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Background: With the development of novel stapling technologies there is a need to provide evidence of equivalent or improved outcomes through in vivo or in vitro studies. The purpose of the current study was to determine if 3-rows of variable-height staples (3.0, 3.5, 4.0mm leg length medial to lateral) could demonstrate equivalent pneumostasis compared to two sizes of the standard 3-row single-height staplers (3.5 or 4.8mm) across the increased indicated tissue thickness range.
Methods: Testing was performed on fresh explanted porcine and canine respiratory organs using a paired method; control and test staple lines were fired on contra lateral lobes (n=11). Tissue thickness was measured with a calibrated device and a single staple reload was fired to transect each of the upper, middle and lower lobes. The lungs were then re-intubated and incrementally insufflated to 15, 20, 30 and 40 cm H20. Staple lines were examined for air leaks at each pressure step and given a grade of 0-3 (0=no leak, 1=single bubbles, 2=multiple discreet bubbles, 3=steady stream of bubbles). Statistical equality was evaluated by the use of a test of two proportions, with 95% confidence intervals based on sample size.
Results: Results demonstrated that 3 rows of variable-height staples provided equivalent pneumostasis compared to the 3.5mm (Blue) and 4.8mm (Green) staples across the increased indicated tissue thickness range, which is inclusive of both the Blue and Green ranges. There were no leaks at 15 or 20 cm H2O. Compared to a Blue Reload, in the indicated tissue thickness range and at insufflation pressures of 30 and 40 cm H20, the variable-height staples reduced the occurrence of air leaks by 18% and 10% (p-values not significant). When compared to a Green Reload, in the indicated tissue thickness range and at the same insufflation pressures, the variable height staples reduced the occurrence of air leaks by 10% and 18% (p-values not significant).
Conclusions: The results of the current study demonstrated that the variable-height staple design provided consistent performance with regard to occurrence of air leaks across the increased indicated tissue thickness range as compared to 3.5 and 4.8mm reloads.