title: Clinical utility of a novel ultrasonic vessel sealing device in transecting and sealing large vessels during laparoscopic hysterectomy using advanced hemostasis mode.
abstract: OBJECTIVE
  The ultrasonic advanced energy study device (AH device) is the first surgical device indicated to seal vessels up to and including 7mm using ultrasonic technology alone. This study assesses clinical experience during total laparoscopic hysterectomy (TLH) using advanced hemostasis mode (AHM).
  
  
  METHODS
  This was a prospective, non-randomized, single arm, multicenter, observational study which did not modify or influence current surgeon technique for elective TLH for benign disease. Each surgeon assessed hemostasis, defined as the hemostatic transection of the uterine vasculature (left/right) with at least one use of the AH device in AHM without the use of additional hemostatic measures other than the AH device. Patients were followed for 4-6 weeks after surgery. Vessel sealing performance was quantitatively assessed for transection and sealing of the uterine artery (UA), the uterine pedicle (UP; defined as cases where the UA could not be 'isolated') and the ovarian pedicle (OP) (when indicated). Adverse events (AEs) related to the AH device or procedures were collected.
  
  
  RESULTS
  Forty patients underwent the procedure. Mean age was 49 years and mean body mass index was 28kg/m(2). Mean surgical duration was 88min. None required conversion to open procedure. Using only the AH device, hemostasis was achieved and maintained in 119 (94.4%) transections (both left and right sides of the UA/UP and OP). Additional hemostasis was achieved in 5 patients using conventional bipolar (4) or monopolar (1) energy. No patient required a blood transfusion postoperatively. Only one adverse event of pain was considered to be related to the use of the ultrasonic AH device during this study.
  
  
  CONCLUSIONS
  These results support that the AH device with its AHM has clinical utility in sealing named vessels in TLH. The new algorithm to deliver energy in the AHM has the potential to reduce the need for additional hemostatic devices or products as well as the potential to reduce the need for multiple instrument changes during surgery.
authors.affiliation: Radboud University Medical Centre, Nijmegen, Netherlands.
authors.forename: Theodoor E
authors.initials: TE
authors.lastname: Nieboer
authors.affiliation: Advocate Lutheran General Hospital, Park Ridge, IL, USA.
authors.forename: Courtney J
authors.initials: CJ
authors.lastname: Steller
authors.affiliation: Ethicon, Inc., Somerville, NJ, USA.
authors.forename: Piet
authors.initials: P
authors.lastname: Hinoul
authors.affiliation: Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA. Electronic address: amaxson@its.jnj.com.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Maxson
authors.affiliation: Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Schwiers
authors.affiliation: Advocate Lutheran General Hospital, Park Ridge, IL, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Miller
authors.affiliation: Radboud University Medical Centre, Nijmegen, Netherlands.
authors.forename: Sjors F
authors.initials: SF
authors.lastname: Coppus
authors.affiliation: The Royal Surrey County Hospital NHS Trust, Guildford, Surrey, UK.
authors.forename: Andrew S H
authors.initials: AS
authors.lastname: Kent
mesh_terms: D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D005260:Female; D006488:Hemostasis, Surgical / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007044:Hysterectomy / Q000379:methods*; D010535:Laparoscopy / Q000379:methods*; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014465:Ultrasonics
keywords: Harmonic; Harmonic Ace +7; Harmonic energy; Laparoscopic hysterectomy; Ultrasonic energy