ACC/SCA&I EXPERT CONSENSUS DOCUMENT
American College of Cardiology/Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards4,4
A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents endorsed by the American Heart Association and the Diagnostic and Interventional Catheterization Committee of the Council on Clinical Cardiology of the AHA
Thomas M. Bashore, MD, FACC, Chair, Writing Committee Member,
Eric R. Bates, MD, FACC, Writing Committee Member*,
Peter B. Berger, MD, FACC, Writing Committee Member,
David A. Clark, MD, FACC, Writing Committee Member,
Jack T. Cusma, PhD, Writing Committee Member,
Gregory J. Dehmer, MD, FACC, Writing Committee Member,
Morton J. Kern, MD, FACC, Writing Committee Member**,
Warren K. Laskey, MD, FACC, Writing Committee Member,
Martin P. O’Laughlin, MD, FACC, Writing Committee Member,
Stephen Oesterle, MD, FACC, Writing Committee Member,
Jeffrey J. Popma, MD, FACC, Writing Committee Member,
Robert A. O’Rourke, MD, FACC, Chair, Task Force Member,
Jonathan Abrams, MD, FACC, Task Force Member,
Eric R. Bates, MD, FACC, Task Force Member,
Bruce R. Brodie, MD, FACC, Task Force Member,
Pamela S. Douglas, MD, FACC, Task Force Member,
Gabriel Gregoratos, MD, FACC, Task Force Member,
Mark A. Hlatky, MD, FACC, Task Force Member,
Judith S. Hochman, MD, FACC, Task Force Member,
Sanjiv Kaul, MBBS, FACC, Task Force Member,
Cynthia M. Tracy, MD, FACC, Task Force Member,
David D. Waters, MD, FACC, Task Force Member and
William L. Winters, Jr, MD, MACC, Task Force Member
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Table of contents
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- Preamble.......2172
- Executive Summary.......2172
- The Cardiac Catheterization Laboratory Environment.......2172
- Same-Day and Outpatient Cardiac Catheterization.......2173
- QA Issues.......2173
- Procedural Issues.......2174
- Personnel Issues.......2174
- Ethical Concerns.......2174
- Imaging Equipment Issues.......2175
- Radiation Safety.......2175
- Special Concerns for the Pediatric Catheterization Laboratory.......2176
- Introduction.......2176
- Organization of Committee and Evidence Review.......2176
- Purpose of This Expert Consensus Document.......2176
- The Evolution of the Cardiac Catheterization Laboratory.......2177
- The Cardiac Catheterization Laboratory Environment.......2177
- The Cardiac Catheterization Laboratory at a Hospital With Cardiac Surgery Capability.......2178
- Patients Eligible for Invasive Cardiac Procedures.......2178
- The Cardiac Catheterization Laboratory at a Hospital Without Cardiac Surgery Capability.......2178
- Patients Eligible for Diagnostic Cardiac Catheterization at a Hospital Without Cardiac Surgery Capability.......2179
- Patients Eligible for Therapeutic Invasive Procedures at a Hospital Without Cardiac Surgery Capability.......2179
- Cardiac Catheterization and Diagnostic Procedures in the Freestanding Laboratory.......2181
- Patients Eligible for Cardiac Catheterization in a Freestanding Laboratory.......2181
- The Mobile Cardiac Catheterization Laboratory.......2181
- Candidates for Same-Day or Ambulatory Cardiac Catheterization........2181
- QA Issues in the Cardiac Catheterization Laboratory.......2183
- Clinical Proficiency.......2183
- Patient Outcomes in the Diagnostic Cardiac Catheterization Laboratory.......2183
- Rates of "Normal" Cardiac Catheterizations.......2183
- Complication Rates During Diagnostic Catheterization.......2183
- Diagnostic Accuracy and Adequacy.......2184
- The Special Case of the "Ad Hoc" PCI.......2184
- Patient Outcomes in the Interventional Cardiac Catheterization Laboratory.......2184
- Equipment Maintenance and Management.......2185
- QI Program Development.......2186
- Minimum Caseload Volumes.......2187
- Procedural Issues in the Performance of Cardiac Catheterization.......2188
- Patient Preparation.......2188
- Sedatives and Relaxants.......2188
- Prevention of Contrast "Allergy".......2188
- Patients With Renal Insufficiency.......2188
- Patients With Diabetes Mellitus.......2189
- Patients Receiving Antiplatelet or Antithrombotic Medications.......2189
- Procedural Issues.......2189
- Sterile Preparation of the Access Site and Vascular Access.......2189
- Right-Heart Catheterization During the Evaluation of Coronary Artery Disease.......2190
- The Routine Use of Temporary Pacing.......2190
- Transseptal Cardiac Catheterization and Percutaneous Balloon Mitral Valvuloplasty.......2190
- Role of Left Ventricular Puncture in the Era of Echocardiography.......2190
- Use of Provocative Agents During Diagnostic Cardiac Catheterization.......2190
- Operator Safety During Cardiac Catheterization in Patients With Communicable Diseases.......2191
- Performance Issues.......2191
- Injection of Coronary Arteries.......2191
- Angiography.......2191
- Pressure Measurement.......2192
- Measurement of Cardiac Output.......2192
- Postprocedural Issues.......2193
- Vascular Hemostasis.......2193
- Reporting of Cardiac Catheterization Results.......2193
- Personnel Issues and Laboratory Design.......2194
- Attending Physician.......2194
- Teaching Attending Physician.......2194
- Secondary Operators.......2194
- Laboratory Director.......2194
- Operating Physicians.......2195
- Cardiovascular Trainee (Fellow).......2195
- Use of Physician Extenders (Physician’s Assistants and Nurse Practitioners).......2195
- Nursing Personnel.......2196
- Non-Nursing Personnel.......2196
- Staffing Patterns.......2196
- Cardiopulmonary Resuscitation.......2197
- Suggested Space Requirements.......2197
- Ethical Concerns.......2197
- Operator Assistant’s Fees, Sharing of Fees, Fee Splitting, and Fee Fixing.......2198
- Unnecessary Services.......2198
- Self-Referral, Self-Ownership, and Self-Reporting.......2198
- Informed Consent.......2198
- Ethics of "Teaching" Diagnostic and Therapeutic Procedures.......2199
- Clinical Research Studies During Diagnostic and Interventional Cardiac Catheterization.......2199
- Imaging Issues.......2199
- Radiographic Equipment.......2200
- Generators.......2200
- X-Ray Tubes.......2200
- Image Intensifiers.......2200
- Developments in X-Ray Detectors.......2201
- Video Components.......2201
- Video Cameras.......2201
- Digital Angiography Issues.......2201
- Effects on X-Ray Requirements.......2202
- Digital Acquisition Requirements.......2202
- Digital Storage and Display.......2202
- Image Formats and Standards: The DICOM Standard.......2203
- Digital Image Resolution.......2203
- Data Compression.......2203
- Telemedicine Applications.......2204
- Quantitative Measurement Methods.......2204
- Further Developments in the DICOM Standard.......2205
- Radiation Safety Issues.......2205
- Terms for Understanding Radiation Exposure in the Cardiac Catheterization Laboratory.......2205
- Biological Risks From Radiation Exposure.......2205
- Measuring Radiation Exposure.......2206
- Minimizing Occupational Exposure.......2206
- Minimizing Radiation Exposure to the Patient.......2206
- Quality Management.......2207
- Special Concerns for the Pediatric Cardiac Catheterization Laboratory.......2207
- Differences in Goals.......2207
- Who Should Perform Catheterization in Adult Congenital Heart Disease?.......2207
- Quality Assurance Issues.......2208
- Inpatient Versus Outpatient Setting for Procedures.......2208
- Operator and Laboratory Volume.......2208
- Procedural Issues.......2209
- Premedication.......2209
- Vascular Access Issues.......2209
- Medications Used During the Procedure and Use of Anesthesia.......2209
- Procedural Performance Differences Compared With the Adult Cardiac Catheterization Laboratory.......2210
- Single-Plane Versus Biplane Angiography.......2210
- Hemodynamics.......2210
- Angiographic Acquisition Differences.......2210
- Radiation Protection and the Pregnant (or Potentially Pregnant) Patient.......2210
- Shunt Measurements.......2211
- Laboratory Personnel Issues.......2211
- Reference List.......2211
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Preamble
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This document has been developed as a Clinical Expert Consensus Document (CECD), combining the resources of the American College of Cardiology (ACC) and the Society for Cardiac Angiography and Interventions (SCA&I). It is intended to provide a perspective on the current state of cardiac catheterization and the laboratories in which these procedures are performed. Clinical Expert Consensus Documents are intended to inform practitioners, payers, and other interested parties of the opinion of the ACC concerning evolving areas of clinical practice and/or technologies that are widely available or new to the practice community. Topics chosen for coverage by expert consensus documents are so designed because the evidence base, experience with technology and/or clinical practice are not considered sufficiently well developed to be evaluated by the formal ACC/American Heart Association (AHA) Practice Guidelines process. Often the topic is the subject of considerable ongoing investigation. Thus, the reader should view the CECD as the best attempt of the ACC to inform and guide clinical practice in areas where rigorous evidence may not yet be available or the evidence to date is not widely accepted. Where feasible, CECDs include indications or contraindications. Some topics covered by CECDs will be addressed subsequently by the ACC/AHA Practice Guidelines Committee.
The Task Force on CECDs makes every effort to avoid any actual or potential conflicts of interest that might arise as a result of an outside relationship or personal interest of a member of the writing panel. Specifically, all members of the writing panel are asked to provide disclosure statements of all such relationships that might be perceived as real or potential conflicts of interest to inform the writing effort. Robert A. O’Rourke, MD, FACC, Chair, ACC Task Force on Clinical Expert Consensus Documents
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Executive summary
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A. The cardiac catheterization laboratory environment.
Cardiac catheterizations are currently performed safely in hospitals with and without cardiac surgical backup. The latest information from the SCA&I lists >2,100 cardiac catheterization laboratories in the U.S. (including Puerto Rico and the Virgin Islands) (1). Of these, 72% provided on-site cardiac surgery (including 85% of those performing coronary intervention). Fifty-eight laboratories were located in nonhospital settings.
In a hospital with cardiac surgery, essentially all patients with cardiovascular disease can undergo invasive studies safely. Full support services include not only cardiovascular surgery but also vascular surgery, nephrology and dialysis, neurology, hematology, and specialized imaging services (e.g., computed tomography, magnetic resonance imaging, and ultrasound). See Table 7 for assessment of proficiency criteria for individual operators and cardiac catheterization laboratories.
In the hospital setting without cardiac surgery capability, many patients can undergo cardiac procedures safely. Exclusions for cardiac catheterization in this setting include patients with acute coronary syndromes, severe congestive heart failure, pulmonary edema due to acute ischemia, a high likelihood of severe multivessel or left main disease based on noninvasive testing, and severe left ventricular dysfunction associated with valvular disease. Certain elective therapeutic interventional procedures such as percutaneous coronary interventions (PCIs) and valvuloplasty should still be performed in facilities that provide cardiac surgical support. The ACC Competence Statement on Recommendations for the Assessment and Maintenance of Proficiency in Coronary Interventional Procedures and the ACC/AHA Guidelines for PCI Procedures (2,3) have addressed the issue of primary angioplasty for acute myocardial infarction in hospitals without cardiac surgery capability. Recent data suggest a lower mortality rate among patients undergoing primary angioplasty in higher-volume centers (4). Hospitals that perform primary angioplasty but are without on-site cardiac surgery capability must have a proven plan for rapid access (within 1 h) to a cardiac surgical operating room in a nearby facility with appropriate hemodynamic support capability for such a transfer. The procedure should be limited to patients with ST-segment elevation MI or new LBBB on ECG, and done in a timely fashion (balloon inflation within 90 ± 30 min of admission) by persons skilled in the procedure (
75 PCIs performed/year) and only in facilities performing a minimum of 36 primary PCIs/year. In accordance with the soon-to-be-published ACC/AHA guidelines for PCI (3), this committee does not endorse the performance of elective PCI in a facility without cardiac surgery capability.
Patients are also being studied in freestanding laboratories (i.e., those that are not physically attached to the hospital). By definition a freestanding laboratory is one where quick transportation of a patient to a hospital by gurney is not possible. These patients clearly must be in stable condition and at the lowest risk for complications. It is vitally important to have mechanisms for backup and bailout in place to provide assistance should patients become unstable in this setting. Although a tertiary hospital serves as an appropriate means for providing proper oversight of a freestanding laboratory, recognized credentialing bodies approved by the local community may be able to provide appropriate oversight to ensure that all issues related to quality assurance (QA) are monitored and addressed. Interventional procedures of any kind should not be performed in a freestanding facility.
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B. Same-day and outpatient cardiac catheterization
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With the decline in risk associated with cardiac catheterization, the performance of invasive procedures in the ambulatory setting has become more popular. However, prehospitalization may still be important in patients receiving anticoagulation therapy or in those with renal failure, diabetes, or a contrast allergy. Early discharge after the procedure may also be inappropriate for certain patients, including those with a procedure-related complication or hemodynamic instability. In addition, some patients are best observed overnight if severe disease is discovered (e.g., significant left main coronary artery disease or severe aortic stenosis) or in the presence of significant comorbid diseases that increase the risk of late complications. A general scheme is presented to help determine who should be excluded from early discharge after cardiac catheterization.
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C. QA issues
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Quality assurance starts with an assessment of clinical proficiency among the operators in the cardiac catheterization laboratory. This is surely one of the most difficult elements to assess, but issues of cognitive knowledge, procedural skill, clinical judgment, and procedural outcomes are all important. QA extends to the performance of the laboratory as a whole. A continuous quality-improvement (QI) program should also be included in the laboratory’s overall design.
One measure of outcome is the number of "normal" diagnostic cardiac catheterizations performed. "Normal" in this regard refers to no disease or insignificant (<50% diameter narrowing) coronary stenoses in patients studied primarily for the identification of coronary artery lesions. It is recognized that there is a difference between coronary arteries that are completely normal and those that have insignificant luminal stenoses. It is further recognized that coronary disease is a dynamic process and that endothelial dysfunction may contribute to certain clinical syndromes. In some laboratories "normal" coronary arteries may be especially prevalent because the patient mix includes a variety of disease states where coronary disease is not the major concern such as cardiomyopathy and valvular disease. The rate of "normals" identified as either insignificant or no obvious luminal narrowing should be in the range of 20% to 27% if proper screening and baseline decision making is operative prior to the catheterization.
Outcomes related to complications for diagnostic catheterization should be very low–<1%. Diagnostic accuracy and adequacy are obviously important parameters as well, though they are rarely tracked. In the interventional cardiac catheterization laboratory the acceptable complication rates are more difficult to gauge, since measures of assessing high-risk patients have not been standardized. Major complications, (i.e., death, acute myocardial infarction, and emergency bypass surgery) from interventional procedures should be <3%.
The minimum number of studies needed to confirm adequate skills in cardiac diagnostic catheterization procedures has never been validated. Given the low risk of diagnostic catheterization, the QI system should be operative and should hold precedence over any arbitrary figures proposed in this setting. The Committee could find no data to support the prior recommendation for a minimum caseload of 150 catheterizations performed by an individual per year. A minimum interventional caseload is 75 cases/year per operator and ideally 400 cases/year for the laboratory. Because of the direct correlation between both laboratory and physician volume and outcomes, a low-volume operator (<75 cases/year) should only work in a high-volume laboratory (>600 cases/year), and even then with mentoring. Low-volume operators in any other setting should not perform interventional procedures. The minimum caseload for operators performing pediatric catheterizations has not been established by data, although a caseload of 50/year has been suggested for individual operators. Pediatric cardiac catheterization laboratories often share space with adult procedural facilities. The pediatric catheterization laboratory should perform at least 75 procedures/year.
Equipment maintenance and management remain an issue, and certain guidelines are provided. Each aspect of the radiographic system should be able to meet these performance expectations. The same is true for the physiological recorders and other specific devices used in the laboratories.
A QI program must be in place. The keys are to develop variables that reflect the quality of care, to collect these variables in a systematic manner, to have a means for statistical analysis of the results, and to develop an approach to problem solving that involves feedback on the effectiveness of the solutions. These programs should provide ongoing educational opportunities for staff as well. The Committee also strongly encourages all laboratories to participate in a national data registry to help benchmark their results and provide an ongoing system for tracking complications.
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D. Procedural issues
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Table of contents
Preamble