title: Transcatheter placement of a low-profile biodegradable pulmonary valve made of small intestinal submucosa: a long-term study in a swine model.
abstract: OBJECTIVE
  We sought to investigate a placement of a percutaneous low-profile prosthetic valve constructed of small intestinal submucosa in the pulmonary position in a swine model.
  
  
  METHODS
  Twelve female farm pigs were stented at the native pulmonary valve to induce pulmonary insufficiency. Once right ventricular dilation occurred, the small intestinal submucosa valve was implanted. The pigs were followed up with transthoracic echocardiographic Doppler scanning. One animal died of heart failure before valve replacement. Animals were euthanized at 1 day, 1 month, 3 months, 6 months, and 12 months after valve implantation.
  
  
  RESULTS
  The small intestinal submucosa pulmonary valve showed effective reversal of pulmonary regurgitation. There were no misplacements during deployment. There were no embolizations. One-year echocardiographic follow-up showed minimal regurgitation and no stenosis for a valve/vessel ratio of 0.78 or greater. Histologic examination demonstrated intensive remodeling of the small intestinal submucosal valve. Within 1 month, the surface was covered by endothelium, and fibroblasts invaded the interior. Over the following months, the small intestinal submucosal valve remodeled without apparent graft rejection.
  
  
  CONCLUSIONS
  The small intestinal submucosa valve has the potential for graft longevity without the need for anticoagulation or immunosuppression. Histologic remodeling of the valve tissue provides a replacement capable of resembling a native valve that can be placed percutaneously with low-profile delivery systems.
authors.affiliation: Department of Pediatrics, University of Illinois, Chicago, IL 60612, USA. cruizmd@uic.edu
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Ruiz
authors.forename: Motofumi
authors.initials: M
authors.lastname: Iemura
authors.forename: Sibyl
authors.initials: S
authors.lastname: Medie
authors.forename: Peter
authors.initials: P
authors.lastname: Varga
authors.forename: William G
authors.initials: WG
authors.lastname: Van Alstine
authors.forename: Susan
authors.initials: S
authors.lastname: Mack
authors.forename: Anna
authors.initials: A
authors.lastname: Deligio
authors.forename: Neal
authors.initials: N
authors.lastname: Fearnot
authors.forename: Ulf H
authors.initials: UH
authors.lastname: Beier
authors.forename: Dusan
authors.initials: D
authors.lastname: Pavcnik
authors.forename: Ziyad M
authors.initials: ZM
authors.lastname: Hijazi
authors.forename: Matti
authors.initials: M
authors.lastname: Kiupel
mesh_terms: D020341:Absorbable Implants; D000818:Animals; D002404:Catheterization; D005260:Female; D006085:Graft Survival; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D007413:Intestinal Mucosa / Q000637:transplantation; D007421:Intestine, Small / Q000637:transplantation*; D023421:Models, Animal; D011664:Pulmonary Valve; D011665:Pulmonary Valve Insufficiency / Q000601:surgery*; D013552:Swine