2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Documen
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Journal of the American College of Cardiology Vol. 59, No. 24, 2012 © 2012 by the American College of Cardiology Foundation and the Society for Cardiovascular Angiography and Interventions ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2012.02.010 EXPERT CONSENSUS DOCUMENT 2012 American College of Cardiology Foundation/ Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents Developed in Collaboration With the Society of Thoracic Surgeons and Society for Vascular Medicine Writing Thomas M. Bashore, MD, FACC, FSCAI, Chair*† David J. Moliterno, MD, FACC, FSCAIʈ Committee Stephen Balter, PHD, FAAPM, FACR, FSIR John W. M. Moore, MD, MPH, FACC, FSCAI* Members Ana Barac, MD, PHD* Sandra M. Oliver-McNeil, DNP, ACNP-BC, John G. Byrne, MD, FACC‡ AACC* Jeffrey J. Cavendish, MD, FACC, FSCAI* Jeffrey J. Popma, MD, FACC, FSCAI* Charles E. Chambers, MD, FACC, FSCAI† Carl L. Tommaso, MD, FACC, FSCAI† James Bernard Hermiller JR, MD, FACC, FSCAI* Scott Kinlay, MBBS, PHD, FACC, FSCAI§ *American College of Cardiology Foundation Representative; †Society for Cardiovascular Angiography and Interventions Representative; ‡So- Joel S. Landzberg, MD, FACC* ciety of Thoracic Surgeons Representative; §Society for Vascular Warren K. Laskey, MD, MPH, FACC, FSCAI* Medicine Representative; and ʈACCF Task Force on Clinical Expert Consensus Documents Representative. Authors with no symbol by Charles R. McKay, MD, FACC* their names were included to provide additional content expertise apart Julie M. Miller, MD, FACC* from organizational representation. ACCF Task Robert A. Harrington, MD, FACC, Chair Mark A. Hlatky, MD, FACC¶ Force Members Alice K. Jacobs, MD, FACC Eric R. Bates, MD, FACC¶ Sanjay Kaul, MBBS, FACC Deepak L. Bhatt, MD, MPH, FACC David J. Moliterno, MD, FACC Charles R. Bridges, MD, MPH, FACC¶ Debabrata Mukherjee, MD, FACC¶ Mark J. Eisenberg, MD, MPH, FACC¶ Robert S. Rosenson, MD, FACC¶ Victor A. Ferrari, MD, FACC Howard H. Weitz, MD, FACC John D. Fisher, MD, FACC Deborah J. Wesley, RN, BSN¶ Timothy Gardner, MD, FACC Federico Gentile, MD, FACC ¶Former Task Force member during this writing effort. Michael F. Gilson, MD, FACC This document was approved by the American College of Cardiology Foundation Moliterno DJ, Moore JWM, Oliver-McNeil SM, Popma JJ, Tommaso CL. 2012 (ACCF) Board of Trustees and Society for Cardiovascular Angiography and American College of Cardiology Foundation/Society for Cardiovascular Angiography Interventions (SCAI) Board of Directors in February 2012 as well as endorsed by and Interventions Expert Consensus Document on Cardiac Catheterization Labora- Society of Thoracic Surgeons and Society for Vascular Medicine in February 2012. tory Standards Update. J Am Coll Cardiol 2012;59:2221–305. For the purpose of complete transparency, disclosure information for the ACCF The executive summary of this article is copublished in Catheterization and Board of Trustees, the board of the convening organization of this document, is Cardiovascular Interventions. available at http://www.cardiosource.org/ACC/About-ACC/Leadership/Officers- Copies: This document is available on the World Wide Web sites of the American and-Trustees.aspx. ACCF board members with relevant relationships with industry to the College of Cardiology (www.cardiosource.org). For copies of this document, please contact document may review and comment on the document but may not vote on approval. Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail [email protected]. The American College of Cardiology Foundation requests that this document be Permissions: Multiple copies, modification, alteration, enhancement, and/or distribu- cited as follows: Bashore TM, Balter S, Barac A, Byrne JG, Cavendish JJ, Chambers tion of this document are not permitted without the express permission of the American CE, Hermiller JB Jr, Kinlay S, Landzberg JS, Laskey WK, McKay CR, Miller JM, College of Cardiology Foundation. Please contact [email protected]. 2222 Bashore et al. JACC Vol. 59, No. 24, 2012 Cardiac Catheterization Laboratory Standards June 12, 2012:2221–305 3.4.1. Overview of the Peer Review Process: TABLE OF CONTENTS Quality Indicators, Data Collection and Analysis, and QA/QI Interventions.........2247 Preamble ....................................................2224 3.4.2. Noncardiologists Performing Cardiac Catheterization ...........................2249 Executive Summary .......................................2224 3.4.3. National Database Use....................2250 3.4.4. Catheterization Laboratory Reporting Requirements .............................2250 3.4.4.1. STORAGE OF INFORMATION 1. Introduction............................................2232 (LENGTH AND TYPE) ...................2252 1.1. Document Development Process and 3.4.5. Equipment Maintenance and Management ..............................2253 Methodology ....................................2233 3.5. Minimum Caseload Volumes 1.1.1. Writing Committee Organization ........2233 ..................2254 1.1.2. Relationships With Industry and 3.5.1. Operator Volumes ........................2254 3.5.1.1. OPERATORS PERFORMING DIAGNOSTIC Other Entities ............................2233 PROCEDURES ........................2254 1.1.3. Consensus Development ..................2233 3.5.1.2. OPERATORS PERFORMING INTERVENTIONAL 1.1.4. Document Methodology ..................2233 CORONARY PROCEDURES...............2255 1.2. Purpose of This Document .....................2234 3.5.1.3. PRIMARY PCI OPERATORS ..............2256 2. The Cardiac Catheterization Laboratory 3.5.1.3.1. PCI OPERATORS IN THE FACILITY WITHOUT CARDIOVASCULAR Environments ..........................................2234 SURGICAL SUPPORT .........2256 3.5.2. Institutional Minimum Caseloads.........2257 2.1. The Current Landscape.........................2234 3.5.2.1. DIAGNOSTIC CATHETERIZATION 2.2. General Complications From Cardiac INSTITUTIONAL VOLUME ................2257 Catheterization Procedures ...................2234 3.5.2.2. INTERVENTIONAL CORONARY CATHETERIZATION 2.3. The Cardiac Catheterization Laboratory at a INSTITUTIONAL VOLUME ................2257 Hospital With Cardiovascular Surgical 3.5.3. Training ..................................2258 3.5.3.1. DIAGNOSTIC CARDIAC CATHETERIZATION Capability ........................................2235 AND PCI ............................2259 2.3.1. Patients Eligible for Invasive Cardiovascular 3.5.3.2. PERIPHERAL VASCULAR PROCEDURES .....2259 Procedures at a Hospital With Full Support 3.5.3.3. STRUCTURAL HEART DISEASE............2260 Services (Including Cardiovascular Surgery)...................................2236 4. Procedural Issues in the Cardiac 2.4. The Cardiac Catheterization Laboratory at a Catheterization Laboratory .........................2261 Hospital Without Cardiovascular Surgical Capability ........................................2236 4.1. Safety in Patients With 2.4.1. Patients Acceptable for Diagnostic Cardiac Communicable Diseases .......................2261 Catheterization at a Facility Without 4.2. Patient Preparation ............................2261 Cardiovascular Surgical Capability ........2237 4.2.1. Minimum Laboratory Data in Preparation 2.4.2. Patients Acceptable for Elective Coronary for the Procedure .........................2262 Intervention in a Facility Without 4.2.2. Patients Receiving Antiplatelet and Cardiovascular Surgical Capability ........2237 Antithrombin Agents .....................2262 2.4.3. Patients Acceptable for PCI in ACS 4.2.3. Chronic Kidney Disease/Renal in a Facility Without Cardiovascular Insufficiency...............................2263 Surgical Capability ........................2240 4.2.3.1. ATTEMPTS TO REDUCE THE RISK OF CONTRAST NEPHROPATHY 3. Quality Assurance Issues in the Cardiac ..............2263 4.2.4. Other Contrast Media Reactions .........2264 Catheterization Laboratory .........................2242 4.2.5. Diabetes Mellitus .........................2264 4.2.6. Sedatives and Relaxants ...................2265 3.1. Patient Outcomes in the Diagnostic 4.2.7. Heparin-Induced Antibodies..............2265 Catheterization Laboratory ....................2243 4.2.8. Pregnant Patients .........................2265 3.1.1. Rate of “Normal Catheterizations” ........2243 4.3. Access Site (Femoral, Radial, Brachial)......2265 3.1.2. Specific Complication Rates Following 4.4. During the Procedure...........................2265 Diagnostic Catheterization................2243 3.1.2.1. ACCESS SITE COMPLICATIONS ...........2243 4.4.1. Medications...............................2265 3.1.2.2. CEREBROVASCULAR COMPLICATIONS......2243 4.4.2. Sterile Techniques ........................2266 3.1.3. Diagnostic Accuracy and Adequacy .......2243 4.4.3. Technical Issues...........................2266 4.4.3.1. CORONARY ANGIOGRAPHY ..............2266 3.2. Patient Outcomes After Coronary 4.4.3.2. VENTRICULOGRAPHY AND VASCULAR Interventional Procedures .....................2244 ANGIOGRAPHY .......................2267 3.2.1. Major Adverse Cardiac or 4.4.3.3. PRESSURE MEASUREMENT ..............2267 ...................2244 Cerebrovascular Events 4.4.3.3.1. HEMODYNAMICS ............2267 3.2.1.1. PCI IN THE SETTING OF ST-ELEVATION 4.4.3.3.2. INTRACORONARY MYOCARDIAL INFARCTION ..............2245 HEMODYNAMICS ............2268 3.2.2. Ad Hoc PCI Issues .......................2245 4.4.3.4.