搜索结果：General thoracic and cardiovascular surgery cases

ESC Committee for Practice Guidelines (CPG): Alec Vahanian (Chairperson) (France), Angelo Auricchio (Switzerland), Jeroen J. Bax (The Netherlands), Claudio Ceconi (Italy), Veronica Dean (France), Gerasimos Filippatos (Greece), Christian Funck-Brentano (France), Richard Hobbs (UK), Peter Kearney (Ireland), Theresa McDonagh (UK), Keith McGregor (France), Bogdan A. Popescu (Romania), Zeljko Reiner (Croatia), Udo Sechtem (Germany), Per Anton Sirnes (Norway), Michal Tendera (Poland), Panos Vardas (Greece), Petr Widimsky (Czech Republic) Document Reviewers: Raffaele De Caterina (CPG Review Coordinator) (Italy), Stefan Agewall (Norway), Nawwar Al Attar (France), Felicita Andreotti (Italy), Stefan D. Anker (Germany), Gonzalo Baron-Esquivias (Spain), Guy Berkenboom (Belgium), Laurent Chapoutot (France), Renata Cifkova (Czech Republic), Pompilio Faggiano (Italy), Simon Gibbs (UK), Henrik Steen Hansen (Denmark), Laurence Iserin (France), Carsten W. Israel (Germany), Ran Kornowski (Israel), Nekane Murga Eizagaechevarria (Spain), Mauro Pepi (Italy), Massimo Piepoli (Italy), Hans Joachim Priebe (Germany), Martin Scherer (Germany), Janina Stepinska (Poland), David Taggart (UK), Marco Tubaro (Italy)Table 1Table 2Preamble Guidelines and Expert Consensus Documents aim to present management and recommendations based on the relevant evidence on a particular subject in order to help physicians to select the best possible management strategies for the individual patient with a specific condition, taking into account not only the impact on outcome but also the risk–benefit ratio particular Guidelines for Guidelines and Expert Consensus Documents in the and also the impact on for in order to to the recommendations for and ESC and Expert Consensus Documents on the ESC in the in the and a the evidence for management a and the risk–benefit for evidence and the particular and to in and the on the the in the to the the ESC ESC Committee for 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Potential conflict of interest: Dr. Chalasani consults for and received grants from Eli Lilly. He consults for NuSirt, AbbVie, Afimmune, Tobira, Madrigal, Shire, Cempra, Ardelyx, Axovant, and Amarin. He received grants from Intercept, Gilead, Galectin, and Cumberland. Dr. Younossi consults for Bristol‐Myers Squibb, Gilead, Intercept, Allergan, and GlaxoSmithKline. He advises for Vertex and Janssen. Dr. Brunt advises for Gilead. Dr. Charlton consults for and received grants from Gilead, Intercept, NGM Bio, Genfit, and Novartis. He received grants from Conatus. Dr. Cusi consults for and received grants from Novo Nordisk. He consults for Tobira. He received grants from Cirius, Novartis, Janssen, Zydus, Nordic, and Lilly. Dr. Rinella consults for Intercept, Gilead, Genfit, Novartis, NGM Bio, and Nusirt. She advises for Fibrogen, Immuron, Enanta, and AbbVie. Dr. Harrison consults for Madrigal, NGM Bio, Genfit, Echosens, Prometheus, Cirius, Perspectum, and HistoIndex. He advises for Garland, Intercept, Novartis, and Pfizer. He is on the speakers' bureau for AbbVie, Gilead, and Alexion. Dr. Sanyal consults for and received grants from Salix, Conatus, Galectin, Gilead, malinckrodt, Echosens‐Sandhill, Novartis, and Sequana. He consults for and is employed by Sanyal Bio. He consults for and owns stock in GenFit, Hemoshear, Durect, and Indalo. He consults for Immuron, Intercept, Pfizer, Boehringer Ingleheim, Nimbus, Nitto Denko, Lilly, Novo Nordisk, Fractyl, Allergan, Chemomab, Affimmune, Teva, and Ardelyx. He received grants from Bristol‐Myers Squibb and Merck. He received royalties from UptoDate. He owns stock in Exhalenz, Arkana, and NewCo LLC. The funding for the development of this Practice Guidance was provided by the American Association for the Study of Liver Diseases. This practice guidance was approved by the American Association for the Study of Liver Diseases on June 15, 2017. Preamble This guidance provides a data‐supported approach to the diagnostic, therapeutic, and preventive aspects of nonalcoholic fatty liver disease (NAFLD) care. A “Guidance” document is different from a “Guideline.” Guidelines are developed by a multidisciplinary panel of experts and rate the quality (level) of the evidence and the strength of each recommendation using the Grading of Recommendations, Assessment Development, and Evaluation system. A guidance document is developed by a panel of experts in the topic, and guidance statements, not recommendations, are put forward to help clinicians understand and implement the most recent evidence. This Practice Guidance was commissioned by the American Association for the Study of Liver Diseases (AASLD) and is an update to the Practice Guideline published in 2012 in conjunction with the American Gastroenterology Association and the American College of Gastroenterology (ACG).1 Sections where there have been no notable newer publications are not modified, so some paragraphs remain unchanged. This narrative review and guidance statements are based on the following: (1) a formal review and analysis of the recently published world literature on the topic (Medline search up to August 2016); (2) the American College of Physicians' Manual for Assessing Health Practices and Designing Practice Guidelines2; (3) guideline policies of the AASLD; and (4) the experience of the authors and independent reviewers with regard to NAFLD. This practice guidance is intended for use by physicians and other health professionals. As clinically appropriate, guidance statements should be tailored for individual patients. Specific guidance statements are evidence based whenever possible, and, when such evidence is not available or is inconsistent, guidance statements are made based on the consensus opinion of the authors.3 This is a practice guidance for clinicians rather than a review article, and interested readers can refer to several recent comprehensive reviews.4 Because this guidance document is lengthy, to make it easier for the reader, a list of all guidance statements and recommendations are provided in a tabular form there be (1) evidence of by or and (2) of of such use of a or the of is with such and can be nonalcoholic fatty liver or nonalcoholic is the of evidence of in the form of is the of and with with or this guidance document be to or or of fatty liver of of and the of in from fatty liver to to of evidence of in the form of of the or evidence of The of to and liver is of with and with or This can to liver and liver of with or evidence of or of with no with are with such and of and is a to in liver in with in is A of and and of in the is a of the of in the A have of from are a for of by was a of for of by was the of using and was to be a of for an of of developed by to an rate of The for in the of are A from using of an rate for of the of such this most the of A from an rate of A recent the of from to be the rate from the is to be to the there is a of publications the of in the are in a recent of the of The the of by is The of is from the and the rate is from As the for a liver liver is not in of the there is no of the or of there have been some to the of by The the of in the are in the The of liver for a is to be The of liver a for is from to the of in the and of in of are not in with of the of This and of been this provides a list of the and and and independent of are with and is the most and for NAFLD. the of from to and is with NAFLD. this the of with have is a of in with some have to of have is to the of and this and can in a the of in with or the of in with NAFLD. this and and are in with NAFLD. The of in with been to be a a the based on to and to The rate of was the rate for with the to and to was the rate in the with the was and The of to and the of and of liver disease to with Association of the of or of the (1) than in or than in (2) or (3) than in and than in (4) or or or and or been a for NAFLD. the of in is than in The of and on have the to have a of have a of the of and to be to be is most of the recent the for be by the to the the of the from to and of the have the of with is evidence with with some of are for such and have the following: with have to The most of in with is disease independent of other is the of in the it is the or of with is the of in with with have an a recent and and to be and and and The for and for to be and The most of with is to or are of is the of in the to the of with the the of the of been to a with are have a have and are to from liver than other of from a of from the not have other was with in the of This of in is to most with have is This of with have a of and with the with or in the of in of the for liver disease is of the recent in with a rate of the of in to with a rate of and in with to with a recent of with and a of an of rate not different from with This is with of with with or liver is the of and the of in the are with As of liver disease is the development of The rate was to be of with of the to to liver to and to it is the for in is the of with the and of the of evidence for or recent of of the of in with is A consensus for be in and in a liver to the on and a is of the of in published literature been Guidance or recent on in and on in is a for when with NAFLD. Evaluation of and for other than liver or A recent of with be for based on the the and and for this have not been Guidance with on have or to liver disease or have liver should be have and up with on or and have liver should be for or and for such or for in and can be there should be for with or not with have of the available evidence of and of there are in the and of NAFLD. 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It is essential that the medical profession play a central role in critically evaluating the evidence related to drugs, devices, and procedures for the detection, management, or prevention of disease. Properly applied, rigorous, expert analysis of the available data documenting absolute and relative benefits and risks of these therapies and procedures can improve outcomes and reduce costs of care by focusing resources on the most effective strategies. One important use of such data is the production of clinical practice guidelines which, in turn, can provide a foundation for a variety of other applications such as performance measures, appropriate use criteria, clinical decision support tools, and quality improvement tools. The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly engaged in the production of guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines is charged with developing, updating, and revising practice guidelines for cardiovascular diseases and procedures, and the Task Force directs and oversees this effort. Writing committees are charged with assessing the evidence as an independent group of authors to develop, update, or revise recommendations for clinical practice. Experts in the subject under consideration have been selected from both organizations to examine subject-specific data and write guidelines in partnership with representatives from other medical practitioner and specialty groups. Writing committees are specifically charged to perform a formal literature review, weigh the strength of evidence for or against particular treatments or procedures, and include estimates of expected health outcomes where data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and clinical outcomes constitute the primary basis for recommendations in these guidelines. The ACCF/AHA Task Force on Practice Guidelines makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the writing committee. Specifically, all members of the writing committee, as well as peer reviewers of the document, are asked to disclose all current relationships and those 24 months prior to initiation of the writing effort that may be perceived as relevant. All guideline recommendations require a confidential vote by the writing committee and must be approved by a consensus of the members voting. Members who were recused from voting are noted on the title page of this document. Members must recuse themselves from voting on any recommendation where their relationships with industry (RWI) and other entities apply. If a writing committee member develops a new relationship with industry during his/her tenure, he/she is required to notify guideline staff in writing. These statements are reviewed by the Task Force on Practice Guidelines and all members during each conference call and/or meeting of the writing committee, updated as changes occur, and ultimately published as an appendix to the document. For detailed information regarding guideline policies and procedures, please refer to the methodology manual for ACCF/AHA Guideline Writing Committees. 1 RWI and other entities pertinent to this guideline for authors and peer reviewers are disclosed in Appendixes 1 and 2, respectively. Disclosure information for the ACCF/AHA Task Force on Practice Guidelines is also available online at http://www.acc.org/about/overview/ClinicalDocumentsTaskForces.cfm. These practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches for diagnosis, management, and prevention of specific diseases or conditions. Clinicians should consider the quality and availability of expertise in the area where care is provided. These guidelines attempt to define practices that meet the needs of most patients in most circumstances. The recommendations reflect a consensus after a thorough review of the available current scientific evidence and are intended to improve patient care. The Task Force recognizes that situations arise where additional data are needed to better inform patient care; these areas will be identified within each respective guideline when appropriate. Patient adherence to prescribed and agreed upon medical regimens and lifestyles is an important aspect of treatment. Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. If these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care and aligned with the patient's best interest. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and the patient in light of all of the circumstances presented by that patient. Consequently, are circumstances in from these guidelines are appropriate. The guidelines will be reviewed by the ACCF/AHA Task Force on Practice Guidelines and current they are or from The guidelines are in the issues of the of the American College of Cardiology and Task Force on Practice Guidelines ACCF/AHA Task Force Guidelines The writing committee a of the medical and scientific literature the use of were to in the were reviewed and additional were by committee were on the and of the and and and disease and patient disease and and and or and were with used as the primary evidence for the The ACCF/AHA Task Force on Practice Guidelines methodology were to write the and published in in were used as the evidence were used only for information but were used in the of The committee reviewed and evidence current recommendations with the of evidence as if the data were from clinical or The committee available evidence as when data were from a or as when the primary of the recommendation consensus or of care. the of these evidence is generally presented in of are identified as or For for data are available, recommendations are on expert consensus and clinical and are as is the use of for where are and treatment is on clinical When recommendations at are by clinical appropriate clinical are if For issues where data are available, a of current practice among the on the writing committee the basis for recommendations and are The for of recommendations and of evidence is in also the an of the of the treatment and an of the of the treatment provide with a of the in treatment of clinical are presented to of the absolute needed to the relative treatment are as relative or on the in the with all other for those are when The writing committee that the evidence for this guideline is in of clinical prior ACCF/AHA those on disease and the will of the evidence for this of studies and from with a interest in specific of disease. The writing committee to on the practitioner with recommendations for and treatment and where identified as such in the The writing committee the expertise of the and effective practice guidelines staff of the and The writing committee also the and of the writing committee members who were to issues of specialty and on the medical with a guideline at patient care. The guideline by a committee of in cardiovascular and For of the ACCF/AHA practice writing expertise been available within these Because of the and of as well as the who such the and from specialty but specialty organizations that the for patients with diseases writing committee members and support of the and they are as with the and These organizations the American Association for American College of American Association of for and of of and for The American College of and the American College of were also on the writing committee. additional expertise the scientific of the were for writing committee or by the on and and and for and reviewed by reviewers by the and reviewers by the as well as 1 or reviewers from each of the the and the It also reviewed by reviewers from the and 1 from the All RWI information and to the writing committee and is published in this approved for by the of the and the and the and and by the American for The disease a range of and disease and to the for and diseases of the and for to in the The of to diseases is studies that the of disease is to and and these for as as to The of or is and and in may for to or patients with disease will be to and the of and treatment and/or for a variety of diseases by all healthcare the for this document. guideline will provide the practitioner with a of and treatment that appropriate care of these patients can be and better The goal of this guideline is to improve the health outcomes and quality of for all patients with disease. guideline diseases any or all of the with the of diseases and the when diseases are disease are in the and the is to the of in for used the diseases are and an and of the with or in is the only to diseases and for have in of of of disease. as the use of these also the with as well as these should be used as a is in the document. the writing committee recommendations on a for as in for patients at on or diseases is and by For of treatment for but are better the of treatment required for and disease the and treatment of patients at for and disease and prior to such an are to the and with of patients with are subject to or of this disease with and making under and specific have been in the of the and of disease been for and clinical are noted in The and of medical in the writing of this guideline will provide for of to the of among all medical is evidence that or to of the to these diseases the for of at in the of disease are identified studies of and of the disease. 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light to make of the are and related to of primary and primary or and of the are disease is at the of of primary may include and or the of or identified by during a for an may in the area of the or the and of the of the have been but most patients with is that provide care for patients with of disease procedures for and should in quality and improvement disease should include and of and of that provide care for patients with of disease procedures for and should and quality and improvement with and medical to for quality improvement and and medical of care on available data and performance in accordance with this of with may require to the will and the of the patient in American College of Cardiology Foundation and and and and American Heart Association of

This clinical practice guideline represents a collaborative effort between the American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The ASCRS Clinical Practice Guidelines Committee is composed of society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. In a collaborative effort, the ASCRS Clinical Practice Guidelines Committee and members of the SAGES Surgical Multimodal Accelerated Recovery Trajectory Enhanced Recovery Task Force and Guidelines Committee have joined together to produce this guideline, written and approved by both societies. The combined ASCRS/SAGES panel worked together to develop the statements in this guideline and approved these final recommendations. Through this effort, the ASCRS and SAGES continue their dedication to ensuring high-quality perioperative patient care. Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January 2012 with significant literature published since then. The combined ASCRS/SAGES committee was created to define current best-quality care for enhanced recovery after colon and rectal surgery. This clinical practice guideline is based on the best available evidence. These guidelines are inclusive and not prescriptive. Their purpose is to provide information on which decisions can be made rather than to dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, healthcare workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM Contemporary colorectal surgery is often associated with long length of stay (8 days for open surgery and 5 days for laparoscopic surgery),3 high cost,3 and rates of surgical site infection approaching 20%.4 During the hospital stay for elective colorectal surgery, the incidence of perioperative nausea and vomiting (PONV) may be as high as 80% in patients with certain risk factors.5 After discharge from colorectal surgery, readmission rates have been noted as high as 35.4%.6 An enhanced recovery protocol (ERP) is a set of standardized perioperative procedures and practices that is applied to all patients undergoing a given elective surgery. In general, these protocols are not intended for emergent cases, but components of them certainly could apply to the emergent/urgent patient. Also known as fast-track protocols or enhanced recovery after surgery (ERAS)1 protocols, the content of these specific protocols may vary significantly, but all are designed as a means to improve patient outcomes. Outcomes of interest to patients and providers include freedom from nausea, freedom from pain at rest, early return of bowel function, improved wound healing, and early hospital discharge.7 Although numerous perioperative protocols currently exist, this clinical practice guideline will evaluate the strength of evidence in support of measures to improve patient recovery after elective colon and rectal resections. A 2011 Cochrane review found that ERPs were associated with a reduction in overall complications and length of stay when compared with conventional perioperative patient management.8 Subsequent studies have shown that ERPs are associated with reduced healthcare costs and improved patient satisfaction.4 ERPs are also associated with improved outcomes regardless of whether patients undergo laparoscopic or open surgery.9 Studies have also shown that ERPs cannot simply be implemented and forgotten but require a continued audit process in place to guide compliance and to continue to improve quality.10–13 There are many different preoperative, intraoperative, and postoperative components in a typical ERP, and it is difficult to identify which are the most beneficial components of the bundle of measures, because they are generally all implemented simultaneously. However, one retrospective review of 8 years of compliance with an ERP identified these items as the strongest predictors of shorter length of stay: no nasogastric tube, early mobilization, early oral nutrition (early discontinuance of intravenous fluids), early removal of epidural, early removal of and This clinical practice guideline will evaluate the evidence ERPs for colorectal surgery. of the SAGES and ASCRS Practice Guidelines Committee worked in of these guidelines from to final were approved by committee and These guidelines were a standardized for the of all of clinical practice which for of a review of the and of the of the of and of the The of specific of studies and of evidence for are available in the but all of the an of and the Cochrane of a of on and were from to and were to of the from the were also in certain and were given in these guidelines. After all of the were a of been identified for and of were for review and evidence with of the evidence based on of the by The final of was the of and by the American of Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January with significant literature published since The of and A of and discharge should be with the patient surgery. of based on discharge for patients undergoing colorectal surgery have been in an which that patients are for discharge when is of oral recovery of function, pain with oral to to no evidence of complications or and patient to the Although are studies that at the of regarding and discharge these are a of and have the of an ERP that discharge on hospital length of compliance with an ERP that patient and discharge been shown in and to be associated with length of stay and The to the discharge to for been as a of However, are between the when patients are discharge and with a to days of length of stay high ERP and on should be included in the of based on The of an is an risk for a length of stay after colorectal The of patient to improve of and hospital length of and hospital costs been in and as as a in is beneficial but a demonstrated that patient was most in the and studies have shown that by an of the site and patient was associated with improved postoperative of reduced rates of postoperative and improved patient regardless of and studies have the of an on is an of been shown to be the most of readmission after from to of an in which patients were in management and an enhanced recovery reduced overall from to and for from to a perioperative care been included in a and review of process measures to postoperative and A may be continued of based on high-quality should be to the of because it been shown to be and to improve of clinical have the of elective surgery. 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The current practice guidelines of the and Society of support this should be surgery in of based on The use of should be with the purpose to by surgery and A Cochrane review in identified in and as to the or found in or The of the review was that was associated with a reduction in the length of hospital stay when compared with or in patients undergoing elective surgery. was not associated with or perioperative complications when compared with or studies were to because of a of A of studies patients no overall in length of stay all of the included when the of patients undergoing surgery, was a in of length of A of whether the of was and found that both and high of surgery improved length of stay when compared with However, when compared with or not a in the length of to the of complications regardless of the or on this most surgery may provide clinical as bowel oral bowel colorectal surgery is the and is associated with reduced of based on A for perioperative care in elective surgery that bowel should not be in surgery based on the it and a 2011 Cochrane no to in However, evidence regarding the of oral to should be Although to be no of in of a of with a reduction in surgical site infection and site with no in the of infection after elective colorectal These are with In a retrospective of a in the in was associated with overall surgical site and retrospective studies in different and a hospital a reduction in surgical site infection with the of to The Surgical a reduction in surgical site infection and a reduction in postoperative in patients who with patients who no bowel was as of a perioperative care bundle at a significant in surgical site infection was elective surgery may be for patients undergoing elective colorectal surgery with or significant of based on as of the of a been as a for postoperative to a surgical procedure with the to the postoperative and The of is were both and These studies were of to of these and on the of in patients who colorectal not The studies with patient evidence for the of on function, of length of and Studies on colorectal and surgery were in of measures, of the and compliance rates with these which the of and the to However, these studies support the of to improve or surgery. There were retrospective and and that in function, and of with at may have the most to with However, in the of or of in compliance with protocols, and these at postoperative studies no in postoperative rates and hospital length of stay with compared with or postoperative or have been should be as a of the enhanced care of based on ERPs are and require between many different to the care of the surgical patient. to all of these protocols are which include preoperative, intraoperative, and postoperative that care between all and for all The current of not been but all of the studies enhanced recovery conventional care have included as of the However, it is not the of standardized that to improved because a by improved outcomes for patients undergoing who were by enhanced recovery compared with a conventional care that included standardized protocol is The of standardized an ERP is not to outcomes. demonstrated in a that to protocol was high in the and but recovery at a of but length of stay was 5 of patients in that were on and that ERPs were to A collaborative from the Society that patients with protocol compliance length of stay and complications than patients with compliance all of the perioperative A clinical audit that compliance with an ERP was associated with shorter length of However, this not been an because a retrospective ERP compliance in clinical practice compared to a clinical the not any in length of or between the Surgical A bundle of measures should be in place to surgical site of based on A care bundle is a set of practices that have been to improve patient outcomes. In a reduction in surgical site from to after of a measures included a with oral of and of of the surgical with measures included use of a wound and use of a wound and measures included removal of the and of the with and perioperative of were also components of the significant was in and A review and studies that use of an surgical care bundle for patients undergoing colorectal surgery reduced the risk of in bundle in the care Although of the studies in this the care all included from a of and for measures that have been included in are a reduction in intravenous for high of and for 5 days vary between different protocols, and the to which a in difficult to A pain management should be and implemented the of of based on studies have demonstrated that is associated with return of bowel and shorter length of of the to is to as oral and rather than them on an The use of or when not and of or have been shown to improve postoperative and and of their that have been shown to surgical and clinical studies have shown that may the risk of one demonstrated in patients of in the after surgery, the risk of was not This on rates to be and and in patients for a days after surgery. demonstrated a risk of in patients undergoing but not elective colorectal surgery The evidence is and not support the of in patients with perioperative and have also been to improve and and postoperative but and may the and of to be of have also been shown to and improve and postoperative the risk of wound or However, are and with have shown in patients undergoing open and laparoscopic colorectal In that the with a been associated with length of stay compared with in laparoscopic colorectal surgery to provide than at the Although many a the of and to and is for open colorectal surgery, but not for use in laparoscopic colorectal surgery. based on Although is the patient or to pain in patients undergoing open colorectal the by not support a recovery in laparoscopic surgery. and have shown that no or may hospital discharge in laparoscopic surgery. 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Table of Contents I. Introduction A. Development of Guidelines B. General Approach C. Preoperative Clinical Evaluation II. Further Preoperative Testing to Assess Coronary Risk A. Clinical Markers B. Functional Capacity C. Surgery-Specific Risk III. Management of Specific Preoperative Cardiovascular Conditions A. Hypertension B. Valvular Heart Disease C. Myocardial Disease D. Arrhythmias and Conduction Abnormalities E. Implantable Pacemakers or ICDs IV. Supplemental Preoperative Evaluation A. Resting Left Ventricular Function B. 12-Lead ECG C. Exercise or Pharmacological Stress Testing D. Coronary Angiography V. Perioperative Therapy or Previous Coronary Revascularization A. Coronary Artery Bypass Grafting B. Percutaneous Coronary Intervention VI. Perioperative Medical Therapy VII. Anesthetic Considerations and Intraoperative Management A. Anesthetic Agent B. Perioperative Pain Management C. Intraoperative Nitroglycerin D. Transesophageal Echocardiography E. Perioperative Maintenance of Body Temperature VIII. Perioperative Surveillance A. Pulmonary Artery Catheters B. Intraoperative and Postoperative ST-Segment Monitoring C. Surveillance for Perioperative MI IX. Postoperative and Long-Term Management References I. Introduction These guidelines represent an update of those published in 1996 and are intended for physicians who are involved in the preoperative, operative, and postoperative care of patients undergoing noncardiac surgery. They provide a framework for considering cardiac risk of noncardiac surgery in a variety of patient and surgical situations. The overriding theme of these guidelines is that preoperative intervention is rarely necessary simply to lower the risk of surgery unless such intervention is indicated irrespective of the preoperative context. The purpose of preoperative evaluation is not simply to give medical clearance but rather to perform an evaluation of the patient’s current medical status; make recommendations concerning the evaluation, management, and risk of cardiac problems over the entire perioperative period; and provide a clinical risk profile that the patient, primary physician, anesthesiologist, and surgeon can use in making treatment decisions that may influence short- and long-term cardiac outcomes. The goal of the consultation is to identify the most appropriate testing and treatment strategies to optimize care of the patient, provide assessment of both short- and long-term cardiac risk, and avoid unnecessary testing in this era of cost containment. A. Development of Guidelines These guidelines are based on an update of a Medline, EMBASE, Cochrane library, and Best Evidence search of the English literature from 1995 through 2000, a review of selected journals, and the expert opinions of 12 committee members representing various disciplines of cardiovascular care, including general cardiology, interventional cardiology, noninvasive testing, vascular medicine, vascular surgery, anesthesiology, and arrhythmia management. As a result of these searches, more than 400 relevant new articles were identified. In addition, draft guidelines were submitted for critical review and amendment to the executive officers representing the American College of Cardiology (ACC) and the American Heart Association (AHA). A large proportion of the data used to develop these guidelines are based on observational or retrospective studies or knowledge of management of cardiovascular disorders in the nonoperative setting. Although the collective body of knowledge about the identification of high- and low-risk patients by perioperative clinical and noninvasive evaluation is substantial, the number of prospective or randomized studies that have been performed to establish the value of different treatments on perioperative outcomes is small. The ACC/AHA classifications of evidence used in this report to summarize the indication for a particular therapy or treatment are as follows: Class I: Conditions for which there is evidence and/or general agreement that a given procedure/therapy is useful and effective. Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of performing the procedure/therapy. Class IIa: Weight of evidence/opinion is in favor of usefulness/ efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/ opinion. Class III: Conditions for which there is evidence and/or general agreement that a procedure/therapy is not useful/effective and in some cases may be harmful. Two versions of the full-text guidelines are available on the World Wide Web sites of both the American College of Cardiology (http://www.acc.org) and the American Heart Association (http://www.americanheart.org); one version highlights the updated material (deleted text in strikeout and new text in red), and the other fully incorporates the changes. This document was approved for publication by the governing bodies of the ACC and the AHA, will be reviewed annually by the Task Force, and will be considered current unless the Task Force revises or withdraws them from distribution. B. General Approach The preoperative cardiac evaluation must be carefully tailored to the circumstances that have prompted the consultation and to the nature of the surgical illness (e.g., acute surgical emergency) as opposed to urgent or elective cases. Successful perioperative evaluation and treatment of cardiac patients undergoing noncardiac surgery requires careful teamwork and communication between the patient, primary care physician, anesthesiologist, consultant, and surgeon. In general, indications for further cardiac testing and treatments are the same as those in the nonoperative setting, but their timing is dependent on such factors as the urgency of noncardiac surgery, the patient’s risk factors, and specific surgical considerations. Coronary revascularization before noncardiac surgery to enable the patient to “get through” the noncardiac procedure is appropriate only for a small subset of patients at very high risk. Preoperative testing should be limited to circumstances in which the results will affect patient treatment and outcomes. A conservative approach to the use of expensive tests and treatments is recommended. C. Preoperative Clinical Evaluation The initial history, physical examination, and electrocardiogram (ECG) assessment should focus on identification of potentially serious cardiac disorders, including coronary artery disease (CAD) [e.g., prior myocardial infarction (MI) and angina pectoris], heart failure (HF), symptomatic arrhythmias, presence of pacemaker or implantable cardioverter defibrillator (ICD), or a history of orthostatic intolerance (1). The presence of anemia may also place a patient at higher perioperative risk (2–4). In addition to identifying the presence of pre-existing manifested heart disease, it is essential to define disease severity, stability, and prior treatment. Other factors that help determine cardiac risk include functional capacity, age, comorbid conditions (e.g., diabetes mellitus, peripheral vascular disease, renal dysfunction, and chronic pulmonary disease), and type of surgery (vascular procedures and prolonged, complicated thoracic, abdominal, and head and neck procedures are considered higher risk). Numerous risk indices have been developed over the past 25 years on the basis of multivariate analyses (5–14). In addition to the presence of CAD and HF, a history of cerebrovascular disease, preoperative elevated creatinine greater than 2 mg per deciliter, insulin treatment for diabetes mellitus, and high-risk surgery have all been associated with increased perioperative cardiac morbidity. Despite these risk indices, there was consensus among the committee members to place clinical risk factors into 3 categories of predictors (see Section II-A). II. Further Preoperative Testing to Assess Coronary Risk Which patients are most likely to benefit from preoperative coronary assessment and treatment? The lack of adequately controlled or randomized clinical trials to define the optimal evaluation strategy led to the proposed algorithm based on collected observational data and expert opinion (see Fig. 1). Since publication of the guidelines in 1996, several studies have suggested that this stepwise approach to the assessment of CAD is both efficacious and cost-effective.Figure 1: Stepwise approach to preoperative cardiac assessment. Steps are discussed in text. *Subsequent care may include cancellation or delay of surgery, coronary revascularization followed by noncardiac surgery, or intensified care.A stepwise bayesian strategy that relies on assessment of clinical markers, prior coronary evaluation and treatment, functional capacity, and surgery-specific risk is outlined in Figure 1. A framework for determining which patients are candidates for cardiac testing is presented in algorithmic form. Successful use of the algorithm requires an appreciation of the different levels of risk attributable to certain clinical circumstances, levels of functional capacity, and types of surgery. These are defined below, after which the algorithm is reviewed step by step. A. Clinical Markers The major clinical predictors (Table 1) of increased perioperative cardiovascular risk are a recent unstable coronary syndrome such as an acute MI (documented MI less than 7 days previously), recent MI (more than 7 days but less than 1 month before surgery), unstable or severe angina, evidence of a large ischemic burden by clinical symptoms or noninvasive testing, decompensated HF, significant arrhythmias (high-grade atrioventricular block, symptomatic arrhythmias in the presence of underlying heart disease, or supraventricular arrhythmias with uncontrolled ventricular rate), and severe valvular disease.Table 1: Clinical Predictors of Increased Perioperative Cardiovascular Risk (Myocardial Infarction, Heart Failure, Death)Intermediate predictors of increased risk are mild angina pectoris, a more remote prior MI (more than 1 month before planned surgery), compensated HF, preoperative creatinine greater than or equal to 2.0 mg per deciliter, and diabetes mellitus. Minor predictors of risk are advanced age, abnormal ECG, rhythm other than sinus, low functional capacity, history of stroke, and uncontrolled systemic hypertension. A history of MI or abnormal Q waves by ECG is listed as an intermediate predictor, whereas an acute MI (defined as at least 1 documented MI less than or equal to 7 days before the examination) or recent MI (more than 7 days but less than or equal to 1 month before the examination) with evidence of important ischemic risk by clinical symptoms or noninvasive study is a major predictor. This definition reflects the consensus of the ACC Cardiovascular Database Committee. In this way, the separation of MI into the traditional 3- and 6-month intervals has been avoided (6,15). Current management of MI provides for risk stratification during convalescence (16). If a recent stress test does not indicate residual myocardium at risk, the likelihood of reinfarction after noncardiac surgery is low. Although there are no adequate clinical trials on which to base firm recommendations, it appears reasonable to wait 4 to 6 weeks after MI to perform elective surgery. B. Functional Capacity Functional capacity can be expressed in metabolic equivalent (MET) levels (Table 2). Multiples of the baseline MET value can be used to express aerobic demands for specific activities. Perioperative cardiac and long-term risks are increased in patients unable to meet a 4-MET demand during most normal daily activities (17–19). The Duke Activity Status Index and other activity scales provide the clinician with a set of questions to determine a patient’s functional capacity (20–22). Energy expenditures for activities such as eating, dressing, walking around the house, and dishwashing range from 1 to 4 METs. Climbing a flight of stairs, walking on level ground at 6.4 km per hour, running a short distance, scrubbing floors, or playing a game of golf 4 to METs. such as and Energy for Surgery-Specific Risk cardiac risk of noncardiac surgery is to 2 important the type of surgery and the of stress associated with the The and of coronary and myocardial can be in the likelihood of perioperative cardiac for surgery. risk for noncardiac surgery can be as and low (Table surgery major surgery, in the and other major vascular peripheral vascular and procedures associated with large and/or procedures include and surgery, head and neck surgery, surgery, and surgery. procedures include and surgery, and for to the algorithm presented in Figure 1. 1 is the urgency of noncardiac not for preoperative cardiac Postoperative risk stratification may be appropriate for some patients who have not such an assessment 2 the patient coronary revascularization in the past If and clinical has of further cardiac testing is not necessary 3 the patient a coronary evaluation in the past 2 If coronary risk was adequately and the were it is not necessary to testing unless the patient has a or new symptoms of coronary the 4 the patient have an unstable coronary syndrome or a major clinical of elective noncardiac surgery is the presence of unstable coronary disease, decompensated HF, symptomatic arrhythmias, and/or severe valvular heart disease to cancellation or delay of surgery the has been and the patient have intermediate clinical predictors of The presence or of prior MI by history or ECG, angina pectoris, compensated or prior HF, preoperative creatinine greater than or equal to 2 mg per deciliter, and/or diabetes to further clinical risk for perioperative coronary of functional capacity and level of surgery-specific risk a approach to identify patients most likely to benefit from further noninvasive 6 major but with intermediate predictors of clinical risk and or functional capacity can surgery with likelihood of perioperative or further noninvasive testing is considered for patients with functional capacity or functional capacity but surgery, for patients with 2 or more intermediate predictors of risk. 7 surgery is for patients with major intermediate predictors of clinical risk and or functional capacity or testing may be considered on an basis for patients clinical but with functional capacity who are those with several clinical predictors of risk who are to vascular surgery. The results of noninvasive testing can be used to determine the for preoperative testing and treatment. In some patients with documented the risk of coronary intervention or cardiac surgery may approach or the risk of the proposed noncardiac surgery. This approach may be it the patient’s long-term some a careful of and functional to a to to coronary III. Management of Specific Preoperative Cardiovascular Conditions A. Hypertension 3 greater than or equal to and greater than or equal to should be controlled before surgery. In such of an can be over several days to weeks of preoperative treatment. If surgery is more can be that in a of or to be of preoperative treatment through the perioperative is B. Valvular Heart Disease for evaluation and treatment of valvular heart disease are to those in the setting. are associated with risk of perioperative or and or before noncardiac surgery to lower cardiac risk disease is and may be with medical therapy and disease can be with or after noncardiac surgery. Medical therapy and are appropriate a delay of several weeks or before noncardiac surgery may have severe may include severe valvular with ventricular in which is limited that during perioperative is C. Myocardial Disease and are associated with an increased of perioperative Management is at preoperative and postoperative medical therapy and of is useful for from or postoperative D. Arrhythmias and Conduction Abnormalities The presence of an arrhythmia or cardiac should a careful evaluation for underlying disease, or metabolic Therapy should be for symptomatic or significant arrhythmias, to an underlying and to the for therapy and cardiac are to those in the nonoperative setting. ventricular and/or ventricular have not been associated with an increased risk of MI or cardiac in the perioperative and or treatment in the perioperative is not E. Implantable Pacemakers or ICDs The type and of evaluation of a pacemaker or on the urgency of the surgery, a pacemaker has or is or the between and and pacemaker should be before surgery and on IV. Supplemental Preoperative Evaluation Specific recommendations for preoperative evaluation must be to patient and The may be appropriate in specific assessment of ventricular stress testing, stress testing, ECG and coronary In most the test of is ECG testing, which can both provide an of functional capacity and myocardial through in the ECG and In patients with important on their ECG (e.g., block, ventricular with or other such as or myocardial should be testing are given A. Resting Left Ventricular Function Resting ventricular has not been to be a of perioperative ischemic for Preoperative Evaluation of Left Ventricular Function Class with current or controlled evaluation has documented severe ventricular dysfunction, preoperative testing may not be Class with prior and patients with of Class As a test of ventricular in patients prior B. 12-Lead ECG The ECG does not identify increased perioperative risk in patients undergoing low-risk surgery, but certain ECG are clinical predictors of increased perioperative and long-term cardiovascular risk in and high-risk patients for Preoperative 12-Lead ECG Class of or ischemic equivalent in or high-risk patients for an or high-risk Class with diabetes mellitus. Class 1. with prior coronary more than years or more than years with 2 or more risk for cardiac Class As a test in undergoing low-risk C. Exercise or Pharmacological Stress Testing for Exercise or Pharmacological Stress Testing Class of patients with intermediate of assessment of patients undergoing initial evaluation for or evaluation of with significant in clinical of of myocardial before coronary Evaluation of of medical assessment after an acute coronary syndrome recent evaluation Class Evaluation of capacity assessment is Class of CAD patients with high or low those with less than 1 those or those with ECG for ventricular of in high-risk the initial after coronary intervention Class stress testing, of patients with ECG that adequate ventricular greater than 1 or likely to or for of or of in D. Coronary Angiography for Coronary Angiography in Perioperative Evaluation Class I: or CAD Evidence for high risk of based on noninvasive test to adequate medical angina, or noncardiac surgery. noninvasive test results in patients at high clinical risk undergoing surgery. Class of intermediate clinical and planned vascular surgery testing should be considered to large on noninvasive testing but high-risk and lower ventricular noninvasive test results in patients at intermediate clinical risk undergoing high-risk noncardiac surgery. noncardiac surgery from acute Class Perioperative or angina and planned low-risk or surgery. Class noncardiac surgery with CAD and no high-risk results on noninvasive after coronary revascularization with capacity than or equal to 7 angina with ventricular and no high-risk noninvasive test for coronary revascularization to medical severe ventricular (e.g., ventricular less than or to for or renal less than years as of evaluation for unless noninvasive testing high risk for V. Perioperative Therapy or Previous Coronary Revascularization A. Coronary Artery Bypass Grafting for coronary artery before noncardiac surgery are to those reviewed in the ACC/AHA guidelines for is rarely indicated simply to “get a patient through” noncardiac surgery. In patients in the Coronary Artery the cardiac risk associated with noncardiac the and head and neck was in those patients who prior undergoing elective noncardiac procedures who are to have high-risk coronary and in long-term likely be by should revascularization before a noncardiac elective surgical procedure of high or intermediate risk (Table B. Percutaneous Coronary Intervention are no controlled trials perioperative cardiac after noncardiac surgery for patients with preoperative medical small observational have suggested that cardiac is in patients who have before noncardiac surgery studies have also a number of from including in some further data are indications for in the perioperative are to those in the ACC/AHA guidelines for use of in general is should between and noncardiac surgery for at least 1 after to for of the has If a coronary is a delay of at least 2 weeks and 4 to 6 weeks should before noncardiac surgery to 4 weeks of therapy and of the to be or VI. Perioperative Medical Therapy recent trials have the of medical therapy before surgery on cardiac Two trials of have been performed perioperative cardiac and the other 6-month with perioperative trials have the of cardiac in the subset of patients with CAD undergoing vascular surgery are very randomized trials of medical therapy before noncardiac surgery to perioperative cardiac and not provide data from which to firm or are to the on of MI or cardiac and on the of ECG to Current that perioperative and may the risk of MI and in high-risk should be days or weeks before elective surgery, with the to a heart between and per Perioperative treatment with may have on myocardial and cardiac this is an in which further be for Perioperative Medical Therapy Class in the recent past to symptoms of angina or patients with symptomatic arrhythmias or hypertension. patients at high cardiac risk to the of on preoperative testing who are undergoing vascular surgery. Class preoperative assessment coronary disease, or major risk factors for coronary Class perioperative of or CAD or major risk factors for Class to to VII. Anesthetic Considerations and Intraoperative Management A. Anesthetic Agent and have cardiac that should be considered in the perioperative appears to be no one the of and is to the of the care which will the for postoperative cardiovascular myocardial and level of the of in which is by have that use of this the of general or but no studies have established to can to increased stress and/or myocardial B. Perioperative Pain Management and/or is a for postoperative studies that management to a in postoperative and C. Intraoperative Nitroglycerin are data about the of in patients at high risk Nitroglycerin should be used only the of other in use have been D. Transesophageal Echocardiography are data on the value of to in cardiac in noncardiac surgical patients to that the value of this for risk is small Guidelines for appropriate use of have been published by the American of and the of Cardiovascular E. Perioperative Maintenance of Body Temperature randomized a of perioperative cardiac in patients who were in a of with care VIII. Perioperative Surveillance A. Pulmonary Artery Catheters Although very studies that have been patient outcomes after treatment with or pulmonary artery 3 are important in benefit risk of pulmonary artery disease severity, of surgery, and The of is a primary most likely to benefit from perioperative use of a pulmonary artery to be those with a recent MI complicated by HF, those with significant CAD who are undergoing procedures associated with significant and those with or ventricular dysfunction, and/or valvular disease who are undergoing high-risk B. Intraoperative and Postoperative ST-Segment Monitoring Intraoperative and postoperative myocardial are predictors of perioperative MI in patients at high risk who noncardiac surgery postoperative is a significant of long-term risk of MI and cardiac in patients at low risk who noncardiac surgery, may and is not associated with evidence that use of in selected patients at high risk may for myocardial C. Surveillance for Perioperative MI studies have the optimal for a perioperative Clinical postoperative ECG and of the of have been most of such as or have also been to be of value In patients with or CAD who are undergoing high-risk at after surgery, and on the 2 days after surgery to be A risk can be based on the of the presence or of new ECG and and of of cardiac is for patients at high risk and those with ECG, or evidence of cardiovascular IX. Postoperative and Long-Term Management Despite optimal perioperative management, some patients will have perioperative which is associated with a to patients who a symptomatic perioperative MI as a result of coronary should be considered after the risks have been Pharmacological therapy with should be as as and a and may also be Perioperative MI a high risk for cardiac who acute MI in the perioperative should careful medical evaluation for residual and ventricular is also appropriate to risk in the large number of elective surgery patients in cardiovascular are during preoperative Although the of surgery is as a specific high-risk most of the patients who have or CAD during their preoperative will not have during elective noncardiac surgery. the preoperative cardiac risk has been by clinical or noninvasive testing, most patients will benefit from to lower or the basis of expert the goal should be to lower the level to less than mg per per

THE pain that accompanies thoracic surgery is notable for its intensity and duration. Acutely, moderate to severe levels of pain may not decrease substantially over the course of hospitalization and the first postoperative month.1Chronically, pain can last for months to years, and even low levels of pain can decrease function.1,2Other than pain syndromes associated with limb amputation, pain after thoracic surgery may be the most recognized pain syndrome associated with a specific surgery. Although used with increasing frequency, thoracoscopic approaches have not had the favorable impact on pain that many had anticipated.3,4Given that the adverse effects of thoracic surgery on pulmonary function can be mitigated by effective perioperative analgesia,5–7it is not surprising that thoracic surgeons have joined anesthesiologists in becoming strong advocates of analgesic interventions known to limit the pain accompanying thoracic surgery. Here, we review evidence-based strategies for preventing and treating this type of pain.Noxious input associated with thoracic surgery is conveyed to the central nervous system along the intercostal, vagus, and phrenic nerves. Afferent phrenic activity is believed to be the source of the shoulder pain that frequently accompanies thoracic procedures because this is curtailed by phrenic8but not suprascapular or epidural blockade.9Intercostal nerve dysfunction resulting from incision, retraction, trocar placement, or suture is common10and likely plays a significant role in the pain accompanying thoracic surgery. In addition, the need for constant respiratory effort and enhanced pulmonary toilet produces an intense and relentless barrage of noxious input to the central nervous system.Initial reports indicated that 50% of patients describe pain 1 yr after thoracotomy, with many continuing to report pain even years later.2Fortunately, the prevalence of postthoracotomy pain may be modifiable, with rates as low as 21% one year after surgery when perioperative pain is managed aggressively.1Surprisingly, video-assisted thoracic surgery (VATS) is associated with a prevalence of chronic pain comparable to that of open procedures,3,4with rates of pain ranging from 22%3to 63%,4which is probably due to intercostal nerve and muscle damage from trocar insertion. In contrast, residual pain 1 yr after surgery is reported to be 25% after median sternotomy,11emphasizing the role that reduced intercostal nerve disruption and improved stability of the closure may play in reducing chronic pain. Several demographic and clinical factors help to identify patients predisposed to development of chronic postsurgical pain. These include anxiety, depression, previous surgery, concurrent pain, lesions of the chest wall, youth, female sex, and increased levels of pain and analgesic use in the perioperative period.1,12–19Lung volumes after thoracic surgery may be reduced by up to 50%, and aggressive analgesic therapy leads to improvements in pulmonary function not observed with standard therapy.5–7Supraventricular tachydysrhythmias are commonly observed after thoracic surgery20and may be less likely in conjunction with certain thoracic epidural analgesic regimens,21although this is more likely due to modification of sympathetic outflow than the associated analgesia. When pain persists, physical activity is reduced,1and even low levels of pain have been associated with reduced physical and social activity as well as global perceptions of decreased health.1,12The optimal perioperative analgesic strategy (fig. 1) is preemptive and multimodal. Although the definition22and efficacy23of preemptive analgesia are debated, several studies strongly suggest that preemptive approaches lead to reductions in pain and/or analgesic use after thoracic surgery.1,7,24–27However, it is equally clear that intraoperative nociception represents only a small portion of the noxious activity encountered during the entire perioperative period that could ultimately sensitize the central nervous system, exacerbating acute pain and initiating chronic pain. A multimodal approach takes into account the multiple pathways by which nociceptive input is conveyed to the central nervous system, the number of pharmacologically distinct mechanisms of modulating this input, the need for effective analgesia throughout the perioperative period and after discharge, and the importance of minimizing side effects, particularly respiratory depression. Although many aspects of analgesic management focus on specific analgesic interventions by the anesthesiologist and surgeon, other features of the surgical management may also impact on the intensity and duration of pain experienced by the patient.Thoracic epidural analgesia is currently the standard for analgesia for thoracic surgery and, in the absence of contraindications, all patients undergoing major open thoracic surgical procedures should have a thoracic epidural catheter placed preoperatively.28,29Epidural catheter placement may also be useful in smaller open procedures and VATS in patients at high risk of severe perioperative pain, pulmonary dysfunction, or both. Ideally, for posterolateral and transverse sternothoracotomy, the tip of the catheter should reside at the dermatome along which the incision will be made. In the case of median sternotomy and muscle-sparing incisions, placement at the T6 interspace is effective. Although the intraoperative use of epidural analgesia may not confer substantial long-term benefits,1intraoperative use may still be desirable as an adjunct to general anesthesia, to ensure epidural catheter function and to facilitate a comfortable transition to the immediate postoperative period.Typical intraoperative management of a thoracic epidural catheter incorporates initial and maintenance doses with a combination of a local anesthetic and a relatively lipophilic opioid. Maintenance doses can be administered as boluses or continuous infusions. Some degree of hypotension is to be expected given the potential for sympathectomy. Judicious fluid and pressor administration avoids the large fluid shifts that could adversely affect physiology, particularly in patients who present with limited cardiac or pulmonary reserve.Postoperatively, patient-controlled epidural analgesia should be initiated and continued until after thoracostomy tube removal. Typically, for thoracic epidural catheters, the epidural infusate combines a low concentration of a long-acting local anesthetic (e.g. , 0.5–1 mg/ml bupivacaine or 1–2 mg/ml ropivacaine) and a relatively lipophilic opioid (e.g. , 5 μg/ml fentanyl30or 10–25 μg/ml hydromorphone). Several well-designed studies have demonstrated improved analgesia when 2 μg/ml epinephrine was added to the infusate.31,32A large number of drugs, including ketamine33(with some reservations),34clonidine,35and neostigmine,36have been advocated as components of epidural analgesia but have not gained widespread acceptance. Typical patient-controlled epidural analgesia regimens after thoracotomy with an epidural catheter at the optimal dermatome would combine a continuous infusion of 4–6 ml/h with demand boluses of 2–4 ml every 10 min. Dysfunctional catheters should be replaced as quickly as possible.Postoperatively, intravenous nonsteroidal antiinflammatory drugs are useful for treating shoulder pain refractory to epidural analgesia and, given their safety and effectiveness as analgesic adjuncts, patients using patient-controlled epidural analgesia should continuously receive oral or intravenous nonsteroidal antiinflammatory drugs during hospitalization and upon discharge.37,38Although the limited effect on platelets of drugs that specifically inhibit cyclooxygenase 2 may be important, the potential of these drugs in the setting of thoracic surgery awaits resolution of their cardiovascular safety.39Regular administration of acetaminophen may also be useful for treating shoulder pain40and can be used in addition to nonsteroidal antiinflammatory drugs. Patient-controlled analgesia with opioids can be used to supplement working epidural infusions, particularly in opioid-tolerant patients. For simplicity, a fixed epidural infusion is complemented by a patient-controlled intravenous infusion of opioids, where the safest initial approach is to permit patient-controlled analgesia demand doses only. For analgesic continuity when making the transition to oral opioid analgesics, the first oral dose should be administered at the time patient-controlled epidural analgesia is discontinued. For patients where pain management may be difficult, the epidural catheter can remain in place to permit rescue analgesia until a satisfactory oral analgesic regimen is established.There are times when for technical, medical, or other reasons thoracic epidural catheter placement is unsuccessful, undesirable, or not possible. There may also be times when surgery, thoracoscopic or other, evolves to an open thoracic procedure or when it is learned intraoperatively that an epidural catheter is dysfunctional. The prompt identification of these situations and institution of alternatives is essential for preventing severe postoperative pain. Although it may facilitate pain management, several case reports demonstrate the profound risks of placing or replacing an epidural catheter while a patient is under general anesthesia.41Although a degree of safety has been demonstrated for lumbar epidural catheter placement during general anesthesia,42it has been argued43that such data may not be reassuring when considering rare but catastrophic events. In addition to addressing problems with thoracic epidural catheter placement, alternatives to epidural catheter placement may also be suitable for VATS and smaller thoracic procedures when many practitioners would otherwise not place an epidural catheter.Alternatives to midthoracic epidural analgesia include lower thoracic and lumbar epidural catheter placement, intercostal nerve blocks (ICNBs), paravertebral blocks, intrapleural catheters, local anesthetic infiltration, and systemic analgesia with one or more agents. Epidural catheters placed several dermatomes from the surgical site require larger volumes of analgesic. Even lumbar placement can be efficacious, particularly when used with hydrophilic opioids such as morphine.44,45ICNBs can be performed percutaneously or under direct vision, using single injections or placement of an intercostal catheter, or with cryotherapy. ICNBs are generally administered as single injections at least two dermatomes above and below the incision. Intercostal catheters can be placed, they but tend to be associated with less reliable spread of local anesthetic as well as rapid local anesthetic absorption and may be less effective than epidural analgesia.46–48Although cryotherapy of the intercostal nerves under direct vision avoids many of these issues, it is not as effective as epidural analgesia with respect to both quality of acute pain relief and preservation of lung function,49and it may also lead to increases in chronic pain.7Paravertebral blocks can be performed as single injections or via a paravertebral catheter. Paravertebral catheters can be placed percutaneously or intraoperatively under direct vision and are more suitable than epidural catheters when coagulopathy is of concern. Intraoperative paravertebral catheter placement precludes to an extent its use in a preemptive fashion. However, as indicated earlier, experience with epidural catheters suggests that this may not be very detrimental, particularly if analgesia for the remainder of the perioperative period is effective. In at least some studies of acute pain, paravertebral blocks may be as effective as thoracic epidural analgesia with respect to pain control and preservation of pulmonary function after thoracotomy.50Intrapleural catheter placement can be performed percutaneously or under direct vision at the time of surgery. Intrapleural catheters are notable for the absorption of local anesthetic and less effective pain control when compared with epidural analgesia.51Local anesthetic infiltration added little to a combination of epidural analgesia and ICNBs.52Systemic analgesics are the main alternative to more invasive techniques, can be adjuncts to these techniques, and become the mainstay of analgesic therapy when invasive approaches are discontinued. Opioids, ideally administered initially via intravenous patient-controlled analgesia and upon discharge orally, are the main component of systemic analgesic therapy for thoracic procedures. Although respiratory depression is a potential side effect with systemic opioids, it should be appreciated that some patients may hypoventilate because of inadequate analgesia, in which case ventilation may actually improve after systemic opioid administration. As with more invasive approaches, nonsteroidal antiinflammatory drugs continue to be an important adjunct to opioid analgesia,53,54along with acetaminophen.40Tramadol administered by continuous intravenous infusion may be as effective as thoracic epidural morphine.55Given their efficacy in other types of surgery, the N -methyl-d-aspartate receptor antagonists ketamine and dextromethorphan, which both enhance epidural analgesia,56–58and the anticonvulsant gabapentin59–61may eventually play prominent roles in providing analgesia for thoracic procedures. Their ability to decrease subsequent pain and analgesic consumption in other procedures and animal models of thoracotomy pain argue for their use, particularly in individuals at high risk of development of substantial perioperative pain or in those individuals in whom more invasive analgesic regimens are not possible.Initial concern that thoracic epidural catheter insertion would lead to more frequent complications has not been borne out. In fact, upper thoracic epidural catheter placement may be associated with fewer serious complications than lower thoracic or lumbar epidural placement.62,63The reason for this probably resides in the increased distance from nerve roots involved in lower extremity, bowel, and bladder function. The potentially catastrophic complications of epidural or intraspinal hematoma are best prevented by realization that motor blockade should not occur with dilute local anesthetic solutions, and postoperative motor weakness should trigger immediate imaging studies and neurosurgical consultation. Clearly, concerns about coagulopathy can limit epidural catheter placement.The concern about pneumothorax with performance of ICNBs is obviated in the case of thoracic surgery because a chest tube is generally placed. However, the total dose of local anesthetic should be carefully calculated, because ICNBs are notable for high systemic blood levels from rapid absorption of local anesthetic. The issues related to paravertebral blocks are similar to those of ICNBs and also include hypotension from sympathectomy in some patients because of the proximity of the paravertebral space to the neuraxis.Although many factors related to patient selection and the need for a particular surgical procedure are unalterable, there remain a number of modifiable technical aspects of the surgery purported to affect postoperative pain. These include the surgical approach (open thoracotomy vs. VATS), the type of incision for open procedures (posterolateral vs. muscle sparing vs. sternotomy vs. transverse sternothoracotomy [“clamshell”]), whether or not ribs are resected, the extent of intercostal nerve preservation, and the method of rib approximation at the conclusion of the procedure. As delineated above, the minimally invasive approach offered by VATS seems to have limited impact on the development of long-term postthoracotomy pain,3,4which is probably due to intercostal nerve and chest wall muscle trauma from trocar insertion. However, there is some evidence that VATS is associated with reductions in acute postsurgical pain, which is likely related to the smaller length of the incision and less rib retraction.64Although the surgical objective may dictate the operative approach, it is useful to note that the incidence of long-term pain after sternotomy11is reported to be less than after thoracotomy. This may be the result of less intercostal nerve and chest wall muscle trauma coupled with a surgical closure that produces a more stable chest wall. Although there are currently no data on pain after transverse sternothoracotomy, the possibility of intercostal nerve trauma and chest wall instability seems to be at least as great as for thoracotomy. Despite their distinct cosmetic advantages, muscle-sparing incisions seem to have minimal impact on postoperative pain development when compared with posterolateral incisions.65–67This is somewhat inconsistent with data indicating reduced intercostal nerve dysfunction after muscle sparing incisions when compared with posterolateral incisions.10Rib resection could reduce intercostal nerve trauma by avoiding trauma created by rib retraction or trocar insertion, and retrospective data from open thoracotomy7and VATS68support this contention. However, it is conceivable that periosteal scarring from rib resection might become a source of pain. Although preservation of the intercostal nerves seems to be a worthy surgical goal, accomplishing this is encumbered by frequent anatomical variation in the course of the nerves69and their lack of bony protection along the entire length of the rib.70Finally, techniques that approximate the ribs so as to minimize suture impingement of the intercostal nerves71or improve rib fixation72have been demonstrated to reduce pain after surgery.Although effective analgesic therapy seems to reduce the intensity and prevalence of chronic pain after thoracic surgery,1,7,26,27some patients, whether undergoing VATS or open procedures, still have development of chronic pain after thoracic surgery. Chronic postthoracotomy pain has been defined somewhat arbitrarily as “pain that recurs or persists along a thoracotomy scar at least two months following the surgical procedure.”73Despite this definition, it is important to identify as early as possible patients with higher than expected pain levels so that appropriate therapy can be initiated, because analgesic therapy that is initiated earlier may be more effective.74,75As indicated above, a number of demographic and clinical factors help to identify patients predisposed to development of chronic postsurgical pain.Long-term pain after thoracic surgery can be localized or radicular in nature and burning or aching in quality. The pain may have a pleuritic component and be exacerbated by movement of the ipsilateral shoulder.73The development of complex regional pain syndrome in the ipsilateral upper extremity can also occur.76As with the evaluation of any pain syndrome, it is essential to consider whether the pain is an indicator of some other process. This is of particular concern when evaluating patients with previous pleural or chest wall lesions, although bony instability, broken wires, retained foreign bodies, and lung herniation can also serve as pain generators. Although most cases of postthoracotomy pain are believed to be neuropathic in origin, myofascial pain can be a contributing and treatable source of discomfort.77The approach to pain after thoracic surgery is guided by the intensity of the pain as well as any associated disability. After a comprehensive evaluation, an individualized treatment plan should be crafted from one or more pharmacologic, interventional, and behavioral options (fig. 2).77–87Because there are still relatively few outcome studies on the treatment of chronic pain after thoracic surgery, most aspects of the approach advocated in figure 2are imputed from studies and experience with other types of chronic pain. Referral to a pain specialist may be necessary for pain that is refractory.The acute and chronic pain that accompanies thoracic surgery is significant but often underappreciated, with an established level of physiologic and functional impact, and unknown social and economic costs. It is likely that an aggressive perioperative analgesic regimen, apart from its more immediate benefits with respect to comfort and pulmonary function, will lead to reductions in longer-term pain.1,7,26,27When it manifests itself, such long-term pain should be pursued early and aggressively using an analgesic strategy tailored to the specific features of that pain.The authors thank Daniel Nyhan, M.D. (Professor, Anesthesiology and Critical Care Medicine, Johns Hopkins Medical Institutions, Baltimore, Maryland), for comments and suggestions.

This article is part of the European guidelines on perioperative venous thromboembolism prophylaxis. For details concerning background, methods and members of the ESA VTE Guidelines Task Force, please, refer to: Samama CM, Afshari A, for the ESA VTE Guidelines Task Force. European guidelines on perioperative venous thromboembolism prophylaxis. Eur J Anaesthesiol 2018; 35:73–76. Introduction The current Executive Summary includes all the recommendations from the 12 chapters of the European guidelines on perioperative venous thromboembolism (VTE) prophylaxis.1–12 The objective is to allow the reader to examine the guidelines rapidly and globally. The rationale of each chapter and relevant references can be found in each separate article. Surgery in the obese patient Bariatric surgery Laparoscopic bariatric procedures for obese patients have a lower risk of VTE than open procedures.1 We suggest using only anti coagulants or intermittent pneumatic compression (IPC) for obese patients with a low risk of VTE during and after bariatric procedures (Grade 2C). We recommend using anti coagulants and IPC together for obese patients with a high risk of VTE (age >55 years, BMI > 55 kg. m−2, history of VTE, venous disease, sleep apnoea, hypercoagulability and pulmonary hypertension) during and after bariatric procedures (Grade 1C). We recommend the use of low molecular weight heparin (LMWH) over low-dose unfractionated heparin (LDUH) (Grade 1C). We suggest a dose of LMWH (3000 to 4000 anti-Xa IU every 12 h subcutaneously) depending on BMI as acceptable for obese patients with a lower risk of VTE (Grade 2B). We suggest the use of a higher dose of LMWH (4000 to 6000 anti-Xa IU every 12 h subcutaneously) as acceptable for obese patients with a higher risk of VTE (Grade 2B). We recommend extended prophylaxis for patients with a high risk of VTE during the post-discharge period for 10 to 15 days (Grade 1C). Non-bariatric surgery We suggest that in surgery with an indication for VTE prophylaxis, a higher prophylactic dose of LMWH (3000 to 4000 anti-Xa IU every 12 h subcutaneously) should be considered for obese patients with a BMI more than 40 kg m−2 undergoing non-bariatric surgery (Grade 2C). For additional and general recommendations, we refer to the section on ‘VTE prophylaxis of obese patients in bariatric surgery’.1 Surgery during pregnancy and the immediate post-partum period Non-obstetric surgery during pregnancy We recommend thromboprophylaxis following surgery during pregnancy or the post-partum period, when they imply, as a consequence, bed-rest, until full mobility is recovered (Grade 1C).2 We suggest that thromboprophylaxis should be used in cases of perioperative infection during pregnancy or the postpartum period (Grade 2C). Caesarean section Thromboprophylaxis is recommended after caesarean section in all cases, except elective caesarean section in low-risk patients (Grade 1C), but there is no clear consensus on the definition of this population. The duration of thromboprophylaxis following caesarean section should be at least 6 weeks for high-risk patients, and at least 7 days for other patients requiring anticoagulation (Grade 1C). Surgery in the elderly Age over 70 years is a risk factor for postoperative VTE (Grade B).3 In elderly patients, we suggest identification of comorbidities increasing the risk for VTE (e.g. congestive heart failure, pulmonary circulation disorders, renal failure, lymphoma, metastatic cancer, obesity, arthritis, post-menopausal oestrogen therapy), and correction if present (e.g. anaemia, coagulopathy) (Grade 2C). We suggest against bilateral knee replacement in elderly and frail patients (Grade 2C). We suggest timing and dosing of pharmacological VTE prophylaxis as in the non-aged population (Grade 2C). In elderly patients with renal failure, low-dose unfractionated heparin (UFH) may be used or weight-adjusted dosing of LMWH (Grade 2C). In the elderly, we recommend careful prescription of postoperative VTE prophylaxis and early postoperative mobilisation (Grade 1C). We recommend multi-faceted interventions for VTE prophylaxis in elderly and frail patients, including pneumatic compression devices, LMWH [and/or direct oral anticoagulants (DOACs) after knee or hip replacement] (Grade 1C). Day surgery and fast-track surgery We recommend that all patients undergoing an ambulatory/fast-track protocol should be assessed for the VTE risk of the procedure and for any personal/additional VTE risk (Grade 1B).4 For patients undergoing a low-risk procedure, without additional risk according to the Caprini score, we recommend general measures of thromboprophylaxis (including early ambulation and optimal hydration) over other specific measures (mechanical or pharmacological) (Grade 1B). For patients undergoing a low-risk procedure with additional risk factors, we recommend general measures of thromboprophylaxis (e.g. early ambulation and optimal hydration) (Grade 1B). We suggest assessing pharmacological prophylaxis with LMWH over other drugs (Grade 2B). We suggest the use of specific mechanical measures (IPC devices) in patients with an increased bleeding risk (Grade 2C). For patients undergoing a high-risk procedure without additional risk factors, we recommend general measures of thromboprophylaxis (e.g. early ambulation, and optimal hydration) (Grade 1B). We suggest the administration of pharmacological prophylaxis with LMWH over other drugs (Grade 2B). We suggest assessing specific mechanical measures (IPC) in patients with an increased bleeding risk (Grade 2C). For patients undergoing a high-risk procedure with additional risk factors, we recommend general measures of thromboprophylaxis (e.g. early ambulation and optimal hydration) and pharmacological prophylaxis with LMWH over other drugs (Grade 1B), or specific mechanical measures (IPC) in patients with an increased bleeding risk (Grade 2C). We suggest the use of aspirin for VTE prevention after total hip arthroplasty, total knee arthroplasty and hip fracture surgery (high-risk orthopaedic procedures) in patients without high VTE risk (Grade 2C). We suggest the use of aspirin for VTE prevention after low-risk orthopaedic procedures in patients with high VTE risk, or other high-risk orthopaedic procedures (e.g. knee arthroscopy) in patients without high VTE risk (Grade 2C). We recommend no pharmacological VTE prevention after low-risk orthopaedic procedures in patients without high VTE risk (Grade 1C). For pharmacological prophylaxis, we recommend a minimum of 7 days’ duration of treatment over protocols lasting 3 days or single-dose protocols (Grade 1B), although in selected cases of fast-track surgery, thromboprophylaxis only during hospitalisation could be an option (Grade 2C). We recommend extending the duration of thromboprophylaxis for up to 4 weeks in specific cases of high-risk procedures, according to general rules (Grade 2B). When the choice of thromboprophylaxis is a LMWH, the first dose could be administrated before surgery (about 12 h before the beginning of the procedure) or after surgery (optimal time from 6 to 8 h after the end of the procedure) (Grade 2C). In case of planned neuraxial anaesthesia for the procedure, postoperative administration seems to be the preferred option (Grade 2C). Intensive care In critically ill patients, we recommend against the routine use of compression duplex ultrasound screening of deep vein thrombosis (DVT) (Grade 1B).5 We recommend an institution-wide protocol for the prevention of VTE that includes the use of mechanical thromboprophylaxis, that is IPC (Grade 1B). For critically ill patients, we recommend using thromboprophylaxis with LMWH or LDUH (Grade 1B), and we recommend LMWH over LDUH (Grade 1B). For VTE prophylaxis in critically ill patients with severe renal insufficiency, we suggest the use of LDUH (Grade 2C), dalteparin (Grade 2B) or reduced doses of enoxaparin (Grade 2C). Monitoring of anti-Xa activity may be considered when LMWH is used in these patients (Grade 2C). The use of pharmacological prophylaxis in patients with severe liver dysfunction should be carefully balanced against the risk of bleeding. If a treatment is administered, the use of LDUH or LMWH is suggested (Grade 2C). We suggest no prophylaxis or the use of IPC in patients with a platelet count less than 50 ×109 l-1and a high-risk of bleeding (Grade 2C). For critically ill patients, we recommend against the routine use of inferior vena cava (IVC) filters for the primary prevention of VTE (Grade 1C). We suggest the use of IVC filters in patients who can neither receive pharmacological prophylaxis nor IPC (Grade 2C). In critically ill patients with suspected or confirmed diagnosis of heparin-induced thrombocytopaenia (HIT), all forms of heparin must be discontinued (Grade 1B). In these patients, immediate anticoagulation with a non-heparin anticoagulant rather than discontinuation of heparin alone is recommended unless there is a strong contra-indication to anticoagulation (Grade 1C). The selection of non-heparin anticoagulants should be based on patient characteristics: argatroban is the first choice in case of renal insufficiency, and bivalirudin in patients undergoing or after cardiac surgery (Grade 2C). The use of fondaparinux can also be considered in these patients (Grade 2C). Cardiovascular and thoracic surgery Cardiac and vascular surgery In the absence of risk factors, we suggest considering the risk of VTE as moderate in patients undergoing coronary artery bypass graft and bioprosthetic aortic valve implantation surgery (Grade 2C). If the risk of bleeding is to be considered high, we suggest the use of mechanical prophylaxis using IPC (Grade 2C).6 The presence of one or more risk factors (age above 70 years, transfusion of more than four units of red blood cell concentrates/fresh frozen plasma/cryoprecipitate/fibrinogen concentrate, mechanical ventilation more than 24 h, postoperative complication (e.g. acute kidney injury, infection/sepsis, neurological complication) should place the cardiac population at high risk for VTE. In this context, we suggest the use of pharmacologic prophylaxis as soon as satisfactory haemostasis has been achieved, in addition to IPC (Grade 2C). Patients undergoing other valve surgery and those with atrial fibrillation should be considered a specific entity at high risk of VTE, as they will mostly require postoperative therapeutic medical ‘bridging’ prior to long-term anticoagulation. Patients undergoing peripheral vascular surgery are considered to have a low risk of VTE and a low risk of bleeding. Stringent medical prophylaxis appears to reduce the event rate significantly. In this population, we suggest medical therapy (Grade 2C). In patients undergoing abdominal aortic aneurysm repair, particularly when an open surgical approach is used, the risk for VTE is higher, with a high bleeding risk. These patients should be considered as having a moderate risk. Patients with additional risk factors, including BMI at least 30 kg m−2, preoperative dyspnoea, chronic steroid usage, ruptured aneurysm, open surgery, operative duration at least 5 h, transfusion of at least 5 U, postoperative mechanical ventilation more than 48 h, postoperative complication (acute kidney injury, infection/sepsis) and re-operation, should be considered as moderate to high risk. In this context, we suggest the use of pharmacological prophylaxis as soon as satisfactory haemostasis is achieved (Grade 2C). We suggest that low-dose aspirin could be used to decrease the incidence of VTE in cardiac and vascular patients, but should not be considered as the sole agent in high-risk patients. (Grade 2C). UFH is associated with the highest risk of developing the prothrombotic condition of HIT. Therefore, in an attempt to minimise the risk of HIT, we suggest that UFH should be used as briefly as possible and replaced by LMWH as soon as the bleeding risk decreases (Grade 2C). In patients with severely impaired renal function (Cockroft and Gault clearance <30 ml min−1) and a high risk of haemorrhagic complications, we suggest close monitoring of the administration of therapeutic UFH and LMWH and adaptation of the dosage (Grade 2C). Thoracic surgery Based on the current literature, patients undergoing thoracic surgery in the absence of cancer could be considered at low risk of VTE. However, as the vast majority of patients undergoing thoracic surgery have a diagnosis of primary or metastatic cancer, they should be considered at high risk for VTE with an equally high bleeding risk. In the absence of evidence regarding patients undergoing minimally invasive procedures, the same risk stratification should be applied as described above. In low-risk patients, we suggest the use of mechanical prophylaxis using IPC (Grade 2C). In high-risk patients, we suggest the use of pharmacological prophylaxis in addition to IPC (Grade 2B). Neurosurgery Patients undergoing craniotomy We recommend that if IPC is used, it should be applied before the surgical procedure or on admission, used continuously (except when the patient is actually walking) and monitored frequently to optimise compliance (Grade 1C).7 If LMWH or LDUH are used, we suggest delayed initiation until at least 24 h after surgery. (Grade 2C). In craniotomy patients at particularly high risk of VTE (additional risk factors including malignancy, motor impairment, prolonged operative time), we suggest considering the initiation of mechanical thromboprophylaxis with IPC preoperatively with addition of LMWH or LDUH postoperatively when the risk of bleeding is presumed to be decreased (Grade 2C). We suggest that thromboprophylaxis should be continued until discharge (Grade 2C). Patients with non-traumatic intra cranial haemorrhage We suggest thromboprophylaxis with IPC (Grade 2C). We recommend the application of IPC on admission, used continuously (except when the patient is actually walking) and monitored frequently to optimise compliance (Grade 1C). For patients who have had non-traumatic intracranial haemorrhage, we suggest giving consideration to commencement of LMWH or LDUH when the risk of bleeding is presumed to be low (Grade 2C). We suggest continuing thromboprophylaxis until full mobilisation of the patient (Grade 2C). Spinal surgery For patients with no additional risk factors, we suggest no active thromboprophylaxis intervention apart from early mobilisation (Grade 2C). For patients undergoing spinal surgery with additional risk factors (limited mobility, active cancer, complex surgical procedure), we recommend starting mechanical thromboprophylaxis with IPC preoperatively (Grade 1C), and we suggest the addition of LMWH postoperatively when the risk of bleeding is presumed to be decreased (Grade 2C). If LMWH is used, we recommend delayed initiation at least until 24 h after surgery and only when haemostasis occurs (Grade 1C). We suggest continued thromboprophylaxis until discharge in high-risk patients (Grade 2C). In patients with spinal cord injury or significant motor impairment, we suggest extending the thromboprophylaxis into the rehabilitation phase of hospital care (Grade 2C). Chronic treatments with anti-platelet agents In patients receiving anti-platelet agents (APA) chronically, we recommend thromboprophylaxis in case of moderate/high VTE risk, whilst assessing the risk of perioperative bleeding (Grade 1B).8 In patients receiving APA chronically, if the risk of VTE outweighs the risk of bleeding, we suggest pharmacological (anticoagulant) prophylaxis (LMWH, DOAC, fondaparinux, depending on the indication) (Grade 2C). In patients treated with dual anti-platelet therapy (recent coronary stent implantation) undergoing a procedure associated with a high risk of VTE, we suggest resuming both APA shortly after the procedure, prioritising over pharmacological VTE prevention (Grade 2C). If an anti-coagulant is associated with an APA, we suggest the administration of the lowest approved dose (Grade 2C). If the risk of bleeding of a combination of an APA and an anticoagulant outweighs the risk of VTE, we suggest considering IPC over anticoagulant prophylaxis, without discontinuing the APA (Grade 2C). Patients in whom neuraxial anaesthesia is planned, although the administration of aspirin alone does not increase the incidence of spinal haematoma, a higher rate of complications could appear if pharmacological thromboprophylaxis is administered concurrently. In these patients, postoperative thromboprophylaxis initiation should be suggested (Grade 2C). After surgery, the first dose of aspirin should be given as soon as possible, once haemostasis is considered adequate (in general, the day after surgery) (Grade 2B). In the case of clopidogrel, the main recommendation is to give the drug without any loading dose between 24 and 48 h after surgery (Grade 2C). Monitoring for clinical signs of bleeding or unexplained anaemia is recommended during concomitant administration of an anticoagulant for thromboprophylaxis (LMWH, UFH, fondaparinux, warfarin or any other) and an APA throughout the postoperative period (Grade 1C). Non-steroidal anti-inflammatory drugs should be avoided in patients treated with APA (Grade 2C). Patients with pre-existing coagulation disorders and after severe perioperative bleeding In patients with inherited bleeding disorders undergoing surgery, we recommend assessment of individual risk for VTE, taking into account the nature of the surgery and anaesthetic, type and severity of haemophilia, age, BMI, history of thrombosis and the presence of malignancy and other high-risk comorbidities. VTE risk should be balanced against the increased bleeding risk associated with anticoagulant use in patients with haemophilia (Grade 1C).9 For the perioperative management of patients with inherited bleeding disorders, we suggest liaison with haematologists to guide treatment (Grade 2C). We suggest that if factor replacement therapy is required for perioperative haemostasis, excess use should be avoided and factor levels monitored carefully (Grade 2C). In patients with inherited bleeding disorders undergoing major surgery, we suggest mechanical thromboprophylaxis, (Grade 2C), especially in factor VII deficiency (Grade 1C). In patients with inherited bleeding disorders undergoing major surgery, we recommend against routine postoperative use of pharmacological thromboprophylaxis, especially for patients with haemophilia A or B (Grade 1B). If the balance of risks favours pharmacological thromboprophylaxis, we suggest that LMWH should be administered as for patients without haemophilia undergoing the same surgery, and factor VIII/IX levels should be maintained at 0.6 to 1.0 IU ml−1 (Grade 2C). In haemophilia patients with inhibitors, we suggest against the use of pharmacological thromboprophylaxis (Grade 2C). We recommend that patients with haemophilia who require perioperative factor concentrate are monitored with daily factor levels for the first 3 to 5 days to guide treatment and to avoid wide fluctuations in factor levels (Grade 1C). We recommend that, for major surgery, factor levels of 0.8 to 1.0 IU ml−1 should be aimed for and not be allowed to fall below 0.5 IU ml−1 or rise above IU ml−1 in the postoperative period (Grade 1B). In general, we recommend against routine screening for patients with haemophilia undergoing surgery (Grade 1C). We recommend that patients treated with factor concentrate in the perioperative and postoperative period should have both factor and factor levels monitored to avoid an rise in factor levels and of factor We recommend levels every 12 h for the first 24 h after major surgery, and daily (Grade 1B). We recommend that the use of factor concentrate with the highest between and factor should be considered to minimise the risk of factor (Grade 1C). We recommend that use of factor concentrate is to a minimum to avoid increasing the risk (Grade 1C). We recommend that all patients receiving factor concentrate have mechanical measures (Grade and suggest that they are considered for pharmacological thromboprophylaxis (Grade 2C). We suggest that alone is for patients with factor deficiency but should not be given as prophylaxis to patients receiving factor concentrate (Grade 2C). In patients with factor VII we suggest that they are considered for pharmacological thromboprophylaxis, if they have associated risk factors (Grade 2C). We suggest that for major surgery, levels should be monitored to levels to for 10 to days postoperatively (Grade 2C). management may require use of concentrate and LMWH, depending on the clinical (Grade 2C). rate should be assessed before any direct oral anticoagulant is and at least once or more frequently as as postoperatively before the of therapeutic when it is suspected that renal function could or (Grade 1C). The use of the to renal function of patients with is suggested (Grade 2C). We suggest that anti-Xa levels may be in cases of severe bleeding in patients with renal receiving LMWH (Grade 1C). of signs of postoperative bleeding is more relevant for the commencement of VTE prophylaxis rather than on any specific (Grade 2C). We suggest against the use of to of perioperative before VTE prophylaxis (Grade 2C). of may be used during severe thrombocytopaenia (Grade 2C). Monitoring anti-Xa may be used to the doses of LMWH in patients with moderate or severe thrombocytopaenia (Grade 2C). In cancer patients or patients with disorders and thrombocytopaenia count pharmacological prophylaxis may be if the platelet count is below pharmacological prophylaxis may only be considered on a and careful monitoring is recommended (Grade 2C). Patients with a high risk (e.g. mechanical heart may from resuming warfarin therapy risk for bleeding (Grade 2C). Patients with a lower than the may from (Grade 2C). The between major bleeding and warfarin should be at least 7 days (Grade 2C). We suggest at the time of bleeding may also be considered to anticoagulation (Grade 2C). We suggest resuming anticoagulant therapy 12 h after of in cases of cardiac (Grade When the risk of bleeding pharmacological VTE prophylaxis may be depending on risk factors (Grade 2C). We recommend that, when the risk of postoperative bleeding is higher than the risk of a full dose anticoagulation may be 48 or h after the procedure (Grade 2B). For patients at high risk for thromboembolism and with a high bleeding risk after surgery, we that a reduced dose of on the after surgery and on the following day postoperative after surgery is (Grade 2B). prophylaxis We recommend an institution-wide protocol for the prevention of VTE that early ambulation, pharmacological thromboprophylaxis with anticoagulants and mechanical thromboprophylaxis (Grade We recommend against the routine use of compression without pharmacological thromboprophylaxis to VTE in patients at and high risk (Grade In patients with to pharmacological thromboprophylaxis, we recommend the use of mechanical prophylaxis with IPC or (Grade and suggest the use of IPC over (Grade 2B). In patients with for pharmacological thromboprophylaxis who are not at high risk for VTE, we suggest no prophylaxis over alone (Grade 2C). In patients receiving pharmacological thromboprophylaxis who are not at high risk for VTE, we recommend against the routine use of mechanical thromboprophylaxis with or IPC (Grade We suggest mechanical and pharmacological prophylaxis in selected patients at high risk for VTE 2B). We suggest the use of IPC rather than in selected high-risk patients in addition to pharmacological thromboprophylaxis (Grade 2B). We recommend the use of aspirin as an option for VTE prevention after total hip arthroplasty, total knee arthroplasty and hip fracture surgery (Grade We suggest the use of aspirin for VTE prevention after total hip arthroplasty, total knee arthroplasty and hip fracture surgery (high-risk procedures) in patients without high VTE risk (Grade 2C). We suggest the use of aspirin for VTE prevention after low-risk orthopaedic procedures in patients with a high VTE risk or other high-risk orthopaedic procedures in patients without a high VTE risk (Grade 2C). We suggest the use aspirin for VTE prevention after total hip arthroplasty, total knee arthroplasty and hip fracture surgery in patients with an increased bleeding risk (Grade 2C). We suggest the use of aspirin for VTE prevention after total hip arthroplasty or total knee arthroplasty in a (Grade 2C). We recommend aspirin with IPC for VTE prevention after total hip arthroplasty, total knee arthroplasty and hip fracture surgery (Grade 1C). We recommend no pharmacological VTE prevention after low-risk orthopaedic procedure in patients without high VTE risk (e.g. knee arthroscopy) (Grade 1C). recommendation can be concerning dose and duration of aspirin treatment and patient We not recommend aspirin for thromboprophylaxis in general surgery 1C). However, this type of prophylaxis could be especially in (Grade 2C), and adequate with should be (Grade 1C). vena cava filters is no clear evidence on the and of IVC filters in patients with a contra-indication for pharmacological and mechanical thromboprophylaxis undergoing surgery or procedures (Grade complications to a (Grade We suggest considering in patients at high VTE risk when pharmacological and mechanical thromboprophylaxis are (Grade 2C). We suggest considering in patients with and with an contra-indication for full anticoagulation and planned major surgery (Grade 2C). We suggest not using to pulmonary in the perioperative (Grade 2B). to this article with the and for of the VTE Task and by the ESA for the ESA of from and in for and for and for or from and for and from and from

These recommendations are based on the following: (1) a formal review and analysis of the recently published world literature on the topic [Medline search up to June 2011]; (2) the American College of Physicians' Manual for Assessing Health Practices and Designing Practice Guidelines;1 (3) guideline policies of the three societies approving this document; and (4) the experience of the authors and independent reviewers with regards to NAFLD. Intended for use by physicians and allied health professionals, these recommendations suggest preferred approaches to the diagnostic, therapeutic and preventive aspects of care. They are intended to be flexible and adjustable for individual patients. Specific recommendations are evidence-based wherever possible, and when such evidence is not available or inconsistent, recommendations are made based on the consensus opinion of the authors. To best characterize the evidence cited in support of the recommendations, the AASLD Practice Guidelines Committee has adopted the classification used by the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) workgroup with minor modifications (Table 1).2 The strength of recommendations in the GRADE system is classified as strong (1) or weak (2). The quality of evidence supporting strong or weak recommendations is designated by one of three levels: high (A), moderate (B) or low-quality (C).2 This is a practice guideline for clinicians rather than a review article and interested readers can refer to several comprehensive reviews published recently.3-8 NAFLD, Nonalcoholic Fatty Liver Disease; NAFL,Nonalcoholic Fatty Liver; NASH, Nonalcoholic Steatohepatitis; T2DM, Type 2 Diabetes Mellitus; AST, Aspartate Aminotransferase; ALT, Alanine Aminotransferase; HOMA,Homeostatic Model Assessment; RCT; Randomized Controlled Trial; PIVENS: Pioglitazone versus Vitamin E versus Placebo for the Treatment of Non-diabetic patients with Nonalcoholic steatohepatitis; TONIC; Treatment of Nonalcoholic Fatty Liver Disease in Children; NAS, NAFLD Activity Score; CK18; Cytokeratin 18 Fragments; ELF, Enhanced Liver Fibrosis Panel; TZD; Thiazolidinediones; UDCA: Ursodeoxycholic Acid; ANA; Anti Nuclear Antibody; ASMA: Anti Smooth Muscle Antibody; US; Ultrasound; CT: Computerized Tomography; MR; Magnetic Resonance. The definition of nonalcoholic fatty liver disease (NAFLD) requires that (a) there is evidence of hepatic steatosis, either by imaging or by histology and (b) there are no causes for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders (Table 2). In the majority of patients, NAFLD is associated with metabolic risk factors such as obesity, diabetes mellitus, and dyslipidemia. NAFLD is histologically further categorized into nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) (Table 3). NAFL is defined as the presence of hepatic steatosis with no evidence of hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or without fibrosis. The incidence of NAFLD has been investigated in a limited number of studies. Two Japanese studies9, 10 reported an incidence rate of 31 and 86 cases of suspected NAFLD per 1,000 person-years respectively, whereas another study from England showed a much lower incidence rate of 29 cases per 100,000 person-years.11 More studies are needed to better understand the incidence of NAFLD across different age, ethnic, and geographic groups. The reported prevalence of NAFLD varies widely depending on the population studied and the definition used. The prevalence of histologically-defined NAFLD was 20% and 51% in two different studies comprised of potential living liver donors.12, 13 The reported prevalence of NAFLD when defined by liver ultrasound ranged between 17% and 46% depending on the population studied.4 In a study consisting of nearly 400 middle aged individuals, the prevalence of NAFLD defined by ultrasonography was 46% and the prevalence of histologically confirmed NASH was 12.2%.14 In the Dallas Heart Study, when assessed by MR spectroscopy the prevalence of NAFLD in the general population was 31%.15 The prevalence of suspected NAFLD when estimated using aminotransferases alone without imaging or histology ranged between 7% and 11%, but aminotransferases can be normal in individuals with NAFLD.4 In summary, estimates of the worldwide prevalence of NAFLD ranges from 6.3% to 33% with a median of 20% in the general population, based on a variety of assessment methods.4 On the other hand, the estimated prevalence of NASH is lower, ranging from 3 to 5%.4 The prevalence of NASH cirrhosis in the general population is not known. Obesity is a common and well documented risk factor for NAFLD. Both excessive BMI and visceral obesity are recognized risk factors for NAFLD. In patients with severe obesity undergoing bariatric surgery, the prevalence of NAFLD can exceed 90% and up to 5% of patients may have unsuspected cirrhosis.4, 16-20 There is a very high prevalence of NAFLD in individuals with type 2 diabetes mellitus (T2DM).4 An ultrasonographic study of patients with T2DM showed a 69% prevalence of NAFLD.21 In another study, 127 of 204 diabetic patients displayed fatty infiltration on ultrasound, and 87% of the patients with fatty infiltration who consented to biopsy had histologic confirmation of NAFLD.22 High serum triglyceride levels and low serum HDL levels are very common in patients with NAFLD. The prevalence of NAFLD in individuals with dyslipidemia attending lipid clinics was estimated to be 50%.23 Age, gender and ethnicity are also associated with a differential prevalence for NAFLD.4 A number of studies have shown that the prevalence of NAFLD increases with age.24-28 The likelihood of disease progression to advanced fibrosis or mortality increases in older patients with NAFLD.29-31 Many recent studies have reported that male gender is a risk factor for fatty liver disease.4 For example, in a study of 26,527 subjects undergoing medical checkups, the prevalence of NAFLD was 31% in men and 16% in women.32 Compared to non-Hispanic whites, Hispanic individuals have significantly higher and non-Hispanic blacks have significantly lower prevalence of NAFLD.15, 33-35 The prevalence of NAFLD in American-Indian and Alaskan-Native populations appears lower, ranging from 0.6% to 2.2%, although the lack of histologic definition makes it likely that is an underestimate.36, 37 There are data to suggest that hypothyroidism, hypopituitarism, hypogonadism, sleep apnea, and polycystic ovary syndrome independent of obesity are important risk factors for the presence of NAFLD (Table 4).3 The evolution of hepatic histologic changes in patients with NAFL and NASH has been investigated by several studies, but these generally included smaller number of patients and had relatively modest duration of follow-up.4, 7 Nonetheless, it is generally agreed that patients with simple steatosis have very slow, if any, histological progression, while patients with NASH can exhibit histological progression to cirrhotic-stage disease.4, 7 The long term outcomes of patients with NAFLD and NASH have been reported in several studies.31, 38-45 Their detailed discussion is beyond the scope of this guideline, but their findings can be summarized as follows; (a) patients with NAFLD have increased overall mortality compared to matched control populations, (b) the most common cause of death in patients with NAFLD, NAFL and NASH is cardiovascular disease, and (c) patients with NASH (but not NAFL) have an increased liver-related mortality rate. Another piece of indirect evidence that supports the progressive nature of NASH is in the features of cryptogenic cirrhosis which is closely related to NAFLD.46, 47 Patients with cryptogenic cirrhosis have disproportionately high prevalence of metabolic risk factors (T2DM, obesity, metabolic syndrome) typical of patients with NAFLD, their liver biopsies frequently show one or more features of NASH, and studies have demonstrated the loss of histological features of NASH with the development of cirrhosis.4, 7, 46, 47 Patients with NAFLD are at increased risk for HCC, but this risk is likely limited to those with advanced fibrosis and cirrhosis.48-53 Several studies investigated the natural history of NASH cirrhosis in comparison to patients with hepatitis C cirrhosis.54-57 One large prospective US-based study55 observed a lower rate of decompensation and mortality in patients with NASH cirrhosis as compared to patients with hepatitis C cirrhosis. However, a more recent international study56 of 247 NAFLD patients with advanced fibrosis and cirrhosis followed over a mean duration of 85.6 ± 54.5 months showed an overall 10-year survival of 81.5% that was not different from matched patients with hepatitis C cirrhosis. Importantly, both studies have shown that patients with NASH cirrhosis are at significantly lower risk for HCC than patients with hepatitis C cirrhosis.55, 56 By definition, NAFLD indicates the lack of any evidence of ongoing or recent consumption of significant quantities of alcohol. However, the precise definition of significant alcohol consumption in patients with suspected NAFLD is uncertain. A recent consensus meeting58 concluded that, for NASH clinical trials candidate eligibility purposes, significant alcohol consumption be defined as >21 drinks per week in men and >14 drinks per week in women over a 2-year period prior to baseline liver histology. Furthermore, this group recommended that validated questionnaires should be used to quantify the amount of alcohol consumption in the context of clinical trials. The definition of significant alcohol consumption in the published NAFLD literature has been inconsistent and ranged from > 1 alcoholic drink (∼ 10 grams of alcohol per one drink unit) per day to > 40 grams per day, and published studies have not always used gender-specific definitions.59 If self-reported alcohol consumption details are not consistent with clinical suspicion when evaluating a patient with suspected NAFLD, confirmation with a family member or a close friend should be considered. Recommendation 1. Ongoing or recent alcohol consumption > 21 drinks on average per week in men and > 14 drinks on average per week in women is a reasonable definition for significant alcohol consumption when evaluating patients with suspected NAFLD in clinical practice. (Strength – 2, Quality - C) Some patients undergoing thoracic and abdominal imaging for reasons other than liver symptoms, signs or biochemistry may demonstrate unsuspected hepatic steatosis. While this phenomenon is not uncommon in clinical practice, studies have not systematically examined the characteristics or natural history of NAFLD in this patient population. Recommendations 2. When patients with unsuspected hepatic steatosis detected on imaging have symptoms or signs attributable to liver disease or have abnormal liver biochemistries, they should be evaluated as though they have suspected NAFLD and worked-up accordingly. (Strength – 1, Evidence -A) 3. In patients with unsuspected hepatic steatosis detected on imaging who lack any liver-related symptoms or signs and have normal liver biochemistries, it is reasonable to assess for metabolic risk factors (e.g., obesity, glucose intolerance, dyslipidemia) and alternate causes for hepatic steatosis such as significant alcohol consumption or medications. (Strength – 1, Evidence -A) 4. In patients with unsuspected hepatic steatosis detected on imaging who are asymptomatic and have normal liver biochemistries, a liver biopsy cannot be recommended. (Strength – 1, Evidence -B) It can be argued that there should be systematic screening for NAFLD, at least among higher-risk individuals attending diabetes and obesity clinics. However, at present there are significant gaps in our knowledge regarding the diagnosis, natural history, and treatment of NAFLD. As liver biochemistries can be within normal ranges in patients with NAFLD and NASH, they may not be sufficiently sensitive to serve as screening tests, whereas liver ultrasound is potentially more sensitive but it is expensive and cumbersome as a screening test. Recommendation 5. Screening for NAFLD in adults attending primary care clinics or high-risk groups attending diabetes or obesity clinics is not advised at this time due to uncertainties surrounding diagnostic tests and treatment options, along with lack of knowledge related to the long-term benefits and cost-effectiveness of screening. (Strength – 1, Evidence -B) Anecdotal experience and some published studies suggest familial clustering and heritability of NAFLD,60-63 but conclusive studies are lacking. In a retrospective cohort study, Willner et al. observed that 18% of patients with NASH have a similarly affected first degree relative.61 A small familial aggregation study observed that patients with NAFLD have a significantly higher number of first degree relatives with cirrhosis and a trend towards familial clustering of NAFLD or cryptogenic cirrhosis than matched healthy controls.62 In another familial aggregation study63 of overweight children with and without NAFLD, after adjusting for age, gender, race, and BMI, the heritability of MR-measured liver fat fraction was 0.386, and fatty liver was present in 18% of family members of children with NAFLD despite normal ALT and lack of obesity. Recommendation 6. Systematic screening of family members for NAFLD is currently not recommended. (Strength – 1, Evidence - B) The diagnosis of NAFLD requires that (a) there is hepatic steatosis by imaging or histology, (b) there is no significant alcohol consumption, (c) there are no competing etiologies for hepatic steatosis, and (d) there are no co-existing causes for chronic liver disease. Common alternative causes of hepatic steatosis are significant alcohol consumption, hepatitis C, medications, parenteral nutrition, Wilson's disease, and severe malnutrition (Table 2). When evaluating a patient with newly suspected NAFLD, it is important to exclude co-existing etiologies for chronic liver disease including hemochromatosis, autoimmune liver disease, chronic viral hepatitis, and Wilson's disease.3 Mildly elevated serum ferritin is common in patients with NAFLD and it does not necessarily indicate increased iron stores.3, 64 Elevated serum ferritin and transferrin saturation in patients with suspected NAFLD should lead to testing for genetic hemochromatosis. Mutations in the HFE gene occur with variable frequency in patients with NAFLD and their clinical significance is unclear.64 One should consider a liver biopsy to assess hepatic iron concentration and to exclude significant hepatic injury and fibrosis in a patient with suspected NAFLD with elevated serum ferritin and a homozygote or compound heterozygote C282Y mutation in the HFE gene.65 Elevated serum autoantibodies are common in patients with NAFLD and are generally considered to be an epiphenomenon.3 In a recently published large study from the NASH Clinical Research Network, positive serum autoantibodies, defined as ANA > 1:160 or ASMA >1:40 were present in 21% of patients with well-phenotyped NAFLD and were not associated with more advanced histologic features.66 Recommendations 7. When evaluating a patient with suspected NAFLD, it is essential to exclude competing etiologies for steatosis and co-existing common chronic liver disease. (Strength – 1, Evidence - A) 8. Persistently high serum ferritin and increased iron saturation, especially in the context of homozygote or heterozygote C282Y HFE mutations may warrant a liver biopsy. (Strength – 1, Evidence - B) 9. High serum titers of autoantibodies in association with other features suggestive of autoimmune liver disease (very high aminotransferases, high globulin) should prompt a more complete work-up for autoimmune liver disease. (Strength – 1, Evidence - B) The natural history of NAFLD is fairly dichotomous – NAFL is generally benign whereas NASH can progress to cirrhosis, liver failure, and liver cancer. Existing dogma posits that liver biopsy is the most reliable approach for identifying the presence of steatohepatitis and fibrosis in patients with NAFLD, but it is generally acknowledged that biopsy is limited by cost, sampling error, and procedure-related morbidity and mortality. Serum aminotransferase levels and imaging tests such as ultrasound, CT, and MR do not reliably assess steatohepatitis and fibrosis in patients with NAFLD. Therefore, there has been significant interest in developing clinical prediction rules and non-invasive biomarkers for identifying steatohepatitis in patients with NAFLD,7 but their detailed discussion is beyond the scope of this practice guideline. The presence of metabolic syndrome is a strong predictor for the presence of steatohepatitis in patients with NAFLD3, 7, 67-69 and may be used to best identify patients with persistently abnormal liver biochemistries who would benefit diagnostically and prognostically from a liver biopsy. There has been intense interest in non-invasive methods to identify advanced fibrosis in patients with NAFLD7;these include the NAFLD Fibrosis Score70, Enhanced Liver Fibrosis (ELF) panel70 and transient elastography. The NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, platelet count, albumin, AST/ALT ratio) and it is calculated using the published formula (http://nafldscore.com). In a meta-analysis of 13 studies consisting of 3,064 patients,7 NAFLD Fibrosis Score has an AUROC of 0.85 for predicting advanced fibrosis (i.e., bridging fibrosis or cirrhosis) and a score < −1.455 had 90% sensitivity and 60% specificity to exclude advanced fibrosis whereas a score > 0.676 had 67% sensitivity and 97% specificity to identify the presence of advanced fibrosis. The ELF panel consists of plasma levels of three matrix turnover proteins (hyaluronic acid, TIMP-1, and PIIINP) had an AUROC of 0.90 with 80% sensitivity and 90% specificity for detecting advanced fibrosis.71 Circulating levels of cytokeratin-18 (CK18) fragments have been investigated extensively as novel biomarkers for the presence of steatohepatitis in patients with NAFLD.7, 72 Wieckowska et al., measured CK18 fragments in plasma that had been obtained from 44 consecutive patients with suspected NAFLD at the time of liver biopsy, and correlated the findings with hepatic immunohistochemistry data.70 Plasma CK18 fragments were markedly increased in patients with NASH compared with patients with simple steatosis or normal biopsies (median 765.7 U/L versus 202.4 U/L or 215.5 U/L, respectively; P < 0.001), and independently predicted NASH (OR 1.95; 95% CI 1.18-3.22 for every 50 U/L increase). This observation was reproduced in several subsequent studies and a recent meta-analysis estimated that plasma CK18 levels have a sensitivity of 78%, specificity of 87%, and an area under the receiver operating curve (AUROC) of 0.82 (95% CI: 0.78-0.88) for steatohepatitis in patients with NAFLD.7 Although these are very encouraging results, currently this assay is not commercially available. Furthermore, as each study utilized a study-specific cut-off value, there is not an established cut-off value for identifying steatohepatitis. Transient elastography, which measures liver stiffness non-invasively, has been successful in identifying advanced fibrosis in patients with hepatitis B and hepatitis C. Although a recent meta-analysis showed high sensitivity and specificity for identifying fibrosis in NAFLD,7 it has a high failure rate in individuals with a higher BMI. Furthermore, it is not commercially available in the United States. Other imaging tools such as MR elastography, although commercially available in the United States, is rarely used in clinical practice. A major limitation of these prediction models and biomarkers is that they have largely been investigated in cross-sectional studies and thus their utility in monitoring disease natural history, predicting outcomes or response to therapeutic intervention is unknown. Recommendations 10. As the metabolic syndrome predicts the presence of steatohepatitis in patients with NAFLD, presence can be used to patients for a liver biopsy. (Strength – 1, Evidence - B) NAFLD Fibrosis Score is a for identifying NAFLD patients with higher likelihood of bridging fibrosis cirrhosis. (Strength – 1, Evidence - B) Although CK18 is a for identifying it is to in clinical practice. (Strength – 1, Evidence - B) Liver biopsy the for liver histology in patients with NAFLD. However, it is expensive and some morbidity and very mortality it should be in those who would benefit the most from diagnostic, therapeutic and Recommendations Liver biopsy should be considered in patients with NAFLD who are at increased risk to have steatohepatitis and advanced fibrosis. (Strength – 1, Evidence - B) The presence of metabolic syndrome and the NAFLD Fibrosis Score may be used for identifying patients who are at risk for steatohepatitis and advanced fibrosis. (Strength – 1, Evidence - B) Liver biopsy should be considered in patients with suspected NAFLD in competing etiologies for hepatic steatosis and co-existing chronic liver cannot be without a liver biopsy. (Strength – 1, Evidence - B) The of patients with NAFLD consists of liver disease as well as the associated metabolic such as obesity, and As patients with NAFLD without steatohepatitis have from a liver at liver disease should be limited to those with Many studies indicate that may aminotransferases and hepatic steatosis when measured either by or MR imaging and In a meta-analysis of and clinical studies between most studies reported in aminotransferases and hepatic steatosis by ultrasound across a of of different and high low high fat However, these studies were as a of largely and using histology as the primary More recent studies also showed an in aminotransferases and hepatic steatosis on histology with in with was investigated in two trials. In the study by et ALT and steatosis by but on liver histology not be evaluated the majority of patients not a liver biopsy. However, in the study by et not or liver histology. The best evidence for loss as a to liver histology in NASH from a that 31 with NASH to changes and a week of moderate for versus The had loss in the alone and to an in steatosis, and but not fibrosis. Importantly, with 7% loss had significant in steatosis, and NAFLD Activity Score There was a in the study by et who > 5% steatosis, whereas individuals with loss had significant in steatosis, and A number of recent studies used MR spectroscopy to assess changes in hepatic fat in response to The from these studies using a variety of either by or in with different have reported a significant in liver fat by an average of from 20% to The degree of hepatic fat was to the of the intervention and generally a loss between to The of without on hepatic steatosis was investigated in studies using MR of a week of over a period of to In but one liver fat without a significant in Recommendations loss generally hepatic steatosis, either by alone or in with increased (Strength – 1, Evidence - A) of at least of appears to steatosis, but a loss to may be needed to (Strength – 1, Evidence - B) alone in adults with NAFLD may hepatic steatosis but to other aspects of liver histology unknown. (Strength – 1, Evidence - B) Several studies investigated the of on aminotransferases and liver histology in patients with studies demonstrated a in and but no significant in liver An consisting of patients with NASH either 2 E or loss for more with than with E or However, there was a modest in hepatic steatosis and inflammation in the of patients undergoing liver biopsies with In a study in patients, NASH in of patients, although of the study was by a significant loss in the more than 10 et reported a lack of in a control of with a and intervention in both groups. Other studies also to show major benefit for on hepatic or liver A recent concluded that months of intervention not aminotransferases or liver histology, compared with intervention independently of or the presence of Recommendation has no significant on liver histology and is not recommended as a treatment for liver disease in adults with (Strength – 1, Evidence - A) Several studies investigated the of and on aminotransferases and liver histology in adults with In an in subjects with NASH, aminotransferases and hepatic steatosis, ballooning and inflammation but not fibrosis. in a subsequent et observed that aminotransferases and hepatic steatosis, but not or fibrosis and also showed et a of in patients with NASH who had glucose or Although there was a significant ± with it significantly aminotransferases, steatosis, and The with in compared to of patients and there was a trend towards in fibrosis among patients to et a of intervention with either or for months in a of patients with While steatosis not significantly compared to hepatocellular injury and fibrosis The study is a large that 247 patients with NASH to E or for The primary was an in 2 with at least 1 in hepatocellular ballooning and in either the inflammation or steatosis and no in the fibrosis It was in in the group compared to in the group and in the E group this study of two primary and E a of was considered to be significant a Therefore, although there were histological benefits associated with this study concluded that not the primary However, of NASH, a secondary was in significantly higher number of

* Developed by the American Society of Anesthesiologists Task Force on Perioperative Transesophageal Echocardiography: Daniel M. Thys, M.D., Chair, New York, New York; Martin D. Abel, M.B.B.Ch., Rochester, Minnesota; Robert F. Brooker, M.D., Wausau, Wisconsin; Michael K. Cahalan, M.D., Salt Lake City, Utah; Richard T. Connis, Ph.D., Woodinville, Washington; Peggy G. Duke, M.D., Atlanta, Georgia; David G. Nickinovich, Ph.D., Bellevue, Washington; Scott T. Reeves, M.D., Charleston, South Carolina; Marc A. Rozner, Ph.D., M.D., Houston, Texas; Isobel A. Russell, M.D., San Francisco, California; Scott C. Streckenbach, M.D., Boston, Massachusetts; Pamela Sears-Rogan, M.D., Washington, DC (American Society of Echocardiography); and William J. Stewart, M.D., Cleveland, Ohio (American College of Cardiology).PRACTICE Guidelines are systematically developed recommendations that assist the practitioner and the patient in making decisions about health care. These recommendations may be adopted, modified, or rejected according to clinical needs and constraints and are not intended to replace local institutional policies. In addition, Practice Guidelines developed by the American Society of Anesthesiologists (ASA) are not intended as standards or absolute requirements, and their use cannot guarantee any specific outcome. Practice Guidelines are subject to revision as warranted by the evolution of medical knowledge, technology, and practice. They provide basic recommendations that are supported by a synthesis and analysis of the current literature, expert and practitioner opinion, open forum commentary, and clinical feasibility data.This update includes data published since the Practice Guidelines for Perioperative Transesophageal Echocardiography were adopted by the ASA and the Society of Cardiovascular Anesthesiologists in 1995 and published in 1996.1For these Guidelines, perioperative transesophageal echocardiography (TEE) refers to TEE performed on surgical patients before, during, or immediately after surgery, including the critical care setting. Evidence of effectiveness is discussed relative to specific settings where perioperative TEE is customarily used (e.g. , cardiac surgery, noncardiac surgery, and critical care).The purposes of these Guidelines are (1) to assist the physician in determining the appropriate application of TEE and (2) to improve the outcomes of surgical patients by defining the utility of perioperative TEE based on the strength of supporting evidence.These Guidelines focus on the application of TEE in surgical patients and potential surgical patients in the setting of cardiac surgery, noncardiac surgery, and postoperative critical care. The Guidelines do not apply to the assessment of nonsurgical patients or to postdischarge follow-up assessment of surgical patients.The Task Force believes that physician proficiency in the use of perioperative TEE is of paramount importance due to the risk of adverse outcomes resulting from incorrect interpretation. The Guidelines do not address training, certification, credentialing, and quality assurance, which are addressed elsewhere.2–5These Guidelines are intended for anesthesiologists and other physicians (e.g. , cardiologists, surgeons, and intensivists) who use TEE in the perioperative setting. Recommen- dations to perform TEE are not applicable when the procedure cannot be performed properly or safely nor do they apply when TEE equipment or skilled examiners are unavailable. The recommendations in this report are based on consideration of the risk benefit ratio for individual patients.The ASA and Society of Cardiovascular Anesthesiologists jointly appointed a task force of 13 members, including anesthesiologists in both private and academic practice from various geographic areas of the United States, two cardiologists (one representing the American College of Cardiology and the other representing the American Society of Echocardiography), and two consulting methodologists from the ASA Committee on Standards and Practice Parameters.The Task Force developed the Guidelines by means of a seven-step process. First, they reached consensus on the criteria for evidence. Second, original published research studies from peer-reviewed journals relevant to TEE were reviewed and evaluated. Third, expert consultants were asked (1) to participate in opinion surveys on the effectiveness of TEE imaging and (2) to review and comment on a draft of the Guidelines developed by the Task Force. Fourth, opinions about the Guidelines recommendations were solicited from a sample of active members of the ASA who personally perform TEE as a part of their practice. Fifth, the Task Force held an open forum at a major international meeting†to solicit input on its draft recommendations. Sixth, the consultants were surveyed to assess their opinions on the feasibility of implementing the Guidelines. Seventh, all available information was used to build consensus within the Task Force to finalize the Guidelines (appendix 1).Preparation of these Guidelines followed a rigorous methodologic process (appendix 2). Evidence was obtained from two principal sources: scientific evidence and opinion-based evidence.Study findings from scientific literature published after 1994 (not excluding sentinel articles published prior to 1994) were aggregated and reported in summary form by evidence category, as described later. All literature (e.g. , randomized controlled trials, observational studies, and case reports) relevant to each topic was considered when evaluating the findings. For reporting purposes in this document, only the highest level of evidence (i.e. , levels 1, 2, or 3 identified below) within each category (i.e. , A, B, or C) is included in the summary.Randomized controlled trials report statistically significant (P < 0.01) differences between clinical interventions for a specified clinical outcome.Information from observational studies permits inference of beneficial or harmful relationships among clinical interventions and clinical outcomes.The literature cannot determine whether there are beneficial or harmful relationships among clinical interventions and clinical outcomes.The lack of scientific evidence in the literature is described by the following conditions.All opinion-based evidence relevant to each topic (e.g. , survey data, open-forum testimony, Internet-based comments, letters, and editorials) was considered in the development of these Guidelines. However, only the findings obtained from formal surveys are reported.Opinion surveys were developed by the Task Force to address each clinical intervention identified in the document. Identical surveys were distributed to two groups of respondents: expert consultants and ASA members.Survey responses from Task Force–appointed expert consultants are reported in summary form in the text. A complete listing of consultant survey responses is reported in a table in appendix 2.Survey responses from a sample of members of the ASA are reported in summary form in the text. A complete listing of ASA member survey responses is reported in a table in appendix 2.Expert consultant and ASA membership survey responses are recorded using a 5-point scale and summarized based on median values.§Open-forum testimony, Internet-based comments, letters, and editorials are all informally evaluated and discussed during the development of Guidelines recommendations. When warranted, the Task Force may add educational information or cautionary notes based on this information.Cardiac and thoracic aortic procedures consist of cardiac and thoracic aortic surgery, and catheter-based intracardiac procedures.Cardiac and thoracic aortic surgery: For cardiac or thoracic aortic surgery patients, the literature reports variations in sensitivity, specificity, or positive and negative predictive values for the detection of abnormalities relating to valvular, coronary, aortic, congenital, and other cardiovascular disease (table 1in appendix 2). Examples of these abnormalities include mitral valve abnormalities, valvular abscesses, myocardial ischemia, aortic dissection, and atrial septal defect (Category B2 evidence ). The literature also reports a range of sensitivity, specificity, and positive and negative predictive values for the confirmation or refinement by TEE of the preoperative diagnosis (table 1in appendix 2). Examples include aortic dissection, aortic intramural hemorrhage, and valvular or mural infective endocarditis lesions (Category B2 evidence ). The ASA members agree and the consultants strongly agree that TEE should be used for all cardiac or thoracic aortic surgery patients.For adult patients without contraindications, TEE should be used in all open heart (e.g. , valvular procedures) and thoracic aortic surgical procedures and should be considered in coronary artery bypass graft surgeries to: (1) confirm and refine the preoperative diagnosis, (2) detect new or unsuspected pathology, (3) adjust the anesthetic and surgical plan accordingly, and (4) assess the results of surgical intervention. In small children, the use of TEE should be considered on a case-by-case basis because of risks unique to these patients (e.g. , bronchial obstruction).Catheter-based intracardiac procedures: Studies with observational findings confirm the utility of TEE or intracardiac echocardiography for guiding management of catheter-based intracardiac procedures (e.g. , occluder device placement, percutaneous valvular procedures, and intracardiac ablation procedures) (Category B2 evidence ). In addition, studies with observational findings report the detection of unsuspected abnormalities by TEE, such as aortic root abscess, atrial thrombi, atrial septal aneurysm, shunting, mitral valve/annular calcification and regurgitation, wall motion abnormalities, and tamponade (Category B2 evidence ). The detection of pericardial effusion is also reported (Category B3 evidence ).Both the consultants and ASA members agree that TEE should be used for patients undergoing transcatheter intracardiac procedures when general anesthesia is provided and intracardiac ultrasound is not used. The ASA members agree and the consultants strongly agree that TEE should be used for septal defect closure or atrial appendage obliteration. Both the consultants and ASA members strongly agree that TEE should be used during catheter-based valve replacement and repair. Finally, both the consultants and ASA members are equivocal regarding the use of TEE during dysrhythmia treatment.For patients undergoing transcatheter intracardiac procedures, TEE may be used.For noncardiac surgery patients, studies with observational findings or case reports note the detection of the following abnormalities by TEE: (1) venous air embolism and patent foramen ovale in neurosurgery (Category B2 evidence ); (2) pericardial effusion and compression of the cardiac chambers in liver transplantation (Category B3 evidence ); (3) intracardiac emboli and patent foramen ovale (Category B2 evidence ), mitral regurgitation, left ventricular hypertrophy, and left ventricular outflow tract obstruction in orthopedic surgery (Category B3 evidence ), (4) left ventricular segmental wall motion abnormalities (Category B2 evidence ), aortic lesions and atrial tumors in vascular surgery (Category B3 evidence ), and (5) atrial septal defect, myocardial ischemia, hypovolemia, pericardial tamponade, thromboembolic events (Category B2 evidence ), pericardial effusion, tamponade, and intrapulmonary emboli in other major surgery (i.e. , lung, renal, abdominal, and head/neck/chest wall surgeries) (Category B3 evidence ).The consultants and ASA members agree that TEE should be used for noncardiac surgical patients when the patient has known or suspected cardiovascular pathology that might result in hemodynamic, pulmonary, or neurologic compromise. The consultants and ASA members both strongly agree that TEE should be used during unexplained persistent hypotension. Further, both the consultants and ASA members agree that TEE should be used when persistent unexplained hypoxemia occurs. The ASA members agree and the consultants strongly agree that TEE should be used when life-threatening hypotension is anticipated.Both the consultants and ASA members agree that TEE should be used during either lung transplantation or major abdominal or thoracic trauma. The consultants agree although the ASA members are equivocal regarding the use of TEE during open abdominal aortic procedures and liver transplantation. Both the consultants and ASA members are equivocal regarding the use of TEE during: (1) endovascular aortic procedures, (2) neurosurgery in the sitting position, and (3) percutaneous cardiovascular interventions (e.g. , femoral artery stenting). Finally, the consultants and ASA members both disagree with the assertion that TEE should be used during orthopedic surgery.TEE may be used when the nature of the planned surgery or the patient's known or suspected cardiovascular pathology might result in severe hemodynamic, pulmonary, or neurologic compromise. If equipment and expertise are available, TEE should be used when unexplained life-threatening circulatory instability persists despite corrective therapy.Studies with observational findings for critically ill patients with an unexplained adverse postoperative clinical course report TEE detection for the following abnormalities: regurgitant valvular lesions, aortic or mitral valve vegetation, aortic dissection, intracardiac mass, tamponade, ventricular failure, and hypovolemia (Category B2 evidence ). Case reports of critically ill postoperative patients indicate that TEE detects abnormalities such as aortic root abscess, pericardial hematoma, atherosclerotic debris in the thoracic aorta, left ventricular hypertrophy, wall motion abnormalities, and ventricular masses (Category B3 evidence ).Both the consultants and ASA members strongly agree that TEE should be used for critical care patients when diagnostic information expected to alter management cannot be obtained by transthoracic echocardiography or other modalities in a timely manner. The ASA members agree and the consultants strongly agree that TEE should be used during unexplained persistent hypotension. They both agree that TEE should be used when persistent unexplained hypoxemia occurs.For critical care patients, TEE should be used when diagnostic information that is expected to alter management cannot be obtained by transthoracic echocardiography or other modalities in a timely manner.Studies with observational findings and case reports indicate that, although rare, potential complications associated with TEE may include esophageal perforation, esophageal injury, hematoma, laryngeal palsy, dysphagia, dental injury, or death (Category B2 evidence ). However, there is insufficient literature to assess whether there are contraindications for the use of TEE (Category D evidence ).Both the consultants and ASA members are equivocal with regard to whether there are no absolute contraindications to TEE other than previous esophagectomy or esophagogastrectomy. Those consultants and ASA members who do not agree that there are no absolute contraindications other than previous esophagectomy or esophagogastrectomy do agree that the following four conditions should be absolute contraindications to TEE: esophageal stricture, tracheoesophageal fistula, postesophageal surgery, and esophageal trauma. Both the consultants and ASA members disagree that the following four conditions should be absolute contraindications to TEE: Barrett esophagus, hiatal hernia, large descending aortic aneurysm, and unilateral vocal cord paralysis. Finally, both the consultants and ASA members are equivocal with regard to whether the following three conditions should be absolute contraindications to TEE: esophageal varices, postradiation therapy, and previous bariatric surgery. The consultants agree but the ASA members are equivocal that Zenker diverticulum and colonic interposition are absolute contraindications. Finally, the ASA members disagree and the consultants are equivocal that dysphagia is an absolute contraindication to TEE.TEE may be used for patients with oral, esophageal, or gastric disease, if the expected benefit outweighs the potential risk, provided the appropriate precautions are applied. These precautions may include the following: considering other imaging modalities (e.g. , epicardial echocardiography), obtaining a gastroenterology consultation using a smaller probe, limiting the examination, avoiding unnecessary probe manipulation, and using the most experienced operator.For these Guidelines, a literature review was used in combination with opinions obtained from expert consultants and other sources (e.g. , ASA members, open forums, Internet postings). Both the literature review and opinion data were based on evidence linkages or statements regarding potential relationships between clinical interventions and outcomes. The efficacy and outcomes from the use of TEE were examined for the following procedures:The impact of the use of perioperative TEE was assessed on the basis of the following:For the literature review, potentially relevant clinical studies published after 1994 were identified via electronic and manual searches of the literature. The electronic and manual searches covered a 16-yr period from 1994 through 2009. More than 8000 citations were initially identified, yielding a total of 861 nonoverlapping articles that addressed topics related to the evidence linkages. After review of the articles, 404 studies did not provide direct evidence and were subsequently eliminated. A total of 457 articles contained direct linkage-related evidence. A complete bibliography used to develop these Guidelines, organized by section, is available as Supplemental Digital Content 2, http://links.lww.com/ALN/A568.Literature reporting the detection of new abnormalities by TEE was summarized, followed by a summary of literature reporting the confirmation of previously diagnosed abnormalities by TEE. The sensitivity, specificity, and positive and negative predictive values for the efficacy of TEE in detecting new abnormalities and in confirming or redefining previous diagnoses were also obtained (table 1). Study findings reporting the misdiagnosis or limited effectiveness of TEE to detect pathology are also listed in table 1.Interobserver agreement among Task Force members and two methodologists was established by interrater reliability testing. Agreement levels using a κ statistic for two-rater agreement pairs were as follows: (1) type of study design, κ= 0.50–1.00; (2) type of analysis, κ= 0.50–0.83; (3) evidence linkage assignment, κ= 0.75–1.00; and (4) literature inclusion for database, κ= 0.78–1.00. Three-rater chance-corrected agreement values were as follows: (1) study design, Sav = 0.66, Var (Sav) = 0.006; (2) type of analysis, Sav = 0.66, Var (Sav) = 0.007; (3) linkage assignment, Sav = 0.83, Var (Sav) = 0.005; and (4) literature database inclusion, Sav = 0.84, Var (Sav) = 0.046. These values represent moderate to high levels of agreement.Consensus was obtained from multiple sources, including (1) survey opinion from consultants who were selected based on their knowledge or expertise in the perioperative use of TEE, (2) survey opinions solicited from active members of the ASA who personally perform TEE as part of their practice, (3) testimony from attendees of a publicly held open forum at an international anesthesia meeting, (4) Internet commentary, and (5) Task Force opinion and interpretation. The survey rate of return was 53% (n = 55 of 103) for the consultants, and 818 surveys were received from active ASA members who indicated that they personally performed TEE as part of their practice. Results of the surveys are reported in tables 2 and 3and summarized in the text of the Guidelines.The consultants were asked to indicate which, if any, of the recommendations would change their clinical practices if the Guidelines were instituted. The rate of return was 14% (n = 14 of 103). The percent of responding consultants expecting a change in their practice associated with each linkage topic was as follows: (1) major cardiac and thoracic aortic surgery, 7%; (2) transcatheter intracardiac procedures, 0%; (3) pacemaker and implanted cardioverter defibrillator lead extraction, 7% (4); neurosurgery, 7% (5); liver transplantation, 0% (6); orthopedic surgery, 7% (7); vascular/endovascular surgery, 7%, (8) other major surgery (i.e. , lung, renal, abdominal, and head/neck/chest wall), 14%; and (9) postoperative critical care, 21%. Eighty-six percent indicated that their clinical practice will not need new equipment, supplies, or training to implement the Practice Guidelines. Eighty-six percent indicated that the Guidelines would not require ongoing changes in their practice which will affect costs. One hundred percent of the respondents indicated that the Guidelines would have no effect on the amount of time spent on a typical case.

An apparent problem with increased numbers of nosocomial infections caused by Staphylococcus epidermidis at a large hospital was studied in a clinical-epidemiological investigation. Thirty-six cases of S. epidermidis infection were confirmed on the thoracic surgery, general surgery, nursery and pediatric services during a 3-year period. Nine cases were fatal and six of these occurred in patients following cardiovascular surgery with implanted prothesis. The majority of cases (25/36) occurred following cardiovascular surgery. The median onset of infection was six days from the date of surgery, suggesting infection during the intraoperative period. Although the number of cases studied remains small, two phage types, 71/108/275a/459 and 407-2, did predominate among these clinical infections. Interestingly, during this same time interval these same types predominated among surgical staff members closely associated with these patients. Resistance to antimicrobials was high among isolates tested, with more than 50% of the strains resistant to six or more antimicrobial agents.

Epidural analgesia is often considered the optimal technique for pain relief after major surgery and has been studied as a measure to improve outcome. Although conclusions from historical studies were promising, more recent studies show no relevant effect. In the following discussion, we will assume regional analgesia does not make a difference in mortality and morbidity and will try to convince ourselves otherwise critically appraising the studies available. HISTORICAL OVERVIEW Rodgers et al.1 published the first and most cited meta-analysis on this topic. They concluded that neuraxial blockade reduces postoperative mortality and other serious complications. However, many of the trials included were already outdated, had methodological flaws, and do not represent current standard of care. All studies were performed before 1997 and a substantial number before 1985. Several studies reported an unusually high mortality rate of up to 27% in the control group.2–6 This neither represented the rest of the population in the meta-analysis nor does it represent current clinical practice with vastly improved outcomes due to less invasive surgical techniques and the widespread introduction of low molecular weight heparins.2 Ballantyne et al.7 demonstrated that the difference in mortality was related to the year in which a study was done, with newer studies finding smaller or no differences in mortality. The study by Yeager et al.,8 included in many reviews and meta-analyses, was flawed both by a 76% incidence of adverse events in the nonepidural group (19 of 25 patients) and by premature termination of inclusion.8 When this study was excluded from the meta-analysis by Beattie et al. (both in 2001 and 2003) as well as the Cochrane review, the mortality difference between epidural and general anesthesia was no longer significantly different.9–11 In a large retrospective study, Wijeysundera et al.12 compared 88,188 patients with and without epidural anesthesia and/or analgesia and found a very small difference in patient outcome (0.2% absolute risk reduction) of borderline significance (P = 0.02). The authors concluded that “this study should not be used to justify the use of epidural analgesia for mortality reduction.” CLINICAL OUTCOMES: CARDIOVASCULAR COMPLICATIONS It has been suggested that epidural analgesia reduces postoperative cardiovascular complications. Three meta-analyses, mainly including studies in vascular surgery, showed a significant reduction in cardiac morbidity with epidural techniques.9–11 Beattie et al.10 included 1173 patients and found a nonsignificant risk reduction of 0.56 (confidence interval [CI], 0.30–1.03, P = 0.06) for myocardial infarction (MI). Only a post hoc subgroup analysis for thoracic epidurals achieved significance (P = 0.04) with an odds ratio of 0.43 (CI, 0.19–0.97).10 In patients undergoing open abdominal aortic surgery, Nishimori et al.9 reported a significant relative risk reduction of 0.52 (CI, 0.29–0.93) for MI in the presence of thoracic epidural analgesia. The results of these 3 studies critically depended on inclusion of the previously discussed study by Yeager et al.8 Without this study, no significant results remained. A meta-analysis focusing on cardiac surgery demonstrated a reduction in supraventricular arrhythmias but not in MI.13 Another meta-analysis, including 70 randomized controlled trials (RCTs) and nearly 5500 mixed surgical patients, did not find a difference in the incidence of MI.14 Two more meta-analyses and 2 RCTs, also including cardiac surgery, also did not demonstrate an effect of epidural analgesia on cardiovascular complications.14–17 In their systematic review of all available evidence, Liu and Wu18 concluded that epidural analgesia failed to significantly reduce cardiovascular complications in a general surgical population. From the evidence above, we can add that the effects on cardiac complications are minimal and limited to a subpopulation of high-risk patients and procedures. CLINICAL OUTCOME: PULMONARY COMPLICATIONS Based on the shortcomings mentioned before and the unknown incidence of pneumonia in the control group, the odds ratio of 0.61 demonstrated by Rodgers et al.1 should be treated with caution. When comparing thoracic epidural analgesia to IV analgesia after coronary artery bypass graft surgery, an odds ratio of 0.41 (CI, 0.27–0.60) for pulmonary complications was found.15 In a multicenter RCT, including 888 patients with at least 1 risk factor, the risk of postoperative respiratory failure was significantly reduced by epidural techniques from 30.2% to 23.3% (P = 0.02), and in a meta-analysis in cardiac surgery, a significant risk reduction of 0.53 (CI, 0.40–0.69) was shown on the compound end point “respiratory complications.”13,16 A large RCT and a meta-analysis could not reproduce these effects.14,17 Similarly, the meta-analysis by Liu and Wu18 did not find a significant difference in pulmonary outcome between systemic and epidural analgesia. Taken together, the influence of epidural analgesia on pulmonary complications, if present at all, is limited to high-risk intrathoracic procedures and high-risk patients. In conclusion, adding epidural analgesia to general anesthesia does not reduce postoperative morbidity and mortality in a general surgical population. It is unlikely that such evidence will appear in the next years because of the decreased incidence of complications. For example, the incidence of pneumonia has decreased from 20% to 28% in the 1980s to 8% to 10% in more recent trials.17,19–22 Moreover, the beneficial effects of epidural analgesia on deep venous thrombosis and pulmonary embolism have been diminished by routine antithrombotic prophylaxis. Finally, surgical techniques advancing toward less invasive procedures, such as endovascular aortic aneurysm repair or thoracoscopic and laparoscopic surgery, are associated with less short-term postoperative morbidity and mortality, thereby further diminishing any potential for a benefit caused by epidural analgesia.23 QUALITY OF ANALGESIA AND FAILURE RATE Most studies comparing epidural analgesia with systemic analgesia reported a difference, which was often statistically significant and in favor of epidural analgesia.24–27 However, the absolute difference ranged from 6 to 17 mm on a 100-mm visual analog scale. Since a commonly accepted minimum difference to detect clinical superiority is 20 to 30 mm difference on a 100-mm visual analog scale, the small statistical difference is not clinically relevant.28,29 Second, treatment of control groups in most studies consisted of parenteral opioids alone or combined with acetaminophen, which cannot be considered state of the art.30,31 An optimal regimen should contain a cyclooxygenase inhibitor (nonsteroidal anti-inflammatory drugs, cyclooxygenase-2 inhibitor, or dipyrone), an N-methyl-D-aspartate receptor antagonist ((S) ketamine), a descending inhibitory pain pathway inhibitor (e.g., clonidine) and possibly an anticonvulsive drug (e.g., pregabalin) in addition to opioids. IV lidocaine has also been proven beneficial.32–41 Clinically most important, the statistical superiority of epidural analgesia was offset by a failure rate of 13% to 47% in experienced hands.42 In the MASTER trial, 42.5% of the inserted epidural catheters were removed before the scheduled 72 hours.16 This was in accordance with other reports.43–47 In conclusion, epidural analgesia provides statistically, but not clinically, superior analgesia to 53% to 87% of patients. The other 13% to 47% will likely experience a period of inadequate analgesia, often requiring rescue systemic analgesia. Therefore, the effect on a group level is not superior to systemic analgesia. ALTERNATIVES TO EPIDURAL ANALGESIA For extremity surgery, continuous peripheral nerve blocks are widely used. As for epidural analgesia, there was no evidence for any effect on long-term outcome.18 Nevertheless, 2 meta-analyses suggested that peripheral nerve blocks facilitated a quicker rehabilitation with less opioid use and less sleep disturbance.48,49 Epidural analgesia and femoral nerve block resulted in comparable analgesia, opioid consumption, postoperative nausea and vomiting incidence and speed of rehabilitation for major knee surgery although femoral blocks caused fewer side effects (hypotension, pruritus, and urinary retention), and increased patient satisfaction.50 For truncal surgery, paravertebral, intercostal, and transversus abdominal plane blocks and wound infusion catheters are alternatives for epidural or systemic analgesia.51 Currently, there is insufficient evidence to judge their value. Local anesthetics work beyond the direct inhibition of local signal transmission in the nerve and modulate the inflammatory response by acting on G protein-coupled receptors.52 Clinical studies demonstrated that a perioperative IV infusion of lidocaine yielded a reduction in duration of postoperative ileus and length of hospital stay accompanied by a reduced stress/inflammation response.33–38,41,53,54 ENHANCED RECOVERY PROGRAMS Thoracic epidural analgesia is sometimes promoted as part of fast-track or enhanced recovery after surgery (ERAS) programs.55 There was substantial heterogeneity in the studies regarding type of surgery, care in the control group as well as the type, and number of interventions that were implemented. Although ERAS reduced length of stay and sometimes postoperative complications, it remains unclear which elements are essential for success and actually contribute to an improved outcome.56 A meta-analysis concluded that implementation of at least 4 interventions, not necessarily including epidural analgesia, resulted in reduction of hospital stay of 2 days and a nearly 50% reduction in complications.47 Success of ERAS is primarily based on a structured and protocol-based approach and a modified attitude toward rehabilitation goals. Although excellent analgesia and dampening of the surgical stress response are needed, epidural analgesia is not the only way to achieve this. The 2 ERAS trials comparing thoracic epidural analgesia with IV analgesia did not find any difference in length of stay, morbidity, or mortality.57,58 The reduction in length of stay achieved within an ERAS program using systemic lidocaine was comparable with that of studies using epidural analgesia.38,41,54 We conclude that there is no evidence that thoracic epidural analgesia should be a compulsory part of an ERAS program. CANCER RECURRENCE A small retrospective study suggested that regional analgesia could improve cancer-free survival, but more recent trials could not reliably reproduce these results.59–62 This leaves the effect itself as well as dependent variables, such as tumor type, anesthesia technique, and molecular mechanisms as a matter of debate.60–63 COMPLICATIONS OF EPIDURAL ANALGESIA Epidural analgesia was considered a safe technique with an incidence of serious complications (neuraxial hematoma and abscess) of <1 in 100,000 patients. However, several studies demonstrated that the setting in which a neuraxial block was performed, as well as the technique used, made a difference in the risk of complications.64–69 The incidence of permanent harm (including paraplegia and death) ranged from <1 in 200,000 spinal punctures performed in an obstetric setting to 1 in 5700 to 12,000 cases for thoracic epidurals in surgical patients.66 These numbers were confirmed by several large studies, some of which report an incidence of up to 1 in every 1000 cases.64–68 Considering the evidence from the last decade, it should now be accepted that a thoracic epidural catheter in surgical patients carries a 10- to 100-fold higher risk, that is, 1 in 1000 to 10,000 for serious complications.64–68 It is unclear whether better reporting of complications is responsible for the higher figures or whether the incidence of neuraxial hematoma has actually increased over the years. Thromboprophylaxis with low molecular weight heparins and other agents might have caused both the decrease in thrombotic surgical complications as well as an increased risk of epidural hemorrhage.70 Anesthesia societies have proposed guidelines for management of anticoagulated patients undergoing neuraxial block.71 Most recommendations in these guidelines are based on case series, pharmacology, and expert opinion, but it is clear that anticoagulant therapy should prevail over the indication for neuraxial anesthesia/analgesia since the evidence for thromboprophylaxis (or other anticoagulants) is much stronger than the evidence for an epidural catheter. In conclusion, there is strong evidence that epidural analgesia or peripheral regional analgesic techniques improve neither perioperative mortality nor postoperative pulmonary and cardiovascular complications to a clinically significant extent for the general surgical population. If any, the advantages of epidural analgesia are limited to high-risk morbid patients undergoing high-risk procedures.51,70 Analgesia is statistically, but not clinically, superior using epidural techniques. The marginal superiority is further offset by failure rates and analgesic alternatives such as (S)-ketamine, clonidine, and IV lidocaine. Epidural analgesia is associated with a small but relevant number of serious complications, especially in the presence of anticoagulant therapy. The risk/benefit balance should be discussed with the patient in the preoperative consultation. In our opinion, epidural analgesia remains a valid option for postoperative analgesia, and all authors regularly use it for patients undergoing major surgery after careful individual risk assessment. However, given the arguments discussed above, epidural analgesia can no longer be considered the standard of care for a general surgical population. DISCLOSURES Name: Fabian O. Kooij, MD. Contribution: This author helped analyze the data and write the manuscript. Attestation: Fabian O. Kooij approved the final manuscript. Name: Wolfgang S. Schlack, MD, PhD, DEAA. Contribution: This author helped write the manuscript. Attestation: Wolfgang S. Schlack approved the final manuscript. Name: Benedikt Preckel, MD, PhD, DEAA. Contribution: This author helped write the manuscript. Attestation: Benedikt Preckel approved the final manuscript. Name: Markus W. Hollmann, MD, PhD, DEAA. Contribution: This author helped write the manuscript. Attestation: Markus W. Hollmann approved the final manuscript. This manuscript was handled by: Terese T. Horlocker, MD.

Article1 March 1944DISSECTING ANEURYSM OF THE AORTA IN YOUNG INDIVIDUALS, PARTICULARLY IN ASSOCIATION WITH PREGNANCY. WITH REPORT OF A CASEMAURICE A. SCHNITKER, F.A.C.P., CHARLES A. BAYER, M.D.MAURICE A. SCHNITKER, F.A.C.P.Search for more papers by this author, CHARLES A. BAYER, M.D.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-20-3-486 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptUntil attention was called to it1, 2 coronary occlusion below the age of 40 was considered rather unusual.Similarly, in the past dissecting aneurysm of the aorta has been held to occur almost exclusively in older individuals particularly in the presence of hypertension. The authors' interest in the occurrence of dissecting aneurysms in young individuals was stimulated by the following case which occurred in a woman of 22, 12 days post partum. 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BAYER, M.D.Affiliations: Toledo, Ohio*Received for publication February 17, 1943.†This paper was completed before the author entered active military service. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byAortic dissection during pregnancy and postpartum in patients with Marfan syndrome: a 21-year clinical experience in 30 patientsPreconception Counseling for Patients With Thoracic Aortic AneurysmsAcute Type A Aortic Dissection and Successful Surgical Repair in a Woman at 21 Weeks Gestational Pregnancy With Maternal and Fetal Survival: A Case ReportPregnancy-related acute aortic dissection in Marfan syndrome: A review of the literatureAortic Dissection in Pregnancy: Management Strategy and OutcomesAortopathyDissecting the Dilemma: Uncontrolled Hypertension in a Pregnant PatientAortopathy in pregnancyMarfan syndrome and pregnancy: maternal and neonatal outcomesDeBakey Type II Aortic Dissection: A Rare Catastrophic Complication of PregnancySpontaneous coronary artery dissection causing acute coronary syndrome in a young patient without risk factorsSpontaneous rupture of acute ascending aortic dissection in a young pregnant woman: A sudden unexpected deathMarfan’s syndrome and other aortopathies in pregnancyStanford Type A Aortic Dissection in Pregnancy: A Diagnostic and Management ChallengeAcute Type A Aortic Dissection in a 31-week Pregnant Patient^|^mdash;A Case Report^|^mdash;Successful Treatment of a Gravida with Acute A Type Aortic Dissection in Late GestationComplicated Postpartum Type B Aortic Dissection and Endovascular RepairDescending Thoracic Aortic Postpartum A aortic dissection and pregnancy: a acute aortic dissection which sudden a case Management of Thoracic Aortic and Endovascular Aortic Dissection in an Woman with A Aortic Dissection in and An of a in New York dissection in the to de A a by an acute aortic Case of Acute Aortic Dissection with the ascending aortic dissection during spontaneous rupture of an aneurysm of the artery as Dissection in in with OF OF IN THE OF of pregnancy following for of the aortic The and dissection in pregnancy: of in the and aortic in dissection in of age and the of of two of with dissection and aortic aneurysm Clinical experimental and dissection and aortic aneurysm Clinical experimental and OF heart disease, cardiovascular disease, and Dissecting Aortic in the of with of the Case of aortic dissection by and of the Aorta A Case with Thoracic Aortic Dissection Pregnancy: A to a Successful A Case der bei einer dissection during of the Aorta and of dissection during pregnancy: Treatment by by of the aortic and death in of serial to aortic dissection in a pregnant patient with of and Aortic in and and in with and A of disease and Coronary A Report of to of Dissecting of the coronary artery artery of without Case report and review of the Aortic ANEURYSM OF THE AORTA IN des Marfan and OF IN WITH REPORT OF 4 and dissecting and in Marfan syndrome in pregnancy: A case und des Aneurysma der aneurysm in for Aortic dissecting aneurysms of coronary aneurysm syndrome in a and artery rupture in a pregnant woman with of the der bei Medionecrosis dissecting aortic aneurysm. A report of cases two Spontaneous of a of the der und des and unexpected in A review of and clinical of the aorta and der Aorta und der A. aneurysm of the ascending aorta during the of pregnancy with Marfan syndrome and pregnancyMarfan dissecting aneurysm of the aorta, and IN THE A. Aortic due to Aortic of Aortic of the Aortic as a of the Marfan F.A.C.P., F. F.A.C.P., Medial Dissecting of the of the aorta with aneurysm in of the OF THE IN in ANEURYSM WITH PREGNANCY. Report of a Treatment of Dissecting of the Aorta of OF of the Aorta The Clinical of aneurysm of coronary artery in the und der der aneurysm of the aorta ANEURYSM OF THE of pregnancy and heart of in in to of the Aorta in ANEURYSM OF THE AORTA WITH of the dissection in pregnancy: A case of syndrome associated with of Aortic and Medial of the by WITH A ANEURYSM IN THE OF OF THE ANEURYSM OF THE AORTA : A OF of Dissection Dissecting of the OF OF THE A REPORT WITH B. 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Article1 October 1964Cardiac Rhythm Disturbances Complicating Resectional Surgery of the LungFRANK M. MOWRY, M.D., E. W. REYNOLDS JR., M.D.FRANK M. MOWRY, M.D., E. W. REYNOLDS JR., M.D.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-61-4-688 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptAdvances in major thoracic surgery have been made possible by new surgical, diagnostic, and anesthetic techniques and by a more complete understanding of the complications of thoracotomy. Baily and Betts (1) and Currens, White, and Churchill (2) emphasized the importance of cardiac rhythm disturbance as a potentially serious complication of thoracotomy. The incidence of arrhythmia after resectional lung surgery has been studied extensively (1-6), and various prophylactic regimens have been proposed (4, 5, 7-9). Because of the frequency with which cardiac rhythm disturbances attend resectional surgery of the lung and the potentially serious results of these arrhythmias, we have evaluated...References1. BailyBetts ACRH: Cardiac arrhythmias following pneumonectomy. New Eng. J. Med. 229: 356, 1943. CrossrefGoogle Scholar2. CURRENSWHITECHURCHILL JHPDED: Cardiac arrhythmias following thoracic surgery. New Eng. J. Med. 229: 360, 1943. CrossrefGoogle Scholar3. MASSIEVALLE RAR: Cardiac arrhythmias complicating total pneumonectomy. Ann. Intern. Med. 26: 231, 1947. LinkGoogle Scholar4. CERNEY CI: The prophylaxis of cardiac arrhythmias complicating pulmonary surgery; a preliminary report. J. Thorac. Surg. 34: 105, 1957. CrossrefMedlineGoogle Scholar5. KROSNICKWASSERMAN AF: Cardiac arrhythmias in the older age group following thoracic surgery. Amer. J. Med. Sci. 230: 541, 1955. CrossrefMedlineGoogle Scholar6. COHENPASTOR MGBH: Delayed cardiac arrhythmias following non-cardiac thoracic surgery. Dis. Chest. 32: 435, 1957. CrossrefMedlineGoogle Scholar7. KITTLECROCKETT CFJE: The etiology and prevention of atrial fibrillation after mitral valvulotomy. J. Thorac. Cardiov. Surg. 38: 353, 1959. CrossrefMedlineGoogle Scholar8. WHEATBURFORD MWTH: Digitalis in surgery: extension of classical indications. J. Thorac. Cardiov. Surg. 41: 162, 1961. CrossrefMedlineGoogle Scholar9. HURTBATES RLM: The value of quinidine in the prevention of cardiac arrhythmias after pulmonary resection. Thorax 13: 39, 1958. CrossrefMedlineGoogle Scholar10. ADAMSSOUDERS HDCR: Thoracic surgery in the aged and debilitated patient. Surg. Clin. N. Amer. 34: 681, 1954. CrossrefGoogle Scholar11. DODDSIMSBONE RBWADJ: Cardiac arrhythmias observed during anesthesia and surgery. Surgery 51: 440, 1962. MedlineGoogle Scholar12. CAMPBELL SM: Anesthesia in thoracic surgery. Surg. Clin. N. Amer. 34: 1007, 1954. CrossrefGoogle Scholar13. ERLANGER H: Cardiac arrhythmias in relationship to anesthesia: past and present concepts. Amer. J. Med. Sci. 243: 651, 1962. CrossrefMedlineGoogle Scholar14. JACOBYZIEGLERHAMELBURGKLASSENFLORY JCWKF: Cardiac arrhythmia: effects of vagal stimulation and hypoxia. Anesthesiology 16: 1004, 1955. CrossrefMedlineGoogle Scholar15. SMITHWILSON JRRS: Studies on the production and maintenance of experimental atrial fibrillation. Amer. Heart J. 27: 176, 1944. CrossrefGoogle Scholar16. WILLMANCOOPERHANLON LVTCR: Prophylactic therapeutic use of digitalis in open heart operations. Arch. Surg. (Chicago) 80: 860, 1960. CrossrefMedlineGoogle Scholar17. RUTLEDGE DI: Evaluation of the cardiac status of the poor risk patient. Surg. Clin. N. Amer. 34: 597, 1954. CrossrefGoogle Scholar18. BRILL IC: Changing concepts in the treatment of sustained atrial fibrillation. Dis. Chest. 41: 334, 1962. CrossrefMedlineGoogle Scholar19. CORDAYGOLDDEVERAWILLIAMSFIELDS EHLBJHJ: Effect of the cardiac arrhythmias on the coronary circulation. Ann. Intern. Med. 50: 535, 1959. LinkGoogle Scholar20. KORYMENEELY RCGR: Cardiac output in auricular fibrillation with observations on the effects of conversion to normal sinus rhythm. J. Clin. Invest. 30: 653, 1951. Google Scholar21. HARVEYFERRERRICHARDSCOURNAND RNMIDWA: Cardiocirculatory performance in atrial flutter. Circulation 12: 507, 1955. CrossrefMedlineGoogle Scholar22. CORDAYROTTENBERG ESF: The clinical aspects of cerebral vascular insufficiency. Ann. Intern. Med. 47: 626, 1947. Google Scholar23. HECHTOSHERSAMUELS HWDAJ: Cardiovascular adjustment in subjects with organic heart disease before and after conversion of atrial fibrillation to normal sinus rhythm. J. Clin. Invest. 30: 647, 1951. Google Scholar24. BELLET S: Clinical Disorders of the Heart Beat. Lea and Febiger, Philadelphia, 1953. Google Scholar25. GOODMANGILMAN LSA: The Pharmacologic Basis of Therapeutics, Macmillan Company, New York, 1955. Google Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAuthors: FRANK M. MOWRY, M.D.; E. W. REYNOLDSJR., M.D.Affiliations: Ann Arbor, MichiganFrom the Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, Mich.Requests for reprints should be addressed to Frank M. Mowry, M.D., Department of Internal Medicine, University Hospital, University of Michigan Medical Center, Ann Arbor, Mich. 48104. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byEffect of lung resection on electrocardiographyAnesthesia Case of the MonthPerioperative Management of Esophagectomy for Patients who Have Severe Cardiovascular ComplicationsLandiolol hydrochloride for early postoperative tachycardia after transthoracic esophagectomySupraventricular Arrhythmias after Thoracotomy: Is There a Role for Autonomic Imbalance?Amiodarone Significantly Decreases Atrial Fibrillation in Patients Undergoing Surgery for Lung CancerPostoperative Atrial FibrillationPostoperative outcome of patients undergoing lung resection presenting with new-onset atrial fibrillation managed by amiodarone or diltiazemThoracic Epidural Bupivacaine Attenuates Supraventricular Tachyarrhythmias After Pulmonary ResectionThoracic Epidural Bupivacaine Attenuates Supraventricular Tachyarrhythmias After Pulmonary ResectionCardiac Risk Assessment in Noncardiac Thoracic SurgeryAtrial Fibrillation after Noncardic SurgeryIncidence of arrhythmias after thoracic surgery: Thoracotomy versus video-assisted thoracoscopyCASE 5—1998 clinical management of patients undergoing concurrent cardiac surgery and pulmonary resectionThe Postpneumonectomy StatePACU AND ICU CAREClinical and Echocardiographic Correlates of Symptomatic Tachydysrhythmias After Noncardiac Thoracic SurgeryRight ventricular dysfunction after major pulmonary resectionPrimum Non Nocere Is The Therapy Worse Than The Disease?What are the risk factors for arrhythmias after thoracic operations?Arritmias postneumectomíaElective pneumonectomy: Factors associated with morbidity and operative mortalityCardiac arrhythmias and myocardial ischemia after thoracotomy for lung cancerPrevention of arrhythmias after noncardiac thoracic operations: Flecainide versus digoxinPrevention of arrhythmias by flecainide after noncardiac thoracic surgeryCardiac Dysrhythmia following PneumonectomyA Method for Predicting Postoperative Lung Function and Its Relation to Postoperative Complications in Patients with Lung CancerComplications of Thoracic Surgery: Avoidance and RecognitionThoracotomy in patients over age seventy yearsManagement of cardiac disease in the general surgical patientSupraventricular Tachyarrhythmias in Hospitalized Adults after SurgeryComplicaciones en cirugia torácicaQuinidine syncopeComplications of Pulmonary ResectionATRIAL FIBRILLATION FOLLOWING THORACOTOMY FOR NON-CARDIAC DISEASES, IN PARTICULAR CANCER OF THE LUNGMechanically Induced Cardiac Arrhythmia following Open Heart SurgeryCentral Circulatory Function Early After Pulmonary SurgeryCardiac arrhythmias following pneumonectomyReaction of bis(mercaptomethyl)phosphonic acid with alkyl and acyl halidesMajor Thoracic Surgery After SixtyPreoperative irradiation in patients undergoing pneumonectomy for carcinoma of the lung 1 October 1964Volume 61, Issue 4Page: 688-695KeywordsAnestheticsArrhythmiaAtrial fibrillationCardiac surgeryLungsPneumoniaSurgeryThoracic surgeryThoracotomy ePublished: 1 December 2008 Issue Published: 1 October 1964 PDF downloadLoading ...

Brief Reports1 December 1978The Risk of Endothelial Infection in Adults with Salmonella BacteremiaPAUL S. COHEN, M.D., THOMAS F. O'BRIEN, M.D., STEPHEN C. SCHOENBAUM, M.D., ANTONE A. MEDEIROS, M.D.PAUL S. COHEN, M.D., THOMAS F. O'BRIEN, M.D., STEPHEN C. SCHOENBAUM, M.D., ANTONE A. MEDEIROS, M.D.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-89-6-931 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptArteritis and endocarditis are rare complications of salmonellosis. The diagnosis of such endothelial infections often requires invasive techniques. Frequently, the diagnosis is not established until the patient has an advanced stage of the disease or dies and postmortem examination is done. A few cures of salmonella arteritis have been achieved by surgery in combination with antibiotics (1-3), which suggests that earlier diagnosis and intervention might improve survival. The clinician must decide when the potential benefit of the invasive diagnostic procedures outweighs the risks. To ascertain which patients with known salmonella bacteremia are most likely to have arteritis and endocarditis, we...References1. MEADEMORAN RJ: Salmonella arteritis—preoperative diagnosis and cure of Salmonella typhimurium aortic aneurysm. N Engl J Med 281:310-312, 1969 CrossrefMedlineGoogle Scholar2. LEWISWARSHAUER JS: Mycotic aneurysm of the abdominal aorta. A case due to Salmonella choleraesuis var. kunzendorf. South Med J 62:597-599, 1969 CrossrefMedlineGoogle Scholar3. FINSETHABBOTT FW: One-stage operative therapy for salmonella mycotic abdominal aortic aneurysm. Ann Surg 179:8-11, 1974 CrossrefMedlineGoogle Scholar4. MUNDTHDARLINGALVARADOBUCKLEYLINTONAUSTEN ERRMRW: Surgical management of mycotic aneurysms and the complications of infection in vascular reconstruction surgery. Am J Surg 117:460-470, 1969 CrossrefMedlineGoogle Scholar5. BLACKKUNZSWARZ PLM: Salmonellosis—a review of some unusual aspects. N Engl J Med 262:811-817, 864-870, 921-926, 1960 CrossrefMedlineGoogle Scholar6. BLUMKEEFER LE: Cryptogenic mycotic aneurysm. Ann Surg 155:398-405, 1962 CrossrefMedlineGoogle Scholar7. ZAKSTRAUSSSAPHRA FLI: Rupture of diseased large arteries in the course of enterobacterial (salmonella) infections. N Engl J Med 258:824-828, 1958 CrossrefMedlineGoogle Scholar8. BUXTONHOLDEFER RW: Primary mycotic aneurysms: review and report of a case. Am Surg 29:863-867, 1963 MedlineGoogle Scholar9. TILLOTSONLERNER JA: Mycotic aneurysm and endocarditis. Two uncommon complications of salmonella infection in the same patient. Am J Cardiol 18:267-274, 1966 CrossrefMedlineGoogle Scholar10. CLIFFSOULENFINESTONE MRA: Mycotic aneurysms—A challenge and a clue. Arch Intern Med 126:977-982, 1970 CrossrefMedlineGoogle Scholar11. KANWARMALHOTRAANDERSENPILZ YVBC: Salmonellosis associated with abdominal aortic aneurysm. Arch Intern Med 134:1095-1098, 1974 CrossrefMedlineGoogle Scholar12. WEINSTEINKAPLAN LK: Salmonella aortitis in a patient with a Hufnagel valve. Circulation 31:755-757, 1965 CrossrefMedlineGoogle Scholar13. SCHNEIDERNERNOFFGOLD PJJ: Acute salmonella endocarditis report of a case and review. Arch Intern Med 120:478-482, 1967 CrossrefMedlineGoogle Scholar14. CONNELLYMATTHAYSPONZO GRR: Salmonella typhimurium abscess formation in a calcified ventricular aneurysm. Chest 66:457-458, 1974 CrossrefMedlineGoogle Scholar15. DORAISWAMIFRIEDMANKAGAN SSA: Salmonella endocarditis complicated by a myocardial abscess. Am J Cardiol 26:104-105, 1970 CrossrefGoogle Scholar16. LANGAKERSVANES OK: Myocardial abscess due to salmonella typhimurium. Br Heart J 35:871-873, 1973 CrossrefMedlineGoogle Scholar17. MCNALLYKENNEDYGRACE ERW: Salmonella infantis infection of a pre-existent ventricular aneurysm. Am Heart J 68:541-547, 1964 CrossrefMedlineGoogle Scholar18. YAMAMOTOMAGIDSONPOSNERMENDEZZUBIATEKAY NOCAPJ: Probable salmonella endocarditis treated with prosthetic valve replacement: a case report. Surgery 76:678-681, 1974 MedlineGoogle Scholar19. ASERKOFFBENNETT BJ: Effect of antibiotic therapy in acute salmonellosis on the fecal excretion of salmonellae. N Engl J Med 281:636-640, 1969 CrossrefMedlineGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. Author, Article, and Disclosure InformationAuthors: PAUL S. COHEN, M.D.; THOMAS F. O'BRIEN, M.D.; STEPHEN C. SCHOENBAUM, M.D.; ANTONE A. MEDEIROS, M.D.Affiliations: Peter Bent Brigham Hospital Harvard Medical School Boston, Massachusetts PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byInvasive Non-typhoidal Salmonella (iNTS) InfectionsCombating human bacterial infectionsEndosvascular Treatment of Mycotic Thoracic Aortic Pseudoaneurysm Secondary to Nontyphoidal Salmonella InfectionAn Extremely Rare Case of Upper Thoracic Salmonella InfectionINFEKTIONSKRANKHEITENEmergency endovascular management of ruptured mycotic aneurysm of the iliac artery using “bare stent-graft technique”Utility of a blood culture time to positivity-incorporated scoring model in predicting vascular infections in adults with nontyphoid Salmonella bacteremiaValue of blood culture time to positivity in identifying complicated nontyphoidal Salmonella bacteremiaSalmonela AortitisInfectious aortitis: A bridge too farInfectious Aortitis: A Life-Threatening Endovascular Complication of Nontyphoidal Salmonella BacteremiaMycotic aneurysm due to Salmonella species: clinical experiences and review of the literatureAcute Aortic Syndrome – More in the SpectrumDerrame pericárdico y pericarditis purulenta por Salmonella : un caso excepcionalNontyphoidal Salmonella Bacteremia Resulting in Thoracic Aortic DissectionSalmonella infective endocarditisTreatment of EndocarditisEndocarditis and Intravascular InfectionsIs 2 weeks of antibiotic therapy enough to treat elderly patients with nontyphoid Salmonella bacteremia? 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Report of a caseInvestigation of a food borne outbreak of salmonehlosis among hospital employeesOne-stage vascular surgery for abdominal aortic aneurysm infected by salmonellaFalse aneurysm formation after Salmonella virchow infection of a pre-existent ventricular aneurysm--survival after surgical resection.Fatal septic thrombophlebitis due toSalmonella enteritidis“Trots and Runs’: Diarrhoea in Travellers to the TropicsThe Spectrum of Salmonella InfectionMycotic aneurysm of the thoracic aorta caused by Salmonella typhimuriumSalmonellal mycotic abdominal‐aortic aneurysmSalmonella typhimurium and rupture of the thoracic aorta.Salmonella infections of the abdominal aorta cured with prolonged antibiotic treatmentRecurrent salmonella infection with a single strain in the acquired immunodeficiency syndromeAbdominal Aortitis and Infected Aneurysms Due to SalmonellaLes artérites aigües distales au cours des salmonellosesSalmonella bacteremia in patients with prosthetic heart valvesSalmonella infections of the mitral valve and abdominal aortaRole of granulocytes and monocytes in experimental Escherichia coli endocarditisSeptic arteritis complicating salmonellosis.RUPTURED ABDOMINAL AORTIC ANEURYSM: A COMPLICATION OF SALMONELLA BOVIS-MORBIFICANS INFECTIONInfektiöse und andere entzündliche Erkrankungen einschließlich TuberkuloseTreatmentCase 46-1981Les infections du liquide d'ascite ou péritonites bactériennes primitivesEffects of immunization and anticoagulation on the development of experimental Escherichia coli endocarditisAssessment and Control of Microbiological Health Risks Presented by FoodsInfective endocarditis caused by gram-negative bacteria: A review of the literature, 1945–1977Treatment of Salmonella InfectionsJOHN V. BENNETT, M.D., ROGER A. FELDMAN, M.D.Salmonella Gastroenteritis in Older PatientsM. IAN BOWMER, M.D. 1 December 1978Volume 89, Issue 6Page: 931-932KeywordsAntibioticsAutopsyBacteremiaEndocarditisSalmonellaSalmonellosisSurgery ePublished: 1 December 2008 Issue Published: 1 December 1978 PDF downloadLoading ...

Received from the University of California–San Diego Medical Center, San Diego, California.DEXMEDETOMIDINE is an α-2 receptor agonist often administered to surgical patients because of its sedative, analgesic, and anxiolytic properties. Although severe bradycardia is a known adverse effect, bradycardia leading to asystole in the clinical setting has yet to be reported. We report a case of cardiac arrest in a patient receiving a dexmedetomidine infusion as a supplement to general anesthesia.A 52-yr-old 60-kg woman with myasthenia gravis presented for thymectomy and excisional biopsy of a right lung mass via median sternotomy. A preoperative chest computed tomography revealed an anterior mediastinal mass suggestive of thymoma and two small right lower lobe densities. She was otherwise healthy and exercised vigorously 3 to 4 times per week. Her myasthenia, diagnosed 2 months previously, caused mild symptoms, including occasional diplopia and mild upper extremity weakness. These symptoms resolved only partially with the use of pyridostigmine, 120 mg orally three times daily. The patient’s preoperative pulmonary function tests were normal, and her preoperative electrocardiogram exhibited normal sinus rhythm at 60 beats per minute.On the day of surgery, the patient took her morning pyridostigmine dose. After placement of an IV catheter, she was taken to the operating room, where routine monitors were applied. Initial vital signs were: blood pressure, 130/65; heart rate, 78 beats per minute; and oxygen saturation, 100%. She received midazolam intravenously in 2-mg increments while a thoracic epidural (T6–7) was placed. The epidural, placed solely for postoperative pain relief, was tested with 3 ml lidocaine, 2%, with 150 μg epinephrine. This test dose resulted in a small thoracic band of anesthesia with no change in heart rate, blood pressure, or motor function. No further medications were administered via the epidural catheter during operative period. At the conclusion of epidural placement, the patient had received a total of 10 mg midazolam and was still fully alert and anxious. Her vital signs at that time were blood pressure, 133/72; heart rate, 75 beats per minute; and oxygen saturation, 100%. After placement of a radial arterial catheter, a loading dose of 1 μg/kg dexmedetomidine was given over 10 min, followed by an infusion at 0.2 μg/kg/h. The patient initially exhibited a transient increase in blood pressure (145/78), and her heart rate decreased to 48 beats per minute.General anesthesia was induced with 250 μg fentanyl, and 200 mg propofol intravenously. No neuromuscular blockade was used. The patient’s vital signs remained stable through induction and laryngoscopy, with heart rate 46–50 beats per minute. Anesthesia was maintained with isoflurane, 0.7–0.9%, in 100% oxygen and the dexmedetomidine infusion. The patient remained stable through the start of surgery with blood pressure 100–105/50–55. On sternal retraction, the patient’s heart rate dropped into the 30s and 0.5 mg atropine was given. Asystole soon followed, at which time she received open cardiac massage and 300 μg IV epinephrine. There was prompt return of the blood pressure and the asystole episode lasted less than 2 min. The dexmedetomidine infusion was discontinued and the remainder of the surgery proceeded uneventfully, with the patient’s blood pressure ranging from 100–110 to 50–60, and her heart rate 50–60 beats per minute. She was awakened at the conclusion of surgery and the trachea was extubated. There was no evidence of neurologic compromise. The patient was discharged to home on the fourth postoperative day.Dexmedetomidine is an α-2 adrenergic receptor agonist with sedative, analgesic, and anxiolytic properties. It has a selectivity for α-2 receptors eightfold greater than clonidine, and it is considered a full agonist at the α-2 adrenergic receptor. 1Dexmedetomidine has been shown to decrease opioid and inhaled anesthetic requirements, making it an attractive adjunct to general anesthesia. 2,3When administered to healthy volunteers, dexmedetomidine causes a dose-dependent decrease in blood pressure and heart rate but does not demonstrate clinically relevant respiratory depression, despite its profound sedative effects. 4,5Its sympatholytic properties, in conjunction with its anesthetic actions, make it an attractive choice for coronary artery surgery 6,7as well as other major operations. 7–10Dexmedetomidine has been observed to display a biphasic arterial blood pressure response, causing transient increase in pressure followed by a sustained decrease. The observed heart rate response seems to be a combination of a baroreflex-mediated reduction in heart rate, coinciding with the transient increase in blood pressure, centrally mediated reduced sympathetic tone, and increased vagal tone. 1,4Severe bradycardia following administration of α-2 agonists is well documented. 1,11,12To our knowledge, however, this is the first reported clinical case of asystole related to the use of dexmedetomidine. A number of factors may have contributed to the development of asystole in this patient. We believe a centrally mediated decrease in sympathetic outflow and increase in parasympathetic outflow resulting from dexmedetomidine, as well as the patient’s autonomic response to abrupt surgical stimulation, were the primary contributors. The bradycardic response observed with dexmedetomidine can be augmented by the concurrent use of other medications with negative chronotropic and/or vagal effects. For example, significant bradycardia was observed in a 5-week-old infant treated with digoxin during sedation with dexmedetomidine. 13In our case, the patient was being treated with pyridostigmine, which increases vagal tone. Pyridostigmine, an anticholinesterase used for the symptomatic treatment of myasthenia gravis, increases the concentration of acetylcholine at muscarinic and nicotinic receptors. The activation of cardiac muscarinic receptors accounts for the drug’s negative chronotropic effect, which is exacerbated by the concomitant administration of other negative chronotropes such as digitalis, calcium channel blockers, and beta blockers. 14Pyridostigmine is known to antagonize and may also potentiate neuromuscular blockers; however, it has no reported interactions with other often used anesthetic agents. 15Although it is unclear whether the pyridostigmine had any significant cardiovascular effects on this patient, it may have interacted with dexmedetomidine in an additive or synergistic fashion.This patient likely had increased vagal tone at baseline, given her level of physical activity and low resting heart rate. Bloor et al. 1also noted bradydysrhythmia in three patients within minutes of dexmedetomidine infusion, when the plasma concentration of dexmedetomidine is presumably high. Their study involved healthy young men with low resting heart rates. These events were associated with increased blood pressure, and Bloor et al. attributed them to reflex-mediated slowing secondary to peripheral hypertensive response. In our patient, the severe bradycardia progressing to asystole coincided temporally with the sternotomy and sternal retraction. This surgical stimulus may have produced a vaso-vagal response, which led to cardiac standstill. Another possibility is that, on sternal retraction, mechanosensory receptors in the heart were stimulated, resulting in the Bezold-Jarisch reflex. This reflex, mediated by vagal efferents and decreased sympathetic vasomotor tone, may cause severe bradycardia and hypotension. 16The patient was given a modest dose of fentanyl prior to induction of anesthesia. Dexmedetomidine has been shown to reduce opioid requirements as well as augment the bradycardia that may be observed with their use. 2,17Another possible, but unlikely, factor in this case is the epidural. As mentioned previously, the epidural was placed to provide only postoperative pain relief, and except for the test dose, no other medications were administered epidurally during surgery. Bradycardia and cardiac arrest are well-documented complications of spinal and epidural anesthesia. 18–22However, although the small epidural test dose could have caused a modest amount of sympatholysis, an hour had elapsed between the placement and testing of the epidural and the episode of asystole. This argues against sympatholysis from the epidural playing a significant role in this event.In summary, we report a case of severe bradycardia progressing to asystole in a patient receiving a dexmedetomidine infusion to supplement general anesthesia. The prompt and effective treatment of this event resulted in complete recovery with no evidence of cardiovascular or neurologic compromise. Several factors combined to cause asystole in this patient, and caution must be exercised when administering dexmedetomidine in the presence of other negative chronotropic influences.

BACKGROUND: The Global Burden of Diseases, Injuries, and Risk Factors Study 2015 provides an up-to-date synthesis of the evidence for risk factor exposure and the attributable burden of disease. By providing national and subnational assessments spanning the past 25 years, this study can inform debates on the importance of addressing risks in context. METHODS: We used the comparative risk assessment framework developed for previous iterations of the Global Burden of Disease Study to estimate attributable deaths, disability-adjusted life-years (DALYs), and trends in exposure by age group, sex, year, and geography for 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks from 1990 to 2015. This study included 388 risk-outcome pairs that met World Cancer Research Fund-defined criteria for convincing or probable evidence. We extracted relative risk and exposure estimates from randomised controlled trials, cohorts, pooled cohorts, household surveys, census data, satellite data, and other sources. We used statistical models to pool data, adjust for bias, and incorporate covariates. We developed a metric that allows comparisons of exposure across risk factors-the summary exposure value. Using the counterfactual scenario of theoretical minimum risk level, we estimated the portion of deaths and DALYs that could be attributed to a given risk. We decomposed trends in attributable burden into contributions from population growth, population age structure, risk exposure, and risk-deleted cause-specific DALY rates. We characterised risk exposure in relation to a Socio-demographic Index (SDI). FINDINGS: Between 1990 and 2015, global exposure to unsafe sanitation, household air pollution, childhood underweight, childhood stunting, and smoking each decreased by more than 25%. Global exposure for several occupational risks, high body-mass index (BMI), and drug use increased by more than 25% over the same period. All risks jointly evaluated in 2015 accounted for 57·8% (95% CI 56·6-58·8) of global deaths and 41·2% (39·8-42·8) of DALYs. In 2015, the ten largest contributors to global DALYs among Level 3 risks were high systolic blood pressure (211·8 million [192·7 million to 231·1 million] global DALYs), smoking (148·6 million [134·2 million to 163·1 million]), high fasting plasma glucose (143·1 million [125·1 million to 163·5 million]), high BMI (120·1 million [83·8 million to 158·4 million]), childhood undernutrition (113·3 million [103·9 million to 123·4 million]), ambient particulate matter (103·1 million [90·8 million to 115·1 million]), high total cholesterol (88·7 million [74·6 million to 105·7 million]), household air pollution (85·6 million [66·7 million to 106·1 million]), alcohol use (85·0 million [77·2 million to 93·0 million]), and diets high in sodium (83·0 million [49·3 million to 127·5 million]). From 1990 to 2015, attributable DALYs declined for micronutrient deficiencies, childhood undernutrition, unsafe sanitation and water, and household air pollution; reductions in risk-deleted DALY rates rather than reductions in exposure drove these declines. Rising exposure contributed to notable increases in attributable DALYs from high BMI, high fasting plasma glucose, occupational carcinogens, and drug use. Environmental risks and childhood undernutrition declined steadily with SDI; low physical activity, high BMI, and high fasting plasma glucose increased with SDI. In 119 countries, metabolic risks, such as high BMI and fasting plasma glucose, contributed the most attributable DALYs in 2015. Regionally, smoking still ranked among the leading five risk factors for attributable DALYs in 109 countries; childhood underweight and unsafe sex remained primary drivers of early death and disability in much of sub-Saharan Africa. INTERPRETATION: Declines in some key environmental risks have contributed to declines in critical infectious diseases. Some risks appear to be invariant to SDI. Increasing risks, including high BMI, high fasting plasma glucose, drug use, and some occupational exposures, contribute to rising burden from some conditions, but also provide opportunities for intervention. Some highly preventable risks, such as smoking, remain major causes of attributable DALYs, even as exposure is declining. Public policy makers need to pay attention to the risks that are increasingly major contributors to global burden. FUNDING: Bill & Melinda Gates Foundation.

General principles of pharmacology and pharmacokinetics. Inhalational anaesthetic agents. Intravenous anaesthetic agents. Local anaesthetic agents. Analgesic drugs. Muscle function and neuromuscular blockage. Sedative and anticonvulsant drugs. Drugs acting on the cardiovascular and autonomic nervous systems. Drugs acting on the respiratory system. Drugs used in renal disease. Basic physics for the anaesthetist. Clinical measurement. Anaesthetic apparatus. The operating theatre environment. Preoperative assessment and premedication. The practical conduct of anaesthesia. Local anaesthetic techniques. Monitoring. Complications during anaesthesia. Metabolism, the stress response to surgery and perioperative thermoregulation. Fluid, electrolyte and acid-base balance. Bleeding disorders and blood transfusion. Intercurrent disease and anaesthesia. Postoperative care. Postoperative pain. Postoperative nausea and vomiting. Day case anaesthesia. .Emergency anaesthesia. Anaesthesia for gynaecological and genitourinary surgery. .Anaesthesia for orthopaedic surgery. Anaesthesia for ENT, maxillofacial and plastic surgery. Anaesthesia for ophthalmic surgery. Dental anaesthesia. Anaesthesia outside the operating theatre. Obstetric anaesthesia and analgesia. Pediatric anaesthesia. Anaesthesia for endocrine and vascular surgery. Neurosurgical anaesthesia. Anaesthesia for thoracic surgery. Anaesthesia for cardiac surgery. Management of chronic pain. Appendices: Clinical trials and statistics. Clinical data

The ESC Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge and the evidence available at the time of their publication. The ESC is not responsible in the event of any contradiction, discrepancy and/or ambiguity between the ESC Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies. Health professionals are encouraged to take the ESC Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic or therapeutic medical strategies; however, the ESC Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver. Nor do the ESC Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations. It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.

The Guidelines represent the views of the ESC and were produced after careful consideration of the scientific and medical knowledge, and the evidence available at the time of their publication. The ESC and EASD are not responsible in the event of any contradiction, discrepancy, and/or ambiguity between the Guidelines and any other official recommendations or guidelines issued by the relevant public health authorities, in particular in relation to good use of healthcare or therapeutic strategies. Health professionals are encouraged to take the Guidelines fully into account when exercising their clinical judgment, as well as in the determination and the implementation of preventive, diagnostic, or therapeutic medical strategies; however, the Guidelines do not override, in any way whatsoever, the individual responsibility of health professionals to make appropriate and accurate decisions in consideration of each patient's health condition and in consultation with that patient and, where appropriate and/or necessary, the patient's caregiver. Nor do the Guidelines exempt health professionals from taking into full and careful consideration the relevant official updated recommendations or guidelines issued by the competent public health authorities, in order to manage each patient's case in light of the scientifically accepted data pursuant to their respective ethical and professional obligations. It is also the health professional's responsibility to verify the applicable rules and regulations relating to drugs and medical devices at the time of prescription.