Endovascular embolization of 150 basilar tip aneurysms with Guglielmi detachable coils: results of the Food and Drug Administration multicenter clinical trial

1998 ◽  
Vol 89 (1) ◽  
pp. 81-86 ◽  
Author(s):  
Joseph M. Eskridge ◽  
Joon K. Song ◽  
_ _

Object. To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device. Methods. The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0–43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0–40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms). Conclusions. Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.

1998 ◽  
Vol 5 (4) ◽  
pp. E3 ◽  
Author(s):  
Joseph M. Eskridge ◽  
Joon K. Song ◽  
_ _

To assess the safety and efficacy of aneurysm embolization performed using Guglielmi detachable coils (GDCs), the authors reviewed the results of a cohort of 150 patients with either ruptured (83 patients) or unruptured (67 patients) basilar tip aneurysms treated with these detachable platinum coil devices in the early part of the United States multicenter GDC clinical trial that led to Food and Drug Administration approval for the device. The most common presentation in this cohort of patients was headache (53%). All patients were entered into the trial after neurosurgical assessment excluded them as candidates for surgical clipping of their aneurysms. Greater than 90% coil packing was achieved in 75% of the patients. For those patients in whom follow-up information was available, the mean angiographic and clinical evaluation follow-up time for 61 patients with ruptured aneurysms was 13.7 months (range 0-43 months) and that for the 49 patients with unruptured aneurysms was 9.8 (range 0-40 months). Conservative mortality rates included up to 23% for the ruptured aneurysm group and up to 12% for the unruptured aneurysm group; the rebleeding rate for treated ruptured aneurysms was up to 3.3% and the bleeding rate for unruptured aneurysms up to 4.1%. Permanent deficits due to stroke in patients with ruptured or unruptured aneurysms occurred in up to 5% and 9%, respectively. Vasospasm occurred in 8% of the patients; it was associated with two deaths. Periprocedural mortality was 2.7% (four patients with ruptured aneurysms). Detachable platinum coil embolization is a promising treatment for ruptured basilar tip aneurysms that are not surgically clippable; in selected patients it offers lower incidences of morbidity and mortality compared with conservative medical management. The role of this procedure in unruptured basilar tip aneurysms is unclear with less supportive results. More long-term follow-up evaluation is necessary and results are expected to improve.


1999 ◽  
Vol 90 (5) ◽  
pp. 843-852 ◽  
Author(s):  
Gerhard Bavinzski ◽  
Monika Killer ◽  
Andreas Gruber ◽  
Andrea Reinprecht ◽  
Cordell E. Gross ◽  
...  

Object. The authors retrospectively analyzed the results of their 6-year experience in the treatment of basilar artery (BA) bifurcation aneurysms by using Guglielmi detachable coils (GDCs).Methods. This analysis involved 45 BA tip aneurysms in 16 men and 29 women who ranged in age from 23 to 78 years (mean 50 years). Seventy-five percent of the aneurysms had ruptured and 25% remained unruptured. Of the group whose aneurysms hemorrhaged, 14 patients were Hunt and Hess Grade I or II and 20 were Hunt and Hess Grades III to V; 32 patients were treated within 2 weeks of their subarachnoid hemorrhage (SAH). Initially, treatment with GDCs was limited to poor-grade high-risk patients who refused surgery or patients in whom surgery proved unsuccessful. Later in the study, good-grade patients with narrow-necked aneurysms were also treated using GDCs.The length of clinical follow up ranged from 1 to 72 months (average 27.4 months) in the 37 surviving patients. In 33 of the 45 aneurysms treated with coil placement, good to excellent results were achieved. There were 12 poor results (27%) including one in a patient from the non-SAH group who suffered a thrombotic complication due to an underlying vasculitis. Eight deaths were recorded in this group of 45 patients. One of these deaths was caused by a complication related to anesthesia, one by unknown causes, and six resulted from complications of the disease. One patient rebled on the 2nd day after the endovascular procedure. The mortality and permanent morbidity rates directly related to the intervention were 2.2% and 4.4%, respectively.Angiographic studies obtained immediately postintervention demonstrated 99 to 100% occlusion in 30 (67%) of the aneurysms; nine (20%) were more than 90% occluded; and six (13%) were less than 90% occluded by the GDCs. Follow-up angiograms were obtained in 31 patients between 2 and 72 months after coil placement. Nineteen (61%) of the follow-up angiograms revealed stable results (that is, no change from initial treatment). Twelve of the 31 showed coil compaction, but only eight of these lesions could accept additional coils.In large aneurysms recanalization was seen in 57%, and some of the larger lesions required as many as four embolizations (mean 1.7) to achieve optimal occlusion. When small-necked aneurysms were analyzed as a subset, a stable angiographic result was seen in 92%.Conclusions. Use of GDCs led to excellent clinical and angiographic results in the majority of patients with BA tip aneurysms included in this limited follow-up study. Rebleeding was encountered in one of the 34 previously ruptured BA aneurysms treated with GDCs, and no hemorrhages have been documented in the 11 unruptured aneurysms treated with GDCs in this series. Long-term follow-up studies are necessary before it is possible to compare adequately the treatment of aneurysms with coil placement to the gold standard of aneurysm clipping.


1998 ◽  
Vol 89 (6) ◽  
pp. 956-961 ◽  
Author(s):  
Tim W. Malisch ◽  
Guido Guglielmi ◽  
Fernando Viñuela ◽  
Gary Duckwiler ◽  
Y. Pierre Gobin ◽  
...  

Object. Embolization of intracranial aneurysms by using Guglielmi detachable coils (GDCs) is proving to be a safe method of protecting aneurysms from rupture. Occasionally, patients with unruptured intracranial aneurysms present with symptoms related to the aneurysm's mass effect on either the brain parenchyma or cranial nerves. In the present study, the authors conducted a retrospective review to evaluate the response to GDC embolization in a series of 19 patients presenting with cranial nerve dysfunction due to mass effect. Methods. Aneurysms were classified by size, shape, wall calcification, and amount of intraluminal thrombus. Patients were classified by duration of symptoms prior to GDC treatment (range < 1 month to > 10 years). Clinical assessment was performed within days of the GDC procedure and at later follow-up appointments (range 1–70 months, mean 24 months). In the immediate post-GDC period, four patients experienced worsening of cranial nerve deficits. Two of the four patients had transient worsening of visual acuity, which later improved to better than baseline status. Another patient who had presented with headache and seventh and eighth cranial nerve deficits from a vertebrobasilar junction aneurysm had improvement in these symptoms, but developed a new diplopia. The fourth patient had worsening of her visual acuity, which had not resolved at the 1-month follow-up examination; this patient later underwent surgical decompression. Conclusions. On late follow-up review, the response was classified as complete resolution of symptoms in six patients (32%), improvement in eight patients (42%), no significant change in four patients (21%), and symptom worsening in one patient (5%). Patients with smaller aneurysms and those with shorter pretreatment duration of symptoms were more likely to experience an improvement in their symptoms following GDC treatment, although statistical significance was not reached in this series (p = 0.603 and p = 0.111, respectively). The presence of aneurysmal wall calcification (six patients) or intraluminal thrombus (12 patients) showed no correlation with the response of mass effect symptoms in these patients.


2003 ◽  
Vol 9 (1_suppl) ◽  
pp. 47-50 ◽  
Author(s):  
Y. Nakai ◽  
M. Sonobe ◽  
K. Sugita ◽  
Y. Matsumaru

The purpose of this study is to evaluate the mid or long-term angiographical stability of Guglielmi Detachable Coils (GDC) after embolization for cerebral aneurysms. Between march 1997 and november 2001, 164 aneurysms, including 116 ruptured and 48 unruptured aneurysms, were treated using GDC at Mito National Hospital. Cerebral angiograms over one month after embolization were obtained in 111 aneurysms, including 71 ruptured and 40 unruptured aneurysms. At the time of initial GDC embolization of the 71 ruptured aneurysms, complete occlusion was achieved in 31 aneurysms, neck remnant in 18 aneurysms, and body filling in 22 aneurysms. Morphological changes were observed in 26 aneurysms (37%) in follow-up. Progressive thrombosis was obtained in 12 out of 71 aneurysms, no changes were shown in 45, and recanalizations occurred in 14. In the initial embolization of the 40 unruptured aneurysms, complete occlusion was achieved in 15 aneurysms, neck remnant in five and body filling in 20 aneurysms respectively. Morphological changes were observed in 12 aneurysms (30%), in which 12 aneurysms showed progressive thrombosis and 28 aneurysms were unchanged. There were significant differences of the long-term angiographical stability between ruptured and unruptured aneurysms. Rigorous follow-up angiography is mandatory when complete aneurysm occlusion is not achieved in ruptured aneurysms.


2001 ◽  
Vol 95 (4) ◽  
pp. 624-632 ◽  
Author(s):  
Ken Uda ◽  
Yuichi Murayama ◽  
Y. Pierre Gobin ◽  
Gary R. Duckwiler ◽  
Fernando Viñuela

Object. The authors present a retrospective analysis of their clinical experience in the endovascular treatment of basilar artery (BA) trunk aneurysms with Guglielmi detachable coils (GDCs). Methods. Between April 1990 and June 1999, 41 BA trunk aneurysms were treated in 39 patients by inserting GDCs. Twenty-seven patients presented with subarachnoid hemorrhage, six had intracranial mass effect, and in six patients the aneurysms were found incidentally. Eighteen lesions were BA trunk aneurysms, 13 were BA—superior cerebellar artery aneurysms, four were BA—anterior inferior cerebellar artery aneurysms, and six were vertebrobasilar junction aneurysms. Thirty-five patients (89.7%) had excellent or good clinical outcomes; procedural morbidity and mortality rates were 2.6% each. Thirty-six aneurysms were selectively occluded while preserving the parent artery, and in five cases the parent artery was occluded along with the aneurysm. Immediate angiographic studies revealed complete or nearly complete occlusion in 35 aneurysms (85.4%). Follow-up angiograms were obtained in 29 patients with 31 aneurysms; the mean follow-up period was 17 months. No recanalization was observed in the eight completely occluded aneurysms. In 19 lesions with small neck remnants, seven (36.8%) had further thrombosis, three (15.8%) remained anatomically unchanged, and nine (47.3%) had recanalization caused by coil compaction. In one patient (2.6%) the aneurysm rebled 8 years after the initial embolization. Conclusions. In this clinical series the authors show that the GDC placement procedure is valuable in the therapeutic management of BA trunk aneurysms. The endovascular catheterization of these lesions tends to be relatively simple, in contrast with more complex neurosurgical approaches. Endosaccular obliteration of these aneurysms also decreases the possibility of unwanted occlusion of perforating arteries to the brainstem.


2004 ◽  
Vol 10 (1_suppl) ◽  
pp. 161-166 ◽  
Author(s):  
Y. Nakai ◽  
M. Sonobe ◽  
T. Takigawa ◽  
T. Yamazaki ◽  
S. Okamoto ◽  
...  

Acute angiographical changes for preventing acute rebleeding on GDC treated cerebral aneurysms were evaluated. From December 2000 to November 2002, 48 total aneurysms in 44 consecutive patients with acute SAH. Acute angiographical evaluations were carried out in 46 aneurysms, including 42 ruptured and 4 unruptured aneurysms. Two cases were excluded because of poor medical condition. In this series, there were no rebleeding cases in acute stage. In the initial embolization for the 46 aneurysms, CO was achieved in eight aneurysms, NR in 15 aneurysms and BF in 23 aneurysms. Acute angiographical observations showed progressive thrombosis in 17 aneurysms (37%). No changes were observed in remaining 29. No recanalization was observed in this series. Only one case of BF, inside the aneurysm bleb was still observed during follow up. Additional embolization was carried out. Progressive thrombosis was frequently observed in GDC treated cerebral aneurysms during acute stage. This angiographical finding seems to show prevention of rebleeding, which is considered important for the management of GDC treatment in acutely ruptured cerebral aneurysm.


1997 ◽  
Vol 86 (2) ◽  
pp. 211-219 ◽  
Author(s):  
Jean Raymond ◽  
Daniel Roy ◽  
Michel Bojanowski ◽  
Robert Moumdjian ◽  
Georges L'Espérance

✓ The surgical treatment of basilar bifurcation aneurysms is difficult and the need for an alternative approach is frequently stated. To assess the efficacy and safety of endovascular treatment of aneurysms located at the basilar bifurcation, the authors prospectively studied angiographic results, clinical results, and complications in 31 patients treated with Guglielmi detachable coils (GDCs). Patients treated acutely after subarachnoid hemorrhage (SAH) were graded according to the Hunt and Hess classification and clinical outcome was determined at 1- and 6-month intervals according to the Glasgow Outcome Scale (GOS). There were 18 women and 13 men, ranging in age from 34 to 67 years (mean age 48 years). Twenty-three were treated acutely after SAH. Clinical Hunt and Hess grades at presentation were as follows: Grade I, six patients; Grade II, three; Grade III, 11; Grade IV, two; and Grade V, one. The GOS score for the group of patients treated acutely was: GOS I, 18 patients; GOS II, III, and IV, one patient each; and GOS V, two patients. There were seven technical complications in this group, most often asymptomatic, but one patient died after aneurysm rupture during treatment and one had residual diplopia at 4 months. Eight patients were treated for incidental basilar bifurcation aneurysms. One technical complication with no neurological deficit occurred in this group of patients with incidental aneurysms. Immediate angiographic results were considered to be satisfactory in 94% of patients, with complete obliteration in 42% and residual neck and dog ears in 52%. There was no bleeding episode after treatment during clinical follow-up periods ranging from 3 to 42 months (mean 15.5 months in 29 surviving patients). Angiographic results were available for 27 patients at 6 months and were as follows: 30% of the lesions were completely obliterated, 59% presented some residual neck, and 11% showed some opacification of the aneurysm sac. During the follow-up period of up to 42 months, a total of seven recurrences were noted, necessitating retreatment with GDCs in five patients. Endovascular treatment of basilar bifurcation aneurysms prevented rebleeding and could be performed without clinically significant complications in 94% of patients. Clinical results after SAH compared favorably with surgical series. Morphological results appear less satisfactory, and long-term angiographic follow-up review is mandatory to detect recurrences.


2002 ◽  
Vol 96 (1) ◽  
pp. 64-70 ◽  
Author(s):  
Bryce Weir ◽  
Lew Disney ◽  
Theodore Karrison

Object. The authors explore the risk of rupture in aneurysms categorized by size. Methods. A computerized database of 945 patients with aneurysms treated between 1967 and 1987 was retrospectively established. All available clinical and radiological studies were abstracted. Because of the recent interest in the size of intracranial aneurysms in relation to their likelihood of rupture, the database was searched with respect to this parameter. In 390 patients representing 41% of all cases, aneurysms were measured by neuroradiologists at the time of diagnosis. In 78% of the 945 patients there was only one aneurysm, and of the 507 aneurysms that were measured, 60% were solitary. Of all patients, 86% had ruptured aneurysms. The average age of all patients was 47 years, and for those with ruptured aneurysms it was 46 years. Of the ruptured aneurysms, 77% were 10 mm or smaller, compared with 85% of the unruptured aneurysms. It was found that 40.3% of the ruptured aneurysms were on the anterior cerebral artery or anterior communicating artery, compared with 13% of the unruptured aneurysms. None of the cavernous internal carotid artery (ICA) aneurysms were ruptured and 65% of the ophthalmic artery (OphA) aneurysms were. Of the unruptured aneurysms, 15% were located in the cavernous ICA or the OphA. Of the ruptured aneurysms, 29% were on the middle cerebral artery, compared with 36% of the unruptured aneurysms. The mean size of ruptured and unruptured aneurysms showed no statistically significant increase with patient age, although the difference in size between the ruptured and unruptured aneurysms decreased with increasing age. The mean size of all ruptured aneurysms (10.8 mm) was significantly larger than the mean size of all unruptured aneurysms (7.8 mm, p < 0.001); the median sizes were 10 mm and 5 mm, respectively. The size of ruptured aneurysms in patients who died in the hospital was significantly larger than those in the patients who survived (12 mm compared with 9.9 mm, p = 0.004). Symptomatic unruptured aneurysms were significantly larger than incidental unruptured aneurysms (14.6 mm compared with 6.9 mm, p = 0.032), which were, in turn, larger than aneurysms that were unruptured and part of a multiple aneurysm constellation. Both ruptured and unruptured aneurysms were larger in male than in female patients, but not significantly. Conclusions. Site and patient age, as well as lesion size, may affect the chance of rupture.


1997 ◽  
Vol 87 (3) ◽  
pp. 374-380 ◽  
Author(s):  
Douglas A. Nichols ◽  
Robert D. Brown ◽  
Kent R. Thielen ◽  
Fredric B. Meyer ◽  
John L. D. Atkinson ◽  
...  

✓ The authors report their experience using electrolytically detachable coils for the treatment of ruptured posterior circulation aneurysms. Twenty-six patients with 28 posterior circulation aneurysms were treated. All patients were referred for endovascular treatment by experienced vascular neurosurgeons. Patients underwent follow-up angiography immediately after treatment, 1 to 6 weeks posttreatment, and 6 months posttreatment. Six-month follow-up angiograms obtained in 19 patients with 20 aneurysms demonstrated that 18 (90%) of the 20 aneurysms were 99 to 100% occluded, one aneurysm (5%) was approximately 90% occluded, and one aneurysm (5%) was approximately 75% occluded. The patient with the aneurysm that was approximately 75% occluded needed additional treatment, consisting of parent artery balloon occlusion, and was considered a treatment failure (3.8% of patients). There was one treatment-associated mortality (3.8%) but no treatment-associated serious neurological or nonneurological morbidity in the patient group. There was no recurrent aneurysm rupture during treatment or during the mean 27-month follow-up period. Endovascular treatment of ruptured posterior circulation aneurysms with electrolytically detachable coils can be accomplished with low morbidity and mortality rates. The primary goal of treatment—preventing recurrent aneurysm—can be achieved over the short term. Endovascular coil occlusion will play an important role in the treatment of ruptured posterior circulation aneurysms, particularly if long-term efficacy in preventing recurrent aneurysm hemorrhage can be documented.


2004 ◽  
Vol 101 (6) ◽  
pp. 1018-1025 ◽  
Author(s):  
Luigi Pentimalli ◽  
Andrea Modesti ◽  
Andrea Vignati ◽  
Enrico Marchese ◽  
Alessio Albanese ◽  
...  

Object. Mechanisms involved in the rupture of intracranial aneurysms remain unclear, and the literature on apoptosis in these lesions is extremely limited. The hypothesis that apoptosis may reduce aneurysm wall resistance, thus contributing to its rupture, warrants investigation. The authors in this study focused on the comparative evaluation of apoptosis in ruptured and unruptured intracranial aneurysms. Peripheral arteries in patients harboring the aneurysms and in a group of controls were also analyzed. Methods. Between September 1999 and February 2002, specimens from 27 intracranial aneurysms were studied. In 13 of these patients apoptosis was also evaluated in specimens of the middle meningeal artery (MMA) and the superficial temporal artery (STA). The terminal deoxynucleotidyl transferase—mediated deoxyuridine triphosphate nick-end labeling technique was used to study apoptosis via optical microscopy; electron microscopy evaluation was performed as well. Apoptotic cell levels were related to patient age and sex, aneurysm volume and shape, and surgical timing. Significant differences in apoptosis were observed when comparing ruptured and unruptured aneurysms. High levels of apoptosis were found in 88% of ruptured aneurysms and in only 10% of unruptured lesions (p < 0.001). Elevated apoptosis levels were also detected in all MMA and STA specimens obtained in patients harboring ruptured aneurysms, whereas absent or very low apoptosis levels were observed in MMA and STA specimens from patients with unruptured aneurysms. A significant correlation between aneurysm shape and apoptosis was found. Conclusions. In this series, aneurysm rupture appeared to be more related to elevated apoptosis levels than to the volume of the aneurysm sac. Data in this study could open the field to investigations clarifying the causes of aneurysm enlargement and rupture.


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