SCAI/AATS/ACC/STS Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part II–Mitral Valve
The following are 10 points to remember about this Expert Consensus Document:
1. Establishing a structural heart disease intervention therapy program requires several key components. The defining principle is that this effort is a joint, institutionally based activity for cardiologists and cardiac surgeons.
2. The critical cornerstone of a transcatheter valve program is a formal, collaborative effort between interventional cardiologists and cardiac surgeons. This element is essential to establishing a transcatheter valve program. The multidisciplinary team is necessary for an interventional valve therapy program and involves far more than just a collaboration between the interventional cardiologist and cardiac surgeon.
3. The 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 a cardiac catheterization laboratory or hybrid operating room/cath lab equipped with a fixed radiographic imaging system with flat-panel fluoroscopy offering catheterization laboratory-quality imaging.
4. The institution should perform 1,000 catheterizations/400 percutaneous coronary interventions per year with acceptable outcomes for conventional procedures compared to National Cardiovascular Data Registry (NCDR) benchmarks.
5. The interventionalist should perform 50 structural procedures per year (including atrial septal defect/patent foreman ovale and trans-septal punctures).
6. The surgical program in the institution should perform 25 total mitral valve procedures per year, of which at least 10 must be mitral valve repairs.
7. For existing programs, 15 mitral procedures are required as total experience, and all cases must be submitted to a single national database.
8. For new programs, no volume criteria can be proposed yet assuming approval would be for high-risk cohorts, 10-15% mortality rate at 30 days, similar to registry or published data. All cases must be submitted to a single national database.
9. Operators must be board certified in interventional cardiology or board certified/board eligible in pediatric cardiology or similar boards from outside the United States. Cardiac surgeons must be board certified in thoracic surgery, or similar foreign equivalent.
10. Transcatheter valve repair or replacement devices are unique in that an understanding not only of early risk, but also of long-term durability, is essential to determining the appropriate patient subgroups for these therapies. Individual centers are also responsible for critically evaluating their own experience, through local and regional quality improvement initiatives, and for participating in national databases and registries that facilitate continued safety and efficacy assessment.
Keywords: Operating Rooms, Fluoroscopy, Cardiac Catheterization, Heart Septal Defects, Atrial, Diagnostic Imaging, Thoracic Surgery, Percutaneous Coronary Intervention, Consensus, Quality Improvement, Heart Valve Diseases, Cardiac Surgical Procedures, United States, Mitral Valve
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