Hemostatic efficacy of an advanced bipolar sealer in open gynecologic, thoracic, and colectomy procedures: A prospective cohort study. (2020)

• Record Type: Journal Article
• Authors: Schilder, Jeanne; Anderson, David; Shah, Fatima; Holcomb, Bryan; Shah, Ahmar; Fullarton, Grant; Ashraf, Shazad; Fegan, Scott; Paterson, Hugh; Schwiers, Michael L.; Singleton, David W.; Waggoner, Jason R.; Fryrear, Raymond; Robb, Bruce W.
• Is Part Of: International journal of surgery open. Volume 24(2020)
• Page Start: 57
• Page End: 63
• Publication Date: 2020
• Subjects: Advanced bipolar -- ENSEAL -- Hemostasis -- Vessel transection -- Open surgery; Surgery -- Periodicals; 617.005
• DOI: 10.1016/j.ijso.2020.03.007
• Languages: English
• ISSNs: 2405-8572

Abstract

Abstract: 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 during open colectomy, gynecologic, and thoracic operations. Materials and methods: The ABP test device was used in colectomy (n = 36), gynecologic (n = 44), and thoracic (n = 21) procedure groups. Vessels transected with the ABP device were graded intraoperatively on a hemostasis scale of 1–4, 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 primary performance 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. Three subjects 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. Highlights: An advanced bipolar tissue sealer provided effective hemostasis in gynecologic, thoracic and colectomy procedures. The sealer showed an acceptable safety profile across three procedure groups. The sealer was judged by investigators to show ease of use in terms of hand positioning and firing.