Safety and Effectiveness Outcomes of a Novel Automated Titanium Suture Fastener Device Applied for Heart Valve Surgery in an Ovine Model

Figures

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  Figure 1. Experimental design and knotting effect of Easy-Knot. (A) Realistic graph of knots on an annuloplasty ring tied by Easy-Knot. (B) Schematic diagram of knotting sites by Easy-Knot (green dot) and manual tying (blue square) for annuloplasty ring fixation. (C) Data acquisition guideline.

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  Figure 2. Blood test results at indicated time points. Blood routine, myocardial zymogram, liver function, kidney function, and coagulation were examined. The normal range is indicated between the two dash lines. (A) RBC, red blood cell count; (B). WBC, white blood cell count; (C) HGB, hemoglobin; (D) PLT, platelet; (E) LDH, lactic dehydrogenase; (F) CK, creatine kinase; (G) ALT, alanine aminotransferase; (H) AST, aspartate transaminase; (I) CRE, creatinine; (J) BUN, blood urea nitrogen; (K) PT, prothrombin time; INR, international normalized ratio; and (L) APTT, activated partial thromboplastin time.

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  Figure 3. Transthoracic echocardiography (TTE) results at indicated time points. (A) MVMV, mean velocity of the mitral valve; (B) PGmean, mean pressure gradient; (C) PSV, peak systolic velocity; and (D) PPG, a peak pressure gradient.

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  Figure 4. Representative in situ view of the left atrium at the implantation site of the annuloplasty ring. Annuloplasty rings were tightly secured by 6 Easy-Knot clips and 6 hand-made knots without any disengagement or displacement at indicated time points. Day 30 (A), Day 60 (B), Day 90 (C), and Day 180 (D).

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  Figure 5. The number of knots wrapped by fiber at indicated time points. **p < 0.01.

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  Figure 6. The ultrastructure of knotting site surface under scanning electron microscope (SEM) and endothelialization. *p < 0.05; **p < 0.01; ns, not significant. (A) The dynamic change of the ultrastructure of endothelial cell coating on the metal surface of titanium clip or the manual-tying knotting site under SEM at indicated time points. (B) Statistical analysis of the percentage of endothelialization in the Easy-Knot group and the manual-tying group. *p < 0.05; **, p < 0.01; ns, not significant.

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  Figure 7. Representative gross and histological view of thrombi at knotting site at Day 180 and thrombosis grade at indicated time points. (A) Morphology of the left atrial surface at the implantation site of the annuloplasty ring. Two of the six titanium clips were completely coated with proliferative fibrous tissue (↑), red thrombosis was observed at 3 thread ends (Δ). (B) Hematoxylin-eosin (H&E) staining of the thread end of a titanium clip (Δ). (C) Thrombosis grade of the Easy-knot group and the manual-tying group at indicated time points. *p < 0.05; **p < 0.01; ns, not significant.

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  Figure 8. Histopathological examination of tissue around the annuloplasty ring at the indicated time. (A) Histopathological examination showed the typical microstructure of the sutures at indicated time points. Δ, fibrous tissue with granulomatous reaction; ↑, slight calcification; ✰, chronic inflammation response. (B) Statistical analyses of pathological lesions. (C) Histopathological examination showed the typical inflammatory cells↑, lymphocyte; Δ, monocyte macrophage. (D) Statistical analyses of pathological lesions. *p < 0.05; **p < 0.01, ns; not significant.

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  Figure 9. (A) Masson trichrome staining of tissue around the annuloplasty ring at indicated time points after implantation and (B) fibrotic thickness analysis. ns; not significant.

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  Figure 10. Gross and histological views of the vital organs (A,B). Gross (A) and histological (B) views of diffused renal infarction (↑) (C,D). Anatomic structures of multifocal fibrous scar (C) (↑) and histopathological examination (D) of multifocal fibrous scar and calcification in the myocardium (↑).