1 2 3 4 5 6 7 8 SCAI Expert Consensus Statement for Advanced Training Programs in Pediatric and Congenital Interventional Cardiac Catheterization Endorsed by the American Heart Association Laurie Armsby, Robert H. Beekman III, Lee Benson, Thomas Fagan, Donald Hagler, Ziyad M. Hijazi, Ralf Holzer, Frank Ing, Jacqueline Kreutzer, Peter Lang, Daniel Levi, Larry Latson, Phillip Moore, Charles Mullins, Carlos E. Ruiz, Robert Vincent For the Congenital Heart Disease Committee of the Society of Cardiac Angiography and Interventions 9 10 11 12 13 14 15 16 17 18 Introduction Pediatric and Congenital Interventional Cardiology is the practice of catheter-based techniques that improve cardiac physiology and circulation through the treatment of heart disease in children and adults with congenital or acquired heart defects. Over the last decade, and since last published training guidelines for pediatric cardiac catheterization and interventional cardiology were published in 2005 (1) the field of Pediatric and Congenital Cardiac Catheterization has evolved into a predominantly interventional discipline. In most cases, it is no longer appropriate to perform a diagnostic cardiac catheterization without the ability to perform an intervention if indications for an interventional procedure are met. 19 20 21 22 23 24 25 The knowledge base and scope of practice for Pediatric Cardiology has grown tremendously over the last few decades, and although virtually all subspecialty areas of Pediatric Cardiology have evolved into ever more complex fields, the time available for each subspecialty experience during the General Pediatric Cardiology fellowship training has not increased, and in many areas, has actually decreased. Given the greatly increased complexity and potential risks of Pediatric and Congenital Interventional Cardiac Catheterization procedures, it is no longer 1
26 27 28 29 30 31 32 33 34 35 36 37 38 appropriate to expect graduating General Pediatric Cardiology fellows to be qualified in this subspecialty at the completion of their core 3-year fellowship. Advanced training programs in Pediatric and Congenital Interventional Cardiac Catheterization have been available at some institutions for a number of years; however, there is marked variation in cumulative experience, educational structure and the scope of practice among these programs. The Society of Cardiac Angiography and Interventions recognizes the importance of advanced training in Pediatric and Congenital Interventional Cardiac Catheterization and recommends the development of guidelines and assessment tools for such programs. The Society feels that it is important for pediatric cardiologists who wish to perform cardiac catheterizations to become proficient in all aspects of cardiac catheterization through at least one additional year of advanced training. Individuals in these programs should perform procedures of gradually increasing complexity under the supervision of an attending interventional cardiologist until they become competent as the sole or primary operator. 39 40 41 42 43 44 45 46 47 48 Advanced training programs in Pediatric and Congenital Interventional Cardiac Catheterization should provide sufficient experience and advanced training for the fellow to become proficient in the applicable techniques and devices available during training, as well as competent to evaluate and learn new techniques as they emerge. By the end of the training program, the fellow should have sufficient expertise to act as an independent provider of diagnostic and interventional cardiac catheterization procedures for affected infants and children, and to act as a primary or consultant provider of these procedures in adults with congenital or acquired structural heart disease. Although newly graduated fellows should be competent, they may benefit greatly from ongoing mentorship by a senior colleague (when available) during the early years following training. 2
49 50 51 52 53 54 55 General Requirements for Programs An advanced trainee in Pediatric and Congenital Interventional Cardiac Catheterization should have successfully completed a core training program in Pediatric Cardiology as specified by the country in which they practice. A thorough understanding of the anatomy, physiology and alternative treatment strategies for the great variety of congenital heart defects is essential to provide the best patient care; this includes an understanding of the natural history of congenital defects, which is required to determine if treatment of a defect is indicated at all. 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 The duration of advanced training can vary, but should be sufficient to gain the experience needed and the skills required to fulfill the competencies listed below. Programs offering advanced training must have the appropriate infrastructure for training in place. In addition to the institutional requirements listed below, the program should provide trainees with exposure to, and experience with, a large number and wide variety of techniques and procedures. The case numbers of specific procedures listed below are only guidelines and may vary among training centers and individual trainees. These numbers (as with previous suggestions) (1) are based on expert consensus and have not been validated as either necessary or adequate. It is also expected that the interventional cardiology training director will utilize an effective performance evaluation tool for ongoing trainee assessment. The ability to measure the outcome of training efforts will be an increasingly important issue in the future. The Competence Assessment Tool below is meant as a guideline for trainers and trainees to consider. In the absence of formal accreditation of advanced training in Pediatric and Congenital Interventional Cardiac Catheterization, no uniform level of competence is as yet defined; however we feel the Competence Assessment Tool offers a valuable guideline to encourage and promote consistency of evaluations during the period of advanced training. 3
72 73 74 Institutional Requirements In order to offer training for advanced fellows, an institution or program should have the following in place and a commitment to the training and mentorship of the trainee: 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 1. An experienced interventional catheterization program director: at least 5 years posttraining with current certification in Pediatric Cardiology (by the American Board of Pediatrics or other country specific credentialing body), current medical licensure and appropriate medical staff appointment. An established record of teaching and research and demonstrated evidence of productivity in scholarship, including publications of original research in the field is desirable. They must have knowledge and experience with, and commitment to, pediatric and congenital interventional cardiology. 2. Sufficient annual case volume to allow for training. 3. A robust teaching environment: The institution and the program must jointly ensure the availability of adequate resources for fellows education. There must be space and equipment for the program, including meeting rooms, examination rooms, computers, visual and other educational aids and work/study space. There should be a demonstrated commitment of the institution to teaching programs (resident, fellow, nursing, other). In addition, fellows should be expected to participate in teaching within the program and institution. 4. Inpatient and outpatient facilities suitable for the treatment of children with congenital heart defects pre- and post-catheterization including intensive care units experienced in the care of all age groups treated in the catheterization laboratory. 5. A cardiac catheterization laboratory, preferably with biplane fluoroscopic and digital imaging equipment along with adequate hemodynamic monitoring and recording equipment and specialty-trained personnel. There must be a full complement of interventional devices (including retrieval and bail-out devices) and resuscitative equipment. 6. A pediatric/congenital cardiac surgical program with adequate staff and facilities to appropriately respond to emergencies related to catheter interventions. 7. Adequate non-invasive imaging facilities including echocardiography, cardiac CT and MRI imaging with expertise in congenital heart disease. 4
102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 8. An established process for pre-catheterization review and planning of all procedures by the operators. 9. A catheterization report system suitable for reporting congenital cardiac defects. 10. An active local quality improvement program, including an M&M (morbidity and mortality conference). Participation in at least one national or international registry / quality improvement program related to pediatric and/or adult congenital cardiac catheterization is desirable. 11. Research facilities, to include at a minimum: adequate personnel and resources for literature review, data collection and analysis for clinical research reviewed by an IRB. Case Numbers Although the appropriate number of cases is arbitrary and difficult to define, during the period of advanced training the fellow should participate as primary operator or first assistant in at least 250 total cases, of which 150 should be interventional procedures and at least 25 interventional procedures should be in neonates (<30 days of age). While there may be some flexibility in case numbers, the interventional procedures should be varied and include the following groups (and suggested minimum numbers): a) Device closures (other than coils and particles); ASD, VSD, PDA, PFO and others using closure devices and plugs: 30 b) Angioplasty procedures (not including primary stenting or compliance testing): 30 c) Valvuloplasty procedures (including transcatheter valve implantation): 15 d) Stent insertion (any vessel): 20 e) Atrial transseptal punctures: 5 f) Procedures to open the atrial septum (BAS, static balloon, blade septostomy, stenting): 5 g) Other procedures including hybrid procedures, pericardiocentesis, endomyocardial biopsies, coil and particle occlusion (without specific number). Competence Assessment of Interventional Fellows Scoring system: Section 1 5
130 131 132 133 134 135 136 137 138 139 140 141 Use EPAs (Entrustable Professional Activities) for knowledge sets and procedures. (2) Level of desired competency from 1-5 as follows: 1 = Has knowledge 2 = May act under full supervision 3 = May act under moderate supervision 4 = May act independently 5 = May act as a supervisor and instructor 1) Patient Care and Performance of Procedures Case-Specific Catheterization Knowledge / Competence 1. Demonstrates the ability to design the appropriate general approach to a procedure, including choice of vascular access sites, equipment required and the sequence of components (hemodynamics, angiographies, interventions) according to specific patient and procedural characteristics (age, weight and height, diagnosis, prior history) 2. Demonstrates proficiency in obtaining vascular access at diverse sites a. Umbilical b. Femoral, jugular/subclavian vein access; arterial access c. Transhepatic vascular access 3. Demonstrates the ability to perform and interpret a hemodynamic transcatheter evaluation, including required hemodynamic calculations 4. Demonstrates the ability to select, perform and interpret necessary and appropriate angiographic studies and use of appropriate radiation parameters 5. Demonstrates basic catheterization skills (catheter selection and manipulation, prepping of balloons, mounting of stents) 6. Demonstrates the ability to evaluate for and perform a variety of interventions, including equipment selection, approach, as well as understanding procedural indications and criteria for procedural success: a. Device closures (ASD/VSD/PFO) b. Other Device closures (PDA, collaterals, fistulas) c. Valvuloplasty 6
d. Balloon angioplasty e. Stenting f. Atrial Septal Interventions g. Hybrid Procedures 7. Demonstrates the ability to recognize when a procedure should not be continued and when other therapeutic strategies, or a future repeat catheterization may be more appropriate Device and Equipment Knowledge 1. Understands available guidewires and catheters and their specific characteristics for use 2. Understands available balloon catheters and their individual characteristics and indications for use 3. Understands available stents and their specific biomechanical characteristics and indications for use 4. Understands other available devices (non-stents) and their specific bio-mechanical characteristics and indications for use Adverse Events 1. Demonstrates awareness of potential adverse events related to individual patient and procedure combinations, and appropriate use of proactive measures to limit the incidence and potential significance of adverse events including radiation exposure and its adverse effects 2. Demonstrates the ability to respond to adverse events as they occur and to ameliorate the impact on the patient using the most appropriate technique 3. Demonstrates competence in leading cardiopulmonary resuscitation of a patient who has a cardiac arrest during cardiac catheterization 4. Demonstrates the ability to perform pericardiocentesis as well as pericardial drain placement 5. Demonstrates the ability to retrieve an embolized device 6. Demonstrates the ability to manage stent migration 7. Demonstrates the ability to manage circumferential balloon ruptures 8. Demonstrates the ability to judge and recognize the variable severity of vascular/cardiac injury and to correctly identify and make use of the therapeutic options (transcatheter, surgical, conservative / non-invasive) 9. Demonstrates the ability to recognize and manage arrhythmias and consult when necessary for arrhythmias occurring in the catheterization laboratory 7
142 143 144 145 146 147 148 149 150 151 152 153 154 155 10. Demonstrates the ability to manage complications at the vascular entry site 2) Medical Knowledge Scoring System: Sections 2-6 1 = Poor: demonstrates minimal ability and/or understanding 2 = Fair: demonstrates some ability and/or understanding 3 = Good: demonstrates the basic knowledge required, but not at an adequate level for independent performance 4 = Excellent: consistently demonstrates an understanding of the concepts and often performs independently 5 = Outstanding: demonstrates independent ability and the ability to mentor others General Catheterization-Related Knowledge and Skills 1. Identifies indications for transcatheter evaluation and therapy (as well as understanding when a transcatheter procedure is not indicated) for interventional as well as diagnostic procedures 2. Understands the role of other imaging modalities in the catheterization laboratory, such as IVUS, ICE, TEE, and rotational angiography 3. Understands the indication, mechanism and side effects of intravascular agents commonly used in the catheterization laboratory, including contrast agents, thrombolytics and anticoagulants, inotropes, antiarrhythmic agents 4. Understands the concepts of radiation physics and the need for radiation protection for patients, staff, and operators. 5. Understands potential renal complications as well as preventive and protective measures, including the identification of high-risk patients, as well as appropriate use of overall contrast load 6. Understands the necessary catheterization data and demonstrates an ability to integrate additional imaging modalities and clinical data 7. Understands the role of and indications for pharmacologic and fluid challenges in the catheterization laboratory 8
156 157 158 159 160 161 8. Demonstrates the ability to create a detailed hemodynamic diagram after a transcatheter evaluation, as well as create a catheterization report 9. Demonstrates the ability to provide post-catheterization care including appropriate follow-up evaluations 10. Understands device trials and regulatory requirements 3) Practice-Based Learning and Improvement: Self-Appraisal and Evaluation 1. Participates regularly in quality assurance (QA/QI) or morbidity and mortality conferences (M&M), which review catheter-based procedures and complications 2. Demonstrates the ability to evaluate, own errors, mistakes and weaknesses 3. Is able to demonstrate improvement based on feed back. 4. Has knowledge of catheter-related quality improvement projects, e.g. radiation safety, catheter M&M, catheterization-related checklists and how to participate. Assimilation of Scientific Evidence 1. Participates regularly in journal clubs and reviews of the literature involving pediatric transcatheter therapies. 2. Has learned the ability to interpret scientific literature including statistical methods taught during residency and core fellowship. 3. Demonstrates competence in incorporating scientific findings into improvements in everyday practice. 4) Interpersonal and Communication Skills 1. Demonstrates the ability to effectively communicate with patients and parents both before and after procedures 2. Demonstrates competence in obtaining informed consent, including explaining risks, benefits and procedural details. 3. Demonstrates the ability to effectively communicate before, during and after procedures with other team members including nurses, catheter lab staff, other interventionalists, other cardiologists and intensivists, radiologists, anesthesiologists. 4. Demonstrates the ability to involve the cardiothoracic 9
162 163 164 surgeon in the procedural decision-making. 5. Demonstrates competence in communication of the postcatheterization plan to the ward or ICU team. 6. Demonstrates competence in communicating a comprehensive discharge plan to families and patients. 5) Professionalism: 1. Demonstrates a commitment to carrying out professional responsibilities in an ethical manner. 2. Demonstrates the ability to work effectively as part of a team 3. Demonstrates sensitivity to a diverse patient population. 4. Demonstrates an ability to carry out responsibilities with appropriate and professional communication skills and appropriate management of anger and other emotions, before, during, and after procedures. 165 166 167 168 169 170 171 172 6) Systems-Based Practice: 1. Demonstrates awareness of the larger context of the health care system including billing, reimbursements and insurance providers. 2. Demonstrates knowledge of state-specific recourses available to patients with congenital heart disease. 3. Demonstrates competence in utilization of resources to provide optimal value to children in need or scheduled for catheterization. 1. Beekman RH, Hellenbrand WE, Lloyd TR, Lock JE, Mullins CE, Rome JJ, David F. Teitel DF. Task Force 3: Training Guidelines for Pediatric Cardiac Catheterization and Interventional Cardiology. 2005;46:1388-1390 2. Cate O, Scheele F. Viewpoint: Competency-Based Postgraduate Training: Can We Bridge the Gap between Theory and Clinical Practice? Academic Medicine, 2007;82: 542-547 173 174 10