The reproducibility of interventional radiology randomized controlled trials and external validation of a classification system.

PURPOSE: The fragility index (FI) measures the robustness of randomized controlled trials (RCTs). It complements the P value by taking into account the number of outcome events. In this study, the authors measured the FI for major interventional radiology RCTs. METHODS: Interventional radiology RCTs published between January 2010 and December 2022 relating to trans-jugular intrahepatic portosystemic shunt, trans-arterial chemoembolization, needle biopsy, angiography, angioplasty, thrombolysis, and nephrostomy tube insertion were analyzed to measure the FI and robustness of the studies. RESULTS: A total of 34 RCTs were included. The median FI of those studies was 4.5 (range 1-68). Seven trials (20.6%) had a number of patients lost to follow-up that was higher than their FI, and 15 (44.1%) had a FI of 1-3. CONCLUSION: The median FI, and hence the reproducibility of interventional radiology RCTs, is low compared to other medical fields, with some having a FI of 1, which should be interrupted cautiously.

The Complexity of Online Patient Education Materials About Interventional Neuroradiology Procedures Published by Major Academic Institutions.

Introduction Health literacy is an independent predictor of population health status and is directly related to the readability of available patient education material. The National Institutes of Health (NIH) and the American Medical Association have recommended that patient education materials (PEMs) be written between a fourth- and a sixth-grade education level. The authors assessed the readability of online PEMs about neurointerventional procedures that have been published by several academic institutions across the US. Methods Online PEMs regarding five common neurointerventional procedures, including mechanical thrombectomy for large vessel occlusion, cerebral diagnostic angiography, carotid artery stenting, endovascular aneurysm embolization, and epidural steroid injection collected from the websites of 20 top institutions in Neurology and Neurosurgery. The materials were assessed via five readability scales and then were statistically analyzed and compared to non-institutional education websites (Wikipedia.com and WebMD.com). Results None of the PEMs were written at or below the NIH's recommended 6th-grade reading level. The average educational level required to comprehend the texts across all institutions, as assessed by the readability scales, was 10-11th grade level. Some materials required a college-level education or higher. Material from non-institutional websites had significantly lower readability scores compared to the 20 institutions. Conclusions Current PEMs related to neurointerventional procedures are not written at or below the NIH's recommended fourth- to sixth-grade education level. Given the complexity of those procedures, significant attention should be pointed toward an improvement in the available online materials.

Multicenter Study for the Treatment of Sidewall versus Bifurcation Intracranial Aneurysms with Use of Woven EndoBridge (WEB).

Background The Woven EndoBridge (WEB) device was explicitly designed for wide-neck intracranial bifurcation aneurysms. Small-scale reports have evaluated the off-label use of WEB devices for the treatment of sidewall aneurysms, with promising outcomes. Purpose To compare the angiographic and clinical outcomes of the WEB device for the treatment of sidewall aneurysms compared with the treatment of bifurcation aneurysms. Materials and Methods A retrospective review of the WorldWideWEB Consortium, a synthesis of retrospective databases spanning from January 2011 to June 2021 at 22 academic institutions in North America, South America, and Europe, was performed to identify patients with intracranial aneurysms treated with the WEB device. Characteristics and outcomes were compared between bifurcation and sidewall aneurysms. Propensity score matching (PSM) was used to match by age, pretreatment ordinal modified Rankin Scale score, ruptured aneurysms, location of aneurysm, multiple aneurysms, prior treatment, neck, height, dome width, daughter sac, and incorporated branch. Results A total of 683 intracranial aneurysms were treated using the WEB device in 671 patients (median age, 61 years [IQR, 53-68 years]; male-to-female ratio, 1:2.5). Of those, 572 were bifurcation aneurysms and 111 were sidewall aneurysms. PSM was performed, resulting in 91 bifurcation and sidewall aneurysms pairs. No significant difference was observed in occlusion status at last follow-up, deployment success, or complication rates between the two groups. Conclusion No significantly different outcomes were observed following the off-label use of the Woven EndoBridge, or WEB, device for treatment of sidewall aneurysms compared with bifurcation aneurysms. The correct characterization of the sidewall aneurysm location, neck angle, and size is crucial for successful treatment and lower retreatment rate. © RSNA, 2022 See also the editorial by Hetts in this issue.

The Reproducibility of Cerebrovascular Randomized Controlled Trials.

BACKGROUND: Numerous randomized controlled trials (RCTs) relevant to the cerebrovascular field have been performed. The fragility index was recently developed to complement the P value and measure the robustness and reproducibility of clinical findings of RCTs. OBJECTIVE: In this study, we evaluate the fragility index for key surgical and endovascular cerebrovascular RCTs and propose a novel RCT classification system based on the fragility index. METHODS: Cerebrovascular RCTs reported between 2000 and 2018 were reviewed. Six key areas were specifically targeted in relation to stroke, carotid stenosis, cerebral aneurysms, and subarachnoid hemorrhage. The correlation between fragility index, number of patients lost to follow-up, and fragility quotient were evaluated to propose a classification system for the robustness of the studies. RESULTS: A total of 20 RCTs that reported significant differences between both study groups in terms of the primary outcome were included. The median fragility index for the trials was 5.5. An additional 30 randomly selected RCTs were added to propose a classification system with high reliability. The difference between the number of patients lost to follow-up and fragility index inversely correlated with the fragility quotient and was used to divide the robustness of the RCTs into 3 classes reflecting the reproducibility of the trial. CONCLUSIONS: Neurosurgeons and neurointerventionalists should exercise caution with interpreting the results of cerebrovascular RCTs, especially when the sample size and events numbers are small and there is a high number of patients who were lost to follow-up, as quantitatively identified using the proposed classification system.

Tumefactive Multiple Sclerosis of the Cervical Spinal Cord: A Rare Case Report.

Tumefactive multiple sclerosis (TMS) is a rare variant of multiple sclerosis (MS) with atypical features that pose a diagnostic challenge. In this study, we report a case of cervical MS in a 19-year-old patient that was diagnosed based on the MRI findings and cerebrospinal fluid analysis. The patient was treated with high-dose steroid and five sessions of plasma exchange with significant improvement.

Plasmablastic Lymphoma, a Rare Entity in Bone Marrow with Unusual Immunophenotype and Challenging Differential Diagnosis.

Plasmablastic lymphoma (PBL) is an aggressive malignancy that usually occurs in the setting of immunosuppression. The immunohistochemical profile of PBL is that of terminally differentiated B lymphocytes. CD138, CD38, and MUM1 are usually immunopositive. However, pan B-cell markers such as CD20 and PAX-5 are usually negative. MYC rearrangement is the most commonly encountered genetic alteration, with immunoglobulin (IG), especially immunoglobulin heavy (IGH) chain, being the most frequent partner. We report a case of PBL in a 48-year-old human immunodeficiency virus- (HIV-) positive male who was admitted to the hospital with signs and symptoms suspicious for tumor lysis syndrome. Bone marrow examination revealed hypercellular marrow with trilineage hypoplasia and sheets of intermediate to large neoplastic cells with basophilic vacuolated cytoplasm comprising the majority of cellular elements of the bone marrow. The neoplastic cells were negative for conventional B-cell, T-cell, plasma cell, and myeloid markers, while flow cytometric analysis revealed an abnormal CD45-dim population that was partially weakly positive for CD71 and CD79b. The diagnosis was initially thought to be a high-grade primitive hematopoietic neoplasm, possibly an acute undifferentiated leukemia. BOB-1, however, was immunopositive in the neoplastic cells, confirming its B-cell origin. MYC was positive by immunohistochemistry and break-apart FISH, as were CD45, MUM-1, and EMA immunostains. There was immunoglobulin kappa (IGK) light chain gene rearrangement by polymerase chain reaction (PCR). Additionally, Epstein-Barr virus- (EBV-) encoded small RNAs (EBER) were positive by in situ hybridization (ISH). The tumor proliferation index by Ki-67 immunostaining approached 95%. Although the tumor cells were negative for CD38 and CD138, the diagnosis of PBL was still rendered. We recommend using a broad spectrum of B-cell markers, including BOB-1 and OCT-2, in such challenging cases of B-cell lymphomas with no expression of conventional B-cell markers. We also emphasize that the negative CD38 and CD138 should not exclude PBL from the differential diagnosis.