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Circulation. 2001;104:2171 6. 878. Kumbhani DJ, Cannon CP, Fonarow GC, et al. Association of hospital primary angioplasty volume in ST-segment elevation myocardial infarction with quality and outcomes. JAMA. 2009;302:2207 13. 879. Krone RJ, Shaw RE, Klein LW, et al. Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current stent era of coronary interventions (from the ACC- National Cardiovascular Data Registry). Am J Cardiol. 2003;92:389 94. KEY WORDS: AHA Scientific Statements y acute coronary syndromes y anticoagulants y antiplatelet agents y antiplatelet agents y arrhythmias, cardiac y coronary artery revascularization interventions: stents y coronary angiography y drug therapy y drug delivery systems 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/SCAI Guideline for Percutaneous Coronary Intervention 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 Number* Glenn N. Levine (Chair) Baylor College of Medicine Professor of Medicine; Director, Cardiac Care Unit None None None None None None None Eric R. Bates (Vice Chair) University of Michigan Professor of Medicine Bristol-Myers Squibb Daiichi-Sankyo Datascope Eli Lilly Merck Sanofi-aventis None None None None None 5.7.2 James C. Blankenship (Vice Chair) Geisinger Medical Center Director of Cardiology and Cardiac Catheterization Laboratories None None None Abiomed AstraZeneca Boston Scientific Conor Medsystems Kai Pharmaceutical Schering-Plough None None 2.1 Steven R. Bailey University of Texas Medical Center-Professor of Medicine and Radiology Volcano None None Boston Scientific None None 5.4.1 John A. Bittl Munroe Heart-Interventional Cardiologist None None None None None None None Bojan Cercek Cedars-Sinai Medical Center-Director, Coronary Care Unit None None None None None None None Charles E. Chambers Penn State Milton S. Hershey Medical Center-Professor of Medicine and Radiology None None None None None None None Stephen G. Ellis Cleveland Clinic Foundation-Section Head, Invasive and Interventional Cardiology Abbott Vascular Boston Scientific Cordis Daiichi-Sankyo Eli Lilly None None Abbott Vascular None None 2.2 Robert A. Guyton Emory Clinic, Inc.-Professor and Chief, Division of Cardiothoracic Surgery None None None Edwards Lifesciences None None 2.1 Steven M. Hollenberg Cooper University Hospital-Director, Coronary Care Unit Eisai None None None None None 5.7.4.3 Umesh N. Khot CV Research Innovations, LLC-President/CEO None None Merck None None None 4.6 Richard A. Lange University of Texas Health Science Center at San Antonio-Professor of Medicine None None None None None None None (Continued) Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e643 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 Number* Laura Mauri Brigham and Women s Hospital-Associate Professor of Medicine, Harvard Medical School Abbott Conor Medsystems (Johnson & Johnson) Cordis Medtronic None None Lutonix Abbott Abiomed Boston Scientific Bristol-Myers Squibb Conor Medsystems Cordis Daiichi-Sankyo Eli Lilly Medtronic Cardiovascular Sanofi-aventis Defendant, Conor, interpretation of clinical trial Roxana Mehran Columbia University Medical Center-Associate Professor of Medicine; Director, Data Coordinating Analysis Center Abbott Vascular Abiomed AlphaMedical AstraZeneca Bracco BMS/ sanofi-aventis DataScope Eli Lilly/Daichii-Sankyo Guerbet The Medicines Company Medtronic Vascular St. Jude None None None None None 4.7 Issam D. Moussa Mayo Clinic-Professor of Medicine; Chair, Division of Cardiovascular Diseases None None None None None None None Debabrata Mukherjee Texas Tech University-Chief, Cardiovascular Medicine None None None None None None None Brahmajee K. Nallamothu University of Michigan-Assistant Professor of Medicine None None None None None None None Henry H. Ting Mayo Clinic-Professor of Medicine; Assistant Dean for Quality 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. 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. Significant relationship. Appendix 2. Reviewer Relationships With Industry and Other Entities (Relevant) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Deepak L. Bhatt Official Reviewer AHA None None None AstraZeneca* Bristol-Myers Squibb* Eisai* Eli Lilly Ethicon* The Medicines Company* PLx Pharma Sanofi-aventis* None None Mauricio G. Cohen Official Reviewer AHA AstraZeneca* Momenta Pharma Xoma Terumo Medical None Invitrox* None None John P. Erwin III Official Reviewer ACCF/AHA Task Force on Performance Measures None None None None None None Kirk Garratt Official Reviewer SCAI Boston Scientific Cordis/Johnson & Johnson The Medicines Company Boston Scientific BMS/ sanofi-aventis* Daiichi-Sankyo/ Eli Lilly* Medtronic The Medicines Company Abbott Vascular Boston Scientific None None None Steven L. Goldberg Official Reviewer SCAI AGA Bristol-Myers Squibb Sanofi-aventis None None None Plaintiff, patient litigation, Alice K. Jacobs Official Reviewer ACCF/AHA Task Force on Practice Guidelines None None Wyeth* Abbott Vascular* Abiomed* Accumetrics* Cardiovascular Research Foundation (DSMB) Harvard Clinical Research Institute TIMI Study Group (DSMB) None None G.B. John Mancini Official Reviewer ACCF Board of Governors GlaxoSmithKline Merck Pfizer Sanofi-aventis None None Merck* None None (Continued) Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e645 Appendix 2. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness W. Douglas Weaver Official Reviewer ACCF Board of Trustees None None None Boehringher Ingelheim (DSMB) Boston Scientific (DSMB) Duke Clinical Research Institute (Johnson & Johnson/Schering Plough)* GlaxoSmithKline NHLBI (DSMB) TIMI Study Group (Johnson & Johnson/ Bayer DSMB) None None Thomas M. Bashore Content Reviewer None None None None None None Christopher E. Buller Content Reviewer Abbott Vascular Toshiba Medical None None Novartis Regado Biosciences None None James A. Burke Content Reviewer ACCF Interventional Scientific Council None None None None None None John G. Byrne Content Reviewer ACCF Surgeons Scientific Council Edwards Lifesciences None None None None None T. Bruce Ferguson Content Reviewer ACCF Surgeons Scientific Council None None None Novadaq Technologies* None None Victor A. Ferrari Content Reviewer None None None NHLBI (DSMB) National Institute for Aging/NIH (DSMB) None None John G. Harold Content Reviewer None None None None None None Biswajit Kar Content Reviewer None None None AstraZeneca Boston Scientific Medtronic VA Cooperative Study None Morton J. Kern Content Reviewer Infraredex Merit Medical* St. Jude Medical* Volcano Therapeutics* None None None None Spencer B. King III Content Reviewer Celonova Biosciences None None Merck (DSMB) Wyeth (DSMB) None None Frederick G. Kushner Content Reviewer None None None Novartis None None David J. Maron Content Reviewer None None Cardiovascular Care Affiliates* None None Plaintiff, acute coronary syndrome, Douglass A. Morrison Content Reviewer 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 Thomas C. Piemonte Content Reviewer ACCF Board of Governors None None None None None Defendant, stent perforation, Peter K. Smith Content Reviewer Eli Lilly None None None None None Sidney C. Smith Content Reviewer None None None None None None Richard W. Snyder Content Reviewer ACCF Board of Governors None None None None Hospital Corporation of America None Patrick L. Whitlow Content Reviewer Edwards Lifesciences* eValve* Medtronic* None None None ICON None David O. Williams Content Reviewer Light Lab/St. Jude Medical None None None None None R. Scott Wright Content Reviewer Hoffman LaRoche* 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. 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. *Significant relationship. No financial benefit. ACCF indicates American College of Cardiology Foundation; AHA, American Heart Association; DSMB, data safety and monitoring board; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; SCAI, Society for Cardiovascular Angiography and Interventions; and TIMI, Thrombolysis In Myocardial Infarction. Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e647 Appendix 3. Abbreviation List ACS acute coronary syndromes AKI acute kidney injury BMS bare-metal stent(s) CABG coronary artery bypass graft surgery CAD coronary artery disease CKD chronic kidney disease CTO chronic total occlusion DAPT dual antiplatelet therapy DES drug-eluting stent(s) ECG electrocardiogram EF ejection fraction EPD embolic protection device FDA US Food and Drug Administration FFR fractional flow reserve GDMT guideline-directed medical therapy GI gastrointestinal GP glycoprotein IABP intra-aortic balloon pump IV intravenous IVUS intravascular ultrasound LAD left anterior descending LIMA left internal mammary artery LV left ventricular LVEF left ventricular ejection fraction MACE major adverse cardiac event MI myocardial infarction MRI magnetic resonance imaging NCDR National Cardiovascular Data Registry PCI percutaneous coronary intervention PPI proton pump inhibitor RCT randomized controlled trial SIHD stable ischemic heart disease STEMI ST-elevation myocardial infarction SVG saphenous vein graft TIMI Thrombolysis In Myocardial Infarction TMR transmyocardial laser revascularization UA/NSTEMI unstable angina/non-ST-elevation myocardial infarction UFH unfractionated heparin Appendix 4. Additional Tables/Figures Appendix 4A. The NCDR CathPCI Risk Score System Variable Scoring Response Categories Risk Score Calculation Total Points Risk of In-Patient Mortality (%) Cardiogenic shock No Yes 10 0.1 Prior CHF No Yes 20 0.3 Peripheral vascular disease No Yes 30 1.1 Chronic lung disease No Yes 40 3.6 NYHA functional class IV No Yes 60 29.0 PCI status (STEMI) Elective Urgent Emergent Salvage 70 57.6 PCI status (no STEMI) Elective Urgent Emergent Salvage 80 81.0 CathPCI indicates catheterization percutaneous coronary intervention; CHF, congestive heart failure; GFR, glomerular filtration rate; NCDR, National Cardiovascular Data Registry; NYHA, New York Heart Association; and STEMI, ST-elevation myocardial infarction. Reproduced with permission from Peterson et al.236 Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e649 Appendix 4C. Strategies to Reduce Radiation Exposure to Patient and Operator Precautions to minimize exposure to patient and operator Use radiation only when imaging is necessary to support clinical care Minimize use of cine Minimize use of steep angles of x-ray beam Minimize use of magnification modes Minimize frame rate of fluoroscopy and cine Keep the image receptor close to the patient Utilize collimation to the fullest extent possible Monitor radiation dose in real time to assess patient risk-benefit during procedure Precautions to specifically minimize exposure to operator Use and maintain appropriate protective garments Maximize distance of operator from x-ray source and patient Keep above-table and below-table shields in optimal position at all times Keep all body parts out of field of view at all times Precautions to specifically minimize exposure to patient Keep table height as high as comfortably possible for operator Vary imaging beam angle to minimize exposure to any single skin area Keep patient s extremities out of beam Appendix 4D. Patient Care Consideration Based on Procedural Radiation Dose Ka,r* PKA FT Action 60 min Physician charts documentation about why exposure at this level occurred, documents whether multiple skin entry angles were used, assesses risk, educates patient about potential for skin injury, and arranges for appropriate follow-up within 30 d. Phone calls may be sufficient with an office visit arranged if issues/questions arise or a potential tissue injury is suspected. 10 Gray Physician contacts radiation safety officer/medical physicist. The radiation safety officer/medical physicist should perform a detailed analysis of PSD. Document a) FOV, b) skin entrance port number, c) known geometry, with a rough geometric setup required. Educate patient about the potential for skin injury and document this in chart. Schedule an office visit in 2 to 4 wk. Gray If calculated PSD is indeed 15 Gray, the physician and/or radiation safety officer/medical physicist should contact hospital risk management within 24 h. Report the event to the Joint Commission and as needed to the appropriate State Department of Health. *Ka,r is total air kerma at reference point; PKA is air kerma-area product; FT is total fluoroscopy time, does not include cine; PSD is peak skin dose, which requires calculations made by a qualified physicist. FOV indicates field of view; and FT, fluoroscopy time. Adapted with permission from Chambers et al.317 Appendix 4B. The SCAI Lesion Classification System Type I lesions (highest success expected, lowest risk) 1. Does not meet criteria for C lesion Type II lesions 1. Meets any of these criteria for ACC/AHA C lesion Diffuse ( 2 cm length) Excessive tortuosity of proximal segment Extremely angulated segments, 90 Inability to protect major side branches Degenerated vein grafts with friable lesions Type III lesions 1. Does not meet criteria for C lesion Type IV lesions 1. Meets any of these criteria for ACC/AHA C lesion Diffuse ( 2 cm length) Excessive tortuosity of proximal segment Extremely angulated segments, 90 Inability to protect major side branches Degenerated vein grafts with friable lesions Occluded for 3 mo ACC indicates American College of Cardiology; AHA, American Heart Association; and SCAI, Society for Cardiovascular Angiography and Interven- tions. Reprinted with permission from Krone et al.879 Appendix 4E. General Considerations in Deciding Between Early Invasive Strategy and Initial Conservative Strategy Early Invasive Strategy Generally Preferred Initial Conservative Strategy Generally Preferred or Reasonable Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy Elevated cardiac biomarkers (TnT or TnI) New or presumably new ST-segment depression Signs or symptoms of heart failure Hemodynamic instability High-risk score (eg, GRACE, TIMI) Sustained ventricular tachycardia PCI within 6 mo Prior CABG Diabetes mellitus Mild to moderate renal dysfunction Reduced LV function (LVEF 40%) Low-risk score (eg, GRACE, TIMI) Absence of high-risk features High risk for catheterization-related complications Patient not a candidate for revascularization (with either PCI or CABG) Patient prefers conservative therapy CABG indicates coronary artery bypass graft surgery; GRACE, Global Registry of Acute Coronary Events; LV, left ventricular; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary intervention; TIMI, Thrombolysis In Myocardial Infarction; TnI, troponin I; and TnT, troponin T. Appendix 4F. Agents for Procedural Sedation and Analgesia Drug Clinical Effects Dose Onset Duration Comments Midazolam Sedation, anxiolysis. No analgesia. Initial 0.5 to 1 mg IV, then titrated. 2 to 3 min 45 to 60 min Reduce dose when used in combination with opioids. May produce paradoxical excitement. Reversible with flumazenil. Fentanyl Analgesia 50 mcg IV. May repeat every 3 min, titrate to effect. 3 to 5 min 30 to 60 min Reduce dosing when combined with benzodiazepines. Reversible with naloxone. Etomidate Sedation, anxiolysis. No analgesia. Sedation: 0.1 mg/kg IV; repeat if inadequate response. 1 min 5 to 15 min Respiratory depression may occur; institutional guidelines vary about administration to nonintubated patients by nonanesthesiologists. May cause myoclonus, nausea, and vomiting. Adrenocortical suppression occurs but is rarely of clinical significance. Not reversible. Propofol Sedation, anxiolysis. No analgesia. Load 1 mg/kg IV; may administer additional 0.5 mg/kg doses as needed to enhance or prolong sedation. 1 min 5 to 15 min Frequent hypotension and respiratory depression; institutional guidelines vary concerning administration to nonintubated patients by nonanesthesiologists. Avoid with egg or soy allergies. Not reversible. Reversal Agents Naloxone Opioid reversal 0.4 to 2 mg IV 2 min 20 to 40 min If shorter acting than reversed drug, serial doses may be required. Flumazenil Benzodiazepine reversal 0.2 mg IV. May repeat every 1 min up to 1 mg. 1 to 2 min 30 to 60 min If shorter acting than reversed drug, serial doses may be required. Do not use in patients receiving long-term benzodiazepines, cyclosporine, isoniazid, lithium, propoxyphene, theophylline, or tricyclic antidepressants. IV indicates intravenous. Levine et al 2011 ACCF/AHA/SCAI PCI Guideline e651