Babu G. Welch

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.

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.

Long-term results of enterprise stent-assisted coiling of cerebral aneurysms.

BACKGROUND The Enterprise Vascular Reconstruction Device and Delivery System (Cordis; the Enterprise stent) was approved for use in conjunction with coiling of wide-necked aneurysms in 2007. No published long-term aneurysm occlusion or complication data exist for the Enterprise system. OBJECTIVE We compiled data on consecutive patients treated with Enterprise stent-assisted coiling of aneurysms from 9 high-volume neurointerventional centers. METHODS A 9 center registry was created to evaluate large volume data on the delayed safety and efficacy of the Enterprise stent system. Pooled data were compiled for consecutive patients undergoing Enterprise stent-assisted coiling at each institution prior to May 2009. RESULTS Two-hundred twenty-nine patients with 229 aneurysms, 32 of which were ruptured aneurysms, were included in the study. Mean clinical and angiographic follow-up was 619.6 ± 26.4 days and 655.7 ± 25.2 days, respectively. Mean aneurysm size was 9.2 ± 0.4 mm. Fifty-nine percent of patients demonstrated 100% coil obliteration and 81% had 90% or higher occlusion at last follow-up angiography. A total of 19 patients (8.3%) underwent retreatment of their aneurysms during the follow-up period. Angiographic in-stent stenosis was seen in 3.4% and thromboembolic events occurred in 4.4%. Overall, 90% of patients who underwent Enterprise-assisted coiling had a modified Rankin Scale score of 2 or less at last follow-up. A poor modified Rankin Scale score was strongly associated with rupture status (P < .001). CONCLUSION Although this study is limited by its retrospective nature, the Enterprise stent system appears to be an effective, safe, and durable treatment for intracranial aneurysms when used in conjunction with coiling.

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.

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.

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.

Clipping of very large or giant unruptured intracranial aneurysms in the anterior circulation: An outcome study - Clinical article

OBJECT Patients with very large or giant unruptured intracranial aneurysms present with ischemic stroke and progressive disability. The aneurysm rupture risk in these patients is extreme-up to 50% in 5 years. In this study the authors investigated the outcome of surgical treatment for these very large aneurysms in the anterior circulation. METHODS Clinical data on 62 patients who underwent surgery for unruptured aneurysms (20-60 mm) between 1998 and 2006 were reviewed. RESULTS Complete aneurysm occlusion (100%) was achieved in 90% of cases, near complete occlusion (90-99%) in 5%. The surgical risk in patients younger than 50 years of age was 8% (Glasgow Outcome Scale score of 1 or 3 within 1 year after surgery). In older patients, the risk increased with advancing age. CONCLUSIONS The treatment of very large or giant unruptured intracranial aneurysms is hazardous and complex and thus best performed only at major cerebrovascular centers with an experienced team of neurosurgeons, interventional neuroradiologists, neurologists, and neuroanesthesiologists. Surgery, with acceptable risks and excellent occlusion rates, is typically the treatment of choice in patients younger than 50 years of age. In older patients, the benefits of endovascular treatment versus surgery versus no treatment must be carefully weighed individually. Minimizing temporary occlusion and the consequent use of intraoperative angiography may help reduce surgical complications.

Stent/coil treatment of very large and giant unruptured ophthalmic and cavernous aneurysms.

BACKGROUND Treatment of VLGUIA remains a challenge. To reduce mass effect and achieve complete occlusion, open surgery has been our favored treatment. However, endovascular therapy is preferred for lesions in the cavernous sinus or for older patients with complicating medical problems. The goal of this study is to investigate outcome of stent and/or coil treatment of VLGUIA. METHODS Beginning in 2002, the neuroform stent has been available to the University of Texas Southwestern Medical Center in Dallas. Since then until 2006, 15 patients were treated for VLGUIA with stenting and/or coiling at this institution. These 15 patients were used for a retrospective analysis in this study. RESULTS Median patient age was 65 years, median aneurysm size was 27 mm (20-37 mm), and median follow-up time was 22 months. Eight aneurysms were localized in the cavernous sinus and 7 at the ophthalmic segment of the internal carotid artery. Four aneurysms were completely occluded (100%); 3 aneurysms, nearly complete (90%-99%); and 8 aneurysms, partial (<90% occlusion). Twelve patients required retreatment. Final GOS was 1 (good recovery) in 11 patients, 2 (moderate disability) in 3 patients, and 3 (severely disabled) in 1 patient. No patient died or deteriorated. CONCLUSIONS Stent/coil management of VLGUIA is constantly evolving. Current treatment results are promising, with very low morbidity/mortality. Disadvantage is the frequent persistence of residual aneurysm.

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.