Operator and Institutional Requirements for Transcatheter MV Intervention: A Summary of the 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document

Mar 09, 2020   |  Mayooran Namasivayam, MBBS, PhD, FACC; Sammy Elmariah, MD, MPH, FACC

Expert Analysis

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Transcatheter interventions for valvular heart disease have now become integral components of cardiovascular care. Currently, transcatheter mitral valve (MV) edge-to-edge repair (MitraClip, Abbott Vascular; Santa Clara, CA), is the only Food and Drug Administration-approved intervention for mitral regurgitation (MR).1 Yet several other transcatheter MV repair devices are under investigation and development. It is expected that in the near future, a number of options for transcatheter MV repair and replacement will be available for routine clinical use.2-5 With such active growth and rapid evolution, it is important to maintain quality of care while facilitating the ongoing innovation that has driven the field of structural heart intervention forward in recent years.

A careful, multidisciplinary approach that incorporates the expertise of a wide range of cardiovascular subspecialists with experience in structural heart interventions is critical to and required for the appropriate selection of patients, as are the effective delivery and execution of these procedures and post-procedure care. Furthermore, standards for operators and institutions must be maintained to ensure optimal clinical outcomes and to facilitate ongoing advancement of this rapidly evolving field. Therefore, the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons (STS) published an expert consensus document outlining the operator and institutional requirements for transcatheter MV intervention, focusing on transcatheter valve repair.6 Here we summarize key aspects of their recommendations.

The first aspect of a successful program is to ensure appropriate knowledge base and experience of involved valve team members, interventional cardiology, cardiac surgery, and cardiac imaging. Proficiency in basic aspects of interventional cardiology is a foundation, with devoted training in transcatheter valve interventions considered a necessity. Technical skills with a specific MV device should be maintained and advanced through proctoring and simulation. Cardiac surgeons should similarly have specific expertise in the surgical management of mitral valvular heart disease. Imaging cardiologists should be proficient in interpretation of transthoracic and transesophageal echocardiography, including quantitative MV assessment, and should have proficiency in guiding structural heart procedures (interventional echocardiography). It is self-evident that all team members should have excellent communication and teamwork skills. Other relevant specialists include anesthesiologists, perfusionists, intensivists, and radiologists. With evidence for mortality benefit for transcatheter mitral intervention in secondary MR for patients with left ventricular systolic impairment, the expansion of the multidisciplinary valve team to include the involvement of heart failure cardiologists and electrophysiologists in the provision of optimal medical therapy and decisions to institute cardiac resynchronization therapy is also recommended. Operator and institutional case volume guidelines are outlined in Table 1.

Table 1: Operator and Institutional Volumes for MV Intervention Program

To optimize outcomes at a new transcatheter MV intervention program, the interventional echocardiographer should document the following:

  • Participation in 10 trans-septal guidance procedures and 30 structural heart procedures (lifetime)

To optimize outcomes at a new transcatheter MV intervention program, the interventionalist (cardiologist or surgeon) should document the following:

  • 50 lifetime structural heart procedures
  • Prior transcatheter MV repair experience (including while proctored) with participation in 20 trans-septal interventions, including 10 as primary or coprimary operator (lifetime)
  • Board eligibility or certification in either interventional cardiology or cardiothoracic surgery
  • Certification of device-specific training

To optimize outcomes at new transcatheter MV intervention programs, sites should have the following:

  • 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 American Board of Thoracic Surgery 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
  • STS star rating ≥2 for at least 2 consecutive performance reporting periods per year for both MV replacement (MVR) and MVR plus coronary artery bypass grafting

To optimize outcomes at established transcatheter MV intervention programs, sites should document the following:

  • >20 transcatheter MV interventions per year or >40 interventions over 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
  • STS star rating >2 for at least 2 consecutive performance reporting periods per year for both MVR and MVR plus coronary artery bypass grafting

The transcatheter MV intervention site should document the following resources and ongoing percutaneous coronary intervention experience:

  • >300 cases per year
  • Participation in National Cardiovascular Data Registry, CathPCI Registry, or equivalent validated registry
  • In-hospital risk-adjusted mortality rate above the lowest 25th percentile for the most recent 4 quarters

Cardiac surgical review is necessary for all patients with primary MR but may not be needed for all patients with secondary MR given the lack of evidence supporting mortality benefit with surgical intervention in this group. The decision for surgical consultation for patients with secondary MR should be assessed on a case-by-case basis and depend upon presence of other potential indications for surgery (e.g., coronary artery disease and multi-valve disease).

A useful forum in which specialists can review and discuss cases is critical; regular multidisciplinary team clinics and/or meetings are recommended. Combined clinics can facilitate comprehensive and simultaneous review of complex patients, and dedicated meeting time allows review and discussion of clinical features, imaging, suitability, and adequate procedure planning.

Although the expertise of operators and teams is a vital foundation to valve programs, the appropriate infrastructure is equally important in achieving optimal clinical outcomes. Institutions in which transcatheter mitral interventions are performed should have an established surgical valve program, with at least two surgeons involved in valvular heart disease surgery, and an established interventional cardiology program proficient in trans-septal interventions (e.g., patent foramen ovale closure, mitral paravalvular closure, and left atrial appendage occlusion). The environment in which transcatheter MV intervention is performed is ideally a hybrid cardiac catheterization laboratory that can convert to an operating room or, at the very least, a cardiac catheterization laboratory with sufficient space for the large number of staff and quantity of equipment necessary for such procedures. Facilities should also have high-quality echocardiography and cardiac computed tomography services and, ideally, access to in-house cardiac magnetic resonance imaging. In addition to the facilities needed to perform transcatheter interventions, institutions must have adequate post-procedure monitoring capability on intensive care and subsequently telemetry units with skilled nursing staff familiar with managing cardiac surgery and interventional cardiology patients. Appropriate discharge planning is necessary, with close attention to medication reconciliation (especially antithrombotic therapy) and specific plans for monitoring of renal function, blood pressure, and pathways for cardiac rehabilitation.

Outcome surveillance and contribution to the STS/ACC TVT Registry is crucial for institutions participating in transcatheter MV interventions.7,8 Outcome surveillance and review can help institutions determine their patient profile, program performance, and processes in comparison to national and international standards. It also permits the field as a whole to have a wider overview of the successes and challenges of transcatheter mitral interventions. Key outcomes to track include mortality, stroke/transient ischemic attack, vascular complication, major bleeding, MR follow-up and mitral stenosis follow-up, rehospitalization for heart failure, need for repeat mitral intervention, and quality-of-life assessment.9

The use of risk-adjustment models to account for the inter-institutional variations in case-mix is also important when comparing to national and international trends. The ability of an institution to adequately surveil and report outcomes depends upon its data management framework, and programs and administrators must dedicate specific resources to data collation, personnel, equipment/infrastructure, and office space. These investments could contribute to and be integrated with local research activities in the field of transcatheter MV interventions. An appropriate quality assurance/quality improvement framework must also be in place, identifying appropriate cases for morbidity and mortality meeting discussions, reviewing appropriate use criteria, and evaluating outcomes relative to national standards.

Finally, an important consideration in the establishment and maintenance of a program offering transcatheter MV intervention is the presence of a referral base that justifies the program's existence and is large enough to maintain sufficient procedural volume to promote experience and quality. Data have shown that there is a learning curve in the first 50 transcatheter mitral intervention cases, with continued improvement up to 200 cases,10 yet the median number of cases performed in the United States does not meet this threshold. Surgical data have shown that when >35 mitral operations are performed in a center, there is improved survival and less need for reoperation.11 It is therefore worth noting that as novel devices are introduced and as the indications, and hence referral criteria, for transcatheter mitral intervention evolve and grow over the next decade, maintaining sufficient volumes with each device and modality of treating MV disease will become highly relevant.

The growth of transcatheter MV interventions will continue in the years to come. Establishing and maintaining a successful program requires dedicated and continued efforts by operators, multidisciplinary teams, and institutions to participate in cycles of acquiring knowledge, building experience, contributing to registries, and evaluating performance. These efforts require foresight and appropriate resource allocation by administrators to ensure the best possible outcomes for patients that should parallel the evolving technical advancements in this space.

References

  1. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med 2018;379:2307-18.
  2. Prendergast BD, Baumgartner H, Delgado V, et al. Transcatheter heart valve interventions: where are we? Where are we going? Eur Heart J 2019;40:422-40.
  3. Sorajja P, Bae R, Gössl M, et al. Complementary Transcatheter Therapy for Mitral Regurgitation. J Am Coll Cardiol 2019;73:1103-4.
  4. Sorajja P, Moat N, Badhwar V, et al. Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients. J Am Coll Cardiol 2019;73:1250-60.
  5. Regueiro A, Granada JF, Dagenais F, Rodés-Cabau J. Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. J Am Coll Cardiol 2017;69:2175-92.
  6. Bonow RO, O'Gara PT, Adams DH, et al. 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 9:[Epub ahead of print].
  7. Chhatriwalla AK, Vemulapalli S, Holmes DR Jr, et al. Institutional Experience With Transcatheter Mitral Valve Repair and Clinical Outcomes: Insights From the TVT Registry. JACC Cardiovasc Interv 2019;12:1342-52.
  8. Sorajja P, Vemulapalli S, Feldman T, et al. Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report. J Am Coll Cardiol 2017;70:2315-27.
  9. Stone GW, Adams DH, Abraham WT, et al. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions: A Consensus Document From the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:308-21.
  10. Stone GW. Volume-Outcome Relationships for Transcatheter Mitral Valve Repair: More Is Better. JACC Cardiovasc Interv 2019;12:1353-5.
  11. Chikwe J, Toyoda N, Anyanwu AC, et al. Relation of Mitral Valve Surgery Volume to Repair Rate, Durability, and Survival. J Am Coll Cardiol 2017;Apr 24:[Epub ahead of print].

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Implantable Devices, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Acute Heart Failure, Interventions and Coronary Artery Disease, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Echocardiography/Ultrasound, Magnetic Resonance Imaging, Nuclear Imaging, Mitral Regurgitation

Keywords: Cardiac Surgical Procedures, Heart Failure, Angiography, Coronary Angiography, Diagnostic Imaging, Cardiac Imaging Techniques, Heart Valve Diseases, Mitral Valve, Mitral Valve Insufficiency, Ischemic Attack, Transient, Mitral Valve Stenosis, Coronary Artery Disease, Fibrinolytic Agents, Cardiac Rehabilitation, Echocardiography, Transesophageal, Thoracic Surgery, Cardiac Resynchronization Therapy, Risk Adjustment, Medication Reconciliation, Patient Discharge, United States Food and Drug Administration, Operating Rooms, Blood Pressure, Reoperation, Quality of Life, Patient Selection, Atrial Appendage, Follow-Up Studies, Foramen Ovale, Patent, Echocardiography, Stroke, Surgeons, Registries, Diagnosis-Related Groups, Referral and Consultation, Surgical Instruments, Cardiac Catheterization, Magnetic Resonance Imaging, Critical Care, Resource Allocation, Tomography, Patient Care Team, Nursing Staff, Telemetry


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