Staple line reinforcement is routinely performed during nonanatomic lung resection utilizing bovine pericardium (peri-strips) and expanded polytetrafluorethylene (ePTFE). Both materials have been previously shown to increase staple line durability and reduce the overall incidence of prolonged air leak, however neither material has been shown to be truly absorbable in in vivo studies. Porcine small intestinal submucosa (SIS) has had many applications as a bioabsorbable tissue reinforcement, but has not previously been studied in either a human or animal model as a reinforcement for nonanatomic pulmonary resection. Its healing properties are well documented in human and animal studies. Our study strictly assessed immediate staple line strength in healthy pig lung tissue at different intrabronchial pressures to demonstrate SIS as an effective pulmonary staple line reinforcement.
Eight pigs were subjected to bilateral apical lung resections with a GIA stapling device; one side was reinforced with SIS, while the other was not reinforced. The lung reinforced was chosen at random so that each animal may serve as its own control. The lungs were then inflated to sequentially increased intrabronchial pressures (5 –75 cm H2O) for 60-second intervals while the chest was filled with saline under direct visualization monitoring for air leak.
Staple lines reinforced with porcine small intestinal submucosa had significantly better durability as determined by Kaplan-Meier survival calculations with respect to leak rate as a function of pressure.
Reinforcement of staple lines with small intestinal submucosa (SIS) allows pulmonary staple lines to tolerate significantly higher intrabronchial pressures without demonstrating air leak at the staple line.
Staple line reinforcement with SIS is effective in terms of improving the leak threshold of the GIA staple lines. Potentially, SIS may prove to be a more suitable material for pulmonary staple line reinforcement in individuals requiring nonanatomic lung resection, due to its healing properties. Long-term in vivo studies are underway to characterize the SIS tissue reaction in the chest, its tendency toward generation of pleural adhesions, resorption and tissue encapsulation.
Douglas Downey, Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Cook, Inc. for providing the (10) staple line reinforcements (at the time of the project not yet available for human use)for our project at no cost to our institution. Each valued at $150.