Provider/Institutional Competence and Documentation
- Physicians should participate in at least quarterly QI, peer review, and/or M&M meetings to maintain privileges, as well as participate in procedural appropriateness evaluations.
- It is recommended that operators perform >50 PCIs/year, averaged over 2 years, and >11 PPCIs/year and that institutions should perform >200 PCIs/year and >36 PPCI/year.
- For institutions without on-site cardiac surgery, oversight to ensure the quality of procedures is paramount. Operators should perform ≥50 PCIs/year, including >11 PPCIs, and the institution should ideally recruit more experienced operators.
Pre-procedure Best Practices
Minimum Content of H&P
- History of Present Illness
- Canadian Cardiovascular Society angina class
- New York State Heart Association heart failure class
- Relevant medications
- Relevant comorbidities
- Review of renal, gastrointestinal, peripheral vascular, neurological and pulmonary systems
- Contrast reaction or other allergies
- Antiplatelet or anticoagulant issues
- Prior airway or moderate sedation issues
- Cardiopulmonary and vascular system
- Peripheral pulses
- Ability to tolerate sedation, and at what level
- Conditions that might affect the procedure
- Risk scores and calculators (www.ScaiPCIRiskApp.org) for predicting complications (e.g., mortality, bleeding, contrast-induced nephropathy
- Methods employed to reduce risk
Informed Consent (IC) Process and Documentation
- The hospital must have a written policy on IC that describes the process used to obtain consent.
- The IC process should be performed in a neutral environment.
- The IC should be in the patient’s native language.
- The patient must be competent and voluntarily provide consent.
- The IC process should be witnessed by a third party.
- Potential treatments that may result from the findings of a diagnostic procedure (e.g., ad hoc PCIs and their attendant risks) should be reviewed, as well as issues surrounding DAPT and restenosis.
- Specific mention should be made of DNR status.
- The consent must be obtained within 30 days and must be reaffirmed on the day of the procedure.
- For patients on chronic warfarin therapy in whom anticoagulation can be held, the international normalized ratio (INR) should be obtained <24 hours prior to the procedure, with the goal INR of <1.8 for femoral procedures.
- Insulin dosing should be adjusted to account for the time that the patient will be NPO.
- Metformin should be held on the day of the procedure and for 48 hours afterward.
Labs and Other Studies
- Patients scheduled for outpatient procedures should have a complete blood count (CBC) and renal profile within 30 days.
- Significant anemia should be addressed prior to the procedure.
- Measurement of the PT/INR should be obtained for those with severe anemia or liver disease.
- A baseline ECG should be obtained.
- Women of childbearing age should have beta-HCG levels checked within 2 weeks of the procedure.
- For patients who have had prior catheterization or coronary/ peripheral bypass surgery, every effort should be made to review procedural reports and prior cardiovascular angiograms to help guide the operator during the procedure.
Table 1. Pre-Procedure Check List for Cardiac Catheterization
|History and Physical Examination:|
|Elective Outpatient Procedures:|
H&P documented within 30 days?
H&P documented within 24 hours of admission?
|History of prior PCI or CABG:||Yes||No|
|If yes, report/s obtained?||Yes||No|
|Stress test/ LVSF assessment:||Yes||No|
|If yes, report/s obtained?||Yes||No|
|Candidacy for Drug-Eluting Stent:|
|1. Major surgery in the past month or next year?||Yes||No|
|2. Is there any clinically overt or suspected bleeding?||Yes||No|
|3. Is patient on chronic anticoagulation (e.g., warfarin, TSOAC)?||Yes||No|
|4. Is there history of/anticipated medication non-adherence? Yes No||Yes||No|
|If yes, was the patient pre-treated?||Yes||No|
|If yes, was the patient desensitized?||Yes||No|
|3. Heparin (HIT):||Yes||No|
|If yes, consider alternative anti-thrombotic agents (DTI)|
|If yes, remove all latex products from procedural use|
|1. Did patient take aspirin within the past 24 hours?||Yes||No|
|2. Did patient take clopidogrel, prasugrel, or ticagrelor within the past 24 hours?||Yes||No|
|3. Did patient take metformin within the past 24 hours?||Yes||No|
|4. Did patient take sildenafil (or other PDE5 inhibitor) within the past 24 hours?||Yes||No|
|5. Did patient receive LMWH within the past 12 hours?||Yes||No|
|If yes for LMWH, time of last dose||__________|
|6. Did patient take anticoagulants||Yes||No|
|If yes, which agent:|
and when was last dose:
|Was informed consent obtained within 30 days?||Yes||No|
|Is there a healthcare proxy?||Yes||No|
|Is the patient DNR or DNI?||Yes||No|
|If yes, was it revoked for procedure?||Yes||No|
|Sedation, Anesthesia and Analgesia:|
|Are ASA and Mallampati Class documented?||Yes||No|
|Is there any contraindication to sedation present?||Yes||No|
|Risk scores applied?||Yes||No|
|Laboratories and Studies:|
|CBC and renal profile within 30 days (outpatient) or 24 hours (inpatient)?||Yes||No|
|Was ECG performed within 24 hours?||Yes||No|
|PT/INR performed within 24 hours (for patients on warfarin)?||Yes||No|
|INR ≤ 1.8?||Yes||No|
|Urine/serum human chorionic gonadotropin (HCG) in woman of childbearing age?||Yes||No|
|Does the patient require pre-procedure hydration?||Yes||No|
|Preferred vascular access:||R L TR TF|
|Same Day Discharge candidate?||Yes||No|
Chronic Kidney Disease (CKD)
- Pre-procedure intravenous (IV) hydration with normal saline should be provided in patients deemed hypovolemic.
- The total contrast dose should be monitored. Risk scores can be helpful in identifying a suggested limit.
- N-acetyl cysteine is no longer recommended for prevention of contrast-induced nephropathy.
Procedure Indications and History and Physical (H&P) Examination Documentation
- Procedural indications should be well documented and reconciled with published AUC.
- Key variables (e.g., anginal class and medication use) must be documented to confirm appropriateness.
- Supporting data, such as a pre-procedure ECG, prior cardiac procedures or surgeries, echocardiography, CT angiography, and/or stress testing results (with characterization of findings as "low-risk", "intermediate-risk" or "high-risk" rather than "abnormal") should be described.
- For procedures with "rarely appropriate" ratings, additional documentation should be included.
- All patients must have an H&P prior to the procedure, performed by either a physician or an advanced practice professional (e.g., physician assistant or nurse practitioner).
Intra-Procedure Best Practices
Infection Control in the Catheterization Laboratory
- Best practices for sterile technique are essential.
- Physicians may use chlorhexidine/ethyl alcohol solutions, or any of the variety of antimicrobial agents available, for the first scrub of the day and all subsequent scrubs.
- Patient drapes that adhere to skin around the access site without loosening during the procedure are important.
- It is reasonable but not mandatory for hats and masks to be worn for every procedure.
- Antibiotic prophylaxis is not indicated for routine coronary procedures, but is often used before permanent implantations other than coronary stents and before vascular closure device (VCD) placement in high-risk subsets, such as diabetics or immunocompromised persons.
- Electric clippers should be used to prepare the femoral access site.
All personnel in the room should wear personal protective equipment, including lead aprons, thyroid shields and radiation badges. Leaded glasses should be used for individuals closest to the radiation source.
|15 Gy||TJC -> hospital risk management/regulatory agencies should be contacted within 24 hours|
All: Wear lead aprons, thyroid shields, radiation badges, lead glasses (when close to radiation source)
Techs: Notify operator when approaching harmful thresholds
Angiographic Contrast Administration
- Non-ionic, low-osmolar contrast (e.g. iohexol, iopamidol, ioversol) should be utilized for the majority of cases.
- Total contrast administered to the patient must be monitored in real time, and CCL staff should inform physicians when the maximum contrast volume of 3.7 x eGFR has been reached.
Universal Protocol and “Time Out” Procedure
- A dedicated “Time Out” protocol should be completed before vascular access or moderate sedation is initiated. (See Table 2)
- Universal infection precaution protocols for the CCL Heart Team should be followed in each case rather than on a case-by-case basis.
- All solutions on the table must be labeled in real-time (not pre-labeled).
- Pre-printed labels for common medications should be incorporated into drape kits, and sheets of blank labels and felt-tip markers must also be available as part of the sterile field.
- A “Pre-PCI Timeout” should be strongly considered, during which there is consideration of:
- Radiation exposure and contrast use
- Issues regarding DAPT
- Adequate pre-treatment with aspirin, P2Y12-receptor inhibitors, and statins
- Baseline hemodynamics
Table 2. Sample “Time Out” Pre-procedure Checklist
- All members of the procedural team must be present for the “Time Out.”
- Time Out must take place immediately before vascular access is obtained.
- The physician taking ultimate responsibility for the procedure should lead the Time Out and ensure each of the following items is announced:
- Patient’s name and medical record number
- Procedure to be performed (e.g., left heart catheterization, coronary angiography, right heart catheterization)
- Confirm that the equipment needed is available or alternatives are available including intended stent type for PCI or cath-possible patients
- Patient’s allergies and premedication if appropriate (e.g., heparin-induced thrombocytopenia, contrast allergy)
- Special laboratory or medical conditions (e.g., INR, GFR)
- Confirm IC signed, witnessed and present