Travis M. Dumont

Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: A US multicenter experience

BACKGROUND The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment. OBJECTIVE To report early postmarket results with the PED. METHODS This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications. RESULTS Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty. CONCLUSION Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.

National trends in carotid artery revascularization surgery

OBJECT Several randomized trials have emerged with conflicting data on the overall safety of carotid artery stenting (CAS) in comparison with carotid endarterectomy (CEA). The authors hypothesize that changes in national trends correspond to publication of randomized trials, including an increase in utilization of CAS after publication of trials favorable to CAS (for example, Carotid and Vertebral Artery Transluminal Angioplasty Study [CAVATAS] and Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy [SAPPHIRE]) and decrease in utilization of CAS after publication of trials favorable to CEA (for example, Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis [EVA3-S] and Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy [SPACE]). METHODS The Nationwide Inpatient Sample was obtained for the years 1998-2008. Individual cases were isolated for principal diagnosis of unilateral or bilateral carotid artery stenosis or occlusion undergoing CEA or CAS. The percentage of CAS for all carotid revascularization procedures was calculated for each year. Perioperative inpatient morbidity, including stroke or death, were calculated and compared. RESULTS The percentage of patients undergoing CAS increased yearly from the start of the observed period to the end, with the exception of a decrease in 2007. The peak utilization of CAS for carotid artery revascularization procedures was 15% of all cases in 2006. The stroke or death rate was consistent at 5% among all patients undergoing CEA for all years, while the incidence of stroke or death decreased among patients undergoing CAS from 9% in 1998 to 5% in 2008. CONCLUSIONS The practice of CAS in the US is expanding, from less than 3% of all carotid artery revascularization procedures to 13% in 2008. The utilization of CAS was seen to correlate with publication of randomized trials. Utilization nearly doubled in 2005 after publication of the CAS-favorable SAPPHIRE in 2004, and decreased by 22% after publication of the CEA-favorable EVA-3S and SPACE in 2007. With the publication of Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST), the authors predict a resultant increase in the rate of CAS for carotid artery disease in the upcoming years.

Intravenous Thrombolysis and Endovascular Therapy for Acute Ischemic Stroke With Internal Carotid Artery Occlusion: A Systematic Review of Clinical Outcomes

Background and Purpose— Strokes secondary to acute internal carotid artery (ICA) occlusion are associated with extremely poor prognosis. The best treatment approach to acute stroke in this setting is unknown. We sought to determine clinical outcomes in patients with acute ischemic stroke attributable to ICA occlusion treated with intravenous (IV) systemic thrombolysis or intra-arterial endovascular therapy. Methods— Using the PubMed database, we searched for studies that included patients with acute ischemic stroke attributable to ICA occlusion who received treatment with IV thrombolysis or intra-arterial endovascular interventions. Studies providing data on functional outcomes beyond 30 days and mortality and symptomatic intracerebral hemorrhage (sICH) rates were included in our analysis. We compared the proportions of patients with favorable functional outcomes, sICH, and mortality rates in the 2 treatment groups by calculating &khgr;2 and confidence intervals for odds ratios. Results— We identified 28 studies with 385 patients in the IV thrombolysis group and 584 in the endovascular group. Rates of favorable outcomes and sICH were significantly higher in the endovascular group than the IV thrombolysis-only group (33.6% vs 24.9%, P=0.004 and 11.1% vs 4.9%, P=0.001, respectively). No significant difference in mortality rate was found between the groups (27.3% in the IV thrombolysis group vs 32.0% in the endovascular group; P=0.12). Conclusions— According to our systematic review, endovascular treatment of acute ICA occlusion results in improved clinical outcomes. A higher rate of sICH after endovascular treatment does not result in increased overall mortality rate.

Inappropriate Prehospital Ventilation in Severe Traumatic Brain Injury Increases In-Hospital Mortality

In the setting of acute brainstem herniation in traumatic brain injury (TBI), the use of hyperventilation to reduce intracranial pressure may be life-saving. However, undue use of hyperventilation is thought to increase the incidence of secondary brain injury through direct reduction of cerebral blood flow. This is a retrospective review determining the effect of prehospital hyperventilation on in-hospital mortality following severe TBI. All trauma patients admitted directly to a single level 1 trauma center from January 2000 to January 2007 with an initial Glasgow Coma Scale (GCS) score <or=8 were included in the study (n = 77). Patients without documented or with late (>20 min) arterial blood gas at presentation (n = 12) were excluded from the study. The remaining population (n = 65) was sorted into three groups based on the initial partial pressure of carbon dioxide: hypocarbic (Pco(2) < 35 mm Hg), normocarbic (Pco(2) 35-45 mm Hg), and hypercarbic (Pco(2) > 45 mm Hg). Outcome was based on mortality during hospital admission. Survival was found to be related to admission Pco(2) in head trauma patients requiring intubation (p = 0.045). Patients with normocarbia on presenting arterial blood gas testing had in-hospital mortality of 15%, significantly improved over patients presenting with hypocarbia (in-hospital mortality 77%) or hypercarbia (in-hospital mortality 61%). Although there are many reports of the negative impact of prophylactic hyperventilation following severe TBI, this modality is frequently utilized in the prehospital setting. Our results suggest that abnormal Pco(2) on presentation after severe head trauma is correlated with increased in-hospital mortality. We advocate normoventilation in the prehospital setting.

Feasibility and Safety of Pipeline Embolization Device in Patients With Ruptured Carotid Blister Aneurysms

BACKGROUND Treatment of internal carotid ruptured blister aneurysms (IC-RBA) presents many challenges to neurosurgeons because of the high propensity for rebleeding during intervention. The role of a Pipeline Embolization Device (PED) in the treatment of this challenging aneurysm subtype remains undefined despite theoretical advantages. OBJECTIVE To present a series of 11 patients treated with a PED and to discuss the management and results of this novel application of flow diverters. METHODS Medical records of patients who presented with IC-RBA from May 2011 to March 2013 were retrospectively reviewed at 6 institutions in the United States. All relevant data were independently compiled. RESULTS A total of 12 IC-RBAs in 11 patients were treated during the study period. Nine (75%) were treated with a single PED; 1 was treated with 2 PEDs; 1 was treated with coils and 1 PED; and 1 was treated with coils and 2 PEDs. Three (27%) had major perioperative complications: middle cerebral artery territory infarction, vision loss, and death. Seven patients demonstrated complete obliteration of the aneurysm in postoperative imaging. Early clinical outcomes were favorable (modified Rankin Scale score, 0-2) in all 10 survivors. CONCLUSION This study demonstrates the feasibility and safety of using the PED to treat IC-RBA with fair initial results. The proper introduction and management of antiplatelet regimen are key for successful results. Bleeding complications related to dual antiplatelet therapy were similar to those in previous studies of stent-assisted coiling for the same population. Larger cohort analysis is needed to define the precise role of flow diverters in the treatment of IC-RBA.

Solitaire flow restoration thrombectomy for acute ischemic stroke: Retrospective multicenter analysis of early postmarket experience after FDA approval

BACKGROUND The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led to Food and Drug Administration (FDA) approval of the Solitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. OBJECTIVE To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. METHODS We conducted a retrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. RESULTS A total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ≤2). Severity of NIHSS score on admission was a strong predictor of poor outcome. CONCLUSION Our study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States. Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

High fidelity virtual stenting (HiFiVS) for intracranial aneurysm flow diversion: in vitro and in silico.

A flow diverter (FD) is a flexible, densely braided stent-mesh device placed endoluminally across an intracranial aneurysm to induce its thrombotic occlusion. FD treatment planning using computational virtual stenting and flow simulation requires accurate representation of the expanded FD geometry. We have recently developed a high fidelity virtual stenting (HiFiVS) technique based on finite element analysis to simulate detailed FD deployment processes in patient-specific aneurysms (Ma et al.J. Biomech. 45:2256–2263, 2012). This study tests if HiFiVS simulation can recapitulate real-life FD implantation. We deployed two identical FDs (Pipeline Embolization Device) into phantoms of a wide-necked segmental aneurysm using a clinical push–pull technique with different delivery wire advancements. We then simulated these deployment processes using HiFiVS and compared results against experimental recording. Stepwise comparison shows that the simulations precisely reproduced the FD deployment processes recorded in vitro. The local metal coverage rate and pore density quantifications demonstrated that simulations reproduced detailed FD mesh geometry. These results provide validation of the HiFiVS technique, highlighting its unique capability of accurately representing stent intervention in silico.

Safety of microvascular decompression for trigeminal neuralgia in the elderly: Clinical article

OBJECT Microvascular decompression (MVD) offers an effective and durable treatment for patients suffering from trigeminal neuralgia (TN). Because the disorder has a tendency to occur in older persons, the risks of surgical treatment in the elderly have been a topic of recent interest. To date, evidence derived from several small retrospective and a single prospective case series has suggested that age does not increase the complication rate associated with surgery. Using a large national database, the authors aimed to study the impact of age on in-hospital complications following MVD for TN. METHODS Using the Nationwide Inpatient Sample (NIS) for the 10-year period from 1999 to 2008, the authors selected all patients who underwent MVD for TN. The primary outcome of interest was the in-hospital mortality rate. Secondary outcomes of interest were cardiac, pulmonary, thromboembolic, cerebrovascular, and wound complications as well as the duration of hospital stay, total hospital charges, and discharge location. An elderly cohort of patients was first defined as those 65 years of age and older and then redefined as those 75 years and older. RESULTS A total of 3273 patients who underwent MVD for TN were identified, having a median age of 57 years. Within this sample, 31.5% were 65 years and older and 10.7% were 75 years and older. The in-hospital mortality rate was 0.68% for patients 65 years or older (p = 0.0087) and 1.16% for those 75 years or older (p = 0.0026). In patients younger than 65 years, the in-hospital mortality rate was 0.13% (3 deaths among 2241 patients). As analyzed using the chi-square test (for both 65 and 75 years as the age cutoff) and the Pearson rank correlation coefficient, the risk of cardiac, pulmonary, thromboembolic, and cerebrovascular complications was higher in older patients (that is, those 65 and older and those 75 and older), but the risks of wound complications and CNS infection were not. The risk of any in-hospital complication occurring in a patient 65 years and older was 7.36% (p < 0.0001) and 10.0% in those 75 years and older (p < 0.0001). There was no difference in the total hospital charges associated with age. The duration of the hospital stay was longer in older patients, and the likelihood of discharge home was lower in older patients. CONCLUSIONS Microvascular decompression for TN in the elderly population remains a reasonable surgical option. However, based on data from a large national database, authors of the present study suggest that complications do tend to gradually increase in tandem with an advanced age. While age does not act as a risk factor in isolation, it may serve as a convenient surrogate for complication rates. The authors hope that this information can be of use in guiding older patients through decisions for the surgical treatment of TN.

Treatment of Distal Anterior Circulation Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience.

BACKGROUND Utilization of the Pipeline embolization device (PED) to treat distal carotid circulation aneurysms has not been well studied. OBJECTIVE To report the collective experience of using PED to treat distal anterior circulation aneurysms. METHODS We retrospectively reviewed clinical and radiographic records of all patients who underwent Pipeline embolization of distal anterior circulation aneurysms at 10 US neurosurgical centers between 2011 and 2013. RESULTS Twenty-eight patients (mean age 51.7 years; 18 women) with 28 aneurysms were included in the analyses. Fifteen aneurysms were fusiform, 5 dissecting, and 8 saccular. Average aneurysm size was 12.3 mm; 7 were giant. Twenty aneurysms were located along the middle cerebral artery, 6 along the anterior cerebral artery, and 2 along the anterior communicating artery. PED deployment was successful in 27 patients, with coils utilized in 6 cases. Clinical follow-up was available for an average of 10.7 months (range 3-26). Twenty-seven patients had follow-up neurovascular imaging: 21 aneurysms had complete occlusion, 4 had residual neck filling, and 2 had residual dome filling. Periprocedural complications (<30 days) occurred in 3 patients (10.7%), including 1 case of device failure resulting in stroke. Outcomes were good (modified Rankin Scale score 0 to 2) in 27 patients (96.4%) and fair (modified Rankin Scale 3) in 1. CONCLUSION PED can be utilized in the treatment of distal anterior circulation aneurysms with difficult anatomy for conventional surgical or endovascular techniques. Larger-scale studies with long-term follow-up are needed to further elucidate the durability of PED treatment and its effect on perforator-rich vascular segments. ABBREVIATIONS ACA, anterior cerebral arteryAcomA, anterior communicating arteryDSA, digital subtraction angiographyMCA, middle cerebral arterymRS, modified Rankin scalePED, Pipeline embolization device.

Endovascular treatment of acute ischemic stroke: the end or just the beginning?

Various endovascular intraarterial approaches are available for treating patients with acute ischemic stroke who present with severe neurological deficits. Three recent randomized trials-Interventional Management of Stroke (IMS) III, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE), and Synthesis Expansion: A Randomized Controlled Trial on Intra-Arterial Versus Intravenous Thrombolysis in Acute Ischemic Stroke (SYNTHESIS Expansion)-evaluated the efficacy of endovascular treatment of acute ischemic stroke and, after failing to demonstrate any significant clinical benefit of endovascular therapies, raised concerns and questions in the medical community regarding the future of endovascular treatment for acute ischemic stroke. In this paper, the authors review the evolution of endovascular treatment strategies for the treatment of acute stroke and provide their interpretation of findings and potential limitations of the three recently published randomized trials. The authors discuss the advantage of stent-retriever technology over earlier endovascular approaches and review the current status and future directions of endovascular acute stroke studies based on lessons learned from previous trials.