Carotid artery bursting pressure and seal time after multiple uses of a vessel sealing device

Blake, Jocelin S.; Trumpatori, Brian J.; Mathews, Kyle G.; Griffith, Emily H.

doi:10.1111/vsu.12648

Cited by 19 publications

(28 citation statements)

References 18 publications

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“…The results of these studies provide evidence that the efficacy of sterilization may be highly method dependent. Blake et al found no change in seal bursting pressures after 15 resterilization cycles of the LigaSure Atlas with ethylene oxide; however, microbial testing was not performed, and the handset assessed in the Blake et al study differed in several design features compared with that assessed in our study. Thus, conclusions cannot be drawn about the efficacy of other methods of sterilization for the LigaSure.…”

Section: Discussioncontrasting

confidence: 61%

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Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5‐mm vessel‐sealing device

et al. 2019

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Objective To evaluate the functional and microbiological safety of a single‐use laparoscopic vessel‐sealing device in a multiuse setting. Study design Ex vivo study. Sample population Twelve 5‐mm LigaSure Maryland jaw devices. Methods Handsets underwent repeated test cycles until failure. The handset packaging was opened, and handsets were agitated in phosphate‐buffered saline (PBS). The PBS was removed, centrifuged, and submitted for culture. Canine ovariectomy was simulated on cadaveric tissue, after which vascular seal quality was evaluated by pressure testing of sealed porcine carotid arteries. The handsets were cleaned and sterilized with hydrogen peroxide gas and repackaged. Results Mean ± SD cycles to failure was 7.7 ± 2.8, with a minimum of 4 and a maximum of 12 use cycles achieved. Eleven of the 12 handsets failed by failure of handset activation after depression of the activation trigger. Only 1 handset failed to hold an adequate vascular seal under 300 mm Hg of pressure. No handset exhibited positive bacterial culture at any cycle. Conclusion The sterilization method used in this study resulted in an excellent microbiological safety profile. Most of the handsets failed by activation button failure. Clinical significance Under the conditions of this study, hydrogen peroxide sterilization achieved microbiological safety. Handsets can successfully be reused until activation button failure without negative effects on the vascular seal or increased risk of infection to the patient.

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Section: Discussioncontrasting

confidence: 61%

“…The manufacturer recommends that these handsets be discarded after a single operative procedure . To increase the affordability of the product, handsets are often sterilized and reused in veterinary medicine . The handsets have the potential to fail during both vessel sealing and tissue division.…”

Section: Introductionmentioning

confidence: 99%

Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5‐mm vessel‐sealing device

et al. 2019

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“…Dehiscence and leakage after gastrointestinal interventions are serious complications associated with substantial morbidity, so safe and effective enterotomy closure is of critical importance to avoid occurrence of septic peritonitis. Leakage pressure testing is commonly performed to evaluate surgical methods that mimic in vivo conditions prior to clinical implementation . In veterinary research, cadaveric samples have been used for leak pressure testing in canine, equine, and ovine studies by using a variety of techniques and temperatures for storage of gastrointestinal specimens prior to definitive experimental testing.…”

Section: Introductionmentioning

confidence: 99%

Ex vivo comparison of the effect of storage temperature on canine intestinal leakage pressures

et al. 2019

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Objective To determine the effect of storage temperature on cadaveric small intestinal leakage pressures after enterotomy. Study design Experimental ex vivo study. Animals Grossly normal jejunal segments from four canine cadavers. Methods Thirty‐six jejunal segments (n = 12 segments/group) were harvested immediately after euthanasia and assigned to a fresh group (tested within 4 hours), chilled group (stored for 24 hours at 4°C before testing), or freeze–thaw group (frozen at −20°C for 7 days and thawed at 21°C for 6 hours before testing). A 2‐cm antimesenteric enterotomy was performed and repaired with 4‐0 monofilament suture in a simple‐continuous pattern. Initial leakage pressure (ILP), maximal intraluminal pressure (MIP), and leakage location were recorded, with testing performed at room temperature. Results Mean ± SD ILP for fresh, chilled, and frozen–thawed specimens was 52.9 ± 8.4, 51.8 ± 11.9 and 29.8 ± 4.4 mm Hg, respectively. There was a difference in ILP among groups (P < .003), with freeze–thaw samples demonstrating lower ILP compared with other groups. There was no difference in MIP between groups (P = .186) There was a difference in leakage location among groups (P = .004), with the majority of chilled and freeze–thaw samples leaking at the suture holes compared with the incisional line in fresh samples. Conclusion Freezing and subsequent thawing prior to specimen testing reduced ILP compared with use of fresh and chilled specimens but did not affect MIP among experimental groups. Clinical significance Cadaveric canine intestinal specimens tested immediately after collection or after chilling for 24 hours should be recommended for ex vivo burst pressure assessment in dogs. Additional studies to evaluate loss in testing viability of chilled intestinal specimens are warranted to help govern experimental methodologies.

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“…The manufacturer recommends the handsets be used only in a single operative procedure before being discarded . However, in the context of veterinary surgery, the handsets are frequently cleaned, resterilized, and reused over multiple procedures, with the goal of increasing affordability . Limited data are available regarding how the operative safety of the instrument is affected by multiple use/resterilization cycles.…”

Section: Introductionmentioning

confidence: 99%

“…A retrospective observational study evaluating LigaSure use in the context of equine orchidectomy did not observe active postoperative hemorrhage or increased surgical site infections in horses when LigaSure handsets were reused and resterilized a median of 8 times . A study investigating reuse of the LigaSure Atlas handset found that the unit continued to form an effective seal through 15 use/resterilization cycles with ethylene oxide resterilization …”

Section: Introductionmentioning

confidence: 99%

Influence of multiple reuse and resterilization cycles on the performance of a bipolar vessel sealing device (LigaSure) intended for single use

et al. 2018

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Carotid artery bursting pressure and seal time after multiple uses of a vessel sealing device

Abstract: The LigaSure Atlas vessel sealing device can be used and resterilized with ethylene oxide up to 15 times with no change in sealing time or bursting pressure of the seal.

Cited by 19 publications

References 18 publications

Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5‐mm vessel‐sealing device

Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5‐mm vessel‐sealing device

Ex vivo comparison of the effect of storage temperature on canine intestinal leakage pressures

Influence of multiple reuse and resterilization cycles on the performance of a bipolar vessel sealing device (LigaSure) intended for single use

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