Medical Devices: Evidence and Research (Dec 2022)

Comparison of Clinical Outcomes of Gripping Surface Technology Staple Reloads versus Standard Staple Reloads Used with Manual Linear Surgical Staplers

  • Fortin SP,
  • Petraiuolo W,
  • Cafri G,
  • Scapini G,
  • Agarwal P,
  • Chakke D,
  • Johnston S,
  • Johnson BH,
  • Coplan PM,
  • Zhang S

Journal volume & issue
Vol. Volume 15
pp. 385 – 399

Abstract

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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 [email protected]: 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

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