Hydrodynamic Assessment of Aortic Valves Prepared from Porcine Small Intestinal Submucosa

  • Sharan Ramaswamy
  • Makensley Lordeus
  • Omkar V. Mankame
  • Lilliam Valdes-Cruz
  • Steven Bibevski
  • Sarah M. Bell
  • Ivan Baez
  • Frank Scholl


Infants and children born with severe cardiac valve lesions have no effective long term treatment options since currently available tissue or mechanical prosthetic valves have sizing limitations and no avenue to accommodate the growth of the pediatric patient. Tissue engineered heart valves (TEHVs) which could provide for growth, self-repair, infection resistance, and long-term replacement could be an ideal solution. Porcine small intestinal submucosa (PSIS) has recently emerged as a potentially attractive bioscaffold for TEHVs. PSIS may possess the ability to recruit endogenous cardiovascular cells, leading to phenotypically-matched replacement tissue when the scaffold has completely degraded. Our group has successfully implanted custom-made PSIS valves in 4 infants with critical valve defects in whom standard bioprosthetic or mechanical valves were not an option. Short term clinical follow-up has been promising. However, no hydrodynamic data has been reported to date on these valves. The purpose of this study was to assess the functional effectiveness of tri-leaflet PSIS bioscaffolds in the aortic position compared to standard tri-leaflet porcine bioprosthetic valves. Hydrodynamic evaluation of acute PSIS function was conducted using a left heart simulator in our laboratory. Our results demonstrated similar flow and pressure profiles (p > 0.05) between the PSIS valves and the control valves. However, forward flow energy losses were found to be significantly greater (p < 0.05) in the PSIS valves compared to the controls possibly as a result of stiffer material properties of PSIS relative to glutaraldehyde-fixed porcine valve tissue. Our findings suggest that optimization of valve dimensions and shape may be important in accelerating de novo valve tissue growth and avoidance of long-term complications associated with higher energy losses (e.g. left ventricular hypertrophy). Furthermore, long term animal and clinical studies will be needed in order to conclusively address somatic growth potential of PSIS valves.


Congenital heart disease Tissue engineering Small intestinal Submucosa Aortic valve Hydrodynamics Energy losses 



Bioprosthetic heart valve


Tissue engineered heart valves


Extra cellular matrix


Porcine small intestinal submucosa


Phosphate buffered solution




Computer-aided drawing

ISO 5840

International Organization for Standardization


Effective orifice area


Standard error of the mean


Food and drug administration



The authors acknowledge funds received from the Department of Biomedical Engineering at Florida International University to carry out this research work. We thank Mr. Andres Pena for assistance with 3D printing.

Conflict of interest

The authors have no conflict of interests.

Statement of human and animal studies

No human and animal studies were carried out by the authors for this article.


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Copyright information

© Biomedical Engineering Society 2016

Authors and Affiliations

  1. 1.Department of Biomedical Engineering, College of Engineering and ComputingFlorida International UniversityMiamiUSA
  2. 2.The Heart InstituteJoe DiMaggio Children’s HospitalHollywoodUSA

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