Efficacy and safety of the novel electrosurgical vessel sealing and cutting instrument BiCision®.
BACKGROUND
The use of energy-based tissue-sealing and cutting instruments is becoming more and more popular in visceral, urological, and gynecological surgery. For their safe and efficacious use in clinical practice, such instruments have to reliably seal vessels with a minimal sealing failure rate, cause minimal thermal damage to adjacent tissue, and have good cutting qualities.


METHODS
The efficacy and safety of the novel energy-based instrument for dissection, hemostasis and cutting (BiCision(®), ERBE) was compared to a commercially available device (EnSeal(®), Ethicon Endo-Surgery). We investigated vessel-sealing reliability (success rate), sealing quality and sealing time, lateral thermal damage cutting quality, tissue sticking to the instrument, burst pressure and delayed complications in an acute and chronic pig model after splenectomy, small bowel resection, nephrectomy, salpingo-oophorectomy, and sealing of peripheral vessels.


RESULTS
For all parameters investigated, BiCision(®) was at least equivalent to EnSeal(®). BiCision(®) was even superior to EnSeal(®) with respect to the burst pressure in arteries (p = 0.044) and veins (p = 0.023) and the cut quality in all locations (arteries, p = 0.0009; veins, p = 0.043). The course of the 7-day chronic study was uneventful except for one animal that developed an intestinal obstruction. None of the animals showed any signs of postoperative bleeding. On second-look laparotomy at day 7, macroscopic inspection of the sealed tissue and vessels did not show any signs of complications or evidence that bleeding had occurred. Histologically, the integrity of vessel wall fusion, thermal alterations, and inflammatory reactions were comparable, confirming substantial equivalence.


CONCLUSIONS
We demonstrated that the efficacy and quality of vessel sealing with BiCision(®) is at least equivalent to those of EnSeal(®) for vessel diameters up to 7 mm. Since EnSeal(®) has already been shown to be safe in clinical practice, BiCision(®) should be as reliable as EnSeal(®) under clinical conditions.
University Hospital for Women, University of Tuebingen, Calwerstr. 7/1, 72076, Tuebingen, Germany. Ralf.Rothmund@med.uni-tuebingen.de
Ralf
R
Rothmund
Bernhard
B
Kraemer
Felix
F
Neis
Sara
S
Brucker
Markus
M
Wallwiener
Ali
A
Reda
Andrea
A
Hausch
Marcus
M
Scharpf
Mara Natascha
MN
Szyrach
D000818:Animals; D004598:Electrosurgery / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D013552:Swine