The AEON stapler (Lexington Medical) is non-inferior to the Tri-Staple (Medtronic) in achieving haemostasis and maintaining staple-line integrity in bariatric surgery, according to a study by researchers from the University of Western Australia and Perth Surgical & Bariatrics, Perth, Australia. However, they noted that it is imperative to note that definitive conclusions cannot be drawn from this single study, and future research with larger sample sizes are essential to validate these findings and explore potential factors influencing stapler performance in bariatric surgery.
The authors stated that gastrointestinal anastomosis (GIA) staplers have “revolutionised” surgical interventions, enlarging the precision and efficiency of gastrointestinal surgeries. Given the current popularity of laparoscopic sleeve gastrectomy (LSG), there are concerns over the haemostasis-related complications and staple-line integrity.
Although there has been extensive assessments of establish GIA staplers (from Medtronic and Ethicon), the authors noted few studies have assessed novel staplers, such as the AEON GIA stapler. Therefore, the researchers conducted a comprehensive analysis of the 30-day complication rates associated with Medtronic Tri-Staple with preloaded buttress material and the naked AEONT GIA staplers in the context of LSG. The aim was to provide valuable insights into their respective effectiveness and safety profiles in achieving optimal haemostasis during LSGs.
Their retrospective analysis included 250 (125 in each group) consecutively enrolled patients with obesity who underwent either primary or revision SG or the sleeve component of single anastomosis-duodeno-ileal bypass with SG (SADI-S) procedures. The surgeries took place in a private hospital from November 2021 to December 2022.
The eligibility criteria for this study included individuals aged 18 years and older, encompassing all sexes. Patients meeting absolute or relative contraindications with bariatric surgery were excluded.
Procedures
In the Medtronic group, the surgical technique for LSG involved the resection of the greater omentum using a LigaSure device (Medtronic). The gastric resection began 4 to 6cm away from the pylorus, following the contour of the bougie, and concluded 1 to 2cm off the angle of His. The initial two stapler firings employed 45mm black Endo GIA reinforced Tri-Staples (Medtronic), followed by subsequent firings using 60mm black Endo GIA reinforced Tri-Staples (Medtronic). These staplers were selected with care to ensure secure closure and effective haemostasis along the staple line. As part of the surgical technique, 4ml of TISSEEL (Baxter) was applied as a haemostatic agent, sprayed along the staple line to enhance haemostasis.
In the AEON group, the greater omentum was dissected off the greater curve using Ligasure from 4 to 6cm proximal to the pylorus all the way to the angle of HIS. A 36 Fr. bougie was positioned along the lesser curve and used for sizing. The first load was 60mm black, preceded by a precompression period of 15 seconds. Subsequently, one 60mm purple AEON staple load was fired across the antrum, following a precompression period of 15 seconds. Three Orange 60mm AEON staple loads were fired along the bougie, each preceded by a precompression period of 15 seconds before firing the devices.
Outcomes
In the Medtronic group, 117 patients (93.6%) underwent primary surgery, 8 patients (6.4%) underwent revision surgery, with 113 patients (90.4%) underwent LSG, with 106 patients (84.8%) undergoing primary SG and 7 patients (5.6%) undergoing revision SG. The SADI-S procedure was performed in 12 patients (9.6%), with 11 patients (8.8%) undergoing primary SADI-S and 1 patient (0.8%) undergoing revision SADI-S.
In the AEON group, 118 patients (94.4%) underwent SG, with 112 patients (89.6%) undergoing primary SG and 4 patients (3.2%) undergoing revision SG. Eight patients (6.4%) underwent SADI-S, with six patients (4.8%) undergoing primary SADI-S and two patients (1.6%) undergoing revision SADI-S. There was no significant differences in the distribution of surgical procedures between the Medtronic and AEON groups.
No statistically significant differences were observed in the preoperative characteristics (aga, BMI, comorbidities etc) between the Medtronic and AEON groups, as well as any of the preoperative risk factors associated with haemostasis-related complications, except for the total number of patients with diabetes and former tobacco users, which were significantly higher (p=0.018 and p=0.008) in the AEON group.
All patients in the Medtronic group received staple-line reinforcement through the use of preloaded buttress material in addition to the application of TISSEEL as a haemostatic agent, whilst only 16.8% of the patients necessitated such reinforcement in the AEON group (the AEON stapler does not include preloaded buttress material).
“Reinforcement with Seamgaurd was specifically used in patients with certain clinical conditions, such as type 1 diabetes, poorly controlled T2DM, known ischemic heart disease, cardiac failure, or those at high risk of postoperative bleeding due to prolonged anticoagulation,” the authors noted. “These decisions were made to address the increased potential for complications in these patient populations and to ensure optimal surgical outcomes.”
The median number of cartridges used during surgery was five for both the Medtronic group (range: 5 [5–7]) and the AEON group (range: 5 [4–7]). Stapler misfiring occurred in 2 cases and stapler malfunction in 2 cases within the Medtronic group, whereas no such events were observed in the AEON group. However, there was no statistically significant difference in the rates of stapler misfiring and malfunction between the two groups (p=0.478).
The researchers carried out leak tests exclusively in high-risk patients, with 11 (8.8%) cases in the Medtronic group and 6 (4.8%) cases in the AEON group, showing no statistically significant difference. The mean operative time was 30±4.8 minutes for the Medtronic group and was significantly longer at 34.5±4.9 minutes for the AEON group (p<0.001). There were no intraoperative complications or deaths occurred in either group. The mean length of hospital stay was significantly shorter in the AEON group (p= 0.039) (1±0.2 days) compared to the Medtronic group (1.1±0.5 days). The 30-day follow-up outcomes showed there were no reports of emergency department visits, readmissions, reoperations, complications or death in either group.
The study also conducted a χ2 test of independence to assess the association between abnormal hemostasis and staple-line integrity. The analysis revealed that the relationship between staple-line bariatric procedures and abnormal hemostasis did not yield statistical significance.
“The findings from this study will contribute to the existing body of knowledge and assist surgeons in making evidence-based decisions regarding selecting GIA staplers, thereby enhancing patient outcomes and ensuring the cost-effectiveness of bariatric surgical procedures,” the authors noted.
The findings were featured in the paper, 'Comparative Analysis of Hemostasis and Staple-Line Integrity between Medtronic Tri-StapleTM with Preloaded Buttress Material and the AEONTM Stapler in Bariatric Surgery', published in Journal of the Society of Laparoscopic & Robotic Surgeons. To access this paper, please click here
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