The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture held annually, bringing together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community. During the SCAI 2019 Scientific Sessions, relevant topics in interventional cardiology were identified with the goals of defining the state of the field, current challenges, and future directions. Topics were determined by nomination, and solidified through a voting process ultimately vetted by SCAI leadership and the industry relations committee. The 2019 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease (SHD), and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship (ELM) program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, and create additional dialogue to aid SCAI in developing specific action items in the future. How should maintenance of skill/competency programming for less frequently used, but critical technologies (atherectomy, mechanical support, PFO closure, etc.) be developed? Should SCAI play a larger role in developing standards and confirming these requirements within the community of providers and practice settings? What would be the ideal role for device manufacturers? Who are other potential stakeholders to consider? The practice of interventional cardiology has been transformed in the last 20 years.1-5 Introduction and refinement of new procedural techniques and medical devices have resulted in significant reduction in morbidity and mortality for patients with cardiovascular disease.6 The complexity of procedures performed by interventional cardiologists in 2019 requires specific manual and cognitive skills as well as familiarity with multiple devices. The group discussed how to balance access to these therapeutic devices while ensuring optimal patient care (i.e., rational dispersion of technology). The discussion centered around three less frequently used but essential novel technologies in the cardiac catheterization laboratory, which might serve as examples to be utilized more broadly. These included coronary atherectomy, mechanical circulatory support (MCS), and patent foramen ovale (PFO) closure. The committee also discussed how to ensure optimal training in complex percutaneous coronary interventions (PCI) procedures such as left main stenting, coronary bifurcations, intracoronary imaging with intravascular ultrasound (IVUS) and optical coherence tomography (OCT), and chronic total occlusions (CTOs). The primary challenge when considering the optimal roll out of novel procedures and/or medical devices intended for niche applications, as opposed to high volume procedures, is that (a) there is a clinical need for widespread access to these technologies, yet (b) given their smaller total procedural volume, it is challenging to maintain a high level of operator competency and to measure uniform quality metrics. Core competency training in procedures fundamental to the practice of interventional cardiology is required and determined by the Accreditation Council for Graduate Medical Education (ACGME). However, newer technologies and procedures are rapidly introduced in the field and often at a pace much faster than the evolution of the competency guidelines. This is especially applicable to the less frequently used technologies and procedures in the catheterization laboratory but nonetheless have a critical role such as the use of lesion modification tools, chronic total occlusion PCI, and large bore peripheral access, among others. Access to these procedures must be available to all patients within a certain geography, but perhaps concentrated in centers or individuals who have received adequate training and are able to maintain their expertise. The discussion also reviewed the benefits and hazards of designated centers of excellence, including potential misuse by hospitals to drive business. It was also acknowledged that existing training standards for these procedures and techniques are heterogeneous and incongruent (Table 1). (1) Didactic in-service training (2) Self-certification letter 25 cases as the primary implanter (1) Peer-to-peer training (2) Ten cases during interventional fellowship plus proctor present for first 3–5 cases for each new device (3) Maintenance of certification: >15 PFO procedures annually (1) Didactic training (2) One training case (PFO or ASD) Impella 2.5 or CP = 2 cases Impella 5.0 = 1 case Impella RP = 1 case Renewal of certification = 5 case per year or 10 every 2 years (1) Online didactic training (2) Wet heart hands-on simulation (3) Complete three cases, one under the supervision of a physician proctor and two under the supervision of BSCI The contemporary practice of interventional cardiology requires a set of common cognitive skills, as well as dedicated procedural skills to master less frequently used but critically important devices. Notably, many such devices will be approved after an individual's original interventional fellowship. The above discussions and presentations will hopefully serve to inform the cardiovascular and interventional community regarding SCAI's vision for the future in training both fellows and interventional cardiologists on both core and novel technologies and procedures. The SCAI Program Directors and Training Standards committee welcomes input from the broader cardiovascular community as we move forward on these initiatives. Should SCAI support a comprehensive critical limb ischemia (CLI) vascular team model? From chronic total coronary artery occlusions to percutaneous valvular therapies to CHD procedures, the purview of percutaneous interventions is rapidly expanding and often preferred by patients given its lower morbidity and mortality. This “minimally invasive” expansion has resulted in fewer open surgical interventions performed in peripheral vascular disease and has generated often unproductive competition between surgical and endovascular subspecialists. In the structural heart arena, a comprehensive “heart team” model has been adopted since the publication of a landmark SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial,8 endorsement of the “heart team” approach by the U.S. and European societies, and the requirement by the Centers for Medicare & Medicaid Services (under its National Coverage Determination for TAVR), that “patient (pre-operatively and post-operatively) should be under the care of a Heart Team: a cohesive, multi-disciplinary, team of medical professionals.”9 This team should include both interventional cardiologists and cardiothoracic surgeons who work synergistically to determine the best possible therapy for each individual patient. To date the application of a team model in the vascular space has unfortunately been challenging and quite limited. During the 2019 SCAI Think Tank session, SCAI leadership, together with industry partners, met to address the barriers to building a CLI team and to determine how the society can help with the adoption of a multidisciplinary team model to manage the complex clinical scenarios of patients with CLI. Successful multispecialty teams have the greatest chance of being formed when both clinical and financial incentives have been aligned. Patients with the most severe form of peripheral arterial disease, critical limb ischemia, with their complex comorbidities, along with the need to reduce amputations, morbidity and mortality, stand to benefit the most from the development of a vascular team. A wide array of revascularization approaches, technically challenging revascularization procedures, treatment of unhealed wounds and infections require the expertise of a multidisciplinary team in order to optimize patients' outcomes. There is a general agreement among CLI providers that a multidisciplinary CLI approach is invaluable,10 but the question remains about how to build and who should comprise such a team (Figure 1). The CLI team should be able to address several aspects of CLI care—assessment of the correct revascularization approach, the revascularization procedure itself, risk factor modification, wound care, infection control, and prostheses/orthoses management. Albeit CLI team building is institution-specific, certain key integral team members must be present on each team. Similar to the BEST-CLI trial, “CLI team” should have a minimum of two revascularization experts on the team: one credentialed in endovascular and the other in open surgical revascularization.11 The SCAI Think Tank group emphasized the importance of guideline-recommended medical therapy in CLI, which has been shown to reduce cardiovascular events, amputations, adverse limb events and mortality in this high-risk population.12 Therefore, SCAI Think Tank group recommended that each team include a cardiovascular specialist with expertise in managing concomitant comorbidities (i.e., coronary artery disease, diabetes, hypertension, cerebrovascular disease, dyslipidemia, etc.). Furthermore, recent data have shown that better glycemic control in diabetics with CLI is associated with improved wound healing and reduces future amputations. Therefore, an endocrinologist or a diabetologist should also be included as part of the CLI team. One of the ways to address the comorbidities would be to create a scorecard for all patients with CLI, which would include a checklist to ensure that all cardiovascular risk factors have been optimized. To address the wounds and infections, the CLI team should include wound care specialists, a surgeon (with expertise in wound care), podiatrists, infectious disease specialists, prosthesis and orthopedics experts, social workers, nutrition experts and nurses. Though revascularization is often recommended and paramount to wound healing, the choice of revascularization technique will vary from patient to patient and institution to institution. The SCAI Think Tank group recommended that before any amputation procedure occurs in a CLI patient, two specialists should review each case: one experienced in complex endovascular techniques and the other in open surgical revascularization. This approach would decrease the number of amputations and motivate institutions to formulate comprehensive multidisciplinary teams. At the overarching healthcare delivery system level, alignment of remuneration incentives among CLI team members is key to building a sustained and successful team, discouraging “turf battles,” and realizing long-term cost saving from prevention of readmissions. The group also felt that each institution should have a physician leader or champion who would be responsible for the education and the building of the multidisciplinary CLI team. Prospectively collecting clinical data and outcomes would be an important component of quality assurance at each institution. On a larger scale, further research from multi-institutional registries is needed, to demonstrate that CLI team approach is associated with saving limbs, fewer readmissions and improved survival. Source: Kolte, D. et al. J Am Coll Cardiol. 2019;73 (19):2477–86 In an effort to help promote CLI education and collaboration during training, the Think Tank group encouraged the development of educational programs focusing on CLI, wherein fellows-in-training from multiple subspecialties (i.e., interventional cardiology, interventional radiology, vascular surgery, podiatry, etc.) could interact, present and discuss CLI cases and various approaches to CLI treatment. SCAI in collaboration with other societies should also support CLI educational programs, geared towards educating our members and providing the tools needed for CLI team building. Examples of these would be CLI-focused lectures, educational pamphlets for patients and referring physicians, and online resources for patients and their families. SCAI Think Tank group recommended fostering collaboration among the various specialties, discouraging “turf battles,” encouraging vascular team building with a goal of better serving our CLI patients. The consensus of the SCAI PAD Think Tank group was that a CLI multidisciplinary team building should be strongly encouraged and supported by the Society. Our patients need to become better educated regarding which institutions have such teams and their respective outcomes. SCAI members should have the tools and support to lead the charge in the formation of CLI vascular teams at individual institutions. The goal of CLI teams should be to reduce and limit the number of amputations and reduce the morbidity and mortality of this high-risk population by ensuring compliance with wound care and guideline-recommended medical therapy. The CLI population is underrecognized, undertreated, and remains at high risk for cardiovascular morbidity and mortality, depression and poor quality of life. Therefore, SCAI and its members need to transcend historical barriers and come together with providers from multiple specialties in order to improve the care of this challenging patient population. Should training in SHD be formalized and standardized? Should there be an ACGME approved fellowship in SHD with its own certification examination? What role should SCAI play in this? The last decade has witnessed the rapid evolution and expansion of the field of SHD, largely driven by exponential growth of transcatheter interventions for valvular heart disease. Since initial United States Food and Drug Administration (FDA) approval of transcatheter aortic valve replacement (TAVR) and mitral valve repair in 2011 and 2013, respectively, nearly 100,000 TAVR procedures and over 7,000 MitraClip procedures have been performed in the United States alone.13-15 The field continues to evolve rapidly—a myriad of unique devices is currently being developed to expand our armamentarium for treating aortic, mitral, pulmonic, and tricuspid valve lesions. Moreover, transcatheter interventions for patent foramen ovale (PFO) and atrial septal defect (ASD) closure, left atrial appendage occlusion, heart failure optimization, and management of hypertrophic obstructive cardiomyopathy and adult CHD, among others, add to the growing complexity of the young field of SHD. In support of these numerous and diverse interventions, the SHD proceduralist must master a broad set of cognitive and technical skills unique to those required for coronary and peripheral vascular interventions in order to gain and maintain proficiency across the full spectrum of SHD interventions. Despite this fact, training for SHD interventions remains less developed and lacks standardization.16 The Society for Cardiovascular Angiography and Interventions (SCAI) therefore convened a Think Tank to consider possible approaches and solutions to address this unmet need within interventional cardiology. Skills gained while mastering one SHD procedure may not translate or contribute to the mastery of other SHD procedures. For example, gaining proficiency with TAVR, which requires large bore vascular access, crossing a stenotic aortic valve, aortic valvuloplasty, and device-specific training as well as cognitive understanding of the evaluation and management of severe aortic stenosis, indications for aortic valve replacement, and hemodynamics, has little in common with transcatheter PFO closure beyond basic proficiency with catheter and wire manipulation. Comprehensive training in the broad array of SHD interventions therefore requires specialized sites with high procedural volumes. However, the SCAI Structural Heart Disease Early Career Task Force Survey, conducted in 2011, suggested that not a single US interventional training program possesses adequate procedural volumes to offer sufficient training in all advanced structural interventions.17 Furthermore, in only four of the 15 types of SHD procedures (intracardiac echocardiography, balloon aortic valvuloplasty, PFO closure, and atrial septal defect closure) was the average number of procedures performed at a site higher than the number felt to be needed by a trainee to gain proficiency. While TAVR procedural volumes may now allow for adequate training opportunities, we suspect that the majority of SHD procedures continue to be performed at low volumes at the majority of sites. Compounding these challenges is the rapid evolution of SHD interventions and the endless introduction of novel procedures and devices that require unique cognitive and technical skills (i.e., coronary sinus catheterization, dry pericardial entry, transcatheter electrosurgery, etc.). Given the novelty and complexity of several transcatheter valve and structural interventions, training pathways are needed to not only accommodate interventional cardiology fellows, but also junior and seasoned interventional cardiologists and SHD proceduralists from other specialties, including cardiovascular surgery and interventional pediatric cardiology. Finally, while there is general agreement that the complexity of SHD interventions warrants a devoted year of fellowship training,18 currently there are no formal funding mechanisms for such training programs and an additional year of fellowship training is burdensome for trainees typically at post-graduate year (PGY) 8 or 9.19 Since 2010, SCAI has expressed a desire for standardized training curriculum and criteria for credentialing or certification within the SHD interventional space.20 While such criteria do not yet exist, the number of formalized SHD training programs in the US has continued to increase. Out of 150 adult interventional cardiology fellowship programs, 40 provide devoted non-ACGME-accredited fellowship training in SHD interventions.21, 22 These programs generally (94%) require training in interventional cardiology before entry and only three programs allow trainees from cardiothoracic surgery.21 Beyond these relatively few programs, training in SHD interventions is limited to FDA–mandated industry-sponsored, device-specific training courses and didactics; on-site clinical specialists and physician proctoring; national conferences with live cases and hands-on training workshops; and simulation training.18 Contemporary intolerance for ad hoc experiential learning from employers, payers, patients, trainees, and trainers has led to sub-specialization within individual fields in response to continued expansion of advanced diagnostics and therapeutics, their associated bibliography and technical requirements, amplified by increasing patient complexity. Yet although formal sub-specialization may support the physician, or protect the institution, it also establishes barriers between professionals isolating certain patient populations in the process, which may be detrimental to overall patient care and service delivery. In the case of CHD, the diagnosis and management has evolved to include patients from the fetus to the elderly. Traditionally, the care of CHD disease has been limited to pediatric cardiologists, but as the CHD population has survived to adulthood, more patients have transitioned into the adult cardiology “space.” While the cardiac disease processes and general management strategies remained unchanged, as the patient evolves from infancy to childhood to adulthood, newly acquired adult co-morbidities may impact the CHD processes and play an increasing role in the overall health of the individual. Hence, the care of these patients has diverged into two related but distinct pathways: Pediatric CHD and adult CHD. Similarly, interventions for these lesions have evolved to include both pediatric CHD and adult CHD interventionalists. Further complicating this transition are external institutional (and political) forces that impact the field of CHD based on the traditions and practices of Pediatric and Internal (Adult) medicine. In CHD, the anatomical complexity and historical treatment record can be virtually patient specific. Opinion based medicine still triumphs over evidence-based medicine in many areas of daily practice. Therefore, definitive examination is not straightforward and unlike adult cardiology's push to declare specialist interest, pediatric cardiology has not moved with the times. Sub-specialty fellowships are not formalized, training sites are not standardized, and training criteria, where they do exist, are based on arbitrary numbers which have not been justified with objective data. In a world where so much of clinical cardiology is credentialed, from the institution to the individual, it seems extraordinary that the group of physicians charged with intervening on the most vulnerable patient group sits without an approved fellowship or distinct certification. The Think Tank co-authors considered this and the extended challenges facing the pediatric and adult congenital interventional cardiology community whose natural home is the Society for Cardiovascular Angiography and Interventions (SCAI). Acknowledging the many factors explaining why pediatric cardiology has fallen behind, the Think Tank unanimously holds the view that training should be both formalized and standardized, ultimately as part of a process leading to accreditation by the Accreditation Council for Graduate Medical Education (ACGME) followed by certification through an appropriate credentialing board. The Think Tank also acknowledged the many obstacles to this process. As much of pediatric and adult congenital interventional cardiology is rare, the chance of exposure to certain diseases and interventions may not consistently be covered annually in all training centers. Therefore, if training standards were set, either flexibility in how they were obtained (e.g., allowing gaps to be filled during the first 5 years post fellowship), or arrangements to encourage training in more than one site would be required. Standards for training cannot be set if there is no certain way to deliver the standard. This is the responsibility of the trainers not the trainee. Various options were discussed to define the core pediatric and adult CHD cohorts. The most obvious, and most contentious of which was the apparently simple question “What elements define a child?”. On balance the Think Tank felt the cut-off age of 18-years, was the most reasonable boundary to adopt. Younger than that, the primary point of contact should be pediatric services. Exceptions to this are easily apparent. Frameworks to accommodate the emancipated minor, or the syndromic association of developmental delay would need to be considered at an institutional level. Similarly, flexibility to make the most of local capabilities seems reasonable. For example, managing the 80 kg, 14-year-old with Kawasaki's disease needing coronary intervention in local adult interventional services in preference to rigidly enforcing age criteria that cause significant travel to a site with pediatric capabilities but little coronary experience. Conversely, a 24-year-old with single ventricle physiology and complex branch pulmonary artery stenoses may still be best managed by the pediatric interventionalist. Therefore, although the primary division may be based on age, ways to support common sense decisions that are in the best interest of the patient must not be compromised by the mentality of “protecting one's turf” on either side of the dividing line. Although there is unanimous agreement regarding credentialing and certification for pediatric interventional cardiac programs and physicians taking care of pediatric patients, we remain uncertain at present about how to extend credentialing into the ACHD arena. The new sub-specialty of ACHD acknowledges the expertise of both pediatric and adult providers who do additional training in ACHD. Interventional cardiology should encourage the utilization of both pediatric and adult providers and their specific skill sets, particularly in the emerging structural space which has clear overlaps with CHD training and practice.24 The ultimate aim therefore should be to encourage creation of a multidisciplinary team in the care of complex patients. The concept of shared skills needs to be promulgated where two operators, one versed in CHD are supported by the capabilities of the local heart team. Focus on the skill set of the team rather than individual should be emphasized. Thus the aim of interventional ACHD/structural care should not be to build barriers, but rather to utilize the unique skills developed by both pediatric and adult physicians. The above topics and initial consensus opinions are meant to be springboards for further discussion and potential action items that can move each field forward incrementally. SCAI welcomes comments and suggestions on any of these topics, as well as potential new areas for focused discussion and relevant collaboration as part of future Think Tanks.
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Oct 25, 2023
Wilbert S. Aronow + 4
Open Access