- Email: [email protected]
TCT-833 Late Lumen Gain with Bioresorbable Vascular Scaffold in the Porcine Model of Spontaneous Untreated Atherosclerosis: a 3-year IVUS and OCT Study
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
B337
TCT-833 Late Lumen Gain with Bioresorbable Vascular Scaffold in the Porcine Model of Spontaneous Untreated Atherosclerosis: a 3-year IVUS and OCT Study
TCT-834 Bioresorbable Scaffolds versus Metallic Drug Eluting Stents – Comparison of Predicted Arterial Stress after Simulated Deployment in Concentric and Eccentric Coronary Lesions
Yanping Cheng,1 Gaoke Feng,2 Jinggang Xia,3 Pawel Gasior,4 Qing Wang,5 Laura Perkins,6 Richard Rapoza,7 Jenn McGregor,8 Gerard Conditt,9 Greg Kaluza,10 Juan Granada11 1 Cardiovascular Research Foundation, ORANGEBURG, New York, United States; 2Cardiovascular Research Foundation, Orangeburg, New York, United States; 3MedStar Washington Hospital Center; 4CRF Skirball Center for Innovation, Fort Lee, New Jersey, United States; 5 abbott vascular, Santa Clara, California, United States; 6Abbott Vascular, Mattaponi, Virginia, United States; 7Abbott Vascular, Santa Clara, California, United States; 8Cardiovascular Research Foundation, Orangeburg, New York, United States; 9CRF-Skirball Center for Innovation, Nyack, New York, United States; 10CRF Skirball Center for Innovation, Orangeburg, New York, United States; 11CRF Skirball Center for Innovation, Orangeburg, New York, United States
Alessandro Schiavone,1 Chad Abunassar,2 Liguo Zhao,3 Syed Hossainy4 1 Winmedica; 2Abbott Vascular, Menlo Park, California, United States; 3 Hospital de Clínicas Caracas; 4Abbott Vascular, Santa Clara, California, United States
BACKGROUND Previously reported interim 1-year imaging evaluation of bioresorbable vascular scaffolds (BVS) in the familial hypercholesterolemic swine (FHS) model of spontaneous untreated atherosclerosis revealed delayed progression of atherosclerosis and more stable neointima as compared to everolimus-eluting metallic stent (EES). Herein the outcomes to 3 years after implantation are presented. METHODS Twenty weeks following initial balloon injury, BVS and EES were implanted in coronary segments of 8 FHS and investigated with multiple imaging modalities at 2 (4 pigs: BVS¼8, EES¼5) and 3 years (4 pigs: BVS¼8, EES¼4). RESULTS Pre-implantation plaque burden was comparable between BVS and EES. Compared to 1 year, OCT and IVUS in BVS were consistent in showing an increase in lumen area primarily due to the scaffold area enlargement at 2 and 3 years (Figure), but no significant change in the lumen area in EES. BVS struts were not discernible in all the implanted segments at 3 years; the total strut box areas were significantly decreased (1-year 10.312.18mm2, 2-year 10.772.23mm2 vs. 3-year 5.812.26mm2, p<0.05). No significant difference was seen in percent area stenosis between two devices at 2 (BVS 396% vs. EES 3812%, p¼0.95) or 3 years (BVS 4817% vs. EES 3111%, p¼0.10).
BACKGROUND Bioresorbable vascular scaffolds provide a new option for the treatment of coronary artery disease with the promise of improved long-term vessel mechanics when compared to permanent metallic drug eluting stents (DES). While this long-term benefit holds great promise, further study is required to clarify the impact of design and material differences between these two implant types. In this study, finite element analysis was used to compare the deployment mechanics of a bioresorbable vascular scaffold (Absorb, Abbott Vascular) and a cobalt chromium metallic drug eluting stent (Xience V, Abbott Vascular) with respect to interactions with the lesion and vessel wall. METHODS Device crimping and deployment simulations were performed for Xience V (XV) and Absorb using Abaqus software (Dassault Systems Inc,) and included tailored material models for both polymeric and metallic implants as well clinically relevant arterial material properties for intima, media, adventitia, and plaque. Plaque morphology was also modeled as concentric and eccentric to clarify any differences in implantation mechanics for both implant types across two lesion types. RESULTS When compared to XV, Absorb exhibited greater conformability to the target lesion geometry along with a reduction in plaque stress (0.750 vs. 1.431 MPa), intima stress (0.253 versus 0.953 MPa), media stress (0.022 vs. 0.034 MPa), and adventitia stress (0.013 versus 0.019 MPa). For both implant types, arterial stresses were higher in the eccentric lesion deployment scenario, however, in this case Absorb induced dramatically lower stress levels in the media (0.183 vs. 0.330 MPa) and adventitia (0.015 vs. 0.049 MPa) when compared to XV. CONCLUSION This simulation study demonstrates that the Absorb scaffold may produce favorable device-artery mechanical interactions when compared to a metallic DES, particularly when deployment occurs in an eccentric lesion. The results of this study also imply that careful balloon post-dilation may be required to manage any increased recoil for absorbable scaffolds. Further work could clarify the time-varying interactions between a bioresorbable scaffold and artery wall. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-835 Endothelial Function Assessed by Expression of Adherens Junctions and Inflammation between Durable and Biodegradable Polymer Drug-Eluting Stents in the Rabbit Iliofemoral Model Kazuyuki Yahagi,1 Frank Kolodgie,2 Daivid Cheng,3 Eduardo Acampado,4 Liang Guo,5 Hiroyoshi Mori,6 Khaja Chinnakondepali,7 Maria Romero,8 Laura Perkins,9 Aloke Finn,10 Renu Virmani11 1 CVPath Institute, Inc., Geithersburg, Maryland, United States; 2CVPath Institute, Gaithersburg, Maryland, United States; 3Unknown, Bethesda, Maryland, United States; 4University Hospital La Timone; 5Division of cardiology, Saiseikai Kumamoto Hospital Cardiovascular center; 6 Division of cardiovascular surgery, Saiseikai Kumamoto Hospital Cardiovascular center; 7St. Luke’s Mid America Institute; 8Duke Clinical Research Institute; 9Abbott Vascular, Mattaponi, Virginia, United States; 10CVPath Institute Inc. and University of Maryland, Baltimore, Gaithersburg, Maryland, United States; 11CVPath Institute, Inc., Gaithersburg, Maryland, United States
CONCLUSION In the FHS model, OCT and IVUS demonstrate relative lumen gain between 1-2 years and 1-3 years after BVS implantation despite significant disease progression. This appears to correspond to the late lumen gain timeline observed in clinical studies and confirms the predictive value of the FHS model for evaluation of BVS. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds
BACKGROUND Stent polymer-coatings have been shown clinically to impact the long-term performance of drug-eluting stents. We compared the expression of VE-cadherin (VE-C), a junctional protein important to permeability of the endothelium, and monocyte/macrophage adhesion between durable fluoropolymer (Xience Alpine, Xience, Abbott Vascular) and biodegradable polymer (Synergy, Boston Scientific) DES. METHODS A total of 24 DES (Xience and Synergy) were equally deployed in iliac arteries of healthy rabbits survived for 14 or 28 days (n ¼ 6 devices/time point). VE-C and macrophages were assessed by immunofluorescent staining and confocal microscopy. Area coverage for VE-C was determined by histomorphometry, while RAM11-positive monocyte/macrophages were semi-quantified from confocal micrographs of every other strut (Figure). RESULTS There were no differences between Xience and Synergy in the extent of luminal surface coverage by VE-C-positive endothelial
B337
TCT-833 Late Lumen Gain with Bioresorbable Vascular Scaffold in the Porcine Model of Spontaneous Untreated Atherosclerosis: a 3-year IVUS and OCT Study
TCT-834 Bioresorbable Scaffolds versus Metallic Drug Eluting Stents – Comparison of Predicted Arterial Stress after Simulated Deployment in Concentric and Eccentric Coronary Lesions
Yanping Cheng,1 Gaoke Feng,2 Jinggang Xia,3 Pawel Gasior,4 Qing Wang,5 Laura Perkins,6 Richard Rapoza,7 Jenn McGregor,8 Gerard Conditt,9 Greg Kaluza,10 Juan Granada11 1 Cardiovascular Research Foundation, ORANGEBURG, New York, United States; 2Cardiovascular Research Foundation, Orangeburg, New York, United States; 3MedStar Washington Hospital Center; 4CRF Skirball Center for Innovation, Fort Lee, New Jersey, United States; 5 abbott vascular, Santa Clara, California, United States; 6Abbott Vascular, Mattaponi, Virginia, United States; 7Abbott Vascular, Santa Clara, California, United States; 8Cardiovascular Research Foundation, Orangeburg, New York, United States; 9CRF-Skirball Center for Innovation, Nyack, New York, United States; 10CRF Skirball Center for Innovation, Orangeburg, New York, United States; 11CRF Skirball Center for Innovation, Orangeburg, New York, United States
Alessandro Schiavone,1 Chad Abunassar,2 Liguo Zhao,3 Syed Hossainy4 1 Winmedica; 2Abbott Vascular, Menlo Park, California, United States; 3 Hospital de Clínicas Caracas; 4Abbott Vascular, Santa Clara, California, United States
BACKGROUND Previously reported interim 1-year imaging evaluation of bioresorbable vascular scaffolds (BVS) in the familial hypercholesterolemic swine (FHS) model of spontaneous untreated atherosclerosis revealed delayed progression of atherosclerosis and more stable neointima as compared to everolimus-eluting metallic stent (EES). Herein the outcomes to 3 years after implantation are presented. METHODS Twenty weeks following initial balloon injury, BVS and EES were implanted in coronary segments of 8 FHS and investigated with multiple imaging modalities at 2 (4 pigs: BVS¼8, EES¼5) and 3 years (4 pigs: BVS¼8, EES¼4). RESULTS Pre-implantation plaque burden was comparable between BVS and EES. Compared to 1 year, OCT and IVUS in BVS were consistent in showing an increase in lumen area primarily due to the scaffold area enlargement at 2 and 3 years (Figure), but no significant change in the lumen area in EES. BVS struts were not discernible in all the implanted segments at 3 years; the total strut box areas were significantly decreased (1-year 10.312.18mm2, 2-year 10.772.23mm2 vs. 3-year 5.812.26mm2, p<0.05). No significant difference was seen in percent area stenosis between two devices at 2 (BVS 396% vs. EES 3812%, p¼0.95) or 3 years (BVS 4817% vs. EES 3111%, p¼0.10).
BACKGROUND Bioresorbable vascular scaffolds provide a new option for the treatment of coronary artery disease with the promise of improved long-term vessel mechanics when compared to permanent metallic drug eluting stents (DES). While this long-term benefit holds great promise, further study is required to clarify the impact of design and material differences between these two implant types. In this study, finite element analysis was used to compare the deployment mechanics of a bioresorbable vascular scaffold (Absorb, Abbott Vascular) and a cobalt chromium metallic drug eluting stent (Xience V, Abbott Vascular) with respect to interactions with the lesion and vessel wall. METHODS Device crimping and deployment simulations were performed for Xience V (XV) and Absorb using Abaqus software (Dassault Systems Inc,) and included tailored material models for both polymeric and metallic implants as well clinically relevant arterial material properties for intima, media, adventitia, and plaque. Plaque morphology was also modeled as concentric and eccentric to clarify any differences in implantation mechanics for both implant types across two lesion types. RESULTS When compared to XV, Absorb exhibited greater conformability to the target lesion geometry along with a reduction in plaque stress (0.750 vs. 1.431 MPa), intima stress (0.253 versus 0.953 MPa), media stress (0.022 vs. 0.034 MPa), and adventitia stress (0.013 versus 0.019 MPa). For both implant types, arterial stresses were higher in the eccentric lesion deployment scenario, however, in this case Absorb induced dramatically lower stress levels in the media (0.183 vs. 0.330 MPa) and adventitia (0.015 vs. 0.049 MPa) when compared to XV. CONCLUSION This simulation study demonstrates that the Absorb scaffold may produce favorable device-artery mechanical interactions when compared to a metallic DES, particularly when deployment occurs in an eccentric lesion. The results of this study also imply that careful balloon post-dilation may be required to manage any increased recoil for absorbable scaffolds. Further work could clarify the time-varying interactions between a bioresorbable scaffold and artery wall. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-835 Endothelial Function Assessed by Expression of Adherens Junctions and Inflammation between Durable and Biodegradable Polymer Drug-Eluting Stents in the Rabbit Iliofemoral Model Kazuyuki Yahagi,1 Frank Kolodgie,2 Daivid Cheng,3 Eduardo Acampado,4 Liang Guo,5 Hiroyoshi Mori,6 Khaja Chinnakondepali,7 Maria Romero,8 Laura Perkins,9 Aloke Finn,10 Renu Virmani11 1 CVPath Institute, Inc., Geithersburg, Maryland, United States; 2CVPath Institute, Gaithersburg, Maryland, United States; 3Unknown, Bethesda, Maryland, United States; 4University Hospital La Timone; 5Division of cardiology, Saiseikai Kumamoto Hospital Cardiovascular center; 6 Division of cardiovascular surgery, Saiseikai Kumamoto Hospital Cardiovascular center; 7St. Luke’s Mid America Institute; 8Duke Clinical Research Institute; 9Abbott Vascular, Mattaponi, Virginia, United States; 10CVPath Institute Inc. and University of Maryland, Baltimore, Gaithersburg, Maryland, United States; 11CVPath Institute, Inc., Gaithersburg, Maryland, United States
CONCLUSION In the FHS model, OCT and IVUS demonstrate relative lumen gain between 1-2 years and 1-3 years after BVS implantation despite significant disease progression. This appears to correspond to the late lumen gain timeline observed in clinical studies and confirms the predictive value of the FHS model for evaluation of BVS. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds
BACKGROUND Stent polymer-coatings have been shown clinically to impact the long-term performance of drug-eluting stents. We compared the expression of VE-cadherin (VE-C), a junctional protein important to permeability of the endothelium, and monocyte/macrophage adhesion between durable fluoropolymer (Xience Alpine, Xience, Abbott Vascular) and biodegradable polymer (Synergy, Boston Scientific) DES. METHODS A total of 24 DES (Xience and Synergy) were equally deployed in iliac arteries of healthy rabbits survived for 14 or 28 days (n ¼ 6 devices/time point). VE-C and macrophages were assessed by immunofluorescent staining and confocal microscopy. Area coverage for VE-C was determined by histomorphometry, while RAM11-positive monocyte/macrophages were semi-quantified from confocal micrographs of every other strut (Figure). RESULTS There were no differences between Xience and Synergy in the extent of luminal surface coverage by VE-C-positive endothelial