Shore-Lesserson Linda, Baker Robert A, Ferraris Victor, Greilich Philip E, Fitzgerald David, Roman Philip, Hammon John
Department of Anesthesiology, Hofstra Northwell School of Medicine, New Hyde Park, New York.
Cardiac Surgery Research and Perfusion, Flinders University and Flinders Medical Centre, Adelaide, South Australia, Australia.
J Extra Corpor Technol. 2018 Mar;50(1):5-18.
Despite more than a half century of "safe" cardiopulmonary bypass (CPB), the evidence base surrounding the conduct of anticoagulation for CPB has not been organized into a succinct guideline. For this and other reasons, there is enormous practice variability relating to the use and dosing of heparin, monitoring heparin anticoagulation, reversal of anticoagulation, and the use of alternative anticoagulants. To address this and other gaps, the Society of Thoracic Surgeons (STS), the Society of Cardiovascular Anesthesiologists (SCA), and the American Society of Extracorporeal Technology (AmSECT) developed an Evidence Based Workgroup. This was a group of interdisciplinary professionals gathered together to summarize the evidence and create practice recommendations for various aspects of CPB. To date, anticoagulation practices in CPB have not been standardized in accordance with the evidence base. This clinical practice guideline was written with the intent to fill the evidence gap and to establish best practices in anticoagulation for CPB using the available evidence. To identify relevant evidence a systematic review was outlined and literature searches were conducted in PubMed® using standardized MeSH terms from the National Library of Medicine list of search terms. Search dates were inclusive of January 2000 to December 2015. The search yielded 833 abstracts which were reviewed by two independent reviewers. Once accepted into the full manuscript review stage, two members of the writing group evaluated each of 286 full papers for inclusion eligibility into the guideline document. Ninety-six manuscripts were included in the final review. In addition, 17 manuscripts published prior to 2000 were included to provide method, context, or additional supporting evidence for the recommendations as these papers were considered sentinel publications. Members of the writing group wrote and developed recommendations based on review of the articles obtained and achieved more than two thirds agreement on each recommendation. The quality of information for a given recommendation allowed assessment of the level of evidence as recommended by the AHA/ACCF Task Force on Practice Guidelines. Recommendations were written in the three following areas 1) Heparin dosing and monitoring for initiation and maintenance of CPB, 2) Heparin contraindications and heparin alternatives, 3) Reversal of anticoagulation during cardiac operations. It is hoped that this guideline will serve as a resource and will stimulate investigators to conduct more research and expand upon the evidence base on the topic of anticoagulation for CPB.
尽管体外循环（CPB）已有半个多世纪的“安全”应用历史，但围绕CPB抗凝操作的证据基础尚未被整理成一份简洁的指南。出于这个以及其他原因，在肝素的使用和剂量、肝素抗凝监测、抗凝逆转以及替代抗凝剂的使用方面，存在着巨大的实践差异。为解决这一问题及其他差距，胸外科医师协会（STS）、心血管麻醉医师协会（SCA）和美国体外技术协会（AmSECT）成立了一个循证工作组。该工作组由跨学科专业人员组成，旨在汇总证据并为CPB的各个方面制定实践建议。迄今为止，CPB中的抗凝实践尚未根据证据基础进行标准化。本临床实践指南旨在填补证据空白，并利用现有证据确立CPB抗凝的最佳实践。为识别相关证据，制定了系统评价方案，并在PubMed®中使用美国国立医学图书馆搜索词列表中的标准化医学主题词（MeSH）进行文献检索。检索日期涵盖2000年1月至2015年12月。检索得到833篇摘要，由两名独立评审员进行评审。一旦进入全文评审阶段，写作组的两名成员对286篇全文进行评估，以确定其是否符合纳入指南文件的资格。最终评审纳入了96篇手稿。此外，还纳入了2000年之前发表的17篇手稿，以提供方法、背景或为建议提供额外的支持证据，因为这些论文被视为标志性出版物。写作组的成员根据对所获文章的评审撰写并制定建议，并就每项建议达成了三分之二以上的共识。根据美国心脏协会/美国心脏病学会实践指南工作组的建议，对给定建议的信息质量进行评估，以确定证据水平。建议涵盖以下三个方面：1）CPB启动和维持时肝素的剂量和监测；2）肝素的禁忌证和肝素替代物；3）心脏手术期间抗凝的逆转。希望本指南能成为一种资源，并激励研究人员开展更多研究，扩大CPB抗凝主题的证据基础。
