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1.
J Neurointerv Surg ; 16(6): 535-536, 2024 May 21.
Article in English | MEDLINE | ID: mdl-38772614
2.
Radiol Case Rep ; 19(6): 2306-2309, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38559657

ABSTRACT

Transient cortical blindness is a known complication of iodinated contrast administration and is believed to reflect osmotic injury or autoregulatory dysfunction of the posterior circulation. Here, we report 2 cases of postangiography transient cortical weakness, a rare clinical analog to transient cortical blindness that affects the anterior circulation. The symptoms, timeline, and imaging findings of transient cortical weakness are distinct from more common post-procedural complications such as acute ischemic stroke or transient ischemic attack.

3.
J Neurosurg ; 140(2): 430-435, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-37548550

ABSTRACT

OBJECTIVE: Despite the adoption of same-day outpatient surgical procedures in some specialties, it remains common practice to admit patients for monitoring after elective endovascular treatment of brain aneurysms to monitor for complications. The necessity of such monitoring has not been fully characterized. Here, the authors reviewed the utilization of imaging during posttreatment hospitalization, a surrogate measure for workup of suspected complications requiring hospital resources, to infer the value of inpatient monitoring after endovascular aneurysm treatment. METHODS: Clinical and angiographic data from eligible patients were retrospectively assessed for demographic characteristics, imaging indications, timing of imaging, and imaging findings. Patients were included if they underwent elective endovascular brain aneurysm treatment, and patients were excluded if significant intraprocedural complications occurred. The recorded imaging modalities included CT, MRI, catheter-based imaging, and ultrasound; plain radiographs were excluded. Multivariable logistic regression analysis was performed to identify predictors of the need for posttreatment imaging. RESULTS: In total, 1229 elective endovascular procedures for brain aneurysm treatment were included. Patients underwent imaging before discharge in 13.4% (165/1229) of cases, with significant findings in 5.0% (61/1229) of cases. The median (interquartile range) time to first posttreatment imaging was 13.2 (4.2-22.8) hours. The need for imaging during posttreatment hospitalization was positively associated with larger aneurysm size (p < 0.05) and negatively associated with underlying cardiovascular disease (p < 0.05). CONCLUSIONS: More than 1 in 8 patients who underwent elective endovascular brain aneurysm treatment required imaging during posttreatment hospitalization, most within the first 24 hours, and 1 in 20 had significant findings. These results suggest the importance of short-term hospitalization after elective endovascular aneurysm treatment.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Intracranial Aneurysm , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Aortic Aneurysm, Abdominal/etiology , Aortic Aneurysm, Abdominal/surgery , Retrospective Studies , Endovascular Procedures/methods , Treatment Outcome , Blood Vessel Prosthesis Implantation/methods , Hospitalization , Hospitals , Elective Surgical Procedures , Risk Factors
4.
J Neurointerv Surg ; 16(3): 272-279, 2024 Feb 12.
Article in English | MEDLINE | ID: mdl-37130751

ABSTRACT

BACKGROUND: Tools predicting intracranial dural arteriovenous fistulas (dAVFs) treatment outcomes remain scarce. This study aimed to use a multicenter database comprising more than 1000 dAVFs to develop a practical scoring system that predicts treatment outcomes. METHODS: Patients with angiographically confirmed dAVFs who underwent treatment within the Consortium for Dural Arteriovenous Fistula Outcomes Research-participating institutions were retrospectively reviewed. A subset comprising 80% of patients was randomly selected as training dataset, and the remaining 20% was used for validation. Univariable predictors of complete dAVF obliteration were entered into a stepwise multivariable regression model. The components of the proposed score (VEBAS) were weighted based on their ORs. Model performance was assessed using receiver operating curves (ROC) and areas under the ROC. RESULTS: A total of 880 dAVF patients were included. Venous stenosis (presence vs absence), elderly age (<75 vs ≥75 years), Borden classification (I vs II-III), arterial feeders (single vs multiple), and past cranial surgery (presence vs absence) were independent predictors of obliteration and used to derive the VEBAS score. A significant increase in the likelihood of complete obliteration (OR=1.37 (1.27-1.48)) with each additional point in the overall patient score (range 0-12) was demonstrated. Within the validation dataset, the predicted probability of complete dAVF obliteration increased from 0% with a 0-3 score to 72-89% for patients scoring ≥8. CONCLUSION: The VEBAS score is a practical grading system that can guide patient counseling when considering dAVF intervention by predicting the likelihood of treatment success, with higher scores portending a greater likelihood of complete obliteration.


Subject(s)
Central Nervous System Vascular Malformations , Embolization, Therapeutic , Radiosurgery , Humans , Aged , Retrospective Studies , Treatment Outcome , Central Nervous System Vascular Malformations/diagnostic imaging , Central Nervous System Vascular Malformations/surgery
5.
Neurosurgery ; 2023 Dec 14.
Article in English | MEDLINE | ID: mdl-38095434

ABSTRACT

BACKGROUND AND OBJECTIVES: Anecdotal cases of rapidly progressing dementia in patients with dural arteriovenous fistulas (dAVFs) have been reported in small series. However, large series have not characterized these dAVFs. We conducted an analysis of the largest cohort of dAVFs presenting with cognitive impairment (dAVFs-CI), aiming to provide a detailed characterization of this subset of dAVFs. METHODS: Patients with dAVFs-CI were analyzed from the CONDOR Consortium, a multicenter repository comprising 1077 dAVFs. A propensity score matching analysis was conducted to compare dAVFs-CI with Borden type II and type III dAVFs without cognitive impairment (controls). Logistic regression was used to identify angiographic characteristics specific to dAVFs-CI. Furthermore, post-treatment outcomes were analyzed. RESULTS: A total of 60 patients with dAVFs-CI and 60 control dAVFs were included. Outflow obstruction leading to venous hypertension was observed in all dAVFs-CI. Sinus stenosis was significantly associated with dAVFs-CI (OR 2.85, 95% CI: 1.16-7.55, P = .027). dAVFs-CI were more likely to have a higher number of arterial feeders (OR 1.56, 95% CI 1.22-2.05, P < .001) and draining veins (OR 2.05, 95% CI 1.05-4.46, P = .004). Venous ectasia increased the risk of dAVFs-CI (OR 2.38, 95% CI 1.13-5.11, P = .024). A trend toward achieving asymptomatic status at follow-up was observed in patients with successful closure of dAVFs (OR 2.86, 95% CI 0.85-9.56, P = .09). CONCLUSION: Venous hypertension is a key angiographic feature of dAVFs-CI. Moreover, these fistulas present at a mean age of 58 years-old, and exhibit a complex angioarchitecture characterized by an increased number of arteriovenous connections and stenosed sinuses. The presence of venous ectasia further exacerbates the impaired drainage and contributes to the development of dAVFs-CI. Notably, in certain cases, closure of the dAVF has the potential to reverse symptoms.

6.
Interv Neuroradiol ; : 15910199231221298, 2023 Dec 17.
Article in English | MEDLINE | ID: mdl-38105434

ABSTRACT

BACKGROUND: Intracranial aneurysms of the middle cerebral artery can be treated using several open surgical and endovascular approaches. Given the growing evidence of clinical equipoise between these various treatment strategies, there is a need to assess the costs associated with each. METHODS: Cost of aneurysm treatment was divided into two categories for comparison. "Initial cost" comprised the total in-hospital expenses for initial aneurysm treatment and "total cost" comprised initial aneurysm treatment and all expenses relating to readmission due to treatment-related complications, prescribed catheter angiograms for monitoring of treatment stability, and any retreatments needed for a given aneurysm. The open surgical group was subdivided into a pterional approach group and a lateral supraorbital (LSO) approach group for. RESULTS: Median initial cost was $37,152 (IQR $31,318-$44,947) for aneurysms treated with the pterional approach, $29,452 (IQR $27,779-$32,826) for aneurysms treated with the LSO approach, and $19,587 (IQR $14,125-$30,521) for aneurysms treated with endovascular approaches. The median total cost was $39,737 (IQR $33,891-$62,259) for aneurysms treated with the pterional approach, $31,785 (IQR $29,513-$41,099) for aneurysms treated with the LSO approach, and $24,578 (IQR $18,977-$34,547) for aneurysms treated with endovascular approaches. Analysis of variance test demonstrated variance across groups for both initial and total cost (p = 0.004, p = 0.008, respectively). In our subsequent analysis, initial cost and total cost were higher in the pterional group than the endovascular group (p = 0.003 and p = 0.006, respectively). CONCLUSIONS: Endovascular treatment of elective aneurysms has a significantly lower cost than open surgical treatment with the pterional approach, but not with the LSO approach. For aneurysms not amenable to endovascular treatment, a minimally invasive LSO approach carries a lower cost burden than a pterional approach.

7.
Clin Neurol Neurosurg ; 229: 107748, 2023 06.
Article in English | MEDLINE | ID: mdl-37146368

ABSTRACT

BACKGROUND AND PURPOSE: Stent-assisted coiling of wide neck bifurcation aneurysms in the anterior communicating segment and basilar tip region can be performed with varying stent configurations, including single stenting or Y-stenting. Y-stenting requires two stents and thus incurs greater cost and procedural complexity than single-stent constructs. The influence of first stent type on the need for Y-stenting remains unknown. MATERIALS AND METHODS: Clinical and angiographic data were retrospectively obtained for patients that underwent stent-assisted coiling for basilar tip or anterior communicating aneurysms at a high-volume center. Patients were included in this study if stent-assisted coiling was performed using Neuroform Atlas or LVIS Jr stents. A multivariate binary logistic regression was performed to measure the influence of first stent type on the need for Y-stenting. RESULTS: Stent-assisted coiling was used to treat 82 aneurysms in 81 patients during the study period, and Y-stenting was performed in 18.3% (15/82) of cases. In multivariate logistic regression analysis, use of LVIS Jr. as the first stent did not significantly influence the need for subsequent Y-stenting after controlling for aneurysm morphology (OR 0.65, 95% CI 0.18-2.43). CONCLUSION: Controlling for aneurysm morphology and location, the use of Y-stenting for stent-assisted coiling was not independently influenced by the choice of LVIS Jr or Neuroform Atlas as the first stent. A larger cohort may reveal differences between these two stents, particularly for aneurysms with large neck sizes.


Subject(s)
Embolization, Therapeutic , Endovascular Procedures , Intracranial Aneurysm , Humans , Retrospective Studies , Treatment Outcome , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Cerebral Angiography , Stents
8.
Front Neurol ; 14: 1156887, 2023.
Article in English | MEDLINE | ID: mdl-37114225

ABSTRACT

Tools and techniques utilized in endovascular brain aneurysm treatment have undergone rapid evolution in recent decades. These technique and device-level innovations have allowed for treatment of highly complex intracranial aneurysms and improved patient outcomes. We review the major innovations within neurointervention that have led to the current state of brain aneurysm treatment.

9.
J Neurointerv Surg ; 15(7): 634-638, 2023 Jul.
Article in English | MEDLINE | ID: mdl-35545427

ABSTRACT

BACKGROUND: Endovascular thrombectomy is not available at all hospitals that offer intravenous thrombolysis, prompting debate regarding the preferred transport destination for acute ischemic stroke. This study aimed to quantify real-world travel time and distance of bypass and non-bypass transport models for large-vessel occlusion (LVO) and non-LVO stroke. METHODS: This cross-sectional study included population data of census tracts in the contiguous USA from the 2014-2018 United States Census Bureau's American Community Survey, stroke (thrombolysis-capable) and thrombectomy-capable centers certified by a state or national body, and road network data from a mapping service. Census tracts were categorized by urbanization level. Data were retrieved from March to November 2020. Travel times and distances were calculated for each census tract to each of the following: nearest stroke center (nearest), nearest thrombectomy-capable center (bypass), and nearest stroke center then to the nearest thrombectomy-capable center (transfer). Population-weighted median and IQR were calculated nationally and by urbanization. RESULTS: 72 538 census tracts, 2388 stroke hospitals, and 371 thrombectomy-capable centers were included. Nationally, population-weighted median travel time for nearest and bypass routing was 11.7 min (IQR 7.7-19.3) and 26.4 min (14.8-55.1), respectively. For transfer routing, the population-weighted median travel times with 60 min, 90 min, and 120 min door-in-door-out times were 94.1 min (78.5-127.7), 124.1 min (108.5-157.7), and 154.1 min (138.4-187.6), respectively. CONCLUSIONS: Bypass routing offers modest travel time benefits for LVO patients and incurs modest penalties for non-LVO patients. Differences are greatest in rural areas. A majority of Americans live in areas for which current guidelines recommend bypass.


Subject(s)
Brain Ischemia , Endovascular Procedures , Ischemic Stroke , Stroke , Humans , Brain Ischemia/surgery , Cross-Sectional Studies , Stroke/surgery , Stroke/epidemiology , Thrombectomy , Treatment Outcome
10.
Interv Neuroradiol ; 29(6): 710-714, 2023 Dec.
Article in English | MEDLINE | ID: mdl-35758311

ABSTRACT

BACKGROUND AND PURPOSE: Flow diversion of intracranial aneurysms with the Pipeline Embolization Device (PED) is frequently performed, but the outcomes of retreatment for aneurysms that failed to occlude after prior treatment with PED have not been well studied. Here, we report the safety and efficacy of PED retreatment after initial failure to occlude. MATERIALS AND METHODS: Clinical and angiographic data from eligible patients were retrospectively assessed for demographics, aneurysm occlusion status, and clinical outcomes. Patients were included in this study if they underwent PED retreatment to treat an aneurysm that had previously been treated with PED. RESULTS: Retreatment of previously flow-diverted aneurysms with PED was performed in 42 cases. At final angiographic follow-up, angiographic improvement was observed after 45% (19/42) of retreatments and complete aneurysm occlusion was observed following 26% (11/42). Significant clinical complications occurred in 10% (4/42) of PED retreatments. CONCLUSIONS: Retreatment of intracranial aneurysms with PED following initial failure to achieve aneurysm occlusion has a low rate of subsequent complete aneurysm occlusion.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Intracranial Aneurysm/etiology , Treatment Outcome , Retrospective Studies , Embolization, Therapeutic/methods , Cerebral Angiography , Retreatment , Follow-Up Studies
11.
J Neurointerv Surg ; 15(9): 903-908, 2023 Sep.
Article in English | MEDLINE | ID: mdl-35944975

ABSTRACT

BACKGROUND: Anterior cranial fossa dural arteriovenous fistulas (ACF-dAVFs) are aggressive vascular lesions. The pattern of venous drainage is the most important determinant of symptoms. Due to the absence of a venous sinus in the anterior cranial fossa, most ACF-dAVFs have some degree of drainage through small cortical veins. We describe the natural history, angiographic presentation and outcomes of the largest cohort of ACF-dAVFs. METHODS: The CONDOR consortium includes data from 12 international centers. Patients included in the study were diagnosed with an arteriovenous fistula between 1990-2017. ACF-dAVFs were selected from a cohort of 1077 arteriovenous fistulas. The presentation, angioarchitecture and treatment outcomes of ACF-dAVF were extracted and analyzed. RESULTS: 60 ACF-dAVFs were included in the analysis. Most ACF-dAVFs were symptomatic (38/60, 63%). The most common symptomatic presentation was intracranial hemorrhage (22/38, 57%). Most ACF-dAVFs drained through cortical veins (85%, 51/60), which in most instances drained into the superior sagittal sinus (63%, 32/51). The presence of cortical venous drainage predicted symptomatic presentation (OR 9.4, CI 1.98 to 69.1, p=0.01). Microsurgery was the most effective modality of treatment. 56% (19/34) of symptomatic patients who were treated had complete resolution of symptoms. Improvement of symptoms was not observed in untreated symptomatic ACF-dAVFs. CONCLUSION: Most ACF-dAVFs have a symptomatic presentation. Drainage through cortical veins is a key angiographic feature of ACF-dAVFs that accounts for their malignant course. Microsurgery is the most effective treatment. Due to the high risk of bleeding, closure of ACF-dAVFs is indicated regardless of presentation.


Subject(s)
Arteriovenous Fistula , Central Nervous System Vascular Malformations , Embolization, Therapeutic , Humans , Cranial Fossa, Anterior/diagnostic imaging , Cranial Fossa, Anterior/surgery , Angiography , Treatment Outcome , Central Nervous System Vascular Malformations/diagnostic imaging , Central Nervous System Vascular Malformations/surgery , Intracranial Hemorrhages/therapy , Arteriovenous Fistula/therapy
13.
World Neurosurg ; 166: e750-e757, 2022 10.
Article in English | MEDLINE | ID: mdl-35931339

ABSTRACT

BACKGROUND: Rates of aneurysm occlusion following treatment with flow-diverting stents have been quantified at predefined time points in clinical trials, but data characterizing the continuous temporal progression of aneurysm occlusion are lacking. This study used real-world variability in timing of angiographic follow-up to characterize the time line of aneurysm occlusion following treatment with the Pipeline embolization device (PED). METHODS: All aneurysms treated with a PED at our institution between 2011 and 2020 were screened. Nonsaccular or ruptured aneurysms were excluded. Aneurysm occlusion status and time since treatment were recorded for each follow-up angiogram. Aneurysm occlusion was characterized using Kaplan-Meier and Cox proportional hazards analysis after censoring at last follow-up or subsequent treatment. RESULTS: There were 290 aneurysms in 222 patients analyzed. The median time of observed aneurysm occlusion was 7.5 months, and overall rate of aneurysm occlusion was 77.9%. Larger aneurysms demonstrated a longer median time to occlusion and lower rate of aneurysm occlusion (P = 0.029). There were no observed differences in the time line of occlusion for aneurysms treated with a single PED or multiple PEDs (P = 0.889) or without or with adjunctive coiling (P = 0.771). CONCLUSIONS: Aneurysms treated with a PED had a median time to observed occlusion of 7.5 months. Occlusion of larger aneurysms occurred more slowly than occlusion of smaller aneurysms following flow diversion. The number of PEDs deployed or the use of adjunctive coiling did not affect the time line or likelihood of aneurysm occlusion. These findings may guide optimal timing of follow-up after treatment with a PED.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Blood Vessel Prosthesis , Follow-Up Studies , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Retrospective Studies , Stents , Treatment Outcome
15.
World Neurosurg ; 167: e303-e309, 2022 Nov.
Article in English | MEDLINE | ID: mdl-35948233

ABSTRACT

OBJECTIVE: Flow diversion of intracranial aneurysms with the pipeline embolization device (PED) may produce angiographically apparent stenosis within the PED, which can lead to secondary ischemic complications. In-stent stenosis can be treated medically with dual antiplatelet therapy (DAPT), but the safety and efficacy of this approach are unknown. In this work, we review the safety and efficacy of DAPT to prevent progression of in-stent stenosis or development of cerebral ischemia. METHODS: Clinical and angiographic data from eligible patients were assessed from a prospectively maintained neurointerventional database. Details surrounding in-stent stenosis and DAPT were extracted. Patients were included in this study if in-stent stenosis was detected at any angiographic follow-up and managed with DAPT. The primary efficacy endpoint was lack of angiographic progression of in-stent stenosis or new ipsilateral infarct following initiation of medical therapy. RESULTS: In total, 23 PED constructs developed in-stent stenosis and were managed with DAPT. Follow-up angiography was available for 19 constructs. Eighty-nine percent (17/19) of PED constructs achieved the primary endpoint of lack of stenosis progression and lack of new ipsilateral ischemic events. Of the 2 PED constructs that failed to achieve the primary endpoint of this study, one demonstrated worsening of in-stent stenosis from 55% to 76% over 16 months, while the other developed ipsilateral ischemic stroke 4 months after detection of in-stent stenosis. In addition, one patient experienced intracranial hemorrhage 9 months after the initiation of DAPT. CONCLUSIONS: Progression of in-stent stenosis and new ipsilateral ischemic events are limited in the presence of DAPT. However, hemorrhagic events related to DAPT may occasionally occur.


Subject(s)
Embolization, Therapeutic , Intracranial Aneurysm , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Intracranial Aneurysm/complications , Platelet Aggregation Inhibitors/therapeutic use , Constriction, Pathologic/complications , Stents , Cerebral Angiography , Treatment Outcome , Retrospective Studies , Follow-Up Studies
16.
J Comput Assist Tomogr ; 46(5): 770-774, 2022.
Article in English | MEDLINE | ID: mdl-35617649

ABSTRACT

BACKGROUND AND PURPOSE: Intracranial hemorrhage (ICH) is a common finding in patients presenting to the emergency department with acute neurological symptoms. Noncontrast head computed tomography (NCCT) is the primary modality for assessment and detection of ICH in the acute setting. RAPID ICH software aims to automatically detect ICH on NCCT and was previously shown to have high accuracy when applied to a curated test data set. Here, we measured the test performance characteristics of RAPID ICH software in detecting ICH on NCCT performed in patients undergoing emergency stroke evaluation at a tertiary academic comprehensive stroke center. MATERIALS AND METHODS: This retrospective study assessed consecutive patients over a 6-month period who presented with acute neurological symptoms suspicious for stroke and underwent NCCT with RAPID ICH postprocessing. RAPID ICH detection was compared with the interpretation of a reference standard comprising a board-certified or board-eligible neuroradiologist, or in cases of discrepancy, adjudicated by a consensus panel of 3 neuroradiologists. Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of RAPID ICH for ICH detection were determined. RESULTS: Three hundred seven NCCT scans were included in the study. RAPID ICH correctly identified 34 of 37 cases with ICH and 228 of 270 without ICH. RAPID ICH had a sensitivity of 91.9% (78.1%-98.3%), specificity of 84.4% (79.6%-88.6%), NPV of 98.7% (96.3%-99.6%), PPV of 44.7% (37.6%-52.1%), and overall accuracy of 85.3% (80.9%-89.1%). CONCLUSIONS: In a real-world scenario, RAPID ICH software demonstrated high NPV but low PPV for the presence of ICH when evaluating possible stroke patients.


Subject(s)
Intracranial Hemorrhages , Stroke , Humans , Intracranial Hemorrhages/diagnostic imaging , Predictive Value of Tests , Retrospective Studies , Stroke/diagnostic imaging , Tomography, X-Ray Computed/methods
18.
Stroke ; 53(7): 2340-2345, 2022 07.
Article in English | MEDLINE | ID: mdl-35420453

ABSTRACT

BACKGROUND: Cranial dural arteriovenous fistulas with cortical venous drainage are rare lesions that can present with hemorrhage. A high rate of rebleeding in the early period following hemorrhage has been reported, but published long-term rates are much lower. No study has examined how risk of rebleeding changes over time. Our objective was to quantify the relative incidence of rebleeding in the early and later periods following hemorrhage. METHODS: Patients with dural arteriovenous fistula and cortical venous drainage presenting with hemorrhage were identified from the multinational CONDOR (Consortium for Dural Fistula Outcomes Research) database. Natural history follow-up was defined as time from hemorrhage to first treatment, rebleed, or last follow-up. Rebleeding in the first 2 weeks and first year were compared using incidence rate ratio and difference. RESULTS: Of 1077 patients, 250 met the inclusion criteria and had 95 cumulative person-years natural history follow-up. The overall annualized rebleed rate was 7.3% (95% CI, 3.2-14.5). The incidence rate of rebleeding in the first 2 weeks was 0.0011 per person-day; an early rebleed risk of 1.6% in the first 14 days (95% CI, 0.3-5.1). For the remainder of the first year, the incidence rate was 0.00015 per person-day; a rebleed rate of 5.3% (CI, 1.7-12.4) over 1 year. The incidence rate ratio was 7.3 (95% CI, 1.4-37.7; P, 0.026). CONCLUSIONS: The risk of rebleeding of a dural arteriovenous fistula with cortical venous drainage presenting with hemorrhage is increased in the first 2 weeks justifying early treatment. However, the magnitude of this increase may be considerably lower than previously thought. Treatment within 5 days was associated with a low rate of rebleeding and appears an appropriate timeframe.


Subject(s)
Central Nervous System Vascular Malformations , Embolization, Therapeutic , Central Nervous System Vascular Malformations/diagnostic imaging , Central Nervous System Vascular Malformations/epidemiology , Cerebral Angiography , Drainage , Humans , Outcome Assessment, Health Care
20.
J Neurosurg ; : 1-6, 2022 Jan 28.
Article in English | MEDLINE | ID: mdl-35090133

ABSTRACT

OBJECTIVE: The Pipeline embolization device (PED) is widely used for the treatment of intracranial aneurysms, including in off-label applications. In this work, the authors compared the real-world efficacy and safety of PED use in on-label and off-label aneurysm treatments. METHODS: Clinical and angiographic data of patients who underwent PED placement at a high-volume academic medical center were retrospectively obtained. Treatments were classified as on-label if they fell within the applications approved by the United States Food and Drug Administration as of 2021. Recorded outcomes included aneurysm occlusion, procedural complications, ischemic events, in-stent stenosis, intracranial hemorrhage, postprocedural functional status, and death. RESULTS: In total, 416 aneurysms in 330 patients were treated with PED, comprising 256 aneurysms that received on-label treatments and 160 that received off-label treatments. The overall rate of complete aneurysm occlusion was 76.4% for on-label aneurysms and 75.6% for off-label aneurysms (p = 0.898). The risk of ischemic stroke in patients who underwent off-label treatments was 15.2%, which was higher than the 4.2% rate in patients who underwent on-label treatment (p = 0.003). All other clinical complications, procedural complications, and long-term functional status were comparable between the on-label and off-label groups. CONCLUSIONS: In real-world practice, off-label use of PED is common and can achieve similar efficacy as on-label use. However, in aggregate, off-label use was found to carry an increased rate of ischemic complications. With judicious attention to safety and individual patient characteristics, these results highlight the scale and general feasibility of off-label PED use by experts.

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