Perioperative safety of Hydrosoft coils.
ABSTRACT Hydrosoft coils were developed to serve as finishing coils to prevent aneurysmal recurrence at the neck. Initial animal studies were encouraging since some studies showed endothelial healing across the neck without recurrence over time. However, theoretical concerns exist regarding the potential threat to parent vessels as the Hydrosoft coils at the neck expand, as well as whether such coils can be adequately supple to safely serve as a true finishing coil. A retrospective review of the initial clinical experience utilizing Hydrosoft coils from three high-volume centers was performed.
Each center was asked to report angiographic (aneurysmal location, aneurysmal maximal size, neck size, incidence of intraprocedural parent vessel thrombosis, coil herniation, aneurysmal rupture as well as Raymond scale and percent occlusion after coiling) and clinical (rupture status, Hunt and Hess grade, incidence of stroke, hemorrhage, vasospasm and hydrocephalus) data on consecutive patients who underwent placement of Hydrosoft coils.
A total of 141 patients were enrolled. Embolization achieved a Raymond scale score of I (complete obliteration) in 79 aneurysms (56%), II (residual neck) in 40 aneurysms (28%) and III (residual dome) in 21 aneurysms (15%); in one case the Hydrosoft coil could not be placed. Procedural morbidity and mortality were 2.1% and 1.4%, respectively. No complications were definitively attributed to the use of Hydrosoft coils. There were three cases (2.1%) of parent vessel thrombosis, two of which resolved after intraprocedural administration of thrombolytic agents and did not lead to neurological sequelae. The incidences of intraprocedural or periprocedural aneurysmal rupture (2.1%), cerebral hemorrhage (3.5%), stroke (4.9%), vasospasm (26.2%) or hydrocephalus (31.1%) were comparable to contemporary literature.
The use of Hydrosoft coils appears to be safe and does not lead to higher complication rates than are currently accepted in the literature. Further prospective studies are required to determine whether the use of Hydrosoft coils results in a lower incidence of aneurysmal recurrence.
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ABSTRACT: To evaluate the perioperative safety and mid-term prognosis (≤12 months) of HydroSoft coils in treating ruptured aneurysms at the anterior circulation compared with bare platinum coils. Patients with aneurysmal subarachnoid hemorrhages admitted to our hospital between January 2009 and March 2012 were retrospectively analyzed. According to strict inclusion and exclusion criteria, cases were selected and classified into two groups: In group A, HydroSoft coils were used as the primary filling coils (≥40 % of total coil length); in group B, only bare platinum coils were used. Cases in both groups were all treated with stent-assistance. A comparison between the two groups was performed for periprocedural complications as well as immediate and mid-term outcomes. The stents used included Enterprise, Neuroform, and Solitaire. Fifty-six aneurysms were in group A patients, and 68 aneurysms were in group B patients. Compared with group B, group A did not have increased incidence of complications but had greater packing attenuation (44.5 ± 8.8-29.8 ± 9.1 %, t = 2.577, P = 0.014) and increased initial complete occlusion rates (63-44 %, χ (2) = 4.161, P = 0.041). Radiologic follow-up were performed in 46 patients from group A and 51 patients from group B. Complete occlusion rates at follow-up were significantly greater in group A than in group B (89.1-70.6 %, χ (2) = 5.08, P = 0.043); the difference in recanalization rates were statistically insignificant between the groups (6.5-5.9 %, P = 1.000). HydroSoft coils proved safe during the periprocedural period and provided greater initial complete occlusion rates, greater packing density, and better follow-up results compared with bare platinum coils.CardioVascular and Interventional Radiology 11/2013; · 2.09 Impact Factor
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ABSTRACT: BACKGROUND: Complete packing of intracranial aneurysms has demonstrated a significant decrease in aneurysm recurrence rates with increased volumetric filling. The HydroCoil Embolization System (HES) was developed to increase volumetric filling within the aneurysm sac to maintain long term occlusion. To further enhance ease of HES deployment, a new next generation embolic coil, the HydroFill coil, was developed. OBJECTIVE: To report the first clinical experience with the HydroFill coil, focusing on safety and effectiveness, with immediate and long term follow-up on cases performed at a single institution by a single operator. METHODS: Retrospective angiographic and clinical analysis was performed on a non-randomized single arm registry of the first consecutive 11 patients with 14 intracranial saccular aneurysms treated during a 9 month period. RESULTS: The immediate angiographic occlusion rate according to the Raymond scale was 100%. Overall packing density of all coils used was 13-135% (mean 64%). The immediate complication rate was 9% (1/11 patients), secondary to a parent vessel occlusion which resolved after intravenous administration of eptifibatide (Integrilin) without neurological sequelae. The angiographic/MR angiography follow-up period for this series was 13-30 months, with an overall complete occlusion rate of 86% (12/14 aneurysms). 2/14 aneurysms (14%) converted from complete occlusion to filling of small neck remnants. Of the two, one (7%) was a cavernous aneurysm that was retreated. CONCLUSIONS: Although this initial case series is small, this study demonstrates safe deployment of the HydroFill coil in ruptured and unruptured aneurysms without major complications, and with a high rate of occlusion on long term follow-up.Journal of Neurointerventional Surgery 04/2013; · 2.50 Impact Factor