Wojciech Poncyljusz1, Artur Zarzycki2, Łukasz Zwarzany3, Thomas H Burke4. 1. Departament of Interventional Radiology, Pomeranian Medical University, Neurointerventional Cath Lab MSW Hospital, Al. Powst. Wielkopolskich 72, 70-111 Szczecin, Poland. Electronic address: wponcyl@poczta.onet.pl. 2. Department of Neurosurgery and Pediatric Neurosurgery, Pomeranian Medical University, Unii Lubelskiej 1, 71-242 Szczecin Poland. Electronic address: arturzarzycki@o2.pl. 3. Departament of Interventional Radiology, Pomeranian Medical University, Neurointerventional Cath Lab MSW Hospital, Al. Powst. Wielkopolskich 72, 70-111 Szczecin, Poland. Electronic address: zwarzany@gmail.com. 4. Microvention-Terumo, Tustin, CA, USA. Electronic address: tom.burke@microvention.com.
Abstract
PURPOSE: The HydroCoil Embolic System (HES) was developed to improve aneurysm filling to provide superior occlusion efficacy, reduce retreatment rates and enhance long-term durability. We performed a randomized clinical trial to compare the effectiveness of bare platinum coils (BPC) vs. HES for unruptured intracranial aneurysms. METHODS:Ninety-six patients underwent endovascular coiling of unruptured intracranial aneurysms. The aneurysms were randomized equally to receive BPC or HES. Immediate angiographic results, number of coils used and complications were evaluated and all cases had 12-month follow-up angiography. RESULTS: Immediate angiographic results demonstrated that 84.0% of aneurysms treated with HES were completely occluded compared to 76.1% of aneurysms treated with BPC (p=0.3310). The mean number of coils utilized to fill the aneurysm was significantly lower in the HES arm (5.04 vs. 6.93). Additional adjunctive techniques were performed in 51.1% of all cases. There were seven patients (7.3%) with postoperative complications during the study period. The coil type used during the treatment did not demonstrate any significant differences on the overall recurrence rate (HES - 18.0%, BPC - 17.4%, p=0.9712). There was a statistically significant difference in the aneurysm size and the neck width between completely occluded aneurysms and aneurysms with residual flow in both immediate angiographic and mid-term follow-up. CONCLUSIONS:Overall, aneurysm size and neck width are the main risk factors associated with aneurysm recurrence. HES compared to BPC required less total number of coils to provide a denser aneurysm filling. However, there were equivocal results with both devices, at the mid-term angiographic follow-up.
RCT Entities:
PURPOSE: The HydroCoil Embolic System (HES) was developed to improve aneurysm filling to provide superior occlusion efficacy, reduce retreatment rates and enhance long-term durability. We performed a randomized clinical trial to compare the effectiveness of bare platinum coils (BPC) vs. HES for unruptured intracranial aneurysms. METHODS: Ninety-six patients underwent endovascular coiling of unruptured intracranial aneurysms. The aneurysms were randomized equally to receive BPC or HES. Immediate angiographic results, number of coils used and complications were evaluated and all cases had 12-month follow-up angiography. RESULTS: Immediate angiographic results demonstrated that 84.0% of aneurysms treated with HES were completely occluded compared to 76.1% of aneurysms treated with BPC (p=0.3310). The mean number of coils utilized to fill the aneurysm was significantly lower in the HES arm (5.04 vs. 6.93). Additional adjunctive techniques were performed in 51.1% of all cases. There were seven patients (7.3%) with postoperative complications during the study period. The coil type used during the treatment did not demonstrate any significant differences on the overall recurrence rate (HES - 18.0%, BPC - 17.4%, p=0.9712). There was a statistically significant difference in the aneurysm size and the neck width between completely occluded aneurysms and aneurysms with residual flow in both immediate angiographic and mid-term follow-up. CONCLUSIONS: Overall, aneurysm size and neck width are the main risk factors associated with aneurysm recurrence. HES compared to BPC required less total number of coils to provide a denser aneurysm filling. However, there were equivocal results with both devices, at the mid-term angiographic follow-up.
Authors: A Rizvi; S M Seyedsaadat; M Alzuabi; M H Murad; R Kadirvel; W Brinjikji; D F Kallmes Journal: AJNR Am J Neuroradiol Date: 2020-05-28 Impact factor: 3.825
Authors: Daniel Knap; Wojciech Gruszka; Dominik Sieroń; Katarzyna Gruszczyńska; Michał Zawadzki; Miłosz Zbroszczyk; Jan Baron Journal: Pol J Radiol Date: 2017-04-10