Clinical outcomes of pre-attached reinforced stapler reloads in thoracic surgery: a prospective case series

BACKGROUND: Reinforced staple lines are less susceptible to leaks or bleeding and may consequently reduce morbidity and complications during or after surgery. However, their safety and benefits as well as the best form of reinforcement are still under debate. This study evaluates the safety of a stapler with pre-attached buttressing material based on adverse events (AEs) in thoracic surgery. METHODS: A multi-center prospective study was conducted to assess the use of stapler reloads with pre-attached staple line reinforcement material in thoracic surgery. The primary endpoint was the rate of device-related AEs reported within 30 days of lung cancer thoracic surgery. AEs, bleeding ≥50 mL, leaks, and 30-day readmissions were reported as additional outcomes. RESULTS: A total of 40 patients underwent lobectomy (n=22), wedge resection (n=10), or other thoracic surgery (n=8). Access was open (n=9) or by video-assisted thoracoscopic surgery (VATS, n=31). One patient was lost to follow-up. Intraoperatively, there were no cases of bleeding ≥50 mL requiring staple line intervention, and three cases (8%) experienced minor leaks that were treated conservatively. Bleeding unrelated to the staple line occurred in 20 patients intraoperatively (50%) and 21 patients postoperatively (54%). Three patients were readmitted (8%) for procedure-related causes and deemed unrelated to the investigational device. Of the AEs reported, one device-related event occurred intraoperatively, associated with minor bleeding. The other 33 AEs were related to infection (15%), bleeding (12%), or leak (9%). There were no deaths during the follow-up period. CONCLUSIONS: This study demonstrates that AEs related to the use of reinforced reloads and occurring during or within 30 days of lung cancer surgery pose minimal safety concerns.