Long-term outcomes of patients with stable coronary disease and chronic kidney dysfunction: 10-year follow-up of the Medicine, Angioplasty, or Surgery Study II Trial.

BACKGROUND: Chronic kidney disease (CKD) is associated with a worse prognosis in patients with stable coronary artery disease (CAD); however, there is limited randomized data on long-term outcomes of CAD therapies in these patients. We evaluated long-term outcomes of CKD patients with CAD who underwent randomized therapy with medical treatment (MT) alone, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). METHODS: Baseline estimated glomerular filtration rate (eGFR) was obtained in 611 patients randomized to one of three therapeutic strategies in the Medicine, Angioplasty, or Surgery Study II trial. Patients were categorized in preserved renal function and mild or moderate CKD groups depending on their eGFR (≥90, 89-60 and 59-30 mL/min/1.73 m2, respectively). The primary clinical endpoint, a composite of overall death and myocardial infarction, and its individual components were analyzed using proportional hazards regression (Clinical Trial registration information: http://www.controlled-trials.com. Registration number: ISRCTN66068876). RESULTS: Of 611 patients, 112 (18%) had preserved eGFR, 349 (57%) mild dysfunction and 150 (25%) moderate dysfunction. The primary endpoint occurred in 29.5, 32.4 and 44.7% (P = 0.02) for preserved eGFR, mild CKD and moderate CKD, respectively. Overall mortality incidence was 18.7, 23.8 and 39.3% for preserved eGFR, mild CKD and moderate CKD, respectively (P = 0.001). For preserved eGFR, there was no significant difference in outcomes between therapies. For mild CKD, the primary event rate was 29.4% for PCI, 29.1% for CABG and 41.1% for MT (P = 0.006) [adjusted hazard ratio (HR) = 0.26, 95% confidence interval (CI) 0.07-0.88; P = 0.03 for PCI versus MT; and adjusted HR = 0.48; 95% CI 0.31-0.76; P = 0.002 for CABG versus MT]. We also observed higher mortality rates in the MT group (28.6%) compared with PCI (24.1%) and CABG (19.0%) groups (P = 0.015) among mild CKD subjects (adjusted HR = 0.44, 95% CI 0.25-0.76; P = 0.003 for CABG versus MT; adjusted HR = 0.56, 95% CI 0.07-4.28; P = 0.58 for PCI versus MT). Results were similar with moderate CKD group but did not achieve significance. CONCLUSIONS: Coronary interventional therapy, both PCI and CABG, is associated with lower rates of events compared with MT in mild CKD patients >10 years of follow-up. More study is needed to confirm these benefits in moderate CKD.

Behavior of ultrasensitive c-reactive protein in myocardial revascularization with and without cardiopulmonary bypass

Abstract Objective: To analyze the inflammation resulting from myocardial revascularization techniques with and without cardiopulmonary bypass, based on ultrasensitive C-reactive protein (US-CRP) behavior. Methods: A prospective non-randomized clinical study with 136 patients was performed. Sixty-nine patients were enrolled for Group 1 (on-pump coronary artery bypass - ONCAB) and 67 patients were assigned to Group 2 (off-pump coronary artery bypass - OPCAB). All study participants had blood samples collected for analysis of glucose, triglycerides, creatinine, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and creatinephosphokinase (CPK) in the preoperative period. The samples of creatinephosphokinase MB (CKMB), troponin I (TnI) and US-CRP were collected in the preoperative period and at 6, 12, 24, 36, 48 and 72 hours after surgery. We also analyzed the preoperative biological variables of each patient (age, smoking, diabetes mellitus, left coronary trunk lesion, body mass index, previous myocardial infarction, myocardial fibrosis). All angiographically documented patients with >70% proximal multiarterial stenosis and ischemia, documented by stress test or classification of stable angina (class II or III), according to the Canadian Cardiovascular Society, were included. Reoperations, combined surgeries, recent acute myocardial infarction, recent inflammatory disease, deep venous thrombosis or recent pulmonary thromboembolism, acute kidney injury or chronic kidney injury were not included. Results: Correlation values between the US-CRP curve and the ONCAB group, the treatment effect and the analyzed biological variables did not present expressive results. Laboratory variables were evaluated and did not correlate with the applied treatment (P>0.05). Conclusion: The changes in the US-CRP at each moment evaluated from the postoperative period did not show any significance in relation to the surgical technique applied.

Behavior of Ultrasensitive C-Reactive Protein in Myocardial Revascularization with and without Cardiopulmonary Bypass.

OBJECTIVE: To analyze the inflammation resulting from myocardial revascularization techniques with and without cardiopulmonary bypass, based on ultrasensitive C-reactive protein (US-CRP) behavior. METHODS: A prospective non-randomized clinical study with 136 patients was performed. Sixty-nine patients were enrolled for Group 1 (on-pump coronary artery bypass - ONCAB) and 67 patients were assigned to Group 2 (off-pump coronary artery bypass - OPCAB). All study participants had blood samples collected for analysis of glucose, triglycerides, creatinine, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and creatinephosphokinase (CPK) in the preoperative period. The samples of creatinephosphokinase MB (CKMB), troponin I (TnI) and US-CRP were collected in the preoperative period and at 6, 12, 24, 36, 48 and 72 hours after surgery. We also analyzed the preoperative biological variables of each patient (age, smoking, diabetes mellitus, left coronary trunk lesion, body mass index, previous myocardial infarction, myocardial fibrosis). All angiographically documented patients with >70% proximal multiarterial stenosis and ischemia, documented by stress test or classification of stable angina (class II or III), according to the Canadian Cardiovascular Society, were included. Reoperations, combined surgeries, recent acute myocardial infarction, recent inflammatory disease, deep venous thrombosis or recent pulmonary thromboembolism, acute kidney injury or chronic kidney injury were not included. RESULTS: Correlation values between the US-CRP curve and the ONCAB group, the treatment effect and the analyzed biological variables did not present expressive results. Laboratory variables were evaluated and did not correlate with the applied treatment (P>0.05). CONCLUSION: The changes in the US-CRP at each moment evaluated from the postoperative period did not show any significance in relation to the surgical technique applied.

Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial.

INTRODUCTION: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. METHODS: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. DISCUSSION: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Tumor lamination in mediastinal giant tumors.

Mediastinum tumors may grow slowly and reach giant proportions without symptoms, hindering surgical removal. Tumor big dimensions difficult surgical maneuvers, with risk of uncontrollable bleeding and prejudice to surrounding structures. It may be necessary the use of exceptional measures such as venous-venous circulatory deviation, pre-operatory embolization and total extracorporeal circulation. We describe the technique of tumor lamination that allows for complete or almost complete resection of such tumors that in many occasions are not resectable. The description is based on the results of four patients treated with mediastinum giant tumors.

Abnormal elevation of myocardial necrosis biomarkers after coronary artery bypass grafting without established myocardial infarction assessed by cardiac magnetic resonance.

BACKGROUND: The diagnosis of peri-procedural myocardial infarction is complex, especially after the emergence of high-sensitivity markers of myocardial necrosis. METHODS: In this study, patients with normal baseline cardiac biomarkers and formal indication for elective on-pump coronary bypass surgery were evaluated. Electrocardiograms, cardiac biomarkers, and cardiac magnetic resonance imaging with late gadolinium enhancement were performed before and after procedures. Myocardial infarction was defined as more than ten times the upper reference limit of the 99th percentile for troponin I and for creatine kinase isoform (CK-MB) and by the findings of new late gadolinium enhancement on cardiac magnetic resonance. We assessed the release of cardiac biomarkers in patients with no evidence of myocardial infarction on cardiac magnetic resonance. RESULTS: Of 75 patients referred for on-pump coronary bypass surgery, 54 (100%) did not have evidence of myocardial infarction on cardiac magnetic resonance. However, all had a peak troponin I above the 99th percentile; 52 (96%) had an elevation 10 times higher than the 99th percentile. Regarding CK-MB, 54 (100%) patients had a peak CK-MB above the 99th percentile limit, and only 13 (24%) had an elevation greater than 10 times the 99th percentile. The median value of troponin I peak was 3.15 (1.2 to 3.9) ng/mL, which represented 78.7 times the 99th percentile. CONCLUSION: In this study, different from CK-MB findings, troponin was significantly increased in the absence of myocardial infarction on cardiac magnetic resonance. Thus, CK-MB was more accurate than troponin I for excluding procedure-related myocardial infarction. These data suggest a higher troponin cutoff for the diagnosis of coronary bypass surgery related myocardial infarction. CLINICAL TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN09454308 . Registered 08 May 2012.

Tumor lamination in mediastinal giant tumors / Laminação tumoral nos tumores gigantes do mediastino

ABSTRACT Mediastinum tumors may grow slowly and reach giant proportions without symptoms, hindering surgical removal. Tumor big dimensions difficult surgical maneuvers, with risk of uncontrollable bleeding and prejudice to surrounding structures. It may be necessary the use of exceptional measures such as venous-venous circulatory deviation, pre-operatory embolization and total extracorporeal circulation. We describe the technique of tumor lamination that allows for complete or almost complete resection of such tumors that in many occasions are not resectable. The description is based on the results of four patients treated with mediastinum giant tumors.

RESUMO Tumores do mediastino podem crescer lentamente e atingir proporções gigantes sem apresentar sintomas, tornando a remoção cirúrgica problemática. As dimensões exacerbadas da neoplasia dificultam as manobras cirúrgicas, com risco de hemorragia incontrolável e comprometimento de estruturas adjacentes, levando à utilização de medidas de exceção, como a derivação circulatória veno-venosa, a embolização pré-operatória e a circulação extracorpórea total. Diante disto, descrevemos a técnica de laminação tumoral, que permite a ressecção total ou quase total de tumores considerados, muitas vezes, irressecáveis, tendo por base os resultados alcançados em quatro pacientes portadores de neoplasias gigantes do mediastino.

Off-pump versus on-pump coronary artery bypass grafting in frail patients: study protocol for the fragile multicenter randomized controlled trial

Abstract Introduction: Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. Methods: FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. Discussion: FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. Trial registration: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

Fixation of the short-term central venous catheter. A comparison of two techniques.

PURPOSE:: To compare the fixation of the central venous catheter (CVC) using two suture techniques. METHODS:: A clinical, analytical, interventional, longitudinal, prospective, controlled, single-blind and randomized study in adult, intensive care unit (ICU) patients. After admission and indication of CVC use, the patients were allocated to the Wing group (n = 35, catheter fixation with clamping wings and retainers) or Shoelace group (n = 35, catheter fixation using shoelace cross-tied sutures around the device). Displacement, kinking, fixation failure, hyperemia at the insertion site, purulent secretion, loss of the device, psychomotor agitation, mental confusion, and bacterial growth at the insertion site were evaluated. RESULTS:: Compared with the Wing group, the Shoelace group had a lower occurrence of catheter displacement (n=0 versus n =4; p = 0.04), kinking (n=0 versus n=8; p=0.001), and fixation failure (n=2 versus n=8; p=0.018). No significant difference was found in bacterial growth (n=20 versus n=14; p=0.267) between groups. CONCLUSION:: The Shoelace fixation technique presented fewer adverse events than the Wing fixation technique.

Fixation of the short-term central venous catheter. A comparison of two techniques

Abstract Purpose: To compare the fixation of the central venous catheter (CVC) using two suture techniques. Methods: A clinical, analytical, interventional, longitudinal, prospective, controlled, single-blind and randomized study in adult, intensive care unit (ICU) patients. After admission and indication of CVC use, the patients were allocated to the Wing group (n = 35, catheter fixation with clamping wings and retainers) or Shoelace group (n = 35, catheter fixation using shoelace cross-tied sutures around the device). Displacement, kinking, fixation failure, hyperemia at the insertion site, purulent secretion, loss of the device, psychomotor agitation, mental confusion, and bacterial growth at the insertion site were evaluated. Results: Compared with the Wing group, the Shoelace group had a lower occurrence of catheter displacement (n=0 versus n =4; p = 0.04), kinking (n=0 versus n=8; p=0.001), and fixation failure (n=2 versus n=8; p=0.018). No significant difference was found in bacterial growth (n=20 versus n=14; p=0.267) between groups. Conclusion: The Shoelace fixation technique presented fewer adverse events than the Wing fixation technique.

Significant elevation of biomarkers of myocardial necrosis after coronary artery bypass grafting without myocardial infarction established assessed by cardiac magnetic resonance.

The release of myocardial necrosis biomarkers after off-pump coronary artery bypass grafting (OPCAB) frequently occurs. However, the correlation between biomarker release and the diagnosis of procedure-related myocardial infarction (MI) (type 5) has been controversial. This study aimed to evaluate the amount and pattern of cardiac biomarker release after elective OPCAB in patients without evidence of a new MI on cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE).Patients with normal baseline cardiac biomarkers referred for elective OPCAB were prospectively included. CMR with LGE was performed in all patients before and after interventions. Measurements of troponin I (cTnI) and creatine kinase MB fraction (CK-MB) were systematically performed before and after the procedure. Patients with new LGE on the postprocedure CMR were excluded.All of the 53 patients without CMR evidence of a procedure-related MI after OPCAB exhibited a cTnI elevation peak above the 99th percentile. In 48 (91%), the peak value was >10 times this threshold. However, 41 (77%) had a CK-MB peak above the limit of the 99th percentile, and this peak was >10 times the 99th percentile in only 7 patients (13%). The median peak release of cTnI was 0.290 (0.8-3.7) ng/mL, which is 50-fold higher than the 99th percentile.In contrast with CK-MB, considerable cTnI release often occurs after an elective OPCAB procedure, despite the absence of new LGE on CMR.

Accuracy of Myocardial Biomarkers in the Diagnosis of Myocardial Infarction After Revascularization as Assessed by Cardiac Resonance: The Medicine, Angioplasty, Surgery Study V (MASS-V) Trial.

BACKGROUND: The lack of a correlation between myocardial necrosis biomarkers and electrocardiographic abnormalities after revascularization procedures has resulted in a change in the myocardial infarction (MI) definition. METHODS: Patients with stable multivessel disease who underwent percutaneous or surgical revascularization were included. Electrocardiograms and concentrations of high-sensitive cardiac troponin I (cTnI) and creatine kinase (CK)-MB were assessed before and after procedures. Cardiac magnetic resonance and late gadolinium enhancement were performed before and after procedures. MI was defined as more than five times the 99th percentile upper reference limit for cTnI and 10 times for CK-MB in percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), respectively, and new late gadolinium enhancement for cardiac magnetic resonance. RESULTS: Of the 202 patients studied, 69 (34.1%) underwent on-pump CABG, 67 (33.2%) off-pump CABG, and 66 (32.7%) PCI. The receiver operating characteristic curve showed the accuracy of cTnI for on-pump CABG, off-pump CABG, and PCI patients was 21.7%, 28.3%, and 52.4% and for CK-MB was 72.5%, 81.2%, and 90.5%, respectively. The specificity of cTnI was 3.6%, 9.4%, and 42.1% and of CK-MB was 73.2%, 86.8%, and 96.4%, respectively. Sensitivity of cTnI was 100%, 100%, and 100% and of CK-MB was 69.2%, 64.3%, and 44.4%, respectively. The best cutoff of cTnI for on-pump CABG, off-pump CABG, and PCI was 6.5 ng/mL, 4.5 ng/mL, and 4.5 ng/mL (162.5, 112.5, and 112.5 times the 99th percentile upper reference limit) and of CK-MB was 37.5 ng/mL, 22.5 ng/mL, and 11.5 ng/mL (8.5, 5.1, and 2.6 times the 99th percentile upper reference limit), respectively. CONCLUSIONS: Compared with cardiac magnetic resonance, CK-MB was more accurate than cTnI for diagnosing MI. These data suggest a higher troponin cutoff for the diagnosis of procedure-related MI.

Impact of Chronic Kidney Disease on Long-Term Outcomes in Type 2 Diabetic Patients With Coronary Artery Disease on Surgical, Angioplasty, or Medical Treatment.

BACKGROUND: Coronary artery disease (CAD) among patients with diabetes and chronic kidney disease (CKD) is not well studied, and the best treatment for this condition is not established. Our aim was to compare three therapeutic strategies for CAD in diabetic patients stratified by renal function. METHODS: Patients with multivessel CAD that underwent coronary artery bypass graft (CABG), angioplasty (percutaneous coronary intervention [PCI]), or medical therapy alone (MT) were included. Data were analyzed according to glomerular filtration rate in three strata: normal (>90 mL/min), mild CKD (60 to 89 mL/min), and moderate CKD (30 to 59 mL/min). End points comprised overall rate of mortality, acute myocardial infarction, and need for additional revascularization. RESULTS: Among patients with normal renal function (n = 270), 122 underwent CABG, 72 PCI, and 76 MT; among patients with mild CKD (n = 367), 167 underwent CABG, 92 PCI, and 108 MT; and among patients with moderate CKD (n = 126), 46 underwent CABG, 40 PCI, and 40 MT. Event-free survival was 80.4%, 75.7%, 67.5% for strata 1, 2, and 3, respectively (p = 0.037). Survival rates among patients with no, mild, and moderate CKD are 91.1%, 89.6%, and 76.2%, respectively (p = 0.001) (hazard ratio 0.69; 95% confidence interval 0.51 to 0.95; p = 0.024 for stratum 1 versus 3). We found no differences for overall number of deaths or acute myocardial infarctions irrespective of strata. The need of new revascularization was different in all strata, favoring CABG (p < 0.001, p < 0.001, and p = 0.029 for no, mild, and moderate CKD, respectively). CONCLUSIONS: Mortality rates were higher in patients with mild and moderate CKD. Higher event-free survival was observed in the CABG group among patients with no and mild CKD. Besides, CABG was associated with less need for new revascularization compared with PCI and MT in all renal function strata. This trial was registered at http://www.controlled-trials.com as ISRCTN66068876.

Comparison between off-pump and on-pump coronary artery bypass grafting in patients with severe lesions at the circumflex artery territory: 5-year follow-up of the MASS III trial.

OBJECTIVES: The technical difficulty in the revascularization of the circumflex artery territory with off-pump surgery may compromise the outcome of this method in clinical follow-up. We aimed to evaluate cardiac events in patients with stable coronary artery disease and severe obstruction of the circumflex system, undergoing coronary artery bypass grafting (CABG) with or without cardiopulmonary bypass. METHODS: MASS III was a single-centre study that evaluated 308 patients with multivessel coronary artery disease randomized to on-pump (153) or off-pump (155) CABG. Of this total, 260 (84.4%) patients had, on coronary angiography, at least one 70% obstruction in the circumflex territory (141 on-pump and 119 off-pump). The combined outcome was death, myocardial infarction, target vessel revascularization (angioplasty or surgery) or hospitalization for cardiac causes. Variables with possible associations (P < 0.1) were included in the multivariate analysis. RESULTS: The two groups were well matched for demographics and clinical and angiographic characteristics. After 5 years of follow-up, off-pump CABG had higher combined events than on-pump had: 25 (21%) vs 17 (12%), hazard ratio 1.88, 95% confidence interval 1.02-3.48, P = 0.041. In the multivariate model with the inclusion of the following variables: age (P = 0.09) and complete revascularization (P = 0.68), off-pump surgery remained as a predictor of combined events in 5 years, P = 0.03. CONCLUSIONS: In patients with multivessel coronary artery disease and severe lesions in the circumflex territory, off-pump coronary artery bypass surgery resulted in a higher incidence of cardiac events at 5-year follow-up. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN59539154 (http://www.controlled-trials.com).

A case of mid-apical obstructive hypertrophic cardiomyopathy treated with a transapical myectomy approach: a case report.

INTRODUCTION: Hypertrophic cardiomyopathy is a genetic cardiac disease characterized by marked variability in morphological expression and natural history. The hypertrophic myocardium is often confined to the septum or lateral wall of the left ventricle, but it can also be encountered in the middle or apical segments of the myocardium. Treatment is based on medical therapy. Others therapies, such as embolization of the septal artery or ventriculomyectomy, are indicated in special situations. Surgery is the standard treatment, and it is classically done via a transaortic approach; however, in cases in which the hypertrophic myocardium is confined to mid-apical segments, a transapical approach is an option. Only a few cases of mid-apical obstructive hypertrophic cardiomyopathy treated with a myectomy using a transapical approach have been reported in the English-language literature. In this report, we present a case of a patient with mid-apical obstructive hypertrophic cardiomyopathy treated using this new approach. CASE PRESENTATION: A 63-year-old Caucasian woman presented with a history of chest pain and shortness of breath causing significant limitations on her daily life activities. She had a history of coronary artery disease. Her physical examination was unremarkable. Transthoracic echocardiography revealed normal systolic function and significant concentric left ventricular hypertrophy that was greater in the mid-apical region. Nuclear magnetic resonance imaging confirmed significant hypertrophy of the median segments of the left ventricle. The patient had persistent symptoms despite receiving optimized medical treatment, and a surgical approach was indicated. As a myectomy using transaortic technique was thought to be difficult to perform in her case, a transapical approach was used. No complications occurred, and her symptoms resolved. CONCLUSION: A transapical myectomy should be taken into consideration for patients with mid-apical obstructive hypertrophic cardiomyopathy that is refractory to medical treatment.

On-pump versus off-pump coronary artery bypass surgery in patients older than 60 years: five-year follow-up of MASS III trial.

BACKGROUND: We aim to evaluate in-hospital events and long-term clinical outcomes in patients over 60 years of age with stable coronary artery disease and preserved left ventricular ejection fraction undergoing off-pump or on-pump coronary artery bypass grafting. METHODS: The MASS III was a single-center randomized trial that evaluate 308 patients with stable coronary artery disease and preserved ventricular function assigned for: 155 to off-pump and 153 to on-pump CABG. Of this, 176 (58.3%) patients were 60 years or older at the time of randomization (90 of-pump and 86 on-pump). The primary short-term end point was a composite of myocardial infarction, stroke, and overall mortality occurring within 30 days after surgery or before discharge, whichever was later. The primary long-term end point was death from any cause within 5 years, non-fatal myocardial infarction between 30 days and 5 years, or additional revascularization between 30 days and 5 years. RESULTS: On-pump CABG had a higher incidence of 30-day composite outcome than off-pump CABG (15,1% and 5.6%, respectively; P = 0.036). However, after the multivariate analysis, this association lost statistical significance, P = 0.05. After 5-year follow-up, there were no significant differences between both strategies of CABG in the composite end points 16.7% and 15.1%; Hazard Ratio 1.07; CI 0.41 - 1.82; P = 0.71, for off-pump and on-pump CABG respectively. CONCLUSIONS: On-pump and off-pump CABG achieved similar results of combined events at short-term and 5-year follow-up. TRIAL REGISTRATION: Clinical Trial Registration Information-URL: http://www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN59539154.

Long-term analysis of left ventricular ejection fraction in patients with stable multivessel coronary disease undergoing medicine, angioplasty or surgery: 10-year follow-up of the MASS II trial.

BACKGROUND: Assuming that coronary interventions, both coronary bypass surgery (CABG) and percutaneous coronary intervention (PCI), are directed to preserve left ventricular function, it is not known whether medical therapy alone (MT) can achieve this protection. Thus, we evaluated the evolution of LV ejection fraction (LVEF) in patients with stable coronary artery disease (CAD) treated by CABG, PCI, or MT as a post hoc analysis of a randomized controlled trial with a follow-up of 10 years. METHODS: Left ventricle ejection fraction was assessed with transthoracic echocardiography in patients with multivessel CAD, participants of the MASS II trial before randomization to CABG, PCI, or MT, and re-evaluated after 10 years of follow-up. RESULTS: Of the 611 patients, 422 were alive after 10.32 ± 1.43 years. Three hundred and fifty had LVEF reassessed: 108 patients from MT, 111 from CABG, and 131 from PCI. There was no difference in LVEF at the beginning (0.61 ± 0.07, 0.61 ± 0.08, 0.61 ± 0.09, respectively, for PCI, CABG, and MT, P = 0.675) or at the end of follow-up (0.56 ± 0.11, 0.55 ± 0.11, 0.55 ± 0.12, P = 0.675), or in the decline of LVEF (reduction delta of -7.2 ± 17.13, -9.08 ± 18.77, and -7.54 ± 22.74). Acute myocardial infarction (AMI) during the follow-up was associated with greater reduction in LVEF. The presence of previous AMI (OR: 2.50, 95% CI: 1.40-4.45; P = 0.0007) and during the follow-up (OR: 2.73, 95% CI: 1.25-5.92; P = 0.005) was associated with development of LVEF <45%. CONCLUSION: Regardless of the therapeutic option applied, LVEF remains preserved in the absence of a major adverse cardiac event after 10 years of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.controlled-trials.com. Registration number ISRCTN66068876.

Impact of diabetes on 10-year outcomes of patients with multivessel coronary artery disease in the Medicine, Angioplasty, or Surgery Study II (MASS II) trial.

INTRODUCTION: Diabetes mellitus is a major cause of coronary artery disease (CAD). Despite improvement in the management of patients with stable CAD, diabetes remains a major cause of increased morbidity and mortality. There is no conclusive evidence that either modality is better than medical therapy alone for the treatment of stable multivessel CAD in patients with diabetes in a very long-term follow-up. Our aim was to compare 3 therapeutic strategies for stable multivessel CAD in a diabetic population and non-diabetic population. METHODS: It was compared medical therapy (MT), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG) in 232 diabetic patients and 379 nondiabetic patients with multivessel CAD. Endpoints evaluated were overall and cardiac mortality. RESULTS: Patients (n = 611) were randomized to CABG (n = 203), PCI (n = 205), or MT (n = 203). In a 10-year follow-up, more deaths occurred among patients with diabetes than among patients without diabetes (P = .001) for overall mortality. In this follow-up, 10-year mortality rates were 32.3% and 23.2% for diabetics and non-diabetics respectively (P = .024). Regarding cardiac mortality, 10-year cardiac mortality rates were 19.4% and 12.7% respectively (P = .031).Considering only diabetic patients and stratifying this population by treatment option, we found mortality rates of 31.3% for PCI, 27.5% for CABG and 37.5% for MT (P = .015 for CABG vs MT) and cardiac mortality rates of 18.8%, 12.5% and 26.1% respectively (P = .005 for CABG vs MT). CONCLUSIONS/INTERPRETATION: Among patients with stable multivessel CAD and preserved left ventricular ejection fraction, the 3 therapeutic regimens had high rates of overall and cardiac-related deaths among diabetic compared with non-diabetic patients. Moreover, better outcomes were observed in diabetic patients undergoing CABG compared to MT in relation to overall and cardiac mortality in a 10-year follow-up.

Ten-year outcomes of patients randomized to surgery, angioplasty, or medical treatment for stable multivessel coronary disease: effect of age in the Medicine, Angioplasty, or Surgery Study II trial.

OBJECTIVE: With progressive aging, coronary artery disease has been diagnosed at more advanced ages. Although patients aged 65 years or more have been referred to surgical or percutaneous coronary interventions, the best option for coronary artery disease treatment remains uncertain. The current study compared the 3 treatment options for coronary artery disease in patients aged 65 years or more and analyzed the impact of age in treatment options. METHODS: Patients were separated according to age: 65 years or more (n = 200) and less than 65 years (n = 411). All patients were followed for 10 years. The rates of overall mortality, acute myocardial infarction, and new revascularizations were analyzed. RESULTS: Of 200 patients aged 65 years or more, 68 were randomized to medical therapy, 68 were randomized to percutaneous coronary intervention, and 64 were randomized to coronary artery bypass grafting. At 10 years, overall survival was 63% (medical therapy), 69% (percutaneous coronary intervention), and 66% (coronary artery bypass grafting) (P = .93). The survival free of combined events was 43% (medical therapy), 38% (percutaneous coronary intervention ), and 66% (coronary artery bypass grafting) (P = .007). The survival free of myocardial infarction was 82% (medical therapy), 77% (percutaneous coronary intervention), and 90% (coronary artery bypass grafting) (P = .17), and survival free of new revascularizations was 59% (medical therapy), 58% (percutaneous coronary intervention ), and 91% (coronary artery bypass grafting) (P = .0003). When the 2 age groups were compared, survival free of myocardial infarction for patients treated by percutaneous coronary intervention was 77% (older patients) and 92% (younger patients) (P = .004). CONCLUSIONS: In this analysis, treatment options for patients aged 65 years or more who have coronary artery disease yield similar overall survival. However, coronary artery bypass grafting was associated with fewer coronary events, and percutaneous coronary intervention was associated with a higher incidence of myocardial infarction.

Cost-effectiveness analysis for surgical, angioplasty, or medical therapeutics for coronary artery disease: 5-year follow-up of medicine, angioplasty, or surgery study (MASS) II trial.

BACKGROUND: The Second Medicine, Angioplasty, or Surgery Study (MASS II) included patients with multivessel coronary artery disease and normal systolic ventricular function. Patients underwent coronary artery bypass graft surgery (CABG, n=203), percutaneous coronary intervention (PCI, n=205), or medical treatment alone (MT, n=203). This investigation compares the economic outcome at 5-year follow-up of the 3 therapeutic strategies. METHODS AND RESULTS: We analyzed cumulative costs during a 5-year follow-up period. To analyze the cost-effectiveness, adjustment was made on the cumulative costs for average event-free time and angina-free proportion. Respectively, for event-free survival and event plus angina-free survival, MT presented 3.79 quality-adjusted life-years and 2.07 quality-adjusted life-years; PCI presented 3.59 and 2.77 quality-adjusted life-years; and CABG demonstrated 4.4 and 2.81 quality-adjusted life-years. The event-free costs were $9071.00 for MT; $19,967.00 for PCI; and $18,263.00 for CABG. The paired comparison of the event-free costs showed that there was a significant difference favoring MT versus PCI (P<0.01) and versus CABG (P<0.01) and CABG versus PCI (P=0.01). The event-free plus angina-free costs were $16,553.00, $25,831.00, and $24,614.00, respectively. The paired comparison of the event-free plus angina-free costs showed that there was a significant difference favoring MT versus PCI (P=0.04), and versus CABG (P<0.001); there was no difference between CABG and PCI (P>0.05). CONCLUSIONS: In the long-term economic analysis, for the prevention of a composite primary end point, MT was more cost effective than CABG, and CABG was more cost-effective than PCI. CLINICAL TRIAL REGISTRATION INFORMATION: www.controlled-trials.com. REGISTRATION NUMBER: ISRCTN66068876.