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Pr. Jens Fielher,
Director of the Department of Diagnostic and Interventional Neuroradiology
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
The flow-diverter (FD) stent analysis from the INSPIRE-A registry data revealed an improved complete aneurysm occlusion rate of 80.6% with Vantage compared to 74.7% with Pipeline Shield with a similar safety profile.
While flow diverter technology underwent an iterative development over the years, newer generations of nitinol-based FDs have increased flexibility and improvements in navigation and deployment, but may have lower radial force, which may be associated with less wall apposition or a higher risk of kinking and fracture. It led to the question of their long-term braid stability, and to the INSPIRE-A registry analysis, by extension.
Unusual case of early proximal fishmouthing and thrombus formation, combined with foreshortening.
Deformations of FD braids were reported before and have been analyzed in a recent meta-analysis that suggested the presence of bias in the evaluation methodology1. This bias can be explained by the absence of standards in the evaluation of FD braids. It turned out that braid deformation and stability is a scarcely standardized and under-investigated subject. Whereas there are multiple occlusion scales, a braid deformation scale was lacking.
To address these issues, a multidisciplinary panel of neurointerventionalists, imaging scientists, and neuroradiologists convened with the goal of establishing consensus recommendations for the standardization of image analyses in FD studies. The panel proposed a standardized methodology for evaluating and reporting radiological outcomes of FD treatment. This methodology is summarized in a white paper with recommendations for clinical studies, that are endorsed by ESMINT, ESNR, OCIN, SILAN, SNIS and WFITN. This paper covers standards for classification of aneurysm location, morphology, measurements, as well as the assessment of aneurysm occlusion, wall apposition, and neck coverage.
As a central subject, 4 specific braid deformation patterns are defined: foreshortening, fish-mouthing, braid hump deformation, and braid collapse, collectively termed “F2B2”.
Fiehler et al. hope it will help facilitate communication of results among specialists, help enable research and development to focus on specific aspects of FD techniques and technology, and ultimately improve outcomes for aneurysm patients. (Ongoing publication)
→ Get more insights by exploring Jens Fiehler's session at LINNC Paris 2023:
About the INSPIRE-A registry
The INSPIRE is a unique, large scale, multitherapy, long-term observational study platform, sponsored by Medtronic Neurovascular. This registry is designed to continuously monitor the safety and performance of any newly commercialized device that is introduced into the neurovascular field by the sponsor. As part of INSPIRE, patients are being prospectively enrolled from a large number of selected sites worldwide, whenever treated with any of the sponsor’s new neurovascular device(s). To ensure real world experience and to reduce bias, all study data are based on patients treated by the device based on routine standard of care. Site data are monitored and safety event data are assessed by an independent clinical events committee, while efficacy is assessed by an independent central core laboratory.
Sponsored by Medtronic—and endorsed by the European Society of Minimally Invasive Neurological Therapy (ESMINT)—the registry is continuously monitoring results in intracranial aneurysm patients treated with Medtronic neurovascular medical devices. These include the Flex, Shield and Vantage flow diverters, all of which belong to the PipelineTM embolisation device family, as well as the Artisse intrasaccular system (all Medtronic).
References
1. Ortega-Gutierrez, S. et al. Braid stability after flow diverter treatment of intracranial aneurysms: a systematic review and meta-analysis. J. NeuroInterventional Surg. 2023
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