Operator and Institutional Requirements for TAVR

Bavaria JE, Tommaso CL, Brindis RG, et al.
2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2018;Jul 18:[Epub ahead of print].

The following are key points to remember from this multisociety Consensus Systems of Care Document on Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement (TAVR):

  1. The primary objective of this consensus document is to promote standards that will help centers achieve high-quality outcomes for patients who have clinically significant aortic valve disease.
  2. The structural measures of quality include the requirement that operators and institutions have the skills, experience, foundational TAVR and surgical aortic valve replacement (SAVR) volume, and facilities that are fundamental to delivering TAVR and SAVR.
  3. A comprehensive multidisciplinary team (MDT) is mandatory for a TAVR program. The defining principle of the MDT is an institutionally based joint cardiology and cardiac surgery effort. TAVR programs should only be established if this multidisciplinary partnership is present. Additional providers including imaging physicians, anesthesiologists, nurses, social services, and administrative support personnel are also necessary.
  4. There are specific and unique cognitive and technical skills that are essential for all physicians for optimal performance of TAVR regardless of specialty background.
  5. Training for TAVR should occur by one of two pathways: 1) a formal training program incorporated into cardiology fellowship or cardiovascular surgical residency, or 2) formal proctorship wherein an established interventional cardiologist or cardiac surgeon participates in an established TAVR program under the tutelage of an experienced team.
  6. The institution performing TAVR should have an active valvular heart disease (VHD) 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 cardiac catheterization laboratory, hybrid catheterization laboratory, or hybrid operating room/catheterization laboratory, an Intersocietal Accreditation Commission (IAC) accredited echocardiography laboratory, a noninvasive vascular laboratory, and CT imaging capabilities with multidetector computed tomography (CT) scanner with a dedicated TAVR algorithm.
  7. This 2018 update addresses the need for a multidisciplinary approach and the importance of patient access, when appropriate, to all treatment options, by requiring that one cardiac surgeon at the TAVR-performing institution, who is part of the MDT, has independently examined the patient face-to-face; evaluated the patient’s suitability for SAVR, TAVR, or medical or palliative therapy; and has documented the rationale for their clinical judgment. There should also be documentation of an additional physician who has independently examined the patient face-to-face, evaluated the patient’s suitability for all forms of valve therapy, and documented the rationale for their clinical judgment. For patients having TAVR, this documentation is typically provided by an interventional cardiologist who is part of the TAVR program, although general cardiologists with an expertise in VHD can provide this documentation.
  8. It should be noted that TAVR is not appropriate for patients who have reached a level of futility (life expectancy despite TAVR of <1 year) and as an end-of-life treatment, as it does not help patients and is not sustainable financially for society.
  9. This 2018 document recommends that sites incorporate methods and processes promoting patient- and family-centered care with informed shared decision making. It should be the goal of each TAVR program that patients participate meaningfully in their healthcare decisions. To this end, patients should be well-informed regarding their options, understand the risks and benefits presented using data on treatment options that are as patient-specific as possible, articulate their treatment- and recovery-related goals, identify preferences and values relative to their care, and integrate these to make a final treatment choice.
  10. The principal outcome measure for TAVR should include in-hospital risk-adjusted all-cause mortality; 30-day risk-adjusted all-cause mortality; 30-day all-cause neurologic events, including transient ischemic attack; 30-day major vascular complication; 30-day major bleeding; and 30-day moderate or severe aortic regurgitation.
  11. A central feature of this document is the need for physicians, hospitals, and other members of the MDT at the local level, in conjunction with professional societies at the national level, to develop and implement a scientifically rigorous approach for quality measurements of TAVR. Submission of data on all commercial TAVR cases to a national registry approved by Centers for Medicare and Medicaid Servicesis a National Coverage Determination (NCD) requirement for all TAVR technologies.
  12. A specific requirement for the initiation of a new TAVR site is a full-time board-eligible or certified (in interventional cardiology or cardiothoracic surgery) primary TAVR operator. The primary TAVR operator should be a member of the MDT at the designated new institution where he/she spends at least 50% of his/her active practice time. The TAVR proceduralist should possess prior experience at an active TAVR site and have participated in at least 100 transfemoral TAVR cases with at least 50 cases as primary operator. The cardiac surgeon must have performed at least 100 SAVRs/lifetime or 50 SAVRs over 2 years with at least 20 SAVRs in the past year prior to initiation of the TAVR program. Also, the same surgeon should spend at least 50% of his/her active practice in the TAVR hospital.
  13. Minimum volume requirements for percutaneous coronary intervention (PCI) and SAVR for new programs reflect the process, infrastructure, and commitment needed for establishing a comprehensive aortic valve program. Therefore, the 2018 criteria for a new program include a minimum volume of 300 PCIs/year with active participation in the National Cardiovascular Data Registry (NCDR)/Cath PCI Registry or a validated state/multi-institutional database that gathers adequate data elements and provides analysis such that individual sites can assess performance with benchmarks for the key domains of patient selection, procedure performance, and clinical outcomes.
  14. The quantity and quality of care standards are more extensive for existing TAVR programs than for new ones. They include performance metrics based on national benchmarks, which are derived from analyses of data from all existing TAVR programs that have submitted data meeting the completeness and quality standards set by the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies (TVT) Registry. An existing TAVR program should perform at least 50 TAVRs per year or 100 TAVRs over 2 years and maintain an STS/ACC TVT Registry score above the bottom 10%. Quality metrics must be monitored, including 1-year survival and functional improvement, as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).
  15. TAVR remains an evolving field with continual changes in indications, equipment, technique, and clinical outcomes. As the indications expand to younger patients, assessing the structural durability of the valve is critical. This document reflects the current state of the art and will evolve over time.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging

Keywords: Angiography, Cardiology Interventions, Aortic Valve Stenosis, Cardiovascular Surgical Procedures, Cardiac Catheterization, CathPCI Registry, Clinical Competence, Diagnostic Imaging, Echocardiography, Education, Medical, Frail Elderly, Geriatrics, Heart Valve Diseases, Heart Defects, Congenital, Heart Valve Prosthesis, Ischemic Attack, Transient, Multidetector Computed Tomography, National Cardiovascular Data Registries, Outcome Assessment, Health Care, Palliative Care, Patient Care Team, Percutaneous Coronary Intervention, Quality of Health Care, Quality of Life, Risk Assessment, Safety, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement

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