Background
External ventricular drainage (EVD) is one of the most common neurosurgical procedures in emergencies. This study aims to find out which factors influence the occurrence of EVD-related ...complications in a comparative investigation of metal needles and polyurethane catheters. This is the first clinical study comparing these two systems.
Methods
Adult patients undergoing pre-coronal EVD placement via freehand burr hole trepanation were included in this prospective study. The exclusion criteria were the open EVD insertion and/or a pre-existing infectious disease of the central nervous system.
Results
Two hundred consecutive patients were enrolled. Of these, 100 patients were treated by using metal EVD (group 1) and 100 patients with polyurethane catheters (group 2). The overall complication rate was 26% (misplacement 13.5%, hemorrhage 12.5%, infection 2.5%, and dislocation 1%) without statistically significant differences between both groups. Generalized brain edema and midline shift had a significant influence on misplacements (generalized brain edema:
p
= 0.0002, Cramer-
V
: 0.307, OR = 7.364, 95% CI: 2.691–20.148; all patients:
p
= 0.001, Cramer-
V
: 0.48, OR = 43.5, 95% CI: 4.327–437.295; group 1:
p
= 0.047, Cramer-
V
: 0.216, OR = 3.75, 95% CI: 1.064–13.221; group 2: midline shift:
p
= 0.038, Cramer-
V
: 0.195, OR = 3.626, 95% CI: 1.389–9.464) all patients:
p
= 0.053, Cramer-
V
: 0.231, OR = 5.533, 95% CI 1.131–27.081; group 1:
p
= 0.138, Cramer-
V
: 0.168, OR = 2.769, 95% CI: 0.813–9.429 group 2. Hemorrhages were associated with the use of oral anticoagulants or antiplatelet therapy (
p
= 0.002; Cramer-
V
: 0.220, OR = 3.798, 95% CI: 1.572–9.175) with a statistically similar influence in both groups.
Conclusion
Generalized brain edema has a significant influence on misplacements in both groups. Midline shift lost its significance when considering only the patients in group 2. Patients under oral anticoagulation and antiplatelet therapy have increased odds of EVD-associated hemorrhage. Metal needles and polyurethane catheters are equivalent in terms of patient safety when there are no midline shift and generalized brain edema.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is ...important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).
Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.
The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%.
This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms.
URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, ...anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).
All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used.
The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms).
This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%).
WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
Background and Purpose
The ThrombX Retriever is a novel mechanical thrombectomy device that adjusts the distance between two mesh segments to axially hold thrombus. A post-market study assessed ...safety and performance in acute ischemic stroke patients with large artery occlusion.
Methods
A single-arm prospective multi-center study enrolled patients at 5 European Centers. Patients had a symptomatic large-artery occlusion of the intracranial Internal Carotid or the Middle Cerebral Artery, M1 segment. The primary outcome measure was the modified treatment in cerebral infarction (mTICI) score, on the immediate post-procedure angiogram after up to three device passes. Key secondary outcome measures were the mTICI score after a single pass and functional independence, defined as an mRS score ≤ 2 at 90 days.
Results
Thirty patients (16 Females, mean age 72 years), with NIHSS 4-25 (mean 15.5) were treated. Twenty-eight (93%) achieved mTICI 2b-3 within 3 passes, and 24 (80%) were with the first pass (FP). FP mTICI 2c-3 reperfusion was achieved in 19 (63%) cases. Seventeen of 24 (71%) patients treated with a balloon guide and the ThrombX Retriever had a FP mTICI 2c-3 reperfusion. After all interventions, mTICI 2b-3 was seen in 30 (100%) patients. Twenty-one of the 29 (73%) patients with 90-day follow-up were functionally independent (mRS≤2). No device-related serious adverse events were observed.
Conclusion
This preliminary study suggests the ThrombX Retriever is safe and has a high rate of substantial reperfusion. A larger prospective trial to assess the device effectiveness is planned.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
Background
Despite multiple studies on the embolization of the middle meningeal artery, there is limited data on the treatment response of recurrent chronic subdural hematomas (CSDH) to embolization ...and on the volume change.
Methods
We retrospectively compared the treatment response and volume change of recurrent CSDHs in a conventional group (second surgery) with an embolization group (embolization as stand-alone treatment) during the time-period from August 2019 until June 2022. Different clinical and radiological factors were assessed. Treatment failure was defined as necessity of treatment for second recurrence. Hematoma volumes were determined in the initial CT scan before first surgery, after the first surgery, before retreatment as well as in an early (1 day–2 weeks) and in a late follow-up CT scan (2–8 weeks).
Results
Fifty recurrent hematomas after initial surgery were treated either by second surgery (
n
= 27) or by embolization (
n
= 23). 8/27 (26,6%) surgically treated and 3/23 (13%) of the hematomas treated by embolization needed to be treated again. This leads to an efficacy in recurrent hematomas of 73,4% in surgically treated and of 87% in embolized hematomas (
p
= 0.189). In the conventional group, mean volume decreased significantly already in the first follow-up CT scan from 101.7 ml (SD 53.7) to 60.7 ml (SD 40.3) (
p
= 0.001) and dropped further in the later follow-up scan to 46.6 ml (SD 37.1) (
p
= 0.001). In the embolization group, the mean volume did decrease insignificantly from 75.1 ml (SD 27.3) to 68 ml (SD 31.4) in the first scan (
p
= 0.062). However, in the late scan significant volume reduction to 30.8 ml (SD 17.1) could be observed (
p
= 0.002).
Conclusions
Embolization of the middle meningeal artery is an effective treatment option for recurrent CSDH. Patients with mild symptoms who can tolerate slow volume reduction are suitable for embolization, whereas patients with severe symptoms should be reserved for surgery.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
In this observational study, we analyzed and described the dynamics of the outcome after aneurysmal subarachnoid hemorrhage (SAH) in a collective of 203 cases. We detected a significant improvement ...of the mean aggregate modified Rankin Score (mRS) in every time interval from discharge to 6 months and up to 1 year. Every forth to fifth patient with potential of recovery (mRS 1-5) at discharge improved by 1 mRS point in the time interval from 6 month to 1 year (22.6%). Patients with mRS 3 at discharge had a remarkable late recovery rate (73.3%, p = 0.000085). Multivariate analysis revealed age ≤ 65 years (odds ratio 4.93; p = 0.0045) and "World Federation of Neurological Surgeons" (WFNS) grades I and II (odds ratio 4.77; p = 0.0077) as significant predictors of early improvement (discharge to 6 months). Absence of a shunting procedure (odds ratio 8.32; p = 0.0049) was a significant predictor of late improvement (6 months to 1 year), but not age ≤ 65 years (p = 0.54) and WFNS grades I and II (p = 0.92). Thus, late recovery (6 month to 1 year) is significant and independent from age and WFNS grade.
Ischemic stroke is one of the leading causes of death and long-term disability in the West. Mechanical revascularization techniques are considered the standard of care for large vessel occlusive ...stroke. Traditional apprenticeship models involve doctors training their skills on patients. Simulation platforms have long been recognized as an alternative to this. There has however been very little robust assessment of the training outcomes achieved on some of these platforms. At best, these simulations increase understanding of the procedural process and may help improve some technical skills; at worst they may instill bad habits and poor technique. The prerequisite of any simulation process must be to teach what to do, with which devices, in the correct sequence as well as what
not
to do. It should provide valid metric-based feedback to the trainee that is objective, transparent, and fair for formative and summative performance feedback. It should deliver a training program that measures the performance progress of trainees against expert benchmarks—benchmarks that represent an evidence-based peer-reviewed standard. In this paper, we present a perspective for PBP training for thrombectomy based on our experience with the process of procedure characterization, metric validation, and early experience of using this approach for proficiency training. Patient outcomes are not only determined by optimal performance in the Angio Suite but also by an efficient patient procedure pathway. There will be value in utilizing the PBP training standard not only for the procedure itself but also for the constituent elements of the stroke pathway to further improve treatment outcomes for ischemic stroke patients.
Mapping the lower extremity with navigated transcranial magnetic stimulation (nTMS) still remains challenging for the investigator. Clinical factors influencing leg mapping with nTMS have not been ...fully investigated yet. The aim of the study was to identify factors which influence the possibility of eliciting motor evoked potentials (MEPs) from the tibialis anterior muscle (TA). Patient records, imaging, nTMS examinations and tractography were retrospectively evaluated. 48 nTMS examinations were performed in 46 brain tumor patients. Reproducible MEPs were recorded in 20 patients (41.67%). Younger age (p = 0.044) and absence of perifocal edema (p = 0.035, Cramer's V = 0.34, OR = 0.22, 95% CI = 0.06-0.81) facilitated mapping the TA muscle. Leg motor deficit (p = 0.49, Cramer's V = 0.12, OR = 0.53, 95%CI = 0.12-2.36), tumor entity (p = 0.36, Cramer's V = 0.22), tumor location (p = 0.52, Cramer's V = 0.26) and stimulation intensity (p = 0.158) were no significant factors. The distance between the tumor and the pyramidal tract was higher (p = 0.005) in patients with successful mapping of the TA. The possibility to stimulate the leg motor area was associated with no postoperative aggravation of motor deficits in general (p = 0.005, Cramer's V = 0.45, OR = 0.63, 95%CI = 0.46-0.85) but could not serve as a specific predictor of postoperative lower extremity function. In conclusion, successful mapping of the TA muscle for neurosurgical planning is influenced by young patient age, absence of edema and greater distance to the CST, whereas tumor entity and stimulation intensity were non-significant.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
To preoperatively detect, by using diffusion-tensor imaging coregistered with anatomic magnetic resonance (MR) imaging, suspected microstructural tissue changes of the trigeminal nerves in patients ...with trigeminal neuralgia (TN) resulting from neurovascular compression.
The study was approved by the institutional review board, and written informed consent was obtained from all patients. Twenty patients (mean age, 51.3 years) with TN and evidence of neurovascular contact were examined with use of a 3.0-T MR unit combined with an eight-channel head coil before undergoing surgical decompression. A single-shot diffusion-tensor echo-planar sequence was used along 15 different diffusion directions, with a b value of 1000 sec/mm(2) and a section thickness of 2 mm. For anatomic correlation, 0.6-mm isotropic three-dimensional fast imaging employing steady-state images were acquired for coregistration with the functional diffusion-tensor maps. After region of interest placement, mean fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were calculated for each nerve by using the paired-sample two-tailed t test (with P < .005 indicating significance) and compared with surgical findings.
FA was significantly lower (P = .004) on the trigeminal neuralgia-affected side (mean FA, 0.203) than on the contralateral side (mean FA, 0.239). ADCs were nearly identical between the normal and TN-affected nerve tissues.
These findings suggest that diffusion-tensor imaging enables the identification and quantification of anisotropic changes between normal nerve tissue and TN-affected trigeminal nerves. Coregistration of anatomic three-dimensional fast imaging employing steady-state imaging and diffusion-tensor imaging facilitates excellent delineation of the cisternal segments of the trigeminal nerves.
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