Last month, the SCAI released their expert consensus paper codifying the best practices in the cardiac catheterization lab.1 This is the second iteration of this document2 and it is a must-read for all those working and running cath labs. I was excited to review the content and hope to share my enthusiasm with all who work in the cath lab. The operations of any cath lab will benefit from having this reference available. The detailed and well-organized presentations regarding what we should and should not be doing in the cath lab will go a long way toward standardizing best care for the invasive treatment of our patients.
At the SCAI Annual Scientific Sessions in Orlando, Florida (May 4-7, 2016), the Society made a small pocket guide (Figure 1) available to its membership for quick reference to important parts of the consensus statement. I thought it would be worthwhile to summarize some of the major findings in the consensus statement (and in the pocket guide) to encourage you to peruse the entire work and begin incorporating some of the best practices into your lab.
The purpose of the best practices statement, noted in the introduction, is to ensure patient safety, cath lab efficiency, and the referring physician and patient’s satisfaction. The hospital should provide the necessary resources to implement best practices through adequate staffing, equipment, and information technology, in order to assure the performance of these practices and encourage ongoing review. The introduction sets the tone for recommendations and discussions, along with indicating who is responsible for various tasks and initiatives.
Institutional and operator qualifications
The provider and institutional competency documentation sections suggest three best practices:
- Physicians should participate in quarterly quality improvement (QI), peer review and/or morbidity/mortality (M&M) meetings for privileging, as well as undergo an assessment of procedural appropriateness.
- Operators should perform >50 percutaneous coronary interventions (PCI)/year, averaged over two years, and >11 primary PCIs for ST-elevation myocardial infarction (STEMI). The institution should perform >200 PCIs/year and >36 primary PCIs for STEMI per year. (These metrics are unchanged from 2012).
- For those institutions without onsite cardiac surgery, oversight to ensure procedure quality is paramount. Should the hospital’s operators have insufficient volumes (as noted above), the institution should consider recruiting more experienced operators.
Preprocedural best practices
The preprocedural best practices section summarizes important patient history and physical exam (H&P) documentation. Not only should all patients have an appropriate H&P on the chart, but it should include, at a minimum, the details of the present illness, the anginal and/or the heart failure class, medications (e.g., the antiplatelet and anticoagulation status), comorbidities, and a focused review of systems. Specifically applicable to the cath procedure, prior allergic reactions to contrast media or other medications must be noted. Any procedure using conscious sedation requires an airway assessment.
The procedural indications should be clearly identified and reconciled with the appropriate use criteria. The informed consent process is delineated. Accurate and timely documentation must be present, as it protects the patient, staff, and the hospital from consequences of litigation. Hospitals should have a written policy that consent is obtained in a neutral environment (i.e., not in the cath lab or on the cath table) and in the patient’s native language. Of course, the patient must be deemed competent to provide voluntary consent. The consent must be witnessed by a third party. Included in the consent should be a description of both diagnostic and anticipated interventional procedures if ad hoc PCI is planned. The attendant risks should be listed for both diagnostic procedures and ad hoc PCI. Infrequently discussed risks involving the use of dual antiplatelet therapy and the potential for restenosis should be addressed. For ad hoc PCI, it is important to note that consent cannot be obtained at the conclusion of the diagnostic procedure, especially if the patient has already been sedated. A consent obtained after the patient receives sedation would be a violation of the informed consent practice and policies [my interpretation – MK]. Lastly, the consent form should include the “do not resuscitate” (DNR) status (some labs do not permit patients who are DNR to proceed with high-risk procedures with no hope of resuscitation).
Pre-procedural checklists increase the safety of complex procedures. The airline industry increased their safety record decades ago with the use of checklists. The obligatory preprocedure “time out” is a method to increase patient safety, born from the checklist system (Figure 2).
Checklists for appropriate medications and procedural needs are provided in the pocket guide for easy implementation of best practices. Key recommendations for cath lab medications are the same as many of those listed in the leading catheterization handbooks. Highlights include holding coumadin until the INR <1.8 for femoral procedures in those patients on coumadin. Reduced insulin dosing should be instituted before the procedure for patients who will be NPO (nothing by mouth). Unfortunately, there is no mention of the fact that we probably should not be keeping patients NPO before contrast studies. Metformin should be held on the day of procedure and for 48 hours afterward. For reference, pertinent lab tests to be checked are also listed in the pocket guide, an especially worthwhile reminder for newer staff members.
Best practices and procedural hazards
Also reviewed in the best practices statement are chronic kidney disease, contrast media dosing, radiation safety and universal precautions. Other well-known practices are also emphasized (many of the intraprocedural best practices have been discussed in previous Cath Lab Digest clinical editors’ pages and are worthy of a repeat read).
Pre-procedural intravenous hydration with normal saline should be provided in all patients deemed hypovolemic. Of course, I would submit that all patients coming to the cath lab benefit from good hydration. The contrast volume during a case should be monitored. Risk scores identify a contrast limit for most patients.
A new section offers a more detailed description of post-procedure needs. For example, the physician-to-patient communication requires a discussion of the findings, interventions, and any complications. The conversation should take place directly with patient and family. (I often emphasize to our fellows that we will have this discussion twice, once at the end of the procedure, and again, after patient’s sedation has worn off.) In our lab, we also provide a small diagram to each patient and family, so they can have something to show to their referring physicians. Often the family cannot fully understand or remember the results of the procedure, especially at a time of high anxiety surrounding cardiac interventions.
The procedure report
It is recommended that the procedure report be generated immediately after the procedure. Key elements of this report were defined from 2013 American College of Cardiology Foundation/American Heart Association key data elements and definitions3, and are quickly available in the pocket guide. A comprehensive procedure report is an important component of lab quality and directly impacts any medical/legal proceedings that may follow, should an adverse event occur.
Access site management
The management of hemostasis devices for both femoral and radial access is well summarized and includes comments on appropriate length and type of monitoring, and time to discharge. Discharge instructions, including activity or driving limitations, are emphasized. An important and often overlooked discussion is that of the duration of dual antiplatelet therapy, intervals of follow-up, and any future stress testing that may be required. Patients should be provided with a device-specific information card. Patients at risk of contrast-induced nephropathy should have a serum creatinine recheck within 3 to 5 days. Same-day discharge patients should be re-contacted by a member of the cath lab team within 24 to 48 hours.
Cath lab governance
New to this year’s best practice statement is a section on cardiac cath lab governance and the roles of the cardiac cath lab director, manager, and hospital administration. While the statement offers many recommendations for best governance, I will highlight three:
- All cardiac catheterization laboratories (CCL) should have a physician director and non-physician manager.
- The CCL director should partner with the manager of QI and physician/hospital administration, provide nurse and heart team training, have oversight of debriefing of adverse events, and possess the authority to delegate and facilitate education and mentorship for all team members.
- A comprehensive list of recommendations enumerates the responsibilities of the cardiac cath lab physician director. The cath lab director should co-chair CCL administrative meetings, resolve personnel problems with the cardiac cath lab manager, attend cardiac cath lab staff meetings, serve as a liaison between staff and physicians, resolve scheduling issues among physicians, coordinate the cath lab call schedule, and assist cath lab manager in preparation of department of health and Joint Commission surveys. The cardiac cath lab physician director is expected to interact with the quality improvement team, implement system cost effectiveness and efficiency strategies, provide academic oversight for fellows on the CCL rotation, conduct evaluations, research, and acquisitions, and direct the launch of a new technology within the program.
Every cardiac cath lab should have a quality assurance (QA) program. Interventional and diagnostic cases for all operators should be randomly selected to undergo peer review. All cardiac cath lab and in-hospital complications should be reviewed at regularly scheduled morbidity and mortality conferences at least quarterly. Cardiac cath lab emergency preparedness protocols should be established and mock emergencies reviewed in preparation to manage disasters. Cardiac cath lab emergency drills for vascular complications, acute stroke, emergency pacing, ventricular fibrillation, cardiac arrest, coronary perforation, contrast reaction, tamponade, and sudden cardiogenic shock should be conducted.
Last, but not least, the patient experience should be reviewed and optimized when possible. Some suggestions to improve the patient experience are included. For example, before the procedure, prompt easy scheduling for outpatients, and minimize or eliminate NPO before the procedure, allowing clear liquids. All outpatient care unit and CCL personnel should introduce themselves by name, update the patients and their families when delays are anticipated, emphasize comfort and privacy for all patients and family members, and always respect confidentiality.
Following the procedure, a full explanation of the procedure results when appropriate is needed. Prompt provision of fluids and food as tolerated makes for a happy patient. Making specific follow-up appointments before discharge, and providing phone number to answer questions and identify post procedure problems will also help eliminate confusion.
The bottom line
I would like to congratulate Dr. Srihari Naidu and colleagues1 on this excellent document that updates us and provides an outstanding reference for the workings of the cath lab. I recommend that all cardiac cath lab personnel, leaders, managers, students, and residents review the 2016 SCAI Expert Consensus Statement on Best Practices in the Cardiac Catheterization Laboratory. I know you will find it as valuable as I did.
Note: SCAI is well prepared to receive requests for digital and/or print pocket guides. SCAI has a vendor that develops/sells all SCAI Physician Reference Pocket Guides. Visit https://www.guidelinecentral.com/shop/best-practices-cardiac-catheterization-laboratory/
- Naidu SS, Aronow HD, Box LC, Duffy PL, Kolansky DM, Kupfer JM, Latif F, Mulukutia SR, Rao SV, Swaminathan RV, Blankenship JC. SCAI expert consensus statement: 2016 best practices in the cardiac catheterization laboratory: (endorsed by the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencionista; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d’Intervention). Catheter Cardiovasc Interv. 2016 May 2. doi: 10.1002/ccd.26551. [Epub ahead of print]
- Naidu SS, Rao SV, Blankenship J, Cavendish JJ, Farah T, Moussa I, Rihal CS, Srinivas VS, Yakubov SJ. Clinical expert consensus statement on best practices in the cardiac catheterization laboratory: Society for cardiovascular angiography and interventions. Catheter Cardiovasc Interv. 2012; 80: 456-464.
- Cannon CP, Brindis RG, Chaitman BR, Cohen DJ, Cross JT Jr, Drozda JP Jr, et al. 2013 ACCF/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes and coronary artery disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on clinical data standards (writing committee to develop acute coronary syndromes and coronary artery disease clinical data standards). J Am Coll Cardiol. 2013 Mar 5;61(9):992-1025. doi: 10.1016/j.jacc.2012.10.005.
Disclosure: Dr. Kern reports he is a consultant and speaker for St. Jude Medical and Volcano Therapeutics, and a consultant for Opsens, ACIST Medical, Heartflow, and Merit Medical.