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A339 Final results from prospective post-market clinical impact trial of presize software. simulation in informing flow diverting stent deployment in aneurysm treatment

neurintsurg · 2025-09-02 · canonical JSON source

3 visible annotations · policy: published · automated confidence ≥ 75.00%

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Introduction Preoperative simulation of flow-diverting stent (FD) deployment in aneurysm treatment could improve procedural accuracy and efficiency compared with standard planning.Aim of study Full recruitment results (103 patients) for first-of-its-kind, multi-centre prospective trial collecting real-world evidence on impact of CE-marked PreSize Neurovascular simulation software (Oxford Heartbeat) on clinical decision-making for FD deployment.Method The interventional neuroradiologist (INR) firstly plans each case, deciding device/size to use without PreSize software (standard planning), then uses PreSize in real-time. INR then decides which device to use in procedure (no prescribing).Data is collected on pre-deployment decision-making and procedure outcomes (including devices used, intraoperative manipulations, simulation accuracy against post-deployment imaging). The registered study (9 hospitals) received ethics and health research approvals, supported by UK’s National Institute of Health and Care Research.Results Average standard-selected FD length was 18.86mm vs. 17.42mm (PreSize). In 52% of cases, standard-selected FD length was different vs. PreSize-selected (in 41%, PreSize-selected length was shorter, by up to 20mm).Average standard-selected FD diameter was 4.08mm vs. 4.24mm (PreSize). In 38% of cases, standard-selected FD diameter was different to PreSize-selected (in 21% PreSize-selected was wider, by up to 1mm). In 90% of cases, device chosen was based directly on PreSize simulation; in only 6 cases balloon angioplasty was performed; in 89% of cases, only 1 device was deployed (1.1 device/patient); prospective simulation accuracy was evaluated 95.6% (mean).Conclusion First-of-its-kind trial presents prospective data on impact of planning simulation on clinical practice, demonstrating pre-deployment real-time planning with PreSize changes device selection from current practice.Conflict of Interest No