A novel secure transfixing blood vessel occluder: comparison with the hemoclip in the porcine model.

BACKGROUND: Secure vessel occlusion is critical to the success of all surgical and interventional procedures. The purpose of this study was to compare in vivo the use of the Amsel Vessel Occluder (AVO), a novel occlusion clip device for secure blood vessel closure, with one of the many commercially available hemoclips, the Ligaclip, in the porcine model.

METHODS: Vessel closure of arteries and veins was performed on 10 swine to compare the ease of use, safety, and efficacy of the AVO with the Ligaclip as well as the tissue response at 7 and 30 d. After heparinization, the targeted vessels (carotid/femoral/brachial arteries and jugular/femoral/brachial veins) were occluded with two clips, either two AVO's or two Ligaclip's, and the vessels transected between the two clips. Any bleeding was recorded. At sacrifice, gross and histopathologic findings were examined for evidence of bleeding or injury to adjacent structures. The tissue response and healing were evaluated by a prospective randomized histopathologic study for the effects of any biological incompatibilities. At time of sacrifice, occluded vessel segments were subjected to nonphysiological pressures ("holding" pressures) to compare efficacy of occlusion in fresh, nonoccluded vessels, and the ability to dislodge the clips once applied.

RESULTS: Twenty veins and 20 arteries between 2-mm and 7-mm outer diameter were occluded in 10 pigs. Each vessel was occluded with either AVO or Ligaclip. Our study confirmed easy and safe AVO application with no dislodgment of any AVO clips once deployed. The AVO showed no intraoperative or postoperative bleeding (AVO = 0/40), while one Ligaclip dislodged resulting in a fatal hemorrhage 16 h after surgery (Ligaclip = 1/40), and on two occasions where, with obvious slippage of the Ligaclip, immediately after deployment, additional clips were placed. The holding pressures for the two clips were similar but unlike the AVO, the Ligaclip was easily dislodged. Histopathologic examination showed no difference in the tissue response and healing of the two clips.

CONCLUSIONS: The AVO is simple to deploy and securely maintains occlusion by transfixing the targeted vessel, unlike the widely used, nontransfixing Ligaclip, that has a tendency to dislodge. As such, the Amsel secure vessel occluder opens up numerous treatment opportunities in both the venous and arterial systems to minimize open, laparoscopic, robotic surgical and interventional procedures, and reduce patient morbidity and its associated health care costs.