Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: Operator and institutional requirements for transcatheter valve repair and replacement, part 1: Transcatheter aortic valve replacement

The granting of staff privileges to physicians is an important mechanism to ensure quality care. The Joint Commission on Accreditation of Healthcare Organizations requires that medical staff privileges be based on professional criteria specified in medical staff bylaws. Physicians are charged with defining the criteria that constitute professional competence and with evaluating their peers accordingly. With the evolution of transcatheter aortic valve replacement (TAVR), an important opportunity arises for both cardiologists and surgeons to come together to identify the criteria for performing these procedures. The Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology Foundation (ACCF), and the Society of Thoracic Surgeons (STS) have, therefore, joined together to provide recommendations for institutions to assess their potential for instituting and/or maintaining a transcatheter valve program. This article concerns TAVR. As TAVR is in its infancy, there are few data on which to base this consensus statement. Therefore, many of these recommendations are based on expert consensus. As the procedures evolve, technology changes, experience grows, and more data is accumulated, there will certainly be a need to update this consensus statement. However, with the Food and Drug Administration (FDA) having just approved the first generation of TAVR devices, the writing committee and participating societies believe that the recommendations listed in this report serve as an appropriate starting point. In some ways, these recommendations apply to institutions more than to individuals. As there is a strong consensus that these new valve therapies are best performed using a team approach, these credentialing criteria may be best applied at the institutional level. Partnering societies used the ACCF's policy on relationships with industry and other entities (RWI) to author this document (http://www.cardiosource.org/Science-And-Quality/Practice-Guidelines-and-Quality-Standards/Relationships-With-Industry-Policy.aspx). To avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the writing committee, all members of the writing committee, as well as peer reviewers of the document, were asked to disclose all current healthcare-related relationships, including those existing 12 months before initiation of the writing effort. A committee of interventional cardiologists and surgeons was formed to include a majority of members with no relevant RWI and be led by an interventional cardiology co-chair and a surgical co-chair with no relevant RWI. Authors with relevant RWI were not permitted to draft or vote on text or recommendations pertaining to their RWI. RWI were reviewed on all conference calls and updated as changes occurred. Author and peer reviewer RWI pertinent to this document are disclosed in Appendices 1 and 2, respectively. In addition, to ensure complete transparency, authors' comprehensive disclosure information (including RWI not pertinent to this document is available as an online supplement to this document http://content.onlinejacc.org/cgi/content/full/j.jacc.2012.02.016/DC1). The work of the writing committee was supported exclusively by the partnering societies without commercial support. Writing committee members volunteered their time to this effort. Conference calls of the writing committee were confidential and attended only by committee members. SCAI, AATS, ACCF, and STS believe that adherence to these recommendations will maximize the chances that these therapies will become a successful part of the armamentarium for treating valvular heart disease in the United States. In addition, these recommendations will hopefully facilitate optimum quality during the delivery of this therapy, which will be important to the development and successful implementation of future, less invasive approaches to structural heart disease. Enabled by the development of new technologies, treatment of valvular heart disease by transcatheter techniques is becoming a favored approach of cardiac providers, resulting in less invasive treatment for patients previously treatable only with open heart surgery or, in many cases, not treatable at all. Recognition from the medical community of the applicability, effectiveness, and practicality of catheter-based transcatheter valve therapies has further increased interest in these treatments. Training program content, standards, credentialing, and board certifications for cardiac surgical procedures and percutaneous coronary intervention (PCI) are well developed, but no such structure exists in the field of percutaneous structural or valvular heart disease therapies. The purpose of this article is to outline criteria for operator and institutional requirements to enable institutions and providers to participate responsibly in this new and rapidly developing field. The emergence of transcatheter aortic valve repair and implantation as an alternative to traditional surgical therapy for valvular diseases has been facilitated by innovative devices, rapidly developing techniques, and careful patient selection [1]. The combination of interventional skills, equipment, collaborative clinical management, surgical approaches, techniques, and decision-making distinguish the qualifications to participate in this field as unique, as does the complexity of the patients requiring these therapies [1-3]. Given both the high-risk nature of these catheter interventions and the availability of established alternative treatment options using traditional surgical approaches, several considerations are important for institutions and operators planning to implement these new technologies. Defining operator and institutional requirements for these novel therapies is an important first step in ensuring their optimal implementation. Establishing a structural heart disease intervention therapy program requires several key components (Tables I and II). The defining principle is that this effort is a joint, institutionally-based activity for cardiologists and cardiac surgeons [1, 4]. Thus, the specialty that provides some of these components will vary from program to program. A transcatheter aortic valve replacement (TAVR) program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership. Comprehensive multidisciplinary teams (MDTs) are, therefore, required for transcatheter valve therapies. The critical cornerstone for establishing a transcatheter valve program is the formal collaborative effort between interventional cardiologists and cardiac surgeons. This element is essential for establishing a transcatheter valve program. No one individual, group, or specialty possesses all the necessary skills for best patient outcomes [1, 5]. The over-arching goal of these programs must be to provide the best possible patient-centered care [1, 6]. As these are new techniques, the correlation between operator experience and performance metrics for these procedures has yet to be established. The current pool of trained individuals is comprised predominantly of those who have participated in industry-sponsored trials aimed at device approval. Therefore, the translation of currently available experiences with transcatheter valve therapies to the “real world” has yet to be evaluated in the United States. Several core concepts should be implemented for all physicians performing these procedures, irrespective of their specialty background [7, 8]. They should all possess extensive knowledge of valvular heart disease, including the natural history of the disease, hemodynamics, appropriate diagnostics, optimal medical therapy, application and outcome of invasive therapies, and procedural and perioperative care [9]. The ability to interpret echocardiographic and other radiographic images (obtained at baseline, during the procedure, and follow-up) is critically important. MDTs and procedural teams need to possess echocardiographic interpretation skills for transthoracic and transesophageal studies. The use of three-dimensional (3D) and four-dimensional echoes may evolve to become essential diagnostic tools. Expertise in the interpretation of computed tomography (CT) scans of the iliofemoral vessels, cardiac anatomy, as well as aortic valvular anatomy, is critical for determining patient eligibility, and the approach for procedures [8, 10]. As noted, there is as yet no demonstrated direct correlation between operator experience with specific procedures and the skills necessary to perform transcatheter valve procedures, although there are some procedures that require similar prerequisite skills such as balloon aortic valvuloplasty (BAV) for TAVR. There are, however, some core concepts that professional societies have accepted as important for both facilities and operators [1, 11, 12]. Minimum training for specific procedures and devices will, for the immediate future, be primarily dictated by FDA approval requirements. Simulation is likely to play a significant role in technical training and proficiency maintenance for these evolving procedures [12-16]. As these procedures become integrated into mainstream care delivery, the strategy for training will likely need to be revised. Minimum requirements for transcatheter valve therapies include an understanding of basic radiation safety necessary for optimal imaging, operator and patient exposure protection, and knowledge of the use of X-ray contrast agents, which may not be standard in cardiac surgery training and experience. Coronary diagnostic procedures Coronary interventions Peripheral vascular diagnostic procedures Peripheral vascular interventions Balloon aortic, mitral, and pulmonic valve dilatation Stent implantation in right ventricle outflow tract and pulmonary arteries Intra-aortic balloon pump (IABP), other cardiac support device placement, including initiation of percutaneous cardiopulmonary bypass Percutaneous ventricular assist device placement Endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR) procedures Transseptal techniques Coronary sinus access Large vessel access and closure Operators should also have experience with specific catheter-based techniques required for valve interventions. Similarly, surgeons should have experience with transapical approaches for left ventricular assist device placement and care of similar high-risk patients to perform transapical TAVR [11, 12, 18]. The experience of an interventionalist or surgeon should be relevant to the transcatheter valve procedure undertaken. In this document, attention will focus on cardiac surgery and interventional cardiology experience relevant to aortic valve intervention The concept of sterile technique must be completely understood and stringently applied to the delivery of transcatheter valve therapies. Interventionalists must understand and be able to function in an environment that has more stringent sterile technique requirements than are common in catheterization laboratories. As one of the leaders of the team performing these procedures, the interventionalist must be able to with these procedures may open or open surgical devices that possess the of as valve will be for valve replacement procedures. for sterile technique are, therefore, to ensure best patient catheterization or with a radiographic with catheterization quality A may be for heart disease. and transesophageal echocardiographic with and in valvular heart disease. to is with vascular of performing and vascular studies. with and who and interpret cardiac studies. implantation must have a sterile environment that must have to the necessary for as well as that may be necessary in the of This for and cardiopulmonary bypass and A interventional is however, in the of such a the interventional cardiac should and and the procedure to requirements for surgery from the as a for to provide for surgical of that surgical requirements. of cardiopulmonary bypass in the interventional for the to the standard required in a cardiac catheterization and time Minimum of to echocardiographic equipment, equipment, surgical team and cardiopulmonary bypass pump interventional should a of equipment, including access endovascular and from to in a of for cardiac diagnostic and interventional vascular closure devices, balloon dilatation from to in and of and and coronary and vascular devices, and other devices, and device with their delivery care with in patients who have open heart valve procedures. of in an is not American College of Cardiology for Cardiovascular Angiography and Interventions on will outline the for a this is is not a prerequisite is not available at many there must be on the part of the to provide these and both and with no time on the A as a of the team is and care and formal multidisciplinary patient clinical care facilities are for the and technical is also in a facilities pulmonary vascular clinical should be of quality and able to the patient on a their these procedures should only be performed in institutions that currently and perform of surgical aortic valve with outcomes that or those established for similar procedures. 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