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Echelon Stapling System associated with lower rates of bleeding-related complications vs. Signia Stapling System

Thu, 08/13/2020 - 10:55
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The Echelon Powered Stapler with Gripping Surface Technology (GST) reloads (Ethicon) was associated with a lower rate of bleeding-related complications compared to the Signia Stapling System with Tri-Staple (Medtronic) among patients undergoing laparoscopic sleeve gastrectomy, according to the first real-world evidence study comparing these two powered surgical stapling systems. The peer-reviewed study, ‘Comparative Effectiveness Assessment of Two Powered Surgical Stapling Platforms in Laparoscopic Sleeve Gastrectomy: A Retrospective Matched Study’, published online in Medical Devices: Evidence and Research, was funded by Ethicon.

“Whereas (ECHELON) GST stabilizes and controls tissue movement through a multi-stage compression, gripping surface technology, and surgeon-controlled power; Signia with Tri-Staple has more tissue movement through a single-stage compression, a stepped cartridge and device-controlled power, thus potentially having different tissue effects intra and postoperatively,” the study authors noted.

The researchers, which included four bariatric surgeons from around the world, used the Premier Healthcare Database of US hospital discharge records to identify and analyse the real-world outcomes of 982 inpatient sleeve gastrectomy patients (491 Echelon Powered Stapler with GST (GST group) and 491 Signia System with Tri-Staple (SIG group)) matched for patient and hospital/provider characteristics from a pool of 5,573 patients who had the procedure between March 2017 and December 2018.

This study’s primary outcome was in-hospital haemostasis-related complications, defined as a composite of either a diagnosis related to haemorrhage and/or acute haemorrhagic anaemia, or a procedure code for blood product transfusion recorded during the surgical. Secondary outcomes included leak, total hospital costs for the surgical admission from the hospital perspective (ie. the cost of the surgical admission to the hospital – rather than charges to the payer/patient or reimbursement from the payer/patient), hospital length of stay, operating room time, and 30-, 60-, and 90-day all-cause inpatient readmission to the same hospital in which the surgical admission occurred.

Outcomes

The outcomes showed that the incidence proportion of haemostasis-related complications was lower in the GST group as compared with the SIG group: three patients/491 [0.61%] for GST vs 11 patients/491 [2.24%] for SIG; p=0.0012; the risk difference between the SIG group and the GST group was 1.63% (p=0.031). This data includes acute post-haemorrhagic anaemia in two of three events in the GST group and eight of 11 events in the SIG group.

Regarding surgical admissions, the differences between the GST and SIG groups were not statistically significant for mean total hospital costs (US$10,666 for GST vs US $11,562 for SIG, p=0.184), mean length of stay (1.6 for GST vs 1.7 days for SIG, p=0.3624), mean operating room time (116.5 for GST vs 116.7 minutes for SIG, p=0.1219) and the incidence proportions of all-cause hospital readmissions within 30 (2.2% for GST vs 2.1% for SIG, p=0.9764), 60 (3.2% for GST vs 2.9% for SIG, p=0.7632) and 90 (3.6% for GST vs 3.2% for SIG, p=0.7968) days after discharge. No surrogate diagnoses for leak were observed in either the GST or SIG groups.

“In this retrospective study of 982 matched patients undergoing sleeve gastrectomy, the Echelon Flex GST system was associated with a lower rate of haemostasis-related complications as compared with the Signia Stapling System,” the authors concluded. “No significant differences were observed in mean total hospital costs, length of stay, operating room time, and incidence proportions of all-cause inpatient readmission within 30, 60, and 90 days post-discharge. Further controlled prospective studies are needed to confirm the validity of this finding.”

To access this paper, please click here