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OBJECTIVES: Analysis of patient injuries offers possibilities for improving quality in patient care. The aim of this study was to identify errors and adverse events leading to patient injuries in the treatment of internal carotid artery stenosis (ICAS). METHODS: A retrospective analysis was performed on data from Finnish patient injury claims and patient insurance center decisions in the treatment of ICAS, 2004-2017. Contributing factors to injury were identified and evaluated. RESULTS: During the 14-year study period, 42 patient injury claims involving ICAS treatment were closed in Finland. One claim involved carotid artery stenting, and the other operations were carotid artery endarterectomies. Nine of the claims were compensated (seven for operations and two for evaluations). Fully trained vascular surgeons had carried out all the operations and evaluations. Stroke was the most common complaint in the claims (n = 12). Six of the compensated patients were symptomatic prior to the interventions. Injuries were related to errors in decision-making and patient selection in two cases. Four patients received compensation for nerve injury and three for stroke. No deaths were compensated as patient injuries. Most negative claim decisions were related to the injury having been unavoidable. CONCLUSION: Compensated patient injuries involving the treatment of ICAS are rare but often serious and mostly involve open surgery. Patient injury claims provide a valuable source of information for recognizing errors in care and offer possibilities to improve patient safety.
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Estenosis Carotídea , Endarterectomía Carotidea , Accidente Cerebrovascular , Humanos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Finlandia/epidemiología , Arteria Carótida Interna/diagnóstico por imagen , Arteria Carótida Interna/cirugía , Estudios Retrospectivos , Stents , Endarterectomía Carotidea/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: Several studies have reported good long-term results in the occlusion of intracranial aneurysms with flow diverter treatment. The aim of this study was to report the safety and six-month follow-up outcomes using the new Surpass Evolve flow diverter in the treatment of intracranial aneurysms. MATERIALS AND METHODS: Consecutive patients with intracranial aneurysm treated with Surpass Evolve flow diverter in two high-volume neurovascular centers between May 2019 and January 2020 were retrospectively reviewed. Procedure-related complications, aneurysm occlusion (O'Kelly-Marotta grading scale), and clinical outcomes were assessed. RESULTS: Twenty-nine patients with 30 aneurysms were included in the study. Favorable aneurysm occlusion (O'Kelly Marotta grading scale C-D) at six-month follow-up was achieved in 21/27 (78%) aneurysms. No clinical procedure related thromboembolic complications were encountered. Twenty-three out of 24 patients with unruptured aneurysms treated with Surpass Evolve remained clinically intact at clinical follow-up. There was one fatal hemorrhagic procedure-related complication (3%). In five patients with ruptured aneurysms, no early or late rebleeds occurred from the aneurysms. CONCLUSIONS: Surpass Evolve FD worked technically well with no intraprocedural thromboembolic complications and occlusion rates comparable to other FDs.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Angiografía Cerebral , Estudios de Seguimiento , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Estudios Retrospectivos , Stents , Resultado del TratamientoRESUMEN
BACKGROUND: The Woven EndoBridge (WEB) is a device for the treatment of intracranial wide-necked bifurcation aneurysms. The safety and effectiveness of WEB for intracranial aneurysms have both been evaluated in previous trials. Our aim was to study the outcomes of recurrent intracranial aneurysms (IAs) treated with WEB. METHODS: Clinical and radiological outcomes of patients with a wide-necked aneurysm recurrence, which was treated with WEB device, were assessed. Imaging follow-up was performed with digital subtraction angiography and/or magnetic resonance angiography. Aneurysm occlusion was determined using by the Raymond-Roy Occlusion Classification (RROC). RROC 1 and RROC 2 were considered as adequate radiological outcome. RESULTS: Twenty-two patients with 23 recurrent IAs were treated with WEB. Of which, 17 of recurrent IAs (74%) previously treated by coiling, three (13%) by clipping and three (13%) by WEB. The most common location of the recurrent IA was the middle cerebral artery (nâ¯=â¯10, 43%). Endovascular treatment with WEB alone was suitable for 20 recurrent IAs (87%). Ancillary devices were also used: coils in two (9%), and a stent in one (4%). Radiological follow-up results available for all patients (range: 3-60 months; median 24 months). Adequate occlusion (RROC I and II) was achieved in 20 recurrent IAs (87%). A hemorrhagic complication occurred 2 weeks post treatment in one patient (5%). CONCLUSIONS: WEB could be an effective treatment with low rates of complications for challenging cases of recurrent wide-necked IAs.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Retrospectivos , Stents , Resultado del TratamientoRESUMEN
Background Limited information is available on mid-term results and quality of life (QOL) after endovascular sclerotherapy of venous malformations. Purpose To compare two agents-polidocanol and ethanol-with a focus on the influence on QOL after sclerotherapy. Material and Methods Forty-one consecutive patients with a venous malformation in the head and neck area or in the extremities were treated with polidocanol between 2008 and 2013. Pre- and post-treatment magnetic resonance imaging (MRI) scans were compared. All patients completed a self-evaluation form on symptoms as well as a QOL questionnaire. The results were compared with previously obtained material during 1991-2001, comprising 44 consecutive, similarly located venous malformation patients subject to ethanol sclerotherapy. Results No significant clinical complications were observed. Subjectively, 19 (46%) of the patients benefitted from the treatment. QOL results showed that 85% of patients had an index < 39 - where 0 represents the highest and 100 the lowest QOL. Patients in the ethanol group had marginally better overall post-treatment QOL results. Post-treatment MRI in 35 patients showed the size of the malformation unchanged in 19 (54%) patients, in ten (29%) there was a decrease (<50%) while in six (17%) the decrease was more significant (>50%). Post-treatment MRI results did not correlate with either subjective symptoms or QOL results. Conclusion Polidocanol sclerotherapy were found to be an effective, safe, and well tolerated treatment option for low flow venous malformations. Routine MRI for follow-up appears redundant and may be omitted.
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Etanol/uso terapéutico , Polietilenglicoles/uso terapéutico , Calidad de Vida , Escleroterapia/métodos , Malformaciones Vasculares/terapia , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Polidocanol , Soluciones Esclerosantes/uso terapéutico , Solventes/uso terapéutico , Resultado del Tratamiento , Adulto JovenAsunto(s)
Angiografía Cerebral/métodos , Arterias Cerebrales/cirugía , Procedimientos Endovasculares/instrumentación , Aneurisma Intracraneal/cirugía , Stents , Anciano , Angiografía de Substracción Digital , Arterias Cerebrales/diagnóstico por imagen , Procedimientos Endovasculares/métodos , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
Lymphatic malformations (LMs) are rare congenital tumors of the lymphatic system often affecting the head and neck area. Because of cosmetic and functional symptoms most patients need to be treated. Traditionally surgical treatment has been considered to be the first-line treatment for LM. However, it is challenging because of the need for complete excision. The risk of poor cosmetic result and damage to surrounding structures is high. Since Ogita presented OK-432 as a treatment for LM in 1987, it has been widely used as the primary treatment. Many papers have been published on this topic but with relatively short follow-up times. We present a material of 36 LMs treated with OK-432 during the period of 1999-2009 and with an average follow-up time of 6 years. Immediate post-treatment results were compared with the late follow-up findings. Primary and late response to therapy was evaluated with an MRI scan by measuring the change in lesion size. At the follow-up visit, all patients were clinically examined and they answered a symptom questionnaire. Later 26/36 patients were also available for a quality of life questionnaire. Primarily 67% demonstrated a complete or marked response. At the follow-up 64% showed a complete or marked response, in 11% the final response was better than the initially observed and only 2 patients had relapsed. The initial response predicted the long-term outcome accurately and the effect of OK-432 sclerotherapy seems to be long lasting. According to the MRI evaluation 80% and subjectively 94% of the patients benefitted from the treatment. Quality of life questionnaire showed high post-treatment satisfaction. We found OK-432 sclerotherapy to be a safe and effective treatment with a long lasting effect in the management of macrocystic LMs.
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Antineoplásicos/uso terapéutico , Anomalías Linfáticas/terapia , Picibanil/uso terapéutico , Escleroterapia/métodos , Adolescente , Adulto , Niño , Preescolar , Femenino , Cabeza , Humanos , Lactante , Anomalías Linfáticas/patología , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Cuello , Estudios Retrospectivos , Torso , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND AND PURPOSE: The optimal antiplatelet regimen after flow diverter treatment of cerebral aneurysms is still a matter of debate. A single antiplatelet therapy might be advantageous in determined clinical scenarios. This study evaluated the efficacy and safety of prasugrel single antiplatelet therapy versus aspirin and clopidogrel dual antiplatelet therapy. MATERIALS AND METHODS: We performed a post hoc analysis of 4 retrospective multicenter studies including ruptured and unruptured aneurysms treated with flow diversion using either prasugrel single antiplatelet therapy or dual antiplatelet therapy. Primary end points were the occurrence of any kind of procedure- or device-related thromboembolic complications and complete aneurysm occlusion at the latest radiologic follow-up (mean, 18 months). Dichotomized comparisons of outcomes were performed between single antiplatelet therapy and dual antiplatelet therapy. Additionally, the influence of various patient- and aneurysm-related variables on the occurrence of thromboembolic complications was investigated using multivariable backward logistic regression. RESULTS: A total of 222 patients with 251 aneurysms were included, 90 (40.5%) in the single antiplatelet therapy and 132 (59.5%) in the dual antiplatelet therapy group. The primary outcome-procedure- or device-related thromboembolic complications-occurred in 6 patients (6.6%) of the single antiplatelet therapy and in 12 patients (9.0%) of the dual antiplatelet therapy group (P = .62; OR, 0.712; 95% CI, 0.260-1.930). The primary treatment efficacy end point was reached in 82 patients (80.4%) of the single antiplatelet therapy and in 115 patients (78.2%) of the dual antiplatelet therapy group (P = .752; OR, 1.141; 95% CI, 0.599-2.101). Logistic regression showed that non-surface-modified flow diverters (P = .014) and fusiform aneurysm morphology (P = .004) significantly increased the probability of thromboembolic complications. CONCLUSIONS: Prasugrel single antiplatelet therapy after flow diverter treatment may be as safe and effective as dual antiplatelet therapy and could, therefore, be a valid alternative in selected patients. Further prospective comparative studies are required to validate our findings.
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Aspirina , Clopidogrel , Aneurisma Intracraneal , Inhibidores de Agregación Plaquetaria , Clorhidrato de Prasugrel , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Clorhidrato de Prasugrel/uso terapéutico , Clorhidrato de Prasugrel/administración & dosificación , Femenino , Masculino , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Retrospectivos , Clopidogrel/uso terapéutico , Clopidogrel/administración & dosificación , Persona de Mediana Edad , Aspirina/uso terapéutico , Aspirina/administración & dosificación , Anciano , Resultado del Tratamiento , Terapia Antiplaquetaria Doble/métodos , Tromboembolia/prevención & control , Tromboembolia/etiología , Adulto , StentsRESUMEN
BACKGROUND: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017â³ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. OBJECTIVE: To evaluate angiographic stability at 1 year. METHODS: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. RESULTS: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.
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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.
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Consenso , Técnica Delphi , Aneurisma Intracraneal , Aneurisma Intracraneal/cirugía , Aneurisma Intracraneal/diagnóstico por imagen , Humanos , Insuficiencia del Tratamiento , Procedimientos Endovasculares/métodos , Estudios de Seguimiento , StentsRESUMEN
INTRODUCTION: Thrombectomy complications remain poorly explored. This study aims to characterize periprocedural intracranial vessel perforation including the effect of thrombolysis on patient outcomes. PATIENTS AND METHODS: In this multicenter retrospective cohort study, consecutive patients with vessel perforation during thrombectomy between January 2015 and April 2023 were included. Vessel perforation was defined as active extravasation on digital subtraction angiography. The primary outcome was modified Rankin Scale (mRS) at 90 days. Factors associated with the primary outcome were assessed using proportional odds models. RESULTS: 459 patients with vessel perforation were included (mean age 72.5 ± 13.6 years, 59% female, 41% received thrombolysis). Mortality at 90 days was 51.9% and 16.3% of patients reached mRS 0-2 at 90 days. Thrombolysis was not associated with worse outcome at 90 days. Perforation of a large vessel (LV) as opposed to medium/distal vessel perforation was independently associated with worse outcome at 90 days (aOR 1.709, p = 0.04) and LV perforation was associated with poorer survival probability (HR 1.389, p = 0.021). Patients with active bleeding >20 min had worse survival probability, too (HR 1.797, p = 0.009). Thrombolysis was not associated with longer bleeding duration. Bleeding cessation was achieved faster by permanent vessel occlusion compared to temporary measures (median difference: 4 min, p < 0.001). DISCUSSION AND CONCLUSION: Vessel perforation during thrombectomy is a severe and frequently fatal complication. This study does not suggest that thrombolysis significantly attributes to worse prognosis. Prompt cessation of active bleeding within 20 min is critical, emphasizing the need for interventionalists to be trained in complication management.
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INTRODUCTION: Intracranial stents have theoretical advantages in the treatment of wide-necked intracranial aneurysms, but the usability of intracranial stents in the retreatment of recurrent intracranial aneurysms is relatively unknown. In this study, we aim to evaluate the safety and efficacy of stent-assisted embolization in the retreatment of recurrent or residual intracranial aneurysms. METHODS: Retrospective evaluation was carried out for 55 consecutive patients (17 men and 38 women; mean age 51.5 years), with 56 recurrent or residual intracranial aneurysms electively retreated with stent-assisted embolization. RESULTS: The technical success rate was 91% (50/55 patients). Procedural complications were encountered with six patients (11%). Angiographic and clinical follow-up data were available for 51 patients (93%), with a mean follow-up period of 28.1 months. No rebleedings were encountered during the study period. The clinical outcome was favorable in 50 patients (91%), with a Glasgow Outcome Score of 4 (N = 14) or 5 (N = 36) at the end of the study period. Poor clinical outcome correlated with very large (>2 cm) total aneurysm size (P = 0.002), large (>10 mm) recurrent aneurysm size (P = 0.011), and occurrence of periprocedural complications (P < 0.001). CONCLUSION: Stent-assisted coil embolization is beneficial for the retreatment of wide-necked recurrent or residual intracranial aneurysms, but stability and permanent occlusion of the recurrent aneurysm is unlikely if the aneurysm exceeds 2 cm in diameter, the recurrent diameter of the aneurysm exceeds 10 mm, or if mass effect is present with the recurrent aneurysm.
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Aneurisma Roto/mortalidad , Aneurisma Roto/terapia , Embolización Terapéutica/mortalidad , Aneurisma Intracraneal/mortalidad , Aneurisma Intracraneal/terapia , Complicaciones Posoperatorias/mortalidad , Stents , Adolescente , Adulto , Anciano , Comorbilidad , Femenino , Finlandia/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Recurrencia , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND AND PURPOSE: Transradial access (TRA) has increased popularity among neurointerventionalists during a short time period but until recently there have been no devices designed especially for radial use. MATERIALS AND METHODS: Consecutive neurointerventional procedures with an intention to perform TRA with the Rist radial access guide catheter between April 2021 and May 2022 were retrospectively reviewed. Possible access site complications, other procedure-related complications and information on successful catherization of the target vessel as well as whether the procedure had been successful were collected. RESULTS: Information from 100 patients was included in the study. The most general procedure was flow diversion (29%) followed by WEB embolization (20 %). Four patients (4%) needed conversion to femoral access. The triaxial system was used in 76% of the procedures. Four patients (4%) experienced access site or device related complications, none of those were serious. Six patients had clinically relevant procedure related complications. CONCLUSIONS: It is concluded that the Rist device can be used safely for a large variety of neurointerventions with a short learning curve.
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Embolización Terapéutica , Procedimientos Endovasculares , Humanos , Arteria Radial/diagnóstico por imagen , Arteria Radial/cirugía , Procedimientos Endovasculares/métodos , Estudios Retrospectivos , Finlandia , Embolización Terapéutica/métodos , Resultado del TratamientoRESUMEN
PURPOSE: To identify factors influencing short- and mid-term radiological outcomes of intracranial aneurysms (IAs) treated with the Woven EndoBridge (WEB). METHODS: A total of 112 patients were treated for IAs with the WEB in at our institution between 2013 and 2020. Patients with 6- and/or 24-months follow-up data were included in the study. Aneurysm occlusion was evaluated using the Raymond-Roy occlusion classification (RR). RR 1 and RR 2 were considered as adequate outcomes, while RR 3 inadequate. RESULTS: Data were available for 91 patients (56 females, 62%) at 6 months and 62 of those patients (39 females, 58%) at 24 months. The adequate occlusion (RR 1/RR 2) rate was 89% (n = 81/91) at the 6-months follow-up and 91% (n = 56/62) at the 24-months follow-up. The treatment-related morbidity rate was 4% (n = 4/91), and mortality rate was 1% (n = 1/91). The predictor for inadequate occlusion at the 6-months follow-up was the lobular shape of an aneurysm (p = .01). The aneurysm's height (p = .02), maximal diameter (p = .001), width (p = .002), aspect ratio (p = .03), dome-to-neck ratio (p = .04), and lobular shape (p= .03) were predictive factors for inadequate occlusion at 24 months. All the thrombosed aneurysms (n = 3) showed unfavorable radiological outcomes and required re-treatment within 24 months. None of the patient-related factors were significant. CONCLUSIONS: The WEB provides favorable occlusion rates and low complications for both ruptured and unruptured wide-necked IAs. Unfavorable radiological outcomes after WEB treatment may be related to aneurysm morphology and size.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Resultado del Tratamiento , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Estudios RetrospectivosRESUMEN
BACKGROUND: Physician variablity in preoperative planning of endovascular implant deployment and associated inaccuracies have not been documented. This study aimed to quantify the variability in accuracy of physician flow diverter (FD) planning and directly compares it with PreSize Neurovascular (Oxford Heartbeat Ltd) software simulations. METHODS: Eight experienced neurointerventionalists (NIs), blinded to procedural details, were provided with preoperative 3D rotational angiography (3D-RA) volumetric data along with images annotated with the distal landing location of a deployed Surpass Evolve (Stryker Neurovascular) FD from 51 patient cases. NIs were asked to perform a planning routine reflecting their normal practice and estimate the stent's proximal landing using volumetric data and the labeled dimensions of the FD used. Equivalent deployed length estimation was performed using PreSize software. NI- and software-estimated lengths were compared with postprocedural observed deployed stent length (control) using Bland-Altman plots. NI assessment agreement was assessed with the intraclass correlation coefficient (ICC). RESULTS: The mean accuracy of NI-estimated deployed FD length was 81% (±15%) versus PreSize's accuracy of 95% (±4%), demonstrating significantly higher accuracy for the software (p<0.001). The mean absolute error between estimated and control lengths was 4 mm (±3.5 mm, range 0.03-30.2 mm) for NIs and 1 mm (±0.9 mm, range 0.01-3.9 mm) for PreSize. No discernable trends in accuracy among NIs or across vasculature and aneurysm morphology (size, vessel diameter, tortuousity) were found. CONCLUSIONS: The study quantified experienced physicians' significant variablity in predicting an FD deployment with current planning approaches. In comparison, PreSize-simulated FD deployment was consistently more accurate and reliable, demonstrating its potential to improve standard of practice.
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BACKGROUND: Flow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD. METHODS: Patients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed. RESULTS: 60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure. CONCLUSIONS: The new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Estudios Retrospectivos , Estudios Prospectivos , Resultado del Tratamiento , Stents , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodosRESUMEN
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.
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BACKGROUND: Vessel perforation during thrombectomy is a severe complication and is hypothesized to be more frequent during medium vessel occlusion (MeVO) thrombectomy. The aim of this study was to compare the incidence and outcome of patients with perforation during MeVO and large vessel occlusion (LVO) thrombectomy and to report on the procedural steps that led to perforation. METHODS: In this multicenter retrospective cohort study, data of consecutive patients with vessel perforation during thrombectomy between January 1, 2015 and September 30, 2022 were collected. The primary outcomes were independent functional outcome (ie, modified Rankin Scale 0-2) and all-cause mortality at 90 days. Binomial test, chi-squared test and t-test for unpaired samples were used for statistical analysis. RESULTS: During 25 769 thrombectomies (5124 MeVO, 20 645 LVO) in 25 stroke centers, perforation occurred in 335 patients (1.3%; mean age 72 years, 62% female). Perforation occurred more often in MeVO thrombectomy (2.4%) than in LVO thrombectomy (1.0%, p<0.001). More MeVO than LVO patients with perforation achieved functional independence at 3 months (25.7% vs 10.9%, p=0.001). All-cause mortality did not differ between groups (overall 51.6%). Navigation beyond the occlusion and retraction of stent retriever/aspiration catheter were the two most common procedural steps that led to perforation. CONCLUSIONS: In our cohort, perforation was approximately twice as frequent in MeVO than in LVO thrombectomy. Efforts to optimize the procedure may focus on navigation beyond the occlusion site and retraction of stent retriever/aspiration catheter. Further research is necessary in order to identify thrombectomy candidates at high risk of intraprocedural perforation and to provide data on the effectiveness of endovascular countermeasures.
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OBJECTIVE: The aim of our multi-center study is to examine 5-year radiological outcomes of intracranial aneurysms (IAs) treated with the Woven EndoBridge (WEB). METHODS: All patients treated with WEB between January 2013 and December 2016 were included. Patient and aneurysm characteristic data was collected from the electronic patient record. Aneurysm occlusion was assessed using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. Complete occlusion and neck remnant were considered as adequate occlusion, whereas aneurysm remnant was assessed as an inadequate occlusion. RESULTS: A total of 66 patients (72.7% female) with 66 IAs (n = 25 acutely ruptured) were treated with WEB. The mean age of patients was 55.6 years (range: 36-71 years). The mean width of the aneurysm neck was 4.5â mm (range: 2-9â mm). 5-year imaging follow-up data was not available for 16.6% patients (n = 11). During the follow up period, 14.5% of IAs (n = 8/55) required retreatment within 24 months of initial treatment with the WEB. A total of 55 IAs were analyzed for 5-year radiological outcome. Of these, including IAs required retreatment, 47.3% of IAs (n = 26/55) were occluded completely, 36.4% (n = 20/55) had neck remnant and 16.3% (n = 9/55) had recanalized. 83.7% of IAs were occluded adequately. None of the IAs rebled after initial treatment with WEB. CONCLUSION: WEB can provide acceptable adequate occlusion rates at 5 years. Furthermore, recanalization appears to be unlikely after the first two years post-treatment. The results of large studies are needed to confirm these promising long term radiological outcomes.
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BACKGROUND: Perimesencephalic and nonperimesencephalic nonaneurysmal subarachnoid hemorrhage (PM-naSAH and NPM-naSAH) have a different bleeding pattern and clinical course. The etiology and risk factors for PM-naSAH and NPM-naSAH are unclear. The objective of this study was to compare risk factors and triggering events between PM-naSAH and NPM-naSAH. METHODS: We reviewed retrospectively all patients (n = 3475) who had undergone cerebral digital subtraction angiography between 2003 and 2020 at our tertiary hospital. Of these, 119 patients had 6-vessel angiography negative subarachnoid hemorrhage (47 (39%) PM-naSAH and 72 (61%) NPM-naSAH) and accurate information about the triggering event was available in 42 (89%) PM-NASAH and 64 (89%) NPM-naSAH patients. RESULTS: PM-naSAH were younger compared to NPM-naSAH (mean age [SD]; 55.3 [11.1] years vs. 59.6 [12.2] years, p = .045. PM-naSAH was triggered during the physical exertion in 79% of patients and 16% of patients with NPM-naSAH (relative risk 5.4; 95% CI, 2.9-10.1, p < .0001). There were no significant difference in sex, smoking, alcohol abuse, hypertension, diabetes, hyperlipidemia, or anticoagulation/antithrombotic usage between PM-naSAH and NMP-naSAH, p > .05. CONCLUSION: Physical exertion was a triggering factor in most of the PM-naSAH cases and the risk was five times greater than in NMP-naSAH. More studies are needed to confirm our results and to study pathophysiology of PM-naSAH and NPM-naSAH.
Asunto(s)
Hemorragia Subaracnoidea , Anticoagulantes , Niño , Fibrinolíticos , Humanos , Esfuerzo Físico , Estudios Retrospectivos , Factores de Riesgo , Hemorragia Subaracnoidea/diagnóstico por imagen , Hemorragia Subaracnoidea/epidemiología , Hemorragia Subaracnoidea/etiologíaRESUMEN
BACKGROUND: Flow diversion of acutely ruptured intracranial aneurysms (IAs) is controversial due to high treatment-related complication rates and a lack of supporting evidence. We present clinical and radiological results of the largest series to date. METHODS: This is a nationwide retrospective study of acutely ruptured IAs treated with flow diverters (FDs). The primary outcome was the modified Rankin Scale (mRS) score at the last available follow-up time. Secondary outcomes were treatment-related complications and the aneurysm occlusion rate. RESULTS: 110 patients (64 females; mean age 55.7 years; range 12-82 years) with acutely ruptured IAs were treated with FDs between 2012 and 2020 in five centers. 70 acutely ruptured IAs (64%) were located in anterior circulation, and 47 acutely ruptured IAs (43%) were blister-like. A favorable functional outcome (mRS 0-2) was seen in 73% of patients (74/102). Treatment-related complications were seen in 45% of patients (n=49). Rebleeding was observed in 3 patients (3%). The data from radiological follow-ups were available for 80% of patients (n=88), and complete occlusion was seen in 90% of aneurysms (79/88). The data from clinical follow-ups were available for 93% of patients (n=102). The overall mortality rate was 18% (18/102). CONCLUSIONS: FD treatment yields high occlusion for acutely ruptured IAs but is associated with a high risk of complications. Considering the high mortality rate of aneurysmal subarachnoid hemorrhage, the prevention of rebleeding is crucial. Thus, FD treatment may be justified as a last resort option.