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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms: The CERUS Study.

BACKGROUND: The Contour is a novel intra-aneurysmal flow disrupting device to treat intracranial aneurysms. OBJECTIVE: To evaluate the safety and effectiveness of the Contour device for treatment of nonruptured intracranial bifurcation aneurysms through a prospective, multicenter, single-arm study. METHODS: Thirty-four patients were enrolled. Primary end points were successful occlusion at 6 mo for efficacy and any major stroke or nonaccidental death up to 30 d or major disabling stroke within 6 mo for safety. Secondary end points were occlusion at 12 mo, retreatment rate, procedure time, and procedure-related/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: In total, 32 of 34 aneurysms were successfully implanted and, 2 of 34 in the intention-to-treat (ITT) group did not receive the Contour and were excluded from follow-up after 30 d. In addition, 2 of 32 were lost to angiographic follow-up and regarded as treatment failure. The primary safety end point was met in 2 patients in the ITT group. In the perprotocol (PP) group, complete occlusion was seen in 14 of 32 (44%) at 6 mo and 22 of 32 (69%) at 12 mo. Adequate occlusion (Raymond-Roy [RR] 1 and 2) was reached in 84% at a last available follow-up. One patient from the ITT group and 1 from the PP group received additional treatment during follow-up. CONCLUSION: The Contour seems to be both safe and effective in the treatment of intracranial bifurcation aneurysms.

Evaluation of an Ultra-Short MRI Protocol for Cerebral Staging Examinations in Melanoma Patients.

PURPOSE: Due to its high sensitivity and lack of radiation, MRI is often used to stage cerebral tumors in patients. In contrast, the relatively long examination times and the limited availability of MRI slots at the clinic might delay these examinations. The aim of this study was to compare an ultra-short MRI protocol with the routinely used standard protocol. MATERIALS AND METHODS: Cerebral MRI of 147 patients with malignant melanoma were evaluated retrospectively, whereby only two sequences (FLAIR images and contrast-enhanced T1 MPR images) were evaluated in one group and images from the whole examination were available for the second group, including five sequences (DWI, T2 TSE, FLAIR, native and contrast-enhanced T1 TSE, and contrast-enhanced T1 MPR). The results of the two groups were compared and tested to determine whether the ultra-short approach was inferior to the full examination. RESULTS: 13.6 % of the patients had cerebral metastases. Overall, 73 metastases were detected: 60 were located supratentorially and 13 infratentorially. Concerning the detection of cerebral metastases, the ultra-short MRI examination, involving only a FLAIR and a contrast-enhanced T1 MPR sequence, was not inferior to the full MRI protocol in general (p = 0.017) and separated by location for supratentorial (p = 0.026) and infratentorial (p = 0.001) metastases. CONCLUSION: For staging purposes, a focused, ultra-short MRI protocol is not inferior to a standard MRI examination. This might open up opportunities for faster staging processes and a more efficient use of the often-restricted MRI capacities. KEY POINTS: · Short MRI protocols for cerebral staging are not inferior to standard examinations.. · Contrast-enhanced images represent the centerpiece of an ultra-short MRI protocol.. · Short MRI protocols might enable a more efficient use of restricted resources.. CITATION FORMAT: · Peters S, Gärtner F, Austein F et al. Evaluation of an Ultra-Short MRI Protocol for Cerebral Staging Examinations in Melanoma Patients. Fortschr Röntgenstr 2022; 194: 409 - 415.

A realistic way to investigate the design, and mechanical properties of flow diverter stents.

PURPOSE: Braided flow diverters (FD) are highly sophisticated, delicate, and intricate mechanical devices used to treat intracranial aneurysms. Testing such devices in vitro, however, remains an unsolved challenge. Here, we evaluate methods to measure flow, design and mechanical properties in vitro. METHODS: Flow properties, cell porosity, pore density, and cell area were evaluated under geometrically realistic conditions by placing FDs in patient-derived, 3D-printed models of human vasculature. 4D flow MRI was used to measure fluid dynamics. Laser microscopy was used to measure the design properties of the FDs. New methods were developed to investigate the bending, circumferential, and longitudinal radial force of the FDs continuously over varying diameters. RESULTS: The placement and flow properties of the FD in the vasculature models were successfully measured by MRI, although artifacts occurred. Likewise, the porosity, pore density, and cell area were successfully measured inside of the models using a laser microscope. The newly developed mechanical methods allowed to measure the indicated forces - to our knowledge for the first time - continuously. CONCLUSION: Modern and specifically tailored techniques, some of which were presented here for the first time, allow detailed insights into the flow, design, and mechanical properties of braided flow diverter stents.

3D-printed, patient-specific intracranial aneurysm models: From clinical data to flow experiments with endovascular devices.

PURPOSE: Flow models of intracranial aneurysms (IAs) can be used to test new and existing endovascular treatments with flow modulation devices (FMDs). Additionally, 4D flow magnetic resonance imaging (MRI) offers the ability to measure hemodynamics. This way, the effect of FMDs can be determined noninvasively and compared to patient data. Here, we describe a cost-effective method for producing flow models to test the efficiency of FMDs with 4D flow MRI. METHODS: The models were based on human radiological data (internal carotid and basilar arteries) and printed in 3D with stereolithography. The models were printed with three different printing layers (25, 50, and 100 µm thickness). To evaluate the models in vitro, 3D rotational angiography, time-of-flight MRI, and 4D flow MRI were employed. The flow and geometry of one model were compared with in vivo data. Two FMDs (FMD1 and FMD2) were deployed into two different IA models, and the effect on the flow was estimated by 4D flow MRI. RESULTS: Models printed with different layer thicknesses exhibited similar flow and little geometric variation. The mean spatial difference between the vessel geometry measured in vivo and in vitro was 0.7 ± 1.1 mm. The main flow features, such as vortices in the IAs, were reproduced. The velocities in the aneurysms were similar in vivo and in vitro (mean velocity magnitude: 5.4 ± 7.6 and 7.7 ± 8.6 cm/s, maximum velocity magnitude: 72.5 and 55.1 cm/s). By deploying FMDs, the mean velocity was reduced in the IAs (from 8.3 ± 10 to 4.3 ± 9.32 cm/s for FMD1 and 9.9 ± 12.1 to 2.1 ± 5.6 cm/s for FMD2). CONCLUSIONS: The presented method allows to produce neurovascular models in approx. 15 to 30 h. The resulting models were found to be geometrically accurate, reproducing the main flow patterns, and suitable for implanting FMDs as well as 4D flow MRI.

Torsional Characterization of Braided Flow Diverter Stents : A New Method to Evaluate Twisting Phenomenon.

PURPOSE: In the interventional treatment of cerebral aneurysms, flow diverter (FD) stents have played a significant role for more than a decade. Many studies have shown good aneurysm occlusion rates and low complication profiles. However, feared complications include acute thrombotic vessel occlusion due to stenotic deformation of the FD during release, the so-called twisting. This work investigates the behavior of different stent types to causative torsion forces in a mechanical model. MATERIALS AND METHODS: Torsion characterization equipment was custom built, and two different FD stents (Derivo, Acandis and P64, Phenox) with n = 3 were tested. One end of the FD was fixed while the other end was twisted while measuring the torsion force. RESULTS: In torsional force vs. the twisting angle graph, a very sharp decrease and increase in force was recorded when the stent collapsed or reopened, respectively, making it possible to characterize for twisting. All six devices showed partial/complete collapse on torsion and showed significant delayed reopening on untwisting. Interestingly on repeated testing, the stent collapsed at earlier angles, probably due to microscopic material defects. Slight variations between stents of the same type suggest that more extensive data sets are needed. CONCLUSIONS: We report a new method to characterize torsion for braided FD stents, which is reliable and reproducible. Additionally, the delayed reopening and the tendency to collapse at earlier angles on consequent testing maneuvers can be significant for clinical usage.

The novel Tenzing 7 delivery catheter designed to deliver intermediate catheters to the face of embolus without crossing: clinical performance predicted in anatomically challenging model.

BACKGROUND: In large vessel occlusionstroke, navigation of aspiration catheters (AC) can be impeded by vessel tortuosity and the ophthalmic artery origin. A novel tapered delivery catheter was designed to facilitate delivery without disturbing the embolus. We assessed AC deliverability in vitro and validated the observations in a first-in-human experience. METHODS: In a vascular model with three challenging craniocervical scenarios, two commercial AC were advanced from the carotid to the middle cerebral artery by four neurointerventionalists. Catheter deliverability with standard microwire and microcatheter (MC) combinations and the Tenzing 7 (T7) Delivery Catheter (Route 92 Medical, San Mateo, CA) were compared. Operators rated aspects of catheter deliverability on a 5-point scale. Results were compared with device delivery patterns at a neurovascular center before and after clinical introduction of T7. RESULTS: In vitro, success rate and speed were higher with T7 (96%; mean 30±10 s) than with MC (65%; 72±47 s, p<0.001 each), with fewer interactions with the occlusion site (T7: 54% vs MC: 77%, p=0.004). T7 received superior ratings regarding carotid artery deflection (T7: 2, IQR1-3 vs MC: 3, IQR2-3, p<0.001), guide catheter pushback (T7: 2, IQR1-3 vs MC: 3, IQR3-3, p<0.001) and ophthalmic artery passage (T7: 1.5, IQR1-2 vs MC: 4, IQR3-5, p<0.001). Before introduction of T7 at a single center, delivery of AC to a large vessel occlusion without crossing was achieved in 15/123 cases (12%). With T7, this rate was 28/31 patients (90.3%). CONCLUSION: Compared with microcatheter and microwire combinations, T7 improves aspiration catheter delivery in vitro, minimizing the need to cross the occlusion. Initial clinical experience appears to validate the model's observations.

Republished: Interhospital teleproctoring of endovascular intracranial aneurysm treatment using a dedicated live-streaming technology: first experiences during the COVID-19 pandemic.

This is a report of the first three cases of endovascular aneurysm treatment that were proctored by a remote interventionalist using a novel high-resolution low-latency streaming technology. The proctor was located in a neurovascular centre and supported the treating interventional teams in two distant cities (up to 800 km/500 miles apart). All aneurysms were treated using the Woven EndoBridge (WEB) embolisation system, either electively or following subarachnoid haemorrhage. On-site proctoring was not possible due to travel restrictions during the COVID-19 pandemic. WEB placement was feasible in all cases. Good rapport between proctors and treating physicians was reported, enabled by the high-resolution image transmission and uninterrupted feedback/discussion via audiostream. No clinical complications were encountered. Short-term follow-up revealed adequate occlusion of all treated aneurysms. The employed streaming technology provided effective remote proctoring during complex aneurysm cases, including the management of technical complications.

Choosing an Effective and Safe Direct Aspiration Setup for Tortuous Anatomy in Acute Ischemic Stroke: In vitro Study in a Physiological Flow Model.

PURPOSE: A direct aspiration first pass technique (ADAPT) is an effective thrombectomy option in patients with acute ischemic stroke. Balloon guide catheters (BGC) seem to improve the efficacy of stent retrievers and ADAPT. The last generation 6F aspiration catheters require 9F BGCs, which are rigid devices that are challenging to position in a tortuous anatomy. In this experimental study the efficacy of 6F ADAPT alone and 5F ADAPT combined with 8F BGC was evaluated. MATERIALS AND METHODS: Either a fibrin rich (white) clot or an RBC rich (red) clot was placed in the M1 segment of a transparent silicon phantom. Physiological hemodynamic conditions were maintained. The clots were retrieved by 6F aspiration catheter via 8F long sheath or 5F aspiration catheter via a flexible 8F BGC. Thrombectomy was performed under direct visual control. The primary endpoints were the number of passes and the number of distal emboli. RESULTS: Ten experiments were made with each clot model and thrombectomy technique (n = 40). Full recanalization could be achieved in every experiment. First pass mTICI 3 could be achieved by 6F ADAPT in 80 % of red clots and 90 % of white clots. Distal emboli were caused in 10 % and 20 %, respectively. When using 5F ADAPT combined with BGC, a first pass mTICI 3 rate of 90 % in red clots and 100 % in white clots could be achieved. A 10 % rate of distal emboli occurred in both groups. In almost all experiments (both techniques), the thrombi clogged the aspiration catheter. No statistically significant differences could be found between the techniques and clot models. CONCLUSION: 6F ADAPT without BGC was as effective as 5F ADAPT combined with a flexible 8F BGC, with both techniques showing high first-pass recanalization rates and low distal emboli rates. Especially in the case of a tortuous anatomy, these setups should be considered as alternatives to a rigid 9F BGC. The thrombus compositions seemed to be irrelevant in this setting. KEY POINTS: · 6F ADAPT with no BGC and 5F ADAPT with BGC were very effective and performed equally.. · Both techniques should be considered in tortuous anatomy.. · In this setting the clot composition showed no effect on the recanalization rate.. CITATION FORMAT: · Madjidyar J, Nerkada L, Larsen N et al. Choosing an Effective and Safe Direct Aspiration Setup for Tortuous Anatomy in Acute Ischemic Stroke: In vitro Study in a Physiological Flow Model. Fortschr Röntgenstr 2021; 193: 544 - 550.

Interhospital teleproctoring of endovascular intracranial aneurysm treatment using a dedicated live-streaming technology: first experiences during the COVID-19 pandemic.

This is a report of the first three cases of endovascular aneurysm treatment that were proctored by a remote interventionalist using a novel high-resolution low-latency streaming technology. The proctor was located in a neurovascular centre and supported the treating interventional teams in two distant cities (up to 800 km/500 miles apart). All aneurysms were treated using the Woven EndoBridge (WEB) embolisation system, either electively or following subarachnoid haemorrhage. On-site proctoring was not possible due to travel restrictions during the COVID-19 pandemic. WEB placement was feasible in all cases. Good rapport between proctors and treating physicians was reported, enabled by the high-resolution image transmission and uninterrupted feedback/discussion via audiostream. No clinical complications were encountered. Short-term follow-up revealed adequate occlusion of all treated aneurysms. The employed streaming technology provided effective remote proctoring during complex aneurysm cases, including the management of technical complications.