Mitral Valve Intervention Systems of Care Document: Key Points

Authors:
Bonow RO, O’Gara PT, Adams DH, et al.
Citation:
2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention: A Joint Report of the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. J Am Coll Cardiol 2019;Dec 16:[Epub ahead of print].

The following are key points to remember from this multisociety Expert Consensus Systems of Care Document on Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention (TMVI):

  1. The primary goal of the updated 2019 recommendations is to promote optimal quality outcomes while balancing the need for access to innovative therapies for transcatheter mitral valve interventions (TMVIs). The structural measures of quality include the requirement that operators and institutions have the skills, experience, foundational surgical volume, and facilities that are fundamental to performing TMVI.
  2. This 2019 expert consensus focuses on the treatment(s) for a given patient rather than focusing on a particular type of intervention. Although the edge-to-edge clip repair device is the only Food and Drug Administration (FDA) approved device for transcatheter mitral valve repair (TMVr), the authors acknowledge the introduction of transcatheter mitral valve replacement (TMVR) in the future. Adherence to these guidelines should maximize the likelihood of incorporating future therapies.
  3. A multidisciplinary team (MDT) is foundational for TMVI. A collaborative MDT should consist of experts in heart failure (HF), electrophysiology, cardiac imaging, interventional cardiology, cardiac valve surgery, cardiac anesthesia, and nursing. The coordinated functioning of the MDT is essential to the process of patient selection, intraprocedural management, post-procedural care, post-discharge follow-up, and outcome reporting. The expertise of two implanting physicians may be required for challenging procedures.
  4. Training for TMVI continues to evolve, and minimum training for specific procedures and devices should follow FDA approval requirements. Trans-septal access to the MV is a fundamental skill for many TMVI procedures, while many TMVR systems require transapical access. MDT experience with these approaches is a prerequisite. Current proposed case volumes for TMVr pertain to the edge-to-edge device for primary or secondary mitral regurgitation (MR).
  5. This update recommends that sites incorporate methods and processes that promote patient-centered care with informed shared decision making. Specifically, this should include a patient-specific, data-driven risk assessment, explanation of treatment options, rationale for the MDT’s recommendations, and incorporation of the patient’s goals and values into treatment decisions.
  6. In the interval since the initial TMVI recommendations, the indication for edge-to-edge TMVr has expanded to include secondary MR, primarily on the basis of the results of the COAPT trial. To achieve clinical outcomes on par with this randomized trial, an echocardiography expert should document MR etiology and severity and cardiologist experienced in HF management should verify guideline-directed management and therapy (GDMT), which may include cardiac resynchronization, prior to TMVr.
  7. Use of TAVR valves for symptomatic patients of prohibitive or high-surgical-risk with degenerated bioprosthetic mitral valves, failed surgical MV repair with annuloplasty ring, and patients with MR due to mitral annular calcification (MAC) continues to evolve.
  8. The principal outcome measures for TMVI mirror those for surgical MV intervention and include: in-hospital and 30-day mortality, 30-day stroke/TIA, 30-day major vascular complication, 30-day major bleeding, 30-day moderate or severe MR, 30-day significant mitral stenosis (MS) (mean gradient >8 mm Hg, valve area <1.5 cm2), 1-year all-cause mortality, change in patient health status versus baseline using Kansas City Cardiomyopathy Questionnaire (KCCQ), 1-year rehospitalization for HF, 1-year repeat MV intervention, 1-year moderate to severe MR, and 1-year significant MS. Data used to fulfill the requirements to maintain a safe, efficient, and effective TMVI program can be generated from the STS/ACC TVT Registry (Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) and STS Adult Cardiac Surgery Database with linkage to the 1-year outcomes tracked by Centers for Medicare & Medicaid Services, and should be reviewed in quarterly MDT meetings. Programs with worse than expected risk-adjusted outcomes compared to the national benchmark should initiate performance improvement programs.
  9. To optimize outcomes at new TMVI sites, the interventionalist (cardiologist or surgeon) should document 50 lifetime structural heart procedures, prior TMVr experience (including while proctored) with participation in 20 trans-septal interventions per lifetime, including 10 as primary or co-primary operator, board eligibility or certification in either interventional cardiology or cardiothoracic surgery, and certification of device-specific training. The interventional echocardiographer should document participation in 10 trans-septal guidance procedures and 30 structural heart procedures (lifetime). Individual sites should have a surgeon who has performed 20 MV surgeries in the previous year or 40 MV surgeries over the previous 2 years, of which at least 50% should be repairs, and who is board eligible or certified by the ABTS or equivalent; minimum site MV surgical volume of 40 cases in the previous year or 80 cases over 2 years, of which at least 50% should be MV repairs; and a STS star rating ≥2 for at least 2 consecutive performance reporting periods per year for both MVR and MVR plus coronary artery bypass grafting (CABG).
  10. Existing TMVr programs should document >20 TMVIs per year or >40 interventions over the prior 2 years; >20 MV surgeries per year or >40 surgeries over 2 years; STS/ACC TVT Registry-reported 30-day all-cause mortality above the lowest decile; participation in the STS Adult Cardiac Surgery database; and STS star rating >2 for at least two consecutive performance reporting periods per year for both MVR and MVR plus CABG.
  11. The TMVI site should document the following resources and ongoing percutaneous coronary intervention (PCI) experience: >300 cases per year, participation in National Cardiovascular Data Registry (NCDR) Cath/PCI or validated equivalent registry, and in-hospital risk-adjusted mortality rate above the lowest 25th percentile for the most recent four quarters.
  12. Institutions should have an active cardiac surgery program supported by at least 2 institutionally based cardiac surgeons and have a full complement of diagnostic and therapeutic facilities including a cardiac catheterization lab or hybrid operating room/catheterization lab; an Intersocietal Accreditation Commission (IAC) accredited echocardiography lab, noninvasive vascular lab, multi-detector computed tomography and cardiac magnetic resonance imaging, and post-procedural recovery and intensive care unit facilities. Institutions should commit financial and personnel resources to support the management of these complex programs.
  13. TMVI is a rapidly evolving field with evolution in indications, equipment, technique, and clinical outcomes. Annual rates of TMVI, in part TMVr for severe MR, are expected to rise in the coming years. Patients with MV disease should have access to all appropriate treatment options and expect high-quality outcomes.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Implantable Devices, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: Accreditation, Cardiac Resynchronization Therapy, Cardiac Surgical Procedures, Cardiology Interventions, Certification, Consensus, Coronary Artery Bypass, Diagnostic Imaging, Echocardiography, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Outcome Assessment (Health Care), Percutaneous Coronary Intervention, Risk Assessment, Transcatheter Aortic Valve Replacement


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