Aaron M Fischman1, Thomas J Ward2, Rahul S Patel2, Aravind Arepally3, Edward Kim2, F Scott Nowakowski2, Robert A Lookstein2. 1. Division of Interventional Radiology, Department of Radiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl., Box 1234, New York, NY 10029.. Electronic address: aaron.fischman@mountsinai.org. 2. Division of Interventional Radiology, Department of Radiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl., Box 1234, New York, NY 10029. 3. Division of Interventional Radiology, Piedmont Radiology, Atlanta, Georgia.
Abstract
PURPOSE: To compare standard coil embolization versus the use of an antireflux microcatheter (ARM) in patients undergoing planning angiography before selective internal radiation therapy (SIRT). MATERIALS AND METHODS: A prospective, single-center trial was performed in which 30 patients were randomly assigned to undergo SIRT with coil embolization or the use of an ARM. The coil group underwent detachable coil embolization of nontarget vessels, and the ARM group underwent infusion of macroaggregated albumin with use of an ARM system, without coil embolization. Single-photon emission computed tomography (CT)/CT was then performed to assess for nontarget distribution. The primary endpoint was fluoroscopy time during planning angiography. Secondary endpoints included deployment time, total procedure time, radiation dose-area product, contrast agent used, and adverse events. Endpoints were evaluated during planning angiography and SIRT. RESULTS: Over a 9-month period, 30 consecutive patients were randomized at a 1:1 ratio between coil embolization and ARM groups. Technical success rates were 100% in both groups. Mean fluoroscopy time was significantly reduced in the ARM group versus the coil embolization group (1.8 min [range, 0.4-4.9 min] vs 6.0 min [range, 1.9-15.7 min]; P = .002). The planning procedure time (P < .001), deployment time (P < .001), dose-area product (P = .04), and amount of contrast agent used (P < .001) were also significantly less in the ARM group than in the coil embolization group. No nontarget distribution was detected in either group. There was no difference between groups in dose delivered on the day of SIRT (P = .71). There were no major or minor adverse events at 30 days. CONCLUSIONS: The use of an ARM during planning angiography can significantly reduce fluoroscopy time, procedure time, and radiation dose.
RCT Entities:
PURPOSE: To compare standard coil embolization versus the use of an antireflux microcatheter (ARM) in patients undergoing planning angiography before selective internal radiation therapy (SIRT). MATERIALS AND METHODS: A prospective, single-center trial was performed in which 30 patients were randomly assigned to undergo SIRT with coil embolization or the use of an ARM. The coil group underwent detachable coil embolization of nontarget vessels, and the ARM group underwent infusion of macroaggregated albumin with use of an ARM system, without coil embolization. Single-photon emission computed tomography (CT)/CT was then performed to assess for nontarget distribution. The primary endpoint was fluoroscopy time during planning angiography. Secondary endpoints included deployment time, total procedure time, radiation dose-area product, contrast agent used, and adverse events. Endpoints were evaluated during planning angiography and SIRT. RESULTS: Over a 9-month period, 30 consecutive patients were randomized at a 1:1 ratio between coil embolization and ARM groups. Technical success rates were 100% in both groups. Mean fluoroscopy time was significantly reduced in the ARM group versus the coil embolization group (1.8 min [range, 0.4-4.9 min] vs 6.0 min [range, 1.9-15.7 min]; P = .002). The planning procedure time (P < .001), deployment time (P < .001), dose-area product (P = .04), and amount of contrast agent used (P < .001) were also significantly less in the ARM group than in the coil embolization group. No nontarget distribution was detected in either group. There was no difference between groups in dose delivered on the day of SIRT (P = .71). There were no major or minor adverse events at 30 days. CONCLUSIONS: The use of an ARM during planning angiography can significantly reduce fluoroscopy time, procedure time, and radiation dose.
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