-
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].
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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
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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
-
ttccmtlrmm2ocw
2224 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
Catheterization Laboratory Standards June 12, 2012:2221–305
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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2012:2221–305 Cardiac Catheterization Laboratory Standards
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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2226 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
Catheterization Laboratory Standards June 12, 2012:2221–305
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
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2228 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
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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.
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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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2230 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
Catheterization Laboratory Standards June 12, 2012:2221–305
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
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2231JACC Vol. 59, No. 24, 2012 Bashore et al.June 12,
2012:2221–305 Cardiac Catheterization Laboratory Standards
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-
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2232 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
Catheterization Laboratory Standards June 12, 2012:2221–305
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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2233JACC Vol. 59, No. 24, 2012 Bashore et al.June 12,
2012:2221–305 Cardiac Catheterization Laboratory Standards
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.
http://www.cardiosource.org
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2234 Bashore et al. JACC Vol. 59, No. 24, 2012Cardiac
Catheterization Laboratory Standards June 12, 2012:2221–305
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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2235JACC Vol. 59, No. 24, 2012 Bashore et al.June 12,
2012:2221–305 Cardiac Catheterization Laboratory Standards
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