Requirements for Transcatheter Pulmonary Valve Repair and Replacement | Ten Points to Remember
- Hijazi ZM, Ruiz CE, Zahn E, et al.
- SCAI/AATS/ACC/STS Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement, Part III: Pulmonic Valve. J Am Coll Cardiol 2015;Mar 24:[Epub ahead of print].
The following are 10 points to remember about this Expert Consensus Statement on operator and institutional requirements for transcatheter valve repair and replacement:
- The emergence of transcatheter pulmonic valve implantation as an alternative to traditional surgical therapy for valvular diseases has been facilitated by innovative devices, rapidly developing techniques, and careful patient selection.
- Defining operator and institutional requirements for these novel therapies is an important first step to ensure their optimal implementation.
- The institution should perform 150 congenital/structural catheterization procedures per year. Of those, 100 should be interventional in nature, including but not limited to stenting of branch pulmonary arteries and the right ventricular outflow tract (RVOT).
- Furthermore, the institution should perform a minimum of 100 open-heart surgical procedures in patients with congenital heart disease (if a Children’s Hospital) or an adult program associated with a Children’s Hospital. The adult program should perform a minimum of 25 adult congenital surgical cases per year.
- The institution should have a Heart Team (interventional cardiologists [pediatric trained or adult trained, as long as they have the expertise in this area], cardiac surgeons, noninvasive cardiologists, cardiac anesthesiologists, cardiovascular radiologists, and others) that is actively engaged in the treatment of congenital and/or structural heart disease. The Heart Team should have experience in the treatment of conditions of the pulmonary valve and the RVOT.
- The institution should have extracorporeal membrane oxygenation (ECMO) capabilities for the rare patient who may require such support.
- The operator should perform at least 100 diagnostic/interventional cases per year, 50 of which should be interventional (congenital/structural) cases per year.
- The operator should attend a peer-to-peer training course, as recommended by the US Food and Drug Administration (FDA). Such courses should discuss the procedure in detail (selection of patients; baseline assessment; procedural technique; potential complications and their management, and how to avoid such complications).
- At a minimum, the first three cases should be performed under the supervision of a proctor. Proctorship is essential in transcatheter pulmonary valve replacement (tPVR), and at the end of the proctoring session, the trainee should be cleared by the proctor to proceed with tPVR independently.
- The institution should be a participant in a national registry (IMPACT) collecting data on all patients undergoing tPVR, in a manner similar to sites performing transcatheter aortic valve replacement (TAVR).
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