Masaru Seguchi MD, PhD, Philine Baumann-Zumstein BSc, Armin Fubel PhD, Martin Pritsch, Alp Aytekin MD, PhD, Philipp Nicol MD, Jonas Altevogt, Michael Joner MD
{"title":"Optical coherence tomography characterization of degradation kinetics between second- and third-generation resorbable magnesium scaffold","authors":"Masaru Seguchi MD, PhD, Philine Baumann-Zumstein BSc, Armin Fubel PhD, Martin Pritsch, Alp Aytekin MD, PhD, Philipp Nicol MD, Jonas Altevogt, Michael Joner MD","doi":"10.1002/ccd.31238","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Aims</h3>\n \n <p>This preclinical study aimed to establish optical coherence tomography (OCT)-derived parameters that could be used in the clinical setting for assessing strut degradation in the third-generation drug-eluting resorbable magnesium scaffold (DREAMS-3G), and characterize the comparative degradation profile against its precursor device (Magmaris<sup>TM</sup> scaffold).</p>\n </section>\n \n <section>\n \n <h3> Methods and Results</h3>\n \n <p>Twelve DREAMS-3G and 10 Magmaris<sup>TM</sup> scaffolds were implanted in juvenile pigs, and OCT images obtained at baseline and follow-up (6 or 12 months). Strut degradation was assessed by planimetric analysis and compared with OCT-derived indices to validate their diagnostic accuracy. A total of 3327 struts of DREAMS-3G and 2995 struts of the Magmaris<sup>TM</sup> scaffold were delineated by OCT. DREAMS-3G exhibited a significantly higher number of visible struts per analyzed frame at 6 months than the Magmaris<sup>TM</sup> scaffold, in the absence of significant differences at 12 months. Attenuation index (AtI) analysis indicated DREAMS-3G degradation was less advanced at 6 months but more advanced at 12 months compared to the Magmaris<sup>TM</sup> scaffold. These OCT-derived indices significantly correlated with the results of the planimetric analysis.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>The current preclinical study validated OCT indices that may serve as clinical surrogate markers for scaffold degradation. AtI analysis indicated that DREAMS-3G showed less degradation at 6 months but more advanced degradation at 12 months compared to the Magmaris<sup>TM</sup> scaffold, which corroborates the findings from planimetric analysis.</p>\n </section>\n </div>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":"104 5","pages":"959-967"},"PeriodicalIF":2.1000,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/ccd.31238","RegionNum":3,"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
Aims
This preclinical study aimed to establish optical coherence tomography (OCT)-derived parameters that could be used in the clinical setting for assessing strut degradation in the third-generation drug-eluting resorbable magnesium scaffold (DREAMS-3G), and characterize the comparative degradation profile against its precursor device (MagmarisTM scaffold).
Methods and Results
Twelve DREAMS-3G and 10 MagmarisTM scaffolds were implanted in juvenile pigs, and OCT images obtained at baseline and follow-up (6 or 12 months). Strut degradation was assessed by planimetric analysis and compared with OCT-derived indices to validate their diagnostic accuracy. A total of 3327 struts of DREAMS-3G and 2995 struts of the MagmarisTM scaffold were delineated by OCT. DREAMS-3G exhibited a significantly higher number of visible struts per analyzed frame at 6 months than the MagmarisTM scaffold, in the absence of significant differences at 12 months. Attenuation index (AtI) analysis indicated DREAMS-3G degradation was less advanced at 6 months but more advanced at 12 months compared to the MagmarisTM scaffold. These OCT-derived indices significantly correlated with the results of the planimetric analysis.
Conclusion
The current preclinical study validated OCT indices that may serve as clinical surrogate markers for scaffold degradation. AtI analysis indicated that DREAMS-3G showed less degradation at 6 months but more advanced degradation at 12 months compared to the MagmarisTM scaffold, which corroborates the findings from planimetric analysis.
期刊介绍:
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.