Safety and efficacy of intracranial aneurysm embolization using the "combined remodeling technique": low-profile stents delivered through double lumen balloons: a multicenter experience.

PURPOSE: Since appearance of the balloon-remodeling technique and stent-assisted coiling, complex aneurysms have been treated successfully by endovascular means worldwide. Although these two techniques have been widely proven, the combination of both traditionally made the procedures more complicated technically. The aim of our study was to determine the technical success, safety, and efficacy of the low-profile stents delivered through double lumen balloons. METHODS: Clinical, procedural, and angiographic data were analyzed. RESULTS: Eighty-four patients (55 women; age range 20-81 years) harboring 86 aneurysms were included in this study. Aneurysm maximal diameter ranged from 2 to 26 mm, with mean 7.5 mm. There were 62 unruptured, 15 recanalized, and 9 acutely ruptured aneurysms. Aneurysm locations were ACoA (31), MCA (36), supraclinoid ICA (4), carotid bifurcation (2), basilar (7), PCA (3), PICA (2), and VA (1). Ninety-three devices were implanted (63 LVIS jr, 15 LEO Baby, 14 ACCLINO Flex and 1 Neuroform Atlas) through the double lumen balloons (Scepter C or XC and Eclipse 2 L). We found 2 minor clinical events (2.4%) and 1 major event (1.2%). Total intra-procedural technical complication rate was 11.6%. Follow-up was available for 71 patients with an average follow-up of 7 months. Complete and near complete occlusion was 90.1%. Residual aneurysms were seen in 9.9%. CONCLUSION: The "combined remodeling technique" with low-profile stents delivered through double-lumen balloons is technically feasible, safe, and effective for the treatment of intracranial aneurysms. This technique allows the operator to avoid extra maneuvers.

Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils. METHODS: A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized. RESULTS: Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; P=0.036). Adverse and serious adverse events were evenly distributed between groups. CONCLUSIONS: Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms. CLINICAL TRIAL REGISTRATION: URL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.

Delayed ipsilateral parenchymal hemorrhage following treatment of intracranial aneurysms with flow diverter.

INTRODUCTION: The use of flow diverters (FDs) has shown promising results, particularly in the treatment of large or complex intracranial aneurysms. However, some complications can occur both during and after FD treatment, including delayed ipsilateral parenchymal hemorrhage (DIPH). The clinical presentation, etiopathogeny, and management of this complication are not well understood. We report a series of four patients with DIPH and discuss the potential mechanisms and modalities of treatment. METHODS: Four patients treated with FDs and presenting with DIPH were diagnosed in two different centers. Clinical and imaging data were reviewed before and after the procedure. Characteristics of the intraparenchymal hematomas, the modalities of treatment, and clinical course were analyzed. RESULTS: Intraparenchymal hemorrhage occurred 1 to 4 days after aneurysm treatment with FDs. All hemorrhages were situated in the ipsilateral hemisphere and were anatomically remote from the treated aneurysm. The four patients were treated with emergency surgery (hematoma evacuation). All patients had a favorable clinical outcome (mRS = 1) at midterm evaluation. Follow-up imaging showed good permeability of the FD in all subjects and complete aneurysm occlusion in all patients. CONCLUSION: From the literature review, DIPH appears to be more frequent than delayed aneurysm rupture and may be a cause of increasing concern for the use of flow diverters. However, the mechanisms of DIPH are not completely understood. Surgical evacuation of the hematoma seems to be feasible with acceptable safety and good clinical outcomes.

Outcome after mechanical thrombectomy using a stent retriever under conscious sedation: comparison between tandem and single occlusion of the anterior circulation.

BACKGROUND AND PURPOSE: In acute ischemic stroke patients, internal carotid artery/middle cerebral artery (ICA/MCA) occlusion in tandem predicts a poor outcome after systemic thrombolysis. This study aimed to compare outcomes after mechanical thrombectomy for tandem and single occlusions of the anterior circulation. MATERIALS AND METHODS: This prospective study included consecutive patients with acute ischemic stroke of the anterior circulation who had undergone mechanical thrombectomy performed with a stent retriever under conscious sedation within 6h of symptom onset. Data on clinical, imaging and endovascular findings were collected. In cases of tandem occlusion, distal thrombectomy (retrograde approach) was performed first whenever possible. Tandem and single occlusions were compared in terms of functional outcome and mortality at 3 months. RESULTS: From May 2010 to April 2012, 42 patients with acute ischemic stroke attributable to MCA and/or ICA occlusion were treated. Eleven patients (26.2%) presented with tandem occlusions and 31 patients (73.8%) had a single anterior circulation occlusion. Baseline characteristics were similar between the two groups. Recanalization status also did not differ significantly (P=0.76), but patients with tandem occlusions had poorer functional outcomes (18.2% vs. 67.7% for single occlusions; P=0.01), a higher mortality rate at 3 months (45.5% vs. 12.9%, respectively; P=0.03) and more symptomatic intracranial hemorrhages at 24h (9.7% vs. 0%, respectively; P=0.01). A high rate of early proximal re-occlusion or severe residual stenosis (66%) was also observed in the tandem group. CONCLUSION: Tandem occlusions had poor clinical outcomes after mechanical thrombectomy compared with single occlusions. The retrograde approach (treatment of distal occlusion first) used in patients under conscious sedation may have contributed to these poor outcomes.

ihtObtura: A novel liquid embolic agent with post-embolization radiopacity loss, in endovascular treatment of brain arteriovenous malformations, dural arteriovenous fistulas, and tumors: CLARIDAD trial.

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.

Predictive factors of outcome and hemorrhage after acute ischemic stroke treated by mechanical thrombectomy with a stent-retriever.

INTRODUCTION: The study attempts to identify notable factors predicting poor outcome, death, and intracranial hemorrhage in patients with acute ischemic stroke undergoing mechanical thrombectomy with stent retriever. These data could be useful to improve the selection of patients for thrombectomy. METHODS: Patients with acute ischemic stroke treated with the Solitaire FR device were retrospectively analyzed from a prospectively collected database. We assessed the effect of selected demographic characteristics, clinical and imaging factors on poor outcome at 3 months (modified Rankin score 3-6), mortality at 3 months, and hemorrhage at day 1 (symptomatic and asymptomatic). RESULTS: From May 2010 to April 2012, 59 consecutive patients with an acute ischemic stroke underwent mechanical thrombectomy. At 3 months, 57.6% of the patients were functionally independent (modified Rankin Scale 0-2) and mortality was 20.4%. Multivariate analyses revealed that a thrombus length > 14 mm (p = 0.02; OR 7.55; 95% CI 1.35-42.31) and longer endovascular procedure duration (p = 0.01; OR 1.04; 95% CI 1.01-1.07) were independently associated with poor outcome. A higher baseline Alberta Stroke Program Early CT (ASPECT) score (p = 0.04; OR 0.79 per point; 95% CI 0.63-0.99) and successful recanalization (p = 0.02; OR 0.07; 95% CI 0.01-0.72) were independent predictors of good functional outcome. Baseline ASPECT score (p < 0.01; OR 0.65; 95% CI 0.54-0.78) independently predicted symptomatic intracranial hemorrhage at day 1. CONCLUSION: Absolute baseline ASPECT score reflects early symptomatic hemorrhage risk and functional outcome at 3 months. Thrombus length measured on MRI play an important role on functional outcome at 3 months after thrombectomy. Further analyses are needed to determine its importance in the selection of patients for mechanical thrombectomy.

Mechanical thrombectomy "as a rescue treatment" of thromboembolic complications during endovascular treatment of intracranial aneurysms.

Acute thromboembolic periprocedural events during endovascular intracranial aneurysm treatment are mostly treated with intravenous or intra-arterial pharmacological thrombolysis. The present report describes a case of mechanical thrombectomy as a rescue treatment that may be an acceptable alternative to the current strategies. The feasibility and safety of stent retrievers in such a clinical indication are also discussed.

Combined use of a double-lumen remodeling balloon and a low-profile stent in the treatment of intracranial aneurysms ('remostent' technique): a technical note.

Remodeling technique and stenting represent important options for intracranial aneurysm treatment, and they sometimes need to be combined. The technology of remodeling balloons and stents has recently evolved with the development of the double-lumen remodeling balloon (Scepter and Ascent) and the low-profile stent (LVIS Jr). This report describes our initial experience with and feasibility of the deployment of the low-profile stent through the balloon's internal guidewire lumen, thereby reducing the number of manoeuvres by combining remodeling and stenting.

The place for remodeling technique and stenting in the endovascular management of intracranial aneurysms: a single-center analysis from 2008 to 2010.

INTRODUCTION: The objective of this study was to analyze the place for the balloon remodeling and stenting in the endovascular treatment of intracranial aneurysms as well as the impact of their use on the failure and complications rates. Analysis was conducted in a recent 3-year period (2008-2010) in a single center. METHODS: A total of 287 aneurysms, harbored by 252 patients (age, 16-87 years; mean, 50.9 ± 13.4 years), were proposed for endovascular treatment. Patient and aneurysms characteristics, modalities of treatment (coiling, remodeling, or stenting), failure rate, and rate of adverse events related to the treatment were analyzed. RESULTS: Treatment failed in 3/287 aneurysms (1.0%). The use of the remodeling technique and stenting increased over time (23.9% and 4.6% in 2008, 39.5% and 14.9% in 2009, and 43.9% and 20.7% in 2010, respectively). The remodeling technique was used in a similar percentage of cases independent of aneurysm characteristics (aneurysm status, location, and size, and neck size), except dome-to-neck ratio. Stenting was more frequently used in unruptured aneurysms, in internal carotid artery aneurysms, and in wide neck aneurysms. The rate of specific adverse events (thromboembolism and intraoperative rupture) was similar in coiling (2.8%), remodeling (6.9%), and stenting (1.1%). The rate of specific adverse events was similar in 2008, 2009, and 2010 (2.3%, 4.4%, and 6.1%, respectively). CONCLUSION: In the endovascular management of intracranial aneurysms, the large use of the remodeling technique combined with stenting in selected cases enables a low rate of treatment failures without increasing the rate of complications.

The Effects of Sampling Lateralization on Bilateral Inferior Petrosal Sinus Sampling for Pediatric Cushing's Disease-A Single Endocrinology Centre Experience and Review of the Literature.

Background: This study aims to analyze the diagnostic accuracy of bilateral inferior petrosal sinus sampling (BIPSS), the gold standard test for the differential diagnosis of ACTH-dependent Cushing's syndrome (CS) in a group of pediatric patients with Cushing's disease (CD). Methods: This is a retrospective analysis which include 12 patients with hypercortisolemia and inconclusive pituitary MRI, who underwent bilateral inferior petrosal sinus sampling (BIPSS) and transsphenoidal surgery (TSS) from 2004 to 2020 in the Children's Memorial Health Institute (CMHI) Warsaw, Poland. Pituitary origin of ACTH secretion was considered if baseline central to peripheral (C/P) ACTH level ratio was ≥ 2 or C/P ratio was ≥ 3 after human corticotropin-releasing hormone (hCRH) stimulation. The diagnosis was histologically confirmed in almost all cases after TSS. Results: The diagnostic accuracy of BIPSS reached 75% at baseline and 83.3% after CRH stimulation. The compatibility of localization of a microadenoma by BIPSS with the surgical location was 66.7%. Conclusions: Owing to its high diagnostic effectiveness, BIPSS remains the best test to differentiate CD from EAS. The indications for the procedure should be carefully considered, because EAS in the pediatric population, unlike in adults, is extremely rare. Moreover BIPSS has only limited value for indicating tumor localization.

Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study.

BACKGROUND: Flow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long-term clinical and angiographic outcomes. METHODS: A prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0-1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3-5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale. RESULTS: Between July 2014 and February 2018, 119 patients were enrolled. Twenty-three patients were excluded. Ninety-six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1-3). Clinical follow-up at 18 months was available in 90 (94%) patients, resulting in a mean follow-up period of 14.8±5.2 months. At last available follow-up of 96 enrolled patients, 91 (95%) remained mRS 0-1. The major morbidity rate (mRS 3-5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow-up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89). CONCLUSION: Our results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality. TRIAL REGISTRATION: DRKS00006103.

Optional Endovascular Therapy of Dissecting Posterior Cerebral Artery Aneurysm.

BACKGROUND: Posterior cerebral artery aneurysms are uncommon, with an occurrence rate of less than 1% of intracranial aneurysms. They have various shapes, including saccular and fusiform. Dissecting aneurysms may occur in distal posterior cerebral artery and they may affect the whole artery. Endovascular therapy is considered as a safe method of treatment and there are different techniques for endovascular therapy. SUMMARY: Posterior cerebral artery aneurysms are uncommon. Endovascular therapy is considered as a safe method of treatment and there are different techniques for endovascular therapy. We present here three cases collected from Maison Blanche Hospital (Intervention Neuroradiology Department, CHU Reims, France) during 2011-2012; they were females, at a young age and the affected side was on the right. The first case was affected at the P2-P3 segment, the aneurysm was fusiform in shape and she presented with ischemic stroke, while the second and third cases were affected at the P2 segment, the aneurysms being saccular in shape; one of them presented with subarachnoid hemorrhage with a history of migraine and the other patient presented with ischemic stroke. All of them had no history of trauma, hypertension or other diseases. One patient was treated by coiling and sacrificing the parent artery, the second patient was treated with stent-assisted coils, and the third one was treated by coiling without sacrificing the parent artery.

Follow-up of intracranial aneurysms treated by flow diverter: comparison of three-dimensional time-of-flight MR angiography (3D-TOF-MRA) and contrast-enhanced MR angiography (CE-MRA) sequences with digital subtraction angiography as the gold standard.

BACKGROUND AND PURPOSE: Follow-up of intracranial aneurysms treated by flow diverter with MRI is complicated by imaging artifacts produced by these devices. This study compares the diagnostic accuracy of three-dimensional time-of-flight MR angiography (3D-TOF-MRA) and contrast-enhanced MRA (CE-MRA) at 3 T for the evaluation of aneurysm occlusion and parent artery patency after flow diversion treatment, with digital subtraction angiography (DSA) as the gold standard. MATERIALS AND METHODS: Patients treated with flow diverters between January 2009 and January 2013 followed by MRA at 3 T (3D-TOF-MRA and CE-MRA) and DSA within a 48 h period were included in a prospective single-center study. Aneurysm occlusion was assessed with full and simplified Montreal scales and parent artery patency with three-grade and two-grade scales. RESULTS: Twenty-two patients harboring 23 treated aneurysms were included. Interobserver agreement using simplified scales for occlusion (Montreal) and parent artery patency were higher for DSA (0.88 and 0.61) and CE-MRA (0.74 and 0.55) than for 3D-TOF-MRA (0.51 and 0.02). Intermodality agreement was higher for CE-MRA (0.88 and 0.32) than for 3D-TOF-MRA (0.59 and 0.11). CE-MRA yielded better accuracy than 3D-TOF-MRA for aneurysm remnant detection (sensitivity 83% vs 50%; specificity 100% vs 100%) and for the status of the parent artery (specificity 63% vs 32%; sensitivity 100% vs 100%). CONCLUSIONS: At 3 T, CE-MRA is superior to 3D-TOF-MRA for the evaluation of aneurysm occlusion and parent artery patency after flow diversion treatment. However, intraluminal evaluation remains difficult with MRA regardless of the sequence used.

Endovascular treatment with flow diverters of recanalized and multitreated aneurysms initially treated by endovascular approach.

PURPOSE: To evaluate the feasibility, safety and efficacy of endovascular treatment with flow diverters in patients with recanalized and multitreated aneurysms in a retrospective, multicenter, single-arm study. METHODS: The study included 29 patients with 29 recanalized aneurysms who were treated by flow diverters (Silk or Pipeline devices). Pre- and post-procedural complications and morbidity and mortality rates were evaluated and functional outcomes (modified Rankin Score (mRS)) at 1 month (short-term) and 3-4 months (mid-term) were compared with preoperative mRS (before the procedure). Mid-term angiographic follow-up was performed assessing aneurysmal occlusion by the Montreal scale (complete occlusion, neck remnant, aneurysm remnant). RESULTS: Placement of the flow diverters was achieved in all patients. Two misdeployments of the flow diverters necessitated balloon dilation in two patients, which was associated with stent delivery in one patient. Permanent morbidity related to treatment was 6.9% (2/29), transient morbidity was 10.3% (3/29) and there were no deaths resulting from the treatment. One patient died from a myocardial infarct 4 weeks after the procedure. 25/29 patients (86.2%) had a good final functional outcome, 26/29 (89.7%) had an unchanged functional outcome and 2/29 patients (6.9%) had clinical worsening. Angiographic follow-up showed complete occlusion in 17/28 patients (60.7%), neck remnants in 6/28 patients (21.4%) and residual aneurysms in 5/28 (17.9%). CONCLUSIONS: Flow diverter placement is feasible and safe in patients with recanalized and multitreated aneurysms. The procedure is associated with a high percentage of good functional outcomes as well as good mid-term anatomical results (82.1%).

Endovascular WEB flow disruption in middle cerebral artery aneurysms: preliminary feasibility, clinical, and anatomical results in a multicenter study.

BACKGROUND: The endovascular treatment of middle cerebral artery (MCA) aneurysms with unfavorable anatomy (wide neck, unfavorable morphology) is frequently challenging. Flow disruption with the WEB is a potentially interesting endovascular treatment for this type of aneurysm. OBJECTIVE: To report in a multicenter series the preliminary treatment experience of MCA aneurysms with flow disruption by the WEB. METHODS: Thirty-three patients with 34 MCA aneurysms were treated with the WEB in 5 European centers. The ability to successfully deploy the WEB, procedure- and device-related adverse events, morbidity and mortality of the treatment, and short-term angiographic follow-up results were analyzed. RESULTS: Most treated aneurysms were unruptured (85.3%) and were between 5 and 10 mm (85.3%) with a neck size ≥ 4 mm (88.2%). The treatment failed in 1 of the 34 aneurysms (2.9%) owing to a lack of appropriate device size. Treatment was performed exclusively with the WEB in 29 of 33 aneurysms (87.9%). Additional treatment (coiling and/or stenting) was used in 4 of 33 aneurysms (12.1%). Mortality of the treatment was 0.0% and morbidity was 3.1% (intraoperative rupture with modified Rankin Scale score of 3 at the 1-month follow-up). In short-term follow-up (range, 2-12 months), adequate occlusion (total occlusion or neck remnant) was observed in 83.3% of aneurysms. CONCLUSION: WEB flow disruption seems to be a promising technique for the treatment of complex MCA aneurysms, particularly those with a wide neck or unfavorable dome-to-neck ratio.

[Treatment for intracranial aneurysms]. / Traitement des anévrismes intracrâniens.

Aneurysm rupture is suspected in case of sudden, intense headache, sometimes associated with nausea or vomiting, focal neurologic deficit or loss of consciousness. Aneurysm rupture is a diagnostic and therapeutic emergency that has to be managed in highly specialized centers. Ruptured aneurysms have to be treated in emergency to avoid rebleeding. Endovascular approach is the first line treatment. The indications for treatment of unruptured have to be discussed according to several factors including patient's age, aneurysm size and location. Follow-up examinations are needed after aneurysm treatment (CTA, MRA, DSA). According to aneurysm risk factors, patients with aneurysms have to stop smoking and their blood pressure should be controlled on a regular basis and treated if needed.