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Neuroradiology |
1 From the Department of Radiology, Centre Hospitalier de l’Université de Montréal, Hôpital Notre-Dame, M-8206, 1560 Sherbrooke St East, Montréal, Québec H2L 4M1, Canada. Received February 16, 2001; revision requested April 2; revision received May 11; accepted June 5. Address correspondence to J.R. (e-mail: je_raymond @hotmail.com).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSION REFERENCES |
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MATERIALS AND METHODS: Twenty-five patients were examined. Aneurysms were most frequently at the basilar bifurcation (n = 19). Sixteen aneurysms were treated electively: six aneurysms that recurred after coil-only embolization and 10 nontreated aneurysms (including four that had failed coil-only embolization). Nine aneurysms were treated acutely following subarachnoid hemorrhage. All lesions except one had a wide neck. A dual-catheter technique was used in 23 patients. Immediate angiographic results, technical incidents, and complications were recorded. Follow-up angiography was performed in 16 patients. Clinical follow-up ranged from 1 to 12 months.
RESULTS: Neck-bridge device–assisted coil packing was successfully performed in 23 lesions, with complete obliteration in three, residual necks in 13, and a minimal residual sac in seven patients. Parent vessel protection failed, with coil protrusion and arterial occlusion, in one of these patients. Other complications that were not directly related to use of the neck-bridge device included retroperitoneal hematoma, rebleeding, coil perforation, and transient embolic arterial occlusion. One patient died of vasospasm and heart failure. Follow-up angiography revealed complete obliteration in four, a residual neck in one, a persistent residual sac in four, and recurrent aneurysm in seven patients. One patient had a small occipital infarction 5 weeks after treatment.
CONCLUSION: The described neck-bridge device is useful for assisting coil embolization of wide-neck bifurcation aneurysms.
Index terms: Aneurysm, basilar, 17.73 • Aneurysm, therapy, 17.1264, 17.1269 • Angiography, 17.1248 • Interventional procedures, 17.1264, 17.1269
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSION REFERENCES |
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The TriSpan (Target Therapeutics/Boston Scientific, Fremont, Calif) is a new device that can be placed at the neck of aneurysms prior to the Guglielmi detachable coil (GDC) embolization procedure (6). The device was designed to allow the safe and controlled placement of platinum coils inserted through a second microcatheter. The purpose of this article is to report our initial experience in treating patients with wide-neck aneurysms with assistance from the aneurysm neck-bridge device (TriSpan).
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSION REFERENCES |
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Procedures
The neck-bridge device is made of three nitinol loops that are partly covered by platinum coils to increase radiopacity. The loops are fixed together at their struts. When the device is positioned at the neck of the aneurysm, the six nitinol strands radiate from the center of the neck to protect the parent vessel and assist in the placement of the coils, which are introduced through a second microcatheter. As the aneurysm is progressively packed with coils, the device becomes fixed inside the lesion so that it can be detached, just like a GDC, at the end of treatment. The device necessitates the use of a 0.018-inch microcatheter with two tip markers.
All patients were treated while under general anesthesia. Bilateral femoral approaches involving the use of 5- and 6-F introducing sheaths permitted placement of the appropriate guiding catheters. For the basilar bifurcation aneurysms, a catheter was placed in the two vertebral arteries, and for the carotid aneurysms, two guiding catheters were positioned inside the internal carotid artery. The procedures were performed with full anticoagulation with heparin, which was maintained until femoral sheaths were retrieved the next morning. A combination of two antiplatelet agents—clopidogrel 75 mg and acetylsalicylic acid 325 mg—was prescribed daily for 1 month, and then only acetylsalicylic acid 325 mg/die was prescribed for 2 months. All procedures were performed by using a single-plane angiographic unit (DFP 2000; Toshiba, Montreal, Quebec, Canada) without three-dimensional reconstruction. In addition, all patients were examined with computed tomography of the brain, and the first 10 patients underwent cerebral angiography, 24 hours after treatment.
The first microcatheter was inserted into the aneurysm to place the bridge device at the neck. To select the appropriate size of the device, the manufacturer proposes using a sizing table. Early in this experience, we tended to select a device that was on average 6 mm larger than the width of the neck. We now tend to use smaller sizes to optimize the position of the device and minimize protrusion. When the neck-bridge device was deployed inside the aneurysm, the carrying microcatheter (Excelsior or FasTracker 18; Target Therapeutics) was slightly retrieved to maximize the room available for opening the neck-bridge device and to minimize the forces against the aneurysmal walls. Once deployed, the neck-bridge device and the microcatheter were gently pulled back to ensure a stable position, in which the loop markers were against the walls of the aneurysm and the stem coil was well centered at the neck and slightly protruding into the parent artery (Fig 1, a, b).
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To prevent premature detachment of the neck-bridge device during electrolytic detachment of the coils, the proximal marker of the device was maintained within the proximal marker of the microcatheter. Coils of decreasing sizes were introduced to pack the aneurysm as completely as possible. The neck-bridge device was electrolytically detached from the pusher wire (which is identical to the GDC design) at the end of the procedure, after retrieval of the coiling microcatheter (Fig 1, d, e). To detach the neck-bridge device, the detachment zone is advanced beyond the microcatheter by pushing the wire of the neck-bridge device so that the proximal marker reaches slightly beyond the proximal marker of the microcatheter. In two patients, a single-catheter technique was attempted: First, the neck-bridge device was detached, and then aneurysmal coil packing through the same microcatheter was performed. All technical complications (ie, coil protrusion, tilting of the neck-bridge device, clot emboli, and/or local femoral complications) were recorded, regardless of whether they were symptomatic. All clinical changes were noted, regardless of whether they were related to the use of the device.
At our institution, follow-up angiography, performed 3–12 months after the procedure, is routinely recommended. Follow-up angiography was actually performed in 16 patients 2–12 months after treatment. At the time this article was written, eight other patients had been treated too recently but were scheduled for follow-up testing. One patient died. Angiographic findings were scored according to a previously published classification system (9) and labeled as complete obliteration, residual neck, residual aneurysm, or failure. The coil placement procedures were performed and the results evaluated by senior authors (J.R., D.R.). Routine clinical follow-up was performed 1 month after the procedure, at the time of follow-up angiography, and by means of telephone interviews conducted 1–12 months later with a standard questionnaire designed to evaluate the Glasgow outcome score.
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RESULTS |
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Visibility of the components of the neck-bridge device that are not covered with platinum is suboptimal (Fig 2), and this poor visibility caused difficulties in interpreting the position of the device, at least early in our experience. The device could, however, be positioned at the neck of the aneurysm with minimal manipulations in 23 of the 25 patients. If the device was deployed in an unsatisfactory position, it could always be retrieved and easily replaced. In two patients, the device could not be used because the angle between the carotid artery and the aneurysm was too acute for adequate deposition (patient 8) or because of the sessile nature of the aneurysm (patient 3). One of these patients was successfully treated with a balloon-assisted technique; in the other, a double-coil technique was used (8).
The neck-bridge device, once properly placed, was stable and supported coil deposition in 21 patients in whom a dual-catheter technique was used. In patient 17, in whom the selected device may have been too small, downward migration of one of the device loops occurred at deposition of the third helical coil. This loop could be replaced inside the neck of the aneurysm by simply advancing the device. In the two patients in whom the single-catheter technique was attempted (patients 15 and 23), tilting of the device, which no longer served its purpose, occurred at subsequent coil packing of the aneurysm. The neck-bridge device permitted satisfactory packing of aneurysms with helical coils. The protection afforded by the device is relative, however: Some coils with a diameter smaller than that of the loops of the neck-bridge device could still protrude inside the parent artery near the end of embolization and thus had to be repositioned before detachment. In two patients, it was decided to leave one loop of coil protruding into the posterior cerebral artery, and there were no clinical consequences.
Complications
Some complications were not directly related to the use of the neck-bridge device. Patient 11 developed a large retroperitoneal hematoma during the 24-hour anticoagulation period that followed treatment; this complication necessitated two transfusions without sequelae. Patient 23 had occlusion of the posterior inferior cerebellar artery 24 hours after treatment. Since the neck-bridge device, which was detached from the start by using a single-catheter technique, was buried within the coil mass, which only partially occluded the aneurysmal sac, this complication was not believed to be related to the use of the device. The patient recovered from a small cerebellar stroke within a few days and had a good outcome (Glasgow outcome score, 1). Patient 9, who was treated acutely after subarachnoid hemorrhage, had rebleeding 1 hour after complete obliteration of the lesion. Follow-up angiography did not reveal a cause for this event. The patient had acute intracranial hypertension, was treated with ventricular drainage and thrombolysis of intraventricular clots, and recovered (Glasgow outcome score, 1 at 8 months).
Patient 2, who had a large ruptured basilar bifurcation aneurysm, had no complications after endovascular treatment with the neck-bridge device. She had an embolic stroke of the left posterior inferior cerebellar arterial territory after bilateral vertebral artery balloon occlusion performed at 1 month because of a persisting residual aneurysm; her outcome was good (Glasgow outcome score, 1). Patient 3 had a sessile wide-neck basilar bifurcation aneurysm that had recently bled. The 14-mm neck-bridge device could not be properly positioned at the neck and was easily retrieved without complication. A double-coil technique permitted packing with three other coils, but coil perforation occurred and treatment with protamine sulphate and interlocking detachable coils (Target Therapeutics) resulted in subarachnoid hemorrhage and left posterior cerebral artery occlusion. The patient recovered but still had dysphasia and hemianopia at 6 months after treatment (Glasgow outcome score, 2).
Complications that may have been directly related to the use of the neck-bridge device occurred in two patients. Patient 21 had transient cortical blindness 5 weeks after treatment, 1 week after therapy with clopidogrel was stopped. Despite a normal neuro-ophthalmologic examination, magnetic resonance (MR) imaging depicted a small right occipital infarction, and control angiography revealed a small crescent of residual aneurysm that was unchanged since treatment. The stem of the neck-bridge device was eccentrically positioned against the lateral wall of the basilar artery (Fig 3).
The second patient (patient 4) was treated acutely after a grade 3 subarachnoid hemorrhage that was caused by the rupture of a giant recurrent aneurysm, 4 years after endovascular treatment performed at another facility. The neck-bridge device, which was excessively oversized, protruded at the level of the superior cerebellar arteries. Attempts to place a last coil at the neck caused displacement of a previously detached coil that had a diameter smaller than that of the neck-bridge device loops. This coil caused thrombotic occlusion of the right posterior cerebral and superior cerebellar arteries, with secondary thalamic and cerebellar infarctions despite intraarterial thrombolysis. At the time this article was written, the patient was slowly recovering but remained disabled owing to left upper arm monoplegia and cognitive deficits (Glasgow outcome score, 3). Patient 6, who was treated during the acute phase of subarachnoid hemorrhage, died of vasospasm and heart failure.
Angiographic Results
Angiographic results are summarized in Table 2. The initial angiographic results were believed to be satisfactory in 17 patients: There were residual necks in 14 patients, and the aneurysm was completely obliterated in three. There was minimal opacification of the aneurysmal sac in eight patients. There were two failures to deploy the neck-bridge device. In patient 24, 24-hour follow-up angiography revealed minimal new protrusion of the neck-bridge device inside the carotid artery, without stenosis or complications. There was no visible clot formation either at the neck of the aneurysms or at the level of the stem coil hanging in the parent artery in any patient at 24 hours. Angiographic follow-up studies were available for 16 patients: at 3 months or longer for 14 patients and at 2 months in two patients. Opacification of a small portion of the aneurysmal sac persisted in four patients and necessitated repeat treatment in two: at 3 months and by means of additional coil packing in patient 16 and at 1 month and by means of bilateral proximal vertebral occlusion in patient 2. Four patients, three of whom had residual aneurysms initially, had a recurrence at follow-up angiography.
In addition, three patients who were treated for recurrences still had a recurrence after repeat treatment with neck-bridge device assistance 7 (patient 10) and 12 (patients 11 and 12) months later. The patient treated with a balloon-assisted technique after neck-bridge device failure had a large recurrent sac at 6 months. Four patients with residual necks immediately after treatment showed complete obliteration of the aneurysm, including the necks, at follow-up angiography performed 4–6 months later (Fig 4).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSION REFERENCES |
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However, most aneurysms occur at bifurcations, which have a geometric configuration that does not allow the routine application of these techniques. Other technical advances, such as three-dimensional coils or double-coil techniques, may permit the introduction of coils inside aneurysms, but they do not offer protection against coil protrusion through the neck. The described aneurysm neck-bridge device is a new detachable instrument that has been designed to address this problem. This device has several advantages: It is introduced through a microcatheter that can be manipulated with ease, as compared with the effort sometimes required with balloon catheters or stents. A single device—rather than two balloons—is used for bifurcation aneurysms. Once this device is placed at the neck of the aneurysm, it provides protection for the entire procedure and thus minimizes maneuvers such as multiple cycles of balloon inflations and deflations. In addition, temporary parent vessel occlusion, which may increase thromboembolic complications (5), is not necessary. Support for coil deposition is constant, and a period of observation for coil stability after balloon deflation and before detachment is not needed. Balloon-assisted techniques are, however, better suited for lateral wall aneurysms; in these cases, the angle between the parent artery and the aneurysm may be too acute for satisfactory deployment and positioning of the neck-bridge device.
Use of the neck-bridge device may necessitate conceptual changes in the way we treat wide-neck aneurysms. Critical issues that must be considered before coil placement in these difficult lesions include (a) the need to build a supporting structure to bridge the neck for future packing with coils, (b) respect of the lumen of the parent artery and its branches to prevent complications, and (c) sufficient coil packing at the neck to ensure satisfactory initial and long-term results. Without parent vessel protection, it is difficult to predict the outcome of the procedure at the time of deposition of the first coil. Once committed to pursuing this treatment, the operator can encounter problems after deposition of multiple coils. The described aneurysm neck-bridge device permits one to target the neck of the aneurysm first. If the device is properly positioned at the neck, packing of the lesion can proceed with greater confidence.
Indications
We initially used this device in patients who presented electively with large aneurysms with wide necks and in patients with recurrent aneurysms found at angiography during the follow-up years after initial GDC embolization. The design of this neck-bridge device is ideal for basilar bifurcations. It can also be used in ophthalmic aneurysms, but the angle between the axis of the parent artery and the neck of the aneurysm should not be so small as to jeopardize the safe delivery or satisfactory placement of all segments of the device. Recurrent aneurysms after endovascular treatment are frequent, particularly in wide-neck bifurcation aneurysms or when initial angiographic results are unsatisfactory. Because surgical clipping of previously coiled basilar aneurysms may be difficult or prone to complications (16,17), so far we have elected to re-treat patients who have recurrent lesions with additional embolizations (9,12). The anatomy of the recurrent lesion is often less favorable for coil placement than the anatomy of the initial lesion. Because the neck-bridge device is designed to support coils at the neck, it could improve the immediate results of repeat treatments and decrease the incidence of second recurrences (9,12).
Complications
The consequences of treating previously untreatable wide-neck aneurysms remain to be determined. Although the device should protect the parent vessel, more aggressive treatments with use of two catheters and the large amount of metal that is in contact with blood flow at the neck may lead to more frequent complications than those associated with GDC embolization in small-neck aneurysms. Some complications may be related to the use of two microcatheters: Thromboembolic complications and dissections may be increased (4,5), and local femoral complications may be doubled because of the need for two approaches. Protrusion of the stem coil inside the parent artery is a specific concern. Slight protrusion probably is of no consequence, but stenosis of the branches of the bifurcation can lead to thromboembolic complications and should be avoided. To prevent these events, sizing of the device is critical.
We are still in the steep part of the learning curve for using this neck-bridge device. The sizing table provided by the manufacturer has yet to be validated with clinical experience. The suggested sizes in the table are based on animal experiment results and geometric extrapolations, and they do not take into account the shape of the aneurysm, the size of the parent artery, or the angles between the artery and its branches—critical factors in the optimal positioning of the device (12). The use of anticoagulation during the procedure is routine at our institution, even acutely after subarachnoid hemorrhage. A discussion regarding the empiric use of heparin was beyond the scope of this article. We believe long interventions with use of multiple microcatheters, the presence of the stem, and the number of coils in contact with blood flow in wide-neck aneurysms are sufficient reasons to operate with systemic anticoagulation. However, in the current series, two complications might have been related to the use of systemic anticoagulation: a retroperitoneal hematoma and rebleeding despite satisfactory coil packing.
The design of the aneurysm neck-bridge device is such that a short portion of the struts of the loops and the stem coil often had to be placed inside the parent artery bifurcation (Figs 1 –3). This position did not cause embolic complications in 17 of 18 patients in whom it was observed for follow-up periods of 1 month to 1 year; however, it may have led to an embolic event 5 weeks after treatment in patient 21. The antiplatelet regimen that we used after treatment is empiric, but it was inspired from experiences with stents in invasive cardiology (18). Longer follow-up periods with larger numbers of patients are necessary to assess the safety of this new method and the incidence of long-term embolic complications.
Morphologic Results and Recurrences
The described neck-bridge device permitted treatment of aneurysms that would have been untreatable otherwise. We think that we achieved satisfactory angiographic results, considering the morphologic features of these lesions. Because of selection of difficult cases, this series cannot be compared to other endovascular or surgical series. The use of the neck-bridge device may permit increased coil packing at the neck and thus favor thrombosis and neointima formation, which are important factors in aneurysmal healing after embolization (19,20). The completely obliterated aneurysms at follow-up angiography in four patients in whom immediate angiographic results had shown residual necks were an encouraging observation. The effects of using the neck-bridge device on long-term angiographic results will be difficult to assess in clinical practice, because the instrument probably will be used selectively in lesions with a high propensity for recurrence. The procedure is still a form of metallic coil embolization and is therefore subject to the deficient healing response that is sometimes associated with this type of treatment (21,22).
In conclusion, the aneurysm neck-bridge device permitted endovascular treatment of wide-neck aneurysms without the need for more complex balloon-assisted techniques. We believe this new device will be an important adjunct to treatment of difficult bifurcation aneurysms.
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FOOTNOTES |
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Author contributions: Guarantor of integrity of entire study, J.R.; study concepts, J.R.; study design, J.R., D.R.; literature research, J.R., D.R., F.G.; clinical studies, J.R., D.R., F.G.; data acquisition, J.R., D.R., F.G.; data analysis/interpretation, J.R., D.R.; manuscript preparation, definition of intellectual content, editing, revision/review, and final version approval, J.R., D.R., F.G.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODS RESULTSDISCUSSION REFERENCES |
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