MedStar Authors catalog › Details for: First Report of Edge Vascular Response at 12Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study.
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First Report of Edge Vascular Response at 12Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study.

by Azizi, Viana; Dan, Kazuhiro; Garcia-Garcia, Hector M; Hideo-Kajita, Alexandre; Kuku, Kayode; Ozaki, Yuichi; Waksman, Ron.
Citation: ; Cardiovascular Revascularization Medicine. 20(5):392-398, 2019 05..Journal: Cardiovascular revascularization medicine : including molecular interventions.Published: ; 2019; ISSN: 1878-0938.Full author list: Abizaid A; Azizi V; Christiansen EH; Dan K; Eeckhout E; Escaned J; Garcia-Garcia HM; Haude M; Hideo-Kajita A; Ince H; Joner M; Kaiser C; Koolen J; Kuku KO; Lemos PA; Neumann FJ; Ozaki Y; Teik LS; Toelg R; von Birgelen C; Waksman R; Wijns W.UI/PMID: 31079817.Subject(s): *Absorbable Implants | Young Adult | Wound Healing | *Ultrasonography, Interventional | Treatment Outcome | *Tomography, Optical Coherence | Time Factors | Risk Factors | Prosthesis Design | Predictive Value of Tests | Plaque, Atherosclerotic | Middle Aged | *Magnesium | Humans | Fibrosis | *Drug-Eluting Stents | *Coronary Artery Disease/th [Therapy] | Coronary Artery Disease/pa [Pathology] | Coronary Artery Disease/dg [Diagnostic Imaging] | *Angioplasty, Balloon, Coronary/is [Instrumentation] | Angioplasty, Balloon, Coronary/ae [Adverse Effects] | Aged | AdultInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access online Digital Object Identifier: https://dx.doi.org/10.1016/j.carrev.2019.02.019 (Click here) Abbreviated citation: ; Cardiovasc Revasc Med. 20(5):392-398, 2019 05.Local Holdings: Available in print through MWHC library: 2002 - present.Abstract: CONCLUSION: At 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS.Abstract: Copyright (c) 2019 Elsevier Inc. All rights reserved.Abstract: INTRODUCTION AND OBJECTIVE: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities.Abstract: METHODS: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12months. The EVR study performed a segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS.Abstract: RESULTS: The segment-level grayscale IVUS (n=10), virtual histology IVUS (n=10), and OCT (n=18) analysis did not show any significant changes after 12months, except for a fibrous plaque area (FPA) reduction of 0.5mm<sup>2</sup> (p=0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80+/-1.43mm<sup>2</sup> (p=0.012) and 2.49+/-1.53mm<sup>2</sup> (p=0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88+/-0.70mm<sup>2</sup> (p=0.048) and a FPA decreased by 0.63+/-0.48mm<sup>2</sup> (p=0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10+/-0.12mm<sup>2</sup> (p=0.045), FPA and fibrous fatty plaque increased 0.54+/-0.53mm<sup>2</sup> (p=0.023) and 0.17+/-0.16mm<sup>2</sup> (p=0.016), respectively. By OCT, there was a lumen area decrease of 0.76+/-1.51mm<sup>2</sup> (p=0.045) in a distal frame.Abstract: SUMMARY: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5mm segments proximal and distal of the actual RMS. As a result, after 12months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS.

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