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1.
Wien Klin Wochenschr ; 2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38748063

RESUMEN

BACKGROUND: Stroke resulting from occlusion of the middle cerebral artery (MCA) can have devastating consequences, potentially leading to a loss of independence. This study aimed to investigate the relationship between the distance to the thrombus (DT) and both ischemic lesion volume (ILV) and clinical outcomes. METHODS: We retrospectively evaluated patients with thromboembolic MCA M1 segment occlusion who underwent neurovascular imaging followed by endovascular thrombectomy (EVT) at two comprehensive stroke centers over a 3-year period (2018-2020). Preinterventional computed tomography (CT) or magnetic resonance (MR) angiography was used to measure DT, defined as the distance from the carotid­T bifurcation to the proximal surface of the M1 occlusion. Postinterventional CT or MR imaging was employed to determine the ILV and clinical outcomes were assessed using the modified Rankin scale (mRS) at 3 months. RESULTS: There were 346 patients evaluated. The median DT was 9.4 mm (interquartile range, IQR 6.0-13.7 mm) and the median ILV was 13.9 ml (IQR 2.2-53.1 ml). After adjustment, an increase in DT was associated with a decrease in odds for a larger ILV (odds ratio, OR 0.96, 95% confidence interval, CI 0.92-0.99, p = 0.041). Through this association, more distal thrombi were associated with good clinical outcome (mRS 0-2; clinical outcome available in 282 patients, p = 0.018). The ILV was inversely associated with better clinical outcome OR 0.52 (95% CI 0.40-0.67). CONCLUSION: Based on the findings, DT was identified as an independent albeit weak predictor for ILV and clinical outcomes in patients with MCA M1 occlusion who underwent EVT.

2.
J Neurointerv Surg ; 2024 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-38760167

RESUMEN

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.

3.
J Neurosurg ; : 1-10, 2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-38820616

RESUMEN

OBJECTIVE: The placement of flow-diverting devices has become a common method of treating unruptured intracranial aneurysms of the internal carotid artery. The progressive improvement of aneurysm occlusion after treatment-with low complication and rupture rates-has led to a dilemma regarding the management of aneurysms in which occlusion has not occurred within 6-24 months. The authors aimed to identify clinical consensus regarding management of intracranial aneurysms displaying persistent filling 6-24 months after flow diversion and to ascertain questions that may drive future investigation. METHODS: An international panel of 67 experts was invited to participate in a multistep Delphi consensus process on the treatment of intracranial aneurysms after failed flow diversion. RESULTS: Of the 67 experts invited, 23 (34%) participated. Qualitative analysis of an initial survey with open-ended questions resulted in 51 statements regarding management of aneurysms showing persistent filling after flow diversion. The statements were grouped into 8 categories, and in the second round, respondents rated the degree of their agreement with each statement on a 5-point Likert scale. Flow diverters with surface modifiers did not influence administration of dual-antiplatelet therapy according to 83%. Consensus was also reached regarding the definition of treatment failure at specific time points, including at 6 months if there is aneurysm growth or persistent rapid flow through the entirety of the aneurysm (96%), at 12 months if there is aneurysm growth or symptom onset (78%), and at 24 months if there is persistent filling regardless of size and filling characteristics (74%). Although experts agreed that the degree of intimal hyperplasia or in-device stenosis could not be ascertained by noninvasive imaging alone (83%), only 65% chose digital subtraction angiography as the preferred modality. At 6 and 12 months, retreatment is preferred if there is persistent filling with aneurysm growth (96%, 96%), device malposition (48%, 87%), or a history of subarachnoid hemorrhage (65%, 70%), respectively, and at 24 months if there is persistent filling without reduction in aneurysm size (74%). Experts favored treatment with an additional flow diverter (87%) over aneurysm clipping, applying the same principles for follow-up (83%) and treatment failure (91%) as for the first flow diverter. CONCLUSIONS: The authors present the consensus practices of experts in the management of intracranial aneurysms without occlusion 6-24 months after treatment with a flow-diverting device.

4.
Front Neurol ; 15: 1286639, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38481942

RESUMEN

Introduction: Endovascular thrombectomy (EVT) and concomitant usage of intravenous alteplase (alteplase) in large vessel occlusion stroke may produce unwanted excess intracerebral hemorrhage (ICH). Whether this applies specifically to isolated occlusion of the M1 segment of the middle cerebral artery (MCA) is unknown. Methods: A retrospective study from two tertiary thrombectomy centers. ICH was determined according to Heidelberg Bleeding Classification (HBC). Factors associated with the occurrence of ICH in EVT alone vs. EVT with alteplase were evaluated using logistic regression analysis. Factors related to the clinical outcome as determined with a modified Rankin scale (mRS) were investigated with univariate and adjusted multivariate logistic regression analysis. The interaction between clinical variables and the usage of alteplase on the occurrence of ICH was evaluated. Results: Any ICH occurred in 156/457 (34.1%) patients Class 1a bleeding in 37 (8.1%), type 2 in 45 (9.8%) Class 1c in 22 (4.8%), Class 2 in 25 (5.5%), and Class 3 (extraparenchymal) in 27 (5.9%). ICH occurred in similar frequency between alteplase-treated patients vs. EVT alone (85/262 [32%] vs. 71/195 [36%]; OR 1.19 (95% CI 0.81-1.76). After adjustment, odds for clinical outcome were lower in ICH patients (OR 0.44 [95% CI 0.25-0.74]), p = 0.002). Higher ICH rate was associated with more EVT steps (p for interaction -0.005), and usage of only stent-retriever (p for interaction =0.005). Conclusion: Utilization of alteplase alongside EVT for MCA M1 occlusion did not result in excessive ICH occurrences or clinical deterioration.

5.
Clin Neurol Neurosurg ; 237: 108132, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38310761

RESUMEN

BACKGROUND AND PURPOSE: Thrombus migration (TM) is a well-established phenomenon in patients with intracranial vessel occlusion, particularly in those who receive alteplase. However, the relationship between TM, reperfusion success, and clinic-radiological outcomes is still being determined. This study aimed to describe the various outcomes in the event of TM in patients with M1 middle cerebral artery (M1 MCA) occlusion. MATERIALS AND METHODS: The study involved a retrospective analysis of patients undergoing endovascular thrombectomy (EVT) due to M1 MCA occlusion from two tertiary centers between January 2015 and December 2020. The proximal positions of thrombi were measured using a curve tool on CT or MR angiography before EVT. Subsequently, measurements were taken on angiographic imaging. Patients were grouped based on the amount of difference between the two measurements: growth (≤ - 10 mm), stability (> -10 mm and ≤ 10 mm), migration (> 10 mm), and resolution. RESULTS: A total of 463 patients (266 [57%] females, median 76 [interquartile range IQR: 65-83] years) were analyzed. Of them, 106 (22.8%) expressed any degree of TM. In multivariate ordinal regression analysis, the alteplase was significantly associated with TM (t = 2.192, p = 0.028), as was the greater interval from first imaging to angiography (t = 2.574, p = 0.010). In multivariate logistical regression analysis, the good clinical outcome measured by the modified Rankin scale (0-2) was not associated with TM status. CONCLUSIONS: Thrombus migration within the M1 MCA segment occurs in almost a quarter of patients, is associated with alteplase administration, and is mainly irrelevant to radiological and clinical outcome.


Asunto(s)
Trombosis , Enfermedades Vasculares , Femenino , Humanos , Masculino , Infarto de la Arteria Cerebral Media/diagnóstico por imagen , Infarto de la Arteria Cerebral Media/cirugía , Estudios Retrospectivos , Activador de Tejido Plasminógeno/uso terapéutico , Angiografía por Resonancia Magnética
6.
J Neurol Surg A Cent Eur Neurosurg ; 85(3): 319-321, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-37257842

RESUMEN

BACKGROUND: Endovascular therapy has revolutionized the treatment of cerebral aneurysms in recent years and decades. So-called intrasaccular devices (i.e., Woven EndoBridge [WEB], MicroVention, Aliso Viejo, California, United States; or Contour, Cerus Neurovascular, Fremont, California, United States) are a promising endovascular technology, especially for wide-based aneurysms. However, long-term outcome data are currently particularly scarce for Contour and strategies for failed Contour cases are lacking. Here, we report the feasibility of microsurgical clipping after failed Contour device embolization. METHODS: Feasibility of microsurgical clipping after failed aneurysm embolization with a Contour intrasaccular device was assessed in a patient. RESULTS: We present the case of a 36-year-old male patient diagnosed with Hunt and Hess grade 1 subarachnoid hemorrhage from an anterior communicating artery aneurysm. The ruptured aneurysm was initially treated with the Contour device. After 3 months, angiographic imaging showed a clear aneurysm residual deemed not endovascularly accessible. The patient was then successfully clipped using microsurgical techniques. The patient was discharged with no neurologic abnormalities. CONCLUSION: After thorough bibliographical research, this presents the first published case report of microsurgical clipping after failed embolization with Contour. The main insights gained after clipping were that the Contour does not significantly disturb or hinder clipping. In contrast to coils in aneurysms to be clipped, the Contour can be easily compressed by the clip blades and does not have to be removed. In addition, the Contour had not migrated into the subarachnoid space and there was no abnormal scarring. Clipping appears to be a reasonable treatment strategy for failure of embolization with Contour if endovascular means are not suitable.


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Hemorragia Subaracnoidea , Masculino , Humanos , Adulto , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Resultado del Tratamiento , Hemorragia Subaracnoidea/diagnóstico por imagen , Hemorragia Subaracnoidea/etiología , Hemorragia Subaracnoidea/cirugía , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Aneurisma Roto/cirugía , Estudios Retrospectivos
7.
J Neurointerv Surg ; 16(4): 405-411, 2024 Mar 14.
Artículo en Inglés | MEDLINE | ID: mdl-37793795

RESUMEN

BACKGROUND: Robotic-assisted neurointervention was recently introduced, with implications that it could be used to treat neurovascular diseases. OBJECTIVE: To evaluate the effectiveness and safety of the robotic-assisted platform CorPath GRX for treating cerebral aneurysms. METHODS: This prospective, international, multicenter study enrolled patients with brain aneurysms that required endovascular coiling and/or stent-assisted coiling. The primary effectiveness endpoint was defined as successful completion of the robotic-assisted endovascular procedure without any unplanned conversion to manual treatment with guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy. The primary safety endpoint included intraprocedural and periprocedural events. RESULTS: The study enrolled 117 patients (74.4% female) with mean age of 56.6 years from 10 international sites,. Headache was the most common presenting symptom in 40/117 (34.2%) subjects. Internal carotid artery was the most common location (34/122, 27.9%), and the mean aneurysm height and neck width were 5.7±2.6 mm and 3.5±1.4 mm, respectively. The overall procedure time was 117.3±47.3 min with 59.4±32.6 min robotic procedure time. Primary effectiveness was achieved in 110/117 (94%) subjects with seven subjects requiring conversion to manual for procedure completion. Only four primary safety events were recorded with two intraprocedural aneurysm ruptures and two strokes. A Raymond-Roy Classification Scale score of 1 was achieved in 71/110 (64.5%) subjects, and all subjects were discharged with a modified Rankin Scale score of ≤2. CONCLUSIONS: This first-of-its-kind robotic-assisted neurovascular trial demonstrates the effectiveness and safety of the CorPath GRX System for endovascular embolization of cerebral aneurysm procedures. TRIAL REGISTRATION NUMBER: NCT04236856.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Procedimientos Quirúrgicos Robotizados , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angiografía Cerebral , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Prospectivos , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Stents , Resultado del Tratamiento
8.
J Neurointerv Surg ; 2023 Jul 07.
Artículo en Inglés | MEDLINE | ID: mdl-37419693

RESUMEN

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.

10.
J Neurointerv Surg ; 15(e3): e402-e408, 2023 Dec 21.
Artículo en Inglés | MEDLINE | ID: mdl-36813552

RESUMEN

BACKGROUND: Endovascular therapy (EVT) has been established as a major component in the acute treatment of large vessel occlusion stroke. However, it is unclear whether outcome and other treatment-related factors differ if patients are treated within or outside core working hours. METHODS: We analyzed data from the prospective nationwide Austrian Stroke Unit Registry capturing all consecutive stroke patients treated with EVT between 2016 and 2020. Patients were trichotomized according to the time of groin puncture into treatment within regular working hours (08:00-13:59), afternoon/evening (14:00-21:59) and night-time (22:00-07:59). Additionally, we analyzed 12 EVT treatment windows with equal patient numbers. Main outcome variables included favorable outcome (modified Rankin Scale scores of 0-2) 3 months post-stroke as well as procedural time metrics, recanalization status and complications. RESULTS: We analyzed 2916 patients (median age 74 years, 50.7% female) who underwent EVT. Patients treated within core working hours more frequently had a favorable outcome (42.6% vs 36.1% treated in the afternoon/evening vs 35.8% treated at night-time; p=0.007). Similar results were found when analyzing 12 treatment windows. All these differences remained significant in multivariable analysis adjusting for outcome-relevant co-factors. Onset-to-recanalization time was considerably longer outside core working hours, which was mainly explained by longer door-to-groin time (p<0.001). There was no difference in the number of passes, recanalization status, groin-to-recanalization time and EVT-related complications. CONCLUSIONS: The findings of delayed intrahospital EVT workflows and worse functional outcomes outside core working hours in this nationwide registry are relevant for optimization of stroke care, and might be applicable to other countries with similar settings.


Asunto(s)
Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular , Humanos , Femenino , Anciano , Masculino , Estudios Prospectivos , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Accidente Cerebrovascular/cirugía , Accidente Cerebrovascular/etiología , Terapia Trombolítica/efectos adversos , Trombectomía/métodos , Isquemia Encefálica/terapia
11.
J Neurosurg ; 139(2): 563-572, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-36708532

RESUMEN

OBJECTIVE: The authors compared the Contour Neurovascular System (Contour) with the Woven EndoBridge (WEB) device for the treatment of wide-necked cerebral aneurysms at a bifurcation or sidewall. METHODS: Prospective clinical and radiological data were collected for all patients treated with either the Contour or WEB at a tertiary university hospital from May 2018 to June 2022. RESULTS: In patients who had at least 3 months of follow-up data available (median patient age 60.0 [IQR 51.8-67.0] years, male/female ratio 1:1.4), the authors compared 40 aneurysms in 34 patients treated with the Contour and 30 aneurysms in 30 patients treated with the WEB. Overall, 26 middle cerebral artery, 24 anterior communicating artery, 9 basilar artery tip, 4 posterior communicating artery, 4 internal carotid artery, 1 anterior cerebral artery, 1 posterior inferior cerebellar artery, and 1 superior cerebellar artery aneurysm were treated. In the Contour cohort, complete occlusion at last follow-up was achieved for 30 aneurysms (75%) and a small neck remnant was seen in 6 aneurysms (15%), summing up to an adequate occlusion rate of 90%. One aneurysm (2.5%) had to be retreated, and 1 symptomatic thromboembolic event (2.5%) was observed with complete remission at discharge. Three adjunctive stents (10%) had to be used due to branch occlusion. In the WEB cohort, adequate occlusion was also seen in 90% of aneurysms (complete occlusion in 19 [63.3%] and remnant neck in 8 [26.7%], with a retreatment rate of 20%). Four WEBs (13.3%) needed additional stent placement due to device protrusion into a branch, 2 asymptomatic thromboembolic events (6.7%) were noted, and 1 major ischemic event (3.3%) due to M2 occlusion was noted. One patient treated with the WEB died between follow-ups of causes unrelated to the aneurysm, treatment, or device. Time from first measurement to deployment and thus total treatment time was significantly shorter in the Contour group (p = 0.004), regardless of whether a prior angiogram was available for aneurysm measurement and device sizing. CONCLUSIONS: Results for the Contour were promising, although longer follow-up is necessary to draw more solid conclusions on the utility and risk profile of this new device compared with the already widely used WEB device. Adequate occlusion at last follow-up was the same for both devices, whereas the probability of complete occlusion at last follow-up was significantly higher for the Contour, and the WEB showed a significantly higher retreatment rate. Median deployment times were significantly shorter with the Contour than the WEB.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Tromboembolia , Humanos , Masculino , Femenino , Persona de Mediana Edad , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Resultado del Tratamiento , Estudios Prospectivos , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Tromboembolia/etiología , Estudios Retrospectivos
12.
J Neurointerv Surg ; 15(2): 172-175, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35292566

RESUMEN

BACKGROUND: Endovascular treatment of intracranial vascular diseases, such as aneurysms, is often challenged by unfavorable vascular anatomy. The Bendit Steerable Microcatheter (Bendit Technologies, Tel Aviv, Israel) has bending and torqueing capabilities designed to improve navigation and stability during device delivery, with or without a guidewire. We describe our preclinical experience with the Bendit 17 and Bendit 21 microcatheters in a rabbit aneurysm model. METHODS: Bifurcation and side wall aneurysms were created surgically in six New Zealand rabbits. We attempted to navigate Bendit devices through the vasculature and enter the aneurysms without a guidewire. Various positions within the aneurysm were selectively explored. Angiographic imaging was used to visualize catheterization, navigation, vascular manipulations, and placement of coils, stents, and intrasaccular devices. RESULTS: We successfully navigated the Bendit microcatheters to all aneurysms without a guidewire. We successfully recanalized a nearly occluded carotid artery and navigated the Bendit through a braided stent. In contrast, we were unable to navigate a comparator device with a guidewire as effectively as the Bendit. Coils were introduced at different locations within the aneurysm and could be pushed, pulled, and repositioned with the Bendit tip. Finally, we used the Bendit to deliver intrasaccular devices designed for terminal aneurysms to treat side wall aneurysms. CONCLUSIONS: Bendit's bending and torqueing abilities, combined with its stability in the bent position, enable quick navigation and optimal deployment of devices. Clinical studies are necessary to determine whether these navigation advantages lead to more efficient treatment of intracranial and peripheral aneurysms.


Asunto(s)
Embolización Terapéutica , Aneurisma Intracraneal , Conejos , Animales , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Embolización Terapéutica/métodos , Stents , Angiografía , Arterias Carótidas
13.
J Neurointerv Surg ; 15(1): 70-74, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-35580985

RESUMEN

Treatment of wide-necked complex intracranial aneurysms continues to challenge neurointerventionalists. Intrasaccular flow diverters have expanded the armamentarium considerably and are now used extensively. While five types of devices have already obtained the CE mark for use within Europe, only the Woven EndoBridge (WEB) device is approved by the US Food and Drug Administration. Other intrasaccular devices are the Luna/Artisse Aneurysm Embolization System (Medtronic), the Medina Embolic Device (Medtronic), the Contour Neurovascular System (Cerus), and the Neqstent Coil Assisted Flow Diverter (Cerus). This mini review will provide a compact overview of these devices and a summary of the current literature.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Resultado del Tratamiento , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Europa (Continente)
14.
J Neurointerv Surg ; 15(8): 771-775, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35853698

RESUMEN

BACKGROUND: Vessel tortuosity poses a challenge during endovascular treatment of neurovascular lesions. Bendit Technologies (Petah Tikva, Israel) has developed flexible, steerable microcatheters designed with unique bending and torquing capabilities. OBJECTIVE: To describe our first-in-human trial of Bendit21. METHODS: Bendit21 was used in our exploratory, prospective, multicenter, open-label, single-arm clinical study, and in two compassionate use cases. Procedures were conducted at four centers in Austria, Germany, Israel, and the United States between May 2021 and March 2022, in patients with neurovascular conditions. The primary endpoints were device-related safety events, successful navigation through the neurovasculature, and, when intended, successful delivery of contrast or therapy. RESULTS: Two patients with giant aneurysms were treated successfully under compassionate use approval. The clinical study included 25 patients (mean age: 63.4±11.8 years; 32.0% female). Fourteen patients (56.0%) had aneurysms, two had arteriovenous malformations/fistulas (8.0%), one had a stroke (4.0%), four (16.0%) had intracranial stenosis, and four (16.0%) had other conditions. Bendit21 was used without a guidewire in 12/25 (48.0%) procedures. Bendit21 was successfully navigated through the vasculature without delays or spasms in all cases (100%). Contrast was delivered as intended in 7/7 (100%) cases. Therapeutic devices were delivered successfully with Bendit as intended in 14/18 (77.8%) cases; four deficiencies occurred in three patients with aneurysms, in whom delivery of coils, an intrasaccular device, or a flow diverter was attempted. There were no device-related safety events or mortalities. CONCLUSIONS: Our initial clinical experience with the Bendit21 microcatheter demonstrates its usefulness in achieving technical success in patients with challenging neurovascular conditions.


Asunto(s)
Fístula Arteriovenosa , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Estudios Prospectivos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Cateterismo , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Fístula Arteriovenosa/terapia , Resultado del Tratamiento , Stents
15.
Neurosurgery ; 91(4): 547-554, 2022 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-35830269

RESUMEN

BACKGROUND: Treatment of small-caliber vessel lesions using flow diverters remains challenging because of vasculature's narrow luminal diameter and tortuosity. This in turn makes navigation and delivery of conventional devices with standard microcatheters more difficult. The Silk Vista Baby (SVB, Balt) flow diversion device was designed for ease of use in vessels with a smaller diameter, distal lesions, and 0.017 ″ microcatheter delivery systems. OBJECTIVE: To report the outcomes of the SVB device on the treatment of posterior inferior cerebellar artery (PICA) aneurysms. METHODS: Databases from different centers were retrospectively reviewed for PICA aneurysms treated with SVB. Demographic information, clinical presentation, radiographic characteristics, procedural complications, and immediate postprocedure outcomes were obtained. RESULTS: Fourteen patients harboring 15 true PICA aneurysms were treated between January 2019 and June 2021. Nine were female (n = 9/14; 64.2%), and the mean age was 51 ± 14.9 years. Most patients had previously ruptured aneurysms, treated by another endovascular technique. Six aneurysms were located distally (n = 6/15; 40%). The mean neck size was 3 mm (SD 1.35, range 2.5-5 mm), whereas the mean PICA diameter was 1.6 mm (SD 0.26, range 1.5-1.7 mm). The mean length of follow-up was 6 months (SD 8.28, range 4.5-16 months). Treatment-related adverse events included 1 case of transient hypoesthesia. Two additional events were reported, but adjudicated as unrelated to the procedure. Complete occlusion, measured as Raymond-Roy class I, was achieved in all cases. CONCLUSION: The SVB device was safely and effectively used in the treatment of PICA aneurysms. The smaller delivery system profile reduces the risk of procedure complications and creates new treatment options for distal lesions.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Adulto , Anciano , Cerebelo/irrigación sanguínea , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/etiología , Aneurisma Intracraneal/cirugía , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Seda , Resultado del Tratamiento , Arteria Vertebral
16.
Neurosurgery ; 90(3): 270-277, 2022 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-35113830

RESUMEN

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.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Accidente Cerebrovascular , Angiografía Cerebral/métodos , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Estudios de Seguimiento , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Prospectivos , Estudios Retrospectivos , Stents , Accidente Cerebrovascular/terapia , Resultado del Tratamiento
17.
J Neurointerv Surg ; 14(4): 384-389, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33986108

RESUMEN

BACKGROUND: Using a surgical aneurysm model, this study assessed the performance of a new flow diverter (FD), the DiVeRt, and evaluated the angiographic and histologic features at different periods after stent deployment. METHODS: Fifteen New Zealand White rabbits were treated 3 days prior to intervention and until euthanization with dual antiplatelets. DiVeRt was implanted in bilateral carotid aneurysms (n=30) as well as in the aorta (n=15). The rate of technical success, assessment of aneurysm occlusion (measured by the O'Kelly-Marotta grading (OKM) scale), and stent patency were examined using angiography and histologic examinations in three groups at 1, 3, and 6 months follow-up (FU). In each FU group one control animal was included and treated with the XCalibur stent (n=3). RESULTS: Overall, DiVeRt placement was successful and without apparent intraprocedural complications. In total, four stents in the carotid artery were occluded and in-stent stenosis was registered in two carotid (7%) and one aortic (6%) vessels. Complete or near complete aneurysm occlusion (OKM scale D1 and C3) was seen in 100% in the 1-month FU group, 70% in the 2-month FU group, and 100% in the 3-month FU group. Histology showed loose, organizing fibrous tissue matrix within the sac and adequate neck endothelialization in all vessels. All branches covered by the DiVeRt remained patent. CONCLUSIONS: The DiVeRt system appears to be feasible and effective for the treatment of aneurysms with high rates of complete aneurysm occlusion, excellent vessel patency, and evidence of high biocompatibility. Occurrences of parent artery occlusion at follow-up did not result in clinical consequences.


Asunto(s)
Aneurisma Intracraneal , Angiografía , Animales , Modelos Animales de Enfermedad , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Conejos , Stents , Resultado del Tratamiento
18.
Clin Neuroradiol ; 32(2): 369-374, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34313798

RESUMEN

BACKGROUND: Pooled data of randomized controlled trials investigating mechanical thrombectomy (MT) to treat anterior circulation large vessel occlusion have demonstrated safety and effectiveness across all age groups, including ≥ 80 years of age; however, only a few nonagenarians were in the ≥ 80 years subgroup. Therefore, the benefit of MT in nonagenarians is mostly unknown. METHODS: Two comprehensive stroke centers retrospectively reviewed all acute ischemic stroke patients who underwent MT for anterior circulation large vessel occlusion (LVO) stroke between February 2016 and August 2020. Revascularization TICI2b/3, symptomatic intracranial hemorrhage (ICH), and functional outcome using modified Rankin scale (mRS) were assessed for cases aged < 80 years, 80-89 years, and 90-99 years. Favorable functional outcome was defined as mRS 0-2 or reaching the prestroke mRS and moderate as mRS 0-3. RESULTS: The final data set comprised a total of 736 cases. Of these, 466 aged < 80 years, 219 aged 80-89 years, and 51 aged 90-99 years. In nonagenarians, TICI 2b/3 revascularization was observed in 84.3% while symptomatic ICH was observed in 4%. These rates were similar to 80-89 years and < 80 years age groups. Favorable and moderate functional outcome as well as death rates differed significantly between nonagenarians and < 80 years (19.6%, 29.4%, 51.0% vs 47.9%, 60.7%, 18.7%, respectively, p < 0.001), but were similar between nonagenarians and octogenarians (29.7%, 38.8%, 38.8%, p = 0.112-0.211). CONCLUSION: A moderate outcome among nonagenarians was observed in about 30%, while mortality rates were about 50%. Withholding mechanical thrombectomy does not appear justifiable, although the absolute treatment effect among nonagenarians remains unknown.


Asunto(s)
Arteriopatías Oclusivas , Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/terapia , Humanos , Hemorragias Intracraneales , Estudios Retrospectivos , Trombectomía , Resultado del Tratamiento
19.
World Neurosurg ; 158: e416-e422, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34763103

RESUMEN

PURPOSE: Although there is class I evidence for mechanical thrombectomy (MT) for anterior circulation large vessel occlusion (LVO) stroke, no high-class evidence exists for the posterior circulation. Here, we sought to compare clinical features of anterior versus posterior LVO as well as predictors of a posterior LVO MT outcome. METHODS: Patients with acute ischemic stroke who underwent MT for anterior and posterior LVO stroke between February 2016 and August 2020 from 2 comprehensive stroke centers were reviewed. Anterior and posterior LVO strokes were compared. In addition, predictors for a favorable outcome (modified Rankin scale [mRS] 0-3), death (mRS 6), and futile revascularization (mRS 4-6 despite TICI 2b/3 revascularization) for posterior LVO were analyzed. RESULTS: Collectively, 813 LVO thrombectomy cases were analyzed, and 77 of 813 cases (9.5%) were located in the posterior circulation. Although favorable 90-day functional outcome rates did not differ between anterior and posterior LVO (P = 0.093), death was significantly more frequent among posterior LVO cases (P = 0.013). In the posterior LVO subgroup, a primary aspiration technique and successful revascularization TICI 2b/3 irrespective of time to the intervention were independently associated with achieving a favorable outcome. Primary aspiration was identified to inversely associate with futile revascularization. CONCLUSION: Anterior and posterior circulation MT patients have distinct clinical profiles. The use of primary aspiration appears fundamental for beneficial outcomes in posterior circulation MT.


Asunto(s)
Arteriopatías Oclusivas , Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Arteriopatías Oclusivas/etiología , Isquemia Encefálica/etiología , Humanos , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Trombectomía/métodos , Resultado del Tratamiento
20.
Drug Discov Today ; 27(4): 1142-1155, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-34838730

RESUMEN

Vasculitis affecting the nervous system is a rare disease that can not only present with nonspecific initial symptoms, but also run a severe course without accurate treatment. Although improvements have been achieved, diagnosis of vasculitis remains challenging, because many classification criteria are unspecific or inconclusive with regard to central nervous system (CNS) manifestations. Currently, beside an isolated primary CNS vasculitis, several systemic types of vasculitis are known to affect the nervous system. In this review, we provide an overview of the pathophysiology, current therapeutic guidelines, and highlight novel treatment strategies for CNS vasculitis.


Asunto(s)
Vasculitis del Sistema Nervioso Central , Sistema Nervioso Central , Humanos , Vasculitis del Sistema Nervioso Central/diagnóstico , Vasculitis del Sistema Nervioso Central/tratamiento farmacológico
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