Introduction The use of balloon remodeling allows for the treatment of aneurysms that were previously considered to be poor candidates for coil embolization. The Scepter C (Microvention, Tustin, California, USA) is a novel temporary occlusion balloon system with a dual coaxial lumen catheter. The design accommodates a more steerable 0.014 inch guidewire with improved control for delivery to the target lesion. We describe our initial experience with the use of this device for balloon remodeling to assist during aneurysm coil embolization.
Methods All aneurysms that were treated with balloon remodeling employing the Scepter C balloon at a single institution (Medical University of South Carolina) from the time it was available in October 2011 to July 2012 were evaluated. Patient demographics, aneurysm characteristics, procedural success, and adverse events were assessed.
Results 52 aneurysms were treated in 48 patients (45 women, three men) with a mean age of 59.3±11 years (mean±SD). Mean aneurysm height was 5.9±3 mm, width 4.4±2 mm with a 3.1±2 mm broad neck. A variety of aneurysms were treated. The most commonly utilized size was the 4 mm×10 mm (n=33) balloon. A Raymond 1 (complete occlusion) was achieved in the majority (n=44; 84.6%) of aneurysms, Raymond 2 (residual neck) in five, and Raymond 3 (residual aneurysm) in five. There was one complication (1.9%) attributed directly to balloon use.
Conclusions Our initial experience with the dual coaxial lumen Scepter C occlusion balloon catheter demonstrates its feasibility for use in balloon remodeling for aneurysm coil embolization. A variety of aneurysms at different locations were treated with satisfactory initial angiographic results and adverse event rates.
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Since the emergence of endovascular coil embolization for the treatment of aneurysms,1 ,2 there have been rapid advances in the field which place it firmly alongside microsurgical clipping as one of the two available methods of securing aneurysms. The use of balloon remodeling, first described by Moret et al,3 represents one of the major advances which have revolutionized the approach to coil embolization of wide necked aneurysms. Balloon remodeling involves the temporary inflation of a balloon across the neck of an aneurysm allowing for coil deployment into aneurysms with unfavorable neck to dome ratios.4 As multiple coils are inserted, a stable three-dimensional structure forms, thereby holding the coil mass within the aneurysm in cases in which coil herniation into the parent vessel is a primary concern. The well described risks of balloon remodeling include perforator occlusion, parent vessel dissection, or rupture and promotion of thromboemboli.5–9
Until recently, the balloons available to the neurointerventionalist included the HyperForm and HyperGlide balloons (ev3 Neurovascular, Plymouth, Minnesota, USA) which are single lumen, over the wire, compliant, non-detachable balloons that accommodate a 0.010 inch guidewire. The Scepter C (Microvention) is a newer temporary occlusion balloon system that has a dual coaxial lumen catheter attached to a low inflation pressure compliant balloon (figure 1).
The design accommodates a larger more steerable 0.014 inch guidewire which enhances its control for delivery to the target lesion. We describe our initial experience with the use of this device for balloon remodeling to assist during aneurysm coil embolization.
A retrospective review of a prospectively entered database of all neurointerventional cases was performed to identify aneurysms that were treated with balloon remodeling employing the Scepter C balloon at a single institution (Medical University of South Carolina) from the time it was available in October 2011 to July 2012. Institutional review board approval was obtained. Charts and angiography images were reviewed to collect patient demographics, procedural events, and angiographic results. All procedures were performed under general anesthesia with intraprocedural anticoagulation with systemic administration of heparin. A 6 French introducer sheath was placed in the common femoral artery and a 6 French guide catheter was advanced into either the internal carotid or the vertebral artery proximal to the vessel of interest.
Patient demographics and devices
Fifty-two aneurysms were treated in 48 patients (45 women, three men) with a mean age of 59.3±11 years (mean±SD). Figure 2 depicts an illustrate case. Twenty-four (46.2%) aneurysms were treated in the setting of subarachnoid hemorrhage. The three available sizes were employed: 4 mm×10 mm (n=33), 4 mm×15 mm (n=18), and 4 mm×20 mm (n=1). The two 6 French guide catheters utilized to deliver the balloon catheter included the Neuron 070 (n=38) (Penumbra Inc, Alameda, California, USA) and Chaperone (n=14) (Microvention Terumo, Irvine, California, USA) guides. The most commonly employed microcatheter was the SL 10 (Boston Scientific, Natick, Massachusetts, USA) (n=46); others include the PX Slim (Penumbra Inc) (n=2), PX 400 (Penumbra Inc) (n=2), Prowler Select (Codman, Raynham, Massachusetts, USA) (n=1), and Neuroscout 14 (Cordis Neurovascular Inc, Bridgewater, New Jersey, USA) (n=1).
Mean aneurysm height was 5.9±3 mm, width 4.4±2 mm with a 3.1±2 mm broad neck. A variety of aneurysms were treated, including those arising from the cavernous (n=2), supraclinoid (n=5), ophthalmic (n=7), superior hypophyseal (n=3), posterior communicating (n=17), anterior choroidal (n=3), carotid terminus (n=1), anterior communicating (n=6), middle cerebral artery (MCA) bifurcation (n=5), superior cerebellar (n=1), and basilar (n=2) arteries. In all but two cases, balloon remodeling was employed as a primary strategy for the introduction of all coils. In the remaining two cases, the balloon was introduced as a rescue strategy. In one case, unassisted coil embolization resulted in herniation of a detached coil into the parent vessel and the balloon was used in an attempt to bolster the herniated coil back into the aneurysm. In the other case, unassisted coiling of an anterior communicating artery aneurysm resulted in intraprocedural aneurysmal perforation and the balloon was then introduced to assist in achieving a complete coil occlusion while halting the resulting hemorrhage.
A Raymond 1 (complete occlusion) was achieved in the majority (n=44; 84.6%) of aneurysms, Raymond 2 (residual neck) in five, and Raymond 3 (residual aneurysm) in five.
There was one adverse event among this patient population that could be attributed directly to balloon use (1.9%). This involved aneurysm perforation during balloon remodeling for coil embolization of a ruptured posterior communicating artery aneurysm in a 64-year-old woman who presented in grade Hunt and Hess II. The perforation occurred during initial introduction of the first coil (target 4 mm×10 cm ultrasoft coil; Stryker Corporation, Kalamazoo, Michigan, USA) which was noted to extend beyond the confines of the aneurysm dome and was followed with a rise in blood pressure. Protamine was administered while the coil was completely introduced and deployed. A follow-up angiogram with the balloon deflated demonstrated no contrast extravasation.
In a case involving a ruptured basilar artery aneurysm, balloon remodeling was initiated in an uncomplicated fashion; however, at balloon deflation there was coil protrusion into the basilar apex partially covering the posterior cerebral artery os. Although this did not result in any neurologic sequelae, the degree of aneurysmal occlusion was unsatisfactory (Raymond 3). In another case, the balloon could not be delivered to the target vessel for balloon remodeling. This occurred during attempted unruptured MCA bifurcation coil embolization; a 4 mm×10 mm Scepter C balloon could not be navigated into the inferior division branch of the MCA. Balloon remodeling was aborted and the patient underwent stent assisted coiling. Finally, an adverse event not directly attributable to balloon use occurred during the treatment of an unruptured ophthalmic artery aneurysm and involved thrombus formation on the coil mass requiring intra-arterial administration of abciximab. The clot dissolved with administration of the lytic agent and the patient suffered no neurologic sequelae.
We have described our initial experience using the coaxial dual lumen Scepter C balloon catheter as an adjunct during aneurysm coil embolization. This is the first report of its type detailing the use of this new device for balloon remodeling. A variety of aneurysms at different locations were treated with a high degree of technical success, satisfactory angiographic results, and acceptable adverse event rate. Our initial results employing this novel balloon catheter compare favorably with published rates of complete angiographic aneurysm occlusion at treatment, thromboembolic adverse event rates and intra-procedural perforations.8
With the more traditional single lumen balloon catheter system, a 0.010 inch companion wire is required to navigate the balloon to the target lesion and to obstruct the distal valve allowing for balloon inflation. In contrast, the newly introduced Scepter C balloon provides a number of advantages which make it a useful device that adds to the armamentarium of neurointerventionalists. The Scepter C catheter also allows for removal of the wire to reshape or exchange for a different microwire while leaving the balloon catheter in place. In contrast, in the single lumen design, the distal end hole for balloon inflation must be occupied by the microwire in order for balloon inflation to be possible. Another advantage of the double lumen catheter is that even if there is retrograde filling of blood products into the lumen of the catheter, they will not obstruct or prevent balloon deflation since the two systems are compartmentalized away from each other in the coaxial design.
In addition, the inner lumen of the Scepter C balloon catheter accommodates the use of a standard 0.014 inch guidewire which provides additional support for navigating the balloon over torturous anatomy, and the wire itself is easier to steer.
Due to its larger diameter, the Scepter C balloon catheter itself is stiffer and less compliant. Thus a potential drawback of the double lumen catheter system includes challenges with navigation. However, we have found that this drawback is offset by the benefit derived from employing a larger guidewire (0.014 inch vs 0.010 inch). There was only one site that the balloon could not be navigated to in this series.
The major limitation to this retrospective study is that it was not designed as a head to head comparison of the newer generation balloon catheter (Scepter C) with the older generation (HyperForm, HyperGlide). For a true comparison, identical aneurysms would be treated with both balloon designs for remodeling and technical success or limitations could be compared directly. However, this design is not practical in the clinical setting and while it could perhaps be modeled with simulation, that technology is not currently available. Rather, the decision was made to try the new technology. Based on our initial positive experience comparing the ease of use of the Scepter C balloon catheter with our own prior experience, it was adopted and we now universally utilize the Scepter C balloon catheter. We suspect this rationale forms the basis of the adoption of new technology throughout treatment centers. Another limitation is that the Raymond determination at the conclusion of treatment was determined by the operator.
Our initial experience with the dual coaxial lumen Scepter C occlusion balloon catheter demonstrates its feasibility for use in balloon remodeling for aneurysm coil embolization. A variety of aneurysm locations were treated with satisfactory initial angiographic results.
Contributors Each author should receive authorship credit based on material contribution to this article, revision of this article, and final approval of this article for submission to this journal.
Competing interests None.
Ethics approval Institutional review board approval was obtained from the Medical University of South Carolina.
Provenance and peer review Not commissioned; externally peer reviewed.