2012 American College of Cardiology Foundation/Society for … · EXPERT CONSENSUS DOCUMENT 2012 American College of Cardiology Foundation/ Society for Cardiovascular Angiography

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/$36.00P

EXPERT CONSENSUS DOCUMENT

2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and InterventionsExpert Consensus Document on Cardiac CatheterizationLaboratory Standards UpdateA 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

ublished by Elsevier Inc. doi:10.1016/j.jacc.2012.02.010

S

S

WritingCommitteeMembers

This document was approved(ACCF) Board of TrusteesInterventions (SCAI) BoardSociety of Thoracic SurgeonsFor the purpose of completeBoard of Trustees, the boardavailable at http://www.cardand-Trustees.aspx. ACCF boadocument may review and comm

The American College of Ccited as follows: Bashore TM,CE, Hermiller JB Jr, Kinlay S

Thomas M. Bashore, MD, FACC, FSCAI, Chair*†tephen Balter, PHD, FAAPM, FACR, FSIR

Ana Barac, MD, PHD*John G. Byrne, MD, FACC‡Jeffrey J. Cavendish, MD, FACC, FSCAI*Charles E. Chambers, MD, FACC, FSCAI†James Bernard Hermiller JR, MD, FACC, FSCAI*

cott Kinlay, MBBS, PHD, FACC, FSCAI§Joel S. Landzberg, MD, FACC*Warren K. Laskey, MD, MPH, FACC, FSCAI*Charles R. McKay, MD, FACC*

by the American College of Cardiology Foundationand Society for Cardiovascular Angiography and

of Directors in February 2012 as well as endorsed byand Society for Vascular Medicine in February 2012.transparency, disclosure information for the ACCFof the convening organization of this document, is

iosource.org/ACC/About-ACC/Leadership/Officers-rd members with relevant relationships with industry to theent on the document but may not vote on approval.ardiology Foundation requests that this document beBalter S, Barac A, Byrne JG, Cavendish JJ, Chambers, Landzberg JS, Laskey WK, McKay CR, Miller JM,

Moliterno DJAmerican Coland Interventitory Standards

The executCardiovascular

Copies: ThiCollege of CarElsevier Inc. Re

Permissionstion of this docCollege of Car

David J. Moliterno, MD, FACC, FSCAI�John W. M. Moore, MD, MPH, FACC, FSCAI*Sandra M. Oliver-McNeil, DNP, ACNP-BC,

AACC*Jeffrey J. Popma, MD, FACC, FSCAI*Carl L. Tommaso, MD, FACC, FSCAI†

*American College of Cardiology Foundation Representative; †Societyfor Cardiovascular Angiography and Interventions Representative; ‡So-ciety of Thoracic Surgeons Representative; §Society for VascularMedicine Representative; and �ACCF Task Force on Clinical ExpertConsensus Documents Representative. Authors with no symbol bytheir names were included to provide additional content expertise apart

Julie M. Miller, MD, FACC* from organizational representation.

ACCF TaskForce Members

Robert A. Harrington, MD, FACC, Chair

Eric R. Bates, MD, FACC¶Deepak L. Bhatt, MD, MPH, FACCCharles R. Bridges, MD, MPH, FACC¶Mark J. Eisenberg, MD, MPH, FACC¶Victor A. Ferrari, MD, FACCJohn D. Fisher, MD, FACCTimothy Gardner, MD, FACCFederico Gentile, MD, FACCMichael F. Gilson, MD, FACC

Mark A. Hlatky, MD, FACC¶Alice K. Jacobs, MD, FACCSanjay Kaul, MBBS, FACCDavid J. Moliterno, MD, FACCDebabrata Mukherjee, MD, FACC¶Robert S. Rosenson, MD, FACC¶Howard H. Weitz, MD, FACCDeborah J. Wesley, RN, BSN¶

¶Former Task Force member during this writing effort.

, Moore JWM, Oliver-McNeil SM, Popma JJ, Tommaso CL. 2012lege of Cardiology Foundation/Society for Cardiovascular Angiographyons Expert Consensus Document on Cardiac Catheterization Labora-Update. J Am Coll Cardiol 2012;59:2221–305.

ive summary of this article is copublished in Catheterization andInterventions.

s document is available on the World Wide Web sites of the Americandiology (www.cardiosource.org). For copies of this document, please contactprint Department, fax 212-633-3820, e-mail [email protected].

: Multiple copies, modification, alteration, enhancement, and/or distribu-ument are not permitted without the express permission of the Americandiology Foundation. Please contact [email protected].

http://www.cardiosource.org/ACC/About-ACC/Leadership/Officers-and-Trustees.aspxhttp://www.cardiosource.org/ACC/About-ACC/Leadership/Officers-and-Trustees.aspxhttp://www.cardiosource.orgmailto:[email protected]:[email protected]

2222 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac Catheterization Laboratory Standards June 12, 2012:2221–305

TABLE OF CONTENTS

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2224

Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2224

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2232

1.1. Document Development Process andMethodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22331.1.1. Writing Committee Organization . . . . . . . .22331.1.2. Relationships With Industry and

Other Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . .22331.1.3. Consensus Development . . . . . . . . . . . . . . . . . .22331.1.4. Document Methodology . . . . . . . . . . . . . . . . . .2233

1.2. Purpose of This Document. . . . . . . . . . . . . . . . . . . . .2234

2. The Cardiac Catheterization LaboratoryEnvironments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2234

2.1. The Current Landscape . . . . . . . . . . . . . . . . . . . . . . . . .2234

2.2. General Complications From CardiacCatheterization Procedures . . . . . . . . . . . . . . . . . . .2234

2.3. The Cardiac Catheterization Laboratory at aHospital With Cardiovascular SurgicalCapability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22352.3.1. Patients Eligible for Invasive Cardiovascular

Procedures at a Hospital With Full SupportServices (Including CardiovascularSurgery). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2236

2.4. The Cardiac Catheterization Laboratory at aHospital Without Cardiovascular SurgicalCapability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22362.4.1. Patients Acceptable for Diagnostic Cardiac

Catheterization at a Facility WithoutCardiovascular Surgical Capability . . . . . . . .2237

2.4.2. Patients Acceptable for Elective CoronaryIntervention in a Facility WithoutCardiovascular Surgical Capability . . . . . . . .2237

2.4.3. Patients Acceptable for PCI in ACSin a Facility Without CardiovascularSurgical Capability . . . . . . . . . . . . . . . . . . . . . . . .2240

3. Quality Assurance Issues in the CardiacCatheterization Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .2242

3.1. Patient Outcomes in the DiagnosticCatheterization Laboratory . . . . . . . . . . . . . . . . . . . .22433.1.1. Rate of “Normal Catheterizations” . . . . . . . .22433.1.2. Specific Complication Rates Following

Diagnostic Catheterization. . . . . . . . . . . . . . . .22433.1.2.1. ACCESS SITE COMPLICATIONS . . . . . . . . . . .22433.1.2.2. CEREBROVASCULAR COMPLICATIONS . . . . . .2243

3.1.3. Diagnostic Accuracy and Adequacy . . . . . . .22433.2. Patient Outcomes After Coronary

Interventional Procedures . . . . . . . . . . . . . . . . . . . . .22443.2.1. Major Adverse Cardiac or

Cerebrovascular Events . . . . . . . . . . . . . . . . . . .22443.2.1.1. PCI IN THE SETTING OF ST-ELEVATION

MYOCARDIAL INFARCTION . . . . . . . . . . . . . .22453.2.2. Ad Hoc PCI Issues . . . . . . . . . . . . . . . . . . . . . . .2245

3.3. Peripheral Vascular Intervention . . . . . . . . . . . . .2246

3.4. Peer Review Continuous QA/QI Program . . . .2246

3.4.1. Overview of the Peer Review Process:Quality Indicators, Data Collection andAnalysis, and QA/QI Interventions. . . . . . . . .2247

3.4.2. Noncardiologists Performing CardiacCatheterization . . . . . . . . . . . . . . . . . . . . . . . . . . .2249

3.4.3. National Database Use. . . . . . . . . . . . . . . . . . . .22503.4.4. Catheterization Laboratory Reporting

Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22503.4.4.1. STORAGE OF INFORMATION

(LENGTH AND TYPE) . . . . . . . . . . . . . . . . . . .22523.4.5. Equipment Maintenance and

Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22533.5. Minimum Caseload Volumes . . . . . . . . . . . . . . . . . .2254

3.5.1. Operator Volumes . . . . . . . . . . . . . . . . . . . . . . . .22543.5.1.1. OPERATORS PERFORMING DIAGNOSTIC

PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . .22543.5.1.2. OPERATORS PERFORMING INTERVENTIONAL

CORONARY PROCEDURES . . . . . . . . . . . . . . .22553.5.1.3. PRIMARY PCI OPERATORS . . . . . . . . . . . . . .2256

3.5.1.3.1. PCI OPERATORS IN THE FACILITY

WITHOUT CARDIOVASCULAR

SURGICAL SUPPORT . . . . . . . . .2256

3.5.2. Institutional Minimum Caseloads. . . . . . . . .22573.5.2.1. DIAGNOSTIC CATHETERIZATION

INSTITUTIONAL VOLUME . . . . . . . . . . . . . . . .22573.5.2.2. INTERVENTIONAL CORONARY CATHETERIZATION

INSTITUTIONAL VOLUME . . . . . . . . . . . . . . . .22573.5.3. Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2258

3.5.3.1. DIAGNOSTIC CARDIAC CATHETERIZATION

AND PCI . . . . . . . . . . . . . . . . . . . . . . . . . . . .22593.5.3.2. PERIPHERAL VASCULAR PROCEDURES . . . . .22593.5.3.3. STRUCTURAL HEART DISEASE . . . . . . . . . . . .2260

4. Procedural Issues in the CardiacCatheterization Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .2261

4.1. Safety in Patients WithCommunicable Diseases . . . . . . . . . . . . . . . . . . . . . . .2261

4.2. Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . .22614.2.1. Minimum Laboratory Data in Preparation

for the Procedure . . . . . . . . . . . . . . . . . . . . . . . . .22624.2.2. Patients Receiving Antiplatelet and

Antithrombin Agents . . . . . . . . . . . . . . . . . . . . .22624.2.3. Chronic Kidney Disease/Renal

Insufficiency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22634.2.3.1. ATTEMPTS TO REDUCE THE RISK OF

CONTRAST NEPHROPATHY . . . . . . . . . . . . . .22634.2.4. Other Contrast Media Reactions . . . . . . . . .22644.2.5. Diabetes Mellitus . . . . . . . . . . . . . . . . . . . . . . . . .22644.2.6. Sedatives and Relaxants . . . . . . . . . . . . . . . . . . .22654.2.7. Heparin-Induced Antibodies. . . . . . . . . . . . . .22654.2.8. Pregnant Patients . . . . . . . . . . . . . . . . . . . . . . . . .2265

4.3. Access Site (Femoral, Radial, Brachial) . . . . . .22654.4. During the Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . .2265

4.4.1. Medications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22654.4.2. Sterile Techniques . . . . . . . . . . . . . . . . . . . . . . . .22664.4.3. Technical Issues. . . . . . . . . . . . . . . . . . . . . . . . . . .2266

4.4.3.1. CORONARY ANGIOGRAPHY . . . . . . . . . . . . . .22664.4.3.2. VENTRICULOGRAPHY AND VASCULAR

ANGIOGRAPHY . . . . . . . . . . . . . . . . . . . . . . .22674.4.3.3. PRESSURE MEASUREMENT . . . . . . . . . . . . . .2267

4.4.3.3.1. HEMODYNAMICS . . . . . . . . . . . .22674.4.3.3.2. INTRACORONARY

HEMODYNAMICS . . . . . . . . . . . .22684.4.3.4. CARDIAC OUTPUT AND VASCULAR

RESISTANCE MEASUREMENTS . . . . . . . . . . .2268

4.4.3.5. SHUNT MEASUREMENT . . . . . . . . . . . . . . . . .2268

2223JACC Vol. 59, No. 24, 2012 Bashore et al.June 12, 2012:2221–305 Cardiac Catheterization Laboratory Standards

4.4.4. Other Diagnostic and TherapeuticProcedures in the Cardiac CatheterizationLaboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2268

4.4.4.1. PULMONARY VASODILATORS IN THE

EVALUATION OF PULMONARY

HYPERTENSION . . . . . . . . . . . . . . . . . . . . . . .22684.4.4.2. VASODILATOR OR INOTROPIC STRESS TESTING

IN AORTIC STENOSIS . . . . . . . . . . . . . . . . . . .22694.4.4.3. TRANSSEPTAL CATHETERIZATION . . . . . . . . .22694.4.4.4. LV PUNCTURE . . . . . . . . . . . . . . . . . . . . . . . .2270

4.5. Therapeutic Interventions for HemodynamicCompromise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22704.5.1. Improving Cardiac Output. . . . . . . . . . . . . . . .2270

4.5.1.1. INTRA-AORTIC BALLOON PUMP . . . . . . . . . . .22704.5.1.2. OTHER CATHETER DEVICES TO IMPROVE

CARDIAC OUTPUT . . . . . . . . . . . . . . . . . . . . .2270

4.6. Pericardiocentesis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2270

4.7. Coronary Artery Catheter Imaging Devices . .22714.7.1. Intracardiac Ultrasound and Doppler . . . . .2271

5. Postprocedural Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2271

5.1. Vascular Hemostasis . . . . . . . . . . . . . . . . . . . . . . . . . . .22715.1.1. Routine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22715.1.2. Use of Vascular Closure Devices . . . . . . . . . .2271

5.2. Medications Postprocedure . . . . . . . . . . . . . . . . . . .22725.2.1. Pain Control and Sedation. . . . . . . . . . . . . . . .22725.2.2. Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22725.2.3. Vagal Complications and Hypotension . . .2272

6. Personnel Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2272

6.1. Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22726.1.1. Attending Physician . . . . . . . . . . . . . . . . . . . . . .22726.1.2. Teaching Attending Physician . . . . . . . . . . . .22736.1.3. Secondary Operators . . . . . . . . . . . . . . . . . . . . . .22736.1.4. Laboratory Director. . . . . . . . . . . . . . . . . . . . . . .22736.1.5. Operating Physicians. . . . . . . . . . . . . . . . . . . . . .2274

6.1.5.1. CARDIOVASCULAR TRAINEE (FELLOW) . . . . .22746.1.6. Use of Physician Extenders (Physician’s

Assistants and Nurse Practitioners) . . . . . . .22746.1.7. Nursing Personnel . . . . . . . . . . . . . . . . . . . . . . . .22756.1.8. Non-Nursing Personnel. . . . . . . . . . . . . . . . . . .2275

6.2. Staffing Patterns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2276

6.3. Cardiopulmonary Resuscitation . . . . . . . . . . . . . . .2276

7. The Hybrid Cardiac Catheterization Laboratory .2276

7.1. Overview and Patient Selection . . . . . . . . . . . . . .2276

7.2. Special Considerations . . . . . . . . . . . . . . . . . . . . . . . .22777.2.1. Staffing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22777.2.2. Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22777.2.3. Room and Floor Design . . . . . . . . . . . . . . . . . .22787.2.4. Ceiling Lighting and Design . . . . . . . . . . . . .22787.2.5. Anesthesia Requirements . . . . . . . . . . . . . . . . .22787.2.6. HVAC Standards . . . . . . . . . . . . . . . . . . . . . . . . .22787.2.7. Table Requirements. . . . . . . . . . . . . . . . . . . . . . .22787.2.8. Audio Video Inputs and Outputs . . . . . . . . .2278

7.3. Representative Procedures Suitableto the Hybrid Room Environment . . . . . . . . . . . . .2279

8. Ethical Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2279

8.1. Operator Assistant’s Fees, Sharing of Fees,

Fee Splitting, and Fee Fixing . . . . . . . . . . . . . . . . . .2279

8.2. Unnecessary Services . . . . . . . . . . . . . . . . . . . . . . . . . .2279

8.3. Self-Referral, Self-Ownership, andSelf-Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2279

8.4. Informed Consent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2280

8.5. Ethics of “Teaching” . . . . . . . . . . . . . . . . . . . . . . . . . . .2280

8.6. Clinical Research Studies During Diagnosticand Interventional Cardiac Catheterization . . . . . .2280

8.7. Physician and Physician Group–IndustryRelations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2281

8.8. Hospital Employment of Physicians . . . . . . . . . .2281

9. X-Ray Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2281

9.1. Equipment and the “Imaging Chain”. . . . . . . . . .22829.1.1. Image Formation . . . . . . . . . . . . . . . . . . . . . . . . .22829.1.2. Digital Storage and Display. . . . . . . . . . . . . . .22839.1.3. Quantitative Measures . . . . . . . . . . . . . . . . . . . .2283

9.2. Radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22839.2.1. Biological Risks . . . . . . . . . . . . . . . . . . . . . . . . . . .22839.2.2. Measuring Radiation Exposure and

Radiation Dosimetry . . . . . . . . . . . . . . . . . . . . . .22849.2.2.1. PATIENT EXPOSURE . . . . . . . . . . . . . . . . . . .22859.2.2.2. OCCUPATIONAL EXPOSURE . . . . . . . . . . . . . .2285

9.2.3. Minimizing Radiation Exposure . . . . . . . . . .22859.2.4. Quality Management and Measurement

of Radiation Exposure in the CardiacCatheterization Laboratory. . . . . . . . . . . . . . . .2285

10. Special Concerns for the Pediatric CardiacCatheterization Laboratory . . . . . . . . . . . . . . . . . . . . . . . . .2287

10.1. Differences in Goals. . . . . . . . . . . . . . . . . . . . . . . . . . . .2287

10.2. Who Should Perform Catheterizationsin the Pediatric Cardiac CatheterizationLaboratory? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2288

10.3. Quality Assurance Issues in the PediatricCardiac Catheterization Laboratory . . . . . . . . . .2288

10.4. Inpatient Versus Outpatient Setting forProcedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2289

10.5. Operator and Laboratory Volumes . . . . . . . . . . . .2289

10.6. Procedural Performance DifferencesCompared With Adult CardiacCatheterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228910.6.1. Pre-Medication and Baseline Laboratory

Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228910.6.1.1. VASCULAR ACCESS ISSUES . . . . . . . . . . . . . .229010.6.1.2. SEDATION AND ANESTHESIA FOR

PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . .229010.6.2. Single-Plane Versus Biplane

Angiography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .229010.6.3. Hemodynamics . . . . . . . . . . . . . . . . . . . . . . . . . . .229110.6.4. Angiographic Acquisition Differences . . . . .229110.6.5. Radiation Protection and Pregnant

(or Potentially Pregnant) Patients . . . . . . . . .229110.6.6. Shunt Measurements . . . . . . . . . . . . . . . . . . . . .2291

10.7. Laboratory Personnel Issues . . . . . . . . . . . . . . . . . .2291

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2292

Appendix 1. Author Relationships With Industry andOther Entities (Relevant)—2012 ACCF/SCAI ExpertConsensus Document on Cardiac Catheterization

Laboratory Standards Update . . . . . . . . . . . . . . . . . . . . . . . . . . . .2300

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Appendix 2. Reviewer Relationships With Industry andOther Entitities (Relevant)—2012 ACCF/SCAI ExpertConsensus Document on Cardiac CatheterizationLaboratory Standards Update . . . . . . . . . . . . . . . . . . . . . . . . . . . .2301

Appendix 3. Abbreviation List . . . . . . . . . . . . . . . . . . . . . . . . . . .2304

Preamble

This document has been developed as an expert consensusdocument by the American College of Cardiology Founda-tion (ACCF) and the Society for Cardiovascular Angiog-raphy and Interventions (SCAI), in collaboration with theSociety of Thoracic Surgeons (STS) and Society for Vas-cular Medicine (SVM). Expert consensus documents areintended to inform practitioners, payers, and other inter-ested parties of the opinion of ACCF and documentcosponsors concerning evolving areas of clinical practiceand/or technologies that are widely available or new to thepractice community. Topics chosen for coverage by thisECD are so designed because the evidence base, theexperience with technology, and/or clinical practice are notconsidered sufficiently well developed to be evaluated by theformal ACCF/American Heart Association (AHA) Prac-tice Guidelines process. Often the topic is the subject ofconsiderable ongoing investigation. Thus, the reader shouldview the ECD as the best attempt of the ACCF anddocument cosponsors to inform and guide clinical practicein areas where rigorous evidence may not yet be available orevidence to date is not widely applied to clinical practice.When feasible, ECDs include indications or contraindica-tions. Some topics covered by ECDs will be addressedsubsequently by the ACCF/AHA Practice GuidelinesCommittee.

The ACCF Task Force on Clinical Expert ConsensusDocuments (TF CECD) makes every effort to avoid anyactual or potential conflicts of interest that might arise as aresult of an outside relationship or personal interest of amember of the writing panel. Specifically, all members ofthe writing panel are asked to provide disclosure statementsof all such relationships that might be perceived as relevanto the writing effort. This information is documented in aable, reviewed by the parent task force before final writingommittee selections are made, reviewed by the writingommittee in conjunction with each conference call and/oreeting of the group, updated as changes occur throughout

he document development process, and ultimately pub-ished as an appendix to the document. External peereviewers of the document are asked to provide this infor-ation as well. The disclosure tables for writing committeeembers and peer reviewers are listed in Appendices 1 and

, respectively, of this document. Additionally, in the spiritf complete transparency, writing committee members’omprehensive disclosure information—including relationships

ith industry and other entities that do not pertain to this

document—is available online. Disclosure information formembers of the ACCF TF CECD—as the oversight groupfor this document development process—is also availableonline.

The work of the writing committee was supported exclu-sively by the ACCF without commercial support. Writingcommittee members volunteered their time to this effort.Meetings and/or conference calls of the writing committeewere confidential and attended only by committee members.

Executive Summary

The last expert consensus document on cardiac catheteriza-tion laboratory standards was published in 2001 (1). Sincethen, many changes have occurred as the setting has evolvedfrom being primarily diagnostic based into a therapeuticenvironment. Technology has changed both the imagingand reporting systems. The lower risk of invasive procedureshas seen the expansion of cardiac catheterization laborato-ries to sites without onsite cardiovascular surgery backupand even to community hospitals where primary percutane-ous coronary intervention (PCI) is now being performed.This has increased the importance of quality assurance (QA)and quality improvement (QI) initiatives. At the same time,the laboratory has become a multipurpose suite with bothdiagnostic procedures to investigate pulmonary hyperten-sion and coronary flow and with therapeutic procedures thatnow include intervention into the cerebral and peripheralvascular systems as well as in structural heart disease. Thesenew procedures have impacted both the adult and pediatriccatheterization laboratories. The approaches now availableallow for the treatment of even very complex heart diseaseand have led to the development of hybrid cardiac cathe-terization laboratories where a team of physicians (includinginvasive cardiologists, cardiovascular surgeons, noninvasivecardiologists, and anesthesiologists) is required.

The Cardiac CatheterizationLaboratory Environments

Despite a growth in procedural sites and in proceduralcapabilities in the cardiac catheterization laboratory, thetotal number of coronary interventional procedures hassteadily declined over the last few years.

Cardiac Catheterization at a Hospital WithCardiovascular Surgery

Full-service hospitals should provide, not only cardiovascu-lar surgery, but also cardiovascular anesthesia and consultingservices in vascular, nephrology, neurology, and hematology.Advanced imaging and mechanical support services shouldalso be available. Not every hospital with onsite cardiovas-cular surgery should be offering all services unless theexpertise is available to evaluate, treat, and handle anypotential complications that occur. Patients requiring highly

specialized procedures or pediatric procedures should have

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studies only in facilities with the medical expertise andequipment to perform these procedures at the highest level.

Cardiac Catheterization at a Facility WithoutCardiovascular Surgery

Despite prior guidelines that suggest limitations to theexpansion of cardiac catheterization without onsite surgicalbackup, the number of these sites has increased dramaticallyover the last decade. The Certificate of Need (CON)regulatory programs have had little impact on this expan-sion. Whether quality and outcomes are similar to hospitalswith onsite cardiovascular surgery remains uncertain. Theactual number of laboratories without surgical backup isdifficult to confirm, but most estimates suggest it is around25% to 35% of all laboratories in the United States. Becauseof fixed costs to maintain these facilities, costs and chargesper patient at these sites may actually be higher than infacilities with onsite surgery.

The remarkably low risk now associated with diagnosticcardiac catheterization suggests that only a few cardiovascularpatients cannot safely undergo procedures in these labora-tories. The 2001 ACC/SCAI consensus document suggestslimiting diagnostic procedures in laboratories without car-diovascular surgical backup to the very lowest-risk patients;the current document lifts almost all these restrictions.Limitations related to age, congestive heart failure (CHF)status, the severity in stress test abnormalities, left ventric-ular (LV) function, and the presence of valve disease have allbeen removed. It is still recommended that patients withpulmonary edema due to ischemia, patients with complexcongenital heart disease, and pediatric patients still betreated only in full-service facilities.

Certain therapeutic procedures should still be done only inacilities with cardiovascular surgical backup. These includeherapeutic procedures in adult congenital heart disease andediatrics. It is generally believed that elective and primaryCI are permissible in sites without cardiovascular surgery,

f there is strict adherence to national guidelines. In partic-lar, there must be a documented working relationship withlarger facility with cardiovascular surgical services and an

mergency transportation system operative. The documentutlines the current guidelines where this is acceptable. Theommittee also believes that it is the responsibility of anyacility performing coronary intervention without cardiovas-ular surgical backup to document that all national risktratification and medication guidelines are being followed.n addition, a QA/QI system must be operative and active,nd, if an ST-elevation myocardial infarction (STEMI)rogram is in place, the laboratory should be operational 24ours a day, 7 days a week. Any national volume guidelinesust also be strictly followed.

Quality Assurance Issues in theCardiac Catheterization Laboratory

The modern cardiac catheterization laboratory is a complex,

highly sophisticated medical and radiological facility where

patients with both chronic-stable and life-threatening ill-nesses are evaluated. With the expansion of laboratories andthe increase in the complexity of procedures, it is essential tohave an active QA/QI system in place regardless of thelaboratory setting. The committee strongly encourages alllaboratories to participate in national registries, such as theACC’s National Cardiovascular Data Registry (NCDR), toensure data are systematically collected and available in apredefined format to allow for future analyses. In thismanner, all laboratories can benchmark their performanceand make appropriate corrections.

Patient Outcomes

The rate of normal or insignificant coronary artery diseaseangiographically found at cardiac catheterization in any 1laboratory obviously varies depending on the types ofpatients studied, but the range is high, varying anywherefrom 20% to 39%.

Complications related to the catheterization procedureare very low and should be �1% for diagnostic proceduresand �2% for elective PCI. The risk is obviously higher inthe setting of an acute myocardial infarction (AMI), buteven in that situation, the overall mortality should be �4%.Complication rates �5% must be considered excessive anda cause for concern and programmatic review.

At least 60% of PCI procedures are done ad hoc follow-ing lesion discovery on a diagnostic angiogram. Althoughthere is no evidence this practice has an adverse effect onoutcomes, ad hoc procedures should be discouraged whenthe patient would benefit from a multidisciplinary discus-sion regarding options for therapy or when an interventionalprocedure at a later time would reduce the risk of contrastnephropathy. In the acute STEMI setting, when multivesseldisease is evident, only the culprit lesion should undergoemergency intervention.

Data relating to outcomes in peripheral vascular andcerebrovascular intervention are incomplete. The technol-ogy continues to evolve as do the indications. Laboratorieshistorically dedicated to coronary disease have had totransform themselves technically, logistically, and adminis-tratively to provide optimal care for this population. Largeimage detectors are often required and are not optimal forcoronary angiography. This area is further complicated bythe fact that noncardiologists (i.e., vascular surgeons andinterventional radiologists) may also be participating, soguidelines, as well as credentialing issues, may vary amongthe groups. Because no clear benchmarks yet exist, partici-pation in an ongoing national database for these proceduresis particularly important.

Peer Review Continuous QA/QI Programs

Most major QA problems are unrelated to equipment butare due to operational factors. These tend to includeinadequate laboratory space, lack of a physician director oradvocate, lack of specific operating rules, and a poor

feedback mechanism. More than ever, a continuous QA/QI

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program must be considered an essential component of thecardiac catheterization laboratory. It should be dedicated tothe lab but not be independent of the other hospitalprograms. It must be adequately staffed and appropriatelyfunded. The basic components must include a committeewith a chair and staff coordinator, a database, and a meansof data collection. There should be goals to eliminateoutliers, reduce variation, and enhance performance. Feed-back mechanisms should be clearly in place. The committeeshould also be committed to educational opportunities forthe staff and incorporating practice standards and guidelinesinto the laboratory operation. Some composite “scorecard”methods should be included that address cognitive knowl-edge, procedural skill, clinical judgment, and proceduraloutcomes. These data need to be collected in a systematicmanner and analyzed appropriately. Often a simple com-parison of outcomes among physicians in the laboratory iseffective in modifying behavior.

To help facilitate organization of a QA/QI process, thecurrent document outlines the major organizational indica-tors, provides a representative case review form, and outlinesthe minimum components that should be included in astandard cardiac catheterization form.

Quality indicators should include structural, patient care,system-specific, guideline-driven, and cost-related items.Structural indicators include factors such as training, con-tinuing medical education (CME), procedural volume,awards, presentations, publications, and credentialing. Pa-tient care indicators include issues such as quality of proce-dures, report generation, timeliness, and appropriateness.System-specific indicators incorporate items such as labturnover, preprocedural processes, emergency responsetime, and staff performance. Guideline-driven indicatorsshould focus on infection control, radiation safety, medica-tion and contrast use, procedural indications, and newdevice usage. Cost-related issues include such things aslength of stay, disposables, types and adequacy of supplies,staffing, and use of off-label devices.

In addition to the above, there should be definedoutcomes-related indicators collected. These include indi-vidual physician complications, service outcomes (e.g., ac-cess, door-to-intervention times, and satisfaction surveys),and financial outcomes.

To do this properly requires a serious commitment fromthe facility administration to ensure that a robust QA/QIprogram is in place and the program committee is active andaggressive regarding its responsibilities.

Minimum Caseload Volumes

Using minimum case volumes as a surrogate for qualitypresumes that a high procedural volume equates to a highskill level and that low-volume operators are less skilled. Infact, there is limited statistical power to make judgments inthe low-volume instance, and the relationship betweenprocedural volume and outcome remains controversial. This

applies to the laboratory facility as well as the physician t

operator. The particular issue of minimum case volumes iscurrently being addressed by a forthcoming update to the“ACCF/AHA/SCAI Clinical Competence Statement onCardiac Interventional Procedures.” This document simplyoutlines the currently available data; the final recommenda-tion awaits the decisions of the competence statementwriting committee.

Establishing an appropriate oversight QA/QI process ismore important than focusing on minimum volumes. Allmajor complications should be reviewed by the QA com-mittee at least every 6 months, and any individual operatorwith complication rates above benchmarks for 2 consecutive6-month intervals should have the issue directly addressedby the QA director and followed up with written conse-quences. Ideally, some subset of all operators should berandomly reviewed at least annually. All operators should berequired to attend regularly cardiac catheterization confer-ences and obtain a minimum of 12 CME hours per year.Stimulation training may assist in improving skills.

The very low complication rate for diagnostic catheter-ization makes suggestions for a minimum volume thresholdparticularly difficult. The prior catheterization standardsdocument suggested 150 cases per year as a minimum, butthat committee acknowledged this was arbitrary and had nodata to support the recommendation (1). This committeefeels that there is no clear minimum volume for diagnosticcatheterization that can be supported and prefers to emphasize theQA process to ensure the procedures are of the highest quality.

The annual minimum operator interventional proceduralvolume of 75 cases per year has become an acceptedstandard. Numerous publications and editorials have ad-dressed this issue in detail. Although some relationshipsbetween operator and/or institutional volumes and out-comes have been described in certain reports, many publi-cations have struggled to confirm these data. Obviously therelationship between volume and outcomes is complex, andmany confounding issues are evident. Low-volume opera-tors in high-volume laboratories tend to fare better. Com-plicating the issue further, however, is the fact that manycompetent interventional cardiologists do not perform �75rocedures each year. Some cardiologists perform PCI primar-ly when on-call, and some are at the beginning or the end ofareers and are either ramping up or winding down a practice.ome perform procedures at multiple facilities, and the data foruch individuals are often incomplete.

The data for primary PCI are particularly difficult toategorize because of the low volumes being performed.his committee believes that it is appropriate for all primaryCIs to be evaluated by the institutional QA committee,

egardless of operator volume. Operators wishing to participate inrimary PCI should be required to attend these review sessions.

The guidelines for the performance of both electivend primary PCI in a facility without cardiovascularurgical backup are also evolving. Recent prospectivetudies and meta-analyses of available data both suggest

hese procedures can be done safely under restrictions.

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The minimum volume issue in this setting will be anotherfocus of the ACCF/AHA/SCAI Writing Committee toUpdate the 2007 Clinical Competence Statement onCardiac Interventional Procedures. Because these pa-tients are at highest risk for complications, nationalguidelines for the proper PCI, particularly in the settingof an AMI, must be strictly followed. The facility musthave a robust QA program, clear and documented sys-tems for the urgent transfer of patients to a facility withcardiovascular surgical support, documentation that allmedication and indication guidelines are being observed,and 24/7 availability.

Training in Interventional Procedures

The use of minimum volumes and rotation duration fortraining in interventional cardiology procedures has beenestablished by the ACCF Core Cardiology Training Sym-posium (COCATS). These are still the established require-ments for Level 1, Level 2, and Level 3 training. These aresummarized in this report, but the committee recognizesthat even here, there is a gradual shift away from minimumnumbers and toward a competence standard. The formaltraining to achieve credentials in peripheral vascular inter-vention is highlighted for cardiology fellows, and comparedwith that of interventional radiologists and vascular sur-geons; little difference actually exists.

Training in structural heart disease intervention is clearlyan area where volume numbers should not supplant evi-dence for competence by a QA review of outcomes. Bydefinition, most of these procedures require a multidisci-plinary approach and should not be attempted by casualoperators. It is recommended that both the training andpractice activity associated with structural heart disease inter-vention be concentrated among a limited number of laborato-ries and operators with a particular interest in these procedures.Often a close working relationship between adult and pediatricoperators provides the optimal environment.

Procedural Issues in the CardiacCatheterization Laboratory

Patient Preparation

A number of procedural issues are addressed. Heightenedawareness of protective care from communicable diseases,such as human immunodeficiency virus (HIV) or hepatitis,is important. Each laboratory should have a written protocolfor increased sterile technique for highly infectious cases.The protocol should include caps, masks, double gloving,and protective eyewear. Disposal methods and disinfectanttechniques are also important.

Patient preparation should include a checklist of items tobe reviewed when the patient first arrives at the laboratory.Appropriate consent should include risks, benefits, alterna-tive therapies, and the potential need for ad hoc procedures.All PCI consent forms should outline the potential for

emergency surgery. A “time-out” should be a required part r

of each procedure and should include the name, the proce-dure, the signed consent, allergies, antibiotic administration,the correct site, confirmation of the pre-wash, the need for anyspecial equipment or imaging, and any pertinent clinical factors(including labs such as the creatinine level). If the radial arteryis to be used, the Allen test results should be noted.

The committee reviewed the minimum laboratory data inpreparation for cardiac catheterization and found a widevariability in practice patterns. The following recommenda-tions were made: 1) routine laboratory data should includethe hemoglobin, platelet count, electrolytes, and creatinineobtained within 2 to 4 weeks of the procedure. These shouldbe repeated if there has been a clinical or medication changewithin that period or recent contrast exposure; 2) unlessthere is known liver disease, a hematologic condition ofconcern, or the ongoing use of warfarin, a protime is notdeemed necessary prior to the procedure; 3) for overnighttests, a nothing by mouth (NPO) order is not always in thebest interest of the patient; fasting should be no more than2 hours after clear liquids or 6 hours after a light meal.Hydration should be considered an important componentprior to contrast administration; and 4) women of child-bearing age should have a urine or serum beta-HCG testwithin 2 weeks of the procedure. There is little fetal riskduring the first 2 weeks of gestation. In addition, thecommittee could find no data to suggest a concern regardingnitinol device use in patients with nickel allergies.

For patients on warfarin, the drug is usually stopped 3days prior to the procedure. An acceptable internationalnormalized ratio (INR) of �1.8 for femoral or �2.2 forradial cases is suggested. Vitamin K reversal is discouraged.Patients on aspirin, unfractionated heparin, low-molecular-weight heparin, or glycoprotein IIb/IIIa inhibitors need nothave the drugs stopped before catheterization. Dabigatranshould be stopped 24 hours prior if the estimated glomerularfiltration rate (eGFR) is �50 mL/min and 48 hours beforeif the eGFR is between 30 mL/min to 50 mL/min.

For patients with chronic kidney disease (CKD), there isa risk of contrast nephropathy following the procedure. Thehighest-risk patients are those with eGFR �60 mL/minand diabetes mellitus. It is recommended that patients withCKD have nephrotoxic drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs), held on the day of theprocedure and that adequate hydration with either intrave-nous (IV) saline or sodium bicarbonate at 1.0 mL/kg/min to1.5 mL/kg/min for 3 to 12 hours prior and 6 to 12 hourspostprocedure should be completed as well. Contrast mediashould be minimized, and either low-osmolar or iso-osmolar contrast should be used. A contrast volume/creatinine clearance ratio of �3.7 has been suggested as aceiling for contrast use to reduce nephrotoxicity risk. Afollow-up creatinine level should be obtained in 48 hours.

cetylcysteine is no longer recommended.Patients with a strong atopic history or prior contrast

llergy should be considered for pre-medication with ste-

oids and/or H1 and H2 blockers. Shellfish allergies are not


considered important for contrast reactions. Diabetic pa-tients usually have the insulin dose reduced by half the nightprior and then held the morning of the procedure. Diabeticpatients should have procedures early in the schedule, ifpossible, to avoid hypoglycemia. Metformin should be heldregardless of the creatinine clearance and not restarted untilthere is postprocedural documentation that the creatininehas returned to baseline. An awareness of the treatment ofanaphylactoid reactions to contrast is important. Delayedhypersensitivity rashes should not be confused with reac-tions to new drugs initiated after the procedure.

Procedural Issues

Radial artery use for access has increased over the last fewyears. Though the procedure may take slightly longer andradiation exposure is slightly higher, the radial access sitehas less vascular complications than the femoral approach.In addition, it allows for earlier ambulation and is particu-larly efficacious in the obese. Medications during the procedureand sterile techniques have not changed over the last decade.

Technical and Hemodynamic Issues

Except for the equipment advances, the actual performanceof coronary angiography has changed little over the lastdecade. Facilities with biplane capabilities are less commonnow. Biplane coronary angiography may reduce total con-trast load in patient with CKD and is important instructural heart intervention. Hemodynamics are lessstressed in most laboratories despite accurate hemodynamicmeasurements being critical in certain disease states (such asconstrictive pericarditis). Intracoronary hemodynamics havemost recently focused on the use of the pressure wire. Thecardiac catheterization procedure can provide informationregarding ventricular performance, cardiac output, vascularresistance, and shunt magnitude. The hemodynamics beforeand after pulmonary vasodilators are also critical to thedecision algorithm on therapy for patients with pulmonaryhypertension. Vasodilator or inotropic stress testing inpatients with low-gradient, low-valve area aortic stenosis,likewise, provides vital information on the best therapeuticoption in these patients. Transseptal catheterization has hadresurgence with the success of such procedures as balloonmitral valvuloplasty and atrial fibrillation ablation. Entryinto the left atrium (LA) provides percutaneous therapeuticoptions for pulmonary vein stenosis and, for some cases,with mitral regurgitation. Myocardial biopsies are useful inrestrictive heart disease and in heart transplant patients.Within the hybrid laboratory environment, LV punctureallows for percutaneous aortic valve replacement via anapical approach. Intracardiac ultrasound and Doppler imagingmethods have proven their value in a number of situations,including atrial septal visualization during percutaneous patentforamen ovale (PFO) or atrial septal defect (ASD) closure,left-sided electrophysiological ablation studies, mitral valvulo-

plasty, and LA appendage occluder deployment.

In addition, there are now therapeutic options to aug-ment cardiac output using placement of an intra-aorticballoon pump or the use of catheters, either connected to arotary pump or that have a rotary micropump within thecatheter itself. The percutaneous application of extracorpo-real membrane oxygenation (ECMO) can now be per-formed in the cardiac catheterization laboratory as well.

The known vagaries of contrast angiography in definingvascular lesion severity and composition has led to thedevelopment of a range of intravascular imaging devices,including intravascular ultrasound (IVUS) and other devicesthat provide plaque imaging with virtual histology and tissueingrowth assessment using optical coherence technology.Although many are still investigational, they all carry someinherent risk of vessel injury that should be appreciated.

Postprocedural Issues

Vascular Hemostasis

In cases of femoral access where no vascular closure deviceis being used, if heparin has been used during the procedure,the activated clotting time (ACT) should return to nearnormal (�180 s) before sheaths are removed and manualcompression applied. Common practice is to confine thepatient to bed after sheath removal. Bed rest for 1 to 2 hoursafter either 4- or 5-F sheaths and 2 to 4 hours after 6- to8-F sheaths is suggested. The radial approach obviatesprolonged bed rest. All patients should have the access siteauscultated prior to discharge. Should a pseudoaneurysmoccur, most can be closed with compression and percutane-ous thrombin.

A bleeding risk score for PCI has been developed fromthe NCDR database. It provides an opportunity to identifythose at highest risk for a vascular complication.

The use of vascular occlusion devices has grown rapidlydespite evidence their application does not reduce overallvascular complications. An AHA Scientific Statement re-garding these devices recommends a femoral arteriogramwith identification of sheath site and vascular features bedone before their use. The use of any vascular device isconsidered a Class IIa (Level of Evidence: B) indication.

Medication Use

Little has changed in the use of sedative and pain controlmedications after the procedure. Hypertension should beaggressively managed with agents such as labetalol, hydral-azine, metoprolol, or nicardipine. Vagal reactions can bequite serious, and pre-medication with narcotics prior tosheath removal may help reduce their occurrence. Hypoten-sion after cardiac catheterization is potentially multifactorialand includes diuresis, ischemia, retroperitoneal bleeding, aswell as vagal reactions. If a retroperitoneal bleed is sus-pected, the most effective rapid response is to return to thelaboratory for contralateral access and identification of the

bleeding site.


Personnel Issues

Little has changed over the last decade in regard topersonnel issues. A cardiac catheterization procedure re-quires a critical mass of interdisciplinary personnel to allowsafe and optimal performance of the procedure. Technicalstaff should be certified. The staff should be providedopportunities for ongoing continuing education.

Defined physician personnel in the cardiac catheteriza-tion include the attending or operating physician (theindividual in charge), the teaching attending physician (oftensupervising cardiology fellows), and secondary operators.

A laboratory director is a prerequisite for all laboratoriesand should be an experienced (generally �5 years) interven-tionalist, board-certified, and familiar, if not proficient, withthe various procedures and technical equipment being usedin the laboratory. In small or new laboratories, a physiciandirector may be just starting his practice. If the director doesnot have �500 PCI procedures performed, his or her casesshould be randomly reviewed by the QA process until thatminimum number is achieved and competence established.The laboratory director may or may not be the interven-tional fellowship director. However, he or she should workclosely with the fellowship training program. The director isresponsible for monitoring physician and staff behavior andensuring their competence. The director should be the labo-ratory’s advocate for adequate resources. He or she shouldcollaborate with hospital personnel to ensure safety and com-pliance with all regulations and possess strong management skillsas well.

Cardiovascular trainees may perform all aspects of theprocedure as their skill level matures, but they cannot beprimary operators and must function under the directsupervision of the attending physician. Physician extenders(nurse practitioners and physician assistants) are primarilyused for the pre- and postprocedural evaluations and follow-up, but in monitored situations, they can directly assist theprimary operator in the actual procedure.

The number and type of nursing personnel varies widely,but a supervising nurse’s role is to manage nonphysiciannursing and technical personnel to ensure patient care isoptimal and that the staff is properly trained and respected.The committee notes there is currently no formal certifica-tion for this position (despite its complexity) and endorses amovement toward such a certification option on a nationallevel.

With the movement away from cine film to digitalstorage and archival systems, it is important to have accessto computer technical support. Because of the increasedimportance of patient and staff radiation safety, laboratoriesshould have routine access to qualified medical and healthphysicists. Support is needed beyond meeting the minimumregulatory safety regulations.

All members of the cardiac catheterization team must

have Basic Life Support certification in cardiopulmonary

resuscitation (CPR) techniques, and the committee stronglyurges certification in advanced cardiac life support as well.

The Hybrid Cardiac Catheterization Laboratory

The hybrid cardiac catheterization laboratory/operatingroom is an integrated procedural suite that combines thetools and equipment available in a cardiac catheterizationlaboratory with anesthesia and surgical facilities and pos-sesses the sterility of an operating room. It must meet all ofthe standard features of both an operating room and acardiac catheterization facility. Procedures suited for ahybrid room include those that require surgical access (i.e.,percutaneous valve replacement, thoracic or abdominalstented grafts, and large-bore percutaneous ventricular assistdevices), those where conversion to an open surgical proce-dure may be required (i.e., bailout or apical approach topercutaneous aortic valve replacement, vascular plug deploy-ment in paravalvular prosthetic valve regurgitation, andpercutaneous ventricular septal defect closure), hybrid treat-ments (i.e., combined PCI or other vascular stenting withsurgical approaches and epicardial atrial fibrillation abla-tion), electrophysiology (EP) device implantation or re-moval, and certain emergency procedures such as ECMOinsertion or emergent thoracotomy.

The staff must be comfortable with both the surgical suiteand the cardiac catheterization laboratory environment.This is generally done by using a specific team to allow forthe necessary training. As the room is neither a standardoperating room nor catheterization laboratory, physiciantraining on its use is also a requirement.

The laboratory location can be either in proximity to theoperating rooms or to the catheterization suite. It must belocated on a clean core or semirestricted corridor wherescrubs, hats, and masks are required. Scrub alcoves are anecessity along with a separate control room with widewindows. These rooms are larger than the standard cardiaccatheterization laboratory room, though radiation shieldingand video equipment are similar. A wide range of lighting isrequired (dim for viewing images and bright for surgicalprocedures). The mounting of the x-ray gantry is importantso as not to interfere with laminar airflow or the anesthe-siologist. The table also differs from the routine laboratoryas surgeons need a fully motorized table and tabletop, yet itmust be compatible with the production of high-qualityx-ray images.

In short, the hybrid laboratory requires considerableplanning and a firm understanding of how the room is to beused before its construction. Its dual function provides anopportunity to expand the procedures in the catheterizationlaboratory. Its stringent requirements demand a cooperativeworking relationship with a variety of disciplines to be a safeand successful endeavor.

Ethical Concerns

A detailed discussion of ethical issues is beyond the scope of

this document. The physician’s primary obligation is always

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to the patient and to no one else regardless of financial,regulatory, or social pressures otherwise. Physician respon-sibilities have increased dramatically with mandates frompayers and the government for an ever-increasing amount ofdocumentation. Much of this is time-consuming and createsunnecessary redundancy with little direct impact on theprimary obligation. The changing healthcare reimburse-ment landscape has driven many physicians to align withlarger health systems where there may be a further increasein the pressure for increased productivity in the face ofdeclining reimbursement. With the decline in the fee-for-service system and the approaching shift toward reimburse-ment bundling, the physician must never leverage patientinterests to produce a better profit margin.

A few of the major ethical concerns are addressed in thissection. They include the inappropriateness of the sharingof fees, fee splitting, and fee fixing. Unnecessary proceduresperformed, especially those justified as malpractice protec-tion, are improper and not in the patient’s interest. Guide-lines for appropriate use in many areas are now emerging toaddress this. Physician self-referral concerns led to theintroduction of the Stark laws in 1989, and these regulationsare designed to limit procedures being done to simplyaugment profit. Informed consent continues to get moreand more complex, but a clear and understandable descrip-tion of the procedure, the alternatives, the benefits, and therisks is simply a mainstay of good patient care. Teachinghospitals have a particular obligation to inform the patientof the skill level of all personnel involved. Cardiology hasbeen the leader in developing evidence-based medicine, andclinical research involving patients requires strict adherenceto safety guidelines and the protocol being employed. Theopportunity for monetary rewards or self-promotion shouldnever override patient safety and respect. Physicians andindustry must work together to advance medical knowledgeand avoid bias. Physicians should not accept industry gifts.Conflict of interest committees are designed to oversee anypotential conflict and are in place to protect both thephysician and the institution.

X-Ray Imaging and Radiation Safety

Substantial changes in the x-ray equipment have occurredover the last decade. The movement from cine film to adigital medium has been completed, and the transition fromthe standard image intensifier to the flat-panel imagedetector is in progress. Flat-panel detectors enhance imageuniformity and brightness and have a much greater dynamicrange compared to the standard image intensifier. Radiol-ogists routinely receive formal training in understandinghow x-ray images are created, but this learning process ismuch more informal in cardiology. This section provides anoverview of how x-ray images are made and discusses therole of each of the pieces of equipment. The major changesover the last decade include changes in the generator, x-raytube, image detector, image processing, and image display.

The dose-area product (DAP) is a measure of the total i

radiation exposure and is derived from an ionizing chamberon the output of the x-ray tube. It does not address theamount of radiation to specific organs. The use of theinterventional reference point (IRP) is recommended toestimate the amount of skin dose the patient receives.

The biological risk from x-rays is due to disruption tothe cellular DNA backbone either by direct or indirect(free-radical) injury. A deterministic injury results inenough individual cellular death to create organ dysfunc-tion. These types of injury are dose-dependent (such asskin burns). A stochastic injury to the DNA results inmutations or cancers, and a single x-ray can be at fault.Although the likelihood of this happening increases withthe dose, it is not dose dependent. The effective doseencompasses the stochastic risk and is used to provide ametric of radiation safety. It is the weighted sum of theestimates of dose to each individual organ. The breast,bone marrow, and lungs are among the most sensitiveorgans in this model. The effective dose correlates withthe DAP.

The IRP dose at the isocenter of the gantry (usually themidportion of the patient) is derived by estimating the dosein the midportion of the patient and then dropping back 15cm (assuming that is where the skin on the patient’s back islocated). It provides an estimate of the deterministic injurydose.

Recommended guidelines for patient and operator doselimits to reduce deterministic and stochastic injury areprovided in the document and reflect current NationalCouncil on Radiation Protection and Measurements(NCRP) reports. The NCRP now accepts as a minimumthe wearing of a single monitoring device on the thyroidcollar; however, the recommended 2-monitor techniqueprovides the best estimate of risk. A pregnant worker mustalso wear a monitor at waist level under the lead apron.Maximum allowable radiation for medical workers is 50millisieverts (mSv) per year whole body and a lifetimecumulative dose of 10 mSv � age.

An understanding of x-ray image formation and basicradiation safety principles allows for the understanding ofmeans to limit exposure to both the patient and operator.Exposure to the patient can be reduced by minimizing theframing rate, reducing imaging time, use of retrospectivelystored fluoroscopy instead of acquisition, use of pulsefluoroscopy, and limiting use of “high-dose” fluoroscopy,avoiding magnification when possible, using collimationand other filters at the output of the x-ray tube, keeping theimage detector close to the patient, and avoiding angulationthat increases the source-to-image distance. For the opera-tor, the same rules apply. Plus it is important to remembertime, distance, and barriers. The impact of x-rays decreasesin proportion to the inverse-square law (1/d2). Lead shield-ng is effective if use properly.

All cardiac catheterization laboratories manufactured since005 are required to provide real-time exposure information,

ncluding reference point air kerma. Most fluoroscopes also


provide DAP readings. A summary of these data should beincorporated in the patient record and part of the QA/QIprocess.

Special Concerns for the PediatricCatheterization Laboratory

There are 120 specialized children’s hospitals in the UnitedStates, and all have cardiac catheterization facilities. Allfacilities that perform cardiac catheterization on pediatric-aged patients must have the full complement of resourcesavailable, including cardiovascular surgery. Pediatric labora-tories may be dedicated facilities or shared with an adultprogram.

Differences in Goals Between the Pediatric Laboratoryand the Adult Laboratory

Diagnostic catheterizations in children are essentially alwaysfocused on structural heart abnormalities. Hemodynamicmeasures plus chamber and vessel angiography are muchmore commonly done than in adult laboratories. Becauseof the variability in patient size, most data are indexed tobody surface area. Often the procedure requires signifi-cant sedation or general anesthesia. Due to improvementsin noninvasive imaging, three fourths of all pediatriccatheterizations are therapeutic and not simply diagnos-tic. A substantial number of unique procedures areperformed in congenital heart disease (such as atrialseptostomy) and are not applicable to adults. Therapeuticprocedures that might also be performed in certain adultcongenital patients include PFO and ASD closure, val-vuloplasty, angioplasty, stent implantation in pulmonaryand arterial vessels, vascular closure (patent ductus arte-riosus, fistulae, anomalous vessels), devise closure of aventricular septal defect, transcatheter pulmonary or aor-tic valve replacement, foreign body retrieval, pericardio-centesis, endomyocardial biopsy, and a range of electro-physiological procedures. Hybrid procedures are becomingmore important where novel access may be provided (i.e.,palliation of the hypoplastic left heart patient with accessprovided directly through the anterior right ventricle).

Who Should Perform Pediatric Catheterizations?

All pediatric catheterizations should have a director respon-sible for all aspects of the laboratory operation, similar to theadult laboratory. Attending physicians should be board-certified in pediatrics and at least board eligible in pediatriccardiology. There may be exceptional cases where a com-petent operator can be granted privileges, but this shouldnot be common practice.

The pediatric age range is from 0 to 18 years. It isrecommended that catheterizations in patients within thisage range be done by a pediatric cardiologist. Adult con-genital heart disease patients may have procedures per-formed by a pediatric cardiologist or with an adult and

pediatric cardiologist together. The only exception is the

adult cardiologist with a special interest and expertise inadult congenital heart disease.

Quality Assurance Issues in the Pediatric CardiacCatheterization Laboratory

Complication rates differ substantially from the adult labo-ratory and are much higher due to the serious nature formany of the disease processes and the critical hemodynamicstate at the times encountered. In 1 registry, adverse eventsin the pediatric laboratory were found to be 16% overall,with 10% related to diagnostic catheterization and 19%related to interventional procedures. Death occurred in0.9%. The latest addition of pediatric data to the ACC-NCDR via the IMPACT (Improving Pediatric and AdultCongenital Treatment) registry should provide ongoingmonitoring of these procedures. By necessity, informedconsent is usually provided by the patient’s parents. Similarconcerns regarding informed consent in the adult laboratorystill apply.

Inpatient Versus Outpatient Settings for Procedures

For most children, an overnight stay following the proce-dure is medically prudent. This is especially the case withyoung children where it is difficult for them to remain stillafter the procedure. Any blood loss may be significant insmall children. Often families have traveled long distances,and local medical attention to a problem may not exist.Despite the small size, the sheaths used during pediatriccatheterizations are similar to those in adults (5-F to 8-F).Each laboratory should establish a written policy on whomight be expected to be discharged immediately followingthe procedure.

Operator and Laboratory Volumes

Similar to the discussion regarding adult laboratories, theheterogeneity of the patient population and the low volumeof procedures make specific minimum volumes problematic.The American Academy of Pediatrics Guidelines suggeststhe use of specific outcome benchmarks rather than mini-mum operator or laboratory volumes as a guide to compe-tence. The committee consensus, however, suggests a min-imum operator volume of 50 per year and a minimumlaboratory volume of �100 per year seems reasonable.

Having a robust QA/QI program in pediatric laboratoriesis of great importance. There should essentially be no“normal” cardiac catheterization procedures. The same rulesoutlined for an adult QA/QI program apply to the pediatriclaboratory otherwise.

Procedural Differences Compared With theAdult Cardiac Catheterization Laboratory

The need for specific baseline laboratory data greatly differsin the pediatric catheterization laboratory. Many patients donot have noncardiac disease and are not on any medications.There is no standard laboratory data required before the

procedure, and no standard pre-medication regiment. Se-


dation is almost always required to perform the procedure.Vascular access is also individualized depending on whetherthe patient is a neonate, young or older child, or is of adultsize. Most procedures are performed via the femoral arteryand vein. Transseptal procedures are common. Newbornprocedures are performed generally via the umbilical vein.Venous access can also be accomplished via the internaljugular, subclavian, basilica, and transhepatic approaches. Invery young children, balloon aortic valvuloplasty or stentingopen the patent ducts may require a carotid artery cut-down.Heparin is variably used during the procedure, whereasvascular occluders are not used in children. As more invasivepercutaneous methods are being developed, the potential forcatastrophic events increases. There should be access toECMO in addition to routine resuscitation equipment.

Biplane x-ray capabilities should be standard, thoughcertain procedures can be done with single-plane systemssatisfactorily.

Hemodynamics and Angiography

Right and left heart hemodynamics and angiography areroutine procedures and require high-resolution equipmentto ensure the diagnosis. The framing rates depend on thepatient’s heart rate and 30 frames per second (fps) is oftenrequired to capture all the necessary information. Due to thehigh heart rates, contrast must be injected at a higher rate(i.e., over 1 to 2 s).

Laboratory Personnel

There is essentially no difference in the types of personnelneeded to run an efficient pediatric catheterization labora-tory dedicated to the highest standards compared with anadult laboratory.

Radiation Protection and Pregnant Patients

The same principles apply in this age group as with adults.Children are more susceptible than adults to the stochasticeffects from ionizing radiation (they live longer and thatincreases the risk of a cancer developing). A urine or serumbeta-HCG level should be obtained within 2 weeks of theprocedure in menstruating women. If a pregnant patientmust be studied, all of the previously described means toreduce radiation exposure should be followed, and theabdominal and groin area should be shielded from directx-ray exposure. Scattered radiation still occurs, however.

Summary

The cardiac catheterization laboratory has undergone majorchanges in the last decade. It is a much more sophisticatedenvironment where a gradual shift in emphasis from adiagnostic laboratory to a therapeutic environment is occur-ring. As the risk of both diagnostic and interventionalprocedures has declined, there has been liberalization in thetypes of patients who may safely have procedures performedin both outpatient settings and in laboratories without

cardiovascular surgical backup. The influence of peripheral

vascular and structural heart intervention has also required achange in focus for many laboratories and has given rise tothe hybrid cardiac catheterization facility. The advances inpercutaneous therapies for structural heart disease are justnow beginning to impact both the adult and pediatriccatheterization laboratory.

Some of the routine practices in many laboratories arebeing questioned. For instance, the committee no longersuggests a protime be obtained before a procedure, unless anabnormality is anticipated. Overnight NPO orders shouldbe replaced with shorter-term fasting as hydration is impor-tant. Acetylcysteine is no longer recommended to reducecontrast nephropathy.

QA is a focus of this report, and its importance ismounting as it becomes harder to justify minimum volumerequirements for both the operator and the laboratory. Theimportance of national databases to provide benchmarks isemphasized.

Radiation safety has also entered into the discussion moreprominently as patients and regulators have expressed con-cern regarding the amount of medical radiation the publicreceives. Measures of the amount of radiation exposureshould be a routine part of the cardiac catheterizationreport.

The cardiac catheterization laboratory and its functionswill continue to evolve and grow over the next decade asnewer devices and treatment options emerge. The cardiaccatheterization laboratory of today differs significantly fromthat of a decade ago. It is anticipated that the cardiaccatheterization laboratory 10 years from now will undergo asimilar evolution.

1. Introduction

The last expert consensus document on cardiac catheteriza-tion laboratory standards from the ACCF and SCAI waspublished in 2001 (1). Although the fundamentals ofinvasive cardiovascular procedures remain unchanged, manychanges have occurred related to the catheterization labo-ratory and its operational environment. Modifications andevolution have occurred with the imaging equipment tech-nology, the range of diagnostic modalities, the spectrum ofpharmacological therapies and mechanical interventions,and the local delivery of cardiovascular health care. Com-munity hospitals without surgical backup have begun per-forming diagnostic catheterizations on higher-risk patientsas well as elective interventional procedures on lower-riskpatients, and community programs have been developedthat permit onsite primary angioplasty on patients withAMI. At the same time, the cardiac catheterization labora-tory has become a multipurpose interventional suite undertak-ing many therapeutic procedures for the coronary, cerebral, andperipheral vessels, providing corrective intervention for con-genital and structural heart disease, sometimes merging with

surgical suites into hybrid procedure rooms for valvular and

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complex nonvalvular interventions. This document is de-signed to update the latest information regarding thecatheterization laboratory environment and its operation.

1.1. Document Development Processand Methodology

The development of consensus documents involves multiplehealthcare professionals and often 2 or more medical soci-eties. Given the importance of practice guidelines andexpert consensus documents, governing principles have beenestablished to ensure the accuracy, balance, and integrity ofthe content, as well as the composition of committeesresponsible for these documents. The ACCF has created amethodology manual for expert consensus document writingcommittees that can be accessed at www.cardiosource.org (2).

.1.1. Writing Committee Organization

his writing committee was commissioned by the ACCFF CECD in conjunction with SCAI. Coordination and

taff support were provided by the ACCF. Nominations forriting group membership were made to the TF CECDith representatives and liaisons solicited from the TFECD, SCAI, STS, and SVM. Care was taken to select

cknowledged experts in cardiovascular catheterizations andnterventions with members from both the academic andrivate practice sectors and representing a diverse geogra-hy. The committee consisted of 16 members: 12 fromCCF, 3 from SCAI, 1 from STS, 1 from SVM, and 1

nvited radiation physicist content expert.

.1.2. Relationships With Industry and Other Entities

s part of the nomination and application process, allriting committee candidates were required to provide anp-to-date disclosure of their relationships with industrynd other entities (RWI). Both the ACCF and SCAIelieve that including experts on writing committees whoave relationships with industry strengthens the writingffort, though a stringent approach to keeping all relation-hips transparent and appropriately managed is necessary.s such, it was required that the majority (�50%) of writing

ommittee members had no RWI relevant to the entireocument. All relevant relationships occurring in the prior2 months were required to be disclosed (Appendix 1),ncluding the nature and extent of the relationship, as wells the establishment of new industry relationships at anyime during the document writing process. Members withelevant RWI were not allowed to draft or vote on docu-ent sections where a conflict may have been perceived

resent.The writing committee chair was selected by the TF

ECD chair, and it was required that this individual haveo relevant RWI. The writing committee chair along withupport staff created and reviewed a tentative outline ofections for the consensus document. Companies, vendors,nd other entities that had products or services related to the

atheterization laboratory document were identified and a

ategorized according to which sections of the document aelationship might exist. Writing committee members werehen selected and assigned to specific sections. Each sectionad a primary author who could have no relevant RWI forhat section or topic area. Each section also had 1 primaryinternal) reviewer from the writing committee.

.1.3. Consensus Development

he writing committee convened by conference call and-mail to finalize the document outline, develop the initialraft, revise the draft per committee feedback, and ulti-ately sign off on the document for external peer review. All

articipating organizations participated in peer review, re-ulting in reviewers representing 371 comments. A group of0 experts, separate from the writing committee, waselected for official review: 3 were nominated by ACCF, 3y SCAI, 2 by STS, and 2 by SVM. In addition, 21 contenteviewers from 3 ACCF Councils provided comments.here were no restrictions regarding the reviewers’ RWI,

hough all reviewers were required to provide full disclosureegarding relevant relationships. This information was madevailable to the writing committee and is included inppendix 2.Comments were reviewed and addressed by the writing

ommittee. A member of the ACCF TF CECD served asead reviewer to ensure that all comments were addresseddequately. Both the writing committee and TF CECDpproved the final document to be sent for board review.he ACCF Board of Trustees and SCAI Board of Direc-

ors reviewed the document, including all peer reviewomments and writing committee responses, and approvedhe document in February 2012.

The STS and SVM endorsed the document in February012. This document is considered current until the TFECD revises or withdraws it from publication.

.1.4. Document Methodology

he writing committee for this expert consensus documentn cardiac catheterization laboratory standards began byeviewing the 2001 “ACC/SCAI Clinical Expert Consen-us Document on Cardiac Catheterization Laboratory Stan-ards” (1). At the same time, the group conducted a brief reviewf the literature and clinical practice evolution relative to theatheterization laboratory environment. With this insight, itas agreed that there was enough important information toarrant a new consensus document. A formal review of the

iterature was performed and clinical data were reviewedonsidering a range of cardiovascular topics including, butot limited to, the following: hospitals and clinical environ-ents with and without surgical back-up for complex

iagnostic and interventional procedures; QA, proficiencies,nd patient safety; procedural and postprocedural manage-ent issues including unique patient groups; new pharma-

ological and mechanical therapies; laboratory designs, im-

ging equipment, and technologies.

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1.2. Purpose of This Document

The workplace and function of the cardiac catheterizationlaboratory has steadily evolved over the last 70 years.Although numerous historic events have occurred duringthis time, and the developmental phases of the catheteriza-tion laboratory are not strictly delineated, 4 broadly definedintervals can be considered. In the earliest phase, roughlyfrom 1940 to 1960, procedures were primarily focused onhemodynamic assessments and structural heart disease.With the development of radiographic techniques andsubsequently surgical revascularization, anatomy-focuseddiagnostic studies became the mainstay of laboratory activityin the interval from 1960 to 1980. The advent of PCI andmultiple percutaneous revascularization devices were thehallmarks requiring changes in the catheterization labora-tory in the era from 1980 to 2000. Most recently, interven-tions on peripheral and cerebrovascular disease, structuralcardiac abnormalities, and percutaneous valve therapies areinfluencing the needs and resources of the catheterizationlaboratory.

2. The Cardiac CatheterizationLaboratory Environments

2.1. The Current Landscape

Over the 10 years since the publication of the “ACC/SCAIClinical Expert Consensus Document on Cardiac Cathe-terization Laboratory Standards” (1), much has changed inthe cardiac catheterization laboratory. The importance ofinvasive hemodynamic assessment has been supplanted bymajor improvements in noninvasive imaging technologies.With this change, there has been an unfortunate loss in thecapability of many laboratories to provide complex hemo-dynamic information, even when it might be of valueclinically. The focus has now shifted primarily to coronaryanatomy assessment, where sophisticated tools now allowfor low-risk coronary interventions that were completelyunavailable just a decade ago. Improved techniques havealso reduced the overall risk for cardiac catheterization andtransformed diagnostic catheterization into an outpatientprocedure. Similar advances in interventional methods havenearly eliminated the need for immediate surgical standbyfor low-risk procedures, and a substantial amount of inter-ventional procedures are now being performed in settingswithout an in-house coronary surgical team even available—something the prior consensus document condemned.

Of the 5,099 hospitals in the United States, the 2007National Healthcare Cost and Utilization Project statisticsnote that a remarkable number of hospitals, a total of 4,345(85.2% of all), now provide cardiac catheterization services,and 1,061 (20.8%) provide cardiac surgical services (3). Asreported in the 2009 Update on Heart Disease and Strokestatistics from the AHA (4), the total number of inpatientcardiac catheterizations, however, actually declined slightly

from 1996 to 2006, despite the incidence of inpatient PCI o

rates increasing from 264 to 267 per 100,000 population.During the same period, the incidence of coronary arterybypass grafting (CABG) declined from 121 to 94 per100,000 patients (5). It is clearly a very dynamic time in thecardiac catheterization laboratory.

2.2. General Complications FromCardiac Catheterization Procedures

With the increase in the widespread use of cardiac cathe-terization, there has been a general decline in the risk of theprocedure. Complication rates from diagnostic catheteriza-tion are quite low. As suggested by the “ACCF/AHA/SCAI Clinical Competence Statement on Cardiac Inter-ventional Procedures” in 2007 (6), complications can generallye divided into 3 major categories: coronary vascular injury,ther vascular events, and systemic nonvascular events. Majordverse cardiac and cerebrovascular events (MACCE) includeeath, stroke, myocardial infarction (MI), and ischemia requir-

ng emergency CABG. MACCE for diagnostic proceduresccurs in �0.1% of diagnostic procedures (6). Additionalomplications include vascular access site complications, con-rast nephropathy, excessive bleeding, and other miscellaneousomplications such as arrhythmias, hypotension, coronaryerforation, and cardiac tamponade. The specific defini-ions of cardiac catheterization complications have beentandardized to a great extent and outlined by theCC-NCDR (7).In a single-center review of diagnostic cardiac catheter-

zation for 7,412 patients over a 10-year period (8), only 230.3%) had major complications, and there were no deathselated to the diagnostic procedure. Complications wereeast common after procedures done by more experiencedhysicians, when smaller catheter sizes were used and whennly left heart (and not left and right heart) procedures wereerformed. Obese patients had more vascular complications.ata from the ACC-NCDR database regarding PCI for

oth elective procedures and for acute coronary syndromesACS) are shown in Table 1 (9). These data reveal a trendoward fewer complications from PCI and a low risk-djusted in-hospital mortality of 2.0% for ACS patientsho had undergone PCI and 0.5% for elective PCIatients.In 2009, the Mayo Clinic published 25-year trend data

egarding their experience with 24,410 PCI procedures (10)Fig. 1). The authors analyzed the first 10 years (1979 to989), the period from 1990 to 1996, the period from 1996o 2003, and then finally the period from 2003 to 2004.hey found that despite an older and sicker population withore comorbid conditions, the success rate from PCI had

mproved from initially 78% to 94%, hospital mortality hadallen from 3.0% to 1.8%, and the need for emergencyABG had dropped from 5% to 0.4%. In their latest

ssessment, major adverse complications following PCI

ccurred in only 4.0% of in-hospital patients.

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2.3. The Cardiac Catheterization Laboratory at aHospital With Cardiovascular Surgical Capability

Table 2 outlines the optimal onsite support services that allowfor cardiac catheterization to be performed safely in any patientwith heart disease. A hospital with all of these services isconsidered a “full-service” facility. Although cardiac surgicalcapability is the defining service, the other important supportservices listed are critical for optimal patient care and manage-ment. The catheterization laboratory in this setting is fullyequipped for the most complex studies. Although directsurgical intervention is infrequently needed during percutane-ous interventional procedures, the associated depth of expertise

Table 1. Complication Rates for PCI Reported From the ACC-N

ACS

Variable

Q1 to Q2 (2005)

(n�92,534)

esion information, %

Previously treated 7.5

Bypass graft lesion 7.7

High-risk (Type C) lesion 43.3

Lesion length �25 mm 20.4

Bifurcation lesion 11.4

rocedural information, %

Radial access 1.2

Multivessel PCI 13.9

Stents used during PCI

DES 83.6

BMS 9.6

Angioplasty only 6.8

rocedural complications and results, %

Dissection 2.4

Acute closure 0.7

Perforation 0.3

Procedural success 93.0

ascular complications, %

Access site occlusion 0.07

Peripheral embolization 0.08

Access vessel dissection 0.20

Pseudoaneurysm 0.42

Arteriovenous fistula 0.07

leeding complications, %

Access site bleeding 1.20

Retroperitoneal bleeding 0.33

Gastrointestinal bleeding 0.54

Genitourinary bleeding 0.20

Other bleeding 0.60

n-hospital outcomes, %

Transfusion after PCI 5.1

Stroke 0.3

Emergency bypass 0.4

Note: all outcomes are self-reported with only a small portion validated. Modified with permissiACS � acute coronary syndrome (includes unstable angina); BMS � bare-metal stent; DES �

intervention.

within the facility (technology, equipment, personnel, and

specialized physicians such as anesthesiologists, perfusionists,and surgeons) have experience with the most complex casesand greater experience with emergent and critically ill patients.Often associated higher volumes translate into improved pa-tient care and outcomes for high-risk patients. Therefore,although surgical service may not be directly required, theassociated local expertise is available should the need arise.Essentially all laboratories that have full support services arelocated in a hospital setting. There may be special situationswhere a mobile laboratory is temporarily attached to or in anadjacent facility beside the hospital. In this latter setting, thesituation should be considered similar to the inpatient labora-

Database

Percutaneous Coronary Intervention

Non-ACS

1 to Q2 (2009) Q1 to Q2 (2005) Q1 to Q2 (2009)

(n�144,989) (n�50,532) (n�79,892)

7.3 8.2 7.5

6.4 6.9 5.9

46.9 33.7 38.7