title: Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To report the safety and feasibility of off-label application of percutaneous pulmonary valve implantation.
  
  
  METHODS
  Retrospective analysis of prospectively collected data.
  
  
  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.
authors.affiliation: Paediatric and Adult Congenital Heart Unit, University Hospitals KU Leuven and UC Louvain, Belgium.
authors.forename: Derize E
authors.initials: DE
authors.lastname: Boshoff
authors.forename: Bjorn L M
authors.initials: BL
authors.lastname: Cools
authors.forename: Ruth
authors.initials: R
authors.lastname: Heying
authors.forename: Els
authors.initials: E
authors.lastname: Troost
authors.forename: Joelle
authors.initials: J
authors.lastname: Kefer
authors.forename: Werner
authors.initials: W
authors.lastname: Budts
authors.forename: Marc
authors.initials: M
authors.lastname: Gewillig
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D005240:Feasibility Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008875:Middle Aged; D018579:Patient Selection; D011356:Product Labeling; D011474:Prosthesis Design; D011665:Pulmonary Valve Insufficiency / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult