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Background Circular staplers perform a critical function for creation of anastomoses in colorectal surgeries. Powered stapling systems allow for reduced force required by surgeons to fire the device and may provide advantages for creating a secure anastomosis. The objective of this study was to evaluate the clinical performance of a novel circular powered stapler in a post-market setting, during left-sided colectomy procedures. Materials and methods Consecutive subjects underwent left-sided colorectal resections that included anastomosis performed with the ECHELON CIRCULAR™ Powered Stapler (ECP). The primary endpoint was the frequency in which a stapler performance issue was observed. Secondary endpoints included evaluation of ease of use of the device via a surgeon satisfaction questionnaire, and monitoring/recording of procedure-related adverse events (AEs). Results A total of 168 anastomoses were performed with the ECP. Surgical approaches included robotic-assisted (n = 74, 44.0%), laparoscopic (n = 71, 42.3%), open (n = 20, 11.9%), and hand-assisted minimally invasive (n = 3, 1.8%) procedures. There were 22 occurrences of device performance issues in 20 (11.9%) subjects during surgery. No positive intraoperative leak tests were observed, and only 1 issue was related to a procedure-related AE or surgical complication, which was an instance of incomplete surgical donut necessitating re-anastomosis. Postoperative anastomotic leaks were experienced in 4 (2.4%) subjects. Clavien-Dindo classification of all AEs indicated that 92.0% were Grades I or II. Participating surgeons rated the ECP as easier to use compared to previously used manual circular staplers in 85.7% of procedures. Conclusion The circular powered stapler exhibited few clinically relevant performance issues, an overall favorable safety profile, and ease of use for creation of left-sided colon anastomoses.

Background Staple line reinforcement (SLR) is a popular tool used by surgeons to increase staple line strength and improve peri-operative hemostasis. However, currently marketed buttress materials require special attention in attachment to the staple anvil and cartridge and may come loose during typical maneuvering of stapling procedures. We have evaluated a new SLR that has an attachment material that affixes buttress across the entire anvil and cartridge face to prevent slipping, twisting, sliding and/or bunching. Methods In benchtop and preclinical testing, the new buttress material (ECHELON ENDOPATH™ Staple Line Reinforcement) was compared to a commercially available SLR for physical characteristics, including strength, absorption, security on the anvil and cartridge during stapler manipulation, impact on the tissue healing response and tissue abrasion. The two SLR's were also compared to a staple line without buttress for hemostasis. Results The new SLR was 180% stronger initially and maintained a greater strength for up to 14 days of exposure to an in vitro solution (p≤0.001), even though it was lighter and exhibited a faster rate of degradation. The new buttress material maintained complete adherence to the anvil and cartridge throughout tissue manipulation, whereas the commercial product lost substantial coverage in 72% of samples. Both SLR's provided superior hemostasis to the non-buttress control, with minimal impact on tissue healing or abrasion. Conclusion Because the new buttress material comes with attachment material affixed across the entire anvil and cartridge face of the stapler and maintains coverage during manipulations, it should be much easier to use. The physical characteristics of the new SLR were as good as or better than current product that requires the buttress to be applied to the cartridge and anvil. In addition, the new SLR is similar in hemostasis to standard products and superior to stapling without the use of buttress. Further research is needed to determine whether these preclinical benefits carry over into a clinical setting.

Manual circular staplers are widely used in colorectal surgery; however, limited literature exists examining complications related to circular anastomoses when such devices are used. The present study evaluated the incidence, predictors, and economic burden of circular anastomotic complications in left-sided colorectal reconstructions involving manual circular staplers. Patients aged ≥18 years who underwent hemicolectomy, low anterior resection, or sigmoidectomy between 1 October 2016 and 31 December 2018 were identified from the Premier Healthcare Database. Manual circular stapler use was identified from hospital administrative billing records. Circular anastomotic complications were defined as a composite endpoint of multiple circular stapler use (proxy for stapler failure) or other circular anastomotic complications (anastomotic leak, bleeding, device/surgical complications, infection, and transfusion). Multivariable analyses were used to model the associations between circular anastomotic complications and total hospital costs, length of stay, operating room time, and 30-, 60-, and 90-day readmission rates. A total of 13,167 patients met the study criteria, of whom 2,984 (22.7%) had circular anastomotic complications. Predictors of circular anastomotic complications included age, procedure type, provider region, and select patient comorbidities. As compared with those who did not, patients who suffered circular anastomotic complications had significantly higher adjusted total hospital costs ($26,924 vs. $18,748; p p p p p p p The present study is limited by the observational nature and potential for measurement error that is inherent to administrative healthcare databases. In this analysis of patients undergoing left-sided colorectal reconstructions involving a manual circular stapler, circular anastomotic complications were associated with adverse economic consequences.

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

Background: An advanced bipolar (ABP) tissue sealer designed for division of major vessels in open procedures was evaluated in a prospective post-market study. The objective was to provide clinical data for assessment of vessel transection, hemostatic performance and ease of use of the ABP device duringopen colectomy, gynecologic, and thoracic operations.Materials and methods: The ABP test device was used in colectomy (n ¼ 36), gynecologic (n ¼ 44), and thoracic (n ¼ 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1e4, defined as follows: Grade1, no bleeding; Grade 2, minor bleeding with no intervention; Grade 3, minor bleeding requiring touchup with the test device or monopolar cautery; and Grade 4, significant bleeding requiring intervention with any additional hemostatic product. The primaryperformance measure was the percentage of vessels that achieved hemostasis grades 3. The primary safety endpoint was the summarization of all ABP device-related adverse events (AEs).Results: For all three procedure groups together, 302 (96.2%) of 314 total vessel transections were scored as hemostasis grades 3, including 270 (86.0%) that were rated Grade 1. Twelve transections (3.8%) were Grade 4, which included 9 vessels transected in the gynecologic group and 3 in the thoracic group. Threesubjects experienced a total of 4 device-related AEs, consisting of hematoma, hypotension, procedural pain, and superficial thermal burn. All 4 device-related AEs were mild in severity.Conclusion: The advanced bipolar device exhibited effective hemostasis, an acceptable safety profile, and ease of use during colectomy, thoracic, and gynecologic procedures.Trial registry number: ClinicalTrials.gov, NCT034411.

Background A narrow-profile powered vascular stapler (PVS) was developed to provide superior access and precise staple placement in thoracic procedures. The objective of this study was to determine if the PVS would yield an equivalent rate of hemostatic interventions compared with standard of care (SOC) staplers in video-assisted thoracoscopic surgery lobectomy. Materials and Methods A randomized, controlled, multicenter study was conducted comparing PVS with SOC staplers in lobectomies performed for non–small cell lung cancer. The primary performance endpoint was the incidence of intraoperative hemostatic interventions, and the primary safety endpoint was the frequency of postoperative bleeding-related interventions. Results A total of 98 subjects participated in the SOC group and 103 in the PVS group. Rates of intraoperative hemostatic interventions were 5.3% and 8.3% for the SOC and PVS groups, respectively. These rates were not statistically different (P = 0.137), although the upper bound of the 95% confidence interval for the difference in intervention rates between PVC and SOC exceeded a predefined 3% criterion for equivalence. Simple compressions were performed more frequently in the PVS subjects, which accounted for the higher intervention rate in this group. Postoperative interventions for bleeding were required in one SOC subject (1.0%) and one subject from the PVS group (0.9%). Procedure-related adverse events occurred in 21 (21.9%) SOC subjects and 23 (21.9%) PVS subjects, with no adverse events related to use of the study devices. Conclusions The PVS exhibited similar overall safety and effectiveness to SOC staplers in video-assisted thoracoscopic surgery lobectomy.