Phase II Trial of Transarterial Embolization Using an n-Butyl-2-Cyanoacrylate/Lipiodol Mixture (JIVROSG-0802).

PURPOSE: To evaluate the embolic effect and the safety of transarterial embolization (TAE) using n-butyl-2-cyanoacrylate (NBCA) in a prospective multicenter trial. MATERIALS AND METHODS: This study was an open-label, multicenter, phase II trial. The inclusion criteria were (1) active bleeding or pseudoaneurysm, (2) true aneurysm, (3) arteriovenous malformation (except cerebral lesion), (4) arteriovenous fistula, or (5) need for arterial distribution before transarterial treatment. Selective TAE with NBCA diluted 2-10 times was performed. The primary endpoint was the success rate of embolization with a per-patient analysis based on the angiographic findings. Secondary endpoints were safety, evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) version 4, and the success rate of embolization with a per-vessel calculation. RESULTS: Sixty-five patients were initially enrolled, but due to protocol violation in two patients, efficacy was ultimately analyzed in 63 patients (103 vessels) and safety was analyzed in 64 patients. The success rate per patient was 98.4% (62/63; 95% confidence interval (CI), 91.5-100.00), and the success rate per vessel was 99.0% (102/103; 95% CI, 94.7-100.0). Adverse events of grade 3 or above based on CTCAE version 4 occurred in 22/64 patients (34.4%). Twelve intraoperative or postoperative adverse events grade 3 or above, which may have been related to embolization using NBCA, occurred in 11/64 patients (17.2%). Three patients died after embolization using NBCA, but their deaths were unrelated to TAE. CONCLUSION: In this prospective multicenter clinical trial, the efficacy of TAE using NBCA was 98.4% and adverse events were clinically acceptable. LEVEL OF EVIDENCE: Level 3b.

Transcatheter arterial embolization with N-butyl cyanoacrylate for acute life-threatening gastroduodenal bleeding uncontrolled by endoscopic hemostasis.

PURPOSE: To investigate the feasibility, efficacy, and safety of transcatheter arterial embolization with N-butyl cyanoacrylate (NBCA) for gastroduodenal nonvariceal bleeding uncontrolled by endoscopic hemostasis. MATERIALS AND METHODS: Between January 2006 and December 2011, a total of 317 patients underwent emergent endoscopic therapy for nonvariceal gastroduodenal bleeding, but hemostasis was not achieved in 20 cases. Emergent surgery was performed immediately following endoscopy in two patients. Arteriography was performed in the remaining 18 patients, and embolization with NBCA was performed in 15 patients (mean age, 71.3 y) in whom the bleeding site was detected on arteriography. For embolization, NBCA was mixed with iodized oil at a ratio of 1:1.5-1:4, and no other embolic material was used in the procedure. Technical and clinical success rates, recurrent bleeding, procedural time, complications, and clinical outcomes were determined for each procedure. RESULTS: Embolization with NBCA was technically and clinically successful in all procedures, without major complications. No patient receiving embolization with NBCA experienced recurrent bleeding or required further treatment after the one-session procedure. All patients were discharged after clinical improvement. The time between puncture of the femoral artery and completion of embolization ranged from 25 to 240 minutes (mean, 66 min), and the time between the microcatheter reaching the ultimate catheter location selected for embolization and hemostasis ranged from 142 to 550 seconds (mean, 322s). CONCLUSIONS: In this limited series, embolization with NBCA was found to be a safe, feasible, and effective treatment for gastroduodenal arterial bleeding when endoscopic hemostasis had failed.

A new flow control technique using diluted epinephrine in the N-butyl-2-cyanoacrylate embolization of visceral artery pseudoaneurysms secondary to chronic pancreatitis.

Although n-butyl-2-cyanoacrylate (NBCA) has been used as an effective liquid embolization material, its indication for pseudoaneurysms has seemingly been limited because of the technical difficulties of using NBCA, such as reflux to the parent artery and causing significant infarction. Thus, considerable skill in using NBCA or a device to control blood flow during its polymerization is required to achieve embolization without severe complications. We report our new technique for controlling blood flow using diluted epinephrine in transcatheter arterial NBCA embolization of five pseudoaneurysms in four cases secondary to hemosuccus pancreaticus.

Endovascular repair of a perforation of the vena caval wall caused by the retrieval of a Gunther Tulip filter after long-term implantation.

Symptomatic penetration of the inferior vena cava (IVC) wall reportedly occurs in 0.3% of patients in whom a filter has been implanted, and it causes injury to the adjacent structures (Bogue et al. in Pediatr Radiol 39(10):1110-1113, 1; Brzezinski et al. in Burns 32(5):640-643, 2). We succeeded in the endovascular repair of perforation of the IVC wall occurring during the retrieval of a penetrated Gunther tulip vena cava filter (Cook, Bjaeverskov, Denmark) after long-term implantation.