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Fernando Viñuela, Gary Duckwiler, and Michel Mawad

✓ From December 1990 to July 1995, the investigators participated in a prospective clinical study to evaluate the safety of the Guglielmi detachable coil (GDC) system for the treatment of aneurysms. This report summarizes the perioperative results from eight initial interventional neuroradiology centers in the United States. The report focuses on 403 patients who presented with acute subarachnoid hemorrhage from a ruptured intracranial aneurysm. These patients were treated within 15 days of the primary intracranial hemorrhage and were followed until they were discharged from the hospital or died.

Seventy percent of the patients were female and 30% were male. The patients' mean age was 58 years old. Aneurysm size was categorized as small (60.8%), large (34.7%), and giant (4.5%); and neck size was categorized as small (53.6%), wide (36.2%), fusiform (6%), and undetermined (4.2%). Fifty-seven percent of the aneurysms were located in the posterior circulation and 43% in the anterior circulation.

Eighty-two patients were classified as Hunt and Hess Grade I (20.3%), 105 Grade II (26.1%), 121 Grade III (30%), 69 Grade IV (17.1%), and 26 Grade V (6.5%). All patients in this study were excluded from surgical treatment either because of anticipated surgical difficulty (69.2%), attempted and failed surgery (12.7%), the patient's poor neurological (12.2%) or medical (4.7%) status, and/or refusal of surgery (1.2%).

The GDC embolization was performed within 48 hours of primary hemorrhage in 147 patients (36.5%), within 3 to 6 days in 156 patients (38.7%), 7 to 10 days in 71 patients (17.6%), and 11 to 15 days in 29 patients (7.2%). Complete aneurysm occlusion was observed in 70.8% of small aneurysms with a small neck, 35% of large aneurysms, and 50% of giant aneurysms. A small neck remnant was observed in 21.4% of small aneurysms with a small neck, 57.1% of large aneurysms, and 50% of giant aneurysms. Technical complications included aneurysm perforation (2.7%), unintentional parent artery occlusion (3%), and untoward cerebral embolization (2.48%). There was a 8.9% immediate morbidity rate related to the GDC technique. Seven deaths were related to technical complications (1.74%) and 18 (4.47%) to the severity of the primary hemorrhage.

The findings of this study demonstrate the safety of the GDC system for the treatment of ruptured intracranial aneurysms in anterior and posterior circulations. The authors believe additional randomized studies will further identify the role of this technique in the management of acutely ruptured incranial aneurysms.

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Guido Guglielmi, Fernando Viñuela, Jacques Dion, and Gary Duckwiler

✓ Fifteen patients with high-risk intracranial saccular aneurysms were treated using electrolytically detachable coils introduced via an endovascular approach. The patients ranged in age from 21 to 69 years. The most frequent clinical presentation was subarachnoid hemorrhage (eight cases). Considerable thrombosis of the aneurysm (70% to 100%) was achieved in all 15 patients, and preservation of the parent artery was obtained in 14. Although temporary neurological deterioration due to the technique was recorded in one patient, no permanent neurological deficit was observed in this series and there were no deaths. It is believed that this new technology is a viable alternative in the management of patients with high-risk intracranial saccular aneurysms. It may also play an important role in the occlusion of aneurysms in the acute phase of subarachnoid hemorrhage.

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Yince Loh and Gary R. Duckwiler

Object

The Onyx liquid embolic system (Onyx) was approved in the European Union in 1999 for embolization of lesions in the intracranial and peripheral vasculature, including brain arteriovenous malformations (AVMs) and hypervascular tumors. In 2001 a prospective, equivalence, multicenter, randomized controlled trial was initiated to support a submission for FDA approval. The objective of this study was to verify the safety and efficacy of Onyx compared with N-butyl cyanoacrylate (NBCA) for the presurgical treatment of brain AVMs.

Methods

One hundred seventeen patients with brain AVMs were treated with either Onyx (54 patients) or NBCA (63 patients) for presurgical endovascular embolization between May 2001 and April 2003. The primary end point was technical success in achieving ≥ 50% reduction in AVM volume. Secondary end points were operative blood loss and resection time. All adverse events (AEs) were reported and assigned a relationship to the Onyx or NBCA system, treatment, disease, surgery, or other/unknown. The Data Safety Monitoring Board adjudicated AEs, and a blinded, independent core lab assessed volume measurements. Patients were monitored through discharge after the final surgery or through a 3- and/or 12-month follow-up if resection had not been performed or was incomplete.

Results

The use of Onyx led to ≥ 50% AVM volume reduction in 96% of cases versus 85% for NBCA (p = not significant). The secondary end points of resection time and blood loss were similar. Serious AEs were also similar between the 2 treatment groups.

Conclusions

Onyx is equivalent to NBCA in safety and efficacy as a preoperative embolic agent in reducing brain AVM volume by at least 50%.

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Fernando Viñuela, Gary Duckwiler, and Michel Mawad

✓From December 1990 to July 1995, the investigators participated in a prospective clinical study to evaluate the safety of the Guglielmi detachable coil (GDC) system for the treatment of aneurysms. This report summarizes the perioperative results from eight initial interventional neuroradiology centers in the United States. The report focuses on 403 patients who presented with acute subarachnoid hemorrhage from a ruptured intracranial aneurysm. These patients were treated within 15 days of the primary intracranial hemorrhage and were followed until they were discharged from the hospital or died.

Seventy percent of the patients were female and 30% were male. The patients' mean age was 58 years old. Aneurysm size was categorized as small (60.8%), large (34.7%), and giant (4.5%); and neck size was categorized as small (53.6%), wide (36.2%), fusiform (6%), and undetermined (4.2%). Fifty-seven percent of the aueurysms were located in the posterior circulation and 43% in the anterior circulation.

Eighty-two patients were classified as Hunt and Hess Grade I (20.3%), 105 Grade II (26.1%), 121 Grade III (30%), 69 Grade IV (17.1%), and 26 Grade V (6.5%). All patients in this study were excluded from surgical treatment either because of anticipated surgical difficulty (69.2%), attempted and failed surgery (12.7%), the patient's poor neurological (12.2%) or medical (4.7%) status, and/or refusal of surgery (1.2%).

The GDC embolization was performed within 48 hours of primary hemorrhage in 147 patients (36.5%), within 3 to 6 days in 156 patients (38.7%), 7 to 10 days in 71 patients (17.6%), and 11 to 15 days in 29 patients (7.2%). Complete aneurysm occlusion was observed in 70.8% of small aneurysms with a small neck, 35% of large aneurysms, and 50% of giant aneurysms. A small neck remnant was observed in 21.4% of small aneurysms with a small neck, 57.1% of large aneurysms, and 50% of giant aneurysms. Technical complications included aneurysm perforation (2.7%), unintentional parent artery occlusion (3%), and untoward cerebral embolization (2.48%). There was a 8.9% immediate morbidity rate related to the GDC technique. Seven deaths were related lo technical complications (1.74%) and 18 (4.47%) to the severity of the primary hemorrhage.

The findings of this study demonstrate the safety of the GDC system for the treatment of ruptured intracranial aneurysms in anterior and posterior circulations. The authors believe additional randomized studies will further identify the role of this technique in the management of acutely ruptured incranial aneurysms.

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Nancy McLaughlin, Radoslav Raychev, Gary Duckwiler, and Neil A. Martin

The finding of dilated, elongated, and tortuous vessels on brain imaging should prompt clinicians to determine what vascular anomaly is present. Importantly, not all suspicious serpentine flow voids are manifestations of arteriovenous malformations or arteriovenous fistulas. Other types of intracranial vasculopathies should also be considered. The authors report a rare case of dilated, tortuous, and redundant left posterior communicating artery and left P2 segment of the posterior cerebral artery identified in a young healthy adult that remained stable over a 30-year period. Dynamic and 3D images were critical for determining the type of vascular anomaly and for guiding appropriate management. The authors propose that this case represents a pure arterial malformation and discuss its distinguishing features.

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Editorial

Onyx embolization of arteriovenous malformations

Giuseppe Lanzino and Harry Cloft

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Yuichi Murayama, Fernando Viñuela, Gary R. Duckwiler, Y. Pierre Gobin, and Guido Guglielmi

Object. Guglielmi detachable coil (GDC) technology is a valuable therapeutic alternative to the surgical treatment of ruptured or incidental intracranial aneurysms. The authors describe their technical and clinical experience in the use of the GDC technique in patients who underwent endovascular occlusion for the treatment of incidentally found intracranial aneurysms.

Methods. One hundred fifteen patients with 120 incidentally found intracranial aneurysms underwent embolization by means of the GDC endovascular technique. Ninety-one patients were females and 24 were males. Patient age ranged from 13 to 80 years. In 64 patients the incidental aneurysms were discovered when unrelated nonneurological conditions signaled the need for angiography or magnetic resonance angiography (Group 1). Twenty patients who presented with incidental aneurysms that were discovered during treatment for an acutely ruptured aneurysm underwent treatment of both types of aneurysm during the acute phase of subarachnoid hemorrhage (SAH) (Group 2). Sixteen patients with incidental aneurysms were treated during the chronic phase of SAH (Group 3). Group 4 included 15 patients who had incidental aneurysms associated with brain tumors or arteriovenous malformations.

Angiographic results revealed complete or near-complete occlusion in 109 aneurysms (91%) and incomplete occlusion in five aneurysms (4%). Guglielmi detachable coil embolization was attempted unsuccessfully in six aneurysms (5%). One hundred nine patients (94.8%) remained neurologically intact or unchanged from their initial clinical status. Five patients (4.3%) deteriorated as a result of immediate procedural complications. All these complications occurred in the first 50 patients treated in the series. No clinical complications were observed in the last 65 patients. In one patient, a partially embolized aneurysm ruptured 3 years postprocedure. In Groups 1 and 3, the average length of hospitalization was 3.3 days.

Conclusions. The evolution of GDC technology has proved to provide safe treatment of incidental aneurysms (a morbidity rate of 0% was achieved in the last 65 patients). The topography of the aneurysm and the clinical condition of the patient did not influence final anatomical or clinical outcomes. The GDC technology also confers a positive economic impact by decreasing hospital length of stay and by eliminating the need for postembolization intensive care.

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Yuichi Murayama, Fernando Viñuela, Gary R. Duckwiler, Y. Pierre Gobin, and Guido Guglielmi

Guglielmi detachable coil (GDC) technology is a valuable therapeutic alternative to the surgical treatment of ruptured or incidental intracranial aneurysms. The authors describe their technical and clinical experience in the utilization of the GDC technique in patients who underwent endovascular occlusion for the treatment of incidentally found intracranial aneurysms.

One hundred fifteen patients with 120 incidentally found intracranial aneurysms underwent embolization using the GDC endovascular technique. Ninety-one patients were female and 24 were male. Patient age ranged from 13 to 80 years. In 64 patients the incidental aneurysms were discovered when unrelated nonneurological conditions indicated the need for angiography or magnetic resonance angiography (Group 1). Twenty patients who presented with incidental aneurysms that were discovered during treatment for an acutely ruptured aneurysm were treated in the acute phase of subarachnoid hemorrhage (SAH) (Group 2). Sixteen patients with incidental aneurysms were treated during the chronic phase of SAH (Group 3). Group 4 included 15 patients who had incidental aneurysms associated with brain tumors or arteriovenous malformations.

Angiographic results showed complete or near complete occlusion in 109 aneurysms (91%) and incomplete occlusion in five aneurysms (4%). Unsuccessful GDC embolization was attempted in six aneurysms (5%). One hundred nine patients (94.8%) remained neurologically intact or unchanged from initial clinical status. Five patients (4.3%) deteriorated due to immediate procedural complications (overall immediate morbidity rate). All of these complications occurred in the first 50 patients treated earlier in this series. No clinical complications were observed in the last 65 patients. Follow-up cerebral angiograms were obtained in 77 patients with 79 aneurysms. The median clinical follow-up period was 16.3 months.

No recanalization was observed in the 52 completely occluded aneurysms. Of the 22 aneurysms with small neck remnants, eight (36%) showed further thrombosis, 7 (32%) remained anatomically unchanged, and seven (32%) showed recanalization due to compaction of the coils. In one patient, a partially embolized aneurysm ruptured 3 years postembolization. In Groups 1 and 3, the average length of hospitalization was 3.3 days.

The evolution of the GDC technology has proved to provide safe treatment of incidental aneurysms (a morbidity rate of 0% was achieved in the last 65 patients). The topography of the aneurysm and the clinical condition of the patient did not influence final anatomical or clinical outcomes. The GDC technology also confers a positive economical impact by decreasing hospital length of stay and by eliminating the need for postembolization intensive care unit care.

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Ken Uda, Yuichi Murayama, Y. Pierre Gobin, Gary R. Duckwiler, and 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.