Prevalence of anaphylactic reactions to aprotinin: Analysis of two hundred forty-eight reexposures to aprotinin in heart operations
01 Jan 1997-The Journal of Thoracic and Cardiovascular Surgery (Elsevier)-Vol. 113, Iss: 1, pp 194-201
TL;DR: A reexposure to aprotinin in patients with a high risk of bleeding is justified, because the benefits of aProtinin treatment outweigh the relative risk of a serious allergic reaction.
About: This article is published in The Journal of Thoracic and Cardiovascular Surgery.The article was published on 1997-01-01 and is currently open access. It has received 165 citations till now. The article focuses on the topics: Aprotinin.
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University of Kentucky1, University of Florida2, Imperial College London3, University of Pennsylvania4, Rush University Medical Center5, Washington University in St. Louis6, Dartmouth College7, Virginia Commonwealth University8, Yeshiva University9, Duke University10, University of Toronto11, Harvard University12
TL;DR: Based on available evidence, institution-specific protocols should screen for high- risk patients, as blood conservation interventions are likely to be most productive for this high-risk subset of patients.
913 citations
TL;DR: Anaphylactic reactions occur on reexposure to a specific antigen and requires the release of proinflammatory mediators through a direct non-immunoglobulin E-mediated release of mediators from mast cells or from complement activation.
Abstract: Anesthesiologists use a myriad of drugs during the provision of an anesthetic. Many of these drugs have side effects that are dose related, and some lead to severe immune-mediated adverse reactions. Anaphylaxis is the most severe immune-mediated reaction; it generally occurs on reexposure to a specific antigen and requires the release of proinflammatory mediators. Anaphylactoid reactions occur through a direct non-immunoglobulin E-mediated release of mediators from mast cells or from complement activation. Muscle relaxants and latex account for most cases of anaphylaxis during the perioperative period. Symptoms may include all organ systems and present with bronchospasm and cardiovascular collapse in the most severe cases. Management of anaphylaxis includes discontinuation of the presumptive drug (or latex) and anesthetic, aggressive pulmonary and cardiovascular support, and epinephrine. Although a serum tryptase confirms the diagnosis of an anaphylactic reaction, the offending drug can be identified by skin-prick, intradermal testing, or serologic testing. Prevention of recurrences is critical to avoid mortality and morbidity.
344 citations
Cites background from "Prevalence of anaphylactic reaction..."
...is less likely to lead to an adverse reaction (91,92)....
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TL;DR: The greatest efficacy and ease-of-use to toxicity ratio is for techniques of anaesthesia that associate analgesia and hypotension at clinical concentrations without the need for potent hypotensive agents.
Abstract: For half a century, controlled hypotension has been used to reduce bleeding and the need for blood transfusions, and provide a satisfactory bloodless surgical field. It has been indicated in oromaxillofacial surgery (mandibular osteotomy, facial repair), endoscopic sinus or middle ear microsurgery, spinal surgery and other neurosurgery (aneurysm), major orthopaedic surgery (hip or knee replacement, spinal), prostatectomy, cardiovascular surgery and liver transplant surgery. Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90 mm Hg, a reduction of mean arterial pressure (MAP) to 50-65 mm Hg or a 30% reduction of baseline MAP. Pharmacological agents used for controlled hypotension include those agents that can be used successfully alone and those that are used adjunctively to limit dosage requirements and, therefore, the adverse effects of the other agents. Agents used successfully alone include inhalation anaesthetics, sodium nitroprusside, nitroglycerin, trimethaphan camsilate, alprostadil (prostaglandin E1), adenosine, remifentanil, and agents used in spinal anaesthesia. Agents that can be used alone or in combination include calcium channel antagonists (e.g. nicardipine), beta-adrenoceptor antagonists (beta-blockers) [e.g. propranolol, esmolol] and fenoldopam. Agents that are mainly used adjunctively include ACE inhibitors and clonidine. New agents and techniques have been recently evaluated for their ability to induce effective hypotension without impairing the perfusion of vital organs. This development has been aided by new knowledge on the physiology of peripheral microcirculatory regulation. Apart from the adverse effects of major hypotension on the perfusion of vital organs, potent hypotensive agents have their own adverse effects depending on their concentration, which can be reduced by adjuvant treatment. Care with use limits the major risks of these agents in controlled hypotension; risks that are generally less important than those of transfusion or alternatives to transfusion. New hypotensive drugs, such as fenoldopam, adenosine and alprostadil, are currently being evaluated; however, they have disadvantages and a high treatment cost that limits their development in this indication. New techniques of controlled hypotension subscribe to the use of the natural hypotensive effect of the anaesthetic drug with regard to the definition of the ideal hypotensive agent. It must be easy to administer, have a short onset time, an effect that disappears quickly when administration is discontinued, a rapid elimination without toxic metabolites, negligible effects on vital organs, and a predictable and dose-dependent effect. Inhalation agents (isoflurane, sevoflurane) provide the benefit of being hypnotic and hypotensive agents at clinical concentrations, and are used alone or in combination with adjuvant agents to limit tachycardia and rebound hypertension, for example, inhibitors of the autonomic nervous system (clonidine, beta-blockers) or ACE inhibitors. When they are used alone, inhalation anaesthetics require high concentrations for a significant reduction in bleeding that can lead to hepatic or renal injury. The greatest efficacy and ease-of-use to toxicity ratio is for techniques of anaesthesia that associate analgesia and hypotension at clinical concentrations without the need for potent hypotensive agents. The first and oldest technique is epidural anaesthesia, but depending on the surgery, it is not always appropriate. The most recent satisfactory technique is a combination treatment of remifentanil with either propofol or an inhalation agent (isoflurane, desflurane or sevoflurane) at clinical concentrations. In light of the current literature, and because of their safety and ease of use, these two techniques are preferred.
275 citations
Cites background from "Prevalence of anaphylactic reaction..."
...of allergic reactions in the event of a second exposure to aprotinin was close to 5%,[42] and in some 4....
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TL;DR: Evidence for the role of pharmacological haemostatic agents in reducing perioperative blood loss and transfusion requirements is reviewed.
Abstract: Skilful surgery combined with blood-saving methods and careful management of blood coagulation will all help reduce unnecessary blood loss and transfusion requirements. Excessive surgical bleeding causes hypovolaemia, haemodynamic instability, anaemia and reduced oxygen delivery to tissues, with a subsequent increase in postoperative morbidity and mortality. The role of anaesthetists in managing surgical blood loss has increased greatly in the last decade. Position of the patient during surgery and the provision of a hypotensive anaesthetic regimen were once considered the most important contributions of the anaesthetist to decreasing blood loss. Now, several pharmacological haemostatic agents are being used by anaesthetists as blood-saving agents. After a brief discussion of the physiology of haemostasis, this article will review the evidence for the role of such agents in reducing perioperative blood loss and transfusion requirements.
163 citations
TL;DR: Tranexamic acid and aprotinin show similar clinical effects on bleeding and allogeneic transfusion in patients undergoing primary elective heart operations and its use is preferable in this type of patient.
121 citations
Additional excerpts
...Bleeding 0-4 hours, mL 100 [50-200] 150 [100-200] 0 [0-50] Bleeding 4-24 hours, mL 150 [100-200] 150 [100-200] 0 [0-0] Total bleeding, mL 250 [150-400] 300 [200-450] 50 [0-50]...
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References
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TL;DR: The effect of high dose aprotinin (Trasylol) was evaluated in three groups of patients undergoing cardiopulmonary bypass: 80 patients having primary aorta-coronary bypass grafting, a prospective, placebo-controlled, double-blind study, and 80 patients receiving saline placebo from the beginning of the procedure until skin closure.
499 citations
TL;DR: It is concluded that aprotinin is extremely effective in reducing bleeding and transfusion requirements and may increase the risk of graft thrombosis.
366 citations
TL;DR: It is demonstrated that high- and low-dose aprotinin significantly reduces the requirement for donor-blood transfusion in repeat CABG patients without increasing the risk for perioperative MI.
Abstract: Background Aprotinin is a serine protease inhibitor that reduces blood loss and transfusion requirements when administered prophylactically to cardiac surgical patients. To examine the safety and dose-related efficacy of aprotinin, a prospective, multicenter, placebo-controlled trial was conducted in patients undergoing repeat coronary artery bypass graft (CABG) surgery. Methods and Results Two hundred eighty-seven patients were randomly assigned to receive either high-dose aprotinin, low-dose aprotinin, pump-prime-only aprotinin, or placebo. Drug efficacy was determined by the reduction in donor-blood transfusion up to postoperative day 12 and in postoperative thoracic-drainage volume. The percentage of patients requiring donor–red-blood-cell (RBC) transfusions in the high- and low-dose aprotinin groups was reduced compared with the pump-prime-only and placebo groups (high-dose aprotinin, 54%; low-dose aprotinin, 46%; pump-prime only, 72%; and placebo, 75%; overall P=.001). The number of units of donor R...
296 citations
TL;DR: Skin testing with both major and minor penicillin determinants is safe using current recommendations, and both reagents are necessary for maximizing the identification of sensitized subjects.
Abstract: Objective. —To establish (1) the prevalence of positive penicillin skin tests among outpatients with well-defined but variable history of penicillin allergy and (2) the reproducibility, safety, and negative predictive value of skin testing with benzylpenicilloyl polylysine (PPL) and a minor-determinant mixture (MDM). Design. —Serial consenting outpatients with current indications for penicillin therapy were skin-tested in duplicate with PPL and MDM. Subjects with negative skin tests (93% of those positive by history and 95% of those negative by history) received therapeutic courses of benzylpenicillin (81%) or ampicillin (19%). Negative predictive value of skin testing was established by 72-hour follow-up for adverse reactions to drug. Setting/Patients. —A total of 5063 consecutive, qualifying outpatients in a Baltimore, Md, sexually transmitted disease (STD) clinic. The study group was young (73% between 20 and 40 years old), 66% male, and 90% black; 25% had history of atopy. Follow-up was 94% complete. Results. —Positive skin tests were observed in 7.1% of 776 individuals with previous history of penicillin allergy and in 1.7% of 4287 subjects negative by history (P Conclusions. —Skin testing with both major and minor penicillin determinants is safe using current recommendations, and both reagents are necessary for maximizing the identification of sensitized subjects. Routine penicillin skin testing can facilitate the safe use of penicillin in 90% of individuals with a previous history of penicillin allergy. (JAMA. 1993;270:2456-2463)
295 citations
TL;DR: In this study, aprotinin was effective in reducing bleeding and blood product transfusion rates, and its use was not associated with an increase in complications.
218 citations