David B. Niemann

US Multicenter Experience With the Wingspan Stent System for the Treatment of Intracranial Atheromatous Disease: Periprocedural Results

Background and Purpose— The current report details our initial periprocedural experience with Wingspan (Boston Scientific/Target), the first self-expanding stent system designed for the treatment of intracranial atheromatous disease. Methods— All patients undergoing angioplasty and stenting with the Gateway balloon–Wingspan stent system were prospectively tracked. Results— During a 9-month period, treatment with the stent system was attempted in 78 patients (average age, 63.6 years; 33 women) with 82 intracranial atheromatous lesions, of which 54 were ≥70% stenotic. Eighty-one of 82 lesions were successfully stented (98.8%) during the first treatment session. In 1 case, the stent could not be delivered across the lesion; the patient was treated solely with angioplasty and stented at a later date. Lesions treated involved the internal carotid (n=32; 8 petrous, 10 cavernous, 11 supraclinoid segment, 3 terminus), vertebral (n=14; V4 segment), basilar (n=14), and middle cerebral (n=22) arteries. Mean±SD pretreatment stenosis was 74.6±13.9%, improving to 43.5±18.1% after balloon angioplasty and to 27.2±16.7% after stent placement. Of the 82 lesions treated, there were 5 (6.1%) major periprocedural neurological complications, 4 of which ultimately led to patient death within 30 days of the procedure. Conclusions— Angioplasty and stenting for symptomatic intracranial atheromatous disease can be performed with the Gateway balloon–Wingspan stent system with a high rate of technical success and acceptable periprocedural morbidity. Our initial experience indicates that this procedure represents a viable treatment option for this patient population.

Wingspan in-stent restenosis and thrombosis: Incidence, clinical presentation, and management

OBJECTIVE: Wingspan (Boston Scientific, Fremont, CA) is a self-expanding stent designed specifically for the treatment of symptomatic intracranial atheromatous disease. The current series reports the observed incidence of in-stent restenosis (ISR) and thrombosis on angiographic follow-up. METHODS: A prospective, intent-to-treat registry of patients in whom the Wingspan stent system was used to treat symptomatic intracranial atheromatous disease was maintained at five participating institutions. Clinical and angiographic follow-up results were recorded. ISR was defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20%. RESULTS: To date, follow-up imaging (average duration, 5.9 mo; range, 1.5-15.5 mo) is available for 84 lesions treated with the Wingspan stent (78 patients). Follow-up examinations consisted of 65 conventional angiograms, 17 computed tomographic angiograms, and two magnetic resonance angiograms. Of these lesions with follow-up, ISR was documented in 25 and complete thrombosis in four. Two of the 4 patients with stent thrombosis had lengthy lesions requiring more than one stent to bridge the diseased segment. ISR was more frequent (odds ratio, 4.7; 95% confidence intervals, 1.4-15.5) within the anterior circulation (42%) than the posterior circulation (13%). Of the 29 patients with ISR or thrombosis, eight were symptomatic (four with stroke, four with transient ischemic attack) and 15 were retreated. Of the retreatments, four were complicated by clinically silent in-stent dissections, two of which required the placement of a second stent. One was complicated by a postprocedural reperfusion hemorrhage. CONCLUSION: The ISR rate with the Wingspan stent is higher in our series than previously reported, occurring in 29.7% of patients. ISR was more frequent within the anterior circulation than the posterior circulation. Although typically asymptomatic (76% of patients in our series), ISR can cause neurological symptoms and may require target vessel revascularization.OBJECTIVEWingspan (Boston Scientific, Fremont, CA) is a self-expanding stent designed specifically for the treatment of symptomatic intracranial atheromatous disease. The current series reports the observed incidence of in-stent restenosis (ISR) and thrombosis on angiographic follow-up. METHODSA prospective, intent-to-treat registry of patients in whom the Wingspan stent system was used to treat symptomatic intracranial atheromatous disease was maintained at five participating institutions. Clinical and angiographic follow-up results were recorded. ISR was defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20%. RESULTSTo date, follow-up imaging (average duration, 5.9 mo; range, 1.5–15.5 mo) is available for 84 lesions treated with the Wingspan stent (78 patients). Follow-up examinations consisted of 65 conventional angiograms, 17 computed tomographic angiograms, and two magnetic resonance angiograms. Of these lesions with follow-up, ISR was documented in 25 and complete thrombosis in four. Two of the 4 patients with stent thrombosis had lengthy lesions requiring more than one stent to bridge the diseased segment. ISR was more frequent (odds ratio, 4.7; 95% confidence intervals, 1.4–15.5) within the anterior circulation (42%) than the posterior circulation (13%). Of the 29 patients with ISR or thrombosis, eight were symptomatic (four with stroke, four with transient ischemic attack) and 15 were retreated. Of the retreatments, four were complicated by clinically silent in-stent dissections, two of which required the placement of a second stent. One was complicated by a postprocedural reperfusion hemorrhage. CONCLUSIONThe ISR rate with the Wingspan stent is higher in our series than previously reported, occurring in 29.7% of patients. ISR was more frequent within the anterior circulation than the posterior circulation. Although typically asymptomatic (76% of patients in our series), ISR can cause neurological symptoms and may require target vessel revascularization.

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) and older (>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.

Angiographic patterns of Wingspan in-stent restenosis.

OBJECTIVE A classification system developed to characterize in-stent restenosis (ISR) after coronary percutaneous transluminal angioplasty with stenting was modified and applied to describe the appearance and distribution of ISR occurring after Wingspan (Boston Scientific, Fremont, CA) intracranial percutaneous transluminal angioplasty with stenting. METHODS A prospective, intention-to-treat, multicenter registry of Wingspan treatment for symptomatic intracranial atherosclerotic disease was maintained. Clinical and angiographic follow-up results were recorded. ISR was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted stent(s) and greater than 20% absolute luminal loss. ISR lesions were classified by angiographic pattern, location, and severity in comparison with the original lesion treated. RESULTS Imaging follow-up (3-15.5 months) was available for 127 intracranial stenotic lesions treated with Wingspan percutaneous transluminal angioplasty with stenting. Forty-one lesions (32.3%) developed either ISR (n = 36 [28.3%]) or complete stent occlusion (n = 5 [3.9%]) after treatment. When restenotic lesions were characterized using the modified classification system, 25 of 41 (61.0%) were focal lesions involving less than 50% of the length of the stented segment: three were Type IA (focal stenosis involving one end of the stent), 21 were Type IB (focal intrastent stenosis involving a segment completely contained within the stent), and one was Type IC (multiple noncontiguous focal stenoses). Eleven lesions (26.8%) demonstrated diffuse stenosis (>50% of the length of the stented segment): nine were Type II with diffuse intrastent stenosis (completely contained within the stent) and two were Type III with proliferative ISR (extending beyond the stented segment). Five stents were completely occluded at follow-up (Type IV). Of the 36 ISR lesions, 16 were less severe or no worse than the original lesion with respect to severity of stenosis or length of the segment involved; 20 lesions were more severe than the original lesion with respect to the segment length involved (n = 5), actual stenosis severity (n = 6), or both (n = 9). Nine of 10 supraclinoid internal carotid artery ISR lesions and nine of 13 middle cerebral artery ISR lesions were more severe than the original lesion. CONCLUSION Wingspan ISR typically occurs as a focal lesion. In more than half of ISR cases, the ISR lesion was more extensive than the original lesion treated in terms of lesion length or stenosis severity. Supraclinoid internal carotid artery and middle cerebral artery lesions have a propensity to develop more severe posttreatment stenosis.

Parametric Color Coding of Digital Subtraction Angiography

BACKGROUND AND PURPOSE: Color has been shown to facilitate both visual search and recognition tasks. It was our purpose to examine the impact of a color-coding algorithm on the interpretation of 2D-DSA acquisitions by experienced and inexperienced observers. MATERIALS AND METHODS: Twenty-six 2D-DSA acquisitions obtained as part of routine clinical care from subjects with a variety of cerebrovascular disease processes were selected from an internal data base so as to include a variety of disease states (aneurysms, AVMs, fistulas, stenosis, occlusions, dissections, and tumors). Three experienced and 3 less experienced observers were each shown the acquisitions on a prerelease version of a commercially available double-monitor workstation (XWP, Siemens Healthcare). Acquisitions were presented first as a subtracted image series and then as a single composite color-coded image of the entire acquisition. Observers were then asked a series of questions designed to assess the value of the color-coded images for the following purposes: 1) to enhance their ability to make a diagnosis, 2) to have confidence in their diagnosis, 3) to plan a treatment, and 4) to judge the effect of a treatment. The results were analyzed by using 1-sample Wilcoxon tests. RESULTS: Color-coded images enhanced the ease of evaluating treatment success in >40% of cases (P < .0001). They also had a statistically significant impact on treatment planning, making planning easier in >20% of the cases (P = .0069). In >20% of the examples, color-coding made diagnosis and treatment planning easier for all readers (P < .0001). Color-coding also increased the confidence of diagnosis compared with the use of DSA alone (P = .056). The impact of this was greater for the naïve readers than for the expert readers. CONCLUSIONS: At no additional cost in x-ray dose or contrast medium, color-coding of DSA enhanced the conspicuity of findings on DSA images. It was particularly useful in situations in which there was a complex flow pattern and in evaluation of pre- and posttreatment acquisitions. Its full potential remains to be defined.

Surgical treatment of blood blister-like aneurysms of the supraclinoid internal carotid artery with extracranial-intracranial bypass and trapping

OBJECT Blood blister-like aneurysms (BBAs) arise from the supraclinoid internal carotid artery (ICA) at non-branching sites. These aneurysms are challenging to treat primarily with either surgical clip placement or endovascular therapy. The authors describe a series of 4 patients who presented with high-grade subarachnoid hemorrhage (SAH) due to a BBA, which was treated with an extracranial-intracranial (EC-IC) bypass followed by trapping of the aneurysm. METHODS Four patients presented with SAH due to a BBA of the ICA. Three of these patients were treated with an endovascular procedure; following the vasospasm period, definitive treatment with EC-IC bypass followed by trapping of the aneurysmal parent vessel was performed. RESULTS Two of the patients who were treated endovascularly suffered rebleeding prior to bypass and trapping. Three of the 4 patients had a good outcome (modified Rankin Scale Score 1 or 2), and 1 patient who suffered 2 episodes of rebleeding died. CONCLUSIONS Treatment of BBAs of the ICA remains difficult, particularly in the setting of high-grade SAH. Patients with this challenging condition often require multiple procedures and have a high incidence of rebleeding. Definitive treatment of these aneurysms consists of EC-IC bypass and surgical or endovascular trapping.

Target Lesion Revascularization After Wingspan Assessment of Safety and Durability

Background and Purpose— In-stent restenosis (ISR) occurs in approximately one-third of patients after the percutaneous transluminal angioplasty and stenting of intracranial atherosclerotic lesions with the Wingspan system. We review our experience with target lesion revascularization (TLR) for ISR after Wingspan treatment. Methods— Clinical and angiographic follow-up results were recorded for all patients from 5 participating institutions in our US Wingspan Registry. ISR was defined as >50% stenosis within or immediately adjacent (within 5 mm) to the implanted stent and >20% absolute luminal loss. Results— To date, 36 patients in the registry have experienced ISR after percutaneous transluminal angioplasty and stenting with Wingspan. Of these patients, 29 (80.6%) have undergone TLR with either angioplasty alone (n=26) or angioplasty with restenting (n=3). Restenting was performed for in-stent dissections that occurred after the initial angioplasty. Of the 29 patients undergoing TLR, 9 required ≥1 interventions for recurrent ISR, for a total of 42 interventions. One major complication, a postprocedural reperfusion hemorrhage, was encountered in the periprocedural period (2.4% per procedure; 3.5% per patient). Angiographic follow-up is available for 22 of 29 patients after TLR. Eleven of 22 (50%) demonstrated recurrent ISR at follow-up angiography. Nine patients have undergone multiple retreatments (2 retreatments, n=6; 3 retreatments, n=2; 4 retreatments, n=1) for recurrent ISR. Nine of 11 recurrent ISR lesions were located within the anterior circulation. The mean age for patients with recurrent anterior circulation ISR was 57.9 years (vs 81 years for posterior circulation ISR). Conclusions— TLR can be performed for the treatment of intracranial Wingspan ISR with a relatively high degree of safety. However, the TLR results are not durable in ≈50% of patients, and multiple revascularization procedures may be required in this subgroup.

CT-determined intracranial volume for a normal population.

Intracranial volume comparisons of patients with craniosynostosis and normal have been contrary to expectations, leading to questioning of the validity of the current normal reference material. Computed tomography-determined intracranial volume is presented for a white normal population. Specifically, intracranial volumes for 157 subjects (82 female and 75 male) were measured from computed tomography data using the Cavalieri estimator: volume determination was based on measuring the area in each computed tomography section. Monomolecular and Gompertz models were applied to find curves of best fit to the intracranial volume as a function of the age. The best fit was obtained using the monomolecular model when the response variable was the logarithmically transformed intracranial volume, and the independent variable was the logarithm of the age from conception. For example, the mean (standard deviation) for male subjects at 1 year and 20 years were 1,125.6 (89.6) ml and 1,472.9 (117.2) ml, respectively, and for female subjects 1,024.9 (84.0) ml and 1,321.7 (108.3) ml, respectively. Although the shape and rate of increase of the female and male curves is similar, the female mean is 1.3 standard deviations below the male mean at 20 years. These curves were compared with the commonly referenced curves of Blinkov (1941), Lichtenberg (1960), and Dekaban (1977). Our male curve is substantially higher than these curves in the age range 8 months to 4 years. Our female curve, however, is approximately 1 standard deviation below Lichtenbergs curve from birth to 7 months. There are then only minor differences between our female curve and Lichtenbergs curve until his curve crosses ours at 41 months, where they significantly diverge from approximately 4.5 years. Our curves indicate that 95% of the final intracranial volume has been attained by 42 months for girls and 46 months for boys.

US Wingspan Registry 12-Month Follow-Up Results

Background and Purpose— The purpose of this study is to present 12-month follow-up results for a series of patients undergoing percutaneous transluminal angioplasty and stenting with the Gateway-Wingspan stenting system (Boston Scientific) for the treatment of symptomatic intracranial atherostenosis. Methods— Clinical and angiographic follow-up results were recorded for patients from 5 participating institutions. Primary end points were stroke or death within 30 days of the stenting procedure or ipsilateral stroke after 30 days. Results— During a 21-month study period, 158 patients with 168 intracranial atherostenotic lesions (50% to 99%) were treated with the Gateway-Wingspan system. The average follow-up duration was 14.2 months with 143 patients having at least 3 months of clinical follow-up and 110 having at least 12 months. The cumulative rate of the primary end point was 15.7% for all patients and 13.9% for patients with high-grade (70% to 99%) stenosis. Of 13 ipsilateral strokes occurring after 30 days, 3 resulted in death. Of these strokes, 76.9% (10 of 13) occurred within the first 6 months of the stenting procedure and no events were recorded after 12 months. An additional 9 patients experienced ipsilateral transient ischemic attack after 30 days. Most postprocedural events (86%) could be attributed to interruption of antiplatelet medications (n=6), in-stent restenosis (n=12), or both (n=1). In 3 patients, the events were of uncertain etiology. Conclusions— After successful Wingspan percutaneous transluminal angioplasty and stenting, some patients continued to experience ipsilateral ischemic events. Most of these ischemic events occurred within 6 months of the procedure and were associated with the interruption of antiplatelet therapy or in-stent restenosis.

C-Arm CT Measurement of Cerebral Blood Volume: An Experimental Study in Canines

BACKGROUND AND PURPOSE: Cerebral blood volume (CBV) is an important parameter in estimating the viability of brain tissue following an ischemic event. We tested the hypothesis that C-arm CT measurements of CBV would correlate well with those made with perfusion CT (PCT). MATERIALS AND METHODS: CBV was measured in 12 canines by using PCT and C-arm CT. Two measurements with each technique were made on each animal; a different injection protocol was used for each of these techniques. PCT was performed by using a 64-section V-scanner. C-arm CT was performed by using a biplane Artis dBA system. PCT images were transferred to a commercially available workstation for postprocessing and analysis; C-arm CT images were transferred to a commercially available workstation for postprocessing and analysis by using prototype software. From each animal, 2 sections from each technique were selected for analysis. RESULTS: There was good agreement of both the color maps and absolute numbers between the 2 techniques. The maximum and mean deviations of values between the 2 techniques for the first 5 animals were 30.20% and 7.82%; for the second 7 animals, these values were 26.79% and 7.40%. The maximum and mean deviations between the 2 C-arm CT studies performed on the first 5 animals were 33.15% and 12.24%; for the second 7 animals, these values were 41.15% and 10.89%. CONCLUSIONS: In these healthy animals, measurement of CBV with C-arm CT compared well with measurements made with PCT.