title: Transcatheter native pulmonary valve and tricuspid valve replacement with the sapien XT: Initial experience and development of a new delivery platform.
abstract: BACKGROUND
  While the Melody valve is unable to be used for replacement of large pulmonary outflow tracts, the 29 mm Sapien XT transcatheter valve, designed specifically for aortic valve replacement, can potentially be used in these large native outflow tracts. Techniques to enable off-label use of the Sapien XT valve for large-diameter pulmonary and tricuspid valve replacement are described.
  
  
  METHODS
  Use of the Sapien valve for transcatheter pulmonary and tricuspid valve replacement using both the commercially available Novaflex+ system and using a novel flexible delivery system was reviewed. This customized flexible delivery platform was constructed using the Ensemble sheath and a 30 mm Nucleus balloon. This system was bench tested prior to its clinical use.
  
  
  RESULTS
  Ten patients had successful implantation of Sapien valves into native right ventricular outflow tracts (RVOTs) (n = 7) or tricuspid valves (n = 3). There was no stenosis or regurgitation after Sapien valve implantation. Several of the pulmonary valve replacement cases were extremely challenging due to the limited flexibility of the Novaflex system. The Sapien valve was crimped onto a 30 mm Nucleus balloon preloaded through an Ensemble sheath. This system was able to consistently deliver the Sapien valve safely in a bench model as well as in native RVOTs in two patients.
  
  
  CONCLUSIONS
  The 29 mm Sapien XT valve allows for large-diameter transcatheter valve replacement in both the pulmonary and tricuspid positions. Initial results of new techniques to utilize a more flexible delivery platform are described that could obviate the need for the Novaflex system. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Pediatrics, Division of Cardiology, UCLA Mattel Children's Hospital, Los Angeles, California. dlevi@mednet.ucla.edu.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Levi
authors.affiliation: Department of Pediatrics, Division of Cardiology, UCLA Mattel Children's Hospital, Los Angeles, California.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Sinha
authors.affiliation: Department of Pediatrics, Division of Cardiology, Kaiser Permanente, Los Angeles, California.
authors.forename: Morris M
authors.initials: MM
authors.lastname: Salem
authors.affiliation: Department of Medicine, Ahmanson Adult Congenital Heart Disease Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
authors.forename: Jamil A
authors.initials: JA
authors.lastname: Aboulhosn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000792:Angiography; D063126:Balloon Valvuloplasty; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D062906:Cardiac Catheters; D002648:Child; D005260:Female; D006349:Heart Valve Diseases / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011356:Product Labeling; D011474:Prosthesis Design; D011664:Pulmonary Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014261:Tricuspid Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D055815:Young Adult
keywords: Sapien valve; Tetralogy of Fallot; pulmonary regurgitation; transcatheter pulmonary valve replacement