TY - JOUR
T1 - Transcatheter placement of a low-profile biodegradable pulmonary valve made of small intestinal submucosa
T2 - A long-term study in a swine model
AU - Ruiz, Carlos E.
AU - Iemura, Motofumi
AU - Medie, Sibyl
AU - Varga, Peter
AU - Van Alstine, William G.
AU - Mack, Susan
AU - Deligio, Anna
AU - Fearnot, Neal
AU - Beier, Ulf H.
AU - Pavcnik, Dusan
AU - Hijazi, Ziyad M.
AU - Kiupel, Matti
N1 - Funding Information:
Supported in part by a grant from Cook, Inc.
PY - 2005/8
Y1 - 2005/8
N2 - 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. Conclusion: 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.
AB - 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. Conclusion: 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.
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U2 - 10.1016/j.jtcvs.2005.04.008
DO - 10.1016/j.jtcvs.2005.04.008
M3 - Article
C2 - 16077416
AN - SCOPUS:23044507734
SN - 0022-5223
VL - 130
SP - 477.e1-477.e9
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 2
ER -