Optimal deep brain stimulation sites and networks for cervical vs. generalized dystonia.

Dystonia is a debilitating disease with few treatment options. One effective option is deep brain stimulation (DBS) to the internal pallidum. While cervical and generalized forms of isolated dystonia have been targeted with a common approach to the posterior third of the nucleus, large-scale investigations regarding optimal stimulation sites and potential network effects have not been carried out. Here, we retrospectively studied clinical results following DBS for cervical and generalized dystonia in a multicenter cohort of 80 patients. We model DBS electrode placement based on pre- and postoperative imaging and introduce an approach to map optimal stimulation sites to anatomical space. Second, we investigate which tracts account for optimal clinical improvements, when modulated. Third, we investigate distributed stimulation effects on a whole-brain functional connectome level. Our results show marked differences of optimal stimulation sites that map to the somatotopic structure of the internal pallidum. While modulation of the striatopallidofugal axis of the basal ganglia accounted for optimal treatment of cervical dystonia, modulation of pallidothalamic bundles did so in generalized dystonia. Finally, we show a common multisynaptic network substrate for both phenotypes in the form of connectivity to the cerebellum and somatomotor cortex. Our results suggest a brief divergence of optimal stimulation networks for cervical vs. generalized dystonia within the pallidothalamic loop that merge again on a thalamo-cortical level and share a common whole-brain network.

First experience with Walrus balloon guide catheter in a whole-body flow model.

PURPOSE: Flow arrest using a balloon guide catheter (BGC) in mechanical thrombectomy (MT) due to large vessel occlusion has been associated with better outcomes. Known limitations of currently commercially available BGCs are incompatibility with large bore aspiration catheters (AC) and lack of distal flexibility. Walrus presents variable stiffness and compatibility with large bore AC. The goal of this study is to describe the first experience with Walrus in a realistic stroke simulation model. METHODS: A full-length modular vascular model under physiological conditions was used. 8F+-Walrus inner-diameter (ID) 0.087in 95 cm combined with 6F-Sofia AC ID 0.070in 131 cm and an 8F-Flowgate2 BGC ID 0.084in 95 cm with a 5F-Sofia AC ID 0.055in 125 cm were used to perform aspiration MT. User surveys, access to target and occlusion site, technique, time of delivery, anatomical change, and catheter kick-back were assessed. RESULTS: Seven neuroradiologists with average of 10 years-experience in MT performed primary aspiration using the above-mentioned combinations in three different anatomies (N = 41). All operators would likely (29%) or very likely (71%) use again Walrus in combination with large bore AC and the majority (86%) found its navigability easier than with other BGCs. Time to reach final BGC position and catheter kick-back did not differ significantly among anatomies or catheter combinations (p > 0.05). However, Walrus was more likely to reach ICA petrous segment (p < 0.05) and intracranial occlusion with AC (p < 0.01). CONCLUSION: The Walrus combined with large bore AC presented significantly better distal access and navigability for primary aspiration in an in vitro stroke model.

Probabilistic mapping of the antidystonic effect of pallidal neurostimulation: a multicentre imaging study.

Deep brain stimulation of the internal globus pallidus is a highly effective and established therapy for primary generalized and cervical dystonia, but therapeutic success is compromised by a non-responder rate of up to 25%, even in carefully-selected groups. Variability in electrode placement and inappropriate stimulation settings may account for a large proportion of this outcome variability. Here, we present probabilistic mapping data on a large cohort of patients collected from several European centres to resolve the optimal stimulation volume within the pallidal region. A total of 105 dystonia patients with pallidal deep brain stimulation were enrolled and 87 datasets (43 with cervical dystonia and 44 with generalized dystonia) were included into the subsequent 'normative brain' analysis. The average improvement of dystonia motor score was 50.5 ± 30.9% in cervical and 58.2 ± 48.8% in generalized dystonia, while 19.5% of patients did not respond to treatment (<25% benefit). We defined probabilistic maps of anti-dystonic effects by aggregating individual electrode locations and volumes of tissue activated (VTA) in normative atlas space and ranking voxel-wise for outcome distribution. We found a significant relation between motor outcome and the stimulation volume, but not the electrode location per se. The highest probability of stimulation induced motor benefit was found in a small volume covering the ventroposterior globus pallidus internus and adjacent subpallidal white matter. We then used the aggregated VTA-based outcome maps to rate patient individual VTAs and trained a linear regression model to predict individual outcomes. The prediction model showed robustness between the predicted and observed clinical improvement, with an r2 of 0.294 (P < 0.0001). The predictions deviated on average by 16.9 ± 11.6 % from observed dystonia improvements. For example, if a patient improved by 65%, the model would predict an improvement between 49% and 81%. Results were validated in an independent cohort of 10 dystonia patients, where prediction and observed benefit had a correlation of r2 = 0.52 (P = 0.02) and a mean prediction error of 10.3% (±8.9). These results emphasize the potential of probabilistic outcome brain mapping in refining the optimal therapeutic volume for pallidal neurostimulation and advancing computer-assisted planning and programming of deep brain stimulation.

Multimodal validation of focal enhancement in intracranial aneurysms as a surrogate marker for aneurysm instability.

PURPOSE: Circumferential enhancement on MR vessel wall imaging has been proposed as a biomarker of a higher risk of rupture in intracranial aneurysms. Focal enhancement is frequently encountered in unruptured aneurysms, but its implication for risk stratification and patient management remains unclear. This study investigates the association of focal wall enhancement with hemodynamic and morphological risk factors and histologic markers of wall inflammation and degeneration. METHODS: Patients with an unruptured middle cerebral artery aneurysm who underwent 3D rotational angiography and 3T MR vessel wall imaging showing focal wall enhancement were included. Hemodynamic parameters were calculated based on flow simulations and compared between enhanced regions and the entire aneurysm surface. Morphological parameters were semiautomatically extracted and quantitatively associated with wall enhancement. Histological analysis included detection of vasa vasorum, CD34, and myeloperoxidase staining in a subset of patients. RESULTS: Twenty-two aneurysms were analyzed. Enhanced regions were significantly associated with lower AWSS, lower maxOSI, and increased LSA. In multivariate analysis, higher ellipticity index was an independent predictor of wall enhancement. Histologic signs of inflammation and degeneration and higher PHASES score were significantly associated with focal enhancement. CONCLUSION: Focal wall enhancement is colocalized with hemodynamic factors that have been related to a higher rupture risk. It is correlated with morphological factors linked to rupture risk, higher PHASES score, and histologic markers of wall destabilization. The results support the hypothesis that focal enhancement could serve as a surrogate marker for aneurysm instability.

Automated versus manual imaging assessment of early ischemic changes in acute stroke: comparison of two software packages and expert consensus.

AIM: The purpose of our study was to compare the agreement of both the total Alberta Stroke Program Early CT Score (ASPECTS) and region-based scores from two automated ASPECTS software packages and an expert consensus (EC) reading with final ASPECTS in a selected cohort of patients who had prompt reperfusion from endovascular thrombectomy (EVT). METHODS: ASPECTS were retrospectively and blindly assessed by two software packages and EC on baseline non-contrast-enhanced computed tomography (NCCT) images. All patients had multimodal CT imaging including NCCT, CT angiography, and CT perfusion which demonstrated an acute anterior circulation ischemic stroke with a large vessel occlusion. Final ASPECTS on follow-up scans in patients who had EVT and achieved complete reperfusion within 100 min from NCCT served as ground truth and were compared to total and region-based scores. RESULTS: Fifty-two patients met our study criteria. Moderate agreement was obtained between both software packages and EC for total ASPECTS and there was no significant difference in overall performance. However, the software packages differed with respect to regional contribution. In this cohort, the majority of infarcted regions were deep structures. Package A was more sensitive in cortical areas than the other methods, but at a cost of specificity. EC and software package B had greater sensitivity, but lower specificity for deep brain structures. CONCLUSION: In this cohort, using the final ASPECTS as ground truth, no clinically significant difference was observed for total ASPECT score between human or automated packages, but there were differences in the characteristics of the regions scored. KEY POINTS: • Some national stroke guidelines have incorporated ASPECTS in their recommendations for selecting patients for endovascular therapy. • Computer-aided diagnosis is a promising tool to aid the evaluation of early ischemic changes identified on CT. • Software packages for automated ASPECTS assessment differed significantly with respect to regional contribution without any significant difference in the overall ASPECT score.

Comparison of Perfusion CT Software to Predict the Final Infarct Volume After Thrombectomy.

BACKGROUND AND PURPOSE: Computed tomographic perfusion represents an interesting physiological imaging modality to select patients for reperfusion therapy in acute ischemic stroke. The purpose of our study was to determine the accuracy of different commercial perfusion CT software packages (Philips (A), Siemens (B), and RAPID (C)) to predict the final infarct volume (FIV) after mechanical thrombectomy. METHODS: Single-institutional computed tomographic perfusion data from 147 mechanically recanalized acute ischemic stroke patients were postprocessed. Ischemic core and FIV were compared about thrombolysis in cerebral infarction (TICI) score and time interval to reperfusion. FIV was measured at follow-up imaging between days 1 and 8 after stroke. RESULTS: In 118 successfully recanalized patients (TICI 2b/3), a moderately to strongly positive correlation was observed between ischemic core and FIV. The highest accuracy and best correlation are shown in early and fully recanalized patients (Pearson r for A=0.42, B=0.64, and C=0.83; P<0.001). Bland-Altman plots and boxplots demonstrate smaller ranges in package C than in A and B. Significant differences were found between the packages about over- and underestimation of the ischemic core. Package A, compared with B and C, estimated more than twice as many patients with a malignant stroke profile (P<0.001). Package C best predicted hypoperfusion volume in nonsuccessfully recanalized patients. CONCLUSIONS: Our study demonstrates best accuracy and approximation between the results of a fully automated software (RAPID) and FIV, especially in early and fully recanalized patients. Furthermore, this software package overestimated the FIV to a significantly lower degree and estimated a malignant mismatch profile less often than other software.

Non-invasive follow-up for intracranial aneurysms treated with contour neurovascular system-comparison of digital subtraction angiography (DSA) to magnetic resonance imaging (MRI) and spectral computed tomography angiography (CTA) in vitro.

PURPOSE: The contour neurovascular system (CNS) is an intrasaccular flow-disrupting device designed for the treatment of intracranial wide-necked bifurcation aneurysms. Metal artifacts limit magnetic resonance imaging (MRI) accessibility after implantation. The purpose of this in vitro study was to evaluate non-invasive imaging alternatives to digital subtraction angiography (DSA). MATERIAL AND METHODS: Three aneurysms of patients originally treated with CNS were three-dimensional (3D)-printed (one at the basilar tip and two at the middle cerebral artery bifurcation). CNS devices were implanted under fluoroscopic control into the 3D models. Post-implantation two-dimensional-DSA, flat panel computed tomography angiography (CTA), MRI, and spectral CTA were performed. RESULTS: Time of flight angiography and T1 weighted sequences showed large susceptibility artifacts at the detachment zone of the devices. A thin-sliced T2 weighted sequence in cross-sectional orientation to the aneurysm allowed visualization of the aneurysm dome, but the aneurysm neck and parent vessel could not be assessed. Focused spectral CTA, especially a 40 keV reconstruction with a metal artifact reduction algorithm (orthopedic metal artifact reduction (OMAR)), showed only minor artifacts at the detachment zone. This approach achieved a very similar result to DSA and flat panel computed tomography, enabling the assessment of the device structure, aneurysm perfusion, and parent vessel perfusion. DISCUSSION AND CONCLUSION: For non-invasive follow-up of CNS, focused 40 keV CTA with OMAR seems to be a valuable option. MRI can be valuable for larger aneurysms to assess the aneurysm dome, but was not suitable for evaluating the parent vessels and aneurysm neck after CNS implantation in this study.

An in-vitro method for comparative analysis of aspiration catheter tracking performance.

BACKGROUND AND PURPOSE: Mechanical thrombectomy (MT) for acute ischemic stroke (AIS) relies on efficient tracking of aspiration catheters through complex vascular anatomies. Differences in catheter design lead to variation in tracking performance which may only become apparent after use in patients. We developed an in-vitro methodology for evaluating aspiration catheter performance under a variety of pre-defined circumstances, that can be used during catheter development for design optimization. METHODS: Validation of the in-vitro methodology involved testing four large bore aspiration catheters on recreated challenging vascular access routes derived from patient angiograms. Two experienced neurointerventionalists conducted the tests under controlled physiological and procedural conditions. Each catheter design was evaluated across 30 unique anatomy-procedural set-up combinations. A fifth, prototype large bore catheter was evaluated by trained engineers to assess the applicability of the in-vitro test. RESULTS: Results from statistical analysis using a general linear model demonstrated the methodology's effectiveness in detecting significant tracking differences among catheter designs (p < 0.01). Minimal inter-operator variability was observed (p = 0.304), while procedural techniques significantly influenced tracking performance (p < 0.01). The tortuosity of the arterial access route notably impacted catheter performance (p < 0.01), with anatomical features revealing varying degrees of influence on desirable and undesirable catheter design aspects. CONCLUSION: We successfully developed a test methodology for evaluating the trackability of large bore aspiration catheters intended for treating acute ischemic stroke with large vessel occlusions. This methodology offers a robust approach to pre-clinical design assessment, utilizing anatomical models that simulate real-world vascular challenges to enhance catheter optimization.

Contour Neurovascular System for endovascular embolization of cerebral aneurysms: a multicenter cohort study of 10 European neurovascular centers.

BACKGROUND: Intrasaccular devices have become increasingly popular in the treatment of cerebral aneurysms, particularly at the bifurcation. Here we evaluate the Contour Neurovascular System, an intrasaccular device for the endovascular treatment of cerebral aneurysms, in a multicenter cohort study, the largest to the best of our knowledge. METHODS: Consecutive patients with intracranial aneurysms treated with the Contour Neurovascular System between February 2017 and October 2022 at 10 European neurovascular centers were prospectively collected and retrospectively reviewed. Patient and aneurysm characteristics, procedural details, and angiographic and clinical outcomes were evaluated. RESULTS: During the study period, 279 aneurysms (median age of patients 60 years, IQR 52-68) were treated with Contour. In 83.2% of patients the device was placed electively, whereas the remaining patients were treated in the setting of acute subarachnoid hemorrhage. The most common locations were the middle cerebral artery (26.5%) followed by the anterior communicating region (26.2%). Median aneurysm dome and neck size were 5.2 mm (IQR 4.2-7) and 3.9 mm (IQR 3-5). Contour size 7 (39%) and 9 (25%) were most used. Thromboembolic and hemorrhagic complications occurred in 6.8% and 0.4% of aneurysms, respectively. Raymond-Roy 1 and 2 occlusions at last follow-up were achieved in 63.2% and 28.3%, respectively, resulting in adequate occlusion of 91.5% of aneurysms. CONCLUSION: This is the largest multicenter study reporting the outcome on the Contour Neurovascular System. At 1 year, the self-evaluated data on safety and efficacy are comparable to data of existing intrasaccular devices. Contour is a promising technology in the treatment of cerebral aneurysms.

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.

BACKGROUND: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. OBJECTIVE: To evaluate angiographic stability at 1 year. METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.

Safety and effectiveness of SOFIA/SOFIA PLUS for direct aspiration as first line treatment in patients with acute anterior ischemic stroke: results from the prospective, multicentric SESAME study.

Background: Mechanical thrombectomy is a cornerstone treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO), yet the optimal technique remains debated. The SOFIA/SOFIA PLUS catheter has emerged as a promising tool for direct aspiration thrombectomy. Purpose: This prospective multi-center study, adhering Good-Clinical-Practice guidelines, aimed to evaluate the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first-line treatment technique in patients with acute anterior circulation LVO. Materials and methods: Between 10/2017 and 12/2021, 246 consecutive patients presenting with AIS due to anterior circulation LVO were enrolled from 14 European centers. Primary treatment with SOFIA catheters was performed within 6 h of symptom onset. Clinical and radiological data were collected, and statistical analyses were conducted. Results: The mean age of the included patients was 71.6 ± 13.9 years, with 44.7% being male. Primary aspiration achieved complete recanalization in 72.8% of patients, with functional independence observed in 63.8% after 90 days. Secondary outcomes included a median NIHSS of 4 at 24 h post-procedure, median ASPECTS of 7 on follow-up imaging, and a mortality rate of 24.4% at 90 days. No device malfunctions were observed, and the rate of symptomatic intracranial hemorrhage was 4.4%. Conclusion: Primary aspiration with the SOFIA/SOFIA PLUS catheter demonstrates favorable safety and efficacy profiles in the treatment of anterior circulation LVO. These findings support the utilization of this technique as a first-line approach in mechanical thrombectomy for AIS, contributing to the growing body of evidence endorsing the effectiveness of direct aspiration thrombectomy in stroke management.

Contour-Assisted coiling with jailed microcatheter May result in better occlusion (CoCoJaMBO) in wide-necked intracranial aneurysms: Proof of principle and immediate angiographic results.

PURPOSE: Wide-necked bifurcation aneurysms, partially thrombosed, and recurrences of large and giant aneurysms are challenging to treat. We report our preliminary experience with a Contour-assisted coiling technique and discuss the periprocedural safety, feasibility, and effectiveness of the approach. METHODS: We retrospectively reviewed consecutive patients who received endovascular treatment for intracranial aneurysms with an intra-aneurysmal flow disruptor (Contour) at two neurovascular centres between October 2018 and December 2020 and identified patients treated with a combination of Contour and platinum coils. Clinical and procedural data were recorded. RESULTS: For this analysis, 8 patients (5 female) aged 60.1 ± 9.2 years on average were identified. Three of 8 aneurysms were associated with previous acute subarachnoid hemorrhage (SAH). The mean average dome height was 12.8 ± 7.6 mm, mean maximum dome width 10.3 ± 5.4 mm, and neck width 5.5 ± 2.5 mm. The mean dome-to-neck ratio was 1.9 ± 1.0. Immediate complete occlusion of the aneurysm was seen in 5 of 8 cases. In one SAH patient, a parent vessel was temporarily occluded but could be reopened rapidly. One device detached prematurely without any sequelae. No other procedural adverse events were recorded. CONCLUSION: From this initial experience, Contour with adjunctive coiling is a safe and technically feasible method for endovascular treatment of large, wide-necked, partially thrombosed, recurrent, or ruptured bifurcation aneurysms. Further studies with larger numbers of patients and longer follow-up are needed to confirm our results.

In vitro and in silico assessment of flow modulation after deploying the Contour Neurovascular System in intracranial aneurysm models.

BACKGROUND: The novel Contour Neurovascular System (Contour) has been reported to be efficient and safe for the treatment of intracranial, wide-necked bifurcation aneurysms. Flow in the aneurysm and posterior cerebral arteries (PCAs) after Contour deployment has not been analyzed in detail yet. However, this information is crucial for predicting aneurysm treatment outcomes. METHODS: Time-resolved three-dimensional velocity maps in 14 combinations of patient-based basilar tip aneurysm models with and without Contour devices (sizes between 5 and 14 mm) were analyzed using four-dimensionsal (4D) flow MRI and numerical/image-based flow simulations. A complex virtual processing pipeline was developed to mimic the experimental shape and position of the Contour together with the simulations. RESULTS: On average, the Contour significantly reduced intra-aneurysmal flow velocity by 67% (mean w/ = 0.03m/s; mean w/o = 0.12m/s; p-value=0.002), and the time-averaged wall shear stress by more than 87% (mean w/ = 0.17Pa; mean w/o = 1.35Pa; p-value=0.002), as observed by numerical simulations. Furthermore, a significant reduction in flow (P<0.01) was confirmed by the neck inflow rate, kinetic energy, and inflow concentration index after Contour deployment. Notably, device size has a stronger effect on reducing flow than device positioning. However, positioning affected flow in the PCAs, while being robust in effectively reducing flow. CONCLUSIONS: This study showed the high efficacy of the Contour device in reducing flow within aneurysms regardless of the exact position. However, we observed an effect on the flow in PCAs, which needs to be investigated further.

Contour device implantation for treatment of intracranial aneurysms in the basilar tip.

INTRODUCTION: Treatment of basilar apex aneurysms will remain challenging regarding the nobility of the parent vessel and their often wide-necked configuration. With endovascular techniques being the treatment approach of choice, novel intrasaccular flow-disruption devices constitute an endovascular embolization option. In this research, we report our experiences in embolizing basilar tip aneurysms with the novel Contour device. MATERIAL AND METHODS: Retrospective analysis of eight patients after Contour implantation into a basilar apex aneurysm. Periprocedural data on intervention times, radiation dose, procedural success and complications were gathered. All patients received follow-up digital subtraction angiography after six months. Further follow-up examination results were analysed given their availability. RESULTS: Contour implantation was successful in all patients. The mean device instrumentation time was 18.8 ± 7.7 min with a mean full intervention time of 100 ± 65.8 min. The mean full procedure radiation dose was 1917 (421-5107) cGy/cm2. After six months, six aneurysms were occluded (Raymond Roy Scale (RRS) 1/2), one showed perfusion inside the device (RRS 3a) and one patient had undergone reintervention due to progression. The aneurysm with constant perfusion at six months was seen to be occluded after 24 months. CONCLUSION: Contour device implantation is a promising feasible alternative endovascular method for embolization of intracranial aneurysms located in the basilar tip with short intervention times and low radiation dosages. Short- and medium-term follow-ups show promising results concerning aneurysm occlusion and reinterventions, however further research is needed to show long-term stability.

The effect of the size of the new contour neurovascular device for altering intraaneurysmal flow.

BACKGROUND: Recently, a novel intrasaccular device (contour neurovascular system, contour) was introduced to treat intracranial aneurysms. Contour is placed at thе aneurysm neck and reduces the intraaneurysmal blood inflow. Contour comes in a range of sizes to target different aneurysms. The efficiency of altering flow with contour and the effect of device size have not yet been investigated. Therefore, we studied the effect of the device size with patient-based aneurysm models using 2D digital subtraction angiography (DSA). METHODS: Three patient-based aneurysm models with necks ranging from 2.7 to 9.7 mm were produced, providing standardized testing conditions. Contours with diameters of 5, 11, and 14 mm were implanted into the models, four of each size. 2D DSA images were acquired before and after implanting contour (15 frames/s, manual contrast injection). After injecting angiographic contrast agent, the DSA signal was recorded over time to calculate the contrast washout time (WOT), which is a measure of flow diversion efficiency. RESULTS: All contour devices caused contrast agent stasis and increased WOT in aneurysm sac (p-value = 0.0005). The median relative WOT was largest for 5-mm contour (6.6 ± 3.2) and similar for 11-mm contour (3.4 ± 2.6) and 14-mm contour (3.2 ± 3.8). The implantation procedure might affect WOT values even for contours of the same size; the overall relative WOT ranged between 1.5 and 10.89. CONCLUSION: The 5-mm contour showed the longest WOT value in our study, while no apparent difference between 11-mm contour and 14-mm contour was found.

Intra-cranial aneurysm treatment with contour or WEB - a single center comparison of intervention times and learning curves.

BACKGROUND AND PURPOSE: Treating aneurysms with intra-saccular flow disruption is a feasible alternative to coil-embolization. Besides the established WEB device, the novel Contour Neurovascular System has emerged as a potentially easier alternative regarding sizing and deployment. We report the learning curve experienced at our center from the first 48 patients treated with Contour and compared it with 48 consecutive WEB cases. METHODS: Both groups were compared concerning intervention time, sizing failures leading to device changes and radiation dose. Additionally, we analyzed potential learning effects by comparing the first 24 Contour cases with our last 24 Contour cases and WEB cases respectively. RESULTS: Patient demographics, acute vs. incidental cases and aneurysm localization were comparable in both groups. The deployment time was faster in our 48 Contour cases (median: 22.0 ± 17.0 min), than in the WEB group (median: 27.5 ± 24.0 min). Total intervention time was similar for Contour (median: 68.0 ± 46.9 min) and WEB cases (median: 69.0 ± 38.0 min). Device implantation times in our WEB cases were slightly shorter in the later cases (median: 25.5 ± 24.1 min) than in the earlier (median: 28.0 ± 24.4 min) cases. In the Contour cohort, deployment times were similar for the first 24 cases (median: 22.0 ± 14.5 min) and the final 24 (median: 22.0 ± 19.4 min). Radiation dose was lower in the Contour group (1469.0 ± 1718 mGy*cm2 vs. 1788.0 ± 1506 mGy*cm2 using the WEB device). Less intra-procedural device changes were performed in the Contour cohort (6 of 48 cases, 12.5%), than in the WEB group (8 of 48 cases, 16.7%). CONCLUSION: Aneurysm occlusion times and consequently radiation doses, as well as the amount of device changes were lower in the Contour group. Occlusion times did not differ in the first and last 24 Contour cases, leading to the assumption that the handling of Contour does not require extended training. A short training effect in occlusion times was noted, however, between the first and last WEB cases as shorter procedure times were seen in the latter cases.

Contour device implantation versus coil embolization for treatment of narrow neck intracranial aneurysms.

The novel Contour device is an intrasaccular flow disruption device designed for treatment of intracranial wide-neck bifurcation aneurysms. Outside its original purpose, Contour implantation can be used to treat aneurysms with a higher dome-to-neck ratio which would be suitable for conventional unassisted coil embolization. We compared both techniques in a retrospective single-center analysis. A total of 42 aneurysms from 42 patients with a dome-to-neck ratio of 1.6 or higher were included in this study. Data on technical success, implantation times, radiation dosages, procedural complications, reinterventions and recurrences were gathered and compared. Technical success was achieved in all cases with both techniques. Aneurysm embolization was achieved significantly faster in the Contour group compared to coiling (Overall p = 0.0002; r = 0.580; acute setting: p = 0.005, r = 0.531; elective setting: p = 0.002, r = 0.607). Significantly less radiation dosage was applied in the Contour group (Overall p = 0.002; r = 0.478; acute group p = 0.006; r = 0.552; elective group p = 0.045; r = 0.397). The number of complications was higher in the coiling group compared to the Contour group (Coiling 7/21 (33,3%); Contour 3/21 (14.3%). There was a higher rate of reinterventions in the coiling group (7.6% vs 21.4%). Outside its original intention, the Contour device seems to be a safe and fast alternative to coil embolization for the treatment of narrow-neck-aneurysms.

Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: the coil-assisted flow diversion safety and performance study (CAFI).

BackgroundThe Neqstent coil-assisted flow diverter (NQS) is a neck bridging device to facilitate coil occlusion of intracranial aneurysms. CAFI is a prospective, single-arm, multicenter study on the safety and performance of the NQS adjunctive therapy device together with platinum coils for treatment of unruptured intracranial aneurysms. METHODS: Thirty-eight patients were enrolled. Primary endpoints were occlusion at 6 months for efficacy, and any major stroke or non-accidental death up to 30 days or major disabling stroke within 6 months for safety. Secondary endpoints were re-treatment rate, procedure time, and procedure/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee. RESULTS: The NQS was successfully implanted in 36/38 aneurysms, 2/38 in the intention-to-treat group did not receive a NQS and were excluded from follow-up after 30 days. In the per protocol group (PP), 33/36 patients were available for angiographic follow-up. Device related adverse events were recorded in 4/38 (10.5%) patients, one hemorrhagic and three thromboembolic. In the PP group, immediate post-treatment adequate occlusion (RR1 and RR2) was seen in 9/36 (25%) and progressed to 28/36 (77.8%) at 6 months. Complete occlusion (RR1) was achieved in 29/36 (80.6%) at the last available angiogram (3/36 were post procedure). The mean procedure time was 129 min (50-300 min, median 120 min). CONCLUSION: The NQS in conjunction with coils appears to be effective in the treatment of intracranial wide-neck bifurcation aneurysms, but its safety remains to be proved in larger series. TRIAL REGISTRATION NUMBER: NCT04187573.

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

BACKGROUND: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER: NCT03844334.

Stimulation site within the MRI-defined STN predicts postoperative motor outcome.

High-frequency stimulation of the subthalamic nucleus (STN-HFS) is highly effective in treating motor symptoms in Parkinson's disease (PD) and medication side effects as well as in improving quality of life. Despite preoperative screening for patients as eligible candidates for this treatment, electrode position may furthermore influence treatment quality. Here, we investigated the relationship between the anatomical site of stimulation within the MRI-defined STN and the outcome of PD patients after STN-HFS. In 30 PD patients with bilateral STN stimulation, we retrospectively defined the boundaries of the STN within the axial target plane of the stereotactic T2-weighted MRI and determined the position of the active electrode contact in relation to the border of the STN. The position of the active contact within the STN was the only variable to predict the outcome of STN stimulation. In contrast, covariates such as age, disease duration, symptom severity, and response to levodopa had no effect. The lateral position of the stimulation contact within the STN led to significantly better clinical improvement, lower stimulation parameters, and less need for postoperative dopaminergic medication. The outcome of patients with stimulation contacts within the medial region of the STN was significantly worse. Precise targeting of the lateral region of the STN is essential for achieving sufficient stimulation efficacy. Preoperative T2-weighted MRI might be a useful component of the targeting procedure to improve the outcome of PD patients.