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Intraoperative imaging techniques to assess coronary artery bypass graft patency. Ann Thorac Surg. 2007; 83:2251 7. 1262. Simons M, Laham RJ, Post M, et al. Therapeutic angiogenesis: potential role of basic fibroblast growth factor in patients with severe ischaemic heart disease. BioDrugs. 2000;14:13 20. 1263. Laham RJ, Sellke FW, Edelman ER, et al. Local perivascular delivery of basic fibroblast growth factor in patients undergoing coronary bypass surgery: results of a phase I randomized, double-blind, placebo- controlled trial. Circulation. 1999;100:1865 71. 1264. Ramphal PS, Coore DN, Craven MP, et al. A high fidelity tissue-based cardiac surgical simulator. Eur J Cardiothorac Surg. 2005;27:910 6. KEY WORDS: AHA Scientific Statements y acute coronary syndromes y anticoagulants y antiplatelet agents y arrhythmias, cardiac y coronary angiography y coronary artery revascularization interventions: stents y drug therapy y heart diseases y myocardial revascularization y platelet aggregation inhibitor y ultrasound Appendix 1.


KEY WORDS: AHA Scientific Statements y acute coronary syndromes y anticoagulants y antiplatelet agents y arrhythmias, cardiac y coronary angiography y coronary artery revascularization interventions: stents y drug therapy y heart diseases y myocardial revascularization y platelet aggregation inhibitor y ultrasound Appendix 1. Author Relationships With Industry and Other Entities (Relevant) 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery Committee Member Employer/Title Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section Numbers* L. David Hillis (Chair) University of Texas Health Science Center at San Antonio Professor and Chair of the Department of Medicine None None None None None None None Peter K. Smith (Vice Chair) Duke University Medical Center: Private Diagnostic Clinic Professor of Surgery; Chief of Thoracic Surgery Eli Lilly Baxter BioSurgery None None None None None 2.2.3 Jeffrey L. Anderson Intermountain Medical Center Associate Chief of Cardiology BMS/sanofi-aventis None None AstraZeneca Gilead Pharma Toshiba None None 2.1.6 John A. Bittl Ocala Heart Institute Munroe Regional Medical Center Interventional Cardiologist None None None None None None None Charles R. Bridges University of Pennsylvania Medical Center Chief of Cardiothoracic Surgery Baxter BioSurgery Zymogenetics Bayer Pharmaceuticals None None None Plaintiff, alleged mitral valve dysfunction, 2009 Defendant, retinal artery occlusion (stroke) after Defendant, timely insertion of IABP after Defendant, timely transport after acute aortic dissection, 2009 Plaintiff, unexpected intra-abdominal hemorrhage and death after AVR, 2009 John G. Byrne Vanderbilt University Medical Center: Division of Cardiac Surgery Chairman of Cardiac Surgery None None None None None None None Joaquin E. Cigarroa Oregon Health and Science University Associate Professor of Medicine None None None None None None None Verdi J. DiSesa John Hopkins Hospital, Division of Cardiac Surgery Clinical Associate None None None None None None None Loren F. Hiratzka Cardiac, Vascular and Thoracic Surgeons, Inc. Medical Director of Cardiac Surgery None None None None None None None Adolph M. Hutter, Jr. Massachusetts General Hospital Professor of Medicine None None None None None None None Michael E. Jessen UT Southwestern Medical Center Professor of Cardiothoracic Surgery Quest Medical None None None None None 2.1.8 Ellen C. Keeley University of Virginia Associate Professor of Internal Medicine None None None None None None None Stephen J. Lahey University of Connecticut Professor and Chief of Cardiothoracic Surgery None None None None None Defendant, mitral valve None (Continued) Hillis et al 2011 ACCF/AHA CABG Guideline e731 Appendix 1.


Continued Committee Member Employer/Title Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Voting Recusals by Section Numbers* Richard A. Lange University of Texas Health Science Center at San Antonio Professor of Medicine None None None None None None None Martin J. London University of California San Francisco, Veterans Affairs Medical Center Professor of Clinical Anesthesia None None None None None None None Michael J. Mack The Heart Hospital Baylor Plano Cardiovascular Surgery, Medical Director Cordis Marquett Medtronic Edwards Lifesciences None None None None None 2.1.3 Manesh R. Patel Duke University Medical Center Associate Professor of Medicine None None None None None None None John D. Puskas Emory University/Emory Healthcare Chief of Cardiac Surgery Marquett Medtronic None None Marquett Medtronic None None 2.1.3 Joseph F. Sabik Cleveland Clinic Foundation Professor of Surgery Edwards Lifesciences Medtronic None None None None None 2.2.2 Ola Selnes John Hopkins Hospital, Department of Neurology Professor of Neurology None None None None None None None David M. Shahian Massachusetts General Hospital Professor of Surgery None None None None None None None Jeffrey C. Trost John Hopkins School of Medicine Assistant Professor of Medicine None None None Toshiba None None 2.1.7 Michael D. Winniford University of Mississippi Medical Center Professor of Medicine None None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication.


The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACCF/AHA, a person has a relevant relationship IF: (a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or (c) the person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply. No financial benefit. Significant relationship. AVR indicates aortic valve replacement; CABG, coronary artery bypass graft surgery; and IABP, intraaortic balloon pump. Appendix 2.


AVR indicates aortic valve replacement; CABG, coronary artery bypass graft surgery; and IABP, intraaortic balloon pump. Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant) 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Robert Guyton Official Reviewer ACCF/ AHA Task Force on Practice Guidelines None None None Edwards Lifesciences None None Jeffrey Jacobs Official Reviewer ACCF/ AHA Task Force on Data Standards None None None None None None L. Kristin Newby Official Reviewer AHA AstraZeneca None None Eli Lilly* GlaxoSmithKline None None Eric D. Peterson Official Reviewer ACCF/ AHA Task Force on Performance Measures AstraZeneca None None BMS/sanofi-aventis Eli Lilly None None Richard J. Shemin Official Reviewer AHA Edwards Lifesciences None None None None None Hector Ventura Official Reviewer ACCF Board of Governors None Actelion Gilead None None None None Thad F. Waites Official Reviewer ACCF Board of Trustees None None None None None None T. Bruce Ferguson, Jr Organizational Reviewer STS None None None None None None Stephen E. Fremes Organizational Reviewer AATS None None None None Merck Defendant, leaking thoracic aortic Defendant, aortic Colleen G. Koch Organizational Reviewer SCA None None None None None None Harold L. Lazar Organizational Reviewer AATS None None None None None None Walter H. Merrill Organizational Reviewer STS None None None None None None Stanton K. Shernan Organizational Reviewer SCA None Philips Healthcare None None None Plaintiff, communication of echocardiography Joseph S. Alpert Content Reviewer Bayer Sanofi-aventis None None None None None Robert M. Califf Content Reviewer AstraZeneca Daiichi-Sankyo GlaxoSmithKline Medtronic Sanofi-aventis None None Eli Lilly Bayer None None Robbin G. Cohen Content Reviewer None None None None None Defendant, death after minimally invasive heart Defendant, diagnosis of aortic dissection, 2010 Plaintiff, renal failure and Aprotinin, 2010 Mark A. Creager Content Reviewer ACCF/ AHA Task Force on Practice Guidelines AstraZeneca Genzyme Merck Roche Vascutek None None Merck None Plaintiff, Fasudil Development: Asahi Pharma v Actelion, (Continued) Hillis et al 2011 ACCF/AHA CABG Guideline e733 Appendix 2.


Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Steven M. Ettinger Content Review ACCF/AHA Task Force on Practice Guidelines None None None Medtronic None None David P. Faxon Content Reviewer Sanofi-aventis None None None None Defendant, cath vascular access site Kirsten E. Fleischmann Content Reviewer None None None None None None Lee Fleisher Content Reviewer None None None Pfizer AstraZeneca Defendant, perioperative Anthony P. Furnary Content Reviewer ACCF Surgeons Scientific Council None None None None None Defendant, Bayer Corp. Trasylol litigation, Valentin Fuster Content Reviewer None None None None None None John W. Hirshfeld, Jr Content Reviewer GlaxoSmithKline None None None None None Judith S. Hochman Content Reviewer ACCF/ AHA Task Force on Practice Guidelines Eli Lilly GlaxoSmithKline None None None None None James L. Januzzi, Jr Content Reviewer Roche None None Roche None None Frederick G. Kushner Content Reviewer Vice Chair, 2012 STEMI Guideline Writing Committee None None None None None None Glenn Levine Content Review Chair, 2011 PCI Guideline Writing Committee None None None None None None Donald Likosky Content Reviewer None None None Maquet Medtronic None None James J. Livesay Content Reviewer Southern Thoracic Surgical Association None None None None None Defendant, acute aortic Defendant, cardiac mortality review, 2010 Defendant, heparin induced Bruce W. Lytle Content CABG Guideline Writing Committee None None None None None None Robert A. Marlow Content CABG Guideline Writing Committee None None None None None None Rick A. Nishimura Content Reviewer ACCF Board of Trustees None None None None None None Patrick O Gara Content Reviewer Chair, Guideline Writing Committee None None None None None None (Continued) Appendix 2.


Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness E. Magnus Ohman Content Reviewer ACCF/ AHA Task Force on Practice Guidelines AstraZeneca Bristol-Myers Squibb Boehringer Ingelheim Gilead Sciences Merck Pozen Sanofi-aventis Boehringer Ingelheim Gilead Sciences None Daiichi-Sankyo Datascope Eli Lilly None None John D. Rutherford Content Reviewer None None None None None None George A. Stouffer Content Reviewer None None None None None Defendant, review of malpractice claim, 2010 Mathew Williams Content ACCF Interventional Scientific Council Edwards Lifesciences Medtronic None None None None None This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review.


Names are listed in alphabetical order within each category of review. According to the ACCF/AHA, a person has a relevant relationship IF: (a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or (b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or (c) the person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *No financial benefit. Significant relationship. AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; CABG, coronary artery bypass graft surgery; PCI, percutaneous coronary intervention; SCA, Society of Cardiovascular Anesthesiologists; STEMI, ST-elevation myocardial infarction; and STS, Society of Thoracic Surgeons. Appendix 3.


AATS indicates American Association for Thoracic Surgery; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; CABG, coronary artery bypass graft surgery; PCI, percutaneous coronary intervention; SCA, Society of Cardiovascular Anesthesiologists; STEMI, ST-elevation myocardial infarction; and STS, Society of Thoracic Surgeons. Appendix 3. Abbreviation List ACE angiotensin-converting enzyme LIMA left internal mammary artery ACS acute coronary syndrome LV left ventricular AF atrial fibrillation LVEF left ventricular ejection fraction AKI acute kidney injury MACE major adverse coronary events ARB angiotensin-receptor blockers MI myocardial infarction BMS bare-metal stent NSTEMI non-ST-elevation myocardial infarction CABG coronary artery bypass graft surgery PAC pulmonary artery catheter CAD coronary artery disease PAD peripheral artery disease CKD chronic kidney disease PCI percutaneous coronary intervention CPB cardiopulmonary bypass RCT randomized controlled trial DAPT dual antiplatelet therapy SIHD stable ischemic heart disease DES drug-eluting stent SIRS systemic inflammatory response system EF ejection fraction STEMI ST-elevation myocardial infarction GDMT guideline-directed medical therapy SVG saphenous vein graft ICU intensive care unit TEE transesophageal echocardiography IMA internal mammary artery TIA transient ischemic attack LAD left anterior descending TMR transmyocardial laser revascularization LDL low-density lipoprotein UA unstable angina Hillis et al 2011 ACCF/AHA CABG Guideline e735


KDIGO CLINICAL PRACTICE GUIDELINE FOR LIPID MANAGEMENT IN CHRONIC KIDNEY DISEASE APPENDIX 1: SEARCH STRATEGY 1. exp kidney glomerulus/ 2. exp kidney disease/ 3. exp kidney function tests/ 4. exp renal replacement therapy/ 5. exp kidney transplantation/ 6. exp kidney, artificial/ 7. exp ultrafiltration/ 8. exp sorption, detoxification/ 9. renal.af. or renal.tw. 10. nephro$.af. or nephro$.tw. 11. kidney.af. or kidney.tw. 12. ur?emia.af. or ur?emia.tw. 13. h?emodialysis.af. or h?emodialysis.tw. 14. (hemofiltr$ or haemofiltr$).af. or (hemofiltr$ or haemofiltr$).tw. 16. Animals/ not humans.mp. 18. exp lipid/ or exp triacylglycerol/ or exp lipoprotein/ 19. exp apoprotein/ 20. exp lipids/ 21. exp cholesterol/ 22. (ldl or vldl or hdl or triglyceride$ or cholesterol or lipoprotein$ or chylomicron$ or apoprotein$ or apolipoprotein$).tw. 23. (dyslipid$ or hypolipid$ or hyperlipid$).tw. APPENDIX 2: CONCURRENCE WITH INSTITUTE OF MEDICINE STANDARDS FOR SYSTEMATIC REVIEWS AND FOR GUIDELINES IOM Standards for Systematic Reviews Part of KDIGO Process?


APPENDIX 2: CONCURRENCE WITH INSTITUTE OF MEDICINE STANDARDS FOR SYSTEMATIC REVIEWS AND FOR GUIDELINES IOM Standards for Systematic Reviews Part of KDIGO Process? 2.1 Establish a team with appropriate expertise and experience to conduct the systematic review Yes 2.1.1 Include expertise in the pertinent clinical content areas Yes 2.1.2 Include expertise in systematic review methods Yes 2.1.3 Include expertise in searching for relevant evidence Yes 2.1.4 Include expertise in quantitative methods Yes 2.1.5 Include other expertise as appropriate Yes 2.2 Manage bias and conflict of interest (COI) of the team conducting the systematic review Yes 2.2.1 Require each team member to disclose potential COI and professional or intellectual bias Yes (not intellectual bias) 2.2.2 Exclude individuals with a clear financial conflict Yes 2.2.3 Exclude individuals whose professional or intellectual bias would diminish the credibility of the review in the eyes of the intended users Not explicitly 2.3 Ensure user and stakeholder input as the review is designed and conducted Yes 2.3.1 Protect the independence of the review team to make the final decisions about the design, analysis, and reporting of the review Yes 2.4 Manage bias and COI for individuals providing input into the systematic review Yes 2.4.1 Require individuals to disclose potential COI and professional or intellectual bias Yes (not intellectual bias) 2.4.2 Exclude input from individuals whose COI or bias would diminish the credibility of the review in the eyes of the intended users No 2.5 Formulate the topic for the systematic review Yes 2.5.1 Confirm the need for a new review Yes 2.5.2 Develop an analytic framework that clearly lays out the chain of logic that links the health intervention to the outcomes of interest and defines the key clinical questions to be addressed by the systematic review No 2.5.3 Use a standard format to articulate each clinical question of interest No 2.5.4 State the rationale for each clinical question No 2.5.5 Refine each question based on user and stakeholder input Yes 2.6 Develop a systematic review protocol Yes 2.6.1 Describe the context and rationale for the review from both a decision-making and research perspective No 2.6.2 Describe the study screening and selection criteria (inclusion/exclusion criteria) Yes 2.6.3 Describe precisely which outcome measures, time points, interventions, and comparison groups will be addressed Yes 2.6.4 Describe the search strategy for identifying relevant evidence Yes 2.6.5 Describe the procedures for study selection Yes 2.6.6 Describe the data extraction strategy Yes 2.6.7 Describe the process for identifying and resolving disagreement between researchers in study selection and data extraction decisions No 2.6.8 Describe the approach to critically appraising individual studies Yes 2.6.9 Describe the method for evaluating the body of evidence, including the quantitative and qualitative synthesis strategies Yes IOM Standards for Systematic Reviews Part of KDIGO Process?


2.6.10 Describe and justify any planned analyses of differential treatment effects according to patient subgroups, how an intervention is delivered, or how an outcome is measured Yes 2.6.11 Describe the proposed timetable for conducting the review Yes 2.7 Submit the protocol for peer review No 2.7.1 Provide a public comment period for the protocol and publicly report on disposition of comments No 2.8 Make the final protocol publicly available, and add any amendments to the protocol in a timely fashion No 3.1 Conduct a comprehensive systematic search for evidence Yes 3.1.1 Work with a librarian or other information specialist trained in performing systematic reviews to plan the search strategy No 3.1.2 Design the search strategy to address each key research question Yes 3.1.3 Use an independent librarian or other information specialist to peer review the search strategy No 3.1.4 Search bibliographic databases Yes 3.1.5 Search citation indexes No 3.1.6 Search literature cited by eligible studies No 3.1.7 Update the search at intervals appropriate to the pace of generation of new information for the research question being addressed Yes 3.1.8 Search subject-specific databases if other databases are unlikely to provide all relevant evidence N/A 3.1.9 Search regional bibliographic databases if other databases are unlikely to provide all relevant evidence N/A 3.2 Take action to address potentially biased reporting of research results No 3.2.1 Search grey-literature databases, clinical trial registries, and other sources of unpublished information about studies No 3.2.2 Invite researchers to clarify information about study eligibility, study characteristics, and risk of bias No 3.2.3 Invite all study sponsors and researchers to submit unpublished data, including unreported outcomes, for possible inclusion in the systematic review No 3.2.4 Handsearch selected journals and conference abstracts No 3.2.5 Conduct a web search No 3.2.6 Search for studies reported in languages other than English if appropriate Yes 3.3 Screen and select studies Yes 3.3.1 Include or exclude studies based on the protocol s prespecified criteria Yes 3.3.2 Use observational studies in addition to randomized clinical trials to evaluate harms of interventions No 3.3.3 Use two or more members of the review team, working independently, to screen and select studies No 3.3.4 Train screeners using written documentation; test and retest screeners to improve accuracy and consistency Yes 3.3.5 Use one of two strategies to select studies: (1) read all fulltext articles identified in the search or (2) screen titles and abstracts of all articles and then read the full texts of articles identified in initial screening 3.3.6 Taking account of the risk of bias, consider using observational studies to address gaps in the evidence from randomized clinical trials on the benefits of interventions No 3.4 Document the search Yes 3.4.1 Provide a line-by-line description of the search strategy, including the date of every search for each database, web browser, etc.


Yes 3.4.2 Document the disposition of each report identified including reasons for their exclusion if appropriate No 3.5 Manage data collection Yes 3.5.1 At a minimum, use two or more researchers, working independently, to extract quantitative and other critical data from each study. For other types of data, one individual could extract the data while the second individual independently checks for accuracy and completeness. Establish a fair procedure for resolving discrepancies do not simply give final decision-making power to the senior reviewer Single extraction 3.5.2 Link publications from the same study to avoid including data from the same study more than once Yes IOM Standards for Systematic Reviews Part of KDIGO Process?


Establish a fair procedure for resolving discrepancies do not simply give final decision-making power to the senior reviewer Single extraction 3.5.2 Link publications from the same study to avoid including data from the same study more than once Yes IOM Standards for Systematic Reviews Part of KDIGO Process? 3.5.3 Use standard data extraction forms developed for the specific SR Yes 3.5.4 Pilot-test the data extraction forms and process Yes 3.6 Critically appraise each study Yes 3.6.1 Systematically assess the risk of bias, using predefined criteria Yes 3.6.2 Assess the relevance of the study s populations, interventions, and outcome measures Yes 3.6.3 Assess the fidelity of the implementation of interventions Yes 4.1 Use a prespecified method to evaluate the body of evidence Yes 4.1.1 For each outcome, systematically assess the following characteristics of the body of evidence: Risk of bias; Consistency; Precision; Directness; Reporting bias Yes 4.1.2 For bodies of evidence that include observational research, also systematically assess the following characteristics for each outcome: Dose response association; Plausible confounding that would change the observed effect; Strength of association Yes 4.1.3 For each outcome specified in the protocol, use consistent language to characterize the level of confidence in the estimates of the effect of an intervention Yes 4.2 Conduct a qualitative synthesis Yes 4.2.1 Describe the clinical and methodological characteristics of the included studies, including their size, inclusion or exclusion of important subgroups, timeliness, and other relevant factors Yes 4.2.2 Describe the strengths and limitations of individual studies and patterns across studies Yes 4.2.3 Describe, in plain terms, how flaws in the design or execution of the study (or groups of studies) could bias the results, explaining the reasoning behind these judgments No 4.2.4 Describe the relationships between the characteristics of the individual studies and their reported findings and patterns across studies No 4.2.5 Discuss the relevance of individual studies to the populations, comparisons, cointerventions, settings, and outcomes or measures of interest No 4.3 Decide if, in addition to a qualitative analysis, the systematic review will include a quantitative analysis (meta-analysis) No 4.3.1 Explain why a pooled estimate might be useful to decision makers No 4.4 If conducting a meta-analysis, then do the following: Use expert methodologists to develop, execute, and peer review the meta-analyses Address the heterogeneity among study effects Accompany all estimates with measures of statistical uncertainty Assess the sensitivity of conclusions to changes in the protocol, assumptions N/A 5.1 Prepare final report using a structured format N/A 5.1.1 Include a report title N/A 5.1.2 Include an abstract N/A 5.1.3 Include an executive summary N/A 5.1.4 Include a summary written for the lay public N/A 5.1.5 Include an introduction (rationale and objectives) N/A 5.1.6 Include a methods section.