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

Abstract

For disclosure of author relationships with industry (RWI), see Appendix 1; for peer reviewer RWI, see Appendix 2.PreambleThe 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 at 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.IntroductionEnabled 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 [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar]. 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 [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 2Ruiz C.E. Feldman T.E. Hijazi Z.M. Holmes Jr, D.R. Webb J.G. et al.Interventional fellowship in structural and congenital heart disease for adults.J Am Coll Cardiol Intv. 2010; 3: e1Abstract Full Text Full Text PDF Scopus (14) Google Scholar, 3Feldman T. Ruiz C.E. Hijazi Z.M. The SCAI Structural Heart Disease Council: Toward addressing training, credentialing, and guidelines for structural heart disease intervention.Catheter Cardiovasc Interv. 2010; 76: E87-E89Crossref PubMed Scopus (17) Google Scholar]. 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 (Table 1, Table 2). The defining principle is that this effort is a joint, institutionally-based activity for cardiologists and cardiac surgeons [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 4Vassiliades Jr, T.A. Block P.C. Cohn L.H. Adams D.H. Borer D.R. et al.The clinical development of percutaneous heart valve technology: a position statement of the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography and Interventions (SCAI).Ann Thorac Surg. 2005; 79: 1812-1818Abstract Full Text Full Text PDF PubMed Google Scholar]. 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.Table 1Transcatheter Aortic Valve Replacement: Criteria for New and Existing ProgramsNew programs Institutional interventional program1000 cath/400 PCI per yearaWith acceptable outcomes for conventional procedures compared to NCDR benchmarks. TAVR interventionalist100 Structural procedures lifetime or 30 left sided structural per year of which 60% should be balloon aortic valvuloplasty(Left sided procedures include EVAR, TEVAR, BAV, AV, and MV prosthetic leak closures and VSD closures). (ASD/PFO closures are not considered left sided procedures)Suitable training on devices to be used Institutional surgical program50 Total AVR per year of which at least 10 AVR should be high-risk (STS score ≥ 6)Minimum of 2 institutionally-based cardiac surgeons in program (more than 50% time at hospital with surgical program) TAVR surgeon100 AVR career, at least 10 of which are “high-risk” (STS score ≥ 6) or 25 AVR per year or 50 AVR in 2 years and at least 20 AVR in last year prior to TAVR initiationExperience with, and management of, peripherally inserted cardiopulmonary bypassExperience with open retroperitoneal exposure of, and surgical intervention on, the iliac arteriesSuitable training on devices to be used TrainingCardiologists must be board certified/eligible in interventional cardiologySurgeons must be board certified/eligible in thoracic surgeryAdditional operators who are trained or experienced in structural heart disease, and have unrestricted hospital privileges in structural procedures, may also be part of the interventional operating team with the interventional cardiologist and cardiovascular surgeonExisting programs InstitutionalPrograms in existence >18 months: 30 TAVR (total experience)Programs in existence <18 months: 2 per month TrainingCardiologists must be board certified/eligible in interventional cardiologySurgeons must be board certified/eligible in thoracic surgeryAdditional operators who are trained or experienced in structural heart disease, and have unrestricted hospital privileges in structural procedures, may also be part of the interventional operating team with the interventional cardiologist and cardiovascular surgeonASD = atrial septal defect; AV = aortic valve; AVR = aortic valve replacement; BAV = balloon aortic valve; EVAR = endovascular aneurysm repair; MV = mitral valve; NCDR = National Cardiovascular Data Registry; PCI = percutaneous coronary intervention; PFO = patent foramen ovale; STS = The Society of Thoracic Surgeons; TAVR = transcatheter aortic valve replacement; TEVAR = thoracic endovascular aortic repair; VSD = ventricular septal defect.a With acceptable outcomes for conventional procedures compared to NCDR benchmarks. Open table in a new tab Table 2Volume and Outcomes for Continued Certification for both New and Existing TAVR Programs Applies to “Inoperable” (PARTNER Cohort B) TAVR PatientsProgram volume of 20 TAVR per year or 40 per 2 years30-day all-cause mortality < 15%30-day all-cause neurologic events including TIAs < 15%Major vascular complication < 15%aAccording to VARC-2 (Valve Academic Research Consortium) [9a] definitions.>90% Institutional follow-up60% 1-year survival rate for nonoperable patients (cohort b)—after the program has been running for 2 years (2-year average)Ongoing CME (or nursing/technologist equivalent) of 10 hr per year of relevant materialAll cases must be submitted to a single national databaseCME = continuing medical education; TAVR = transcatheter aortic valve replacement; TIA = transient ischemic attack.a According to VARC-2 (Valve Academic Research Consortium) [9aValve Academic Research Consortium. Revised standardized endpoint definitions for transcatheter aortic valve implantation (VARC-2). Manuscript in preparation.Google Scholar] definitions. Open table in a new tab Knowledge Base and SkillsThe 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 [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 5Herrmann H.C. Baxter S. Ruiz C.E. Feldman T.E. Hijazi Z.M. et al.Results of the society of cardiac angiography and interventions survey of physicians and training directors on procedures for structural and valvular heart disease.Catheter Cardiovasc Interv. 2010; 76: E106-E110Crossref PubMed Scopus (39) Google Scholar]. The over-arching goal of these programs must be to provide the best possible patient-centered care [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 6Cameron A. Laskey W. Sheldon W. SCAI ad hoc task force on ethics in invasive and interventional cardiology.Catheter Cardiovasc Interv. 2004; 61: 157-162Crossref PubMed Scopus (28) Google Scholar].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 [7Kouchoukos N.T. Bavaria J.E. Coselli J.S. De la Torre R. Ikonomidis J.S. et al.Guidelines for credentialing of practitioners to perform endovascular stent-grafting of the thoracic aorta.J Thorac Cardiovasc Surg. 2006; 131: 530-532Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar, 8Beller G.A. Winters Jr, W.L. Carver J.R. King S.B. McCallister B.D. et al.28th Bethesda Conference Task Force 3: Guidelines for credentialling practicing physicians.J Am Coll Cardiol. 1997; 29: 1148-1162Abstract Full Text PDF PubMed Scopus (17) Google Scholar]. 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 [9Guidelines for standards in cardiac surgeryAdvisory Council for Cardiothoracic Surgery, American College of Surgeons.Bull Am Coll Surg. 1997; 82: 27-29Google Scholar].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 [8Beller G.A. Winters Jr, W.L. Carver J.R. King S.B. McCallister B.D. et al.28th Bethesda Conference Task Force 3: Guidelines for credentialling practicing physicians.J Am Coll Cardiol. 1997; 29: 1148-1162Abstract Full Text PDF PubMed Scopus (17) Google Scholar, 10Vahanian A. Alfieri O.R. Al-Attar N. Antunes M.J. Bax J. et al.Transcatheter valve implantation for patients with aortic stenosis: A position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).Eur J Cardiothorac Surg. 2008; 34: 1-8Crossref PubMed Scopus (248) Google Scholar].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 [1Holmes Jr, D.R. Mack M.J. Kaul S. et al.ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement.Ann Thorac Surg. 2012; 93: 1340-1395Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 11Peterson E.D. Coombs L.P. DeLong E.R. et al.Procedural volume as a marker of quality for CABG surgery.JAMA. 2004; 291: 195-201Crossref PubMed Scopus (256) Google Scholar, 12Crawford F.A. Anderson R.P. Clark R.E. Grover F.L. Kouchoukos N.T. et al.Volume requirements for cardiac surgery credentialing: a critical examination.Ann Thorac Surg. 1996; 61: 12-16Abstract Full Text PDF PubMed Scopus (56) Google Scholar]. 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 [13Bashankaev B. Baido S. Wexner S.D. Review of available methods of simulation training to facilitate surgical education.Surg Endosc. 2011; 25: 28-35Crossref PubMed Scopus (55) Google Scholar, 14Hislop S.J. Hedrick J.H. Singh M.J. Rhodes J.M. Gillespie D.L. et al.Simulation case rehearsals for carotid artery stenting.Eur J Vasc Endovasc Surg. 2009; 38: 750-754Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar, 15Cacho F. Doblare M. Holzapfel G.A. A procedure to simulate coronary artery bypass graft surgery.Med Biol Eng Comput. 2007; 45: 819-827Crossref PubMed Scopus (40) Google Scholar, 16Tedesco M.M. Pak J.J. Harris Jr, E.J. Krummel T.M. Dalman R.L. et al.Simulation-based endovascular skills assessment: The future of credentialing?.J Vasc Surg. 2008; 47 (discussion:1014): 1008-1016Abstract Full Text Full Text PDF PubMed Scopus (81) Google Scholar, 17Seymour N.E. Gallaher A.G. Roman S.A. O'Brien M.K. Bansal V.K. et al.Virtual reality training improves operating room performance: results of a randomized, double-blinded study.Ann Surg. 2002; 236 (discussion:463–4): 458-463Crossref PubMed Scopus (2063) Google Scholar]. 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.Training in the use of closed systems for hemodynamic monitoring and contrast injections will result in optimal integration into catheterization laboratories and hybrid environments. Catheter and wire skills, including knowledge of the use of various techniques and the equipment available to access complex anatomy and negotiating necessary vascular and anatomic structures are required. Understanding of the interplay of wires, catheters, and anatomy is required for completion of these procedures. These skills can be acquired in a variety of ways. Prior experience with a variety of interventional techniques is important. These include but are not limited to:•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 closureOperators 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 [11Peterson E.D. Coombs L.P. DeLong E.R. et al.Procedural volume as a marker of quality for CABG surgery.JAMA. 2004; 291: 195-201Crossref PubMed Scopus (256) Google Scholar, 12Crawford F.A. Anderson R.P. Clark R.E. Grover F.L. Kouchoukos N.T. et al.Volume requirements for cardiac surgery credentialing: a critical examination.Ann Thorac Surg. 1996; 61: 12-16Abstract Full Text PDF PubMed Scopus (56) Google Scholar, 18Bonow R.O. Carabello B.A. Chatterjee K. Leon de JR, A.C. Faxon D.P. et al.2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease).J Am Coll Cardiol. 2008; 52: e1-e140Abstract Full Text Full Text PDF PubMed Scopus (1218) Google Scholar]. 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 enforce compliance with these standards. These procedures may involve open or partially open surgical components. Also, large devices that possess the same risk of infection as conventional valve prostheses will be implanted, especially for valve replacement procedures. Operating theater standards for sterile technique are, therefore, mandatory to ensure best patient outcomes.FacilitiesThe institution should have an active valvular heart disease surgical program with at least two institutionally-based cardiac surgeons experienced in valvular surgery, and should contain a full range of diagnostic imaging and therapeutic facilities including:1Cardiac catheterization laboratory or hybrid operating room (OR)/cath lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy, offering catheterization laboratory quality imaging. A biplane unit may be advantageous, particularly for congenital heart disease.2Noninvasive imagingaEchocardiographic laboratory. Transthoracic and transesophageal echocardiographic capabilities with sonographers and echocardiographers experienced in valvular heart disease. Access to 3D echocardiography is preferable.bVascular laboratory (noninvasive) with vascular specialists capable of performing and interpreting vascular studies.cCT laboratory with CT technologists and specialists who can acquire and interpret cardiac CT studies.3Physical space—The implantation suite must have a sterile environment that meets OR standards. Furthermore, it must have sufficient space to accommodate the necessary equipment for uncomplicated implantations as well as any additional equipment that may be necessary in the event of complications. This includes space for anesthesiology, echocardiography, and cardiopulmonary bypass equipment and personnel. A specifically designed hybrid OR interventional suite is ideal; however, in the absence of such a facility, the interventional cardiac suite should have:aCirculating heating, ventilation, and air conditioning laminar flow diffusers (providing smooth, undisturbed air flow and usually placed directly over the procedure table) to meet air requirements for surgery rooms.bAsymmetrical/symmetrical six-lamp 2 × 4 troffers (the inverted, usually metal trough suspended from the ceiling as a fixture for fluorescent lighting) to provide adequate high-output lighting for surgical intervention.cAdequate number of power receptacles that meet surgical equipment requirements.dCapability of running cardiopulmonary bypass apparatus in the interventional suite.eGas outlets for the anesthesia machine.fAdequate room size to accommodate the standard equipment required in a cardiac catheterization laboratory (eg, high-definition displays and monitors, O2 analyzer, defibrillator/resuscitation cart, O2 supply, suction, compressed air, CO-oximeter, activated clotting time analyzer).gMinimum room size of 800 square feet (74.3 m2) to accommodate echocardiographic equipment, sonographers, anesthesia equipment, emergency CT surgical team and cardiopulmonary bypass equipment (eg, surgeon, assistant, scrub tech, pump techs), if needed.4Fungible equipment—The interventional suite should stock a large variety of fungible equipment, including various access kits, endovascular sheath and introducers ranging from 4 to 26 F in various lengths, a wide range of guide wires for various purposes, cardiac diagnostic and interventional catheters, vascular closure devices, balloon dilatation catheters ranging from 2 to 30 mm in diameter and of various lengths and profiles, bare metal and covered stents (eg, coronary and peripheral), occlusive vascular devices, snares and other retrieval devices, drainage catheters, and various implantable device sizes with their delivery systems.5Postprocedure intensive care facility with personnel experienced in managing patients who have undergone conventional open heart valve procedures.6Use of mobile C-arm imaging system in an OR is not adequate.7HYBRID OR—The “2012 American College of Cardiology Foundation/Society for Cardiovascular Angiography and Interventions Expert Consensus Document on Cardiac Catheterization Laboratory Standards Update” will outline the specifications for a hybrid Cath Lab/OR [18aBashore 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.J Am Coll Cardiol. 2012 May 8; ([E-pub ahead of print])https://doi.org/10.1016/j.jacc.2012.02.010Abstract Full Text Full Text PDF PubMed Scopus (160) Google Scholar]. Though this is preferable, it is not a prerequisite since it is not available at many institutions.Most importantly, there must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved. A dedicated administrator as a member of the team is necessary.Other Institutional ResourcesFor preprocedure and postprocedure care and joint formal multidisciplinary patient consultation, adequate outpatient clinical care facilities are necessary. Appropriate office space for the medical, nursing, and technical personnel involved is also required, preferably in a central setting. Ancillary testing facilities (ie, pulmonary function, echocardiography, vascular Duplex scanning, clinical laboratory, multislice CT) should be of high quality and able to accommodate the patient load on a timely basis.By their very nature, these complex procedures should only be performed in institutions that currently and routinely perform large volumes of surgical aortic valve operations with outcomes that equal or exceed those established nationally for similar procedures. Similarly, only institutions with interventional cardiology programs that have established and successful programs with BAV, catheter closure of periprosthetic valvular leaks, insertion of ventricular septal closure devices with outcomes that equal or exceed those established nationally for similar procedures should develop an integrated structural heart MDT.The institutional commitment required for a successful program goes beyond the necessary space, personnel, and specialized facilities set forth above. The complex and time consuming preprocedure patient triage process and the amount and intensity of postprocedure patient care after discharge are very labor intensive for the physician and nursing staff, as are the informed consents and communications with patients, families, and referring providers. In addition to supporting the core nursing and technical support staff, arrangements between the institution and the physicians need to be structured to reimburse physician efforts dedicated to nonreimbursable hours of clinical care and medical management of the program.The complexity of transcatheter valve procedures and the magnitude of institutional resources required are similar to established heart transplant and cardiac assist device programs, where dedicated professionals, a minimum of infrastructure, MDT, registered nurse/nurse practitioner (NP), providers, coordinators,