Use and safety of aprotinin in routine clinical practice: A European postauthorisation safety study conducted in patients undergoing cardiac surgery.

Background: Aprotinin has been used to reduce blood loss and blood product transfusions in patients at high risk of major blood loss during cardiac surgery. Approval by the European Medicines Agency (EMA) for its current indication is limited to patients at high risk of major blood loss undergoing isolated coronary artery bypass graft surgery (iCABG).

Objective: To report current real-world data on the use and certain endpoints related to the safety of aprotinin in adult patients.

Cardiothoracic Anesthesia and Critical Care in the United Kingdom (UK) Part 1: Some Insights Into the History and Development.

This review is intended to highlight some of the historic events that contributed to the development of thoracic and cardiac anesthesia and surgery in Great Britain and Northern Ireland (UK). The aim of this first of two parts is to concentrate on the development of techniques, facilities, and pharmacology that allowed progress and advancement in patient management that were developed primarily in the UK. However, progress usually requires input from a wide variety of sources of knowledge, and cardiothoracic practice is no exception.

Tranexamic acid in cardiac surgery: is there a cause for concern?

The withdrawal of marketing approval for aprotinin resulted in more clinicians administering tranexamic acid to patients at increased risk of bleeding and adverse outcome. The latest in a series of retrospective analyses of observational data is published in Critical Care and suggests an increase in mortality, when compared to data from the aprotinin era, in those patients having surgery when a cardiac chamber is opened. The added observation of an increase in cerebral excitatory phenomena (seizure activity) with tranexamic acid has a known mechanism and questions if such patients should be given this drug.

Aprotinin and renal dysfunction.

Aprotinin is a polypeptide serine protease inhibitor used to prevent bleeding and need for transfusions in patients having heart surgery. A recent analysis of an observational study data set suggested the use of aprotinin was associated with an increased risk of developing renal failure. The present article reviews the data from basic science studies in tissues, animals and man together with the data from observational studies and randomised controlled trials.

Dynamics of nitroglycerin-induced exhaled nitric oxide after lung transplantation: evidence of pulmonary microvascular injury?

Background: In search of real-time molecular correlates to ischemia-reperfusion-induced lung injury, we explored the hypothesis that liberation of nitric oxide (NO) into exhaled breath after pulmonary microvascular bioconversion of nitroglycerin (GTN) is attenuated in clinical lung transplantation.

Methods: Exhaled NO was measured under basal conditions and after intravenous administration of GTN in patients undergoing lung transplantation. Patients undergoing routine cardiac surgery served as controls.

Perioperative blood transfusion and blood conservation in cardiac surgery: the Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists clinical practice guideline.

Background: A minority of patients having cardiac procedures (15% to 20%) consume more than 80% of the blood products transfused at operation. Blood must be viewed as a scarce resource that carries risks and benefits. A careful review of available evidence can provide guidelines to allocate this valuable resource and improve patient outcomes.

Long-term outcome of patients with perioperative myocardial infarction as diagnosed by troponin I after routine surgical coronary artery revascularization.

Objective: Diagnosis of perioperative myocardial infarction (P-MI) after coronary artery bypass graft (CABG) surgery traditionally relied on a combination of electrocardiographic and enzyme assay changes. Patients with Q-wave P-MIs who survive to hospital discharge have a poorer long-term prognosis. Troponin assays are more sensitive and specific for detecting minor P-MI, with an increased incidence of P-MI being reported.

Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes.

Background: Inappropriate activation of hemostasis and inflammation may contribute to postoperative morbidity and mortality. The serine protease inhibitor, aprotinin, has been shown to prevent tissue and organ injury in laboratory and animal studies. In this retrospective analysis, we evaluated the relationship of aprotinin therapy with organ dysfunction in humans undergoing coronary artery bypass graft surgery (CABG).

Safety aspects of aprotinin therapy in cardiac surgery patients.

Aprotinin is the only agent with Class A Level 1 evidence for reduction in rates of transfusion and return to operating theatre to control bleeding after heart surgery. Principal on the list of safety issues raised over the years are increased risk for: a) thrombosis; and b) renal dysfunction. With multiple administrations, hypersensitivity reactions have emerged as a further safety concern.

Correlation between pulmonary gas exchange and basal and nitroglycerin (GTN)-induced exhaled nitric oxide (eNO) in patients undergoing cardiac surgery.

The relationship between eNO and events in the alveolar-capillary unit in acute lung injury remains to be established. Since endogenous eNO largely originates from the airway epithelium, but nitroglycerin (GTN)-induced eNO is due to microvascular/alveolar metabolism, we have proposed to use basal and GTN-induced eNO as metabolic markers of the airway--and microvascular/alveolar function, respectively. The current work investigates the relationship between basal and GTN-induced eNO and oxygenation parameters (PaO(2)/FiO(2) ratio) in patients undergoing cardiac surgery utilising cardiopulmonary bypass (CPB).

The comparison and validity of troponin I assay systems in diagnosing myocardial ischemic injury after surgical coronary revascularization.

Objective: A prospective observational study was conducted to test the agreement between 2 commercially available automated cardiac troponin-I immunoassay systems (Opus Plus, Behring Diagnostics UK Ltd, Hounslow, UK; AxSYM, Abbott Laboratories, Abbott Park, IL) and to determine a normal reference range and threshold value indicative of perioperative myocardial infarction (PMI) after elective coronary artery bypass graft (CABG) surgery for the Opus Plus system.

Design: Prospective, observational study. Setting : Single institution, cardiothoracic specialty hospital.

Platelet transfusions during coronary artery bypass graft surgery are associated with serious adverse outcomes.

Background: Platelet (PLT) transfusions are administered in cardiac surgery to prevent or treat bleeding, despite appreciation of the risks of blood component transfusion. The current analysis investigates the hypothesis that PLT transfusion is associated with adverse outcomes associated with coronary artery bypass graft surgery (CABG).

Study Design And Methods: Data originally collected during double-blind placebo-controlled phase III trials for licensure of Trasylol (aprotinin injection) were retrospectively analyzed.

Myocardial protection using fructose-1,6-diphosphate during coronary artery bypass graft surgery: a randomized, placebo-controlled clinical trial.

Unlabelled: In vitro and in vivo studies suggest that fructose-1,6-diphosphate (FDP), an intermediary glycolytic pathway metabolite, ameliorates ischemic tissue injury through increased high-energy phosphate levels and may therefore have cardioprotective properties in patients undergoing coronary artery bypass graft (CABG) surgery. We designed a randomized, placebo-controlled, double-blinded, sequential-cohort, dose-ranging safety study to test 5 FDP dosage regimens in patients (n = 120; 60 FDP, 60 control) undergoing CABG surgery. Of these dosage regimens, 3 produced no benefit, 1 produced improved cardiac function, and 1 required adjustment as a result of metabolic acidosis.

Anaesthesia: the patient's point of view.

Patients scheduled for surgical procedures continue to express concerns about their safety, outcome, and comfort. All medical interventions carry risks, but the patient often considers anaesthesia as the intervention with the greatest risk. Many still worry that they will not wake up after their surgery, or that they will be awake during the operation.

Efficacy and safety of remifentanil in coronary artery bypass graft surgery: a randomized, double-blind dose comparison study.

Objectives: To compare the efficacy and safety of 3 doses of remifentanil as part of a total intravenous anesthesia technique with low-dose propofol in patients undergoing coronary artery bypass graft (CABG) surgery.

Design: Multicenter, multinational, double-blind, randomized, dose comparison study.

Setting: Nine hospitals in 5 countries.

[Changes of exhaled nitrogen-monoxide concentration in acute ischemia-reperfusion injury of the lung].

Introduction: Nitric oxide (NO) plays an important role in both the physiological control of the pulmonary vascular bed and in the pathophysiology of several lung diseases. Though our knowledge regarding NO has became wider several aspects are still a matter of debate. The technical developments allowing direct measurements of NO in the expired air have provided an opportunity to evaluate NO production and consumption in the clinical setting and exhaled NO has become a diagnostic and monitoring tool in acute and chronic lung diseases.

Coronary revascularization: a procedure in transition from on-pump to off-pump? The role of glucose-insulin-potassium revisited in a randomized, placebo-controlled study.

Objective: To investigate an optimized glucose-insulin-potassium (GIK) solution regimen as an alternate myocardial protective strategy in off-pump coronary artery bypass graft (OP-CAB) surgery and as a supplement to conventional coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).

Design: Prospective, randomized, placebo-controlled.

Setting: Single institution, cardiothoracic specialty hospital.