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Stephen P Fortin,1 William Petraiuolo,2 Guy Cafri,1 Gustavo Scapini,3 Pratyush Agarwal,4 Divya Chakke,4 Stephen Johnston,1 Barbara H Johnson,1 Paul M Coplan,1,5 Shumin Zhang1 1MedTech Epidemiology and Real-World Data Science, Office of the Chief Medical Officer, Johnson & Johnson, New Brunswick, NJ, USA; 2Medical Affairs, Ethicon, Cincinnati, OH, USA; 3Regional Medical Affairs, Johnson & Johnson, São Paulo, Brazil; 4Mu Sigma, Bengaluru, Karnataka, India; 5University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USACorrespondence: Stephen P Fortin, MedTech Epidemiology and Real-World Data Science, Office of the Chief Medical Officer, Johnson & Johnson, 410 George St, New Brunswick, NJ, USA, Tel +1 908 927 4844, Email sfortin1@its.jnj.comPurpose: Linear surgical staplers reduce rates of surgical adverse events (bleeding, leaks, infections) compared to manual sutures thereby reducing patient risks, surgeon workflow disruption, and healthcare costs. However, further improvements are needed. Ethicon Gripping Surface Technology (GST) reloads, tested and approved by regulatory authorities in combination with powered staplers, may reduce surgical risks through improved tissue grip. While manual staplers are used in some regions due to affordability, clinical data on GST reloads used with manual staplers are unavailable. This study compared surgical adverse event rates of manual staplers with GST vs standard reloads. These data may be used for label changes in China and Latin America.Patients and Methods: Patients undergoing general or thoracic surgery between October 1, 2015 and August 31, 2021 using ECHELON FLEX™ manual staplers with GST or standard reloads were identified from the Premier Healthcare Database. GST reloads were compared to standard reloads for non-inferiority in bleeding and anastomotic leak for general surgery. Secondary outcomes included sepsis for general surgery, and bleeding and prolonged air leak for thoracic surgery. Covariate balancing was performed using stable balancing weights.Results: The general and thoracic surgery cohorts contained 4571 (GST: 2780; standard: 1791) and 814 (GST: 514; standard: 300) patients, respectively. GST reloads were non-inferior to standard reloads for bleeding and anastomotic leak (adjusted cumulative incidence ratio: 1.02 [90% CI: 0.71, 1.45] and 1.03 [90% CI: 0.72, 1.46], respectively) for general surgery. Compared with standard reloads, GST reloads had a similar incidence of sepsis (2.2% vs 2.1%) for general surgery and lower incidences of bleeding (9.5% vs 16.0%) and prolonged air leak (12.6% vs 14.0%,) for thoracic surgery.Conclusion: GST reloads, compared to standard reloads, used with ECHELON FLEX™ manual staplers had comparable perioperative bleeding and anastomotic leak for general surgery, and lower incidences of safety events for thoracic surgery.Keywords: real-world evidence, safety, ECHELON, general surgery, thoracic surgery

Background Patients with medically intractable GERD after laparoscopic sleeve gastrectomy (LSG) have limited surgical options. Fundoplication is difficult post-LSG. Roux-en-Y gastric bypass may be used as a conversion procedure but is more invasive with potential for serious complications. Magnetic sphincter augmentation (MSA) is a less invasive GERD treatment alternative. The objective of this study was to assess safety and efficacy outcomes of MSA after LSG. Methods The primary outcome of this observational, multicenter, single-arm prospective study was the rate of serious device and/or procedure-related adverse events (AEs). The efficacy of the LINX device was measured comparing baseline to 12-month post-implant reductions in distal acid exposure, GERD-HRQL score, and average daily PPI usage. Results Thirty subjects who underwent MSA implantation were followed 12 months post-implant. No unanticipated adverse device effects were observed. There were two adverse events deemed serious (dysphagia, pain, 6.7%) which resolved without sequelae. GERD-HRQL scores showed significant improvement (80.8%, P P = 50% reduction of total distal acid exposure time (baseline 16.2%, 12 months 11%; P = 0.038). Conclusions Post-LSG, MSA showed an overall improvement of GERD symptoms, and reduction in PPI use with explants within anticipated range along with improvement in distal esophageal acid exposure time. Graphical Abstract

Liver metastasis in nude mice was studied using LoVo, a cell line developed from a patient with adenocarcinoma of the colon. LoVo cells injected into the spleen of 4-week-old nude mice showed 100% tumorigenicity in the spleen and metastases to the liver. This system was used to study ways in which to improve the efficacy of 5-FU, which was used in combination with alpha-2a interferon. Our results show that interferon can potentiate the effect of 5-FU in inhibiting liver metastases. Either drug given alone did not show comparable inhibition.