Non-powered stapler linked to fewer postoperative air leaks than powered stapler in severe emphysema LVRS
Photo by Marcelo Leal / Unsplash
Key Takeaway
Consider non-powered stapler data in LVRS for severe emphysema as preliminary; larger trials are needed.
A single-center, single-blinded randomized controlled trial compared two surgical staplers in 19 patients (32 procedures) with severe lung emphysema undergoing lung volume reduction surgery. The intervention was the non-powered AEON Endostapler, and the comparator was the Echelon Flex Powered Plus Stapler. The primary outcome was the duration of postoperative air leak.
For the incidence of immediate postoperative air leaks, the non-powered stapler was associated with air leaks in 6 of 17 procedures (35.3%), compared to 9 of 15 procedures (60%) with the powered stapler. The median time to air leak closure was 14.3 hours for the non-powered stapler versus 93.2 hours for the powered stapler. The hazard ratio for faster air leak closure with the non-powered stapler was 1.6, but this was not statistically significant (95% CI, 0.73-3.3; P = .25).
Safety and tolerability data were not reported. Key limitations include the small sample size, single-center design, and the non-significant statistical result for the primary time-to-event analysis. Both stapler systems were found to be feasible for use in this population. The findings suggest a potential signal favoring the non-powered device for reducing air leaks, but the evidence is of low certainty and cannot support definitive superiority claims.
View Original Abstract ↓
OBJECTIVES: This study aimed to assess whether the use of the non-powered AEON Endostapler during lung resection in patients with severe lung emphysema reduces the duration of postoperative air leak, as measured by the air leak volume over time, in comparison to the Echelon Flex Powered Plus Stapler.
METHODS: A total of 32 lung volume reduction surgeries were performed on 19 patients, stratified by side of the operation. These procedures were randomly assigned to utilize either the non-powered or the powered stapler. Postoperative air leak was monitored using a digital recording system. The time to air leak closure, the incidence and severity of air leaks, and the duration of chest tube placement were evaluated.
RESULTS: Immediate postoperative air leaks were observed in 6 of 17 procedures (35.3%) using the non-powered stapler and in 9 of 15 procedures (60%) performed with the powered stapler. The median time to closure of the air leak was also considerably shorter in the non-powered procedures: 14.3 hours [6.7, 116] compared to 93.2 hours [2.1, 159] for the powered treatments. Cox regression analysis yielded a hazard ratio of 1.6 (95% CI, 0.73-3.3) for a faster air leak closure with the non-powered stapler (P = .25).
CONCLUSIONS: Both stapler systems are feasible for use in patients with severe lung emphysema. However, our results show an earlier air leak closure and a lower incidence of postoperative air leaks with the use of a non-powered stapler.
CLINICAL REGISTRATION NUMBER: https://clinicaltrials.gov/study/NCT05628415? term=LVRS&rank=9, 28.11.2022.
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