Alexandre Hideo-Kajita1, Hector M Garcia-Garcia2, Michael Haude3, Michael Joner4, Jacques Koolen5, Hüseyin Ince6, Alexandre Abizaid7, Ralph Toelg8, Pedro A Lemos9, Clemens von Birgelen10, Evald Høj Christiansen11, William Wijns12, Franz-Josef Neumann13, Christoph Kaiser14, Eric Eeckhout15, Lim Soo Teik16, Javier Escaned17, Viana Azizi1, Kayode O Kuku1, Yuichi Ozaki1, Kazuhiro Dan1, Ron Waksman1. 1. Interventional Cardiology Department, MedStar Washington Hospital Center, Washington, DC, USA. 2. Interventional Cardiology Department, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. 3. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. 4. Deutsches Herzzentrum Muenchen und Deutsches Zentrum fuer Herz-Kreislaufforschung e.V., Munich, Germany. 5. Cardiologie, Catharina Ziekenhuis, Eindhoven, the Netherlands. 6. Vivantes Klinikum im Friedrichshain and Am Urban, Department of Cardiology, University of Rostock, Berlin, Germany. 7. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. 8. Herzzentrum Segeberger Kliniken, Henstedt-Ulzburg, Germany. 9. Instituto do Coração - HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. 10. Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands. 11. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 12. Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. 13. Klinik fur Kardiologie und Angiologie II, Universitats-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. 14. Department of Cardiology, University Hospital, Basel, Switzerland. 15. Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. 16. Department of Cardiology, National Heart Center Singapore, Singapore, Singapore. 17. Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.
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. 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 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. 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 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. CONCLUSION: At 12 months, 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. 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 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, 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.
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. 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 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. 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 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame. CONCLUSION: At 12 months, 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. 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 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, 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.