Jeffrey R Nagel, Erik Groot Jebbink, Stefan P M Smorenburg, Arjan W J Hoksbergen, Rutger J Lely, Michel Versluis, Michel M P J Reijnen
{"title":"Optimizing the Radiopacity of an Injectable Polymer on Fluoroscopy used for Treatment of Type II Endoleak After Endovascular Aneurysm Repair.","authors":"Jeffrey R Nagel, Erik Groot Jebbink, Stefan P M Smorenburg, Arjan W J Hoksbergen, Rutger J Lely, Michel Versluis, Michel M P J Reijnen","doi":"10.1007/s13239-025-00779-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Type II endoleaks (T2EL) are a common complication after endovascular aneurysm repair. AneuFix is a newly designed elastic polymer for T2EL. AneuFix contains tantalum for visualization during fluoroscopy, which is crucial for monitoring the polymer in the side branches. The purpose of this study was to find the lowest concentration tantalum that is sufficient for safe injection in the aneurysmal sac.</p><p><strong>Methods: </strong>AneuFix polymer with tantalum concentrations between 0 and 30% was injected into endoleak phantoms, connected to a pulsatile flow setup and with a realistic background for fluoroscopy. Furthermore, the radiopacity was investigated on fluoroscopic systems from three different vendors, using static phantoms. Results from both the dynamic and static phantoms were qualitatively evaluated by 10 clinical experts.</p><p><strong>Results: </strong>Concentrations of ≥ 20% tantalum were consistently detected within the first 5 mm after entering the side branch, with a corresponding contrast-to-noise ratio of 2.23 ± 0.21. Furthermore, sufficient detectability scores (of at least 3 out of 5) were given to ≥ 15% tantalum. Significant differences were found in detectability scores on different fluoroscopic systems, using the default lowest-radiation-dose scan protocol for each system.</p><p><strong>Conclusions: </strong>This study showed that tantalum concentrations ≥ 20% are consistently detected on fluoroscopy in the specified region. Compared to the original 30%, this would reduce imaging artifacts from high attenuation and scattering on follow-up imaging, while retaining sufficient detectability during injection. However, because of differences in fluoroscopic systems and scan protocols between hospitals, the combination of tantalum concentration and scan protocol should be optimized for each clinical setting.</p>","PeriodicalId":54322,"journal":{"name":"Cardiovascular Engineering and Technology","volume":" ","pages":""},"PeriodicalIF":1.6000,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiovascular Engineering and Technology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1007/s13239-025-00779-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: Type II endoleaks (T2EL) are a common complication after endovascular aneurysm repair. AneuFix is a newly designed elastic polymer for T2EL. AneuFix contains tantalum for visualization during fluoroscopy, which is crucial for monitoring the polymer in the side branches. The purpose of this study was to find the lowest concentration tantalum that is sufficient for safe injection in the aneurysmal sac.
Methods: AneuFix polymer with tantalum concentrations between 0 and 30% was injected into endoleak phantoms, connected to a pulsatile flow setup and with a realistic background for fluoroscopy. Furthermore, the radiopacity was investigated on fluoroscopic systems from three different vendors, using static phantoms. Results from both the dynamic and static phantoms were qualitatively evaluated by 10 clinical experts.
Results: Concentrations of ≥ 20% tantalum were consistently detected within the first 5 mm after entering the side branch, with a corresponding contrast-to-noise ratio of 2.23 ± 0.21. Furthermore, sufficient detectability scores (of at least 3 out of 5) were given to ≥ 15% tantalum. Significant differences were found in detectability scores on different fluoroscopic systems, using the default lowest-radiation-dose scan protocol for each system.
Conclusions: This study showed that tantalum concentrations ≥ 20% are consistently detected on fluoroscopy in the specified region. Compared to the original 30%, this would reduce imaging artifacts from high attenuation and scattering on follow-up imaging, while retaining sufficient detectability during injection. However, because of differences in fluoroscopic systems and scan protocols between hospitals, the combination of tantalum concentration and scan protocol should be optimized for each clinical setting.
期刊介绍:
Cardiovascular Engineering and Technology is a journal publishing the spectrum of basic to translational research in all aspects of cardiovascular physiology and medical treatment. It is the forum for academic and industrial investigators to disseminate research that utilizes engineering principles and methods to advance fundamental knowledge and technological solutions related to the cardiovascular system. Manuscripts spanning from subcellular to systems level topics are invited, including but not limited to implantable medical devices, hemodynamics and tissue biomechanics, functional imaging, surgical devices, electrophysiology, tissue engineering and regenerative medicine, diagnostic instruments, transport and delivery of biologics, and sensors. In addition to manuscripts describing the original publication of research, manuscripts reviewing developments in these topics or their state-of-art are also invited.