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  • 1
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    Safety and efficacy of balloon-mounted stent in the treatment of symptomatic intracranial atherosclerotic disease: a multicenter experience
    BMJ ; 2022
    In:  Journal of NeuroInterventional Surgery Vol. 14, No. 8 ( 2022-08), p. 756-761
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 14, No. 8 ( 2022-08), p. 756-761
    Abstract: Randomized clinical trials have failed to prove that the safety and efficacy of endovascular treatment for symptomatic intracranial atherosclerotic disease (ICAD) is better than that of medical management. A recent study using a self-expandable stent showed acceptable lower rates of periprocedural complications. Objective To study the safety and efficacy of a balloon-mounted stent (BMS) in the treatment of symptomatic ICAD. Methods Prospectively maintained databases from 15 neuroendovascular centers between 2010 and 2020 were reviewed. Patients were included if they had severe symptomatic intracranial stenosis in the target artery, medical management had failed, and they underwent intracranial stenting with BMS after 24 hours of the qualifying event. The primary outcome was the occurrence of stroke and mortality within 72 hours after the procedure. Secondary outcomes were the occurrence of stroke, transient ischemic attacks (TIAs), and mortality on long-term follow-up. Results A total of 232 patients were eligible for the analysis (mean age 62.8 years, 34.1% female). The intracranial stenotic lesions were located in the anterior circulation in 135 (58.2%) cases. Recurrent stroke was the qualifying event in 165 (71.1%) while recurrent TIA was identified in 67 (28.9%) cases. The median (IQR) time from the qualifying event to stenting was 5 (2–20.75) days. Strokes were reported in 13 (5.6%) patients within 72 hours of the procedure; 9 (3.9%) ischemic and 4 (1.7%) hemorrhagic, and mortality in 2 (0.9%) cases. Among 189 patients with median follow-up time 6 (3–14.5) months, 12 (6.3%) had TIA and 7 (3.7%) had strokes. Three patients (1.6%) died from causes not related to stroke. Conclusion Our study has shown that BMS may be a safe and effective treatment for medically refractory symptomatic ICAD. Additional prospective randomized clinical trials are warranted.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/neurintsurg-2021-017818
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 2
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    General anesthesia vs procedural sedation for failed NeuroThrombectomy undergoing rescue stenting: intention to treat analysis
    BMJ ; 2022
    In:  Journal of NeuroInterventional Surgery
    Details
    In: Journal of NeuroInterventional Surgery, BMJ
    Abstract: There is little data available to guide optimal anesthesia management during rescue intracranial angioplasty and stenting (ICAS) for failed mechanical thrombectomy (MT). We sought to compare the procedural safety and functional outcomes of patients undergoing rescue ICAS for failed MT under general anesthesia (GA) vs non-general anesthesia (non-GA). Methods We searched the data from the Stenting and Angioplasty In Neuro Thrombectomy (SAINT) study. In our review we included patients if they had anterior circulation large vessel occlusion strokes due to intracranial internal carotid artery (ICA) or middle cerebral artery (MCA-M1/M2) segments, failed MT, and underwent rescue ICAS. The cohort was divided into two groups: GA and non-GA. We used propensity score matching to balance the two groups. The primary outcome was the shift in the degree of disability as measured by the modified Rankin Scale (mRS) at 90 days. Secondary outcomes included functional independence (90-day mRS0-2) and successful reperfusion defined as mTICI2B-3. Safety measures included symptomatic intracranial hemorrhage (sICH) and 90-day mortality. Results Among 253 patients who underwent rescue ICAS, 156 qualified for the matching analysis at a 1:1 ratio. Baseline demographic and clinical characteristics were balanced between both groups. Non-GA patients had comparable outcomes to GA patients both in terms of the overall degree of disability (mRS ordinal shift; adjusted common odds ratio 1.29, 95% CI [0.69 to 2.43], P=0.43) and rates of functional independence (33.3% vs 28.6%, adjusted odds ratio 1.32, 95% CI [0.51 to 3.41] , P=0.56) at 90 days. Likewise, there were no significant differences in rates of successful reperfusion, sICH, procedural complications or 90-day mortality among both groups. Conclusions Non-GA seems to be a safe and effective anesthesia strategy for patients undergoing rescue ICAS after failed MT. Larger prospective studies are warranted for more concrete evidence.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/jnis-2022-019376
    Language: English
    Publisher: BMJ
    Publication Date: 2022
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  • 3
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    Abstract WP181: Treatment of Unruptured Small and Medium Wide-Necked Aneurysms of the Internal Carotid Artery Using the 64-Wire Surpass Evolve: Results of the SEASE International Registry
    Ovid Technologies (Wolters Kluwer Health) ; 2024
    In:  Stroke Vol. 55, No. Suppl_1 ( 2024-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 55, No. Suppl_1 ( 2024-02)
    Abstract: Introduction: The management of wide-necked internal carotid artery (ICA) aneurysms is technically challenging with established endovascular and microsurgical techniques that are limited by the associated morbidity and/or recurrence. The PREMIER study first demonstrated high rates of complete occlusion without parent vessel stenosis or permanent neurological complications after the treatment of wide-necked small and medium-sized intracranial ICA aneurysms with the 48-wire pipeline. We aimed to assess the effectiveness and safety of the new generation 64-wire Surpass Evolve (SE) flow diverter for the treatment of the same intracranial ICA aneurysm population. Methods: This is a sub-analysis from the Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) registry, an observational cohort study including 15 academic institutions in North America and Europe spanning between 2020-2023. Analysis included patients with unruptured wide-necked saccular aneurysms (not previously treated), measuring 〈 12 mm along the ICA segments. Primary effectiveness was complete occlusion (Raymond Roy Class 1) without retreatment at 1-year follow-up (core lab adjudicated), and primary safety was major stroke (ischemic/hemorrhagic) in the territory supplied by the target artery or death. Results: 129 cases were included (median age 58 years, IQR: 50-67 years, 85% females). Median aneurysm and neck size were 5.8 mm (IQR: 4.0-7.5) and 4.1 (IQR, 3.0-5.5). Most aneurysms were in the ICA C6 segment (66.7%, 86/129), followed by the C7 segment (21.0%, 21/129). Successful implantation was encountered in 99% (128/129) of the cases. At a median 10.1 months (IQR: 6.3-12.6), the rate of complete occlusion was 75.2% (91/121), ≥50% in-stent stenosis 7% (9/129), and retreatment 0.8% (1/129). Major stroke and overall mortality were reported in 1.6% (2/129) of the cases. Conclusion: Our study evaluating outcomes from the SEASE international multicenter registry found that patients with wide-necked unruptured saccular small to medium-sized aneurysms can be effectively treated with the 64-wire chrome-cobalt SE. Furthermore, the SE showed a considerable safety profile for this patient population.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.55.suppl_1.WP181
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
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  • 4
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    Rescue intracranial stenting for failed posterior circulation thrombectomy: analysis from the Stenting and Angioplasty in NeuroThrombectomy (SAINT) study
    BMJ ; 2023
    In:  Journal of NeuroInterventional Surgery
    Details
    In: Journal of NeuroInterventional Surgery, BMJ
    Abstract: Recent trials have shown improved outcomes after mechanical thrombectomy (MT) for vertebrobasilar occlusion (VBO) stroke. However, there is a paucity of data regarding safety and outcomes of rescue intracranial stenting (RS) after failed MT (FRRS+) for posterior circulation stroke. We sought to compare RS to failed reperfusion without RS (FRRS−). Methods This is a retrospective analysis of the Stenting and Angioplasty in NeuroThrombectomy (SAINT) study, a multicenter collaboration involving prospectively collected databases. Patients were included if they had posterior circulation stroke and failed MT. The cohort was divided into two groups: FRRS+ and FRRS− (defined as modified Thrombolysis In Cerebral Infarction (mTICI) score 0–2a). The primary outcome was a shift in the degree of disability as measured by the modified Rankin Scale (mRS) at 90 days. Secondary outcomes included mRS 0–2 and mRS 0–3 at 90 days. Safety measures included rates of symptomatic intracranial hemorrhage (sICH), procedural complications, and 90-day mortality. Sensitivity and subgroup analyses were performed to identify outcomes in a matched cohort and in those with VBO, respectively. Results A total of 152 failed thrombectomies were included in the analysis. FRRS+ (n=84) was associated with increased likelihood of lower disability (acOR 2.24, 95% CI 1.04 to 4.95, P=0.04), higher rates of mRS 0–2 (26.8% vs 12.5%, aOR 4.43, 95% CI 1.22 to 16.05, P=0.02) and mRS 0–3 (35.4% vs 18.8%, aOR 3.13, 95% CI 1.08 to 9.10, P=0.036), and lower mortality (42.7% vs 59.4%, aOR 0.40, 95% CI 0.17 to 0.97, P=0.04) at 90 days compared with FRRS− (n=68). The rates of sICH and procedural complications were comparable between the groups. Sensitivity and subgroup analyses showed similar results. Conclusion In patients with posterior circulation stroke who had failed MT, RS resulted in better functional outcomes with comparable safety profile to procedure termination.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/jnis-2023-020676
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 5
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    Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study
    BMJ ; 2024
    In:  Journal of NeuroInterventional Surgery
    Details
    In: Journal of NeuroInterventional Surgery, BMJ
    Abstract: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. Methods The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. Results In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0–2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4–9.0] mm, and the median neck width was 3.6 [2.7–5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4–12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. Conclusion These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/jnis-2024-021503
    Language: English
    Publisher: BMJ
    Publication Date: 2024
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  • 6
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    Stenting and Angioplasty in Neurothrombectomy: Matched Analysis of Rescue Intracranial Stenting Versus Failed Thrombectomy
    Ovid Technologies (Wolters Kluwer Health) ; 2022
    In:  Stroke Vol. 53, No. 9 ( 2022-09), p. 2779-2788
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 53, No. 9 ( 2022-09), p. 2779-2788
    Abstract: Successful reperfusion is one of the strongest predictors of functional outcomes after mechanical thrombectomy (MT). Despite continuous advancements in MT technology and techniques, reperfusion failure still occurs in ≈15% to 30% of patients with large vessel occlusion strokes undergoing MT. We aim to evaluate the safety and efficacy of rescue intracranial stenting for large vessel occlusion stroke after failed MT. Methods: The SAINT (Stenting and Angioplasty in Neurothrombectomy) Study is a retrospective analysis of prospectively collected data from 14 comprehensive stroke centers through January 2015 to December 2020. Patients were included if they had anterior circulation large vessel occlusion stroke due to intracranial internal carotid artery and middle cerebral artery-M1/M2 segments and failed MT. The cohort was divided into 2 groups: rescue intracranial stenting and failed recanalization (modified Thrombolysis in Cerebral Ischemia score 0–1). Propensity score matching was used to balance the 2 groups. The primary outcome was the shift in the degree of disability as measured by the modified Rankin Scale at 90 days. Secondary outcomes included functional independence (90-day modified Rankin Scale score 0–2). Safety measures included symptomatic intracranial hemorrhage and 90-day mortality. Results: A total of 499 patients were included in the analysis. Compared with the failed reperfusion group, rescue intracranial stenting had a favorable shift in the overall modified Rankin Scale score distribution (acOR, 2.31 [95% CI, 1.61–3.32]; P 〈 0.001), higher rates of functional independence (35.1% versus 7%; adjusted odds ratio [aOR], 6.33 [95% CI, 3.14–12.76] ; P 〈 0.001), and lower mortality (28% versus 46.5%; aOR, 0.55 [95% CI, 0.31–0.96]; P =0.04) at 90 days. Rates of symptomatic intracerebral hemorrhage were comparable across both groups (7.1% versus 10.2%; aOR, 0.99 [95% CI, 0.42–2.34]; P =0.98). The matched cohort analysis demonstrated similar results. Specifically, rescue intracranial stenting (n=107) had a favorable shift in the overall modified Rankin Scale score distribution (acOR, 3.74 [95% CI, 2.16–6.57]; P 〈 0.001), higher rates of functional independence (34.6% versus 6.5%; aOR, 10.91 [95% CI, 4.11–28.92]; P 〈 0.001), and lower mortality (29.9% versus 43%; aOR, 0.49 [95% CI, 0.25–0.94] ; P =0.03) at 90 days with similar rates of symptomatic intracerebral hemorrhage (7.5% versus 11.2%; aOR, 0.87 [95% CI, 0.31–2.42]; P =0.79) compared with patients who failed to reperfuse (n=107). There was no heterogeneity of treatment effect across the prespecified subgroups for improvement in functional outcomes. Conclusions: Acute intracranial stenting appears to be a safe and effective rescue strategy in patients with large vessel occlusion stroke who failed MT. Randomized multicenter trials are warranted.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.121.038248
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2022
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  • 7
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    Triple therapy versus dual-antiplatelet therapy for dolichoectatic vertebrobasilar fusiform aneurysms treated with flow diverters
    BMJ ; 2023
    In:  Journal of NeuroInterventional Surgery Vol. 15, No. 7 ( 2023-07), p. 655-663
    Details
    In: Journal of NeuroInterventional Surgery, BMJ, Vol. 15, No. 7 ( 2023-07), p. 655-663
    Abstract: Dolichoectatic vertebrobasilar fusiform aneurysms (DVBFAs) have poor natural history when left untreated and high morbimortality when treated with microsurgery. Flow diversion (FD) with dual-antiplatelet therapy (DAPT) is feasible but carries high risk of perforator occlusion and progression of brainstem compression. Elaborate antithrombotic strategies are needed to preserve perforator patency while vessel remodeling occurs. We compared triple therapy (TT (DAPT plus oral anticoagulation)) and DAPT alone in patients with DVBFAs treated with FD. Methods Retrospective comparison of DAPT and TT in patients with DVBFAs treated with FD at eight US centers. Results The groups (DAPT=13, TT=14) were similar in age, sex, clinical presentation, baseline disability, and aneurysm characteristics. Radial access use was significantly higher in the TT group (71.4% vs 15.3%; P=0.006). Median number of flow diverters and adjunctive coiling use were non-different between groups. Acute ischemic stroke rate during the oral anticoagulation period was lower in the TT group than the DAPT group (7.1% vs 30.8%; P=0.167). Modified Rankin Scale score decline was significantly lower in the TT group (7.1% vs 69.2%; P=0.001). Overall rates of hemorrhagic complications (TT, 28.6% vs DAPT, 7.7%; P=0.162) and complete occlusion (TT, 25% vs DAPT, 54.4%; P=0.213) were non-different between the groups. Rate of moderate-to-severe disability at last follow-up was significantly lower in the TT group (21.4% vs 76.9%; P=0.007). Conclusions Patients with DVBFAs treated with FD in the TT group had fewer ischemic strokes, less symptom progression, and overall better outcomes at last follow-up than similar patients in the DAPT group.
    Type of Medium: Online Resource
    ISSN: 1759-8478 , 1759-8486
    URL: Article
    DOI: 10.1136/jnis-2022-019151
    Language: English
    Publisher: BMJ
    Publication Date: 2023
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  • 8
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    Abstract WMP95: Anesthesia Modality in Endovascular Treatment for Distal Medium Vessel Occlusion Stroke: Intention-to-Treat Matched Analysis
    Ovid Technologies (Wolters Kluwer Health) ; 2024
    In:  Stroke Vol. 55, No. Suppl_1 ( 2024-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 55, No. Suppl_1 ( 2024-02)
    Abstract: Background: The optimal anesthesia modality during endovascular treatment (EVT) for distal medium vessel occlusion (DMVO) strokes is uncertain. We aimed to evaluate the impact of the anesthesia modality on procedural and clinical outcomes following EVT for DMVO strokes. Methods: This is a retrospective analysis of a prospectively collected database from 14 comprehensive stroke centers in the United States and Europe. Patients were included if they had DMVO due to MCA-M3/4, ACA-A1/A2-3, or PCA-P1/P2-3 and underwent EVT. The cohort was divided into two groups: general anesthesia (GA) and non-general anesthesia (non-GA). The primary analysis compared the two groups based on the intention-to-treat principle. The secondary analysis compared both groups according to the as-treated approach. We used propensity scores to balance the two groups at a 1:1 ratio. The primary outcome was the shift in the degree of disability as measured by the 90-day mRS. Secondary outcomes included successful reperfusion, mRS0-1, and mRS0-2 at 90-days. Safety measures included procedural complications, symptomatic intracerebral hemorrhage (sICH), and 90-day mortality. Results: A total of 365 patients were eligible for analysis. In the intention-to-treat analysis (130 matched pairs), baseline demographic and clinical characteristics were balanced. There was no difference in the degree of disability (mRS ordinal shift; acOR 1.64, 95%-CI [0.78-3.46], P=0.19) between the two groups. GA had comparable rates of successful reperfusion (aOR2.66, 95%CI [0.75-9.42] ,P=0.13), 90-day mRS0-1 (aOR1.07, 95%CI[0.41-2.78],P=0.89), 90-day mRS0-2 (aOR1.46, 95%CI[0.60-3.55] ,P=0.41), procedural complications (aOR1.08, 95%CI[0.20-5.79],P=0.93), sICH (aOR3.28, 95%CI[0.81-13.34] , P=0.10), and 90-day mortality (aOR0.82, 95%CI [0.35-1.95],P=0.66) compared to the non-GA group. Similarly, when comparing 150 matched pairs using the as-treated principle, GA and non-GA showed comparable outcomes. Conclusions: In patients with DMVO undergoing EVT, GA and non-GA had similar procedural and clinical outcomes, as well as safety measures. Further, larger controlled studies are warranted.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.55.suppl_1.WMP95
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
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  • 9
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    Abstract WP198: Balloon Guide Catheter Impact on Angiographic and Clinical Outcomes in Distal Medium Vessel Occlusion Strokes Undergoing Thrombectomy
    Ovid Technologies (Wolters Kluwer Health) ; 2024
    In:  Stroke Vol. 55, No. Suppl_1 ( 2024-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 55, No. Suppl_1 ( 2024-02)
    Abstract: Background: The use of balloon guide catheter (BGC) has been associated with better reperfusion and clinical outcomes in mechanical thrombectomy (MT) for large vessel occlusion strokes (LVOS). The association between BGC and angiographic and clinical outcomes in patients with distal medium vessel occlusion strokes (DMVO) undergoing MT has not been investigated. Methods: This is a retrospective analysis of a prospectively collected database from 14 comprehensive stroke centers in the United States and Europe. Patients were included if they had anterior circulation DMVO due to MCA-M3/M4 or ACA-A1/A2-3 and were treated with MT using stentriever, contact aspiration, or a combination of both techniques as first-line therapy. The cohort was divided into two groups: 1) BGC and 2) non-BGC. Uni and multivariable analyses were used to identify predictors of first pass effect (FPE) defined as eTICI grade 2C or 3 after single device pass, as well as mRS0-1, mRS0-2, and mortality at 90 days. Results: A total of 199 patients were eligible for analysis. The BGC group (n=73) had comparable baseline characteristics as compared to the non-BGC group (n=126), except for lower median age and frequency of hyperlipidemia, atrial fibrillation, and White patients, and higher frequency of tandems. Procedurally, the BGC group had a less frequent use of contact aspiration (23.3% vs. 53.2%), and higher proportions of stent-retriever use (35.6% vs. 13.5%) and combined technique (41.1% vs. 33.3%; P 〈 0.001) as first-line therapy. A lower number of passes (1 vs. 2, P 〈 0.001), shorter procedure time (40 vs. 46 minutes, P=0.029), and higher FPE rates (53% vs 13%; P 〈 0.001) were observed in the BGC group. On multivariable analysis, the BGC group showed higher rates of FPE (53.4% vs. 13.7%, aOR 6.74, 95%CI [3.08-14.75], P 〈 0.001), 90-day mRS 0-1 (42.9% vs. 27.1%, aOR 2.28, 95%CI [1.06-4.91], P=0.035), and 90-day mRS 0-2 (60.3% vs. 41.5%, aOR 2.47, 95%CI [1.15-5.31] , P=0.02). The rates of successful reperfusion at the end of the procedure, sICH, and 90-day mortality were comparable between both groups. Conclusions: The present study suggests that the use of BGC in DMVO undergoing MT is associated with improved angiographic and clinical outcomes with no safety concerns. Prospective studies are warranted.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.55.suppl_1.WP198
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
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