title: Beating-heart percutaneous mitral valve repair using a transcatheter endovascular suturing device in an animal model.
abstract: BACKGROUND
  The edge-to-edge (Alfieri) technique for mitral valve repair is a versatile method of treating mitral insufficiency. Because of its simplicity, it has been applied in minimally invasive surgery, and recently, in the design of endovascular closed-heart devices.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the acute in-vivo safety and feasibility of a novel percutaneous mitral valve repair system based on Alfieri technique in an animal model.
  
  
  METHODS
  Under general anesthesia, 11 pigs (90-100 kgs), underwent percutaneous Alfeiri procedure. The right femoral vein was punctured and the mitral valve was approached via a standard transeptal puncture. Combined intracardiac echo and fluoroscopic guidance was used. The procedure included: the positioning of a guide catheter for multiple access to the left atrium and for directing devices; the use of a therapy device to capture the free edge of the mitral valve leaflets using vacuum, and to deliver the suture to the valve and finally the fixation with a Nitinol suture clip, and trimming of the suture with a fastener catheter.
  
  
  RESULTS
  Leaflet capture, suture placement, and suture-clip deployment was successful in all 11 animals. There were no acute cardiac or access site complications. Procedural time (from wire in left atrium to completion of the procedure was 18 +/- 9 min (range 9-30 min). Blood loss was 67 +/- 44 ml (range 0-125 ml). A double orifice configuration was visible by echocardiography at the end of the procedure in all animals.
  
  
  CONCLUSIONS
  This acute animal study demonstrated the feasibility of a beating heart percutaneous Alfieri procedure in a non-diseased porcine valve using an endovascular suturing device to safely access the mitral valve, place a stitch through the mitral valve leaflets, and deploy a suture-clip that reproduces the surgical technique. Clinical application of this device in humans needs to be evaluated.
authors.affiliation: Edwards Lifesciences, 1 Edwards Way, Irvine, CA 92614, USA. tasneem.naqvi@cshs.org
authors.forename: Tasneem Z
authors.initials: TZ
authors.lastname: Naqvi
authors.forename: Maurice
authors.initials: M
authors.lastname: Buchbinder
authors.forename: David
authors.initials: D
authors.lastname: Zarbatany
authors.forename: Julie
authors.initials: J
authors.lastname: Logan
authors.forename: Mia
authors.initials: M
authors.lastname: Molloy
authors.forename: Glenn
authors.initials: G
authors.lastname: Balke
authors.forename: Robert
authors.initials: R
authors.lastname: Ainsworth
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D015150:Echocardiography, Doppler; D018618:Echocardiography, Doppler, Color; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D005471:Fluoroscopy; D019918:Heart Valve Prosthesis Implantation; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D023421:Models, Animal; D012107:Research Design; D013536:Suture Techniques / Q000295:instrumentation*; D013552:Swine