(SLC-013) Clinical Outcomes Among Patients Undergoing Lung Resection and Gastrointestinal Surgery Using Two Innovative Surgical Staplers in Routine Clinical Practice: A Multi-Institutional Database Study

Background: ECHELON™ 3000 Staplers (ECH3000), designed to give surgeons better access and control, have demonstrated improved performance in benchtop testing; however, no prior research has evaluated their performance in clinical settings.

Objectives: To compare clinical outcomes among patients undergoing lung resection and gastrointestinal surgery using ECH3000 vs. ECHELON™+ Staplers (ECH+) in routine clinical practice.

Methods: This retrospective comparative cohort study identified patients aged ≥18 years undergoing lung resection (LR) or gastrointestinal (GI) surgery using either ECH3000 or ECH+ between 4-01-2022 to 9-30-2023 in the Premier Healthcare Database, one of the most comprehensive large multi-institutional electronic healthcare databases in the US. All analyses were stratified by procedure type. The primary endpoint was 30-day prolonged air leak in the LR cohort and 30-day anastomotic leak in the GI cohort. In both cohorts, the secondary endpoint was 30-day bleeding-related complications. Covariate balancing propensity score (CBPS) weighting was applied to balance the distribution of baseline characteristics between study groups. The difference in the cumulative incidence of primary and secondary endpoints between study groups was calculated. Variance was estimated using a non-parametric bootstrap and 95% confidence intervals (CI) were constructed. The non-inferiority in the difference of the cumulative incidences of prolonged air leak and anastomotic leak (primary endpoints) were evaluated using a non-inferiority margin of 10% and 5%, respectively, at a one-sided significance level of 2.5%.

Results: A total of 910 (ECH3000: 277; ECH+: 633) and 7,675 (ECH3000: 915; ECH+: 6,760) patients met the study eligibility criteria in the LR and GI cohorts, respectively. ECH3000 was non-inferior to ECH+ in terms of both prolonged air leak in the LR cohort (difference=0.68% [95% CI: -4.58%, 5.93%]; p-value compared to a non-inferiority margin of 10%: 0.0003) and anastomotic leak in the GI cohort (difference=0.26% [95% CI: -1.21%, 1.73%]; p-value compared to a non-inferiority margin of 5%: < 0.0001). Bleeding-related complications were lower among patients undergoing LR using ECH3000 (difference=-6.97% [95% CI: -12.18%, -1.77%]) and comparable between stapling devices among patients undergoing GI surgery (difference=0.38% [95% CI: -1.53%, 2.28%]).

Conclusions: ECH3000 was non-inferior to ECH+ in terms of prolonged air leak among patients undergoing LR and anastomotic leak among patients undergoing GI surgery. Bleeding-related complications were comparable among patients undergoing GI surgery, but lower among patients undergoing LR using ECH3000 as compared to ECH+.