Abbas, Rawad

Introduction: Optimizing patient selection and time-to-intervention will be crucial to the success of future clinical trials seeking to implement therapies and improve intracerebral hemorrhage (ICH) patient outcomes. Automated and accurate ICH and perihematomal edema (PHE) volumetry carries significant potential to strengthen trials targeting ICH and PHE expansion. Aims: The Quantification of Hematoma and Perihematomal Edema Volumes in Intracerebral Hemorrhage (QUANTUM) trial was designed with aims of (1) validating a fully automated artificial intelligence (AI) method for supratentorial, spontaneous ICH and PHE volumetry against the manual and semiautomated quantification methods and (2) establishing a model framework for the translation of AI technology through conduct of a clinical trial under the equivalence hypothesis paradigm. Methods: This trial was a prospective, randomized, clinical study with blinded outcome assessment. Six independent raters were randomized in a 1:1 ratio to ICH and PHE volumetry from non-contrast CT scans in the Virtual International Stroke Trials Archive with either the semiautomated or manual quantification method. The primary outcomes were equivalence between (1)ICH volume measurements on admission (<24h from symptom onset) for the manual versus the fully automated or the sem-automated quantification methods, and (2)PHE volume measurements on day 3 (72±12h from symptom onset) for the manual versus the fully automated or the semiautomated quantification methods. The required sample size was 126 ICH and 126 PHE measurements, based upon a significance level of 0.025 to account for the two equivalence tests. Results: The geometric mean relative discrepancies between the fully automated and the manual ICH and PHE volume measurements did not cross the pre-specified 10% equivalence margin. The geometric mean relative discrepancies between the semiautomated and the manual ICH and PHE volume measurements did cross the pre-specified 10% equivalence margin. The fully automated method (mean 10.0±2.7s/scan) was significantly faster than the manual (mean 189±199 s/scan; P <0.001) and semiautomated (mean 79±68s/scan; P <0.001) methods. Conclusions: ICH and PHE volumes quantified by AI could replace clinician measurements within a 10% error margin and with substantially greater efficiency. The semiautomated method could not replace manual measurements. This trial demonstrated feasibility of the equivalence hypothesis framework for AI validation studies.

Background Flow-diverter stents (FDS) have become the standard of care for a wide range of intracranial aneurysms, but their efficacy/safety in the context of recurrent/recanalized aneurysms following stent-assisted coiling (SAC) is not well established. We evaluate the outcomes of FDS retreatment in a large multicenter cohort. Methods We retrospectively analyzed data from 118 patients across 22 institutions who underwent FDS retreatment for recurrent/persistent aneurysms after SAC (2008–22). The primary outcome was angiographic occlusion status at last follow-up, categorized as complete (100%), near-complete (90–99%), or incomplete (<90%) occlusion. Secondary outcomes included procedural complications and clinical outcomes measured by the modified Rankin Scale (mRS). Results A total of 118 patients (median age 57, 74.6% female) with median follow-up of 15.3 months were identified. Complete occlusion was achieved in 62.5% and near-complete occlusion in 25%. FDS deployment within the pre-existing stent was successful in 98.3% of cases. Major complications occurred in 3.4% of cases, including postoperative aneurysmal rupture with resultant mortality (1.6%) and thromboembolic events with long-term disability (1.6%). Favorable clinical outcomes (mRS 0–2) were observed in 95.1% of patients. Wider aneurysm neck diameter was a significant predictor of incomplete occlusion (adjusted OR (aOR) 1.23 per mm, P=0.044), with male sex trending towards association with non-occlusion (aOR 3.2, P=0.07), while baseline hypertension was associated with complete occlusion (aOR 0.32, P=0.048). Conclusions FDS treatment for recurrent/residual aneurysms after SAC represents a viable treatment option for these challenging cases with acceptable safety and reasonable occlusion rates, although lower than de novo FDS occlusion rates.

OBJECTIVE Preclinical studies suggest that robotic carotid artery stenting (CAS) could be superior to manual CAS. However, very limited comparative data exist for patients who have undergone robotic versus manual CAS. In addition, no data exist comparing the costs of manual and robotic CAS. METHODS All robotic CAS cases at two academic neurosurgery centers were retrospectively reviewed and 1:1 propensity matched with manual CAS cases. Personnel costs, supply costs, and total procedure costs were collected in collaboration with hospital administration by using time-driven activity-based cost analysis. RESULTS A total of 24 robotic CAS operations were performed between 2019 and 2023. Comorbidities and baseline procedural characteristics were well matched between robotic and manual cases. Unplanned manual conversion was observed in only 1 robotic case (4.2%). Robotic CAS complications and outcomes were comparable to manual. Robotic CAS was associated with a significantly increased fluoroscopy time (29.0 vs 19.2 minutes; p < 0.001). Robotic procedure time (88.9 ± 18.2 minutes) was significantly (p = 0.003) longer than manual time (68.72 ± 22.4 minutes). Health personnel costs ($1589.71 ± $176.92 vs $1375.99 ± $233.39, p = 0.005); supply costs ($3918.25 ± $421.20 vs $2152.74 ± $1030.26, p < 0.001); and total procedure costs ($5306.11 ± $608.95 vs $3437.56 ± $1165.67, p < 0.001) were greater for robotic CAS. CONCLUSIONS In the first multicenter study and largest sample to date, the authors show that robotic CAS, with a low rate of procedural failure and postoperative complications, is safe and feasible. In addition, robotic CAS achieves comparable clinical outcomes to manual CAS. Robotic CAS was associated with increased fluoroscopy time, but fluoroscopy time decreased as operators gained familiarity with the CorPath GRX system. Robotic CAS was associated with a greater procedural cost, which was driven by greater personnel and supply costs. Robotic CAS failed to show superiority to manual CAS. These findings set a foundation for randomized controlled trials of robotic CAS, and also highlight the need for further studies to optimize robotic CAS and reduce its associated costs.