Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study

Logan Rawlins,1 Barbara H Johnson,2 Stephen S Johnston,2 Nivesh Elangovanraaj,3 Mohit Bhandari,4 Ricardo V Cohen,5 Karl Peter Rheinwalt,6 Raymond Fryrear,2 Sanjoy Roy2 1Allegheny Health Network Bariatric & Metabolic Institute, Pittsburgh, PA, USA; 2Johnson & Johnson Medical Device Company, Cincinnati, OH, USA; 3Mu Sigma, Bangalore, India; 4Mohak Bariatric and Robotic Surgery Centre, Indore, India; 5The Center for the Treatment of Obesity and Diabetes, Hospital Alemão Oswaldo Cruz, Sao Paulo, Brazil; 6St. Franziskus-Hospital, Cologne, GermanyCorrespondence: Stephen S JohnstonDirector, Real-World Data Analytics and Research, Epidemiology, Medical Devices, Johnson & Johnson, 410 George Street, New Brunswick, NJ, USTel +1-443-254-2222Email sjohn147@its.jnj.comObjective: To compare outcomes between the two latest innovations in powered stapling technology, the ECHELON FLEX™ GST system (GST) and the Signia™ Stapling System (SIG), among patients undergoing sleeve gastrectomy for obesity.Patients and Methods: Using the Premier Healthcare Database of US hospital discharge records, we selected patients undergoing inpatient sleeve gastrectomy with dates of surgical admission between March 1, 2017 (SIG launch), and December 31, 2018. Outcomes measured during the surgical admission included in-hospital hemostasis-related complications (bleeding/transfusion; primary outcome), leak, total hospital costs, length of stay (LOS), and operating room time; 30-, 60-, and 90-day all-cause inpatient readmissions were also examined. We used 1:1 cardinality matching to balance the GST and SIG groups on numerous patient and hospital/provider characteristics, allowing a maximum standardized mean difference (SMD) ≤ 0.05 for all matching covariates. Generalized estimating equations (GEE) accounting for hospital-level clustering were used to compare the study outcomes between the GST and SIG groups.Results: Of the 5573 identified cases, there were 491 patients in each group (982 total) after matching. The observed incidence proportion of hemostasis-related complications during the surgical admission was lower in the GST group as compared with the SIG group (3 events/491 [0.61%] vs 11 events/491 [2.24%]; odds ratio [SIG=reference] = 0.28, 95% CI=0.13– 0.60, P=0.0012). Differences between the GST and SIG groups were not statistically significant for leak, total hospital costs, LOS, OR time, and all-cause inpatient readmission at 30, 60, and 90 days.Conclusion: In this retrospective study of 982 matched patients undergoing sleeve gastrectomy, the ECHELON FLEX™ GST system was associated with a lower rate of hemostasis-related complications as compared with the Signia™ Stapling System. Further controlled prospective studies are needed to confirm the validity of this finding.Keywords: sleeve gastrectomy, surgical staplers, bleeding, leak, cost