This cohort study included 85 patients (PPT=40; control=45) undergoing endovascular treatment for complex unruptured intracranial aneurysms. The intervention group received pre-procedural testing (PPT) using patient-specific models, while the control group was treated without PPT. The study setting and follow-up duration were not reported.
Primary analysis of the Training Fidelity Score indicated high scores across the PPT group, with a median of 4.33/5. Secondary outcomes assessed perceived clinical utility, intraoperative strategy changes, procedural time, radiation exposure, device waste, and safety. Perceived clinical utility was high and increased significantly after the procedure in the PPT group. Intraoperative strategy changes were not recorded in the PPT group, compared to 6 of 45 cases in the control group, yielding a relative risk (RR) of 0.09 (p=0.027). Reductions were noted for treatment time, radiation exposure, and device waste, though specific absolute numbers were not reported.
Safety data indicated tolerability without compromising safety; adverse events, serious adverse events, and discontinuations were not reported. The study authors note that prospective multicenter validation is required to confirm these findings. Consequently, the evidence supports the use of PPT in pre-interventional preparation but remains limited by its single-center cohort design and lack of reported funding or conflict of interest details.
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Background: Even for experienced operators, endovascular treatment of unruptured intracranial aneurysms involves intraoperative uncertainty that may lead to adjustments in strategy, prolong the procedure, and potentially cause inefficiency and device waste. This study aimed to evaluate whether pre-procedural testing (PPT) of endovascular treatment using patient-specific models was associated with increased operator confidence and perceived clinical utility, including improvements in procedural efficiency and reduced resource waste. Methods: We enrolled a cohort of patients who underwent PPT before endovascular treatment for complex unruptured intracranial aneurysms and compared their outcomes with a control group treated without PPT. The primary outcome was the Training Fidelity Score, a composite of three operator-reported Likert items defined a priori. Secondary outcomes included perceived clinical utility, intraoperative strategy changes, procedural time, radiation exposure, device waste and safety. Results: A total of 85 patients met the inclusion criteria (PPT=40; control=45). The Training Fidelity Score was high across the PPT group (median, 4.33/5). Perceived clinical utility was high and further increased significantly after the procedure. A significant reduction was observed in intraoperative strategy changes, with no changes recorded in the PPT group, compared to 6/45 in the control group (RR 0.09; p=0.027). Reductions in treatment time, radiation exposure and device waste were also noted. Conclusion: PPT using patient-specific models was associated with increased operator confidence, fewer intraoperative strategy changes, improved procedural efficiency, and reduced device waste without compromising safety. These findings support its use in pre-interventional preparation, but require prospective multicenter validation.