Evaluation of the performance of an endoscopic 3-mm electrothermal bipolar vessel sealing device intended for single use after multiple use-and-resterilization cycles.
Journal
Veterinary surgery : VS
ISSN: 1532-950X
Titre abrégé: Vet Surg
Pays: United States
ID NLM: 8113214
Informations de publication
Date de publication:
Jun 2020
Jun 2020
Historique:
received:
19
09
2019
revised:
22
11
2019
accepted:
18
01
2020
pubmed:
14
2
2020
medline:
4
11
2020
entrez:
14
2
2020
Statut:
ppublish
Résumé
To evaluate the performance of an endoscopic 3-mm electrothermal bipolar vessel sealing device (EBVS) intended for single use after multiple use-and-resterilization cycles. Ex vivo study. Eight 3-mm EBVS handpieces. Handpieces were subjected to a maximum of 15 cycles of testing, including simulated surgery, sealing and burst pressure testing of porcine carotid arteries, reprocessing, and hydrogen peroxide plasma resterilization. Failure was defined as two sequential vascular seal leakage events occurring at <250 mm Hg. Histological evaluation, maximum external temperature of the jaws, sealing time, tissue adherence, jaw surface characterization, and mechanical deterioration were studied. Failure rate was analyzed by using a Kaplan-Meier curve. Linear and ordinal logistic mixed models were used to analyze sealing time, handpiece jaw temperature, and adherence score. Mean ± SD diameter of arteries was 3.22 ± 0.35 mm. Failure was observed starting at cycle 10 and going up to cycle 13 in 37.5% (3/8) of the handpieces. Tissue adherence increased after each cycle (P < .001). Maximum external temperature (79.8°C ± 13.9°C) and sealing time (1.8 ± 0.5 seconds) were not significantly different throughout cycles up to failure. A flatter surface and large scratches were observed microscopically throughout the jaw surface after repeated use and resterilization. The 3-mm EBVS handpiece evaluated in this study can be considered safe to use for up to nine reuse-and-resterilization cycles. These data provide the basis for establishing preliminary guidelines for the reuse and hydrogen peroxide plasma resterilization of an endoscopic 3-mm EBVS handpiece.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
O120-O130Subventions
Organisme : Ontario Veterinary College Pet Trust Fund (to A.S).
Informations de copyright
© 2020 The American College of Veterinary Surgeons.
Références
Tharakan SJ, Hiller D, Shapiro RM, Bose SK, Blinman TA. Vessel sealing comparison: old school is still hip. Surg Endosc. 2016;30(10):4653-4658. https://doi.org/10.1007/s00464-016-4778-0.
Chekan EG, Davison MA, Singleton DW, Mennone JZ, Hinoul P. Consistency and sealing of advanced bipolar tissue sealers. Med Devices (Auckl). 2015;8:193-199. https://doi.org/10.2147/MDER.S79642.
Berdah SV, Hoff C, Poornoroozy PH, Razek P, Van Nieuwenhove Y. Postoperative efficacy and safety of vessel sealing: an experimental study on carotid arteries of the pig. Surg Endosc. 2012;26(8):2388-2393. https://doi.org/10.1007/s00464-012-2177-8.
Devriendt N, Van Goethem B, Van Brantegem L, et al. Comparison of a 5-mm and 10-mm vessel sealing device in an open ovariectomy model in dogs. Vet Rec. 2017;180(17):425-425. https://doi.org/10.1136/vr.104016.
Bolder Surgical. JustRight surgical vessel sealing system. https://boldersurgical.com/justright-vessel-sealing-system/. Accessed February 4, 2020.
Kramer Eric A, Rentschler ME. Energy-based tissue fusion for sutureless closure: applications, mechanisms, and potential for functional recovery. Annu Rev Biomed Eng. 2018;20.
McCready J, Beaufrère H, Singh A, Oblak M, Sanchez A. Laparoscopic ovariectomy in guinea pigs: a pilot study. Vet Surg. In press. Doi:https://doi.org/10.1111/vsu.13243
Blake JS, Trumpatori BJ, Mathews KG, Griffith EH. Carotid artery bursting pressure and seal time after multiple uses of a vessel sealing device. Vet Surg. 2017;46(4):501-506. https://doi.org/10.1111/vsu.12648.
Kuvaldina A, Hayes G, Sumner J, Behling-Kelly E. Influence of multiple reuse and resterilization cycles on the performance of a bipolar vessel sealing device (LigaSure) intended for single use. Surg. 2018;47(7):951-957. https://doi.org/10.1111/vsu.12948.
Valenzano D, Hayes G, Gludish D, Weese S. Performance and microbiological safety testing after multiple use cycles and hydrogen peroxide sterilization of a 5-mm vessel-sealing device. Vet Surg. 2019;48(5):885-889. https://doi.org/10.1111/vsu.13191.
Gracia-Calvo LA, Martín-Cuervo M, Jiménez J, et al. Intra and postoperative assessment of re-sterilised LigaSure Atlas for orchidectomies in horses: clinical study. Vet Rec. 2012;171(4):98. https://doi.org/10.1136/vr.100601.
Gardeweg S, Bockstahler B, Duprè G. Effect of multiple use and sterilization on sealing performance of bipolar vessel sealing devices. PLoS One. 2019;14(8):e0221488. https://doi.org/10.1371/journal.pone.0221488.
Renton D, Denk P, Varban O. Reprocessed single-use devices in laparoscopy: assessment of cost, environmental impact, and patient safety. Surg Endosc. 2018;32(10):4310-4313. https://doi.org/10.1007/s00464-018-6275-0.
Okhunov Z, Yoon R, Lusch A, et al. Evaluation and comparison of contemporary energy-based surgical vessel sealing devices. J Endourol. 2018;32(4):329-337. https://doi.org/10.1089/end.2017.0596.
Cezo JD, Passernig AC, Ferguson VL, Taylor KD, Rentschler ME. Evaluating temperature and duration in arterial tissue fusion to maximize bond strength. J Mech Behav Biomed Mater. 2014;30:41-49. https://doi.org/10.1016/j.jmbbm.2013.10.007.
Brecht L, Wallwiener M, Schott S, et al. Implementation of a novel efficacy score to compare sealing and cutting devices in a porcine model. Surg Endosc. 2018;32(2):1002-1011. https://doi.org/10.1007/s00464-017-5778-4.
Chen J, Manwaring PK, Scott RR, Manwaring KH, Glasgow RE. Ferromagnetic heating for vessel sealing and division: utility and comparative study to ultrasonic and bipolar technologies. Surg Innov. 2015;22(4):329-337. https://doi.org/10.1177/1553350615580648.
Sindram D, Martin K, Meadows JP, et al. Collagen-elastin ratio predicts burst pressure of arterial seals created using a bipolar vessel sealing device in a porcine model. Surg Endosc. 2011;25(8):2604-2612. https://doi.org/10.1007/s00464-011-1606-4.
Seehofer D, Mogl M, Boas-Knoop S, et al. Safety and efficacy of new integrated bipolar and ultrasonic scissors compared to conventional laparoscopic 5-mm sealing and cutting instruments. Surg Endosc. 2012;26(9):2541-2549. https://doi.org/10.1007/s00464-012-2229-0.
Mantke R, Halangk W, Habermann A, et al. Efficacy and safety of 5-mm-diameter bipolar and ultrasonic shears for cutting carotid arteries of the hybrid pig. Surg Endosc. 2011;25(2):577-585. https://doi.org/10.1007/s00464-010-1224-6.
Wallwiener CW, Junginger SH, Zubke W, et al. Bipolar vessel sealing: instrument contamination and wear have little effect on seal quality and success in a porcine in vitro model. Langenbecks Arch Surg. 2014;399(7):863-871. https://doi.org/10.1007/s00423-014-1234-2.
Wyatt HL, Richards R, Pullin R, Yang THJ, Blain EJ, Evans SL. Variation in electrosurgical vessel seal quality along the length of a porcine carotid artery. Proc Inst Mech Eng Part H. 2016;230(3):169-174. https://doi.org/10.1177/0954411915621092.
Okada S, Shimada J, Ito K, Ishii T, Oshiumi K. Surface-processing technology of a microgrooving and water-repellent coating improves the fusion potential of an ultrasonic energy device. Surg Endosc. 2017;31(2):887-893. https://doi.org/10.1007/s00464-016-5048-x.
Cezo JD, Kramer EA, Schoen JA, Ferguson VL, Taylor KD, Rentschler ME. Tissue storage ex vivo significantly increases vascular fusion bursting pressure. Surg Endosc. 2015;29(7):1999-2005. https://doi.org/10.1007/s00464-014-3900-4.
Cezo JD, Kramer E, Taylor KD, Ferguson V, Rentschler ME. Temperature measurement methods during direct heat arterial tissue fusion. IEEE Trans Biomed Eng. 2013;60(9):2552-2558. https://doi.org/10.1109/TBME.2013.2260542.
Van Doormaal TPC, Sluijs JH, Vink A, Tulleken CAF, Van Der Zwan A. Comparing five simple vascular storage protocols. J Surg Res. 2014;192(1):200-205. https://doi.org/10.1016/j.jss.2014.05.001.
Stemper BD, Yoganandan N, Stineman MR, Gennarelli TA, Baisden JL, Pintar FA. Mechanics of fresh, refrigerated, and frozen arterial tissue. J Surg Res. 2007;139(2):236-242. https://doi.org/10.1016/j.jss.2006.09.001.
Chow MJ, Zhang Y. Changes in the mechanical and biochemical properties of aortic tissue due to cold storage. J Surg Res. 2011;171(2):434-442. https://doi.org/10.1016/j.jss.2010.04.007.
O'Leary SA, Doyle BJ, McGloughlin TM. The impact of long term freezing on the mechanical properties of porcine aortic tissue. J Mech Behav Biomed Mater. 2014;37:165-173. https://doi.org/10.1016/j.jmbbm.2014.04.015.
Reyes DAG, Brown SI, Cochrane L, Motta LS, Cuschieri A. Thermal fusion: effects and interactions of temperature, compression, and duration variables. Surg Endosc. 2012;26(12):3626-3633. https://doi.org/10.1007/s00464-012-2386-1.
Song C, Tang B, Campbell PA, Cuschieri A. Thermal spread and heat absorbance differences between open and laparoscopic surgeries during energized dissections by electrosurgical instruments. Surg Endosc. 2009;23:2480-2487. https://doi.org/10.1007/s00464-009-0421-7.
Richter S, Kollmar O, Schilling MK, Pistorius GA, Menger MD. Efficacy and quality of vessel sealing: comparison of a reusable with a disposable device and effects of clamp surface geometry and structure. Surg Endosc. 2006;20(6):890-894. https://doi.org/10.1007/s00464-005-0380-6.
Blau PJ. Asperities. Encyclopedia of Tribology. Boston, MA: Springer; 2013:118-120. https://doi.org/10.1007/978-0-387-92 897-5_167.
Brady JT, Bhakta A, Steele SR, et al. Reprocessed bipolar energy for laparoscopic colectomy: is it worth it? Am J Surg. 2017;214(1):59-62. https://doi.org/10.1016/j.amjsurg.2017.02.012.