Peter Kim Nelson

CURATIVE ENDOVASCULAR RECONSTRUCTION OF CEREBRAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE: THE BUENOS AIRES EXPERIENCE

OBJECTIVESThe Pipeline embolization device (PED) (Chestnut Medical Technologies, Inc., Menlo Park, CA) is a new microcatheter-delivered endovascular construct designed to achieve the curative reconstruction of the parent arteries giving rise to wide-necked and fusiform intracranial aneurysms. We present our initial periprocedural experience with the PED and midterm follow-up results for a series of 53 patients. METHODSPatients harboring large and giant wide-necked, nonsaccular, and recurrent intracranial aneurysms were selected for treatment. All patients were pretreated with dual antiplatelet medications for at least 72 hours before surgery and continued taking both agents for at least 6 months after treatment. A control digital subtraction angiogram was typically performed at 3, 6, and 12 months. RESULTSFifty-three patients (age range, 11–77 years; average age, 55.2 years; 48 female) with 63 intracranial aneurysms were treated with the PED. Small (n = 33), large (n = 22), and giant (n = 8) wide-necked aneurysms were included. A total of 72 PEDs were used. Treatment was achieved with a single PED in 44 aneurysms, with 2 overlapping PEDs in 17 aneurysms, and with 3 overlapping PEDs in 2 aneurysms. The mean time between the treatment and last follow-up digital subtraction angiogram was 5.9 months (range, 1–22 months). Complete angiographic occlusion was achieved in 56%, 93%, and 95% of aneurysms at 3 (n = 42), 6 (n = 28), and 12 (n = 18) months, respectively. The only aneurysm that remained patent at the time of the 12-month follow-up examination had been treated previously with stent-supported coiling. The presence of a preexisting endoluminal stent may have limited the efficacy of the PED reconstruction in this aneurysm. No aneurysms demonstrated a deterioration of angiographic occlusion during the follow-up period (i.e., no recanalizations). No major complications (stroke or death) were encountered during the study period. Three patients (5%), all with giant aneurysms, experienced transient exacerbations of preexisting cranial neuropathies and headache after the PED treatment. All 3 were treated with corticosteroids, and these symptoms resolved within 1 month. CONCLUSIONEndovascular reconstruction with the PED represents a safe, durable, and curative treatment of selected wide-necked, large and giant cerebral aneurysms. The rate of complete occlusion at the time of the 12-month follow-up examination approached 100% in the present study. To date, no angiographic recurrences have been observed during serial angiographic follow-up.

The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial

BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow diverting devices represents a novel constructive technique for the treatment of cerebral aneurysms. We present the results of the first prospective multicenter trial of a flow-diverting construct for the treatment of intracranial aneurysms. MATERIALS AND METHODS: Patients with unruptured aneurysms that were wide-necked (>4 mm), had unfavorable dome/neck ratios (<1.5), or had failed previous therapy were enrolled in the PITA trial between January and May 2007 at 4 (3 European and 1 South American) centers. Aneurysms were treated with the PED with or without adjunctive coil embolization. All patients underwent clinical evaluation at 30 and 180 days and conventional angiography 180 days after treatment. Angiographic results were adjudicated by an experienced neuroradiologist at a nonparticipating site. RESULTS: Thirty-one patients with 31 intracranial aneurysms (6 men; 42–76 years of age; average age, 54.6 years) were treated during the study period. Twenty-eight aneurysms arose from the ICA (5 cavernous, 15 parophthalmic, 4 superior hypophyseal, and 4 posterior communicating segments), 1 from the MCA, 1 from the vertebral artery, and 1 from the vertebrobasilar junction. Mean aneurysm size was 11.5 mm, and mean neck size was 5.8 mm. Twelve (38.7%) aneurysms had failed (or recurred after) a previous endovascular treatment. PED placement was technically successful in 30 of 31 patients (96.8%). Most aneurysms were treated with either 1 (n = 18) or 2 (n = 11) PEDs. Fifteen aneurysms (48.4%) were treated with a PED alone, while 16 were treated with both PED and embolization coils. Two patients experienced major periprocedural stroke. Follow-up angiography demonstrated complete aneurysm occlusion in 28 (93.3%) of the 30 patients who underwent angiographic follow-up. No significant in-construct stenosis (≥50%) was identified at follow-up angiography. CONCLUSIONS: Intracranial aneurysm treatment with the PED is technically feasible and can be achieved with a safety profile analogous to that reported for stent-supported coil embolization. PED treatment elicited a very high rate (93%) of complete angiographic occlusion at 6 months in a population of the most challenging anatomic subtypes of cerebral aneurysms.

Treatment of Intracranial Aneurysms by Functional Reconstruction of the Parent Artery: The Budapest Experience with the Pipeline Embolization Device

BACKGROUND AND PURPOSE: Aneurysm treatment by intrasaccular packing has been associated with a relatively high rate of recurrence. The use of mesh tubes has recently gained traction as an alternative therapy. This article summarizes the midterm results of using an endoluminal sleeve, the PED, in the treatment of aneurysms. MATERIALS AND METHODS: A total of 19 wide-neck aneurysms were treated in 18 patients: 10 by implantation of PEDs alone and 9 by a combination of PED and coils. Angiographic and clinical results were recorded immediately and at 6 months following treatment. RESULTS: Immediate angiographic occlusion was achieved in 4 and flow reduction, in another 15 aneurysms. Angiography at 6 months demonstrated complete occlusion in 17 and partial filling in 1 of 18 patients. There was no difference between coil-packed and unpacked aneurysms. Of 28 side branches covered by ≥1 device, the ophthalmic artery was absent immediately in 1 and at 6 months in another 2 cases. One patient experienced abrupt in-stent thrombosis resulting in a transient neurologic deficit, and 1 patient died due to rupture of a coexisting aneurysm. All giant aneurysms treated with PED alone were demonstrated by follow-up cross-sectional imaging to have involuted by 6 months. CONCLUSIONS: Treatment of large, wide-neck, or otherwise untreatable aneurysms with functional reconstruction of the parent artery may be achieved with relative safety using dedicated flow-modifying devices with or without adjunctive use of intrasaccular coil packing.

Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial

PURPOSE To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND METHODS The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. RESULTS PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the studys primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). CONCLUSION PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

Safety and Efficacy of Adjunctive Balloon Remodeling during Endovascular Treatment of Intracranial Aneurysms: A Literature Review

BACKGROUND AND PURPOSE: Concurrent temporary inflation of a nondetachable balloon in the parent artery has been reported to be useful during endovascular coiling of complex, wide-neck aneurysms, facilitating truer coil reconstruction of the native vessel. Nevertheless, there exists concern that adjunctive use of balloon assistance may lead to increased adverse events during aneurysm coiling. MATERIALS AND METHODS: A literature search of all of the unassisted and balloon-remodeling studies published between 1997 and 2006 was conducted with application of strict selection criteria based on the reporting of complication incidence and outcome. The final cohort was analyzed to determine rates and clinical outcomes of iatrogenic aneurysm rupture and thromboembolism. Additional data were collected on the degree of initial and follow-up aneurysm occlusion rates. RESULTS: A total of 83 potential studies (4973 patients) were identified, from which 23 articles reporting results for 867 traditional-unassisted and 273 balloon-assisted coiled aneurysms met inclusion criteria for the analysis of thromboembolic complications, and 21 articles with 993 routinely coiled and 170 balloon-remodeled aneurysms were eligible for iatrogenic perforation analysis. No statistically significant difference was found in the rates of thromboembolism. Iatrogenic perforation rates were also comparable, though the overall numbers were too few for meaningful statistical analysis. Both initial and follow-up aneurysm occlusion rates were higher in balloon-assisted cases. CONCLUSION: This largest-to-date literature review and meta-analysis did not demonstrate a higher incidence of thromboembolic events or iatrogenic rupture with the use of adjunctive balloon remodeling compared with unassisted coiling. Balloon remodeling appears to result in higher initial and follow-up aneurysm occlusion rates.

CURATIVE RECONSTRUCTION OF A GIANT MIDBASILAR TRUNK ANEURYSM WITH THE PIPELINE EMBOLIZATION DEVICE

OBJECTIVETo demonstrate the curative reconstruction of a giant circumferential basilar trunk aneurysm using the Pipeline embolization device (PED) (Chestnut Medical Technologies, Inc., Menlo Park, CA) alone, without embolization coils. METHODSA 13-year-old female patient was referred for the treatment of a 4-cm, partially thrombosed, circumferential midbasilar trunk aneurysm. Her presenting symptoms included headache, nystagmus, and left upper-extremity ataxia. Open surgical and conventional endovascular treatment options were thought to be of unacceptably high risk and unlikely to achieve a definitive treatment. The patient underwent PED treatment under a Food and Drug Administration compassionate use exemption. RESULTSAn endovascular construct was built across the affected segment of the basilar trunk with 7 serially placed, telescoping PEDs, which bridged the 29-mm aneurysm neck. Completion angiography demonstrated considerably decreased flow into the aneurysm, with stasis persisting into the venous phase of angiography. No technical complications were encountered. No new neurological symptoms were evident, and the patients original presenting symptoms resolved completely within 24 hours after the procedure. She was discharged on postoperative Day 3. Computed tomography performed on postoperative Day 5 demonstrated no change in the size of the collective aneurysm-thrombus mass. Conventional angiography performed on postoperative Day 7 showed anatomic reconstruction of the basilar artery and complete occlusion of the circumferential aneurysm. The patient remains neurologically normal. CONCLUSIONThe PED provides a safe and definitive constructive treatment option for large, giant, and fusiform/circumferential aneurysms. The PED can achieve complete aneurysm occlusion without embolization coils. When applied judiciously, the PED may be used safely in vascular segments that give rise to eloquent perforators.

Stent-Supported Aneurysm Coiling: A Literature Survey of Treatment and Follow-Up

BACKGROUND AND PURPOSE: Stent-supported aneurysm coiling has been utilized with increasing frequency over the past few years, particularly for addressing treatment of complex and wide-neck aneurysms. A sizable body of literature describing various experiences with stent-supported coiling now exists. The purpose of this research was to carry out a comprehensive literature survey of stent-supported aneurysm coiling. MATERIALS AND METHODS: A survey of papers reporting results with stent-assisted aneurysm coiling through January 2011 was conducted to identify the prevalence of stent-related and other complications, occlusion rates, and clinical and angiographic follow-up data. RESULTS: Thirty-nine articles with 1517 patients met inclusion criteria for initial analysis, follow-up analysis, or both. Overall, 9% of cases were confounded by a technical stent-related issue, including 4% failure of deployment. The overall procedure complication rate was 19%, with periprocedural mortality of 2.1%. Approximately 45% of aneurysms were completely occluded at first treatment session, increasing to 61% on follow-up. Approximately 3.5% in-stent stenosis and 0.6% stent occlusion were observed at angiographic follow-up. Delayed stroke or transient ischemic attack was reported in 3% of subjects. Within a subset of articles, the incidence of stent-related issues in the first 10 patients was significantly higher than in subsequent subjects, supporting the notion of a procedural “learning curve.” CONCLUSIONS: In experienced hands, the morbidity of stent-supported coiling is somewhat higher compared with “traditional” coiling. As might be expected, execution of the procedure appears improved with experience. Complete occlusion rates remain somewhat low. More and longer term angiographic follow-up information is needed to understand delayed stent-related issues and to better define the durability of treatment.

Curative cerebrovascular reconstruction with the Pipeline embolization device: the emergence of definitive endovascular therapy for intracranial aneurysms

Endovascular, endosaccular, coil embolization has emerged as an established therapy for both ruptured and unruptured cerebral aneurysms. However, many aneurysms are not cured using conventional endovascular techniques. Coil embolization often results in incomplete aneurysm occlusion or recanalization in the ensuing months after treatment. The Pipeline embolization device (PED; Chestnut Medical) represents a new generation endoluminal implant which is designed to treat aneurysms by reconstructing the diseased parent artery. Immediately after implantation, the PED functions to divert flow from the aneurysm, creating an environment conducive to thrombosis. With time, the PED is incorporated into the vessel wall as neointimal–endothelial overgrowth occurs along the construct. Ultimately, this process results in the durable complete exclusion of the aneurysm from the cerebrovasculature and a definitive endoluminal reconstruction of the diseased parent artery.

Very late thrombosis of a pipeline embolization device construct: Case report

BACKGROUND The Pipeline embolization device (PED) is a new endoluminal construct designed to exclude aneurysms from the parent cerebrovasculature. We report the very late (>1 year) thrombosis of a PED construct placed for the treatment of a left vertebral aneurysm. CLINICAL PRESENTATION A patient with an occluded right vertebral artery and a large, fusiform intracranial left vertebral artery aneurysm was treated with PED and coil reconstruction. A durable, complete occlusion of the aneurysm was confirmed with control angiography at 1 year. The patient remained neurologically normal for 23 months until he experienced a transient visual disturbance followed weeks later by a minor brainstem stroke. INTERVENTION Imaging evaluation showed thrombosis of the PED construct with complete occlusion of the left vertebral artery. After this stroke, he was initially treated with dual antiplatelet therapy and was then converted to warfarin. The patient remained neurologically stable for 5 months until he experienced progressive basilar thrombosis that ultimately resulted in a fatal stroke. CONCLUSION The PED represents a promising new endovascular technology for the treatment of cerebral aneurysms; however, as an investigational device, long-term follow-up data are sparse at this point. The etiology of the very late thrombosis of the PED construct in this case remains unknown; however, this report underscores the need for a continued, careful systematic evaluation and close long-term follow-up of treated patients.

Degree of handedness and cerebral dominance

Objective: To examine the relationship between the degree of handedness and hemispheric language dominance in patients with epilepsy. Methods: The authors examined the relationship between degree of handedness and hemispheric language dominance in 174 epilepsy surgery candidates using the intracarotid amobarbital procedure and results from a modified version of the Edinburgh Handedness Inventory. Results: The incidence of atypical language dominance increased linearly with the degree of left-handedness, from 9% in strong right-handers (laterality quotient [LQ] = +100) to 46% in ambidextrous individuals and 69% in strong left-handers (LQ = −100). Conclusions: The incidence of atypical language dominance depends not only on the direction but also on the degree of handedness. In addition, direction of language dominance varies with hemisphere of seizure focus and degree of handedness. A familial history of sinistrality may have an additional effect on the likelihood of atypical dominance.