Original Bionanocellulose Conduit As An Alternative Option For Pulmonary Valve Replacement - A Large Animal Model Pilot Study.
Piotr Siondalski1, Magdalena Kolaczkowska1, Maciej Kowalik1, Bart Meuris2.
1Medical University of Gdansk, Gdansk, Poland, 2Katholic University, Leuven, Belgium.
Objective: Currently, there exists no consensus as to the most durable prosthesis for a pulmonary valve replacement. This dilemma is faced by patients with certain congenital heart disease previously repaired and as adults require reoperations. Bionanocellulose (BNC) is a resistant, non-biodegradable, non-pyrogenic, with low level of hemolysis and clotting, original bioimplant. We hypothesized if BNC heart valve prostheses could be an attractive alternative for patients faced with the prospect of a pulmonary valve replacement. Methods: We conducted a large animal model experiment where three adult sheep underwent open-heart surgery and cardiopulmonary bypass and an original BNC conduit, constructed by the Medical University of Gdansk, was implanted in the pulmonary position. The sheep were followed for six months during which time clinical and laboratory parameters were analyzed. Echocardiographic control at 3 and 6 months was performed. After six-months (which corresponds to 10-year follow up in a human population) the sheep were sacrificed and an autopsy was performed and the BNC conduit was studied. Results: All three sheep survived the operation and no adverse events were noted in the 6-month postoperative follow-up, all three sheep showed good recovery and normal health status. Interval laboratory findings were normal with no signs of hemolysis or infection. Echocardiographic analysis after 6 months revealed 6-10 mmHg of mean pressure gradient - this normal in sheep, trace regurgitation in two sheep, excellent cusp motion and coaptation. At autopsy x-ray analysis of the BNC conduits revealed no structural defects in the leaflets with only minimal calcification present. Histological examination showed a slight thickening of the wall and cusps due to new tissue overgrowth both on the intimal and adventitial side. No material failure, no calcification inside the material, only minor calcification extrinsic to the matrix was observed. Conclusions: Bionanocellulose is a very promising material for vascular and heart valve prostheses. Further studies in a human population are needed to verify our findings.
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