Control of inferior vena cava injury during laparoscopic surgery using a double balloon-equipped central venous catheter: proof of concept in a live porcine model.

BACKGROUND: Iatrogenic inferior vena cava (IVC) injury is a rare but potentially life-threatening complication during laparoscopic surgery. This experimental study aimed to assess the hemostatic ability of a new device, double balloon-equipped central venous (DB-CV) catheter, for IVC injury. METHODS: The DB-CV catheter comprises a triple-lumen sphincterotome combined with two dilating balloons having a diameter of 25 mm. The experimental procedures were performed in five pigs. The DB-CV catheter was inserted via the right femoral vein. For the IVC occlusion test, correct placement of the balloons was confirmed by indocyanine green fluorescence imaging, and hemodynamic data were recorded. For the IVC injury test, a 3- to 4-mm circumferential incision was created in IVC, and hemostasis was initiated using balloon inflation 5 s after the injury. RESULTS: Hemodynamic changes were minimal, with a 20 mmHg reduction in the mean arterial pressure because of IVC occlusion. All bleeding from IVC injuries was successfully temporarily stopped by direct balloon compression, with a mean time to hemostasis of 69 s and mean blood loss of 32 ml. Subsequently, the positioning of IVC injuries between two balloons made it possible to suture the injured IVC. CONCLUSIONS: Balloon occlusion using the DB-CV catheter provides a rapid temporal hemostatic effect and can overcome the serious condition of massive hemorrhage from IVC injuries.

Prevention of neointimal formation after angioplasty using nuclear factor-κB decoy oligodeoxynucleotide-coated balloon catheter in rabbit model.

BACKGROUND: Despite the advent of drug-eluting stents, restenosis after endovascular intervention is still a major limitation in the treatment of cardiovascular disease. To regulate the multiple biological mechanisms underlying restenosis, we focused on inhibition of an important transcription factor, nuclear factor-kappaB (NFκB), using a decoy strategy. METHODS AND RESULTS: For site-specific application of NFκB decoy oligodeoxynucleotides into target vessels during angioplasty, we developed a balloon catheter-based delivery system combined with biocompatible nanoparticles as oligodeoxynucleotides carriers. To clarify the therapeutic effect at the site of neointima, balloon angioplasty of the rabbit carotid arteries was performed at 4 weeks after initial endothelial denudation. This delivery system exhibited successful transfer of fluorescence-labeled nanospheres into the neointima in short-term contact with target vessels, and fluorescence could be detected ≥1 week after angioplasty. Consistently, local application of NFκB decoy oligodeoxynucleotides -loaded nanospheres resulted in significant inhibition of neointimal formation, associated with inhibition of NFκB binding activity in the injured arteries. The therapeutic effects were caused by inhibition of macrophage recruitment through the suppression of monocyte chemoattractant protein-1, vascular cell adhesion molecule-1, and CC chemokine ligand 4 expression and inhibition of vascular smooth muscle cell growth via a decrease in the expression of cyclin A and proliferating cell nuclear antigen. Importantly, application of NFκB nanospheres accelerated restoration of the endothelial cell monolayer, associated with enhanced expression of phosphorylated Bcl-2 in endothelial cells. CONCLUSIONS: A drug-coated balloon catheter using NFκB decoy oligodeoxynucleotides significantly inhibited the development of neointimal hyperplasia in rabbits. The present study indicates the possibility of a novel therapeutic option to prevent restenosis after angioplasty.