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Complete Tricuspid Valve Regeneration: A novel minimally invasive surgical technique and new surgical paradigm
Walter D. Boyd, MD1, James L. Cox, MD2, Anna M. Fallon, PHd3, J N. Young, MD1, Robert G. Matheny, MD3.
1University of California Davis, Sacramento, CA, USA, 2Washington University, Saint Louis, MO, USA, 3Cormatrix Cardiovascular, Alpharetta, GA, USA.

OBJECTIVE: Preliminary clinical experience with valve repair using matrix bioscaffolds (Cormatrix) has demonstrated that this material can remodel into the patients own tissue. Valves currently available for tricuspid valve replacement were not designed for the tricuspid position and do not provide annular to ventricular continuity resulting in suboptimal hemodynamics and physiology after implantation. The objective of the current study was to determine if complete valvular regeneration could be accomplished in a chronic ovine model using a uniquely designed matrix bioscaffold valve implanted via a new surgical technique.
METHODS: A chronic study using an ovine model (n=4) evaluated valve function up to one year after implantation. The heart was approached through a small thoracotomy cardiopulmonary bypass established and the native tricuspid valve, including chordae excised. Based on annular size and annulus-papillary muscle depth, a Matrix sleeve valve was constructed. The ventricular end of the construct was first attached to the three papillary muscles and the annular end of the construct sutured to the annulus in a running fashion. Serial post-operative echocardiography was performed at 1 week, bimonthly, and at termination to evaluate in vivo valve function. Study animals were sacrificed at 3, 5, 8, and 12 months. Histological evaluation and scanning electron microscopy (SEM) were performed. .
RESULTS: Echocardiography intraoperatively demonstrated immediate valve competence in all animals. Throughout the study, the leaflets maintained their compliance and did not calcify or thicken. After 3 months, the explanted valves had the trileaflet structure of native valves and histological examination showed diffuse cellular infiltration with a confluent endothelial lining as shown by eNOS staining and SEM demonstrating remodelling. By 5 months, papillary muscle attachment sites were beginning to resemble native chordae. By 8 months, the leaflets demonstrated collagen glycosaminoglycan and elastin distribution similar to native leaflets.

CONCLUSIONS: These results demonstrate tricuspid valve regeneration is possible using a novel matrix bioscaffold constructed in a unique design and implanted using a minimally-invasive approach. ECM material recruits host stem cells and remodels into endothelialized tissue indistinguishable from the host’s native valve both grossly and histologically. Preliminary human implantation has been performed with excellent results at one year.

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