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:

Peter B Licht, MD, PhD, Professor of Surgery, Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark, Goran Ribaric, MD, Medical, Regional Safety Officer, Johnson & Johnson, Hamburg, Germany, Traves Crabtree, MD, Associate Professor of Surgery, Department of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, Michael Lanuti, MD, Director, Thoracic Oncology, Division of Thoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts, Laureano Molins, MD, PhD, FETCS, Head of Thoracic Surgery, Department of Thoracic Surgery, University of Barcelona, Barcelona, Spain, Susan Knippenberg, MBA, Senior Project Manager, Ethicon, Cincinnati, Ohio, Michael Schwiers, MS, Principal Statistician, Ethicon, Cincinnati, Ohio, Andrew Yoo, MD, Director of Epidemiology, Johnson & Johnson, New Brunswick, New Jersey

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