title: Prospective Clinical Study to Evaluate Clinical Performance of a Powered Surgical Stapler in Video-assisted Thoracoscopic Lung Resections.
abstract: Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective research evaluates intraoperative and postoperative data associated with VATS, using a new surgical stapling device, in two different geographic regions (the U.S. and Europe). A total of 226 subjects across 10 institutions were enrolled in this study. The primary endpoint was occurrence and duration of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant difference in air leak or other clinical outcome was detected. Additional research is needed to characterize optimal cartridge selection to tissue properties and how these may potentially impact clinical outcomes.
authors.affiliation: Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.
authors.forename: Peter B
authors.initials: PB
authors.lastname: Licht
authors.affiliation: Johnson & Johnson, Hamburg, Germany.
authors.forename: Goran
authors.initials: G
authors.lastname: Ribaric
authors.affiliation: Department of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Traves
authors.initials: T
authors.lastname: Crabtree
authors.affiliation: Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael
authors.initials: M
authors.lastname: Lanuti
authors.affiliation: Department of Thoracic Surgery, University of Barcelona, Barcelona, Spain.
authors.forename: Laureano
authors.initials: L
authors.lastname: Molins
authors.affiliation: Ethicon, Cincinnati, Ohio.
authors.forename: Susan
authors.initials: S
authors.lastname: Knippenberg
authors.forename: Michael
authors.initials: M
authors.lastname: Schwiers
authors.affiliation: Johnson & Johnson, New Brunswick, New Jersey.
authors.forename: Andrew
authors.initials: A
authors.lastname: Yoo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000295:instrumentation* / Q000706:statistics & numerical data*; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D013528:Surgical Staplers; D020775:Thoracic Surgery, Video-Assisted / Q000295:instrumentation* / Q000706:statistics & numerical data*; D016896:Treatment Outcome