Title: Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: Time to rewrite the label?
Authors: Boshoff, DE ×
Cools, Bjorn
Heying, Ruth
Troost, Els
Kefer, J
Budts, Werner
Gewillig, Marc #
Issue Date: May-2013
Publisher: Wiley-Liss
Series Title: Catheterization and Cardiovascular Interventions vol:81 issue:6 pages:987-995
Article number: 10.1002/ccd.24594
Abstract: INTRODUCTION: Percutaneous pulmonary valve implantation is now considered feasible and safe. "Native" right ventricular outflow tract (RVOT), small diameter conduits (less than 16mm) 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 2 Sapien® valves were successfully implanted in 23 patients (16.9 years; range 6.1 to 80.5 years). In 22 patients, pre-stenting was performed 4.8 months (range 0 to 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 pre-stenting underwent PPVI, with a final RVOT diameter of 21.5mm [range 16 to 26mm]. Group 2 patients consisted of 2 elderly patients with pulmonary valve stenosis and severe RVOT calcifications. Group 3 (n=13) had an existing conduit (nominal 15.9±3.2mm, range10 to 20mm). The conduit was augmented from 14.7±3.5 mm to 20±1.6mm 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 pre-stenting makes the procedure safe and predictable. Updating the indications for PPVI should be considered. © 2012 Wiley Periodicals, Inc.
ISSN: 1522-1946
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Cardiovascular Developmental Biology
× corresponding author
# (joint) last author

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