Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study

Arthur, Adam S; Hoit, Daniel; Coon, Alexander L.; Almandoz, Josser E Delgado; Elijovich, Lucas; Çekirge, Saruhan; Fiorella, David

doi:10.1136/neurintsurg-2017-013310

Cited by 21 publications

(17 citation statements)

References 8 publications

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“…Therefore, the trial cases represent the first clinical experience that US physicians had with the device. A training program, which included hands-on experience using a lifelike simulator, was used 10. This program helped to familiarize investigators with the device’s characteristics, sizing, and deployment.…”

Section: Methodsmentioning

confidence: 99%

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Arthur

Molyneux

Coon

et al. 2019

J NeuroIntervent Surg

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259

207

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IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration number NCT02191618

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Section: Methodsmentioning

confidence: 99%

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Arthur

Molyneux

Coon

et al. 2019

J NeuroIntervent Surg

Self Cite

259

207

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“…10 Our fluoroscopy time of 34 minutes (AE18) is similar to other WEB related studies. 27,28 For all variables related to procedure times and radiation, the use of single implant solutions versus implantation of multiple devices carries an intuitive advantage.…”

Section: Discussionmentioning

confidence: 99%

Comparison of operating room variables, radiation exposure and implant costs for WEB versus stent assisted coiling for treatment of wide neck bifurcation aneurysms

et al. 2020

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Background The WEB device offers another option for treating wide neck bifurcation aneurysms (WNBA). The objective was to compare procedure variables, radiation and implant cost between WEB and stent assisted coiling (SAC) for WNBA. Methods A retrospective comparison of similarly sized WNBA treated with SAC or WEB over 5-years was performed. The operating room (arrival-departure), anesthesia (intubation-extubation), procedure duration (puncture-closure), fluoroscopy time and radiation dose(m-Gy) were recorded from the patients’ charts. Implant cost per case of all implants (stents, coils, WEB) that were opened whether deployed or not was captured including any coils used in the WEB cases. The implant cost represented the true cost incurred by the institution. Results There were 46 WEB and 41 SAC cases with no significant difference in aneurysm size. There were more MCA and ACOMM (p = 0.005) and more ruptured aneurysms (p = 0.02) in the WEB group. Regarding procedure variables (hours:minutes): Operating room time WEB 2:31 (±0:37) versus SAC 3:41 (±0:50) (p < 0.0001); anesthesia duration WEB 2:05 (±0:31) versus SAC 3:13 (±0:51) (p < 0.0001) and procedure duration WEB 1:16 (±0:29) versus SAC 2:09 (±0:46) (p < 0.0001). Regarding radiation: Fluoroscopy time WEB 0:34 (±0:18) versus SAC 1:06 (±0:35) (p < 0.0001) and radiation dose WEB 2392(±1086)m-Gy versus SAC 3442 (±1528)m-Gy (p = 0.0007). The implant cost was $17,028(±$5,527) for the WEB versus $23,813 (±$7,456) for the SAC group (p < 0.0001). Conclusion The WEB group had significantly shorter operating room, procedure and anesthesia duration compared to the SAC group. The radiation dose and fluoroscopy time was lower for the WEB group. The total implant cost per case was significantly lower for the WEB versus the SAC group.

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“…Previous studies have shown the benefit of using selected anatomies for evaluating device behavior and hands-on demonstration in artificial training settings 27. A study performed by Arthur et al in 2018, incorporated in the WEB Intrasaccular Therapy Study28 demonstrated the significance of creating a physical environment comprising a vascular simulator with patient-specific anatomies for education and training when introducing new technologies in clinical practice 27. HANNES may be particularly well qualified for such endeavors given its modular design, which allows easy testing of devices across a range of relevant anatomies.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of a modular in vitro neurovascular procedure simulation for intracranial aneurysm embolization

Nawka

Spallek

Kuhl

et al. 2019

J NeuroIntervent Surg

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BackgroundRapid development in endovascular aneurysm therapy continuously drives demand for suitable neurointerventional training opportunities.ObjectiveTo investigate the value of an integrated modular neurovascular training environment for aneurysm embolization using additively manufactured vascular models.MethodsA large portfolio of 30 patient-specific aneurysm models derived from different treatment settings (eg, coiling, flow diversion, flow disruption) was fabricated using additive manufacturing. Models were integrated into a customizable neurointerventional simulator with interchangeable intracranial and cervical vessel segments and physiological circuit conditions (‘HANNES’; Hamburg ANatomic Neurointerventional Endovascular Simulator). Multiple training courses were performed and participant feedback was obtained using a questionnaire.ResultsTraining for aneurysm embolization could be reliably performed using HANNES. Case-specific clinical difficulties, such as difficult aneurysm access or coil dislocation, could be reproduced. During a training session, models could be easily exchanged owing to standardized connectors in order to switch to a different treatment situation or to change from ‘treated’ back to ‘untreated’ condition. Among 23 participants evaluating hands-on courses using a five-point scale from 1 (strongly agree) to 5 (strongly disagree), HANNES was mostly rated as ‘highly suitable for practicing aneurysm coil embolization’ (1.78±0.79).ConclusionHANNES offers a wide variability and flexibility for case-specific hands-on training of intracranial aneurysm treatment, providing equal training conditions for each situation. The high degree of standardization offered may be valuable for analysis of device behavior or assessment of physician skills. Moreover, it has the ability to reduce the need for animal experiments.

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Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study

Abstract: A new program of neurovascular-replicator-based physician training was employed within the WEB-IT study. This represents a new methodology for education and training that may be an effective means to optimize technical success and patient safety during the introduction of a new technology.

Cited by 21 publications

References 8 publications

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Comparison of operating room variables, radiation exposure and implant costs for WEB versus stent assisted coiling for treatment of wide neck bifurcation aneurysms

Evaluation of a modular in vitro neurovascular procedure simulation for intracranial aneurysm embolization

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