An Update on the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction Trial: 1-Year Safety and Angiographic Results.

BACKGROUND AND PURPOSE: The safety and efficacy of the PulseRider for the treatment of wide-neck, bifurcation aneurysms at the basilar and carotid terminus locations were studied in a prospective trial, the Adjunctive Neurovascular Support of Wide-Neck Aneurysm Embolization and Reconstruction (ANSWER) trial, reporting on initial 6-month angiographic and clinical results. This report provides insight into the longer term durability and safety with 12-month data. MATERIALS AND METHODS: Aneurysms treated with the PulseRider among enrolled sites were prospectively studied. Updated 12-month data on clinical and imaging end points are included. RESULTS: Thirty-four patients were enrolled (29 women, 5 men) with a mean age of 60.9 years. The mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range, 2.3-11.6 mm). At 1 year, there were no device migrations or symptomatic in-stent stenoses. Raymond-Roy I occlusion was achieved in 53% of cases at the time of treatment and progressed to 61% and 67% at 6 and 12 months, respectively. Adequate occlusion (Raymond-Roy I/II) progressed from 88% at 6 months to 90% at 12 months. No recanalizations were observed. There was 1 delayed ischemic event. Good outcome (mRS 0-2) was achieved in 90% of patients. CONCLUSIONS: The updated 1-year results from the ANSWER trial demonstrate aneurysm stability and an acceptable safety profile for aneurysms treated at the basilar apex and carotid terminus. Prospective data from a larger set of aneurysms treated at other locations are required to assess how treatment with PulseRider compares with alternatives for treating wide-neck bifurcation aneurysms.

Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.

Geographic Differences in Endovascular Treatment and Retreatment of Cerebral Aneurysms.

BACKGROUND AND PURPOSE: Comparing outcomes between endovascular aneurysm coiling trials can be difficult because of heterogeneity in patients and end points. We sought to understand the impact of geography on aneurysm retreatment in patients enrolled in the Matrix and Platinum Science Trial. MATERIALS AND METHODS: Post hoc analysis was performed on data from the Matrix and Platinum Science trial. Patients were stratified as either North American or international. Baseline patient demographics, comorbidities, aneurysm characteristics, procedural complications, and clinical and angiographic outcomes were compared. RESULTS: We evaluated 407 patients from 28 North American sites and 219 patients from 15 international sites. Patient demographics differed significantly between North American and international sites. Aneurysms were well occluded postprocedure more often at international than North American sites (P < .001). Stents were used significantly more often at North American sites (32.7% [133 of 407]) compared with international sites (10.0% [22 of 219]; P < .001). At 455 days, there was no difference in the proportion of patients alive and free of disability (P = .56) or with residual aneurysm filling (P = .10). Ruptured aneurysms were significantly more likely to have been retreated at North American sites within the first year (P < .001) and at 2 years (P < .001). Among all patients for whom the treating physician believed there to be Raymond 3 aneurysm filling at follow-up, absolute rates of retreatment at international and North American sites were similar by 2-year follow-up. CONCLUSIONS: Data from the Matrix and Platinum Science Trial demonstrate that aneurysm retreatment occurs with different frequency and at different times in different regions of the world. This trend has critical value when interpreting trials reporting short-term outcomes, especially when judgment-based metrics such as retreatment are primary end points that may or may not take place within the defined study follow-up period. Though these variations can be controlled for and balanced within a given randomized trial, such differences in practice patterns must be accounted for in any attempt to compare outcomes between different trials. Despite these differences, endovascular-treated intracranial aneurysms around the world have similar clinical outcomes.

Patients prone to recurrence after endovascular treatment: periprocedural results of the PRET randomized trial on large and recurrent aneurysms.

BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

Flow diversion versus traditional endovascular coiling therapy: design of the prospective LARGE aneurysm randomized trial.

BACKGROUND AND PURPOSE: The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality. Using well-established, traditional endovascular techniques, this is generally achievable with a high level of safety and efficacy. These techniques involve either constructive treatment of the aneurysm (coils with or without an intravascular stent) or deconstruction (coil occlusion) of the aneurysm and the parent artery. While established as safe and efficacious, the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence. Parent artery deconstruction, though immediately efficacious in achieving complete and durable occlusion, does require occlusion of a major intracranial blood vessel and is associated with risk of stroke. MATERIALS AND METHODS: Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms. Once excluded successfully, the vessel reconstruction and aneurysm occlusion appears durable. The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies. By comparison, conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms. Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA (or appropriate regulatory body) approved devices. RESULTS: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. CONCLUSIONS: This paper details the trial design of the LARGE trial, a blinded, prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters.

Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial.

BACKGROUND AND PURPOSE: The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix(2) polyglycolic/polylactic acid biopolymer-modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death. MATERIALS AND METHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix(2) and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months. RESULTS: At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix(2) (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size. CONCLUSIONS: Tested Matrix(2) coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.

ICONE: An International Consortium of Neuro Endovascular Centres.

SUMMARY: The proliferation of new endovascular devices and therapeutic strategies calls for a prudentand rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisation a land methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the designand execution of basic science, device developmentand clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across aspectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or pre clinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from clientsponsored financial agreements will be redirected to the academic and research objectives of the organization. The Consortium wishes to work inconcert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.

Influence of patient age and stenosis location on wingspan in-stent restenosis.

BACKGROUND AND PURPOSE: Wingspan is a self-expanding, microcatheter-delivered microstent specifically designed for the treatment of symptomatic intracranial atherosclerotic disease. Our aim was to discuss the effect of patient age and lesion location on in-stent restenosis (ISR) rates after percutaneous transluminal angioplasty and stenting (PTAS) with the Wingspan system. MATERIALS AND METHODS: Clinical and angiographic follow-up results were recorded for all patients from 5 participating institutions. ISR was defined as >50% stenosis within or immediately adjacent (within 5 mm) to the implanted stent and >20% absolute luminal loss. For the present analysis, patients were stratified into younger (55 years) age groups. RESULTS: ISR occurred at a rate of 45.2% (14/31) in the younger group and 24.2% (15/62) in the older group (odds ratio, 2.6; 95% confidence interval, 1.03-6.5). In the younger group, ISR occurred after treatment of 13/26 (50%) anterior circulation lesions versus only 1/5 (20%) posterior circulation lesions. In the older group, ISR occurred in 9/29 (31.0%) anterior circulation lesions and 6/33 (18.2%) posterior circulation lesions. In young patients, internal carotid artery lesions (10/17 treated, 58.8%), especially those involving the supraclinoid segment (8/9, 88.9%), were very prone to ISR. When patients of all ages were considered, supraclinoid segment lesions had much higher rates of both ISR (66.6% versus 24.4%) and symptomatic ISR (40% versus 3.9%) in comparison with all other locations. CONCLUSION: Post-Wingspan ISR is more common in younger patients. This increased risk can be accounted for by a high prevalence of anterior circulation lesions in this population, specifically those affecting the supraclinoid segment, which are much more prone to ISR and symptomatic ISR than all other lesions.

Effect of carotid artery stenting on cognitive function in patients with carotid artery stenosis: preliminary results.

BACKGROUND AND PURPOSE: Stenosis of the carotid artery may be a cause of reduced cognitive performance that can be ameliorated with placement of a stent. The goal of this study was to measure cognitive performance and speed of psychomotor performance prospectively before and after carotid stent placement. MATERIALS AND METHODS: Patients referred for stent placement for a unilateral carotid artery stenosis were enrolled in the study. Neuropsychologic testing was performed with a Mini-Mental State Examination, an extended mental status examination, a subjective cognitive status measure, and a psychomotor performance test for speed. The severity of the stenosis was measured on angiograms performed before stent placement. Three months after stent placement, CT angiograms were performed and the neuropsychologic testing was repeated. Differences in neuropsychologic test scores before and after stent placement were calculated and tested for significance with a Student t test. RESULTS: Seventeen patients with a single unilateral carotid stenosis of more than 50% completed the study. Stenosis of the carotid artery averaged 80% before treatment and 18% after treatment. After stenting, the scores from the extended mental status examination improved significantly. The scores from the subjective cognitive status measure also improved. No significant change was noted in the scores from the Mini-Mental State Examination or in the speed of psychomotor performance. CONCLUSION: Carotid stent placement in patients with a unilateral stenosis of the carotid artery resulted in significant improvement in cognitive test scores in this highly selected patient group. Further studies are needed to confirm these preliminary observations.

Noninvasive measurement of intra-aneurysmal pressure and flow pattern using phase contrast with vastly undersampled isotropic projection imaging.

BACKGROUND AND PURPOSE: Currently, more reliable parameters to predict the risk of aneurysmal rupture are needed. Intra-aneurysmal pressure gradients and flow maps could provide additional information regarding the risk of rupture. Our hypothesis was that phase contrast with vastly undersampled isotropic projection reconstruction (PC-VIPR), a novel 3D MR imaging sequence, could accurately assess intra-aneurysmal pressure gradients in a canine aneurysmal model when compared with invasive measurements. MATERIALS AND METHODS: A total of 13 surgically created aneurysms in 8 canines were included in this study. Pressure measurements were performed in the parent vessel, aneurysm neck, and 5 regions within the aneurysmal sac with a microcatheter. PC-VIPR sequence was used to obtain cardiac-gated velocity measurements in a region covering the entire aneurysm. The velocity and pressure gradient maps derived from the PC-VIPR data were then coregistered with the anatomic DSA images and compared with catheter measurements. RESULTS: In 7 of the bifurcation aneurysms, the velocity flow maps demonstrated a recirculation flow pattern with a small neck-to-dome pressure gradient (mean, +0.5 mm Hg). In 1 bifurcation aneurysm, a flow jet extending from the neck to the dome with significantly greater pressure gradient (+50.2 mm Hg) was observed. All sidewall aneurysms had low flow in the sac with intermediate pressure gradients (mean, +8.3 mm Hg). High statistical correlation existed between PC-VIPR aneurysmal pressures and microcatheter pressure measurements (R = 0.82, P < .01). CONCLUSION: PC-VIPR can provide anatomic as well as noninvasive quantitative and qualitative hemodynamic information in the canine aneurysm model. The PC-VIPR intra-aneurysmal pressure measurements correlated well with catheter measurements.

CT angiographic appearance of in-stent restenosis of intracranial arteries treated with the Wingspan stent.

Four patients underwent angioplasty and stenting of medically refractory symptomatic intracranial atherosclerosis with the new Wingspan stent system. In all 4 patients, CT angiography (CTA) showed an abnormality within the stented segment that was suggestive of nonocclusive in-stent thrombus. However, subsequent conventional angiography findings were typical for in-stent restenosis. The CTA imaging features of in-stent restenosis are important to recognize, and the misinterpretation of in-stent restenosis as in-stent thrombus may result in inappropriate management.

Natural history of the canine vein pouch aneurysm model.

BACKGROUND AND PURPOSE: The canine vein pouch aneurysm model is widely used for testing and development of devices directed at the endovascular treatment of aneurysms. Our purpose was to determine the incidence of spontaneous thrombosis and rupture of these aneurysms. MATERIALS AND METHODS: A retrospective review of laboratory records of canine vein pouch aneurysms made during a 6-year period was performed. The aneurysm and parent artery dimensions as well as incidences of spontaneous thrombosis and rupture were noted. RESULTS: During the interval studied, 326 vein patch aneurysms were made in 310 canines. Of these, 102 were sidewall (lateral) and 224 were bifurcation aneurysms. Spontaneous occlusion occurred in 9 of the sidewall aneurysms and in only 1 of the bifurcation aneurysms. None of the aneurysms ruptured. CONCLUSION: Spontaneous occlusion of the sidewall canine vein patch aneurysm occurred less than 10% of the time; in the bifurcation aneurysms, it almost never occurred. These characteristics enhance the value of this model for use in testing of devices intended for the endovascular treatment of aneurysms.

Use of self-expanding stents in distal small cerebral vessels.

BACKGROUND: Previously, endovascular treatment of wide-necked aneurysms and stenosis involving small vessels measuring <2 mm in diameter was limited. There are no reports in the literature addressing stent placement in small distal cerebral vessels. Recent experience with the Neuroform stent has shown that this device can be safely and effectively used to treat aneurysms in vessels of this caliber. MATERIALS AND METHODS: We report 8 cases of Neuroform stent placement into cerebral vessels measuring <2 mm in diameter (range, 1.1-1.8 mm). All stents were placed for aneurysm treatment in conjunction with coiling. Lesion locations and number were as follows: anterior communicating artery region (n = 5), pericallosal artery A2-A3 (n = 1), middle cerebral artery (MCA) M1-M2 (n = 1), and MCA M3-M4 (n = 1). Clinical follow-up ranged from 4.5 to 18 months. Imaging follow-up was performed with MR imaging/MR angiography. RESULTS: All procedures were successfully performed without immediate or delayed device-related complications. Intraprocedural thrombus developed within the stent in 2 patients and immediately resolved with 10 mg of intra-arterial abciximab. Follow-up at 18 months demonstrated durable results. There were no clinical neurologic symptoms related to the treated vessel territory at follow-up. CONCLUSION: Development of newer low-profile endovascular devices allows access and ability to treat lesions farther out in the smaller cerebral vessels. We have safely and successfully treated 8 vessels smaller than 2 mm in diameter with newer self-expanding stents with good short- and intermediate-term results. Further follow-up and more experience are necessary to determine long-term results.

Physiologic and anatomic assessment of a canine carotid artery stenosis model utilizing phase contrast with vastly undersampled isotropic projection imaging.

BACKGROUND AND PURPOSE: Noninvasive assessment of the hemodynamic significance of carotid stenosis is often performed with MR angiography and supplemented with carotid Doppler sonography. Phase contrast with vastly undersampled isotropic projection reconstruction (PC-VIPR), a novel MR imaging technique, accelerates phase-contrast MR flow imaging and provides both images of the vessels and measurements of blood-flow velocities. For this study, we determined the accuracy of PC-VIPR blood-flow velocity measurements to determine pressure gradients across an experimental carotid stenosis. MATERIALS AND METHODS: A focal stenosis was surgically created in each common carotid artery of 6 canines. Digital subtraction angiography (DSA) was performed, and the degree of stenosis was determined using the North American Symptomatic Carotid Endarterectomy Trial methodology. A microcatheter was positioned in the carotid artery proximal and distal to the stenosis, and pressures were measured in the vessel through the catheter. PC-VIPR was then performed on a 1.5T MR imaging scanner with parameters producing 0.8-mm isotropic voxel resolution. From the velocity measurements, pressure gradients were calculated from the Navier-Stokes relationship to compare with the pressures measured by a catheter. RESULTS: Carotid stenoses in the 50%-85% range were produced in the 12 arteries. Pressure gradients across the stenoses ranged from 6 to 26 mm Hg. The pressure gradient calculated from the PC-VIPR data correlated (r = 0.91, P < .0001) with the actual pressure measurements. CONCLUSION: With PC-VIPR, a novel MR imaging technique, the hemodynamic effect of a stenosis on flow and pressure can be evaluated.

Effect of Guglielmi detachable coil placement on intraaneurysmal pressure: experimental study in canines.

BACKGROUND AND PURPOSE: Treatment of ruptured aneurysms with Guglielmi detachable coils (GDCs) has been shown to prevent repeat bleeding. To assess whether GDC coiling alters aneurysmal pressure, we measured intraaneurysmal pressure in two canine types of carotid artery aneurysms before and after GDC placement. METHODS: A 0.014-inch guidewire with a pressure transducer was inserted into parent arteries and domes of surgically created aneurysms. Intravascular static pressures were recorded before and during saline power injections (10, 20, and 30 mL over 1 and 2 s), before and after GDC placement. Common femoral arterial pressure was monitored. RESULTS: Saline power injections reproducibly and abruptly increased pressure in parent arteries and aneurysms. Mean intraaneurysmal pressure varied (18 +/- 4 [10 mL] to 75 +/- 15 mm Hg [30 mL]), independent of injection duration. Intraaneurysmal baseline pressures were higher after GDC placement (111 +/- 10 versus 93 +/- 15 mm Hg; P =.05). Aneurysmal pressure increases with saline injections were slightly higher after GDC placement, which dampened intraaneurysmal pressure amplitude at baseline (26.5 +/- 5.6 versus 19.6 +/- 7.4 mm Hg; P =.003) and during hypertension (25.3 +/- 5.4 versus 19.8 +/- 7.5 mm Hg, P =.002). The pressure increase slope with saline injection was delayed with GDC placement (0.24 +/- 0.1 versus 0.38 +/- 0.19 s; P <.001). CONCLUSION: Graded saline power injections into parent arteries can rapidly increase intraaneurysmal pressure. GDC treatment did not attenuate mean intraaneurysmal pressures, but both dampened the pressure amplitude and delayed pressure increases during locally induced hypertension.

Evaluation of the TriSpan neck bridge device for the treatment of wide-necked aneurysms: an experimental study in canines.

BACKGROUND AND PURPOSE: Many wide-necked aneurysms are difficult or impossible to treat with the Guglielmi detachable coil (GDC). The purpose of this study was to evaluate the use of a neck bridging device, the TriSpan coil, in combination with standard GDCs for the treatment of wide-necked aneurysms in an experimental canine aneurysm model. METHODS: Of 24 experimental aneurysms in 12 animals, 19 (7 lateral and 12 terminal) were treated with the TriSpan coil in conjunction with standard GDCs. Digital subtraction angiography (DSA) was performed on all animals immediately after treatment. In 6 animals, follow-up DSA and histological evaluation were performed 4 weeks after treatment. In the remaining 6, DSA was done at both 90 and 180 days after treatment. Histological evaluation was done immediately after the 180-day angiographic evaluation. RESULTS: The TriSpan was easy to use in conjunction with the standard GDC. Because of their geometry, some lateral aneurysms were difficult or impossible to treat with this device. Greater than 90% aneurysm occlusion was obtained in all 19 aneurysms. In no instance was there evidence of coil migration, herniation, or aneurysm recanalization. Histological evaluation of the tissue surrounding the TriSpan coil showed tissue responses similar to that seen with standard GDCs. CONCLUSIONS: These results show that the TriSpan coil in conjunction with standard GDCs can be used safely and effectively for the treatment of wide-necked aneurysms in this canine model. Positioning and deployment of the neck bridge in aneurysms having an acute angle with the long axis of their parent artery are difficult or impossible. It is likely that this device, used in conjunction with the standard GDC, will allow treatment of some wide-necked aneurysms that are not treatable with the GDC alone.

Definition of the ostium (neck) of an aneurysm revealed by intravascular sonography: an experimental study in canines.

BACKGROUND AND PURPOSE: The major factor influencing the effectiveness of Guglielmi detachable coils (GDCs) in the treatment of saccular aneurysms is the size of the aneurysm's ostium (neck). Current imaging techniques often do not allow accurate assessment of aneurysm neck morphology. The primary purpose of this study was to determine the feasibility of using intravascular sonography to provide this information. METHODS: Lateral and bifurcation aneurysms were created in each of six adult mongrel dogs by using a well-established surgical technique. Aneurysms were evaluated with digital subtraction angiography and intravascular sonography before (n = 12) and after (n = 6) treatment with GDCs. Angiography was performed using standard techniques. Sonography was performed using both a commercially available 2.6F 40-MHz catheter and a preproduction 0.014-inch 40-MHz imaging core wire housed in a Tracker catheter. Angiograms and sonograms were reviewed independently by two observers to assess the clarity and accuracy with which they depicted the size of each aneurysm's ostium. Posttreatment intravascular sonograms were evaluated for the extent to which they depicted the completeness of aneurysm obliteration. Two-dimensional reformatted images were made of the intravascular sonographic pullback sequences. RESULTS: In all instances, intravascular sonography provided clear definition of the aneurysm's neck (ostium) morphology as well as its relationship to the parent artery and adjacent branches, especially when 2D reformatted images were obtained. The position of coils in aneurysms was also clearly defined. CONCLUSION: Intravascular sonography is a novel technique for viewing the ostium (neck) of an aneurysm. It provides information not available with current angiographic methods.