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PURPOSE: Intracranial aneurysms present significant health risks, as their rupture leads to subarachnoid haemorrhage, which in turn has high morbidity and mortality rates. There are several elements affecting the complexity of an intracranial aneurysm. However, criteria for defining a complex intracranial aneurysm (CIA) in open surgery and endovascular treatment could differ, and actually there is no consensus on the definition of a "complex" aneurysm. This DELPHI study aims to assess consensus on variables defining a CIA. METHODS: An international panel of 50 members, representing various specialties, was recruited to define CIAs through a three-round Delphi process. The panelists participated in surveys with Likert scale responses and open-ended questions. Consensus criteria were established to determine CIA variables, and statistical analysis evaluated consensus and stability. RESULTS: In open surgery, CIAs were defined by fusiform or blister-like shape, dissecting aetiology, giant size (≥ 25 mm), broad neck encasing parent arteries, extensive neck surface, wall calcification, intraluminal thrombus, collateral branch from the sac, location (AICA, SCA, basilar), vasospasm context, and planned bypass (EC-IC or IC-IC). For endovascular treatment, CIAs included giant size, very wide neck (dome/neck ratio ≤ 1:1), and collateral branch from the sac. CONCLUSIONS: The definition of aneurysm complexity varies by treatment modality. Since elements related to complexity differ between open surgery and endovascular treatment, these consensus criteria of CIAs could even guide in selecting the best treatment approach.
Subject(s)
Delphi Technique , Endovascular Procedures , Intracranial Aneurysm , Intracranial Aneurysm/surgery , Humans , Endovascular Procedures/methods , Consensus , Female , Neurosurgical Procedures/methodsABSTRACT
BACKGROUND: Endovascular embolization is frequently used for vascular lesions of the head and neck. Newer agents may help to enhance visualization and improve treatment outcomes. METHODS: The CLARIDAD clinical trial was a prospective, single center, first-in-man investigation of neurovascular embolization using the novel embolic agent ihtObtura for a broad indication, covering the need for a liquid embolic agent in head and neck procedures. The primary outcomes assessed were therapeutic efficacy to deliver ihtObtura to embolize the catheterized pedicle and associated angiographic vascularity, and subsequent loss of radiopacity. Safety endpoints included procedural adverse events, modified Rankin Scale (mRS) score, morbidity, and mortality. Radiologic and clinical follow-up evaluations were conducted at 30, 90, 180 days, and 1 year post-treatment. RESULTS: 65 consecutive patients (mean age 37.8 years, 50.8% women) were treated over 129 sessions. A total of 42 brain arteriovenous malformations (AVMs; 90% grades III and IV), 8 dural arteriovenous fistulas (DAVFs), and 15 hypervascular tumors were treated with ihtObtura using an average of 3.9 mL per session and 7.7 mL per patient. We achieved therapeutic effectiveness in 99% of catheterizations. Radiopacity loss was complete after 74.3% of the sessions at 30 days, 95.6% at 90 days, and 100% at the 1 year follow-up. Serious adverse events (mRS score >2) occurred in two patients (3.1%) with previously ruptured high grade AVMs leading to one death and one permanent disabling morbidity. CONCLUSIONS: The study showed that ihtObtura was a novel, safe, and effective liquid embolic agent for the treatment of AVMs, DAVFs, and hypervascular tumors. Its key property of significant radiopacity loss contributes to improve anatomical understanding, particularly in staged procedures, as well as reduction in post-procedural imaging artifact. There may be additional benefits of eliminating tantalum from the embolic mixture in terms of lesion penetration.
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Purpose: Monitoring radiation dose and time parameters during radiological interventions is crucial, especially in neurointerventional procedures, such as aneurysm treatment with embolization coils. The algorithm presented detects the presence of these embolization coils in medical images. It establishes a bounding box as a reference for automated collimation, with the primary objective being to enhance the efficiency and safety of neurointerventional procedures by actively optimizing image quality while minimizing patient dose. Methods: Two distinct methodologies are evaluated in our study. The first involves deep learning, employing the Faster R-CNN model with a ResNet-50 FPN as a backbone and a RetinaNet model. The second method utilizes a classical blob detection approach, serving as a benchmark for comparison. Results: We performed a fivefold cross-validation, and our top-performing model achieved mean mAP@75 of 0.84 across all folds on validation data and mean mAP@75 of 0.94 on independent test data. Since we use an upscaled bounding box, achieving 100% overlap between ground truth and prediction is not necessary. To highlight the real-world applications of our algorithm, we conducted a simulation featuring a coil constructed from an alloy wire, effectively showcasing the implementation of automatic collimation. This resulted in a notable reduction in the dose area product, signifying the reduction of stochastic risks for both patients and medical staff by minimizing scatter radiation. Additionally, our algorithm assists in avoiding extreme brightness or darkness in X-ray angiography images during narrow collimation, ultimately streamlining the collimation process for physicians. Conclusion: To our knowledge, this marks the initial attempt at an approach successfully detecting embolization coils, showcasing the extended applications of integrating detection results into the X-ray angiography system. The method we present has the potential for broader application, allowing its extension to detect other medical objects utilized in interventional procedures.
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Importance: The time-benefit association of endovascular thrombectomy (EVT) in ischemic stroke with patient-reported outcomes is unknown. Objective: To assess the time-dependent association of EVT with self-reported quality of life in patients with acute ischemic stroke. Design, Setting, and Participants: Data were used from the Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) trial, which tested the effect of nerinetide on functional outcomes in patients with large vessel occlusion undergoing EVT and enrolled patients from March 1, 2017, to August 12, 2019. The ESCAPE-NA1 trial was an international randomized clinical trial that recruited patients from 7 countries. Patients with EuroQol 5-dimension 5-level (EQ-5D-5L) index values at 90 days and survivors with complete domain scores were included in the current study. Data were analyzed from July to September 2023. Exposure: Hospital arrival to arterial puncture time and other time metrics. Main Outcomes and Measures: EQ-5D-5L index scores were calculated at 90 days using country-specific value sets. The association between time from hospital arrival to EVT arterial-access (door-to-puncture) and EQ-5D-5L index score, quality-adjusted life years, and visual analog scale (EQ-VAS) were evaluated using quantile regression, adjusting for age, sex, stroke severity, stroke imaging, wake-up stroke, alteplase, and nerinetide treatment and accounting for clustering by site. Using logistic regression, the association between door-to-puncture time and reporting no or slight symptoms (compared with moderate, severe, or extreme problems) was determined in each domain (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) or across all domains. Time from stroke onset was also evaluated, and missing data were imputed in sensitivity analyses. Results: Among 1105 patients in the ESCAPE-NA1 trial, there were 1043 patients with EQ-5D-5L index values at 90 days, among whom 147 had died and were given a score of 0, and 1039 patients (mean [SD] age, 69.0 [13.7] years; 527 male [50.7%]) in the final analysis as 4 did not receive EVT. There were 896 survivors with complete domain scores at 90 days. There was a strong association between door-to-puncture time and EQ-5D-5L index score (increase of 0.03; 95% CI, 0.02-0.04 per 15 minutes of earlier treatment), quality-adjusted life years (increase of 0.29; 95% CI, 0.08-0.49 per 15 minutes of earlier treatment), and EQ-VAS (increase of 1.65; 95% CI, 0.56-2.72 per 15 minutes of earlier treatment). Each 15 minutes of faster door-to-puncture time was associated with higher probability of no or slight problems in each of 5 domains and all domains concurrently (range from 1.86%; 95% CI, 1.14-2.58 for pain or discomfort to 3.55%; 95% CI, 2.06-5.04 for all domains concurrently). Door-to-puncture time less than 60 minutes was associated higher odds of no or slight problems in each domain, ranging from odds ratios of 1.49 (95% CI, 1.13-1.95) for pain or discomfort to 2.59 (95% CI, 1.83-3.68) for mobility, with numbers needed to treat ranging from 7 to 17. Results were similar after multiple imputation of missing data and attenuated when evaluating time from stroke onset. Conclusions and Relevance: Results suggest that faster door-to-puncture EVT time was strongly associated with better health-related quality of life across all domains. These results support the beneficial impact of door-to-treatment speed on patient-reported outcomes and should encourage efforts to improve patient-centered care in acute stroke by optimizing in-hospital processes and workflows.
Subject(s)
Endovascular Procedures , Ischemic Stroke , Patient Reported Outcome Measures , Quality of Life , Thrombectomy , Time-to-Treatment , Humans , Thrombectomy/methods , Male , Female , Aged , Ischemic Stroke/surgery , Ischemic Stroke/therapy , Endovascular Procedures/methods , Middle Aged , Aged, 80 and overABSTRACT
OBJECTIVE: The placement of flow-diverting devices has become a common method of treating unruptured intracranial aneurysms of the internal carotid artery. The progressive improvement of aneurysm occlusion after treatment-with low complication and rupture rates-has led to a dilemma regarding the management of aneurysms in which occlusion has not occurred within 6-24 months. The authors aimed to identify clinical consensus regarding management of intracranial aneurysms displaying persistent filling 6-24 months after flow diversion and to ascertain questions that may drive future investigation. METHODS: An international panel of 67 experts was invited to participate in a multistep Delphi consensus process on the treatment of intracranial aneurysms after failed flow diversion. RESULTS: Of the 67 experts invited, 23 (34%) participated. Qualitative analysis of an initial survey with open-ended questions resulted in 51 statements regarding management of aneurysms showing persistent filling after flow diversion. The statements were grouped into 8 categories, and in the second round, respondents rated the degree of their agreement with each statement on a 5-point Likert scale. Flow diverters with surface modifiers did not influence administration of dual-antiplatelet therapy according to 83%. Consensus was also reached regarding the definition of treatment failure at specific time points, including at 6 months if there is aneurysm growth or persistent rapid flow through the entirety of the aneurysm (96%), at 12 months if there is aneurysm growth or symptom onset (78%), and at 24 months if there is persistent filling regardless of size and filling characteristics (74%). Although experts agreed that the degree of intimal hyperplasia or in-device stenosis could not be ascertained by noninvasive imaging alone (83%), only 65% chose digital subtraction angiography as the preferred modality. At 6 and 12 months, retreatment is preferred if there is persistent filling with aneurysm growth (96%, 96%), device malposition (48%, 87%), or a history of subarachnoid hemorrhage (65%, 70%), respectively, and at 24 months if there is persistent filling without reduction in aneurysm size (74%). Experts favored treatment with an additional flow diverter (87%) over aneurysm clipping, applying the same principles for follow-up (83%) and treatment failure (91%) as for the first flow diverter. CONCLUSIONS: The authors present the consensus practices of experts in the management of intracranial aneurysms without occlusion 6-24 months after treatment with a flow-diverting device.
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OBJECTIVE: Until now, giant intracranial aneurysms (GIAs) have in many cases been a vascular disease that was difficult or impossible to treat, not least due to the lack of availability of a large-format stent. In this multicentre study, we report on the first five clinical applications of the Accero®-Rex-Stents (Acandis, Pforzheim, Germany) in the successful treatment of fusiform cerebral giant aneurysms. MATERIAL AND METHODS: The Accero®-Rex-Stents are self-expanding, braided, fully radiopaque Nitinol stents designed for aneurysm treatment. The stent is available in three different sizes (diameter 7-10 mm, length 30-60 mm) and intended for endovascular implantation in vessels with diameters of 5.5-10 mm. RESULTS: Five patients (all male, age 54.4 ± 8.1 years) with large fusiform aneurysms of the posterior circulation were treated endovascularly using the Accero®-Rex-Stents. There were no technical complications. One major ischemic complication occurred. A significant remodeling and reduction in the size of the stent-covered aneurysms was already seen in the short-term post-interventional course. CONCLUSIONS: The Accero®-Rex-Stents were successfully and safely implanted in all five patients with fusiform giant aneurysms, showing technical feasibility with promising initial results and significant aneurysm size reduction in already available follow-up imaging. KEY POINT: With the Accero-Rex-Stents, a new device is available that offers another treatment option for rare cerebral fusiform giant aneurysms with very large parent vessels.
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BACKGROUND: Immediate non-contrast post-interventional flat-panel detector CT (FPDCT) has been suggested as an imaging tool to assess complications after endovascular therapy (EVT). We systematically investigated a new imaging finding of focal hyperdensities correlating with remaining distal vessel occlusion after EVT. METHODS: A single-center retrospective analysis was conducted for all acute ischemic stroke patients admitted between July 2020 and December 2022 who underwent EVT and immediate post-interventional FPDCT. A blinded core lab performed reperfusion grading on post-interventional digital subtraction angiography (DSA) images and evaluated focal hyperdensities on FPDCT (here called the distal occlusion tracker (DOT) sign). DOT sign was defined as a tubular or punctiform, vessel confined, hyperdense signal within the initial occlusion target territory. We assessed sensitivity and specificity of the DOT sign when compared with DSA findings. RESULTS: The median age of the cohort (n=215) was 74 years (IQR 63-82) and 58.6% were male. The DOT sign was positive in half of the cohort (51%, 110/215). The DOT sign had high specificity (85%, 95% CI 72% to 93%), but only moderate sensitivity (63%, 95% CI 55% to 70%) for detection of residual vessel occlusions. In comparison to the core lab, operators overestimated complete reperfusion in a quarter of the entire cohort (25%, 53/215). In more than half of these cases (53%, 28/53) there was a positive DOT sign, which could have mitigated this overestimation. CONCLUSION: The DOT sign appears to be a frequent finding on immediate post-interventional FPDCT. It correlates strongly with incomplete reperfusion and indicates residual distal vessel occlusions. In the future, it may be used to complement grading of reperfusion success and may help mitigating overestimation of reperfusion in the acute setting.
Subject(s)
Aneurysm, False , Humans , Aneurysm, False/diagnostic imaging , Aneurysm, False/therapy , UkraineABSTRACT
PURPOSE: Intracranial arteriovenous malformations (AVMs) treated at our institution with modern techniques of endovascular intervention were analysed for the rate of complete occlusion, associated morbidity, and mortality. To our knowledge, this is the first series from the UK evaluating the effectiveness of endovascular embolisation as a primary treatment for selected cases. METHODS: All newly referred AVMs between January 2017 and June 2022 were reviewed and those treated with primary endovascular intervention were identified. Details of the endovascular procedures were retrospectively reviewed. RESULTS: In 5½ years, 41.1% of AVMs referred to our institution have been triaged for primary endovascular intervention. Sixty-eight AVMs were embolised and followed-up: 44 ruptured and 24 unruptured. Spetzler-Martin grading varied from I to III, and a single AVM was grade IV. The approach was arterial in 73.5%, solely venous in 7.4%, and combined in 19.1%. The mean follow-up was 18 months for imaging and 26 months for clinical assessment. Complete obliteration was achieved in 95.6%. Ruptured AVM cohort: The rate of functional deterioration was 13.6%. Unruptured AVM cohort: The rate of functional deterioration secondary to complications from embolisation was 4.2%. CONCLUSIONS: Endovascular embolisation may be a favourable option for primary AVM treatment in carefully selected patients. However, selection criteria need to be better delineated for more specialists to consider this as a primary therapy.
Subject(s)
Embolization, Therapeutic , Intracranial Arteriovenous Malformations , Radiosurgery , Humans , Treatment Outcome , Retrospective Studies , Radiosurgery/methods , Intracranial Arteriovenous Malformations/diagnostic imaging , Intracranial Arteriovenous Malformations/therapy , United KingdomABSTRACT
BACKGROUND: Numerous questions regarding procedural details of distal stroke thrombectomy remain unanswered. This study assesses the effect of anesthetic strategies on procedural, clinical and safety outcomes following thrombectomy for distal medium vessel occlusions (DMVOs). METHODS: Patients with isolated DMVO stroke from the TOPMOST registry were analyzed with regard to anesthetic strategies (ie, conscious sedation (CS), local (LA) or general anesthesia (GA)). Occlusions were in the P2/P3 or A2-A4 segments of the posterior and anterior cerebral arteries (PCA and ACA), respectively. The primary endpoint was the rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 3) and the secondary endpoint was the rate of modified Rankin Scale score 0-1. Safety endpoints were the occurrence of symptomatic intracranial hemorrhage and mortality. RESULTS: Overall, 233 patients were included. The median age was 75 years (range 64-82), 50.6% (n=118) were female, and the baseline National Institutes of Health Stroke Scale score was 8 (IQR 4-12). DMVOs were in the PCA in 59.7% (n=139) and in the ACA in 40.3% (n=94). Thrombectomy was performed under LA±CS (51.1%, n=119) and GA (48.9%, n=114). Complete reperfusion was reached in 73.9% (n=88) and 71.9% (n=82) in the LA±CS and GA groups, respectively (P=0.729). In subgroup analysis, thrombectomy for ACA DMVO favored GA over LA±CS (aOR 3.07, 95% CI 1.24 to 7.57, P=0.015). Rates of secondary and safety outcomes were similar in the LA±CS and GA groups. CONCLUSION: LA±CS compared with GA resulted in similar reperfusion rates after thrombectomy for DMVO stroke of the ACA and PCA. GA may facilitate achieving complete reperfusion in DMVO stroke of the ACA. Safety and functional long-term outcomes were comparable in both groups.
Subject(s)
Anesthetics , Brain Ischemia , Endovascular Procedures , Stroke , Humans , Female , Middle Aged , Aged , Aged, 80 and over , Male , Posterior Cerebral Artery , Treatment Outcome , Stroke/surgery , Thrombectomy/adverse effects , Thrombectomy/methods , Retrospective Studies , Endovascular Procedures/methodsABSTRACT
BACKGROUND: Predicting a challenging clot when performing mechanical thrombectomy in acute stroke can be difficult. One reason for this difficulty is a lack of agreement on how to precisely define these clots. We explored the opinions of stroke thrombectomy and clot research experts regarding challenging clots, defined as difficult to recanalize clots by endovascular approaches, and clot/patient features that may be indicative of such clots. METHODS: A modified DELPHI technique was used before and during the CLOTS 7.0 Summit, which included experts in thrombectomy and clot research from different specialties. The first round included open-ended questions and the second and final rounds each consisted of 30 closed-ended questions, 29 on various clinical and clot features, and 1 on number of passes before switching techniques. Consensus was defined as agreement ≥â¯50%. Features with consensus and rated ≥â¯3 out of 4 on the certainty scale were included in the definition of a challenging clot. RESULTS: Three DELPHI rounds were performed. Panelists achieved consensus on 16/30 questions, of which 8 were rated 3 or 4 on the certainty scale, namely white-colored clots (mean certainty score 3.1), calcified clots under histology (3.7) and imaging (3.7), stiff clots (3.0), sticky/adherent clots (3.1), hard clots (3.1), difficult to pass clots (3.1) and clots that are resistant to pulling (3.0). Most panelists considered switching endovascular treatment (EVT) techniques after 2-3 unsuccessful attempts. CONCLUSION: This DELPHI consensus identified 8 distinct features of a challenging clot. The varying degree of certainty amongst the panelists emphasizes the need for more pragmatic studies to enable accurate a priori identification of such occlusions prior to EVT.
Subject(s)
Brain Ischemia , Endovascular Procedures , Stroke , Thrombosis , Humans , Delphi Technique , Thrombosis/diagnostic imaging , Thrombosis/therapy , Thrombosis/pathology , Stroke/diagnostic imaging , Stroke/surgery , Thrombectomy/methods , Endovascular Procedures/methods , Brain Ischemia/pathology , Treatment OutcomeABSTRACT
BACKGROUND: Infarct in a new territory (INT) is a known complication of endovascular stroke therapy. We assessed the incidence of INT, outcomes after INT, and the impact of concurrent treatments with intravenous thrombolysis and nerinetide. METHODS: Data are from ESCAPE-NA1 trial (Safety and Efficacy of Nerinetide [NA-1] in Subjects Undergoing Endovascular Thrombectomy for Stroke), a multicenter, international randomized study that assessed the efficacy of intravenous nerinetide in subjects with acute ischemic stroke who underwent endovascular thrombectomy within 12 hours from onset. Concurrent treatment and outcomes were collected as part of the trial protocol. INTs were identified on core lab imaging review of follow-up brain imaging and defined by the presence of infarct in a new vascular territory, outside the baseline target occlusion(s) on follow-up brain imaging (computed tomography or magnetic resonance imaging). INTs were classified by maximum diameter (<2, 2-20, and >20 mm), number, and location. The association between INT and clinical outcomes (modified Rankin Scale and death) was assessed using standard descriptive techniques and adjusted estimates of effect were derived from Poisson regression models. RESULTS: Among 1092 patients, 103 had INT (9.3%, median age 69.5 years, 49.5% females). There were no differences in baseline characteristics between those with versus without INT. Most INTs (91/103, 88.3%) were not associated with visible occlusions on angiography and 39 out of 103 (37.8%) were >20 mm in maximal diameter. The most common INT territory was the anterior cerebral artery (27.8%). Almost half of the INTs were multiple (46 subjects, 43.5%, range, 2-12). INT was associated with poorer outcomes as compared to no INT on the primary outcome of modified Rankin Scale score of 0 to 2 at 90 days (adjusted risk ratio, 0.71 [95% CI, 0.57-0.89]). Infarct volume in those with INT was greater by a median of 21 cc compared with those without, and there was a greater risk of death as compared to patients with no INT (adjusted risk ratio, 2.15 [95% CI, 1.48-3.13]). CONCLUSIONS: Infarcts in a new territory are common in individuals undergoing endovascular thrombectomy for acute ischemic stroke and are associated with poorer outcomes. Optimal therapeutic approaches, including technical strategies, to reduce INT represent a new target for incremental quality improvement of endovascular thrombectomy. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02930018.
Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Female , Humans , Aged , Male , Ischemic Stroke/complications , Treatment Outcome , Stroke/diagnostic imaging , Stroke/drug therapy , Stroke/surgery , Brain Ischemia/diagnostic imaging , Brain Ischemia/drug therapy , Brain Ischemia/surgery , Thrombectomy/methods , Infarction , Endovascular Procedures/adverse effectsABSTRACT
PURPOSE: Endovascular treatment of spinal AVMs is limited by low complete cure rates. Transarterial extensive treatment with liquid embolics carries the risk of clinically relevant ischemic complications. We report two cases of symptomatic spinal AVMs treated by a transvenous approach with retrograde pressure cooker technique. METHODS: In two selected cases, transvenous navigation aimed at retrograde pressure cooker embolization. RESULTS: Retrograde venous navigation was possible with two parallel microcatheters, and the pressure cooker technique with ethylenvinylalcohol-polymer was applicable in both cases. One AVM was occluded completely, and one subtotally due to a second draining vein. No clinical complications occurred. CONCLUSION: A transvenous approach for embolization with liquid embolics may offer advantages in treating certain spinal AVMs.
Subject(s)
Embolization, Therapeutic , Intracranial Arteriovenous Malformations , Humans , Veins , Embolization, Therapeutic/methods , Intracranial Arteriovenous Malformations/therapy , Treatment OutcomeABSTRACT
Background Evidence supporting a potential benefit of thrombectomy for distal medium vessel occlusions (DMVOs) of the anterior cerebral artery (ACA) is, to the knowledge of the authors, unknown. Purpose To compare the clinical and safety outcomes between mechanical thrombectomy (MT) and best medical treatment (BMT) with or without intravenous thrombolysis for primary isolated ACA DMVOs. Materials and Methods Treatment for Primary Medium Vessel Occlusion Stroke, or TOPMOST, is an international, retrospective, multicenter, observational registry of patients treated for DMVO in daily practice. Patients treated with thrombectomy or BMT alone for primary ACA DMVO distal to the A1 segment between January 2013 and October 2021 were analyzed and compared by one-to-one propensity score matching (PSM). Early outcome was measured by the median improvement of National Institutes of Health Stroke Scale (NIHSS) scores at 24 hours. Favorable functional outcome was defined as modified Rankin scale scores of 0-2 at 90 days. Safety was assessed by the occurrence of symptomatic intracerebral hemorrhage and mortality. Results Of 154 patients (median age, 77 years; quartile 1 [Q1] to quartile 3 [Q3], 66-84 years; 80 men; 94 patients with MT; 60 patients with BMT) who met the inclusion criteria, 110 patients (median age, 76 years; Q1-Q3, 67-83 years; 50 men; 55 patients with MT; 55 patients with BMT) were matched. DMVOs were in A2 (82 patients; 53%), A3 (69 patients; 45%), and A3 (three patients; 2%). After PSM, the median 24-hour NIHSS point decrease was -2 (Q1-Q3, -4 to 0) in the thrombectomy and -1 (Q1-Q3, -4 to 1.25) in the BMT cohort (P = .52). Favorable functional outcome (MT vs BMT, 18 of 37 [49%] vs 19 of 39 [49%], respectively; P = .99) and mortality (MT vs BMT, eight of 37 [22%] vs 12 of 39 [31%], respectively; P = .36) were similar in both groups. Symptomatic intracranial hemorrhage occurred in three (2%) of 154 patients. Conclusion Thrombectomy appears to be a safe and technically feasible treatment option for primary isolated anterior cerebral artery occlusions in the A2 and A3 segment with clinical outcomes similar to best medical treatment with and without intravenous thrombolysis. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Zhu and Wang in this issue.
Subject(s)
Brain Ischemia , Infarction, Anterior Cerebral Artery , Stroke , Male , Humans , Aged , Stroke/diagnostic imaging , Stroke/drug therapy , Stroke/surgery , Brain Ischemia/etiology , Retrospective Studies , Infarction, Anterior Cerebral Artery/etiology , Treatment Outcome , Thrombectomy/methodsABSTRACT
BACKGROUND: Endovascular embolization is a feasible treatment for cranial dural arteriovenous fistulas (DAVFs). New embolic agents aim to improve the success of DAVF embolization. OBJECTIVE: To assess the safety, efficacy, and short-term outcome of the treatment of DAVFs using the new liquid embolic agent Squid. METHODS: The LIQUID study is a prospective, observational multicenter study on the treatment of high-grade (Cognard type ≥3) DAVFs with the embolic agent Squid. The primary outcome measures were safety (ie, morbidity and mortality), as well as the occlusion rate 90 to 180 days after treatment. RESULTS: In eight centers, 53 patients (mean age 59.8 years, 22.6% female) were treated in 55 treatment sessions. Of the DAVFs, 56.6% were Cognard type III, 41.5% type IV, and 18.9% were ruptured. Squid 18 was used in 83.6% and Squid 12 in 32.7% of the treatments. The overall rate of intraprocedural or postprocedural adverse events (AEs) was 18.2%. Procedure-related AEs resulting in permanent morbidity were observed in 3.6%. One patient (1.8%) died unrelated to the procedure due to pulmonary embolism. The final complete occlusion rate at 90 to 180 days was 93.2%. After a mean follow-up of 5.5 months, the modified Rankin Scale (mRS) score was stable or improved in 93.0%. In one of the patients, worsening of the mRS score was related to the procedure (1.8%). CONCLUSION: Squid is a safe and effective liquid embolic agent for the treatment of high-grade DAVFs.
Subject(s)
Central Nervous System Vascular Malformations , Embolization, Therapeutic , Humans , Female , Middle Aged , Male , Prospective Studies , Treatment Outcome , Central Nervous System Vascular Malformations/diagnostic imaging , Central Nervous System Vascular Malformations/therapy , Central Nervous System Vascular Malformations/etiology , Embolization, Therapeutic/adverse effects , Embolization, Therapeutic/methods , Polyvinyls , Retrospective StudiesABSTRACT
BACKGROUND: Remote access of trainees to training centers via video streaming (tele-observership, efellowship) emerges as an alternative to acquire knowledge in endovascular interventions. Situational awareness is a summary term that is also used in surgical procedures for perceiving and understanding the situation and projecting what will happen next. A high situational awareness would serve as prerequisite for meaningful learning success during tele-observerships. We hypothesized that live perception of the angiographical procedures using streaming technology is feasible and sufficient to gain useful situational awareness of the procedure. METHODS: During a European tele-observership organized by the European Society of Minimally Invasive Neurological Therapy (ESMINT) and its trainee association (EYMINT), a total of six neurointerventional fellows in five countries observed live cases performed by experienced neurointerventionalists (mentors) in six different high-volume neurovascular centers across Europe equipped with live-streaming technology (Tegus Medical, Hamburg, Germany). Cases were prospectively evaluated during a 12-month period, followed by a final questionnaire after completion of the course. RESULTS: A total of 102/161 (63%) cases with a 1:1 allocation of fellow and mentor were evaluated during a 12-month period. Most frequent conditions were ischemic stroke (27.5%), followed by embolization of unruptured aneurysms (25.5%) and arteriovenous malformations (AVMs) (15.7%). A high level of situational awareness was reported by fellows in 75.5% of all cases. After finishing the program, the general improvement of neurointerventional knowledge was evaluated to be extensive (1/6 fellows), substantial (3/6), and moderate (2/6). The specific fields of improvement were procedural knowledge (6/6 fellows), technical knowledge (3/6) and complication management (2/6). CONCLUSION: Online streaming technology facilitates location-independent training of complex neurointerventional procedures through high levels of situational awareness and can therefore supplement live hands-on-training. In addition, it leads to a training effect for fellows with a perceived improvement of their neurointerventional knowledge.
Subject(s)
Fellowships and Scholarships , Humans , Europe , GermanyABSTRACT
BACKGROUND: Vessel tortuosity poses a challenge during endovascular treatment of neurovascular lesions. Bendit Technologies (Petah Tikva, Israel) has developed flexible, steerable microcatheters designed with unique bending and torquing capabilities. OBJECTIVE: To describe our first-in-human trial of Bendit21. METHODS: Bendit21 was used in our exploratory, prospective, multicenter, open-label, single-arm clinical study, and in two compassionate use cases. Procedures were conducted at four centers in Austria, Germany, Israel, and the United States between May 2021 and March 2022, in patients with neurovascular conditions. The primary endpoints were device-related safety events, successful navigation through the neurovasculature, and, when intended, successful delivery of contrast or therapy. RESULTS: Two patients with giant aneurysms were treated successfully under compassionate use approval. The clinical study included 25 patients (mean age: 63.4±11.8 years; 32.0% female). Fourteen patients (56.0%) had aneurysms, two had arteriovenous malformations/fistulas (8.0%), one had a stroke (4.0%), four (16.0%) had intracranial stenosis, and four (16.0%) had other conditions. Bendit21 was used without a guidewire in 12/25 (48.0%) procedures. Bendit21 was successfully navigated through the vasculature without delays or spasms in all cases (100%). Contrast was delivered as intended in 7/7 (100%) cases. Therapeutic devices were delivered successfully with Bendit as intended in 14/18 (77.8%) cases; four deficiencies occurred in three patients with aneurysms, in whom delivery of coils, an intrasaccular device, or a flow diverter was attempted. There were no device-related safety events or mortalities. CONCLUSIONS: Our initial clinical experience with the Bendit21 microcatheter demonstrates its usefulness in achieving technical success in patients with challenging neurovascular conditions.