disease and normal left ventricular function prospectively followed in the MASS II Trial, a randomized study to compare treatments for multivessel CAD and preserved left ventricle function. Follow-up time was 5 years. Survival curves were calculated with the Kaplan-Meier method, and evaluated with the log-rank statistic. We assessed the relationship between baseline variables and the composite end-point of death, myocardial infarction and refractory angina using a Cox proportional hazards survival model. Finally, using an ex-vivo organ culture we have reproduced the arterialization of SV implants by culturing human SV either under venous hemodynamic condition (flow: 5 mL/min; no pressure) or arterial hemodynamic condition (flow: 50 mL/min; pressure: 80 mm Hg) for 1 day. MTHFR gene expression was quantified by real time RT-PCR in 15 SV from different individuals in both experimental conditions. RESULTS: There were no significant differences among individuals within each genotype group for baseline clinical characteristics. A statistically significant association between the TT genotype, associated with increased serum levels of Hcy, and cardiovascular mortality after 5 years was verified (p=0.007) in individuals submitted to CABG surgery. In addition, MTHFR TT genotype was still significantly associated with a 4.4 fold increased risk in cardiovascular outcomes (p=0.01) even after adjustment of a Cox multivariate model for age, sex, hypertension, diabetes, LDL, HDL, triglycerides, and number of diseased vessels in this population. Finally, a significant reduction in MTHFR gene expression was demonstrated in human SV when submitted to an arterial hemodynamic condition (p=0.02). CONCLUSIONS: There is a dynamic regulation of MTHFR gene expression during the arterialization process of human saphenous vein grafts resulting in lower levels of gene expression when in an arterial hemodynamic condition. In addition, the C677T MTHFR functional variant is associated with a worse outcome in individuals submitted to CABG. Taken together, these data suggest an important role of Hcy metabolism in individuals after CABG.

Single-lung ventilation with contralateral lung deflation: a simplified method for multivessel off-pump coronary artery bypass grafting.

There are many new alternative methods of minimally invasive myocardial revascularization that can be applied in selected patients who have multivessel coronary artery disease. However, these techniques often require new and expensive equipment. Most multivessel myocardial revascularization is performed via median sternotomy and involves the use of a conventional endotracheal tube. Both lungs are ventilated, and frequently the left pleural cavity is opened. In contrast, single-lung deflation naturally moves the mediastinum within the thorax toward the collapsed lung, without the need to open the pleural cavities. Herein, we describe a simple alternative procedure that facilitates off-pump multivessel coronary artery bypass grafting via complete median sternotomy: single-lung ventilation with contralateral lung deflation. This technique better exposes the more distal right and circumflex coronary artery branches with or without the opening of the pleural cavities.

Five-year follow-up of the Medicine, Angioplasty, or Surgery Study (MASS II): a randomized controlled clinical trial of 3 therapeutic strategies for multivessel coronary artery disease.

BACKGROUND: Despite routine use of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), no conclusive evidence exists that either modality is superior to medical therapy (MT) alone for treating multivessel coronary artery disease with stable angina and preserved ventricular function. METHODS AND RESULTS: The primary end points were total mortality, Q-wave myocardial infarction, or refractory angina requiring revascularization. The study comprised 611 patients randomly assigned to undergo CABG (n=203), PCI (n=205), or MT (n=203). At the 5-year follow-up, the primary end points occurred in 21.2% of patients who underwent CABG compared with 32.7% treated with PCI and 36% receiving MT alone (P=0.0026). No statistical differences were observed in overall mortality among the 3 groups. In addition, 9.4% of MT and 11.2% of PCI patients underwent repeat revascularization procedures compared with 3.9% of CABG patients (P=0.021). Moreover, 15.3%, 11.2%, and 8.3% of patients experienced nonfatal myocardial infarction in the MT, PCI, and CABG groups, respectively (P<0.001). The pairwise treatment comparisons of the primary end points showed no difference between PCI and MT (relative risk, 0.93; 95% confidence interval, 0.67 to 1.30) and a significant protective effect of CABG compared with MT (relative risk, 0.53; 95% confidence interval, 0.36 to 0.77). CONCLUSIONS: All 3 treatment regimens yielded comparable, relatively low rates of death. MT was associated with an incidence of long-term events and rate of additional revascularization similar to those for PCI. CABG was superior to MT in terms of the primary end points, reaching a significant 44% reduction in primary end points at the 5-year follow-up of patients with stable multivessel coronary artery disease.

Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study.

BACKGROUND: Cardiovascular 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/DESIGN: We 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 Simpson's 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. DISCUSSION: Many 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).

Valor do índice de risco cardiovascular na detecção de doença aterosclerótica determinada pela ultra-sonografia dos vasos supra-aórticos / Value of cardiovascular risk index for the detection of atherosclerotic disease determined by duplex scan of supra-aortic vessels

A detecção não invasiva de doença aterosclerótica pela ultra-sonografia tradicionalmente é feita pelo Duplex em território das artérias carótidas, não havendo anteriores de avaliação no tronco braquiocefálico (TBC). Objetivo: estudar a correlação entre a presença de doenças aterosclerótica determinada pelo Duplex dos vasos supra-aórticos com os escores de risco de Framingham e a prevalência de síndrome metabólica...

Impact of diabetes on five-year outcomes of patients with multivessel coronary artery disease.

BACKGROUND: Diabetes mellitus is a major cause of coronary artery disease. Despite improvement in the management of patients with stable coronary artery disease, diabetes remains a major cause of increased morbidity and mortality. Although coronary artery bypass grafting surgery (CABG) and percutaneous coronary intervention are widely used, no conclusive evidence exists that either treatment modality is better than medical therapy alone for the treatment of stable single- or multivessel coronary disease in patients with diabetes. METHODS: We compared medical therapy, percutaneous coronary intervention, and CABG in 499 diabetic patients (38.5%) and 799 nondiabetic patients (61.5%) with single- or multivessel coronary disease. The composite primary endpoint was cardiac-related death, Q-wave myocardial infarction, or refractory angina requiring revascularization. RESULTS: We treated 1,298 patients with either CABG (n = 524), percutaneous coronary intervention (n = 378), or medical therapy (n = 396). More deaths occurred among patients with diabetes than among patients without diabetes, regardless of which option was used (p < 0.001). When treatment modalities were stratified according to the number of diseased vessels, CABG was shown to be more beneficial for patients with diabetes and multivessel disease than for patients with diabetes and single-vessel disease (p < 0.001). However, when stratified by treatment, patients with diabetes receiving medical therapy had a worse prognosis than patients with diabetes treated with CABG (p = 0.005). CONCLUSIONS: All three therapeutic regimens resulted in high rates of cardiac-related deaths among patients with diabetes compared with patients without diabetes. Moreover, we observed better outcomes among patients with diabetes and multivessel coronary artery disease undergoing CABG regarding the primary endpoint at 5-year follow-up.

Holt-Oram syndrome presenting as agenesis of the left pericardium.

We report on a case of a 60-year-old man with progressive heart failure, mitral and aortic valve insufficiency and bilateral asymmetrical skeletal upper-limb deformities. Central to the suspicion of Holt-Oram syndrome in this patient was the surgical finding of agenesis of the left pericardium. A Holt-Oram syndrome diagnostic was confirmed through molecular analysis of the TBX5 gene. A new amino acid substitution at position 61 of the TBX5 gene was identified and confirmed the clinical diagnosis of Holt-Oram syndrome. The clinical presentation of the present case broadens the clinical spectrum of Holt-Oram syndrome and point out the importance of Tbx 5 in pericardium development. It is still an unstudied issue whether TBX5 mutations may also be present in other clinical presentations where absence of the pericardium is a feature.

Long-term follow up of the Biocor porcine bioprosthesis in the mitral position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to review the long-term results of mitral valve replacement (MVR) with the Biocor porcine bioprosthesis, in order to investigate patient survival and valve-related complications. METHODS: Data were presented for 546 patients (320 females, 226 males; mean age 49.2 +/- 17.1 years) who underwent MVR with the Biocor porcine bioprosthesis between March 1983 and December 2000. Preoperatively, rheumatic fever was present in 42.3% of patients. Associated procedures were performed in 179 patients (32.7%), and myocardial revascularization in 54 (9.9%). Preoperatively, 41.9% of patients were in NYHA class IV. Postoperative follow up was conducted by telephone interviews, questionnaires, or examination of hospital records. RESULTS: The hospital mortality was 9.5% (n=52); of these patients, 30 died after their first MVR and 22 after mitral reoperation. Mortality after isolated MVR was 7.6%. The total follow up was 2,148.9 patient-years, and actuarial survival was 45.0 +/- 15.8% at 15 years. Freedom from structural valve deterioration (SVD) was 51.8 +/- 13.8% for patients aged <50 years, 88.7 +/- 5.1% for those aged 51-60 years, and 84.0 +/- 9.8% for those aged 61-80 years. The incidence of prosthetic valve endocarditis was low, with 88.8 +/- 6.1% non-recurrence in 15 years. Freedom from reoperation was 33.9 +/- 10.4%, and from thromboembolism was 82.3 +/- 15.0%. Freedom from valve-related mortality was 80.7 +/- 12.5% during a 15-year period. CONCLUSION: The 15-year clinical results with the Biocor porcine bioprosthesis in the mitral position were excellent in a young, predominantly rheumatic, patient population which, preoperatively, was in a grave clinical condition. The incidence of valve-related complications was low, as was that of SVD in patients aged >50 years.

Clinical judgment and treatment options in stable multivessel coronary artery disease: results from the one-year follow-up of the MASS II (Medicine, Angioplasty, or Surgery Study II).

OBJECTIVES: This study examined the predictive power of clinical judgment in the incidence of cardiovascular end points in a group of individuals with multivessel coronary artery disease (CAD) followed up in the MASS II (Medicine, Angioplasty, or Surgery Study II). BACKGROUND: There is still no consensus on the best treatment for patients with stable multivessel CAD and preserved left ventricular function. METHODS: Preferred treatment allocation was recorded for each of the 611 randomized patients in the MASS II trial before randomization. We have divided our sample according to physician-guided decision and randomization result into two categories: concordant or discordant. The incidence of the points of cardiac death, myocardial infarction, and refractory angina was compared between concordant and discordant patients. RESULTS: The number of concordant individuals was 292 (48.2%), and this number was not different between the three studied treatments (p = 0.11). A significant difference (p = 0.02) was disclosed because of an increased incidence of combined end point events in discordant patients. In the multivariate Cox hazard model, clinical judgment was a powerful predictor of outcome (p = 0.01) even after adjustment for other covariates. The main subgroup explaining this difference was a significant shift toward a worse outcome in the subgroup of discordant patients who underwent percutaneous coronary intervention (PCI) (p = 0.003). CONCLUSIONS: Angiographic variables were more often used in making clinical decisions regarding PCI than clinical variables, and the only independent predictor of concordance status in the PCI group was the number of diseased vessels (p = 0.01). Our data are a reminder that physician judgment remains an important predictor of outcomes.

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). CONCLUSIONS: 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.

Co-infection ratios versus inflammation, growth factors and progression of early atheromas.

Mycoplasma pneumoniae (MP) and Chlamydophila pneumoniae (CP) antigens are encountered in complicated atheromas and may be implicated in the diversity of atherosclerotic lesions. Mycoplasma can downregulate the immune system, altering levels of inflammation, which may favor the proliferation of other co-infectious agents. In the present study we analyze whether initially stable human atheromas exhibit different ratios of MP/CP antigens compared to ongoing atheromatous lesions. Two groups were examined for the presence of inflammatory cells, macrophages, growth factors and infectious agents: Group I (GI), n=16, early stable atheromas, <4 CD68(+) macrophages/400 x field, showing a normal distribution and a fibrous cap; Group II (GII), n=14, growing atheromas, > or =4 CD68+ cells/400 x field, lacking a fibrous cap, showing a non-normal macrophage distribution. The amounts of CP (but not MP) antigens and lymphocytes in GI were significantly lower than in GII. MP/CP ratios were higher in GI. MP correlated with CP and PDGFB in GI (r=0.79 and r=0.83, p<0.001), but not in GII (r=-0.4 and r=-0.08, p=0.81). MP and CP antigens are already present in early atheromas, and a higher MP/CP ratio correlates with increased growth factors, lower inflammation and plaque stability.