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

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:

Performance of the ENSEAL X1 Curved Jaw Tissue Sealer in thoracic procedures in a Japanese cohort: a case series report

“…The low rate of product-related AE’s in this thoracoscopic case series is similar to the rate observed with the X1 Large Jaw device in open thoracic procedures (0%) [ 9 ]. Of further interest is literature which suggests that the utilization of vessel sealing devices in thoracic procedures not only may improve hemostasis but also could reduce surgeon stress, intra-operative bleeding, post-operative drainage, and drainage duration when compared to the conventional endostapler [ 10 , 17 , 19 ].…”

“…The present study demonstrates efficacy of the X1CJ in performing thoracic blood vessel transection in a prospective case series. Over 97% of blood vessels sealed with the device required minimal to no additional hemostatic intervention for successful transection, similar to the results observed for the X1 Large Jaw device in open thoracic procedures (96.7%) [ 9 ]. Only three vessel seals required any intervention at all, and importantly, those subjects each had less than 35 mL of total blood loss during the procedure and no transfusions were required.…”

“…The findings of adequate burst pressure, lowered blood loss and drainage have been found in a separate study of an advanced bipolar device [ 11 ]. The older version of the device, the X1 Large Jaw Tissue Sealer, was studied in a variety of open procedures, including thoracic, and was found to provide a high rate of hemostasis and few adverse events [ 12 ].…”

“…Previously, an advanced bipolar device designed for open procedures, the ENSEAL X1 Large Jaw Tissue Sealer, has been tested successfully in a variety of open thoracic procedures [ 9 ]. The ENSEAL X1 Curved Jaw Tissue Sealer (X1CJ) is an advanced bipolar tool used to seal and cut blood vessels in minimally invasive procedures.…”

Electrothermal Vessel Sealing Versus Conventional Suturing in Abdominal Hysterectomy: A Randomised Trial

“…With controlled energy delivery, a single instrument grasps, cuts, and creates distinct seals with burst strength comparable to clips and sutures [1], thus obliviating the need for multiple instruments during surgery. Numerous studies have shown their compelling applicability in a variety of open surgeries including hysterectomy through vaginal and minimally invasive routes [2][3][4]. However, data is conflicting for abdominal hysterectomy, as available studies have not shown any compelling applicability of the EBVS systems with respect to operative time and blood loss [5][6][7].…”