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BACKGROUND: Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The SOFAST study collected clinical evidence on the safety and efficacy of the 6 French SOFIA Flow Plus aspiration catheter (SOFIA 6F) when used as first-line treatment. METHODS: This was a prospective, multicenter investigation to assess the safety and efficacy of SOFIA 6F used for first-line aspiration. Anterior circulation LVO stroke patients were enrolled. The primary endpoint was the final modified Thrombolysis in Cerebral Infarction (mTICI)≥2b rate. Secondary endpoints included first-pass and first-line mTICI≥2b rates, times from arteriotomy to clot contact and mTICI≥2b, and 90-day modified Rankin Scale (mRS)≤2. First-line and final mTICI scores were adjudicated by an independent imaging core lab. Safety events were assessed by an independent clinical events adjudicator. RESULTS: A total of 108 patients were enrolled across 12 centers from July 2020 to June 2022. Median age was 67 years, median National Institutes of Health Stroke Scale (NIHSS) was 15.5, and 56.5% of patients received intravenous thrombolytics. At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively. With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively. After the first pass, 75.0%, 70.4%, and 50.9% achieved mTICI≥2b, ≥2c, and 3, respectively. Median times from arteriotomy to clot contact and successful revascularization were 12 and 17 min, respectively. At 90 days, 66.7% of patients achieved mRS≤2. CONCLUSIONS: First-line aspiration with SOFIA 6F is safe and effective with high revascularization rates and short procedure times.
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BACKGROUND: The optimal recanalization goal and number of endovascular thrombectomy (EVT) passes for elderly patients with large vessel occlusion strokes is unclear. METHODS: Consecutive patients 80 years or older undergoing EVT were identified from 2016 to 2022 at a single center. Clinical information, procedural details, and modified treatment in cerebral ischemia (mTICI) scores were collected. Primary outcome was modified Rankin scale (mRS) at 90 days. Bivariate and multivariable analyses were conducted to assess associations between mTICI scores, EVT passes, and 90-day outcomes. RESULTS: One hundred twenty-six patients were identified. At 90 days, mTICI 2b recanalization resulted in high rates of poor outcomes (8.7% functional independence and 60.9% mortality) not significantly different from mTICI 0, 1 or 2a (median mRS 6 vs. 6, P = 0.61). Complete recanalization (mTICI 2c or 3) led to significantly better mRS outcomes at 90 days compared to mTICI 2b (median mRS 4 vs. 6, adjusted P = 0.038), with 26.8% functional independence and 37.8% mortality. In multivariable analysis, complete recanalization was significantly associated with better 90-day outcomes than mTICI 2b or lower recanalization (odds ratio 4.24 [95% Confidence interval 1.46-12.3]; P = 0.002), while the number of passes was not independently associated with worse outcomes (P = 0.98). CONCLUSIONS: For octogenarians, mTICI 2b recanalization yields limited clinical benefit and results in poor 90-day outcomes. In contrast, complete recanalization is independently associated with significantly better outcomes. Thus, once the decision is made to pursue EVT in the elderly, mTICI 2c or better recanalization should be the angiographic goal. Providers should not withhold thrombectomy passes based on age alone.
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Procedimientos Endovasculares , Trombectomía , Humanos , Trombectomía/métodos , Masculino , Procedimientos Endovasculares/métodos , Femenino , Anciano de 80 o más Años , Resultado del Tratamiento , Angiografía Cerebral , Estudios Retrospectivos , Accidente Cerebrovascular/cirugía , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular Isquémico/cirugía , Accidente Cerebrovascular Isquémico/diagnóstico por imagenRESUMEN
BACKGROUND: While endovascular thrombectomy (EVT) is beneficial for patients with acute large vessel occlusion ischemic strokes, a significant portion of patients still do poorly despite successful recanalization. Identifying patients at high risk for poor outcomes can be helpful for future clinical trial design and optimizing acute stroke triage. METHODS: Consecutive EVT patients were identified from 2016 to 2021 at a Comprehensive Stroke Center, and clinical information was recorded. Poor outcome was defined as a 90-day modified Rankin Scale (mRS) of 4 or greater despite achieving a modified thrombolysis in cerebral infarction (mTICI) score of 2b or greater. Multivariable regression analyses were used to identify risk factors for poor outcomes, and a scoring system was constructed. RESULTS: 483 patients with successful recanalization were identified. From a randomly selected training cohort (n = 357), the 10-point BAND score was constructed from independent risk factors for poor outcomes: baseline disability (1 point: baseline mRS ≥ 2), age (1 point: 60-69 years, 2 points: 70-79 years, 3 points: 80-84 years, 4 points: 85 years or older), NIHSS (2 points: 13-17, 3 points: 18-22, and 4 points: ≥ 23), and delay from last known normal (1 point: ≥ 6 h). The BAND score was significantly associated with rates of poor outcomes (p < 0.001), and it achieved an area under the receiver-operating characteristic curve (AUC) of 0.80 (95 %CI 0.76-0.85) in our training cohort and 0.78 (95 %CI 0.70-0.86) in our validation cohort (n = 126). Overall, the BAND score had a significantly higher AUC value than the widely validated THRIVE score and the THRIVE-EVT calculation (p = 0.001 and 0.029, respectively). Among patients with high BAND scores (7 or higher), 88.2 % had poor outcomes. CONCLUSION: The BAND score is a simple tool to predict poor outcomes despite successful recanalization. Future studies are needed to confirm the BAND score's external validity.
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Isquemia Encefálica , Procedimientos Endovasculares , Accidente Cerebrovascular , Anciano , Humanos , Persona de Mediana Edad , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/terapia , Isquemia Encefálica/complicaciones , Infarto Cerebral/etiología , Procedimientos Endovasculares/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Accidente Cerebrovascular/etiología , Trombectomía/efectos adversos , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
BACKGROUND: Large vessel recanalization (LVR) before endovascular therapy (EVT) for acute large vessel ischemic strokes is a poorly understood phenomenon. Better understanding of predictors for LVR is important for optimizing stroke triage and patient selection for bridging thrombolysis. METHODS: In this retrospective cohort study, consecutive patients presenting to a comprehensive stroke center for EVT treatment were identified from 2018 to 2022. Demographic information, clinical characteristics, intravenous thrombolysis (IVT) use, and LVR before EVT were recorded. Factors independently associated with different rates of LVR were identified, and a prediction model for LVR was constructed. RESULTS: 640 patients were identified. 57 (8.9%) patients had LVR before EVT. A minority (36.4%) of LVR patients had significant improvements in National Institutes of Health Stroke Scale. Independent predictors for LVR were identified and used to construct the 8-point HALT score: hyperlipidemia (1 point), atrial fibrillation (1 point), location of vascular occlusion (internal carotid: 0 points, M1: 1 point, M2: 2 points, vertebral/basilar: 3 points), and thrombolysis at least 1.5 hours before angiography (3 points). The HALT score had an area under the receiver-operating curve (AUC) of 0.85 (95% CI 0.81 to 0.90, P<0.001) for predicting LVR. LVR before EVT occurred in only 1 of 302 patients (0.3%) with low (0-2) HALT scores. CONCLUSIONS: IVT at least 1.5 hours before angiography, site of vascular occlusion, atrial fibrillation, and hyperlipidemia are independent predictors for LVR. The 8-point HALT score proposed in this study may be a valuable tool for predicting LVR before EVT.
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Fibrilación Atrial , Isquemia Encefálica , Procedimientos Endovasculares , Hiperlipidemias , Accidente Cerebrovascular , Humanos , Terapia Trombolítica , Estudios Retrospectivos , Isquemia Encefálica/diagnóstico por imagen , Isquemia Encefálica/cirugía , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/cirugía , Trombectomía , Hiperlipidemias/tratamiento farmacológico , Resultado del TratamientoRESUMEN
BACKGROUND AND OBJECTIVES: Magnetic resonance-guided focused ultrasound (MRgFUS) central lateral thalamotomy (CLT) has not yet been validated for treating refractory neuropathic pain (NP). Our aim was to assess the safety and potential efficacy of MRgFUS CLT for refractory NP. METHODS: In this prospective, nonrandomized, single-arm, investigator-initiated phase I trial, patients with NP for more than 6 months related to phantom limb pain, spinal cord injury, or radiculopathy/radicular injury and who had undergone at least one previous failed intervention were eligible. The main outcomes were safety profile and pain as assessed using the brief pain inventory, the pain disability index, and the numeric rating scale. Medication use and the functional connectivity of the default mode network (DMN) were also assessed. RESULTS: Ten patients were enrolled, with nine achieving successful ablation. There were no serious adverse events and 12 mild/moderate severity events. The mean age was 50.9 years (SD: 12.7), and the mean symptom duration was 12.3 years (SD: 9.7). Among eight patients with a 1-year follow-up, the brief pain inventory decreased from 7.6 (SD: 1.1) to 3.8 (SD: 2.8), with a mean percent decrease of 46.3 (SD: 40.6) (paired t -test, P = .017). The mean pain disability index decreased from 43.0 (SD: 7.5) to 25.8 (SD: 16.8), with a mean percent decrease of 39.3 (SD: 41.6) ( P = .034). Numeric rating scale scores decreased from a mean of 7.2 (SD: 1.8) to 4.0 (SD: 2.8), with a mean percent decrease of 42.8 (SD: 37.8) ( P = .024). Patients with predominantly intermittent pain or with allodynia responded better than patients with continuous pain or without allodynia, respectively. Some patients decreased medication use. Resting-state functional connectivity changes were noted, from disruption of the DMN at baseline to reactivation of connectivity between DMN nodes at 3 months. CONCLUSION: MRgFUS CLT is feasible and safe for refractory NP and has potential utility in reducing symptoms as measured by validated pain scales.
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Ultrasonido Enfocado de Alta Intensidad de Ablación , Neuralgia , Humanos , Persona de Mediana Edad , Hiperalgesia , Neuralgia/diagnóstico por imagen , Neuralgia/cirugía , Estudios Prospectivos , Tálamo/diagnóstico por imagen , Tálamo/cirugía , Resultado del Tratamiento , AdultoRESUMEN
BACKGROUND: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. OBJECTIVE: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. METHODS: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). RESULTS: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). CONCLUSIONS: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. TRIAL REGISTRATION NUMBER: NCT04514562.
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BACKGROUND: Peri-procedural blood loss and hemodilution occur in patients undergoing mechanical thrombectomy (MT) for ischemic stroke; however, its relationships with thrombectomy passes, procedure times, and clinical outcomes are unknown. METHODS: Consecutive patients undergoing MT for anterior circulation large-vessel occlusion ischemic strokes were identified at a Comprehensive Stroke Center. Clinical information, modified treatment in cerebral ischemia (mTICI) scores, and modified Rankin Scores (mRS) at 90 days were prospectively collected from 2012 to 2021. Hemoglobin measurements before and after MTs were collected retrospectively via chart review, and changes were quantified. Patients with new-onset severe anemia (defined as post-MT hemoglobin less than 10g/dL) were identified. Modified Rankin scale (mRS) at 90 days was used to measure clinical outcomes. RESULTS: Four-hundred and forty-five patients were identified. Hemoglobin decreased 1.27 ± 1.05â g/dL after MT on average. Greater number of thrombectomy passes and longer procedure times were associated with larger decreases in hemoglobin (p < 0.001 and p = 0.002, respectively). 11.5% (51 of 445) of patients had new-onset severe anemia, and this incidence was significantly higher with more thrombectomy passes (6.4% for one pass, 11.9% for two passes, and 17.4% for three or more passes; p = 0.010). In multivariable analyses, new-onset severe anemia was associated with significantly higher odds of 90-day poor outcomes (mRS 3-6, OR 2.70 [95%CI 1.12-6.51], p = 0.027) and death (OR 2.73 [95%CI 1.06-7.04], p = 0.037) compared to mild post-MT anemia. CONCLUSIONS: More thrombectomy passes and longer procedure times were significantly associated with larger peri-procedural decreases in hemoglobin. Patients with new-onset hemoglobin less than 10â g/dL are at risk of poor outcomes.
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OBJECTIVES: There have been sporadic reports of ischemic spinal cord injury (SCI) during venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. The authors observed a troubling pattern of this catastrophic complication and evaluated the potential mechanisms of SCI related to ECMO. DESIGN: This study was a case series. SETTING: This study was performed at a single institution in a University setting. PARTICIPANTS: Patients requiring prolonged VA-ECMO were included. INTERVENTIONS: No interventions were done. This was an observational study. MEASUREMENTS AND MAIN RESULTS: Four hypotheses of etiology were considered: (1) hypercoagulable state/thromboembolism, (2) regional hypoxia/hypocarbia, (3) hyperperfusion and spinal cord edema, and (4) mechanical coverage of spinal arteries. The SCI involved the lower thoracic (T7-T12 level) spinal cord to the cauda equina in all patients. Seven out of 132 (5.3%) patients with prolonged VA-ECMO support developed SCI. The median time from ECMO cannulation to SCI was 7 (range: 6-17) days.There was no evidence of embolic SCI or extended regional hypoxia or hypocarbia. A unilateral, internal iliac artery was covered by the arterial cannula in 6/7 86%) patients, but flow into the internal iliac was demonstrated on imaging in all available patients. The median total flow (ECMO + intrinsic cardiac output) was 8.5 L/min (LPM), and indexed flow was 4.1 LPM/m2. The median central venous oxygen saturation was 88%, and intracranial pressure was measured at 30 mmHg in one patient, suggestive of hyperperfusion and spinal cord edema. CONCLUSIONS: An SCI is a serious complication of extended peripheral VA-ECMO support. Its etiology remains uncertain, but the authors' preliminary data suggested that spinal cord edema from hyperperfusion or venous congestion could contribute.
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Oxigenación por Membrana Extracorpórea , Traumatismos de la Médula Espinal , Isquemia de la Médula Espinal , Humanos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/métodos , Traumatismos de la Médula Espinal/diagnóstico por imagen , Traumatismos de la Médula Espinal/etiología , Traumatismos de la Médula Espinal/terapia , Isquemia de la Médula Espinal/diagnóstico por imagen , Isquemia de la Médula Espinal/etiología , Hipoxia/etiología , Hipoxia/terapia , Infarto , Estudios RetrospectivosRESUMEN
BACKGROUND: Elevated International Normalized Ratio (INR) is a marker of coagulopathy, but its impact on outcomes following mechanical thrombectomy (MT) in patients with stroke is unclear. This study investigates the impact of mild INR elevations on clinical outcomes following MT. METHODS: In this retrospective cohort study, consecutive patients with stroke treated with MT were identified from 2015 to 2020 at a Comprehensive Stroke Center. Demographic information, past medical history, INR, National Institutes of Health Stroke Scale score, use of tissue plasminogen activator, and last known normal to arteriotomy time were recorded. Outcome measures included modified Thrombolysis in Cerebral Infarction (mTICI) score, modified Rankin Scale (mRS) score at 90 days, and intracerebral hemorrhage (ICH). Patients were divided into two groups: normal INR (0.8-1.1) and mildly elevated INR (1.2-1.7). RESULTS: A total of 489 patients were included for analysis, of which 349 had normal INR and 140 had mildly elevated INR. After multivariable adjustments, mildly elevated INR was associated with lower odds of excellent outcomes (mRS 0-1, OR 0.24, p=0.009), lower odds of functional independence (mRS 0-2, OR 0.38, p=0.038), and higher odds of 90-day mortality (OR 3.45, p=0.018). Elevated INR was not associated with a higher likelihood of ICH, and there were no differences in rates of HI1, HI2, PH1, or PH2 hemorrhagic transformations; however, elevated INR was associated with significantly higher odds of 90-day mortality in patients with ICH (OR 6.22, p=0.024). This effect size was larger than in patients without ICH (OR 3.38, p<0.001). CONCLUSION: In patients with stroke treated with MT, mildly elevated INR is associated with worse clinical outcomes after recanalization and may worsen the mortality risk of hemorrhagic transformations.
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Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Activador de Tejido Plasminógeno/uso terapéutico , Accidente Cerebrovascular Isquémico/etiología , Trombectomía/efectos adversos , Relación Normalizada Internacional , Estudios Retrospectivos , Resultado del Tratamiento , Accidente Cerebrovascular/cirugía , Accidente Cerebrovascular/etiología , Hemorragia Cerebral/inducido químicamente , Isquemia Encefálica/cirugía , Isquemia Encefálica/tratamiento farmacológicoRESUMEN
BACKGROUND: High levels of platelet inhibition have been associated with hemorrhagic complications following Pipeline embolization of intracranial aneurysms. We therefore titrate clopidogrel dosing to maintain a moderate level of platelet inhibition using the VerifyNow P2Y12 assay. However, many patients demonstrate dramatic increases in platelet inhibition following treatment despite being on a consistent antiplatelet regimen. We therefore elected to explore the incidence of this phenomenon and possible predisposing factors. METHODS: All successful Pipeline aneurysm treatments performed at our institution from 2011 to 2019 with moderate procedure-day platelet inhibition levels as indicated by a VerifyNow PRU of 60-235 were included. Patients who received glycoprotein IIb/IIIa inhibitors and those treated for ruptured/symptomatic lesions were excluded. The incidence of excessive platelet inhibition defined by a PRU<60 within 8 weeks of treatment was noted. Multivariable logistic regression was performed to determined independent predictors of the phenomenon. RESULTS: Some 190 treatments were performed in 178 qualifying patients. A post-procedure PRU <60 occurred following 79% of treatments, documented on average after 8.5 (range 1-47) days. A higher procedure day hematocrit level (P=0.003, OR 1.09, 95% CI 1.029 to 1.152) was an independent predictor of reaching a PRU <60, while intra-procedural midazolam exposure (P=0.044, OR 0.44, 95% CI 0.201 to 0.980) and a higher procedure-day PRU (P=0.047, OR 0.99, 95% CI 0.982 to 1.000) were associated with a reduced odds. Time-since-procedure and hematocrit levels were associated with excessive platelet inhibition when excluding patients who initially demonstrated hyperresponse. CONCLUSION: Elevations in platelet inhibition were frequently observed following flow diversion with Pipeline.
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Embolización Terapéutica , Aneurisma Intracraneal , Humanos , Inhibidores de Agregación Plaquetaria , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/tratamiento farmacológico , Plaquetas , Clopidogrel , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Malignant cerebral edema (MCE) and intracranial hemorrhage (ICH) are associated with poor neurological outcomes despite revascularization after mechanical thrombectomy (MT). The factors associated with the development of MCE and ICH after MT are not well understood. OBJECTIVE: To determine periprocedural factors associated with MCE, ICH, and poor functional outcome. METHODS: We retrospectively analyzed anterior cerebral circulation large vessel occlusion cases that underwent MT from 2012 to 2019 at a single Comprehensive Stroke Center. Multivariate logistic regression analyses were performed to determine significant predictors of MCE, ICH, and poor functional outcome (modified Rankin Scale, 3-6) at 90 d. RESULTS: Four hundred patients were included. Significant independent predictors of MCE after MT included initial stress glucose ratio (iSGR) (odds ratio [OR], 14.26; 95% CI, 3.82-53.26; P < .001), National Institutes of Health Stroke Scale (NIHSS) (OR, 1.10; 95% CI, 1.03-1.18; P = .008), internal carotid artery compared with M1 or M2 occlusion, and absence of successful revascularization (OR, 0.16; 95% CI, 0.06-0.44; P < .001). Significant independent predictors of poor functional outcome included MCE (OR, 7.47; 95% CI, 2.20-25.37; P = .001), iSGR (OR, 5.15; 95% CI, 1.82-14.53; P = .002), ICH (OR, 4.77; 95% CI, 1.20-18.69; P = .024), NIHSS (OR, 1.10; 95% CI, 1.05-1.16; P < .001), age (OR, 1.04; 95% CI, 1.03-1.07; P < .001), and thrombolysis in cerebral infarction 2C/3 recanalization (OR, 0.12; 95% CI, 0.05-0.29; P < .001). CONCLUSION: Elevated iSGR significantly increases the risk of MCE and ICH and is an independent predictor of poor functional outcome. Thrombolysis in cerebral infarction 2C/3 revascularization is associated with reduced risk of MCE, ICH, and poor functional outcome. Whether stress hyperglycemia represents a modifiable risk factor is uncertain, and further investigation is warranted.
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Edema Encefálico , Isquemia Encefálica , Hiperglucemia , Accidente Cerebrovascular , Edema Encefálico/etiología , Isquemia Encefálica/complicaciones , Humanos , Hiperglucemia/complicaciones , Hemorragias Intracraneales/complicaciones , Estudios Retrospectivos , Accidente Cerebrovascular/etiología , Trombectomía/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: The utility of using the VerifyNow P2Y12 platelet inhibition assay in patients undergoing Pipeline embolization of intracranial aneurysms remains controversial. As we have routinely employed the assay for patients undergoing flow diversion, we elected to explore the relationship between P2Y12 hyporesponse as indicated by a P2Y12 Reaction Units (PRU) value >200 and treatment outcomes, including intraprocedural platelet aggregation and ischemic complications. METHODS: All successful intracranial aneurysm Pipeline treatments performed at our institution from November 2011 to May 2019 were included. The rate of P2Y12 hyporesponse and treatment outcomes were evaluated. Multivariable logistic regression was utilized to determine independent predictors of treatment outcomes. RESULTS: 333 qualifying treatments were performed in 297 patients. Clopidogrel hyporesponse was initially noted in 24%, falling to 17% by day-of-procedure by dose titration. A glycoprotein (GP) IIb/IIIa inhibitor was administered prophylactically in 3% of cases for persistent, profound hyporesponse. 27 (8.1%) patients developed acute platelet aggregation; only 6 demonstrated day-of-procedure P2Y12 hyporesponse. Day-of-procedure hyporesponse was not associated with intraprocedural platelet aggregation or ischemic complications. Greater Pipeline embolization device (PED) diameter was associated with a reduced odds of platelet aggregation (OR 0.38, 95% CI 0.17 to 0.85; p=0.019). Antiplatelet non-compliance (OR 25.20, 95% CI 3.86 to 164.61; p=0.001) and treatment of posterior circulation aneurysms (OR 5.23, 95% CI 1.22 to 22.33; p=0.026) were the only independent predictors of ischemic complications. CONCLUSIONS: P2Y12 hyporesponse was not associated with acute platelet aggregation or ischemic complications in our patients undergoing Pipeline embolization of intracranial aneurysms, possibly due to aggressive management of the hyporesponse using clopidogrel dose titration and/or GP IIb/IIIa inhibitor administration.
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Embolización Terapéutica , Aneurisma Intracraneal , Clopidogrel , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Agregación Plaquetaria , Inhibidores de Agregación Plaquetaria/farmacología , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Intracranial aneurysms are common in the adult population and carry a risk of rupture leading to catastrophic subarachnoid hemorrhage. Treatment of aneurysms has evolved significantly, with the introduction of new techniques and devices for minimally invasive and endovascular approaches. Follow-up imaging after aneurysm treatment is standard of care to monitor for recurrence or other complications, and the preferred imaging modality and schedule for follow-up are areas of active research. The modality and follow-up schedule should be tailored to treatment technique, aneurysm characteristics, and patient factors.
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Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Hemorragia Subaracnoidea , Adulto , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Stents , Hemorragia Subaracnoidea/diagnóstico por imagen , Hemorragia Subaracnoidea/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs. METHODS: This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded. RESULTS: A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler-Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related. CONCLUSION: This study demonstrates the safety of Apollo for Onyx embolization of bAVMs. CLINICAL TRIAL REGISTRATION: CNCT02378883.
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Embolización Terapéutica , Malformaciones Arteriovenosas Intracraneales , Adulto , Encéfalo , Dimetilsulfóxido/efectos adversos , Embolización Terapéutica/efectos adversos , Femenino , Humanos , Malformaciones Arteriovenosas Intracraneales/diagnóstico por imagen , Malformaciones Arteriovenosas Intracraneales/terapia , Masculino , Persona de Mediana Edad , Polivinilos/efectos adversos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
OBJECTIVE: MR-guided focused ultrasound (MRgFUS) is increasingly being used to treat patients with essential tremor (ET) and Parkinson's disease (PD) with thalamotomy and pallidotomy, respectively. Pallidotomy is performed off-center within the cranium compared to thalamotomy and may present challenges to therapeutic lesioning due to this location. However, the impact of target location on treatment efficiency and ability to create therapeutic lesions has not been studied. This study aimed to compare the physical efficiency of MRgFUS thalamotomy and pallidotomy. METHODS: Treatment characteristics were compared between patients treated with thalamotomy (n = 20) or pallidotomy (n = 20), matched by skull density ratios (SDR). Aspects of treatment efficiency were compared between these groups. Demographic and comparative statistics were conducted to assess these differences. Acoustic field simulations were performed to compare and validate the simulated temperature profile for VIM and GPi ablation. RESULTS: Lower SDR values were associated with greater energy requirement for thalamotomy (R2 = 0.197, p = 0.049) and pallidotomy (R2 = 0.342, p = 0.007). The impact of low SDR on efficiency reduction was greater for pallidotomy, approaching significance (p = 0.061). A nearly two-fold increase in energy was needed to reach 50°C in pallidotomy (10.9kJ) than in thalamotomy (5.7kJ), (p = 0.002). Despite lower energy requirement, the maximum average temperature reached was higher in thalamotomy (56.7°C) than in pallidotomy (55.0°C), (p = 0.017). Mean incident angle of acoustic beams was lesser in thalamotomy (12.7°) than in pallidotomy (18.6°), (p < 0.001). For all patients, a lesser mean incident angle correlated with a higher maximum average temperature reached (R2 = 0.124, p = 0.026), and less energy needed to reach 50°C (R2=0.134, p = 0.020). Greater skull thickness was associated with a higher maximum energy for a single sonication for thalamotomy (R2 = 0.206, p = 0.045) and pallidotomy (R2 = 0.403, p = 0.003). An acoustic and temperature field simulation validated similar findings for thalamotomy and pallidotomy in a single patient. CONCLUSION: The centrally located VIM offers a more efficient location for therapeutic lesioning compared to GPi pallidotomy in SDR matched cohort of patients. The impact on therapeutic lesioning with lower SDR may be greater for pallidotomy patients. As newer off-center targets are investigated, these findings can inform patient selection and treatment requirements for lesion production.
RESUMEN
OBJECTIVE: Magnetic resonance-guided focused ultrasound (MRgFUS) ablation of the globus pallidus interna (GPi) is being investigated for the treatment of advanced Parkinson's disease symptoms. However, GPi lesioning presents unique challenges due to the off-midline location of the target. Furthermore, it remains uncertain whether intraprocedural MR thermometry data can predict final lesion characteristics. METHODS: The authors first performed temperature simulations of GPi pallidotomy and compared the results with those of actual cases and the results of ventral intermediate nucleus (VIM) thalamotomy performed for essential tremor treatment. Next, thermometry data from 13 MRgFUS pallidotomy procedures performed at their institution were analyzed using 46°C, 48°C, 50°C, and 52°C temperature thresholds. The resulting thermal models were compared with resulting GPi lesions noted on postprocedure days 1 and 30. Finally, the treatment efficiency (energy per temperature rise) of pallidotomy was evaluated. RESULTS: The authors' modeled acoustic intensity maps correctly demonstrate the elongated, ellipsoid lesions noted during GPi pallidotomy. In treated patients, the 48°C temperature threshold maps most accurately predicted postprocedure day 1 lesion size, while no correlation was found for day 30 lesions. The average energy/temperature rise of pallidotomy was higher (612 J/°C) than what had been noted for VIM thalamotomy and varied with the patients' skull density ratios (SDRs). CONCLUSIONS: The authors' acoustic simulations accurately depicted the characteristics of thermal lesions encountered following MRgFUS pallidotomy. MR thermometry data can predict postprocedure day 1 GPi lesion characteristics using a 48°C threshold model. Finally, the lower treatment efficiency of pallidotomy may make GPi lesioning challenging in patients with a low SDR.
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Globo Pálido/cirugía , Imagen por Resonancia Magnética/métodos , Procedimientos Neuroquirúrgicos/métodos , Palidotomía/métodos , Enfermedad de Parkinson/diagnóstico por imagen , Enfermedad de Parkinson/cirugía , Cirugía Asistida por Computador/métodos , Procedimientos Quirúrgicos Ultrasónicos/métodos , Adulto , Anciano , Algoritmos , Temblor Esencial/cirugía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Cráneo/anatomía & histología , Temperatura , Tálamo/anatomía & histologíaRESUMEN
BACKGROUND: Subarachnoid hemorrhage (SAH) is most commonly caused by a ruptured vascular lesion. A significant number of patients presenting with SAH have no identifiable cause despite extensive cerebrovascular imaging at presentation. Significant neurological morbidity or mortality can result from misdiagnosis of aneurysm. OBJECTIVE: To generate a model to assist in predicting the risk of aneurysm in this patient population. METHODS: We conducted a retrospective study of all patients aged ≥18 yr admitted to a single center from March 2008 to March 2018 with nontraumatic SAH (n = 550). Patient information was compared between those with and without aneurysm to identify potential predictors. Odds ratios obtained from a logistic regression model were converted into scores which were summed and tested for predictive ability. RESULTS: Female sex, higher modified Fisher or Hijdra score, nonperimesencephalic location, presence of intracerebral hemorrhage, World Federation of Neurosurgical Societies (WFNS) score ≥3, need for cerebrospinal fluid diversion on admission, and history of tobacco use were all entered into multivariable analysis. Greater modified Fisher, greater Hijdra score, WFNS ≥3, and hydrocephalus present on admission were significantly associated with the presence of an aneurysm. A model based on the Hijdra score and SAH location was generated and validated. CONCLUSION: We show for the first time that the Hijdra score, in addition to other factors, may assist in identifying patients at risk for aneurysm on cerebrovascular imaging. A simple scoring tool based on patient sex, SAH location, and SAH burden can assist in predicting the presence of an aneurysm in patients with nontraumatic SAH.
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Hemorragia Cerebral/diagnóstico por imagen , Aneurisma Intracraneal/diagnóstico por imagen , Índice de Severidad de la Enfermedad , Hemorragia Subaracnoidea/diagnóstico por imagen , Adulto , Anciano , Hemorragia Cerebral/complicaciones , Estudios de Cohortes , Femenino , Humanos , Hidrocefalia/complicaciones , Hidrocefalia/diagnóstico por imagen , Aneurisma Intracraneal/etiología , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Hemorragia Subaracnoidea/complicacionesRESUMEN
INTRODUCTION: The Sofia 6-French PLUS catheter is a recently approved aspiration catheter for use in neuro-endovascular procedures. The description of Sofia 6-French PLUS use in acute ischemic stroke is limited. OBJECTIVE: The purpose of this article is to describe our initial experience with the new Sofia 6-French PLUS catheter for treatment of acute ischemic stroke and to report on its safety and efficacy. METHODS: We performed a retrospective study of 54 thrombectomy cases treated with the Sofia 6-French PLUS catheter. Mean patient age and admission National Institutes of Health Stroke Scale score were 65.30 (1.92) and 15.98 (0.89), respectively. The most common sites of vessel occlusion included the M1 segment (50%) and internal carotid artery (31%). Thrombectomy was performed using the direct aspiration first pass technique and/or aspiration in conjunction with a stent retriever. RESULTS: Successful navigation of the Sofia 6-French PLUS catheter to the site of thromboembolus was achieved in 94% of cases. Revascularization was achieved in a total of 47 cases (87%). Mean time from groin access to revascularization was 42.79 (3.23) min. There were no catheter-related complications. Final outcome data was available for 44 patients (81%). Of these patients, 41% achieved a good outcome (modified Rankin scale score of 0-2) at 60-90 day follow-up, 41% had a poor outcome (modified Rankin 3-5) and eight patients died (18%). CONCLUSIONS: We demonstrate the safe and effective use of the Sofia 6-French PLUS catheter for treatment of acute ischemic stroke. Future studies in the form of a randomized clinical trial or multicenter registry are warranted to further evaluate its comparative safety and efficacy.
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Catéteres , Procedimientos Endovasculares/instrumentación , Accidente Cerebrovascular/cirugía , Trombectomía/instrumentación , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: Magnetic resonance-guided focused ultrasound ablation of the thalamic ventral intermediate nucleus is a safe and effective treatment for medically refractory essential tremor. However, indirect targeting of the ventral intermediate nucleus using stereotactic coordinates from normal neuroanatomy can be inefficient. We therefore evaluated the feasibility of supplementing this method with direct targeting of the dentato-rubro-thalamic tract. METHODS: We retrospectively identified four patients undergoing magnetic resonance-guided focused ultrasound ablation for essential tremor in which preoperative diffusion tractography imaging of the dentato-rubro-thalamic tract was fused with T2 weighted-imaging and utilized for intra-procedural targeting. The size and location of the dentato-rubro-thalamic tract and 24-hour lesion, as well as the center of the stereotactic coordinates, was evaluated. Finally, the amount of overlap between the dentato-rubro-thalamic tract and the lesion was calculated. RESULTS: The 24-hour lesion size was homogeneous in the cohort (mean 31.3 mm2, range 30-32 mm2), while there was substantial variation in the dentato-rubro-thalamic tract area (mean 14.3 mm2, range 3-24 mm2). The center of the stereotactic coordinates and dentato-rubro-thalamic tract diverged by more than 1 mm in mediolateral and anterposterior directions in all patients, while the dentato-rubro-thalamic tract and lesion centers were in close proximity (mean mediolateral separation 1 mm, range 0.1-2.2 mm; mean anteroposterior separation 0.75 mm, range 0.4-1.2 mm). There was greater than 50% coverage of the dentato-rubro-thalamic tract by the lesion in all patients (mean 82.9%, range 66.7-100%). All patients experienced durable tremor relief. CONCLUSION: Direct targeting of the dentato-rubro-thalamic tract using diffusion tractography imaging fused to T2 weighted-imaging may be a useful strategy for focused ultrasound treatment of essential tremor. Further investigation of the technique is warranted.