Patterns of use of perioperative angiotensin-converting enzyme inhibitors in coronary artery bypass graft surgery with cardiopulmonary bypass: effects on in-hospital morbidity and mortality.

Background: Despite proven benefit in ambulatory patients with ischemic heart disease, the pattern of use of angiotensin-converting enzyme inhibitors (ACEIs) in coronary artery bypass graft surgery has been erratic and controversial.

Methods And Results: This is a prospective observational study of 4224 patients undergoing coronary artery bypass graft surgery. The cohort included 1838 patients receiving ACEI therapy before surgery and 2386 (56.

Is randomization to placebo safe? Risk in placebo-controlled angina trials: angina risk meta-analysis.

Objective: It was the aim of this study to document the risks of symptomatic patients with angina in placebo-controlled, anti-anginal drug development trials in which symptom-limited exercise testing was used as the primary endpoint.

Patients And Methods: The original case report forms submitted to the United States Food and Drug Administration in support of approval of new or supplemental new drug applications between 1973 and 2001 were identified and subjected to a by-patient meta-analysis, utilizing both a maximum likelihood analysis and classical Mantel-Haenszel methods.

Results: There were 63 placebo-controlled, clinical trials that randomized 10,865 patients, with 1,047 patient-years of observation time.

Lack of effectiveness of the pulmonary artery catheter in cardiac surgery.

Background: The pulmonary artery catheter (PAC) continues to be used for monitoring of hemodynamics in patients undergoing coronary artery bypass graft (CABG) surgery despite concerns raised in other settings regarding both effectiveness and safety. Given the relative paucity of data regarding its use in CABG patients, and given entrenched practice patterns, we assessed the impact of PAC use on fatal and nonfatal CABG outcomes as practiced at a diverse set of medical centers.

Methods: Using a formal prospective observational study design, 5065 CABG patients from 70 centers were enrolled between November 1996 and June 2000 using a systemic sampling protocol.

A multinational study of the influence of health-related quality of life on in-hospital outcome after coronary artery bypass graft surgery.

Background: The effect of health-related quality of life on in-hospital outcomes after coronary artery bypass grafting surgery has not been investigated in international multicenter studies. We hypothesized that poor preoperative health status is associated with mortality and length of hospital stay.

Methods: In the Multicenter Study of Perioperative Ischemia Epidemiology II, preoperative Short-Form 12, Mental Component Summary (MCS), and Physical Component Summary (PCS) scores were obtained prospectively from 4,811 patients (3,834 men, 977 women) undergoing coronary artery bypass grafting surgery at 72 centers in 17 countries.

Impact of hyperglycemia on perioperative mortality after coronary artery bypass graft surgery.

Objective: The roles of perioperative hyperglycemia and diabetes in the risk stratification of patients undergoing coronary artery bypass graft surgery are unclear. The aim of this study is to explore the influence of perioperative hyperglycemia on postoperative mortality.

Method: A prospective, observational study of 5050 patients undergoing cardiopulmonary bypass for coronary artery bypass graft surgery at 70 international centers was conducted, with 7500 measured variables per patient and outcomes adjudicated centrally.

Postoperative red blood cell transfusion and morbid outcome in uncomplicated cardiac surgery patients.

Objective: To evaluate postoperative red blood cell (RBC) transfusion and its association with postoperative cardiac events and multiorgan morbidity in uncomplicated cardiac surgery patients.

Methods: A cohort of 945 patients from the 5,436 coronary artery bypass grafting patients enrolled in the international Multicenter Study of Perioperative Ischemia (McSPI) Epidemiology II (EPI II) study was investigated. Inclusion criteria were low to moderate risk profile, postoperative hemoglobin level ≥ 10 g/dl, minimal postoperative blood loss, and no evidence of any morbid event on the day of surgery.

Predictive value of the National Institutes of Health Stroke Scale and the Mini-Mental State Examination for neurologic outcome after coronary artery bypass graft surgery.

Objective: We intended to define the role of the National Institutes of Health Stroke Scale and the Mini-Mental State Examination in identifying adverse neurologic outcomes in a large international sample of patients undergoing cardiac surgery.

Methods: We evaluated 4707 patients undergoing cardiac surgery with cardiopulmonary bypass at 72 centers in 17 countries between November 1996 and June 2000. Prespecified overt neurologic outcomes were categorized as type I (clinically diagnosed stroke, transient ischemic attack, encephalopathy, or coma) or type II (deterioration of intellectual function).

Pulse pressure and risk of adverse outcome in coronary bypass surgery.

Background: Among ambulatory patients, an increase in pulse pressure (PP) is a well-established determinant of vascular risk. The relationship of PP and acute perioperative vascular outcome among patients having coronary artery bypass graft (CABG) surgery is less well known.

Methods: We conducted a prospective observational study involving 5436 patients having elective CABG surgery requiring cardiopulmonary bypass.

The ongoing variability in blood transfusion practices in cardiac surgery.

Background: Although blood utilization has been under considerable scrutiny for the past two decades, particularly for surgery, studies comparing perioperative blood transfusion practices between countries are rare, and the evolution of international standards remains unknown. Therefore, the objective of this evaluation was to compare the perioperative transfusion of blood components in cardiac surgery in multiple centers in different countries.

Study Design And Methods: Transfusion practice was investigated prospectively in 70 centers among 16 countries.

Differential association of cognitive and somatic depressive symptoms with heart rate variability in patients with stable coronary heart disease: findings from the Heart and Soul Study.

Objective: To determine if depression associated with low heart rate variability (HRV) in patients post myocardial infarction (MI), but not in patients with stable coronary heart disease (CHD), may be the result of differential associations of somatic and cognitive depressive symptoms with HRV.

Methods: To examine the association of somatic and cognitive depressive symptoms with 24-hour HRV, we performed a cross-sectional study of 863 outpatients with stable CHD. The severity of somatic and cognitive depressive symptoms was determined using factor analysis of items of the Patient Health Questionnaire (PHQ-9).

Impact of preoperative anemia on outcome in patients undergoing coronary artery bypass graft surgery.

Background: The risk of preoperative anemia in patients undergoing heart surgery has not been described precisely. Specifically, the impact of low hemoglobin per se or combined with other risk factors on postoperative outcome is unknown. Thus, we determined the effects of low preoperative hemoglobin and comorbidities on postoperative adverse outcomes in patients with coronary artery bypass graft in a large comprehensive multicenter study.

Coronary artery bypass graft surgery--care globalization: the impact of national care on fatal and nonfatal outcome.

Objective: In an international, prospective, observational study, we contrasted adverse vascular outcomes among four countries and then assessed practice pattern differences that may have contributed to these outcomes.

Methods: A total of 5065 patients undergoing coronary artery bypass graft surgery were analyzed at 70 international medical centers, and from this pool, 3180 patients from the 4 highest enrolling countries were selected. Fatal and nonfatal postoperative ischemic complications related to the heart, brain, kidney, and gastrointestinal tract were assessed by blinded investigators.

Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery.

Context: Acute safety concerns have been raised recently regarding certain hemorrhage-sparing medications commonly used in cardiac surgery. However, no comprehensive data exist regarding their associations with long-term mortality.

Objective: To contrast long-term all-cause mortality in patients undergoing coronary artery bypass graft (CABG) surgery according to use of 2 lysine analog antifibrinolytics (aminocaproic acid and tranexamic acid), the serine protease inhibitor aprotinin, or no antibleeding agent.

Risk index for perioperative renal dysfunction/failure: critical dependence on pulse pressure hypertension.

Background: An acute renal event after coronary bypass graft surgery is associated with high mortality and substantial additive cost.

Methods And Results: This prospective and descriptive study of 4801 patients having coronary bypass graft surgery with cardiopulmonary bypass from November 1996 to June 2000 at 70 centers in 16 countries established associations between predictor variables and postoperative renal composite (renal dysfunction and/or renal failure) from a cohort of 2381 patients and developed a risk index assessed in a validation cohort of 2420 patients. Postoperative renal composite occurred in 231 patients (4.

Preoperative statin therapy is associated with reduced cardiac mortality after coronary artery bypass graft surgery.

Objective: Statin therapy in ambulatory populations is associated with a significant reduction in adverse cardiovascular events, including death and myocardial infarction. Much less is known about the beneficial effects of statins on acute perioperative cardiovascular events. The purpose of this study was to determine whether preoperative statin therapy is associated with a reduced risk of early cardiac death or nonfatal, in-hospital postoperative myocardial infarction after primary, elective coronary artery bypass graft surgery requiring cardiopulmonary bypass.

Post-reperfusion myocardial infarction: long-term survival improvement using adenosine regulation with acadesine.

Objectives: The purpose of this study was to assess the safety and efficacy of the adenosine regulating agent (ARA) acadesine for reducing long-term mortality among patients with post-reperfusion myocardial infarction (MI).

Background: No prospectively applied therapy exists that improves long-term survival after MI associated with coronary artery bypass graft (CABG) surgery-a robust model of ischemia/reperfusion injury. Pretreatment with the purine nucleoside autocoid adenosine mitigates the extent of post-ischemic reperfusion injury in animal models.

The risk associated with aprotinin in cardiac surgery.

Background: The majority of patients undergoing surgical treatment for ST-elevation myocardial infarction receive antifibrinolytic therapy to limit blood loss. This approach appears counterintuitive to the accepted medical treatment of the same condition--namely, fibrinolysis to limit thrombosis. Despite this concern, no independent, large-scale safety assessment has been undertaken.

Hormone replacement therapy is safe in women undergoing coronary artery bypass grafting.

In postmenopausal women, hormone replacement therapy (HRT) does not substantially reduce the incidence of cardiovascular disease and may produce a short-term increase in risk. Therefore, we investigated whether HRT increased risk in patients with severe coronary artery disease necessitating surgery We prospectively studied 4,782 patients undergoing coronary artery bypass grafting at 70 centers in 17 countries from November 1996 through June 2000. Patients were selected using a systematic sampling technique.

Depression and heart rate variability in patients with stable coronary heart disease: findings from the Heart and Soul Study.

Context: Depression is associated with low heart rate variability (HRV) in patients following myocardial infarction, suggesting that alterations in the autonomic nervous system may contribute to the adverse cardiac outcomes associated with depression. Whether depression is associated with low HRV in patients with stable coronary heart disease (CHD) is not known.

Objective: To examine the association between major depression and 24-hour HRV in patients with stable CHD.

Adverse gastrointestinal complications after cardiopulmonary bypass: can outcome be predicted from preoperative risk factors?

Unlabelled: Adverse gastrointestinal (GI) outcome after cardiac surgery is an infrequent event but is a clinically important health care problem because of associated increased morbidity and mortality. The ability to identify patients at greatest risk before surgery may be helpful in planning appropriate perioperative management strategies. We examined the pre- and intraoperative characteristics of 2417 patients from 24 diverse United States medical centers enrolled in the Multicenter Study of Perioperative Ischemia Study who were undergoing cardiac surgery using cardiopulmonary bypass as predictors for adverse GI outcome.

A multicenter risk index for atrial fibrillation after cardiac surgery.

Context: Atrial fibrillation is a common, but potentially preventable, complication following coronary artery bypass graft (CABG) surgery.

Objectives: To assess the nature and consequences of atrial fibrillation after CABG surgery and to develop a comprehensive risk index that can better identify patients at risk for atrial fibrillation.

Design, Setting, And Participants: Prospective observational study of 4657 patients undergoing CABG surgery between November 1996 and June 2000 at 70 centers located within 17 countries, selected using a systematic sampling technique.

Impact of pexelizumab, an anti-C5 complement antibody, on total mortality and adverse cardiovascular outcomes in cardiac surgical patients undergoing cardiopulmonary bypass.

Background: During cardiac surgery requiring cardiopulmonary bypass, pro-inflammatory complement pathways are activated by exposure of blood to bio-incompatible surfaces of the extracorporeal circuit and reperfusion of ischemic organs. Complement activation promotes the generation of additional inflammatory mediators thereby exacerbating tissue injury. We examined the safety and efficacy of a C5 complement inhibitor for attenuating inflammation-mediated cardiovascular dysfunction in cardiac surgical patients undergoing cardiopulmonary bypass.

Prevalence of risk factors, and not gender per se, determines short- and long-term survival after coronary artery bypass surgery.

Objective: Much attention has been directed towards female gender as an independent risk factor for in-hospital mortality after coronary artery bypass grafting surgery; however, the effects of surgery are known to persist for 6 months or more. Studies that have compared postoperative survival in women and men beyond hospital discharge report disparate results with regard to the independent effect of gender per se on ultimate survival.

Design: This investigation was a prospective, observational study.