A Proposal for the Core Curriculum for Training of “Advanced Level Cardiology Specialist Assistants”

For the Performance of Percutaneous Coronary Interventions (PCIs) and Non-Coronary Interventions: Part II Report of the International Society of Advanced Level Medical Imaging Physician Specialists (ALMIPS) and the Committee on Training Standards© Writing Committee Members Jack P. Chen, MD, FACC, FSCAI, FCCP Chuck Williams, BS, RPA, RT(R) (CV) (CI), RCIS, FSICP Harvey A. Koolpe, MD1 Manuel Viamonte, Jr., MD Morton Kern, MD David E. Allie, MD Craig Walker, MD Douglas C. Morris, MD Michele Doughty Voeltz, MD Constantin Cope, MD Siro Buendia, MD Jackson Thatcher, MD Phyllis Williams, RN, ASN, CEN, CVT Neil E. Holtz, RCIS, BS, EMT-P Pattie Freschett, RN, BSN, BBA, CVT Nicole Geiger, RCIS, AS Trevor E. Smith, HM-1, USN Harrell Carmicheal, SFC, USA Dereck Carver, RCIS, AS Betty Brooks, RN, ASN, CEN, TNCC, CVT Joe Brown, RCPT Marsha Holton, CCRN, RCIS, FSICP Wes Todd, BS, RCIS Kathy A. Groce, RN, MSN, RCPT Alexander Andreu, RT(R), AS, CVT Williams Embil, BS, CVT Jackson Thatcher, MD Phyllis Williams, RN, ASN, CEN, CVT Neil E. Holtz, RCIS, BS, EMT-P Jeff Davis, RRT, RCIS, FSICP Tracy Simpson, RCIS, FSICP Pattie Freschett, RN, BSN, BBA, CVT Nicole Geiger, RCIS, AS Trevor E. Smith, HM-1, USN Harrell Carmicheal, SFC, USA Dereck Carver, RCIS, AS Betty Brooks, RN, ASN, CEN, TNCC, CVT Joe Brown, RCPT Marsha Holton, CCRN, RCIS, FSICP Wes Todd, BS, RCIS Kathy A. Groce, RN, MSN, RCPT Alexander Andreu, RT(R), AS, CVT William Embil, BS, CVT Jill Kathe, RN, ASN, BS, CVT Lynn Taillon, BS Wayne Cochran, BS, RCIS Adele Serio, RN, BSN, RCIS Amanda Walters, RT(R), BS, AS Ashley Williams, BS Brent Rodriquez, RCIS, RCPT, RPFT, BS Christine Lucas-Testa, APRN, MSN Christine Bienvenue-Kauffman, RT(R), CVT Craig Cummings, RCIS, FSICP Daniel R. Jones, RCIS, BS Deborah Curl, RN, BSN, CVT Harvey McKinley, RCIS Jarrod A. Williams, BA Jason Wilson, RCIS Jeff Mays, RN, ASN, CVT Jennifer Malecki, RN, ASN, CVT Kacie Reynolds, AS, CVT Kenneth A. Gorski, RN, RCIS, FSICP Kristen Williams, RT(R)(MR) Lorena Hendry, PA-C, BS Mary Condon, CVT, AS Melissa Broddle, RT(R), AS, CVT Patricia Thomas, MBA, RCIS, FSICP Patrick Hoier, BS, RCIS, FSICP Rhoda Hammer, RN, MS, BSN, RCIS Ray Lenius, MEd, RCIS Robin Copeland RN, BSN Ronald B.Williams, RT(R)(MR) Sheila Debastiani, RT(R) Shataundia Reese, RN, BSN, CVT Shelley Ryan, RN Stacey Funicello, CMOA Susan Steinbis, ARNP, MSN Teresa B. Waters, MBA, BS, RT(R) Terry Scott, RN, BSN, CVT Tiffany Prats, BS, BBA Tim Rohrschneider, RT(R), BMSc, CVT Preamble The procedures of cardiac catheterization and coronary intervention have advanced to a level requiring sophisticated training to facilitate the procedure and provide best patient care. It is the purpose of this document to introduce the curriculum which may lead to the training and certification of a specialized non-physician practitioner, the Advanced Level Cardiology Specialist Assistant, assisting in the performance of cardiac catheterization, and coronary and non-coronary cardiac interventions. Furthermore, it is the intention of the International Society of Medical Imaging Physician Specialists and the Committee on competency training standards to develop a set of standards for attainment and maintenance of skills that require sound judgment based on perception, reason and technical skills that are important in order to assist or perform interventional cardiac procedures and non-coronary interventional procedures with the use of ultramodern technology under the direct supervision of or with direct assistance from board-certified/eligible cardiologists, cardiothoracic surgeons and vascular surgeons. I. Introduction Percutaneous coronary intervention (PCI) refers to balloon angioplasty and coronary stent implantations, and other sophisticated devices that augment cardiac interventions. Since PCIs are very complex procedures, an advanced level cardiology specialist assistant must have tangible cognitive and excellent technical skills. The degree of technical variables that can occur from one patient to another patient must be understood. The advanced level cardiology specialist assistant must have to ability to assist the physician in charge with management of serious complications that can occur. Immediate recognition of an adverse event requires knowledge, experience, skill and judgment. When a unexpected event occurs, how allied health professionals respond emergently varies between peers. When technical difficulties occur, the potential for significant variation in safety and efficacy during a procedure can lead to severe cardiac malfunction and death. With the assistance of the International Society of Medical Imaging Physician Specialists, Inc. and contributors, this document was developed as separate pathway for competency training in percutaneous coronary interventions and non-coronary interventional procedures. This document attempts to determine the standards of quality and content specifications for the process of credentialing and state licensing of advanced level cardiology specialist assistants in the United States and abroad. II. Purpose This material was completed by the authors, who reviewed medical data for the following reasons: A. To familiarize applicants with the rates of success and for complications for procedures B. To correlate success rates in PCIs and non-coronary interventions between the performance of an advanced level cardiology specialist assistant and success rates as analyzed by outcome statistics based on risk-adjustments. C. To evaluate success rates of procedures and the relationship with the activity level of medical facility as determined by outcome statistics based on risk-adjustments. D. To establish the criteria that would be used to evaluate the proficiency of advanced level cardiology specialist assistants. E. To determine disease processes and other medical risk factors that could be used to evaluate the specificities of procedures through the expected rates of expected outcomes and complications. F. To extend the scope of practice of advanced level cardiology specialist assistants to include non-coronary interventional procedures. G. To develop the training standards of advanced level cardiology specialist assistants, who will function under the medical directorship of board-certified/eligible invasive/interventional cardiologists, cardiothoracic surgeons and vascular surgeons. III. Writing Committee Composition The committee members were chosen because of their broad range of education, experience, and technical skills as physicians, physician assistants, nurse practitioners, radiographers, radiology practitioner assistants and registered nurses, and because each functions completely in invasive or non-invasive cardiovascular settings. Each member was identified on the basis of at least one of the following factors: A. A broad range of experience in academic settings and practice as allied health caregivers. B. A broad range of experience as educators in cardiovascular technology programs. C. A broad cross-section of interventional allied healthcare professionals who have managed or have extensive cardiovascular labs providing a broad range of PCIs and non-coronary interventions. D. A broad range of clinical experience (10 years or more) with considerable involvement with PCIs and non-coronary interventional studies (10,000 cases). E. A broad range of experience as a board-certified/eligible interventional cardiologist, cardiothoracic surgeon or vascular surgeon. IV. Literature Review The literature review was completed with the assistance of the authors and contributors, who have been involved with percutaneous interventional cardiac and non-coronary coronary interventional studies for at least ten (10) years. The bibliography covers the need for benchmarks for standards of quality and identifies the variances in risk adjustment that can affect success and complication rates. The review was directed towards procedural outcomes and the latest devices used to perform interventional procedures in order to: A. Evaluate methods to monitor if PCIs are performed within the guidelines established by the American Heart Association (AHA), American College of Cardiology (ACC), Society of Cardiovascular Angiography and Interventions (SCAI), and American College of Chest Physicians (ACCP). B. Include non-coronary interventions [i.e. mitral valve clipping, inferior vena cava (IVC) filter placements, valvuloplasties, percutaneous aortic valve replacements]. C. Examine data that focuses on the rapport between physicians, the advanced level cardiology specialist assistant and the medical facility. D. Develop the pathway that evaluates the proficiency levels of the supervising physician, the advanced level cardiology specialist assistant and the facility with statistical outcomes. E. Develop the pathway to evaluate the performance of low-caregivers and institutions. F. Establish guidelines to evaluate the programs providing didactic training and clinical training for advanced level cardiology specialist assistants. G. Assist the credentialing organization with development of a recognized and accredited examination process for advanced level cardiology specialist assistants. V. Clinical Training Path A. Supervised by an attending board-certified/eligible interventional cardiologist responsible for the care of the patient. B. Supervised by an attending board-certified/eligible cardiothoracic surgeon responsible for the patient. C. Supervised by an attending board-certified/eligible vascular surgeon responsible for the patient. D. Be involved in the planning of the procedure and versed in the indications for the procedure. E. Assist in selecting the instruments for the procedure. F. Handle technical manipulations of a case. G. Must complete at least 350 therapeutic procedures. VI. Clinical Practice Pathway A. Understands role of the supervising physician. B. Understands the roles of the support staff members. C. Understands need to maintain an excellent rapport with supervising physicians, referring physicians, support staff members and other team members that conveys confidence and direction as an advanced practice team member. D. Develops effective rapport with patient and family members, which includes bedside manner. E. Required to maintains advanced cardiac life support (ACLS) and basic life support (BLS) certification [pediatric advanced life support (PALS) if involved with pediatric studies]. F. Handles adverse events professionally without causing alarm in patient or support staff. G. Remains focused on mental well-being of patient throughout procedure and on vital signs (blood pressure, cardiac rhythms, and respiratory status) and has plan to correct events if needed. H. Able to handle procedure-induced cardiac conductive events such as bradycardia, supraventricular tachycardia, 1st, 2nd, and 3rd degree heart blocks, atrial fibrillation, atrial flutter, ventricular fibrillation, asystole and pulseless electric activity. I. Knows when to ask for help or when to discontinue a procedure when the procedure cannot be completed safely. J. Exhibits excellent knowledge for managing patient discomfort with the use of appropriate analgesic and sedative medications. K. Has extensive knowledge and experience with emergency lab protocols and procedures. L. Understands need for a standard work protocol that remains important to any cath lab team. VII. Indications A. ST-elevation myocardial infarction (STEMI) B. Non-STEMI C. Unstable angina D. Post myocardial infarction (MI) angina E. Post cardiac surgery angina F. MI at young age G. Complicated “Q-wave” MIs H. Post MI – Cardiac mechanical complications [mitral regurgitation (MR), ventricular septal defect (VSD)] I. Post MI – congestive heart failure (CHF) J. Cardiogenic shock K. Valvular stenosis L. Septal defects M. Pulmonary embolization VIII. Contraindications A. Electrolyte imbalances/digitalis intoxification B. Malignant hypertension C. Febrile illness D. Congestive heart failure E. Hemorrhage (anticoagulation with INR >2, PTT > 18 sec) F. Severe contrast media sensitivities G. Gastrointestinal (GI) bleeding H. Mental and physical incapacitation that limits cooperation I. Refusal to undergo coronary artery bypass grafting (CABG) or cardiac surgery if needed emergently J. Absolute reasons 1. Unable to sign informed consent due to mental incompetence 2. Inexperienced cardiologist and lack of proper imaging equipment 3. Inexperienced advanced level cardiology specialist assistant 4. Inexperienced advanced level cardiology specialist assistants with lack of education in use of ionizing or non-ionizing radiation and experience 5. Inappropriate facility tools (i.e. code cart, intubation, lack of manpower) IX. Procedures A. PCI and related procedures that require direct supervision 1. Coronary angioplasties a. Left anterior descending coronary artery (LAD) (proximal, mid, distal) b. Diagonals (1st, 2nd, 3rd) c. Ramus intermedialis d. Circumflex (proximal, mid, distal) e. Obtuse marginals (1st, 2nd, 3rd) f. Right coronary artery (RCA) (proximal, mid, distal) g. Right patent ductus arteriosus (RPDA) h. Continuation of RCA [left ventricular (LV) branch] i. Anomalous coronary arteries 2. Left ventricular assist device – intra-aortic balloon pump (IABP) insertion 3. Intracardiac echocardiography (ICE) 4. Temporary pacemaker insertions 5. Swan-Ganz catheter placements 6. Vascular closure device placements B. PCI and related procedures that require direct supervision with direct assistance 1. Bifurcation/ostial lesions a. LAD (proximal, mid, distal) b. Diagonals (1st, 2nd, 3rd) c. Ramus intermediatus d. Circumflex (proximal, mid, distal) e. Obtuse marginals (1st, 2nd, 3rd) f. RCA (proximal, mid, distal) g. RPDA h. Continuation of RCA (LV branch) i. Anomalous coronary arteries 2. Stent Placements a. Type A lesions 1) LAD (proximal, mid, distal) 2) Diagonals (1st, 2nd, 3rd) 3) Ramus intermediatus 4) Circumflex (proximal, mid, distal) 5) Obtuse marginals (1st, 2nd, 3rd) 6) RCA (proximal, mid, distal) 7) RPDA 8) Continuation of RCA (LV branch) 9) Anomalous coronary arteries b. Type B and C lesions 1) LAD (proximal, mid, distal) 2) Diagonals (1st, 2nd, 3rd) 3) Ramus intermediatus 4) Circumflex (proximal, mid, distal) 5) Obtuse marginals (1st, 2nd, 3rd) 6) RCA (proximal, mid, distal) 7) RPDA 8) Continuation of RCA (LV branch) 9) Anomalous coronary arteries 3. Atherectomies 4. Atherotomies 5. Rotablations 6. Photo-ablations 7. Intravascular hemodynamic study a. Pressure wire [fractional flow reserve (FFR)] b. Flowwire [blood flow signal (BFS)] 8. Intravascular ultrasound (IVUS) 9. Atrial septal defect (ASD)/patent foramen ovalve (PFO)/VSD closures 10. Valvuloplasties a. Mitral b. Aortic c. Pulmonic 11. Left ventricular assist devices a. TandemHeart 1) Insertion 2) Removal b. Cancion System 1) Insertion 2) Removal 12. Mitral valve clipping 13. Percutaneous aortic valve replacements 14. IVC filter placements 15. Pericardiocentesis 16. Cardioversion 17. Transeptal ablation of septal hypertrophy (HOCM) 18. Pseudoaneurysm repair X. Pre-Procedure Guidelines – Education and consent of patients A. Physician and advanced level allied health professional meet with patient and family in a serene setting. B. Informed consent is obtained after indications, potential risks, expectations, alternatives to procedure, and all possible outcomes are discussed with patient and family members, if present. C. Does not underestimate discomfort and duration of procedure. D. Explanation of breathing during coronary angiography. E. Explanation for PCI and/or or non-coronary intervention procedures is completed. XI. History and Physical A. A complete cardiac history and physical is completed B. Documentation of angina, dyspnea, syncope and other cardiovascular disease is recorded. C. Previous medical records are obtained with focus on conditions such as advanced cerebrovascular disease, diabetes Type II, peripheral vascular disease, pulmonary hypertension, and renal insufficiency or failure. D. Documentation of contrast media and/or medication allergies and reactions is completed. E. Physical exam is performed and process that focuses on the cardiopulmonary system and vascular system. F. Palpation of peripheral pulses must be done and charted. G. Auscultation for vascular bruits to select appropriate access site. XII. Laboratory and other clinical examinations A. Current chest radiographs, electrocardiogram (ECG), and laboratory data are reviewed. B. Review of echocardiograms and previous cardiac catheterization are completed C. An ECG, CBC with platelet count, electrolytes, serum creatinine, BUN, GFR, electrolytes, serum creatinine, BUN, GFR, and PT/PTT are obtained and reviewed. D. If a history of a blood loss, anemia or other bleeding diathesis exists, evaluation of coagulation system is completed. E. Evaluation of the coagulation system is required, if the patient has been on an anticoagulation therapy program. F. Creatinine and glomerular filtration rate (GFR) values are required if the patient has a history of renal impairment or renal failure. XIII. Procedural Requirements A. Evaluation and monitoring of patient 1. Choice of the appropriate vascular approach is based on the history and physical examination, types of procedures to be performed and clinical laboratory data 2. Proper position of the patient on the procedural table for proper cineangiographic projections is done 3. Access sites a. Brachial sites b. Femoral sites c. Radial sites 4. Functional IV access with an 18 ga or 20 ga Angiocath 5. Use of table pads, arm rests and pillows for comfort 6. Continuous ECG and hemodynamic pressure monitoring is required 7. Vital signs are recorded at the following durations a. Pre-procedure – every 15 minutes b. During procedure (conscious sedation) – every 5 minutes c. Post procedure – every 15 minutes for 2 hours, then every 30 minutes for 4 hours. 8. Radiolucent defibrillation pads are placed appropriately, if high-risk patient with history of ventricular dysrhythmias. 9. Defibrillation, intravenous access, intubation, suction equipment and emergency medications required by current AHA ACLS guidelines are available and in proximity of the patient in the procedure rooms as well as the pre-procedural and post-procedural patient areas. 10. Arterial blood pressure should be constantly monitored directly and/or by automated cuff or finger probe. 11. Arterial oxygen saturations must be done with pulse-oximetry on all patients pre-procedurally, during procedure and post- procedurally whether the patient has/does not have respiratory issues and will not be administered moderate conscious sedation. 12. Patient education about the procedure and equipment is completed in a non-threatening and considerate manner in order to lower anxiety. 13. Assessment of urinary output needs are addressed and are based on the duration of the procedure, urinary retention, ease of bedpan or urinal placement, and length of required bedrest. 14. Principles of IV sedation as approved by the hospital conscious sedation committee required. 15. Current ACLS certification and PALS (if pediatric studies are performed) are required for the attending physician and all advanced level cardiology specialist assistants. B. Planning of the Procedure 1. Prior to any procedure, the order of events are discussed with the attending and support staff. This process shall be individualized to the specific needs of each patient and focuses on the: a. Condition and stability of patient. b. Length of arterial access time. c. Reduction in repeated measurements. d. Reduction in number of catheter exchanges. e. Grouping of hemodynamic measurements so calculations can be completed with less procedure (vessel) time. 2. Diagnostic questions are answered during each procedure. C. Equipment needed to perform procedure should include: 1. Inventory of a variety of preformed catheters is required 2. Pressure transducers 3. Temporary pacemaker and pacing catheters a. Single chamber (VVI, asynchronize) b. Dual chamber (DVI, AAI, VVI, asynchronize modes) c. Transthoracic external pacing 4. External defibrillator (biphasic) with ability to perform synchronization for cardioversions as well as defibrillation 5. Variety of teflon-coated guide wires and hydrophilic wires 6. Pressure and doppler arterial wires 7. IVUS with IVUS catheters 8. Intracardiac echocardiography unit and catheters 9. Rotablation unit, advance devices and burrs 10. Photo-ablation unit and variety of catheters 11. Thrombectomy devices (e.g. AngioJet, Pronto catheter, Export catheter, Fletch catheter) 12. Left ventricular assist devices a. Intra-aortic balloon pump 1) IABP balloon kits – various sizes 2) Transducer setups 3) Helium tanks – spare b. Cancion System c. TandemHeart System XIV. Vascular Access A. If femoral, radial, or brachial arterial sites are used for access, knowledge of anatomy, appropriate indications and palpations are important and are indicated. B. Knowledge of sterile procedure, draping and local anesthesia is required. C. Arterial and venous percutaneous and cut-down access methods are practiced with proficiency. D. Dexterity of the hands is developed for recognition of proper wire movement for sheath and catheter placements to avoid access site complications such as site dissection, air emboli, embolization or displacement of lines. E. Difficult accesses require awareness of useful methods (techniques) to gain entry. F. Knowledge and how to use the following devices is required before any procedure begins: 1. Hydrophilic wires 2. Steerable wires 3. Long sheaths in tortuous proximal and external iliac arteries and moderately or severely dilated aortic areas 4. Contrast media and fluoroscopy for guidance 5. Valsalva maneuver to access common femoral veins 6. Fluoroscopy to identify the appropriate femoral puncture site 7. Micropuncture techniques 8. Vascular ultrasound to gain access XV. Angiography A. Size and style of catheters and sheaths are chosen. B. Knowledge of Judkins, Amplatz and other catheters used to perform cardiac angiography and angioplasty. C. Quick recognition of pressure dampening, understands implications and non-seating of catheters. D. Observes ostial pressures before, during and after contrast media injections. E. Ensures adequate vessel opacification with appropriate amount of contrast media and force during systole and diastole cycles without injecting an air embolus or thrombus. F. Responds rapidly to post-injection dysrhythmias and/or hypotension. G. Determines angiographic views that permits quality imaging with the lesser use of contrast media and radiation exposure. H. Communicates expectations with patient throughout procedure 1. Discomfort (local anesthetic, contrast media injections) 2. Procedural cause of transient angina. I. Determines angiographic views that permit quality imaging with the lesser use of contrast media and radiation exposure. J. Communicates expectations with patient throughout procedure. 1. Discomfort (local anesthetic, contrast media injections) 2. Procedural cause of transient angina K. Couples knowledge with dexterity to cross normal or diseased aortas with appropriate techniques, projections, catheters and guide wire options. L. Understands necessity of proper panning sequences with excellent hand coordination. M. Understands importance of panning when collateral vessels fill distal areas of contralateral and ipsilateral occluded arteries. N. Understands how to use exchange wires to change catheters. O. Understands how manipulate percutaneous transluminal coronary angioplasty (PTCA) guide wires, PTCA balloons and stent balloons across lesions and how to remove the devices as needed. P. Able to operate left ventricular assist devices and manage patients in cardiogenic shock. XVI. Post-Procedure Care A. Technical ingenuity 1. Evaluation and documentation of vascular integrity 2. Immediate post-procedural patient care 3. Monitoring and location of patient for post-procedural care 4. Length of bedrest and immobilization of extremity B. Management of complications 1. Adverse contrast media and medication sensitivities a. Urticaria (mild, moderate, severe) b. Anaphylactoid reactions (mild, moderate, severe) c. Anaphylactic shock 1) Respiratory distress and arrest 2) Cardiac arrest d. Current ACLS and PALS guidelines 2. Knowledge of ECG rhythms and cardiac dysrhythmias 3. Access sites a. Hematoma b. Hemorrhage (retroperitoneal, external) c. A-V fistulae d. Pseudo-aneurysms e. Thrombotic and embolic events f. Dissections 4. Neurologic events a. Transient ischemic attacks (TIAs) b. Blurred or loss of vision c. Loss of sensory function d. Stroke or cerebrovascular accident (CVA) e. Loss of motor function f. Paresis or paralysis 5. Adverse events caused by improper use of instrumentation a. Lack of knowledge with operating sophisticated devices used for complex interventional studies b. Tactile issues with catheter insertion c. Issues with manipulation of catheters d. Problems with catheter, PTCA balloon, PTCA guide wire removal 6. Non-vascular system adverse events a. Hazards of cardiovascular imaging b. Contrast-induced nephropathy c. Pulmonary congestion (CHF, edema) d. Hemodynamic and angiographic interpretation 1) Hemodynamic analyses a) Principles and methods of calculating cardiac output b) Calculations of stenotic valvular areas (planimetry, computer assisted) c) Detection of intra-cardiac shunts d) Calculation of intracardiac shunt ratios e) Analyses and explanation of pressure waveforms and measurements 2) Rapport with patient a) Discusses outcome with a patient, family members, referring physician b) Discusses prognosis, alternative treatment regimens and need for compliance of medical management plans with patients, family members, referring physician and involved healthcare and team members, so continuity of education and care occurs. XVII. Hemodynamics A. System Instrumentation 1. Fluid-filled pressure recording systems 2. Doppler and pressure wire systems 3. Calculation of cardiac output (valve procedures) 4. Oximetry and oxygen saturation B. Normal Cardiac Physiology 1. Left heart pressures [left ventricle (LV), left ventricular end diastolic pressure (LVEDP), aortic (AO), left atrium (LA)] 2. Right heart pressures [right atrium (RA), right ventricle (RV), mean pulmonary arterial pressure (mPA), pulmonary wedge capillary pressure (PWCP), right ventricular end diastolic pressure (RVEDP), right pulmonary artery (RPA), left pulmonary artery (LPA)] 3. Oximetry 4. Cardiac output/index 5. Vascular resistance [systemic (SVR) and pulmonary (PVR) vascular resistances] 6. Cardiac pharmacology 7. Exercise physiology C. Cardiac Pathophysiology 1. Coronary artery disease 2. Valvular disease 3. Pulmonary hypertension 4. Pericardial disease 5. Myocardial disease 6. Hypotensive cardiac disease 7. Congenital heart disease a. Anomalies of the coronary arteries b. Aortic anomalies (coarctation) c. Atrial defects d. Valvular disease e. Ventricular disease f. Other congenital heart defects g. Malposition of the heart (dextrocardia, situs inversus) 8. Oximetry and hemodynamic studies a. ASD/PFO b. VSD c. Patent ductus arteriosus (PDA) XVIII. Cardiovascular Pharmacology An advanced level cardiology specialist assistant must have the knowledge and understanding of the use of medications, which includes controlled substances, indications, incompatibilities with other medications, indications for use, side effects, dosage and reversal of controlled substances during treatment of the patient in the cath lab suites before, during and after the procedure. A. Pre-Procedure preparation for diagnostic and interventional studies 1. Preparation of the patient and previously prescribed medications. a. NPO (nothing by mouth) after midnight except sufficient amount to take oral medications 3 hours pre-procedure. b. Scheduled oral medications and anti-anginal medications should be continued. c. Aspirin, clopidogrel, nonsteroidal anti-inflammatory medications are not discontinued. d. If a heparin IV infusion is being administered for unstable or crescendo angina, discontinuance is not necessary. ACT should be done following access. e. IV access should be obtained. IV fluids maybe necessary to maintain hydration of the renal bodies except for patients with a history of CHF or pulmonary edema. 0.9% NaCl solution is most common IV fluid, administered at least 75 ml/hr. f. Diabetic patients should have blood glucose levels done before the procedure 1) If blood glucose readings are over 200, short-acting lipro or aspart insulin should be given (1 unit of insulin per 50 points above 200). 2) D5W IV infusion may be warranted in diabetics if hypoglycemia occurs 3) Beta blockers may mask usual symptoms of hypoglycemia 4) If sudden changes in consciousness or other physiological parameters occur, then D50 must be administered. 5) If procedure is delayed significantly, blood glucose levels should be repeated prior to procedure. g. INR levels should be less then 2.0. Oral anticoagulation medications should be discontinued. h. Diuretics are usually held prior to cath i. Anti-anginals and antihypertensive medications may be given with small sips of water (record vital signs before any medications are given). 2. Premedication prior to procedure a. Allergy preparation (contrast media) – per SCAI guidelines b. Beta blockers – discontinue in allergic patients if possible c. Pre-cath sedation 1) Benzodiazepines 2) Antihistamines 3) Analgesics 4) Reversal agents 5) Oxygen 3. Medications used during procedure a. Contrast medias b. Analgesics c. Anaphylactoid agents d. Anti-emetics e. Anticoagulants f. Anti-seizure agents g. Cardiac anti-arrhythmics h. Fibrinolytics i. H1 antihistamines j. H2 histamine antagonists k. Hydrocortisone l. Oxygen m. Platelet aggregate inhibitors n. Pressor agents o. Renovascular agents p. Reversal agents q. Sedatives XIX. Radiation Safety A. Radiation safety guidelines/radiation dose limits 1. Maximum permissible doses (MPD) a. Physician responsibilities are to reduce radiation doses to patients, support staff, and himself or herself through awareness of general exposure guidelines for occupational workers or occupational persons. b. Advanced level cardiology specialist assistants as well as members of the support staff are responsible for adhering to the general guidelines for occupational and non-occupational persons. c. General exposure guidelines for occupational workers. d. Tissue weighting factors along with sensitive organs. 2. Fluoroscopy versus digital imaging radiation exposure a. Basic fluoroscopy – 5 R/min (most systems function between 2-3 R/min). b. Digital imaging angiography @ 15 fps for 7-8 seconds can generate exposure levels that exceed levels produced with fluoroscopy. c. High-dose fluoroscopy 1) No limit on exposure (R/min) 2) Most have a continuous audible sound when used 3) Requires constant manual pedal usage 3. Radiation doses a. Patient exposure 1) Source to tabletop shall not be less then 18 inches (45.72 cm) 2) Use proper collimation (shutters should always be noticeable at edges of viewing field during fluoroscopy and imaging). 3) Use least amount of fluoroscopy 4) Use least amount of digital imaging time (6-8 seconds per run) 5) Use lowest clinically acceptable frame rate (15 fps) 6) Use lowest acceptable magnification for coronary angiography (17-18 cm or 20-22 cm). 7) Perform pregnancy test on all female patients between 12 and 60 years of age. b. Understands Consumer-Patient Radiation and Safety Act of 1981 1) Statement of purpose 2) Definitions 3) Promulgation of standards 4) Model statute 5) Compliance 6) Federal radiation guidelines 7) State radiation guidelines 8) Applicability to federal agencies c. Physician and support staff exposure 1) Distance (inverse square law) 2) As Low As Reasonably Achievable (ALARA) 3) 1° beam exposure 4) Scatter radiation (2° exposure) a) From patient b) From lateral filtration areas of x-ray tube (3 meters) 5) Record total fluoroscopic time 6) Record total time of angiographic runs 7) Angulation of imaging views (caudal views) 8) Brachial and radial arterial access cases double the dose to the operators 9) Use lowest frames per sec (15 fps) and acceptable magnification for ventriculography and coronary angiography d. Shielding 1) Wrap-around lead aprons 2) Thyroid collars 3) Lead glasses 4) Movable lead barriers B. Radiation Safety 1. Methods of measurement 2. Units of measurement a. Exposure (Roentgen, R) b. Absorbed dose (Rad, r) 1 Gray (Gy) = 100 rads c. Dose equivalent (Rem) 1 Sievert (Sv) = 100 Rems d. Effective Dose Equivalent (EDE) 3. Types of radiation injury a. Nonstochastic deterministic effects (direct-threshold doses) 1) Early effects 2) Acute radiation syndromes 3) Late effects b. Stochastic (probabilistic) effects 1) Assumption thresholds do not exist 2) Probability of injury is proportional to dose at any level 3) Carcinogenic effect (delayed) 4) Mutagenetic effect (reproductive cells before conception) 5) Teratogenetic events (in utero fetal exposure)

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