<scp>SCAI</scp> position statement on adult congenital cardiac interventional training, competencies and organizational recommendations

Abstract

Congenital heart disease (CHD) is the most common congenital anomaly and occurs in ~0.8% of all live births. Medical and surgical advancements over the past 80 years have resulted in markedly improved survival, and the majority of CHD patients are now surviving to reach adulthood. The number of adults with CHD (ACHD) in the United States now exceeds the number of pediatric patients.1 This changing demographic trend towards adulthood was first recognized in the early 1970s, and several clinics specializing in ACHD were developed in the 1980s.2 Over the past 40 years, there has been an incremental increase in the number of ACHD clinics and specialty centers, mostly based at large academic medical centers, and often staffed by both adult and pediatric cardiology specialists. Along with the rise in the number of ACHD patients, there has been a parallel increase in the volume and variety of transcatheter interventional procedures applicable to ACHD patients. The definition of ACHD can be somewhat arbitrary depending on the various stakeholders managing CHD patients and the institutional culture and expertise. Most agree that age 18 years is the typical cutoff that separates pediatric from adult patients. However, some Children's hospitals will accept CHD patients as old as 26 years or even older, especially if they have been cared for all of their lives in the same institution. Often, during the college age years (18–22 years), patients and their parents may prefer continued care with their pediatric cardiologist. Meanwhile, there are also adult cardiologists and hospitals willing to manage late adolescent CHD patients, especially those with adult weight ranges and those with comorbidities such as diabetes, hypertension and dyslipidemia. Issues of contraception, pregnancy planning and pregnancy management in young women with ACHD require special consideration and teams experienced in this area of ACHD, be they pediatric or adult specialists, are best suited to care for these patients. Models of “expert ACHD centers” that exist currently vary widely from collaboration between a free-standing children's hospital that collaborates with a partner adult hospital/s, to a children's hospital embedded within an adult medical center to adult hospitals with no affiliation with a Children's hospital but that have collaborative arrangements with pediatric cardiologists. While diversity of ACHD centers exists, it is clear that a team approach involving both pediatric and adult CHD experts and multispecialty collaborators is optimal for the best care of ACHD patients from adolescence through older adulthood. The rapid rise in the number and complexity of transcatheter interventional procedures performed in this population has prompted the publication of consensus recommendations from stakeholder organizations regarding the delivery of ACHD interventional care, including recommendations within the ACC/AHA guidelines explicitly stating that interventional procedures should be performed at regional ACHD centers by qualified specialists with training and experience in ACHD interventional care and in laboratories with appropriate staffing and experience to fulfill this task.3 The Adult Congenital Heart Association (ACHA) was founded as a national organization in the United States that includes patients and medical professionals and helps educate and empower ACHD patients and their families. In 2014, the ACHA developed an ACHD center accreditation process that includes a comprehensive list of staffing and care process requirements (https://www.achaheart.org/provider-support/accreditation-program/). The ACHA's accreditation steering committee attempted to establish certain well-defined quality measures for the delivery of ACHD care in the United States. This accreditation program has become a cornerstone for ensuring that comprehensive care centers for ACHD meet prespecified acceptable thresholds, including recommendations for the delivery of transcatheter interventional care. The ACHA Comprehensive Care Center requirements state that ACHD interventions should be performed by trained and experienced specialists at centers with adequate facilities and expertise to deliver such care. The availability of around the clock interventional and surgical coverage is critical, as is the participation of the ACHD team in the periprocedural care as well as long-term anticipatory planning of these patients. Specialized training in ACHD has taken place at pioneering ACHD programs in the United States for over three decades. The early training programs did not include a uniform curriculum but relied on the age-old technique of a master clinician accepting to tutor and train willing apprentices who would then go on to establish grow new and established ACHD programs. These specialists came from both adult and pediatric cardiology backgrounds, hence, the majority of established ACHD programs in the United States currently include adult and pediatric cardiac specialists working collaboratively. Interventional ACHD procedures are currently performed by both pediatric and adult specialists at pediatric, adult, and combined hospital settings.4 ACHD was certified as a unique sub-specialty by the American Board of Medical Specialties in 2012 and the American Board of Internal Medicine instituted a certifying examination that, thus far, has been given in 2015 and 2017; there are now over 300 physicians from pediatric and adult cardiology backgrounds certified as ACHD specialists in the United States. The Accreditation Council for Graduate Medical Education (ACGME) now certifies ACHD training programs for a 2-year fellowship in ACHD that can be offered after successful completion of fellowship training in adult or pediatric cardiology. Within the 2-year ACHD fellowship curriculum is a requirement for a minimum of 2 months of catheterization training and there are an additional 6 months that can be utilized for research and/or elective rotations. In recognition of the need for specific recommendations regarding interventional training, an expert consensus statement from the Society for Cardiovascular Angiography and Interventions (SCAI) was published in 2010.5, 6 The authors appropriately highlighted that “training needs to be aligned with the goals and priorities of a “basic” or “advanced” level; moreover the training should be categorized into either “acquired” or “congenital” interventional cardiology. Moreover, the experts concluded that fellowship training in structural and congenital interventions is but “a foundation for a lifetime of learning and maturation, and very few trainees will master more than either the basics of a very select number of complex procedures during a 1- or even 2-year program.” The experts recommended a minimum fellowship duration of one year but strongly encouraged ongoing mentorship and continued learning thereafter. This consensus document also highlighted the importance of integrated multidisciplinary care in partnership with established centers of excellence in ACHD. An additional expert consensus document from SCAI was published in 2014 focusing on interventional training in pediatric (and congenital) interventional cardiology.7 This document was not specific to ACHD and was primarily focused on pediatric interventional training. The experts proposed case numbers of specific procedures and encouraged the utilization of a performance evaluation tool for ongoing trainee assessment. The duration of training can vary but the experts recommended at least 250 total cases be performed, 150 of which should be interventional procedures. ACHD-specific case numbers and case types were not stated. Multidisciplinary stakeholders from the interventional and ACHD communities were invited to attend a roundtable meeting organized by SCAI at the 2018 SCAI Scientific Sessions. Attendees included pediatric interventionalists, adult structural interventionalists, ACHD specialists, and observers representing industry stakeholders. Three fellow trainees were also present in the role of scribes and charged with documenting the discussions. Meeting participants are listed in Table S1. The attendees were evenly split into three groups, each led by a meeting co-chair and focused on the following priorities: (a) ACHD interventional training, (b) competency for physicians already in practice, and (c) institutional and team requirements for the delivery of ACHD interventional care. Following a brief overview and instructions by the meeting chairman, the experts proceeded to debate and discuss their group mandates for 90 min. Each group reported on their conclusions, concerns, and recommendations at the end of the meeting. SCAI received financial support for the roundtable from Abbott Laboratories, Edwards Lifesciences, and Medtronic Inc. Industry supporters did not participate in planning, content development, or tactical execution of the meeting. Meeting attendees received honoraria for their participation. This position statement summarizes the key judgments and recommendations that were drafted at the roundtable and refined in subsequent discussions among members of the writing group. The resulting document has been developed according to SCAI Publications Committee policies for writing group composition, disclosure and management of relationships with industry (RWI), internal and external review, and organizational approval. The writing group has been organized to ensure diversity of perspectives and demographics, multi-stakeholder representation, and appropriate balance of RWI. Relevant author disclosures are included in Table S2. Before appointment, members of the writing group were asked to disclose all relevant financial relationships with industry (>$25,000) from the 12 months prior to their nomination. A majority of the writing group disclosed no relevant financial relationships. Disclosures were periodically reviewed during document development and updated as needed. SCAI policy requires that writing group members with a current financial interests are recused from participating in discussions or voting on relevant recommendations. The work of the writing group was supported exclusively by SCAI, a nonprofit medical specialty society, without commercial support. Writing group members contributed to this effort on a volunteer basis and did not receive payment from SCAI. Recommendations were discussed by the full writing group on a series of teleconferences and during two additional in-person meetings until all group members agreed on the text and qualifying remarks. All recommendations are supported by a short summary of the evidence or specific rationale. Additionally, the writing group conducted a survey of ACHA-accredited ACHD programs to ascertain diagnostic and interventional case volumes and practice setting(s) from the prior year. This information was used to inform recommendations on optimal procedural volumes. Survey results are presented in Table S3. The draft manuscript was posted for public comment in December 2019 and the document was revised to address pertinent comments. The writing group unanimously approved the final version of the document. The SCAI Publications Committee and Executive Committee endorsed the document as official society guidance in February 2020. There are both cognitive and procedural skillsets that are necessary in order to perform interventional ACHD catheterization. Individuals seeking to be competent in ACHD interventional care should have a deep understanding of congenital heart disease, in addition to demonstrating the technical/procedural skills necessary to perform interventions. The recommendations provided herein are intended to ensure that trainees who seek to perform ACHD interventions possess training in both realms (the cognitive tools and the procedural skillset) to become competent. Recommendations are not intended to be a mandate, but rather to help ensure that the training of ACHD interventionalists will include both cognitive and procedural aspects of ACHD. Moreover, it is important to recognize that trainees may come from diverse educational backgrounds, including pediatric cardiology, adult interventional cardiology, and adult congenital cardiology; it is imperative that logical pathways be available for individuals from these diverse backgrounds. The experts recognize that some invasive or interventional training in ACHD may have taken place during general pediatric cardiology fellowship, ACHD fellowship, or adult structural or coronary interventional fellowship. However, in general, this does not constitute an adequate amount of training in ACHD interventions and additional focused training is necessary. A trainee who has completed a general pediatrics residency followed by a general pediatric cardiology fellowship and additional pediatric interventional cardiology training. It should be noted that accredited fellowships in pediatric interventional cardiology do not yet exist. A trainee who has completed an internal medicine residency followed by a general adult cardiology fellowship and adult interventional cardiology fellowship (with a primary focus on coronary interventions). A trainee who has completed an internal medicine residency, adult cardiology fellowship, followed by a 12-month adult interventional cardiology fellowship and a separate 12-month adult structural fellowship (with the latter focused on procedures for acquired structural diseases, such as transcatheter aortic valve replacement, transcatheter mitral valve repairs, etc.). These trainees may have had limited exposure to complex congenital interventions but may have participated in atrial septal occlusion procedures and other “simple” CHD interventions. A trainee who has completed a pediatric or adult cardiology fellowship and thereafter has completed or is enrolled in an ACHD fellowship and desires to train further in ACHD interventions. Completion of an interventional training program does not ensure that physicians are fully capable of independently performing all ACHD interventional procedures. Competency goes beyond training, and should be thought of as an ongoing process. At the conclusion of any fellowship program, the physician has only achieved the minimum level of competency to go on to the next stage. Lifelong learning and multidisciplinary collaboration are the overarching principles in this field. Thereafter, an emerging ACHD interventionalist is best served both by continued mentorship and interactions with the other stakeholders in this field. The duration and depth of such mentorship may vary from individual to individual but is certainly worthwhile to have in the first 5 years out of training. The congenital heart team remains critical in providing both the mentorship as well as the collaboration for the maturation process. The duration of ACHD interventional training is highly dependent on the procedural volume and the achievement of competence by the trainee. The procedural volume recommendations made in the next section should serve as the primary determinant of training duration and in a busy ACHD interventional program should be achievable over a 12–24 month period. It is imperative that the training also include appropriate risk stratification for interventional procedures,8 potential complications, and the appropriate management of said complications. Although case volumes tend to be somewhat arbitrary, the advanced ACHD interventional trainee should develop technical skills (as a primary operator or first assistant) on a sufficient volume and variety of procedures in order to achieve competence and comfort with all aspects of the procedure.9 For trainees with a pediatric interventional background it is recommended that all cases are performed in adults in order to achieve competence in ACHD patients. For trainees with an ACHD or adult interventional background it is recommended that at least 10% (and no more than 25%) of cases are performed in children. It is important for adult providers to engage with and work along-side their pediatric interventional counterparts and in so doing gain knowledge and experience in the management of children with CHD. There are certain interventional procedures that are uncommon in the ACHD population (e.g., VSD closure) but are more frequently performed in the pediatric population; therefore, the adult trainee may gain more exposure to such procedures in the pediatric population. Device closures: Angioplasty/stenting procedures In addition to the above procedural volume recommendations the trainee must demonstrate knowledge of angiographic projections to support interventions in a variety of CHD subtypes such as coarctation of the aorta, branch pulmonary artery stenting, pulmonary valve implantation, intracardiac baffles and selective coronary angiography. There is a growing trend towards the performance of hybrid interventions and the trainee should develop experience in working collaboratively with congenital heart surgeons around complex cases requiring surgical access. Understanding surgical capabilities, techniques, approaches, and potential complications is required for appropriate patient selection and sound decision making. The ACHD interventional program training director is responsible supervising the trainee and for signing off on individual procedural volumes. There must be demonstrated competence not only in the technical maneuvers required to conduct an intervention but also in an in depth knowledge of procedural complications and bail out strategies. It is the responsibility of the program director to ensure that the requisite knowledge base has been achieved prior to certifying a trainee. Appropriate ACHD case exposure and volume are clearly needed in order to ensure adequate training. It is imperative that training centers have sufficient ACHD interventional case volume and variety to facilitate such training. ACHD interventional training programs should have an annual case volume that exceeds 150 with a minimum of 100 interventional procedures. Physicians performing training should be experienced in ACHD interventions and are expected to commit sufficient time and effort into the procedural training, didactic education and mentorship of the and should that the have performed the sufficient number of procedures as above and that the are in and have the technical skills and knowledge base to perform ACHD interventions. It should be noted that no trainees will master the variety of ACHD interventions during the training and ongoing learning and mentorship are strongly of competency for physicians that are no in a training program is given the of practice operator case complexity and practice It would be to who have been performing interventional cardiology on adult congenital patients for years to for an examination or to go to fulfill additional training guidelines to interventionalists already in practice to for and for definition of minimum acceptable procedural volumes. than it is that all ACHD interventionalists should their case case complexity and competency is very to and at least in be based on case complexity must also be and cases be into complex A case volume at an ACHA-accredited comprehensive care center that the of complex ACHD procedures is for the development and of procedural These procedures are often performed by an interventional team that may of pediatric and adult interventional specialists working This a to develop and the competence of more than one individual of the multidisciplinary In general, ACHD interventional competency should require an case volume of at least ACHD cases year with over ACHD interventions. VSD artery coarctation pulmonary valve valve septal procedural numbers and is and such as the or the Congenital Cardiovascular Interventional should be used by all ACHD of competency by of cognitive procedural volume and procedural complexity is critical and should be performed by all A effort by the various and including SCAI, and ACHA would be in the ACHD interventionalists by to general knowledge and to procedural volumes and The two have an of interventional procedures in the of congenital cardiology. The number and variety of occlusion and transcatheter and other has The of new and is to to grow It is imperative that physicians of and to the available tools by participating in ongoing procedural training and most often provided by industry ACHD interventionalists be expected to adequate volume in all the potential ACHD procedures and of provided by the of should be industry would procedural volumes and as needed. ACHD interventionalists should be expected to for procedures performed than It is imperative that physicians in practice of in the of ACHD and ACHD interventions. at educational in the United States and the are in this There are that can be utilized to and increase cognitive knowledge of ACHD such as the and ACHD learning center of education is an of the ongoing of ACHD interventionalists already in practice should to at least of year focused on congenital interventions. between adult and pediatric interventional specialists is for the of comprehensive ACHD care. an adult interventional specialists often have expertise in coronary interventions and certain structural interventions (e.g., transcatheter aortic valve and mitral valve pediatric interventionalists may have expertise in pulmonary artery interventions and interventions. a collaborative between adult and pediatric interventionalists is most for adult patients with CHD. It is imperative that individual and commit to this collaborative care in order to the quality care to these patients. of the common ACHD procedures are performed in the pediatric population. A collaboration between a interventionalist and an congenital interventionalist can both physicians to gain exposure to additional procedural volume and of the of their care providers For both adult and children's to children's to adult CHD specific The growing number and complexity of ACHD interventional procedures the development of ACHD-specific and for the delivery of comprehensive interventional care. training of specialists is key and should be of both adult and pediatric specialists. Moreover, it is imperative that care for this population be by multidisciplinary teams that adult and pediatric expertise in a and collaborative ACHD and comprehensive care center accreditation are important that serve to the delivery of care to this population. training and education are as is institutional to the delivery of and care. planning and stakeholder collaboration is necessary to establish and help competency for physicians in The writing group the of the following individuals who participated in the 2018 SCAI ACHA and and Table 2018 SCAI ACHD Table S2. Writing Disclosures of with Industry Table S3. of survey to Adult Congenital Heart Association accredited comprehensive care centers, 26 program to the The is not responsible for the content or of any information by the than should be to the author for the

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