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: 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; · 1.38 Impact Factor