Abstract 11544: Novel Bio-Engineered Tricuspid Valve Demonstrates Physiologic Remodeling and Growth With Preserved Function
Background: Valve replacement options in children lack the ability to grow with the patient and hence require multiple reoperations. Small intestinal submucosa derived extracellular matrix (SIS-ECM) has been used successfully as a patch for repair in a variety of tissues including vessels and myocardium.
Hypothesis: A complete valve bioprosthesis made of SIS-ECM is hypothesized to grow appropriately and remodel into functional native valve tissue. The objective of this study is to evaluate growth, structure and function of SIS-ECM tricuspid valve in a growing ovine model.
Methods: A total of 12 three-month-old lambs with a median weight of 18 (16-23) kg were studied. SIS-ECM TV was placed in 8 lambs. For control, 2 conventional bioprosthetic valves (BP) and 2 age-matched controls with native valves (NV) were studied. All lambs underwent serial echocardiography to assess valve annulus diameter, valve and right ventricular (RV) function, and mechanical and histologic evaluation.
Results: The SIS-ECM valve demonstrated physiologic growth shown by an incremental increase in annular diameter similar to NV [Figure 1a]. 11 of 12 (SIS-ECM, BP and NV) had stable trivial to mild regurgitation. One SIS-ECM valve had severe regurgitation due to a flail leaflet. All SIS-ECM valves had full mobility without stenosis and RV systolic function remained normal. Histopathology showed migration of resident mesenchymal cells (αSMA positive) in the proximal half of the leaflet at 3 months and the entire leaflet by 8 months post implant [Figure 1b] and demonstrated ECM organization similar to NV. There was no calcification (Alizarin red). On mechanical testing SIS-ECM valve demonstrated an elastic modulus similar to NV by 8 months [Figure 1c].
Conclusion: SIS-ECM TV bioprostheses demonstrate growth and ECM structure similar to NV with preserved valve function. The SIS-ECM valve provides a novel solution for valve replacement in children.
Author Disclosures: F. Zafar: None. R.B. Hinton: None. R.A. Moore: None. R.S. Baker: None. R. Bryant: None. D.A. Narmoneva: None. M.D. Taylor: None. D.L. Morales: Research Grant; Modest; CorMatrix Cardiovascular, Inc.
- © 2014 by American Heart Association, Inc.