PICS/AEPC/APPCS/CSANZ/SCAI/SOLACI: Expert Consensus Statement on Cardiac Catheterization for Pediatric Patients and Adults With Congenital Heart Disease Article Swipe

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Ralf J. Holzer , Lisa Bergersen , John Thomson , Jamil Aboulhosn , Varun Aggarwal , Teiji Akagi , Mazeni Alwi , Aimee K. Armstrong , Emile Bacha , Lee Benson , Regina Bökenkamp , Mário Carminati , Bharat Dalvi , James A. DiNardo , Thomas E. Fagan , Kenneth A. Fetterly , Frank F. Ing , Damien Kenny , Dennis Kim , Emily Kish , Michael L. O’Byrne , Clare O’Donnell , Xiangbin Pan , Joseph Paolillo , Carlos A. C. Pedra , Alejandro Peirone , Harsimran Singh , Lars Søndergaard , Ziyad M. Hijazi · YOU? · · 2023 · Open Access · · DOI: https://doi.org/10.1016/j.jscai.2023.101181

Pediatric Cardiac Interventional Standards—Better Late Than Never!Journal of the Society for Cardiovascular Angiography & InterventionsVol. 3Issue 1101251PreviewThere is an adage in pediatrics that "children should not just be treated as small adults." For cardiologists, this can be expanded to "congenital heart disease is not adult heart disease in a smaller anatomy." The first comprehensive cardiac catheterization standards consensus statement was published more than 20 years ago1 and established a detailed description of the ideal cardiac catheterization laboratory program standards to deliver quality care to patients. That document primarily focused on the adult population and devoted little space for the pediatric cardiac catheterization laboratory, encompassing only 4 pages of the 43 written. Full-Text PDF Open Access 1Table of contents 12Preamble 33Executive summary 44Introduction 124.1Writing committee 124.2Project timeline 134.3Evidence and consensus 134.4Project scope and goals 134.4.1Resource-limited environments 134.4.2ACHD patients 145Catheterization laboratory management and administration 145.1Physician leadership 145.1.1Director of the congenital cardiac catheterization program 145.1.2Substantive catheterizing physicians 155.2Nonphysician leadership 155.2.1Catheterization laboratory manager 155.2.2Administrative leadership 165.3Catheterization laboratory staffing 165.3.1General staffing considerations 165.3.2Team members of the congenital cardiac catheterization laboratory 175.4Policies and guidelines 185.5Considerations for ACHD patients 195.6Considerations for resource-limited environments196Procedural training and competency 196.1Providing minimum case number requirements 196.2Procedural training: General cardiology core and interventional trainees 196.2.1Introduction 196.2.2Prerequisites for training 206.2.3Assessment of training progress and competency 206.2.4Staged procedural competency: Trainee 216.3Procedural competency: Interventional cardiologists 226.3.1Ongoing procedural training 226.3.2Introducing new procedures 236.3.3Case-specific requirements 236.4Procedural competency: Nonphysician staff 236.4.1General competency 236.4.2Case-specific requirements 236.4.3Continued education and training 236.5Considerations for ACHD patients 236.5.1General operator background 236.5.2Occasional practice 246.5.3Requirements for performing ACHD interventions 246.5.4Dedicated ACHD interventional training 256.5.5Cooperation/collaboration with adult cardiologists experienced in structural heart disease and coronary artery disease 256.6Considerations for resource-limited environments 257The ideal pediatric and congenital cardiac catheterization laboratory suite 257.1General considerations 267.1.1Layout and size of the pediatric and congenital cardiac catheterization laboratory 267.1.2HVAC 277.1.3Considerations for multiple use 287.1.4The hybrid pediatric and congenital cardiac catheterization laboratory 287.2X-Ray equipment 287.2.1Single plane vs biplane 287.2.2Output/storage/analysis 287.2.3Equipment features 287.2.4Maintenance 297.2.5Longevity 297.3Non–x-ray equipment 297.3.1Vascular ultrasound 297.3.2Physiologic and laboratory data 297.3.3Echocardiography 297.3.4Radiofrequency generator 297.3.5Intravascular ultrasound 297.4Consumable supplies 297.4.1General considerations 297.4.2Approach to stock inventory 307.5Storage 307.5.1General considerations 307.5.2In- and out-of-room storage 307.6Considerations for ACHD patients 307.7Considerations for resource-limited environments 308Facility requirements 318.1General considerations 318.2Types of facilities 318.2.1Leadership structures 318.3Facility requirements for the pediatric and congenital cardiac catheterization laboratory 328.3.1Specific facility requirements to support the pediatric and congenital cardiac catheterization laboratory 328.3.2Organizational requirements to support the pediatric and congenital cardiac catheterization laboratory 328.4Considerations for ACHD patients 328.4.1Facility types and collaboration 328.4.2Multidisciplinary team 338.4.3Other facility requirements for ACHD patients 348.4.4ACHD Institutional support 348.5Considerations for resource-limited environments 349Surgical backup and circulatory support 349.1Introduction and background 349.1.1Surgical backup vs extracorporeal membrane oxygenation backup 349.1.2Surgical backup: Existing recommendations 349.1.3Extracorporeal membrane oxygenation backup: Existing recommendations 349.2Backup categories by urgency 359.3Extracorporeal membrane oxygenation/circulatory backup recommendations 359.4Surgical backup 359.4.1General recommendations 359.4.2Surgical operator 369.5Preparedness, activation and other logistics 369.5.1Backup activation 369.5.2Backup location 379.5.3Equipment 379.5.4Training 379.6Considerations for ACHD patients 379.7Considerations for resource-limited environments 3710Anesthesia and sedation 3710.1Types of sedation in the congenital catheterization laboratory 3710.2Staffing and training requirements 3810.2.1Operator-managed sedation 3810.2.2Sedation and anesthesia provided by a trained anesthesiologist 3910.3Equipment and monitoring requirements 3910.4Intraprocedural communication 3910.5Considerations for ACHD patients 4010.6Considerations for resource-limited environments 4011X-ray imaging and radiation safety 4011.1Physics of the catheterization laboratory equipment 4111.2Measures of radiation 4111.3Effects of radiation exposure 4111.4Dose reduction strategies 4211.4.1Equipment quality and calibration 4211.4.2Equipment operating protocols and settings 4211.4.3Best practices of operator conduct 4311.4.4Three-dimensional imaging 4411.5Radiation safety for patients and staff 4411.5.1Patients 4411.5.2Catheterization laboratory personnel 4411.5.3Pregnant staff 4411.5.4Pregnant patients 4511.6Oversight and monitoring 4511.6.1Oversight 4511.6.2Patient monitoring 4511.6.3Staff monitoring 4511.7Training and education 4611.8Regulatory requirements 4611.9Considerations for ACHD patients 4611.10Considerations for resource-limited environments 4612Quality and safety 4612.1Internal data and records 4612.2Targeting quality assurance and quality improvement: Adverse events in the pediatric and congenital cardiac catheterization laboratory 4612.2.1Recording patient and procedural adverse events 4712.2.2Quality assurance, internal analysis and learning opportunities 4712.3Continuous quality improvement 4712.4External performance measurement, risk adjustment, and comparative reporting 4812.5QI projects and resources 4812.6Regulatory requirements 4812.7Considerations for resource-limited environments 4813Preprocedural management 4813.1Patient selection: Congenital case management discussions 4913.2Procedure-specific case preparation 4913.2.1Imaging and chart review 4913.2.2Risk assessment 4913.2.3Procedural timing 5013.2.4Expected hospital stay 5013.2.5Additional preprocedural testing 5013.2.6Equipment, supplies, and support 5113.2.7Concomitant procedures 5113.2.8Patient-specific considerations 5113.3Informed consent 5113.4Precase clinical review 5213.5"Nil by mouth" guidelines 5213.6When to cancel or postpone a case 5213.7Transportation 5213.7.1Intubated and ventilated patients 5213.7.2Transporting patients on extracorporeal membrane oxygenation, ventricular assist device, or with high-frequency oscillatory ventilation 5213.8Preprocedural team huddle 5313.9Preparation for adverse events 5313.10Considerations for ACHD patients 5313.10.1Adult comorbidities and ACHD-specific considerations 5313.11Considerations for resource-limited environments 5414Intraprocedural management 5414.1Time out 5414.2Infection prevention 5414.3Hemodynamic calibration 5414.4Patient positioning 5514.5Vascular access 5514.6Intraprocedural documentation 5514.7Image acquisition and retention 5514.8Intraprocedural adverse events 5514.9Intraprocedural drug administration 5614.10Vascular hemostasis 5614.11Considerations for ACHD patients 5615Postprocedural management 5615.1Patient destination 5615.2Patient handoffs/transfer of care 5715.3Postprocedural monitoring 5715.4Bedrest guidelines 5815.5Structured procedure reporting 5815.6Procedure logs 5815.7Outpatient discharge planning and instructions 5815.8Considerations for ACHD patients 5916Procedures requiring specific preparations and setup 5916.1Hybrid procedures 5916.1.1Types of hybrid procedures 5916.1.2Environments for hybrid procedures 5916.1.3Staffing 6016.1.4Equipment and other requirements 6016.2Procedures in premature infants 6116.2.1Preprocedure considerations in premature infants 6116.2.2Transport and catheterization laboratory preparation for premature infants 6116.2.3Intraprocedure consideration for premature infants 6116.3Procedures done outside the congenital catheterization laboratory 6116.4Fetal interventional procedures 6116.4.1Starting a fetal program 6217Coronary interventions in pediatric patients 6217.1Coronary artery dilation/stent 6217.2Coronary artery fistula occlusion 6318Other considerations 6318.1Privacy, confidentiality and data protection 6318.2Participation of industry 6418.3Taped cases and live cases 64References 64Appendices 71Appendix A: Author relationship with industry and other entities 71Appendix B: External reviewers 72Appendix C: Abbreviations and glossary 72Supplementary Appendix S1: Core trainee catheterization rotation evaluationSupplementary Appendix S2: Assessment and evaluation of the interventional trainee This document has been developed as an expert consensus document by the Pediatric and Congenital Interventional Cardiovascular Society (PICS), the Association for European Paediatric and Congenital Cardiology (AEPC), the Asia-Pacific Pediatric Cardiac Society (APPCS), the Cardiac Society of Australia and New Zealand (CSANZ), Society for Cardiovascular Angiography & Interventions (SCAI), and the Latin American Society of Interventional Cardiology (SOLACI), with additional endorsement from the Congenital Cardiac Anesthesia Society (CCAS) and the American Association of Physicists in Medicine (AAPM, Sections 7 and 11).Endorsement: American Association of Physicists in Medicine (Sections 7 and 11) and the Congenital Cardiac Anesthesia Society. Endorsement: American Association of Physicists in Medicine (Sections 7 and 11) and the Congenital Cardiac Anesthesia Society. This expert consensus document is intended to inform practitioners, payors, hospital administrators, and other parties as to the opinion of the aforementioned societies about best practices for cardiac catheterization and transcatheter management of pediatric and adult patients with congenital heart disease (CHD), with added accommodations for resource-limited environments. The practice of cardiac catheterization in this patient population has evolved considerably in recent decades, as have significant local, regional, national, and international variations in practice standards. Many areas of practice are evolving at a fast pace, and for the most part, rigorous evidence-based data are not available to guide clinical practice. In the context of current medicine-based evidence, an expert consensus document was considered the most appropriate document format to provide recommendations specific to cardiac catheterization in this patient population. As part of this document's development process, it has been important to make a concerted effort to avoid any actual or potential conflicts of interest. All writing committee (WC) members provided disclosure statements as to relationships with industry or other entities (if any) that may be perceived as relevant to the content of this document. This was reviewed prior to finalizing the WC and updated at various stages throughout the writing, review, and revision processes. All relevant relationships with industry (RWI), including those without any financial interest, are listed for all WC members (Appendix A).1Bashore T.M. Balter S. Barac A. et al.2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions expert consensus document on cardiac catheterization laboratory standards update: A report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents developed in collaboration with the Society of Thoracic Surgeons and Society for Vascular Medicine.J Am Coll Cardiol. 2012; 59: 2221-2305https://doi.org/10.1016/j.jacc.2012.02.010Crossref PubMed Scopus (182) Google Scholar Requirements for cardiac catheterization procedures in pediatric patients and patients with CHD differ greatly from adult coronary or structural interventions, with limited existing practice standard recommendations. Those standards that do exist are often overly broad and do not account for variations in practices across the globe. Consequently, this document outlines comprehensive best practice recommendations including modifications and adaptations for resource-limited environments and adult CHD patients. The director of the congenital cardiac catheterization program is an essential requirement for laboratories practicing CHD catheterization and intervention. When the CHD program is embedded within a larger adult facility with shared cardiac catheterization laboratories (cath labs), it becomes important that the director of the congenital cardiac catheterization program maintains an associated leadership role. The director of the congenital cardiac catheterization program should be a fully trained and certified congenital interventional cardiologist with significant clinical experience, ideally >5 years beyond completion of fellowship or similar training, with verifiable experience of at least 500 congenital cardiac catheterization cases performed as first operator following completion of training. The director is responsible for overall clinical performance and strategic direction of the congenital cardiac catheterization program. He/she will require protected time to fulfill those duties, at minimum the equivalent of 0.1 full-time equivalent (FTE), but ideally at least 0.2 FTE. The director is expected to be a role model, must have demonstrable commitment to standard setting, and be responsible for maintaining a respectful teamwork environment. He/she should encourage best practices and quality of care through robust quality assurance (QA) and quality improvement (QI) processes, including data sharing and outcomes reporting. Other responsibilities include mentoring junior colleagues and all staff, overseeing privileging, training, maintaining current practice standards, safeguarding 24/7 coverage, and introducing new clinical procedures. The director also is responsible for introducing and implementing policies and protocols involving performance management, counseling, and grievance procedures. A cath lab manager or equivalent is a desirable ideal standard for any cath lab. The cath lab manager (usually a senior staff member) functions as a team leader for the nursing and technical staff, working in close cooperation with the medical director and administrative leadership overseeing the program. The responsibilities of the cath lab manager overlap with the medical director but with a more specific focus on the cath lab's nursing and technical staff and inventory management. Staffing standards ideally should include sufficient personnel to safely assume the roles of scrub assistant, circulator, and recorder/monitor. Ideal staffing would require 2 circulators, as this allows for help during strategic points in a case and provides coverage for emergencies and complications. Additional assistance may be needed for complex interventions, hybrid procedures, and cases with operator-managed sedation (OMS). Cath lab staff should ideally be cross-trained for multiple roles within the laboratory. For some complex congenital cases, having 2 qualified and fully trained operators may aid patient safety and good outcomes. The decision to arrange cases with a second fully qualified operator should be initiated by the main operating physician. When 2 qualified operators are performing the interventions together (if and when deemed necessary), the additional physician should be reimbursed for the time and/or (where applicable) recognized in terms of reported work "Relative Value Units" or similar policies of the country and facility involved. •Where local regulations dictate that adults must be treated by adult cardiologists, procedural staffing models that also include pediatric and/or adult congenital heart disease (ACHD) cardiologists should be adopted.•In facilities where the adult congenital interventional cardiologist and pediatric cardiac interventional cardiologist report through separate (adult and pediatric) leadership structures, regular meetings of the entire congenital interventional team are important. •Cross-training is an essential requirement.•Physician and nonphysician staff may have multiple roles to fill.•Operators may have to perform a procedure with limited assistance during a case. One of the greatest challenges when it comes to training, experience, and competency is provision of minimum case number requirements. In this document, the WC agreed to an approach where (low) minimum case numbers are provided. On their own, this does not guarantee competence, but below those minimum numbers, it is extremely unlikely that an operator would have the necessary competence. This was combined with other assessment tools and requirements that further supplement the competency requirements. Trainees pursuing an advanced interventional fellowship should have acquired core training in the basic principles of cardiac catheterization, including an introduction to basic technical skills. A thorough assessment and selection process should be put into place prior to offering an opportunity for an advanced fellowship. The duration of advanced training may vary but should be a minimum of 1 year. While recommendations for total case numbers are somewhat subjective, any program under which a trainee wishes to pursue interventional training should guarantee a high variety of complex interventional procedures and ideally perform a minimum of 200 congenital cardiac catheterizations per year (per advanced fellow being trained) in that institution. It is the responsibility of the training program director and catheterization program director to monitor core and dedicated interventional fellows in all aspects of their training. Curricular competencies include systems-based practice, practice-based learning and improvement, professionalism, and interpersonal and communication skills. Competency-based training or competence by design is an assessment format to determine training progress and competency. It requires the trainee to achieve an expected level of competency in predefined tasks rather than simply spending a defined amount of time in the subspecialty service or performing a certain number of procedures. Achievement of competency should be measured, monitored, and documented throughout the entire training curriculum. Interventional training can be structured in several formats. The basic level of training is recommended for all pediatric cardiology trainees. The goal of such training is to provide basic knowledge of hemodynamics, angiography, radiation safety, indications, risks, and benefits of interventional procedures in pediatric patients and adults with CHD. The trainee's role during the basic level of training should be as an active participant. It is important that core training to required levels of competency can be provided without necessarily scrubbing into every case during the catheterization rotations. The intermediate and advanced levels of training will be acquired through additional year(s) of dedicated interventional training following core training. The trainee undergoing advanced training should be afforded a greater experience and level of independence in the procedures than attained during the core competencies. At the conclusion of a trainee's program, it will be the (training) program director's responsibility to confirm the trainee has acquired the skills to perform basic interventional procedures independently up to the required level of competency. After completion of an interventional training program, early-career interventional cardiologists will not be fully capable of independently performing all types of interventional procedures. It is essential that the early-career junior interventional cardiologist has the availability of a senior operator to help develop and enhance his/her interventional skills for at least 2 to 5 years after training, and for many complex procedures even longer. Introducing new procedures requires that the interventional cardiologist perform several procedures under the supervision of a senior operator with adequate experience in the procedure. The organization should have a clearly documented process in place that monitors outcomes of these procedures once the operator performs these procedures independently. An adequate procedural volume is important. Maintaining competency for operators may be challenging if less than 75 interventional cardiac catheterization procedures are performed as a first operator per year, or if the program performs less than 150 cardiac catheterization procedures in pediatric and adult patients with CHD. Every team member participating in a congenital cardiac catheterization procedure should have the appropriate skills to perform the role-specific tasks that may be expected of him or her. Competency is acquired through experience. In laboratories offering pediatric cardiac catheterization, a minimum number of cases should be required for nonphysician staff: at least 75 congenital cases per year per staff member (50 of which should be in pediatric patients). •Primary operators performing ACHD catheterizations and interventions should possess extensive knowledge of CHD.•Recommendations for ACHD interventional training include participation as a first or second operator in a total of 150 ACHD procedures (100 interventional), with at least 10% of cases (but no more than 25%) performed in children.•Caring for ACHD patients requires a different skill set than caring for patients with coronary artery disease (CAD) or structural heart disease. As such, occasional practice should be strongly discouraged. As such, procedures must only be performed by operators who also have the required training and background in CHD. This will require either dedicated interventional pediatric cardiac training, formal ACHD interventional training, or (for experienced operators coming from a nonpediatric and non-ACHD background) to have performed at least 300 ACHD cases of wide variety and complexity.•Operators wishing to perform cardiac catheterizations in adult patients with CHD should maintain an adequate annual procedural volume. As an ideal standard, these operators should perform at least 50 ACHD cases, with 30 ACHD being of interventional nature.•Procedure-specific minimum case numbers need to be performed under guidance of an experienced ACHD operator prior to performing any of these cases independently. •Formal training requirements may be difficult to implement.•Specific volume requirements may not be achievable.•The availability of a senior operator to help develop and enhance the interventional skills of a junior interventional cardiologist may be limited. While exact dimensions of a procedure room may vary based on individual cath lab equipment configurations, appropriate are with a procedure room of less than 500 and ideally at least the cath lab have a of structural such as the need for and for and the room Other should be to the main cath lab This a room with an to the procedure a equipment support a scrub and sufficient access to storage Additional requirements will need to be to and A hybrid cardiac catheterization suite has several additional requirements beyond that for a standard cath lab. a hybrid suite should have an 200 of procedure room a dedicated that can be of ideally as as to For pediatric and congenital cardiac catheterization laboratory procedures, biplane imaging is extremely for imaging complex in exposure to radiation and As such this is the ideal standard for most data should ideally be fully An important of the equipment is the size of the the of which will be by case of adult vs and number of and are necessary to performance and to avoid should be on at least a an for the where many pediatric patients have to to the of radiation the of patients and procedures, a wide of supplies are While equipment does not need to be it is important to specific equipment by who often by training differ in the that procedures are should maintain a stock of equipment to up with a minimum number of is The laboratory manager should maintain detailed of all and levels of that should be in stock for congenital It is that a specific be performed supplies not available during a case. environments for equipment are which should be and as many may in access to the of available supplies is necessary for practice. some of and more storage is necessary for all the of these should ideally be done in such a that staff the laboratory during a procedure to equipment is are need to a may have to laboratories to of availability of a biplane strategies are necessary to the for specific may be of facilities that provide congenital cardiac catheterization include the hospital within an adult facility of a larger medical hospital to an adult facility of a larger medical service within an adult and cardiac hospital in care are different administrative and financial models to support congenital cardiac catheterization At the ideal of the is the fully hospital with all service fully within the hospital but within a larger combined facility in a larger medical In this the best as it has all the benefits of a also having all adult support in the this specific need to be at all other facility to and for and requirements to support a congenital cardiac catheterization program require access to core cardiac which include the cardiac cardiac congenital cardiac care and care and cardiac are in close support include access to and laboratory for pediatric and imaging with trained in 24/7 for important as as other support and requirements include a formal congenital case management dedicated policies for and extracorporeal membrane oxygenation a radiation safety program, a and program, as as specific protocols and support for procedures such as fetal ACHD procedures, areas within the hospital for and care need to be such as will need

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PICS/AEPC/APPCS/CSANZ/SCAI/SOLACI: Expert Consensus Statement on Cardiac Catheterization for Pediatric Patients and Adults With Congenital Heart Disease

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Ralf J. Holzer, Lisa Bergersen, John Thomson, Jamil Aboulhosn, Varun Aggarwal, Teiji Akagi, Mazeni Alwi, Aimee K. Armstrong, Emile Bacha, Lee Benson, Regina Bökenkamp, Mário Carminati, Bharat Dalvi, James A. DiNardo, Thomas E. Fagan, Kenneth A. Fetterly, Frank F. Ing, Damien Kenny, Dennis Kim, Emily Kish, Michael L. O’Byrne, Clare O’Donnell, Xiangbin Pan, Joseph Paolillo, Carlos A. C. Pedra, Alejandro Peirone, Harsimran Singh, Lars Søndergaard, Ziyad M. Hijazi

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Medicine, Cardiac catheterization, Psychological intervention, Consensus conference, Heart disease, Interventional cardiology, Cardiology, Internal medicine, Pediatrics, Family medicine, Psychiatry

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