Effect of the ex situ physical and in situ chemical modification of bacterial nanocellulose on mechanical properties in the context of its potential applications in heart valve design.

Bacterial nanocellulose (BNC) is a promising material for heart valve prostheses. However, its low strength properties limit its applicability in cardiovascular surgery. To overcome these limitations, the mechanical properties of BNC can be improved through modifications. The aim of the research was to investigate the extent to which the mechanical properties of BNC can be altered by modifying its structure during its production and after synthesis. The study presents the results of various analyses, including tensile tests, nanoindentation tests, X-ray diffraction (XRD) tests, scanning electron microscopy (SEM), Fourier-transform infrared spectroscopy (FTIR) and Raman spectroscopy, conducted on BNC chemically modified in situ with hyaluronic acid (BNC/HA) and physically modified ex situ through a dehydration/rehydration process (BNC 25DR, BNC105DR, BNC FDR and BNC/HA 25DR, BNC/HA 105DR, BNC/HA FDR). The results demonstrate that both chemical and physical modifications can effectively shape the mechanical properties of BNC. These modifications induce changes in the crystalline structure, pore size and distribution, and residual stresses of BNC. Results show the effect of the crystalline structure of BNC on its mechanical properties. There is correlation between hardness and Young's modulus and Iα/Iß index for BNC/HA and between creep rate of BNC/HA, and Young's modulus for BNC vs Iα/Iß index.

Bacterial cellulose as a promising material for pulmonary valve prostheses: In vivo study in a sheep model.

OBJECTIVES: Currently, no consensus exists regarding the most durable prosthesis for pulmonary valve replacement. Bacterial cellulose is a resistant, nonbiodegradable, nonpyrogenic bioimplant with low hemolysis and clotting properties. We hypothesized that bacterial cellulose heart valve prostheses could be an attractive alternative for pulmonary valve replacement. METHODS: We conducted a large animal model experiment in three adult sheep. The animals underwent open-heart surgery and cardiopulmonary bypass for bacterial cellulose conduit implantation in the pulmonary position. The sheep were followed for seven months, and clinical and laboratory parameters were analyzed. Echocardiographic evaluations were performed at 3 and 7 months. After seven months, the sheep were sacrificed and an autopsy was performed. The explanted conduits were radiologically and histopathologically analyzed. RESULTS: All sheep survived the operation, showing good recovery and normal health status; no adverse events were noted during the 7-month postoperative follow-up. Interval laboratory findings were normal with no signs of hemolysis or infection. Echocardiographic analysis after 7 months revealed a normal mean pressure gradient with excellent cusp motion and coaptation; a trace of regurgitation was found in two sheep. X-ray analysis of the explanted conduits revealed no structural defects in the leaflets with minimal calcification. Histological examination showed slight thickening of the conduit by pannus formation. No material failure, no calcification inside the material, and only minor calcification extrinsic to the matrix were observed. CONCLUSIONS: This pilot study provides evidence that bacterial cellulose may be suitable for pulmonary valve prostheses and surgical pulmonary artery plasty. Further studies on the high pressure side of the left heart are needed.

In Vitro Study of a Stentless Aortic Bioprosthesis Made of Bacterial Cellulose.

PURPOSE: The paper present findings from an in vitro experimental study of a stentless human aortic bioprosthesis (HAB) made of bacterial cellulose (BC). Three variants of the basic model were designed and tested to identify the valve prosthesis with the best performance parameters. The modified models were made of BC, and the basic model of pericardium. METHODS: Each model (named V1, V2 and V3) was implanted into a 90 mm porcine aorta. Effective Orifice Area (EOA), rapid valve opening time (RVOT) and rapid valve closing time (RVCT) were determined. The flow resistance of each bioprosthesis model during the simulated heart systole, i.e. for the mean differential pressure (ΔP) at the time of full valve opening was measured. All experimental specimens were exposed to a mean blood pressure (MBP) of 90.5 ± 2.3 mmHg. RESULTS: The V3 model demonstrated the best performance. The index defining the maximum opening of the bioprosthesis during systole for models V1, V2 and V3 was 2.67 ± 0.59, 2.04 ± 0.23 and 2.85 ± 0.59 cm2, respectively. The mean flow rate through the V3 valve was 5.7 ± 1, 6.9 ± 0.7 and 8.9 ± 1.4 l/min for stroke volume (SV) of 65, 90 and 110 mL, respectively. The phase of immediate opening and closure for models V1, V2 and V3 was 8, 7 and 5% of the cycle duration, respectively. The mean flow resistance of the models was: 4.07 ± 2.1, 4.28 ± 2.51 and 5.6 ± 2.32 mmHg. CONCLUSIONS: The V3 model of the aortic valve prosthesis is the most effective. In vivo tests using BC as a structural material for this model are recommended. The response time of the V3 model to changed work conditions is comparable to that of a healthy human heart. The model functions as an aortic valve prosthesis in in vitro conditions.