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).
Keywords: Cardiac Surgical Procedures, Catheterization, Child, Consensus, Extracorporeal Membrane Oxygenation, Heart Defects, Congenital, Heart Ventricles, Heart Valve Diseases, Pulmonary Artery, Pulmonary Valve, Patient Selection, Registries, Surgeons, Transcatheter Aortic Valve Replacement, United States Food and Drug Administration
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