Perspective:

The following are 10 points to remember about operator and institutional requirements for transcatheter valve repair and replacement.

1. The fast-moving evolution of transcatheter valve therapy (TAVR) provides an important opportunity for cardiologists and surgeons to come together to identify the institutional and operator criteria for performing these procedures.

2. The 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.

3. Physicians performing these procedures, irrespective of their specialty background, 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.

4. 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 cardiac catheterization laboratory, echocardiographic laboratory, vascular laboratory, and computed tomography laboratory.

5. 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, multidisciplinary team, registered nurses/nurse practitioners, providers, coordinators, databases, and quality reporting are essential for optimal patient outcomes.

6. The multidisciplinary team approach is highlighted by the collaboration between the interventional cardiologist and cardiac surgeon, but must also include key providers from other physician groups (e.g., anesthesiology, radiology, noninvasive cardiology, intensive care, etc.).

7. Institutional surgical requirements for TAVR include >50 total AVR procedures/year, with ≥10 high risk and >2 institutionally based cardiac surgeons. Interventional institutional requirements include 1,000 caths/400 percutaneous coronary interventions per year.

8. Individual requirements for a surgeon include board certified/eligible in thoracic surgery; >100 AVR/career including 10 high-risk patients OR >25 AVR/year or 50 AVR in 2 years AND >20 in the last year prior to TAVR.

9. Individual requirements for an interventionalist include board certified/eligible in interventional cardiology; 100 structural procedures per lifetime or 30 left-sided structural per year, of which 60% should be balloon aortic valvuloplasty.

10. 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 (e.g., Society of Thoracic Surgeons/American College of Cardiology TVT Registry) that facilitate continued safety and efficacy in the assessment of novel, and, as yet unproven, therapeutic options.