Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?

INTRODUCTION: Percutaneous pulmonary valve implantation is now considered feasible and safe. "Native" right ventricular outflow tract (RVOT), small diameter conduits (<16 mm) and relatively large RVOT with a dynamic outflow aneurysm are currently considered off-label uses. Extending indications creates concerns of safety, ethics, reimbursement, and liability.
AIM OF STUDY: To report the safety and feasibility of off-label application of percutaneous pulmonary valve implantation.
DESIGN: Retrospective analysis of prospectively collected data. PATIENTS AND METHODS: Off-label indications: conduit-free RVOT or patients with an existing but undersized conduit.
RESULTS: Twenty-one Melody® valves and two Sapien® valves were successfully implanted in 23 patients (16.9 years; range 6.1-80.5 years). In 22 patients, prestenting was performed 4.8 months (range 0-69.2) before valve implantation (15 covered and 13 bare stents). Stent endothelial ingrowth was allowed for at least 2 months prior to implantation of the percutaneous valve if stent stability or sealing by the covering was presumed to be insufficient. Group 1 patients (n = 8) had a "conduit-free" RVOT after transannular/infundibular patch and after prestenting underwent percutaneous pulmonary valve implantation (PPVI), with a final RVOT diameter of 21.5 mm (range 16-26 mm). Group 2 patients consisted of two elderly patients with pulmonary valve stenosis and severe RVOT calcifications. Group 3 (n = 13) had an existing conduit (nominal 15.9 ± 3.2 mm; range 10-20 mm). The conduit was augmented from 14.7 ± 3.5 to 20 ± 1.6 mm with PPVI. The RVOT preparation and valve implantations were uneventful.
CONCLUSIONS: PPVI is safe and feasible in selected patients with an off-label indication. Creating an adequate "landing zone" by prestenting makes the procedure safe and predictable. Updating the indications for PPVI should be considered.