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1.
J Neurol ; 2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38967650

ABSTRACT

BACKGROUND: While mechanical thrombectomy is considered standard of care for large vessel occlusions, scientific evidence to support treatment for distal and medium vessel occlusions remains scarce. PURPOSE: To evaluate feasibility, safety, and outcomes in patients with low National Institute of Health Stroke Scale scores undergoing mechanical thrombectomy for treatment of distal medium vessel occlusions. MATERIALS AND METHODS: Retrospective data review and analysis of prospectively maintained databases at 41 academic centers in North America, Asia, and Europe between January 2017 and January 2022. Characteristics and outcomes were compared between groups with low stroke scale score (≤ 6) versus and higher stroke scale scores (> 6). Propensity score matching using the optimal pair matching method and 1:1 ratio was performed. RESULTS: Data were collected on a total of 1068 patients. After propensity score matching, there were a total of 676 patients included in the final analysis, with 338 patients in each group. High successful reperfusion rates were seen in both groups, 90.2% in ≤ 6 and 88.7% in the > 6 stroke scale groups. The frequency of excellent and good functional outcome was seen more common in low versus higher stroke scale score patients (64.5% and 81.1% versus 39.3% and 58.6%, respectively). The 90-day mortality rate observed in the ≤ 6 stroke scale group was 5.3% versus 13.3% in the > 6 stroke scale group. CONCLUSION: Mechanical thrombectomy in distal and medium vessel occlusions, specifically in patients with low stroke scale scores is feasible, though it may not necessarily improve outcomes over IVT.

2.
AJNR Am J Neuroradiol ; 45(7): 906-911, 2024 Jul 08.
Article in English | MEDLINE | ID: mdl-38977286

ABSTRACT

BACKGROUND AND PURPOSE: Despite the numerous studies evaluating the occlusion rates of aneurysms following WEB embolization, there are limited studies identifying predictors of occlusion. Our purpose was to identify predictors of aneurysm occlusion and the need for retreatment. MATERIALS AND METHODS: This is a review of a prospectively maintained database across 30 academic institutions. We included patients with previously untreated cerebral aneurysms embolized using the WEB who had available intraprocedural data and long-term follow-up. RESULTS: We studied 763 patients with a mean age of 59.9 (SD, 11.7) years. Complete aneurysm occlusion was observed in 212/726 (29.2%) cases, and contrast stasis was observed in 485/537 (90.3%) of nonoccluded aneurysms. At the final follow-up, complete occlusion was achieved in 497/763 (65.1%) patients, and retreatment was required for 56/763 (7.3%) patients. On multivariable analysis, history of smoking, maximal aneurysm diameter, and the presence of an aneurysm wall branch were negative predictors of complete occlusion (OR, 0.5, 0.8, and 0.4, respectively). Maximal aneurysm diameter, the presence of an aneurysm wall branch, posterior circulation location, and male sex increase the chances of retreatment (OR, 1.2, 3.8, 3.0, and 2.3 respectively). Intraprocedural occlusion resulted in a 3-fold increase in the long-term occlusion rate and a 5-fold decrease in the retreatment rate (P < .001), offering a specificity of 87% and a positive predictive value of 85% for long-term occlusion. CONCLUSIONS: Intraprocedural occlusion can be used to predict the chance of long-term aneurysm occlusion and the need for retreatment after embolization with a WEB device. Smoking, aneurysm size, and the presence of an aneurysm wall branch are associated with decreased chances of successful treatment.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Intracranial Aneurysm/surgery , Male , Female , Middle Aged , Embolization, Therapeutic/instrumentation , Embolization, Therapeutic/methods , Retrospective Studies , Treatment Outcome , Aged , Risk Factors
3.
J Neurosurg ; : 1-8, 2024 May 31.
Article in English | MEDLINE | ID: mdl-38820613

ABSTRACT

OBJECTIVE: Disparities in the epidemiology and growth rates of aneurysms between the sexes are known. However, little is known about sex-dependent outcomes after microsurgical clipping of unruptured intracranial aneurysms (UIAs). The aim of this study was to examine sex differences in characteristics and outcomes after microsurgical clipping of UIAs and to perform a propensity score-matched analysis using an international multicenter cohort. METHODS: This retrospective cohort study involved the participation of 15 centers spanning four continents. It included adult patients who underwent clipping of UIAs between January 2016 and December 2020. Patients were stratified according to their sex and analyzed for differences in morbidities and aneurysm characteristics. Based on this stratification, female patients were matched to male patients in a 1:1 ratio with a caliper width of 0.1 using propensity score matching. Endpoints included postoperative complications, neurological performance, and aneurysm occlusion at discharge and 24 months after clip placement. RESULTS: A total of 2245 patients with a mean age of 57.3 (range 20-87) years were included. Of these patients, 1675 (74.6%) were female. Female patients were significantly older (mean 57.6 vs 56.4 years, p = 0.03) but had fewer comorbidities. Aneurysms of the internal carotid artery (7.1% vs 4.2%), posterior communicating artery (6.9% vs 1.9%), and ophthalmic artery (6.0% vs 2.8%) were more commonly treated surgically in females, while clipping of aneurysms of the anterior communicating artery was more frequent in males (17.0% vs 25.3%; all p < 0.001). After propensity score matching, female patients were found to have had significantly fewer pulmonary complications (1.4% vs 4.2%, p = 0.01). However, general morbidity (24.5% vs 25.2%, p = 0.72) and mortality (0.5% vs 1.1%, p = 0.34), as well as neurological performance (p = 0.58), were comparable at discharge in both sexes. Lastly, rates of aneurysm occlusion at the time of discharge (95.5% vs 94.9%, p = 0.71) and 24 months after surgery (93.8% vs 96.1%, p = 0.22) did not significantly differ between male and female patients. CONCLUSIONS: Despite overall differences between male and female patients in demographics, comorbidities, and treated aneurysm location, sex did not relevantly affect surgical performance or perioperative complication rates.

4.
J Neurosurg ; : 1-6, 2024 Mar 08.
Article in English | MEDLINE | ID: mdl-38457799

ABSTRACT

OBJECTIVE: Treatment of intracranial aneurysms by flow diversion is safe and effective and is increasingly popular. However, the correct treatment paradigm for aneurysms incompletely treated by initial placement of a flow diverter has not been established, nor have the subsequent natural history and occlusion rates of such aneurysms. The authors sought to outline the natural history of such aneurysms, which to date have been considered partially treated. METHODS: The authors retrospectively reviewed consecutive cases from 6 high-volume neurointerventional services, including all cases in which the first follow-up imaging after placement of a flow diverter showed incomplete occlusion of the aneurysm, and for which subsequent clinical and/or radiological follow-up was available. All included patients were treated with the Pipeline Flex embolization device or the Pipeline Flex embolization device with Shield Technology. Subsequent radiographic and clinical outcome data were collected and analyzed using the Kaplan-Meier survival function. RESULTS: A total of 263 patients with persistently patent aneurysms on first follow-up imaging after flow diversion were identified. Of these, 204 had clinical follow-up and 152 had additional imaging follow-up. Of this final cohort, 148 aneurysms were unruptured, and 4 were ruptured. The average aneurysm size by maximum dimension was 10.8 mm. The average recorded follow-up was 27.8 months in the cohort, with some patients followed for as long as 9 years from treatment. Over the course of 403 person-years of follow-up, no delayed aneurysm ruptures were recorded. Both with and without retreatment, aneurysms showed a trend toward progressive occlusion over time. Complications related to device placement were low. CONCLUSIONS: Aneurysms that have been incompletely treated by flow diversion have a benign natural history with progression toward occlusion over time, with or without retreatment.

5.
Neurosurg Rev ; 47(1): 116, 2024 Mar 14.
Article in English | MEDLINE | ID: mdl-38483647

ABSTRACT

BACKGROUND: The Woven EndoBridge (WEB) devices have been used for treating wide neck bifurcation aneurysms (WNBAs) with several generational enhancements to improve clinical outcomes. The original device dual-layer (WEB DL) was replaced by a single-layer (WEB SL) device in 2013. This study aimed to compare the effectiveness and safety of these devices in managing intracranial aneurysms. METHODS: A multicenter cohort study was conducted, and data from 1,289 patients with intracranial aneurysms treated with either the WEB SL or WEB DL devices were retrospectively analyzed. Propensity score matching was utilized to balance the baseline characteristics between the two groups. Outcomes assessed included immediate occlusion rate, complete occlusion at last follow-up, retreatment rate, device compaction, and aneurysmal rupture. RESULTS: Before propensity score matching, patients treated with the WEB SL had a significantly higher rate of complete occlusion at the last follow-up and a lower rate of retreatment. After matching, there was no significant difference in immediate occlusion rate, retreatment rate, or device compaction between the WEB SL and DL groups. However, the SL group maintained a higher rate of complete occlusion at the final follow-up. Regression analysis showed that SL was associated with higher rates of complete occlusion (OR: 0.19; CI: 0.04 to 0.8, p = 0.029) and lower rates of retreatment (OR: 0.12; CI: 0 to 4.12, p = 0.23). CONCLUSION: The WEB SL and DL devices demonstrated similar performances in immediate occlusion rates and retreatment requirements for intracranial aneurysms. The SL device showed a higher rate of complete occlusion at the final follow-up.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Treatment Outcome , Intracranial Aneurysm/surgery , Intracranial Aneurysm/etiology , Embolization, Therapeutic/adverse effects , Propensity Score , Retrospective Studies , Cohort Studies , Endovascular Procedures/adverse effects
6.
Neurosurg Focus ; 56(3): E4, 2024 03.
Article in English | MEDLINE | ID: mdl-38427989

ABSTRACT

OBJECTIVE: With recent advancements in minimally invasive techniques, endovascular embolization has gained popularity as a first-line treatment option for spinal dural arteriovenous fistulas (sDAVFs). The authors present their institution's case series of sDAVFs treated endovascularly and surgically, and they performed a systemic review to assess the outcomes of both modalities of treatment. METHODS: The authors conducted a retrospective observational study of 24 consecutive patients with sDAVFs treated between 2013 and 2023. The primary outcome was the rate of occlusion, which was compared between the surgically and endovascularly treated sDAVFs. They also conducted a systemic review of all the literature comparing outcomes of endovascular and surgical treatment of sDAVFs. RESULTS: A total of 24 patients with 24 sDAVFs were studied. The mean patient age was 63.8 ± 15.5 years, and the majority of patients were male (n = 19, 79.2%). Of the 24 patients, 8 (33.3%) received endovascular treatment, 15 (62.5%) received surgical treatment, and 1 (4.2%) patient received both. Complete occlusion at first follow-up was higher in the surgical cohort but did not achieve statistical significance (66.7% vs 25%, p = 0.52). Recurrence was higher in the endovascular cohort (37.5% vs 13.3%, p = 0.3), while the rate of postprocedural complications was higher in the surgical cohort (13.3% vs 0%, p = 0.52); however, neither of these differences was statistically significant. CONCLUSIONS: Endovascular embolization in the management of sDAVFs is an alternative treatment to surgery, whose long-term efficacy is still under investigation. These findings suggest overall comparable outcomes between endovascular and open surgical treatment of sDAVFs. Future studies are needed to determine the role of endovascular embolization in the overall management of sDAVFs.


Subject(s)
Central Nervous System Vascular Malformations , Endovascular Procedures , Humans , Male , Female , Middle Aged , Aged , Treatment Outcome , Neurosurgical Procedures/methods , Endovascular Procedures/methods , Spine , Central Nervous System Vascular Malformations/diagnostic imaging , Central Nervous System Vascular Malformations/surgery , Observational Studies as Topic
7.
Neuroradiology ; 66(4): 631-641, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38381145

ABSTRACT

PURPOSE: Our purpose was to assess the efficacy and safety of the pRESET LITE stent retriever (Phenox, Bochum, Germany), designed for medium vessel occlusion (MeVO) in acute ischemic stroke (AIS) patients with a primary MeVO. METHODS: We performed a retrospective analysis of the MAD MT Consortium, an integration of prospectively maintained databases at 37 academic institutions in Europe, North America, and Asia, of AIS patients who underwent mechanical thrombectomy with the pRESET LITE stent retriever for a primary MeVO. We subcategorized occlusions into proximal MeVOs (segments A1, M2, and P1) vs. distal MeVOs/DMVO (segments A2, M3-M4, and P2). We reviewed patient and procedural characteristics, as well as angiographic and clinical outcomes. RESULTS: Between September 2016 and December 2021, 227 patients were included (50% female, median age 78 [65-84] years), of whom 161 (71%) suffered proximal MeVO and 66 (29%) distal MeVO. Using a combined approach in 96% of cases, successful reperfusion of the target vessel (mTICI 2b/2c/3) was attained in 85% of proximal MeVO and 97% of DMVO, with a median of 2 passes (IQR: 1-3) overall. Periprocedural complications rate was 7%. Control CT at day 1 post-MT revealed a hemorrhagic transformation in 63 (39%) patients with proximal MeVO and 24 (36%) patients with DMVO, with ECASS-PH type hemorrhagic transformations occurring in 3 (1%) patients. After 3 months, 58% of all MeVO and 63% of DMVO patients demonstrated a favorable outcome (mRS 0-2). CONCLUSION: Mechanical thrombectomy using the pRESET LITE in a combined approach with an aspiration catheter appears effective for primary medium vessel occlusions across several centers and physicians.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Aged , Female , Humans , Male , Brain Ischemia/complications , Ischemic Stroke/etiology , Retrospective Studies , Stents , Stroke/etiology , Thrombectomy , Treatment Outcome , Aged, 80 and over
8.
Eur Stroke J ; 9(2): 328-337, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38409796

ABSTRACT

BACKGROUND: Mechanical thrombectomy (MT) has revolutionized the treatment of acute ischemic stroke (AIS) due to large vessel occlusion (LVO), but its efficacy and safety in medium vessel occlusion (MeVO) remain less explored. This multicenter, retrospective study aims to investigate the incidence and clinical outcomes of vessel perforations (confirmed by extravasation during an angiographic series) during MT for AIS caused by MeVO. METHODS: Data were collected from 37 academic centers across North America, Asia, and Europe between September 2017 and July 2021. A total of 1373 AIS patients with MeVO underwent MT. Baseline characteristics, procedural details, and clinical outcomes were analyzed. RESULTS: The incidence of vessel perforation was 4.8% (66/1373). Notably, our analysis indicates variations in perforation rates across different arterial segments: 8.9% in M3 segments, 4.3% in M2 segments, and 8.3% in A2 segments (p = 0.612). Patients with perforation had significantly worse outcomes, with lower rates of favorable angiographic outcomes (TICI 2c-3: 23% vs 58.9%, p < 0.001; TICI 2b-3: 56.5% vs 88.3%, p < 0.001). Functional outcomes were also worse in the perforation group (mRS 0-1 at 3 months: 22.7% vs 36.6%, p = 0.031; mRS 0-2 at 3 months: 28.8% vs 53.9%, p < 0.001). Mortality was higher in the perforation group (30.3% vs 16.8%, p = 0.008). CONCLUSION: This study reveals that while the occurrence of vessel perforation in MT for AIS due to MeVO is relatively rare, it is associated with poor functional outcomes and higher mortality. The findings highlight the need for increased caution and specialized training in performing MT for MeVO. Further prospective research is required for risk mitigation strategies.


Subject(s)
Ischemic Stroke , Thrombectomy , Humans , Ischemic Stroke/surgery , Ischemic Stroke/epidemiology , Ischemic Stroke/therapy , Male , Retrospective Studies , Female , Aged , Middle Aged , Incidence , Thrombectomy/adverse effects , Thrombectomy/methods , Treatment Outcome , Aged, 80 and over
9.
J Neurosurg ; 141(1): 175-183, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38181513

ABSTRACT

OBJECTIVE: By providing a more physiological approach to the treatment of intracranial aneurysms, the Pipeline embolization device (PED) has revolutionized the endovascular treatment of aneurysms. Although there are many flow diverters on the market, the authors report their experience with the PED, the first flow diverter to be approved by the Food and Drug Administration. They aimed to assess the efficacy and safety of PED flow diversion for the treatment of a wide range of aneurysms, as well as to look at factors affecting occlusion. METHODS: This is a retrospective study of a prospectively maintained database of patients treated with the PED between January 2011 and December 2019. Charts were reviewed for patient, aneurysm, and procedure characteristics. The primary outcomes of interest were complication rates, occlusion outcomes (O'Kelly-Marotta grading scale), and functional outcomes (modified Rankin Scale [mRS]). Secondary outcomes included predictors of incomplete occlusion at 6 and 24 months of follow-up. RESULTS: The study cohort included 581 patients with 674 aneurysms. Most aneurysms (90.5%) were in the anterior circulation and had a saccular morphology (85.6%). Additionally, 638 aneurysms (94.7%) were unruptured, whereas 36 (5.3%) were acutely ruptured. The largest mean aneurysm diameter was 8.3 ± 6.1 mm. Complications occurred at a rate of 5.5% (n = 32). The complete occlusion rate was 89.3% at 24 months' follow-up, and 94.8% of patients had a favorable neurological outcome (mRS score 0-2) at the last follow-up. On multivariate analysis, predictors of incomplete aneurysm occlusion at 6 months were hypertension (OR 1.7, p = 0.03), previous aneurysm treatment (OR 2.4, p = 0.001), and increasing aneurysm neck diameter (OR 1.2, p = 0.02), whereas a saccular morphology was protective (OR 0.5, p = 0.05). Predictors of incomplete occlusion at 24 months were increasing aneurysm neck diameter (OR 1.2, p = 0.01) and previous aneurysm treatment (OR 2.3, p = 0.01). CONCLUSIONS: The study findings are corroborated by those of previous studies and trials. The complete occlusion rate was 89.3% at 24 months' follow-up, with 94.8% of patients having favorable functional outcomes (mRS score 0-2). Aneurysm treatment before PED deployment and an increasing aneurysm neck diameter increase the risk of incomplete occlusion at 6 and 24 months.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Humans , Intracranial Aneurysm/therapy , Embolization, Therapeutic/methods , Embolization, Therapeutic/instrumentation , Embolization, Therapeutic/adverse effects , Male , Female , Middle Aged , Retrospective Studies , Treatment Outcome , Aged , Adult , Cohort Studies , Endovascular Procedures/methods , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Follow-Up Studies
10.
J Neurosurg ; 140(4): 1054-1063, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-37856406

ABSTRACT

OBJECTIVE: Flow diversion created a paradigm shift in the treatment of intracranial aneurysms. The new flow redirection endoluminal device with X technology (FRED X) is the latest update of the recent Food and Drug Administration-approved FRED. The FRED X is engineered to reduce material thrombogenicity and enhance vessel healing. In this study, the authors aimed to evaluate the feasibility and early safety and efficacy of the new FRED X. METHODS: The authors retrospectively collected and analyzed data from patients who had undergone flow diversion with the new FRED X at four tertiary cerebrovascular centers in the United States from February 2022 through July 2022. RESULTS: Forty-four patients with 45 aneurysms treated using 46 devices comprised the overall study cohort and were divided into two groups: 39 patients with unruptured aneurysms and 5 patients with ruptured aneurysms. The mean patient age was 57.7 ± 9.1 years, and most patients were female (84%). Ninety-one percent of the aneurysms were saccular, with the majority (93%) located in the anterior circulation, specifically the posterior communicating (27%) and carotid ophthalmic (27%) territories. The mean maximum aneurysm diameter was 5.6 ± 4.6 mm, and 20% of the lesions had been previously treated. The mean procedure time was 61.6 minutes, with a mean cumulative fluoroscopy time of 24.6 minutes. Additionally, 7% of the lesions received adjunct treatment. Stent placement was successful in 100% of cases, achieving good wall apposition and complete neck coverage. Further, immediate aneurysm contrast stasis > 90% was observed in 61% of cases. Symptomatic postoperative complications occurred in 3 patients in the unruptured cohort and 1 patient in the ruptured cohort. All patients in the study were discharged on dual antiplatelet regimens with a modified Rankin Scale score of 0. At 6 months after treatment, 89% of cases had adequate occlusion, with < 6% of cases having asymptomatic in-stent stenosis. All patients had excellent functional outcomes. CONCLUSIONS: FRED X for the treatment of an intracranial aneurysm is technically feasible alone or in conjunction with intrasaccular embolization. In addition, the study results showed very promising early safety and efficacy. Follow-up studies should establish the long-term safety and efficacy profiles of this new stent.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Female , Middle Aged , Aged , Male , Retrospective Studies , Treatment Outcome , Feasibility Studies , Endovascular Procedures/methods , Stents , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Embolization, Therapeutic/methods
11.
Interv Neuroradiol ; : 15910199231190596, 2023 Oct 09.
Article in English | MEDLINE | ID: mdl-37807823

ABSTRACT

INTRODUCTION: Idiopathic intracranial hypertension (IIH) can result in headaches, pulsatile tinnitus, papilledema, and other neurological symptoms. Weight loss can alleviate some symptoms of IIH. This study aims to investigate the effect of venous sinus stenting on post-operative weight and body mass index (BMI) changes among IIH patients. The secondary objective is to investigate the relationship between post-operative weight changes and papilledema resolution. METHODS: Patients with papilledema undergoing venous sinus stenting for IIH were retrospectively reviewed from two comprehensive North American cerebrovascular centers. Patient demographics, surgical course, post-operative outcomes, and weight were analyzed. A systematic review and meta-analysis of post-operative weight in stented IIH patients was conducted. RESULTS: Twenty-eight patients with a diagnosis of IIH and papilledema who underwent venous sinus stenting were identified across two institutions. Patients had a mean pre-operative weight of 103.2 kg, which decreased to 101.5 kg at 3-month follow up (p = 0.0757). Patients at 6-month follow-up saw a weight decrease to 97.4 kg (p = 0.0066). Patients who saw papilledema resolution saw a mean greater decrease in weight (-4.5%) at 6-month follow up than those whose papilledema did not resolve (-1.7%), although this was insignificant (p = 0.1091). A total of 41 patients were included in the meta-analysis. Patients had an average of 1.1 increase in BMI at 3-month follow up. CONCLUSIONS: This study shows that venous sinus stenting leads to modest weight reduction in IIH patients, and those with resolved papilledema experience slightly greater weight loss. Further research is necessary to determine the clinical significance of these findings.

12.
Clin Neurol Neurosurg ; 233: 107895, 2023 10.
Article in English | MEDLINE | ID: mdl-37556969

ABSTRACT

BACKGROUND: The treatment of non-acute subdural hematoma (NASDH) is challenging due to its high recurrence rates and comorbidities of mostly elderly patients. Middle meningeal artery embolization (MMAE) recently emerged as an alternative to surgery in the treatment of NASDH. OBJECTIVE: To describe a single center's experience of MMAE with Onyx for NASDH and compare it to a surgically treated historical cohort. METHODS: We performed a retrospective analysis of patients undergoing MMAE for NASDH from 2019 to 2021. MMAE was performed with ethylene vinyl alcohol copolymer (Onyx). Comparisons were made with a historical cohort from 2010 to 2018 who underwent surgical evacuation only, before and after propensity score matching. Outcomes were assessed clinically and radiographically. RESULTS: We included 44 consecutive patients (55 MMAEs) who underwent MMAE, with a median follow-up of 63.5 days. Twenty-four NASDHs underwent upfront embolization, 17 adjunctive, and 14 for recurrence after prior surgical evacuation, with no significant differences in hematoma and mRS reduction between them. Two patients died during hospitalization and 2 during follow-up, unrelated to the procedure. Mean SDH thickness decreased by 48.3% ± 38.1% (P < 0.001) on last follow-up, which did not correlate with the amount of Onyx injected. Six (13.6%) patients required surgical rescue after embolization. There were no procedure-related complications. The mean modified Rankin Scale (mRS) on admission was 2.8 ± 1.5, which decreased significantly to 1 [1,4] at the last follow-up (P = 0.033). The MMAE (41 hematomas; upfront and adjunctive embolization) and Surgical Evacuation-only (461 hematomas) cohorts were balanced with propensity score mathing. Matching was successful for 41 MMAE and 41 surgical-only hematoma pairs, and only hypertension remained significantly different between the two groups, but there was no significant difference in any outcome. CONCLUSION: MMAE for NASDH seems safe and effective in appropriately selected patients, non-inferior to surgery, and may become a minimally-invasive alternative. Given our encouraging results, large-scale clinical randomized trials are warranted.


Subject(s)
Embolization, Therapeutic , Hematoma, Subdural, Acute , Hematoma, Subdural, Chronic , Humans , Aged , Hematoma, Subdural, Chronic/therapy , Meningeal Arteries/diagnostic imaging , Meningeal Arteries/surgery , Retrospective Studies , Propensity Score , Treatment Outcome , Embolization, Therapeutic/methods , Hematoma, Subdural, Acute/diagnostic imaging , Hematoma, Subdural, Acute/surgery
13.
Clin Trials ; 19(5): 534-544, 2022 10.
Article in English | MEDLINE | ID: mdl-35786006

ABSTRACT

BACKGROUND: Hematoma and perihematomal edema volumes are important radiographic markers in spontaneous intracerebral hemorrhage. Accurate, reliable, and efficient quantification of these volumes will be paramount to their utility as measures of treatment effect in future clinical studies. Both manual and semi-automated quantification methods of hematoma and perihematomal edema volumetry are time-consuming and susceptible to inter-rater variability. Efforts are now underway to develop a fully automated algorithm that can replace them. A (QUANTUM) study to establish inter-quantification method measurement equivalency, which deviates from the traditional use of measures of agreement and a comparison hypothesis testing paradigm to indirectly infer quantification method measurement equivalence, is described in this article. The Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study aims to determine whether a fully automated quantification method and a semi-automated quantification method for quantification of hematoma and perihematomal edema volumes are equivalent to the hematoma and perihematomal edema volumes of the manual quantification method. METHODS/DESIGN: Hematoma and perihematomal edema volumes of supratentorial intracerebral hemorrhage on 252 computed tomography scans will be prospectively quantified in random order by six raters using the fully automated, semi-automated, and manual quantification methods. Primary outcome measures for hematoma and perihematomal edema volumes will be quantified via computed tomography scan on admission (<24 h from symptom onset) and on day 3 (72 ± 12 h from symptom onset), respectively. Equivalence hypothesis testing will be conducted to determine if the hematoma and perihematomal edema volume measurements of the fully automated and semi-automated quantification methods are within 7.5% of the hematoma and perihematomal edema volume measurements of the manual quantification reference method. DISCUSSION: By allowing direct equivalence hypothesis testing, the Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage study offers advantages over radiology validation studies which utilize measures of agreement to indirectly infer measurement equivalence and studies which mistakenly try to infer measurement equivalence based on the failure of a comparison two-sided null hypothesis test to reach the significance level for rejection. The equivalence hypothesis testing paradigm applied to artificial intelligence application validation is relatively uncharted and warrants further investigation. The challenges encountered in the design of this study may influence future studies seeking to translate artificial intelligence medical technology into clinical practice.


Subject(s)
Brain Edema , Artificial Intelligence , Brain Edema/diagnostic imaging , Brain Edema/etiology , Cerebral Hemorrhage/complications , Cerebral Hemorrhage/diagnostic imaging , Edema/diagnostic imaging , Hematoma/diagnostic imaging , Humans
14.
J Neurosurg ; 137(6): 1786-1793, 2022 12 01.
Article in English | MEDLINE | ID: mdl-35535832

ABSTRACT

OBJECTIVE: Stent-assisted coil (SAC) embolization has been the mainstay endovascular treatment for bifurcation aneurysms. The recent introduction of the Woven EndoBridge (WEB) device has presented an alternative endovascular treatment modality for these aneurysms. Direct comparisons of outcomes between these two modalities are limited in the literature. Here, the authors compared the outcomes of bifurcation aneurysms treated with SAC and WEB devices. METHODS: This retrospective single-center study comprised 148 bifurcation aneurysms that were treated endovascularly with SAC or WEB devices between 2011 and 2019. The primary outcome was complete occlusion of the aneurysm at 6 months on catheter angiography. RESULTS: The SAC and WEB cohorts comprised 85 and 63 aneurysms, respectively. The baseline characteristics were well balanced after inverse probability weight (IPW) adjustment, except for smoking status. The 6-month complete occlusion rate was higher in the WEB cohort than the SAC cohort (67.4% vs 40.6%; unadjusted OR [95% CI] 3.014 [1.385-6.563], p = 0.005). However, this difference in complete occlusion rates did not remain significant after IPW adjustment and multiple imputations. The neck remnant rate was lower in the WEB cohort than the SAC cohort (20% vs 50%; OR [95% CI] 0.250 [0.107-0.584], p = 0.001), and this difference remained significant after IPW adjustment (OR [95% CI] 0.304 [0.116-0.795], p = 0.015) and multiple imputations. CONCLUSIONS: Use of SAC and WEB demonstrated comparable 6-month complete occlusion rates for bifurcation aneurysms. WEB appeared to be associated with a lower rate of neck remnant at 6 and 12 months compared with SAC. WEB was also associated with fewer complications and decreased retreatment rates compared with SAC.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Retrospective Studies , Treatment Outcome , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Stents , Cerebral Angiography
15.
J Stroke Cerebrovasc Dis ; 31(3): 106282, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34998043

ABSTRACT

BACKGROUND AND OBJECTIVES: Groundbreaking trials have shown the tremendous efficacy of mechanical thrombectomy for large vessel occlusions. Currently, mechanical thrombectomy is limited to patients with NIHSS scores ≥6. We investigated the feasibility and safety of MT in patients presenting with NIHSS scores <6. MATERIALS AND METHODS: A retrospective review of patient who presented with acute ischemic stroke due to large vessel occlusion with an NIHSS score <6 between 2015 - 2021. The patients were then divided into two groups: those who received mechanical thrombectomy and those who did not. RESULTS: Among 83 patients, 41 received a mechanical thrombectomy while 42 received medical treatment only. The mean age in the mechanical thrombectomy group was 66 years versus 60 years in the medical group (p = 0.06). Risk factors for stroke did not differ significantly between both groups. 14 patients (34.1%) in the mechanical thrombectomy group and 20 (47.6%) in the medical group received tissue plasminogen activator. No significant difference in clinical improvement (NIHSS) at discharge (p=0.85) or the mRS score at 90 days (p = 0.15) was noted. Mechanical thrombectomy was associated with smaller infarct size (p=0.04) and decreased mortality (p=0.03). CONCLUSIONS: Mechanical thrombectomy is safe and effective for patients who present with large vessel occlusions and low initial NIHSS scores. Therefore, the decision to offer the patient mechanical thrombectomy or not should not be decided by NIHSS score alone. Rather, the decision should be multifactorial with the aim of maximizing the patients' outcomes.


Subject(s)
Ischemic Stroke , Mechanical Thrombolysis , Aged , Humans , Ischemic Stroke/therapy , Mechanical Thrombolysis/adverse effects , Retrospective Studies , Treatment Outcome
16.
World Neurosurg ; 158: e592-e597, 2022 02.
Article in English | MEDLINE | ID: mdl-34775088

ABSTRACT

OBJECTIVE: Spinal vascular malformations (SVMs) are a heterogenous group of vascular abnormalities. The gold standard for diagnosis of SVMs is spinal digital subtraction angiography (DSA), which can be challenging because of the large number of segmental arteries that need to be catheterized and the limitations in term of contrast volume used and fluoroscopy time. We describe and compare the use of the time-resolved imaging of contrast kinetics (TRICKS) sequence and DSA in the diagnosis of spinal dural arteriovenous fistulas (SDAVFs) in our institution. METHODS: This is a retrospective cohort study of 27 patients who had a TRICKS MRI followed by a DSA for the diagnosis of their SDAVFs between November 2003 and November 2021. RESULTS: A total of 19 (70.4%) patients were positive for a SDAVF on both TRICKS MRI and DSA. Out of those 19, 9 (47.4%) were in the exact location on both TRICKS MRI and DSA whereas 10 (52.6%) were in different locations. With respect to the 10 patients who had discrepancies in their SDAVF localization between the 2 modalities, 9 (90%) patients had a 1-level difference and 1 (10%) had a 2-level difference. CONCLUSIONS: TRICKS MRI represents an accurate screening tool to be performed before a spinal DSA in order to guide the interventionalist to focus on the correct level ±2 levels; this extra noninvasive screening tool will decrease the risk of a kidney injury from an overuse of contrast and minimize the fluoroscopy/radiation overexposure.


Subject(s)
Central Nervous System Vascular Malformations , Vascular Malformations , Angiography, Digital Subtraction/methods , Central Nervous System Vascular Malformations/diagnostic imaging , Feasibility Studies , Humans , Magnetic Resonance Angiography/methods , Magnetic Resonance Imaging , Retrospective Studies
17.
J Neurosurg ; 136(5): 1266-1272, 2022 May 01.
Article in English | MEDLINE | ID: mdl-34624864

ABSTRACT

OBJECTIVE: Wide-neck bifurcation cerebral aneurysms have historically required either clip ligation or stent- or balloon-assisted coil embolization. This predicament led to the development of the Woven EndoBridge (WEB) aneurysm embolization system, a self-expanding mesh device that achieves intrasaccular flow disruption and does not require antithrombotic medications. The authors report their operative experience and 6-month follow-up occlusion outcomes with the first 115 aneurysms they treated via WEB embolization. METHODS: The authors reviewed the first 115 cerebral aneurysms they treated by WEB embolization after FDA approval of the WEB embolization device (from February 2019 to January 2021). Data were collected on patient demographics and clinical presentation, aneurysm characteristics, procedural details, postembolization angiographic contrast stasis, and functional outcomes. RESULTS: A total of 110 patients and 115 aneurysms were included in our study (34 ruptured and 81 unruptured aneurysms). WEB embolization was successful in 106 (92.2%) aneurysms, with a complication occurring in 6 (5.5%) patients. Contrast clearance was seen in the arterial phase in 14 (12.2%) aneurysms, in the capillary phase in 16 (13.9%), in the venous phase in 63 (54.8%), and no contrast was seen in 13 (11.3%) of the aneurysms studied. Follow-up angiography was performed on 60 (52.6%) of the aneurysms, with complete occlusion in 38 (63.3%), neck remnant in 14 (23.3%), and aneurysmal remnant in 8 (13.3%). Six (5.5%) patients required re-treatment for persistent aneurysmal residual on follow-up angiography. CONCLUSIONS: The WEB device has been successfully used for the treatment of both unruptured and ruptured wide-neck bifurcation aneurysms by achieving intrasaccular flow diversion. Here, the authors have shared their experience with its unique technical considerations and device size selection, as well as critically reviewed complications and aneurysm occlusion rates.

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