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J Thorac Cardiovasc Surg 2005;130:477-484
© 2005 The American Association for Thoracic Surgery

Evolving Technology

Transcatheter placement of a low-profile biodegradable pulmonary valve made of small intestinal submucosa: A long-term study in a swine model

Carlos E. Ruiz, MD, PhD a , * , Motofumi Iemura, MD a , Sibyl Medie, MS a , Peter Varga, MD a , William G. Van Alstine, DVM, PhD b , Susan Mack, BA c , Anna Deligio, CRT a , Neal Fearnot, PhD c , Ulf H. Beier, MD, PhD a , Dusan Pavcnik, MD, PhD d , Ziyad M. Hijazi, MD e , Matti Kiupel, DVM, PhD f

a Division of Pediatric Cardiology, Department of Pediatrics, University of Illinois at Chicago, Chicago, Ill
b Purdue University, West Lafayette, Ind
c Medical Institute, West Lafayette, Ind
d Dotter Interventional Institute, Oregon Health Sciences University, Portland, Ore
e Division of Pediatric Cardiology, University of Chicago, Children’s Hospital, Chicago, Ill
f College of Veterinary Medicine, Michigan State University, East Lansing, Mich.

Received for publication November 19, 2004; revisions received February 3, 2005; accepted for publication April 14, 2005.

* Address for reprints: Carlos E. Ruiz, MD, PhD, Division of Pediatric Cardiology, University of Illinois at Chicago, 840 S Wood St (Rm 1250), Chicago, IL 60612. (Email: cruizmd{at}uic.edu).

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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