Aquilla S Turk

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.

ADAPT FAST study: a direct aspiration first pass technique for acute stroke thrombectomy.

Background The development of new revascularization devices has improved recanalization rates and time, but not clinical outcomes. We report a prospectively collected clinical experience with a new technique utilizing a direct aspiration first pass technique with large bore aspiration catheter as the primary method for vessel recanalization. Methods 98 prospectively identified acute ischemic stroke patients with 100 occluded large cerebral vessels at six institutions were included in the study. The ADAPT technique was utilized in all patients. Procedural and clinical data were captured for analysis. Results The aspiration component of the ADAPT technique alone was successful in achieving Thrombolysis in Cerebral Infarction (TICI) 2b or 3 revascularization in 78% of cases. The additional use of stent retrievers improved the TICI 2b/3 revascularization rate to 95%. The average time from groin puncture to at least TICI 2b recanalization was 37 min. A 5MAX demonstrated similar success to a 5MAX ACE in achieving TICI 2b/3 revascularization alone (75% vs 82%, p=0.43). Patients presented with an admitting median National Institutes of Health Stroke Scale (NIHSS) score of 17.0 (12.0–21.0) and improved to a median NIHSS score at discharge of 7.3 (1.0–11.0). Ninety day functional outcomes were 40% (modified Rankin Scale (mRS) 0–2) and 20% (mRS 6). There were two procedural complications and no symptomatic intracerebral hemorrhages. Discussion The ADAPT technique is a fast, safe, simple, and effective method that has facilitated our approach to acute ischemic stroke thrombectomy by utilizing the latest generation of large bore aspiration catheters to achieve previously unparalleled angiographic outcomes.

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.

Initial clinical experience with the ADAPT technique: A direct aspiration first pass technique for stroke thrombectomy

Background The development of new revascularization devices has improved recanalization rates and time but not clinical outcomes. We report our initial results with a new technique utilizing a direct aspiration first pass technique with a large bore aspiration catheter as the primary method for vessel recanalization. Methods A retrospective evaluation of a prospectively captured database of 37 patients at six institutions was performed on patients where the ADAPT technique was utilized. The data represent the initial experience with this technique. Results The ADAPT technique alone was successful in 28 of 37 (75%) cases although six cases had large downstream emboli that required additional aspiration. Nine cases required the additional use of a stent retriever and one case required the addition of a Penumbra aspiration separator to achieve recanalization. The average time from groin puncture to at least Thrombolysis in Cerebral Ischemia (TICI) 2b recanalization was 28.1 min, and all cases were successfully revascularized. TICI 3 recanalization was achieved 65% of the time. On average, patients presented with an admitting National Institutes of Health Stroke Scale (NIHSS) score of 16.3 and improved to an NIHSS score of 4.2 by the time of hospital discharge. There was one procedural complication. Discussion This initial experience highlights the fact that the importance of the technique with which new stroke thrombectomy devices are used may be as crucial as the device itself. The ADAPT technique is a simple and effective approach to acute ischemic stroke thrombectomy. Utilizing the latest generation of large bore aspiration catheters in this fashion has allowed us to achieve excellent clinical and angiographic outcomes.

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.

Very Late Thrombosis of Flow-Diverting Constructs after the Treatment of Large Fusiform Posterior Circulation Aneurysms

BACKGROUND AND PURPOSE: The PED is a new endoluminal construct designed to exclude aneurysms from the parent cerebrovasculature. We report the very late (>1 year) thrombosis of PED constructs in 2 patients. RESULTS: Two patients with very large fusiform basilar trunk aneurysms underwent parent artery reconstruction with the PED. Both patients were maintained on dual antiplatelet therapy throughout the first year following treatment. Follow-up conventional angiography, performed 12 months after treatment, demonstrated, in both patients, thrombosis of most of the aneurysm with minimal residual flow through the construct and into the aneurysm fundus. In response to the residual filling, clopidogrel was discontinued (aspirin therapy was maintained). Both patients presented with symptomatic acute occlusions of the PED constructs within 14 days of clopidogrel discontinuation. DISCUSSION: Patient 1 presented with constitutional symptoms that progressed to severe headache without other neurologic signs or symptoms. Occlusion of the PED construct was confirmed with conventional angiography. MR imaging demonstrated no evidence of infarction or parenchymal injury. The headaches were managed successfully with steroid therapy. Patient 2 presented with a syndrome of acute basilar occlusion with brain stem stroke. Complete occlusion was confirmed on angiography. Emergent thrombolysis with mechanical revascularization was performed successfully; however, the patient ultimately succumbed to the infarction. CONCLUSIONS: It appears that flow-diverting constructs built across large circumferential aneurysms may remain thrombogenic for much longer than conventional intracranial or peripheral bare metal stents. Constructs in these patients may remain susceptible to very late thrombosis, >1 year after implantation. These patients likely require long-term dual antiplatelet therapy (>1 year) to provide adequate prophylaxis against thrombosis. If these types of aneurysms demonstrate persistent residual filling months after PED reconstruction, operators should consider the placement of additional devices as an alternative to the discontinuation of 1 of the antiplatelet medications.

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.

Distal aspiration with retrievable stent assisted thrombectomy for the treatment of acute ischemic stroke

Objective Flexible large lumen aspiration catheters and stent retrievers have recently become available in the USA for the revascularization of large vessel occlusions presenting within the context of acute ischemic stroke (AIS). We describe a multicenter experience using a combined aspiration and stent retrieval technique for thrombectomy. Design A retrospective analysis to identify patients receiving combined manual aspiration and stent retrieval for treatment of AIS between August 2012 and April 2013 at six high volume stroke centers was conducted. Outcome variables, including recanalization rate, post-treatment National Institutes of Health Stroke Scale (NIHSS) score, symptomatic intracranial hemorrhage, discharge 90 day modified Rankin Scale (mRS) score, and mortality were evaluated. Results 105 patients were found that met the inclusion criteria for this retrospective study. Successful recanalization (Thrombolysis in Cerebral Infarction score 2B) was achieved in 92 (88%) of these patients. 44% of patients had favorable (mRS score 0–2) outcomes at 90 days. There were five (4.8%) symptomatic intracerebral hemorrhages and three procedure related deaths (2.9%). Conclusions Mechanical thrombectomy utilizing combined manual aspiration with a stent retriever is an effective and safe strategy for endovascular recanalization of large vessel occlusions presenting within the context of AIS.

Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial

This prospective, randomized, multicenter study compares the efficacy of the Matrix versus bare metal coils. A group of 626 patients were divided between the 2 coil types and aneurysm recurrence and hemorrhage were assessed 1 year after procedures. Recurrences were associated with initial incomplete obliterations and the bare metal coils were not inferior to Matrix coils. Thus, due to cost differences, utilization of Matrix coils may not be justified. BACKGROUND AND PURPOSE: The ability of polymer-modified coils to promote stable aneurysm occlusion after endovascular treatment is not well-documented. Angiographic aneurysm recurrence is widely used as a surrogate for treatment failure, but studies documenting the correlation of angiographic recurrence with clinical failure are limited. This trial compares the effectiveness of Matrix2 polyglycolic/polylactic acid biopolymer–modified coils with bare metal coils and correlates the angiographic findings with clinical failure (ie, target aneurysm recurrence), a composite end point that includes any incident of posttreatment aneurysm rupture, retreatment, or unexplained death. MATERIALS AND METHODS: This was a multicenter randomized noninferiority trial with blinded end point adjudication. We enrolled 626 patients, divided between Matrix2 and bare metal coil groups. The primary outcome was target aneurysm recurrence at 12 ± 3 months. RESULTS: At 455 days, at least 1 target aneurysm recurrence event had occurred in 14.6% of patients treated with bare metal coils and 13.3% of Matrix2 (P = .76, log-rank test) patients; 92.8% of target aneurysm recurrence events were re-interventions for aneurysms that had not bled after treatment, and 5.8% of target aneurysm recurrence events resulted from hemorrhage or rehemorrhage, with or without retreatment. Symptomatic re-intervention occurred in only 4 (0.6%) patients. At 455 days, 95.8% of patients with unruptured aneurysms and 90.4% of those with ruptured aneurysms were independent (mRS ≤ 2). Target aneurysm recurrence was associated with incomplete initial angiographic aneurysm obliteration, presentation with rupture, and a larger aneurysmal dome and neck size. CONCLUSIONS: Tested Matrix2 coils were not inferior to bare metal coils. Endovascular coiling of intracranial aneurysms was safe, and the rate of technical success was high. Target aneurysm recurrence is a promising clinical outcome measure that correlates well with established angiographic measurements.