97 results on '"Rapoza, R"'
Search Results
2. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years
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Onuma, Y. (Yoshinobu), Honda, Y. (Yasuhiro), Asano, T. (Taku), Shiomi, H. (Hiroki), Kozuma, K. (Ken), Ozaki, Y. (Yukio), Namiki, A. (Atsuo), Yasuda, S. (Satoshi), Ueno, T. (Takafumi), Ando, K. (Kenji), Furuya, J. (Jungo), Hanaoka, K.I. (Keiichi Igarashi), Tanabe, K. (Kengo), Okada, K. (Kozo), Kitahara, H. (Hideki), Ono, M. (Masafumi), Kusano, H. (Hajime), Rapoza, R. (Richard), Simonton, C. (Charles), Popma, J.J. (Jeffrey J.), Stone, G.W. (Gregg), Fitzgerald, P.J. (Peter J.), Serruys, P.W.J.C. (Patrick), Kimura, T. (Takeshi), Onuma, Y. (Yoshinobu), Honda, Y. (Yasuhiro), Asano, T. (Taku), Shiomi, H. (Hiroki), Kozuma, K. (Ken), Ozaki, Y. (Yukio), Namiki, A. (Atsuo), Yasuda, S. (Satoshi), Ueno, T. (Takafumi), Ando, K. (Kenji), Furuya, J. (Jungo), Hanaoka, K.I. (Keiichi Igarashi), Tanabe, K. (Kengo), Okada, K. (Kozo), Kitahara, H. (Hideki), Ono, M. (Masafumi), Kusano, H. (Hajime), Rapoza, R. (Richard), Simonton, C. (Charles), Popma, J.J. (Jeffrey J.), Stone, G.W. (Gregg), Fitzgerald, P.J. (Peter J.), Serruys, P.W.J.C. (Patrick), and Kimura, T. (Takeshi)
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Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehens
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- 2020
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3. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent Multimodality Imaging Through 3 Years
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Onuma, Yoshinobu, Honda, Y, Asano, T, Shiomi, H, Kozuma, K, Ozaki, Y, Namiki, A, Yasuda, S, Ueno, T, Ando, K, Furuya, J, Hanaoka, KI, Tanabe, K, Okada, K, Kitahara, H, Ono, M, Kusano, H, Rapoza, R, Simonton, C, Popma, JJ, Stone, GW, Fitzgerald, PJ, Serruys, PWJC, Kimura, T, Onuma, Yoshinobu, Honda, Y, Asano, T, Shiomi, H, Kozuma, K, Ozaki, Y, Namiki, A, Yasuda, S, Ueno, T, Ando, K, Furuya, J, Hanaoka, KI, Tanabe, K, Okada, K, Kitahara, H, Ono, M, Kusano, H, Rapoza, R, Simonton, C, Popma, JJ, Stone, GW, Fitzgerald, PJ, Serruys, PWJC, and Kimura, T
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- 2020
4. Life-stage dependent, in situ dietary patterns of the lobate ctenophore Mnemiopsis leidyi Agassiz 1865
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Rapoza, R., Novak, D., and Costello, J. H.
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- 2005
5. Chapter 21 - Business Perspective: Case Study: Commercialized Cell-Free Cardiovascular Implant
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Sheehy, A., Lambert, B., and Rapoza, R.
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- 2016
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6. Bioresorption and Vessel Wall Integration of a Fully Bioresorbable Polymeric Everolimus-Eluting Scaffold Optical Coherence Tomography, Intravascular Ultrasound, and Histological Study in a Porcine Model With 4-Year Follow-Up
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Nakatani, S., Ishibashi, Y., Sotomi, Y., Perkins, L., Eggermont, J., Grundeken, M.J., Dijkstra, J., Rapoza, R., Virmani, R., Serruys, P.W., Onuma, Y., and Cardiology
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optical coherence tomography ,biodegradable polymer ,coronary intervention ,pathology ,bioresorbable scaffold ,intravascular ultrasound - Abstract
The aim of the present study was to investigate the relationship between the integration process and luminal enlargement with the support of light intensity (LI) analysis on optical coherence tomography (OCT), echogenicity analysis on intravascular ultrasound, and histology up to 4 years in a porcine model. In pre-clinical and clinical studies, late luminal enlargement has been demonstrated at long-term follow-up after everolimus-eluting poly-l-lactic acid coronary scaffold implantation. However, the time relationship and the mechanistic association with the integration process are still unclear. Seventy-three nonatherosclerotic swine that received 112 Absorb scaffolds were evaluated in vivo by OCT, intravascular ultrasound, and post-mortem histomorphometry at 3, 6, 12, 18, 24, 30, 36, 42, and 48 months. The normalized LI, which is the signal densitometry on OCT of a polymeric strut core normalized by the vicinal neointima, was able to differentiate the degree of connective tissue infiltration inside the strut cores. Luminal enlargement was a biphasic process at 6 to 18 months and at 30 to 42 months. The latter phase occurred with vessel wall thinning and coincided with the advance integration process demonstrated by the steep change in normalized LI (0.26 [interquartile range (IQR): 0.20 to 0.32] at 30 months versus 0.68 [IQR: 0.58 to 0.83] at 42 months, p < 0.001). In this pre-clinical model, late luminal enlargement relates to strut integration into the arterial wall. Quantitative LI analysis on OCT could be used as a surrogate method for monitoring the integration process of poly-l-lactic acid scaffolds, which could provide insight and understanding on the imaging-related characteristics of the bioresorption process of polylactide scaffolds in human
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- 2016
7. Differential thrombotic prolapse burden in either bioresorbable vascular scaffolds or metallic stents implanted during acute myocardial infarction The snowshoe effect: Insights from the maximal footprint analysis
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Diletti, Roberto, Van der Sijde, Jors, Karanasos, Antonios, Fam, JM, Felix, Cordula, van Mieghem, Nicolas, Regar, Evelyn, Rapoza, R, Zijlstra, Felix, van Geuns, Robert Jan, and Cardiology
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- 2016
8. Angiographic Geometric Changes of the Lumen Arterial Wall After Bioresorbable Vascular Scaffolds and Metallic Platform Stents at 1-Year Follow-Up
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Gomez Lara, Josep, Brugaletta, S, Farooq, V, van Geuns, Robert Jan, de Bruyne, B, Windecker, S, McClean, D, Thuesen, L, Dudek, D, Koolen, J, Whitbourn, R, Smits, PC (Pieter), Chevalier, B, Morel, Marie-Angele, Dorange, C, Veldhof, S, Garcia Garcia, Hector, Rapoza, R, Garcia-Garcia, HM, Ormiston, JA, Serruys, PWJC (Patrick), Cardiology, and Radiology & Nuclear Medicine
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Diastole ,1 year follow up ,Coronary Angiography ,Internal medicine ,Absorbable Implants ,Coronary stent ,medicine ,Humans ,coronary geometry ,Arterial wall ,Angioplasty, Balloon, Coronary ,skin and connective tissue diseases ,Everolimus ,Tissue Scaffolds ,business.industry ,Coronary Stenosis ,Stent ,Middle Aged ,Coronary Vessels ,metallic platform stent (MPS) ,Treatment Outcome ,medicine.anatomical_structure ,Cardiology ,Female ,Stents ,sense organs ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,bioresorbable vascular scaffolds (BVS) ,Follow-Up Studies ,medicine.drug ,Artery ,Lumen (unit) - Abstract
Objectives The aim of this study was to compare the angiographic changes in coronary geometry of the bioresorbable vascular scaffolds (BVS) and metallic platform stent (MPS) between baseline and follow-up. Background Coronary geometry changes after stenting might result in wall shear stress changes and adverse events. The BVS have better conformability, compared with MPS, but still modify artery geometry. It is uncertain whether the BVS resorption can restore the coronary anatomical configuration at midterm follow-up. Methods All patients of the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions) and SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trials treated with a single 3.0 x 18 mm device and imaged at baseline and 6- to 12-month follow-up were eligible. Coronary geometry changes were assessed with quantitative angiography as changes in curvature and angulation. Curvature and angulation changes between systole and diastole were investigated to assess hinging movements of the coronary artery. Results One hundred sixty-one patients (86 BVS, and 75 MPS) were included. Baseline angiographic characteristics were similar. From post-implantation to follow-up, curvature increased 8.4% (p < 0.01) with BVS and decreased 1.9% (p = 0.54) with MPS; p = 0.01. Angulation increased 11.3% with BVS (p < 0.01) and 3.8% with MPS (p = 0.01); p < 0.01. From pre-implantation to follow-up, BVS decreased 3.4% the artery curvature (p = 0.05) and 3.9% the artery angulation (p = 0.16), whereas MPS presented with 26.1% decrease in curvature (p < 0.01) and 26.9% decrease in angulation (p < 0.01), being larger with MPS (p < 0.01, both). Hinging movements in curvature from pre-implantation to follow-up decreased 19.7% with BVS and 39.0% with MPS (p = 0.27) and decreased 3.9% with BVS and 26.9% with MPS in angulation (p < 0.01). Conclusions At midterm follow-up, the BVS tended to restore the coronary configuration and the systodiastolic movements to those seen before implantation. The coronary geometry remained similar to that seen at after implantation with MPS. (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System [BVS EECSS] in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00856856) (J Am Coll Cardiol Intv 2011;4:789-99) (C) 2011 by the American College of Cardiology Foundation
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- 2011
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9. Temporal Evolution of Strut Light Intensity After Implantation of Bioresorbable Polymeric Intracoronary Scaffolds in the ABSORB Cohort B Trial - An Application of a New Quantitative Method Based on Optical Coherence Tomography
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Nakatani, S., Onuma, Y., Ishibashi, Y., Eggermont, J., Zhang, Y.J., Campos, C.M., Cho, Y.K., Liu, S.N., Dijkstra, J., Reiber, J.H.C., Perkins, L., Sheehy, A., Veldhof, S., Rapoza, R., Es, G.A. van, Garcia-Garcia, H.M., Geuns, R.J. van, Serruys, P.W., and ABSORB Cohort B Investigators
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Light intensity analysis ,Bioresorbable vascular scaffold ,Optical coherence tomography ,Bioresorption ,Coronary artery disease - Published
- 2014
10. Temporal Evolution of Strut Light Intensity After Implantation of Bioresorbable Polymeric Intracoronary Scaffolds in the ABSORB Cohort B Trial - An Application of a New Quantitative Method Based on Optical Coherence Tomography
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Nakatani, S, Onuma, Yoshinobu, Ishibashi, Y, Eggermont, J, Zhang, Y, Campos, CA, Cho, YK, Liu, SN, Dijkstra, J (Jouke), Reiber, JHC (Johan), Perkins, L, Sheehy, A, Veldhof, S, Rapoza, R, Es, Gerrit-anne, Garcia Garcia, Hector, van Geuns, Robert Jan, Serruys, PWJC (Patrick), Cardiology, and Surgery
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Background: Quantitative light intensity analysis of the strut core by optical coherence tomography (OCT) may enable assessment of changes in the light reflectivity of the bioresorbable polymeric scaffold from polymer to provisional matrix and connective tissues, with full disappearance and integration of the scaffold into the vessel wall. The aim of this report was to describe the methodology and to apply it to serial human OCT images post procedure and at 6, 12, 24 and 36 months in the ABSORB cohort B trial. Methods and Results: In serial frequency-domain OCT pullbacks, corresponding struts at different time points were identified by 3-dimensional foldout view. The peak and median values of light intensity were measured in the strut core by dedicated software. A total of 303 corresponding struts were serially analyzed at 3 time points. In the sequential analysis, peak light intensity increased gradually in the first 24 months after implantation and reached a plateau (relative difference with respect to baseline [% Dif]: 61.4% at 12 months, 115.0% at 24 months, 110.7% at 36 months), while the median intensity kept increasing at 36 months (% Dif: 14.3% at 12 months, 75.0% at 24 months, 93.1% at 36 months). Conclusions: Quantitative light intensity analysis by OCT was capable of detecting subtle changes in the bioresorbable strut appearance over time, and could be used to monitor the bioresorption and integration process of polylactide struts.
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- 2014
11. Echogenicity as a surrogate for bioresorbable everolimus-eluting scaffold degradation: analysis at 1-, 3-, 6-, 12- 18, 24-, 30-, 36- and 42-month follow-up in a porcine model
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Campos, C.A.M. (Carlos), Ishibashi, Y. (Yuki), Eggermont, J. (Jeroen), Nakatani, T. (Tomoya), Cho, Y.-K. (Yun-Kyeong), Dijkstra, J. (Jouke), Reiber, J.H.C. (Johan), Sheehy, A. (Alexander), Lane, J. (Jennifer), Kamberi, M. (Marika), Rapoza, R. (Richard), Perkins, L. (Laura), Garcia-Garcia, H.M. (Hector), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Campos, C.A.M. (Carlos), Ishibashi, Y. (Yuki), Eggermont, J. (Jeroen), Nakatani, T. (Tomoya), Cho, Y.-K. (Yun-Kyeong), Dijkstra, J. (Jouke), Reiber, J.H.C. (Johan), Sheehy, A. (Alexander), Lane, J. (Jennifer), Kamberi, M. (Marika), Rapoza, R. (Richard), Perkins, L. (Laura), Garcia-Garcia, H.M. (Hector), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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The objective of the study is to validate intravascular quantitative echogenicity as a surrogate for molecular weight assessment of poly-l-lactide-acid (PLLA) bioresorbable scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California). We analyzed at 9 time points (from 1- to 42-month follow-up) a population of 40 pigs that received 97 Absorb scaffolds. The treated regions were analyzed by echogenicity using adventitia as reference, and were categorized as more (hyperechogenic or upperechogenic) or less bright (hypoechogenic) than the reference. The volumes of echogenicity categories were correlated with the measurements of molecular weight (Mw) by gel permeation chromatography. Scaffold struts appeared as high echogenic structures. The quantification of grey level intensity in the scaffold-vessel compartment had strong correlation with the scaffold Mw: hyperechogenicity (correlation coefficient = 0.75; P < 0.01), upperechogenicity (correlation coefficient = 0.63; P < 0.01) and hyper + upperechogenicity (correlation coefficient = 0.78; P < 0.01). In the linear regression, the R2 for high echogenicity and Mw was 0.57 for the combination of hyper and upper echogenicity. IVUS high intensity grey level quantification is correlated to Absorb BVS residual molecular weight and can be used as a surrogate for the monitoring of the degradation of semi-crystalline polymers scaffolds.
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- 2015
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12. Echogenicity as a surrogate for bioresorbable everolimus-eluting scaffold degradation: analysis at 1-, 3-, 6-, 12-18, 24-, 30-, 36-and 42-month follow-up in a porcine model
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Campos, CA, Ishibashi, Y, Eggermont, J, Nakatani, S, Cho, YK, Dijkstra, J (Jouke), Reiber, JHC (Johan), Sheehy, A, Lane, J, Kamberi, M, Rapoza, R, Perkins, L, Garcia Garcia, Hector, Onuma, Yoshinobu, Serruys, PWJC (Patrick), Campos, CA, Ishibashi, Y, Eggermont, J, Nakatani, S, Cho, YK, Dijkstra, J (Jouke), Reiber, JHC (Johan), Sheehy, A, Lane, J, Kamberi, M, Rapoza, R, Perkins, L, Garcia Garcia, Hector, Onuma, Yoshinobu, and Serruys, PWJC (Patrick)
- Abstract
The objective of the study is to validate intravascular quantitative echogenicity as a surrogate for molecular weight assessment of poly-l-lactide-acid (PLLA) bioresorbable scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California). We analyzed at 9 time points (from 1- to 42-month follow-up) a population of 40 pigs that received 97 Absorb scaffolds. The treated regions were analyzed by echogenicity using adventitia as reference, and were categorized as more (hyperechogenic or upperechogenic) or less bright (hypoechogenic) than the reference. The volumes of echogenicity categories were correlated with the measurements of molecular weight (Mw) by gel permeation chromatography. Scaffold struts appeared as high echogenic structures. The quantification of grey level intensity in the scaffold-vessel compartment had strong correlation with the scaffold Mw: hyperechogenicity (correlation coefficient = 0.75; P < 0.01), upperechogenicity (correlation coefficient = 0.63; P < 0.01) and hyper + upperechogenicity (correlation coefficient = 0.78; P < 0.01). In the linear regression, the R-2 for high echogenicity and Mw was 0.57 for the combination of hyper and upper echogenicity. IVUS high intensity grey level quantification is correlated to Absorb BVS residual molecular weight and can be used as a surrogate for the monitoring of the degradation of semi-crystalline polymers scaffolds.
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- 2015
13. The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: Insights from the first-in-man ABSORB Cohort B and SPIRIT II trials
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Gogas, B.D. (Bill), Bourantas, C.V. (Christos), Garcia-Garcia, H.M. (Hector), Onuma, Y. (Yoshinobu), Muramatsu, T. (Takashi), Farooq, V. (Vasim), Diletti, R. (Roberto), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Chevalier, B. (Bernard), Thuesen, L. (Leif), Smits, P.C. (Pieter), Dudek, D. (Dariusz), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), McClean, D. (Dougal), Dorange, C. (Cecile), Miquel-Hébert, K. (Karine), Veldhof, S. (Susan), Rapoza, R. (Richard), Ormiston, J.A. (John), Serruys, P.W.J.C. (Patrick), Gogas, B.D. (Bill), Bourantas, C.V. (Christos), Garcia-Garcia, H.M. (Hector), Onuma, Y. (Yoshinobu), Muramatsu, T. (Takashi), Farooq, V. (Vasim), Diletti, R. (Roberto), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Chevalier, B. (Bernard), Thuesen, L. (Leif), Smits, P.C. (Pieter), Dudek, D. (Dariusz), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), McClean, D. (Dougal), Dorange, C. (Cecile), Miquel-Hébert, K. (Karine), Veldhof, S. (Susan), Rapoza, R. (Richard), Ormiston, J.A. (John), and Serruys, P.W.J.C. (Patrick)
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Aims: To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES). Methods and results: Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive re
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- 2013
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14. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm.
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Serruys P.W., Diletti R., Onuma Y., Farooq V., Gomez-Lara J., Brugaletta S., Van Geuns R.J., Regar E., De Bruyne B., Dudek D., Thuesen L., Chevalier B., McClean D., Windecker S., Whitbourn R., Smits P., Koolen J., Meredith I., Li D., Garcia-Garcia H.M., Ormiston J.A., Veldhof S., Rapoza R., Serruys P.W., Diletti R., Onuma Y., Farooq V., Gomez-Lara J., Brugaletta S., Van Geuns R.J., Regar E., De Bruyne B., Dudek D., Thuesen L., Chevalier B., McClean D., Windecker S., Whitbourn R., Smits P., Koolen J., Meredith I., Li D., Garcia-Garcia H.M., Ormiston J.A., Veldhof S., and Rapoza R.
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Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background(s): BVS are a novel approach to treating coronary lesions and are untested in small vessels. Method(s): The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Result(s): At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 +/- 0.18 mm vs. 0.21 +/- 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 +/- 6.0% vs. 19.8 +/- 8.5%; p = 0.3643). Conclusion(s): The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels. © 2011 American College of Cardiology Foundation.
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- 2012
15. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold
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Brugaletta, S. (Salvatore), Gomez-Lara, J. (Josep), Garcia-Garcia, H.M. (Hector), Heo, J.H. (Jungho), Farooq, V. (Vasim), Geuns, R.J.M. (Robert Jan) van, Chevalier, B. (Bernard), Windecker, S.W. (Stephan), McClean, D. (Dougal), Thuesen, L. (Leif), Whitbourn, R. (Robert), Meredith, I. (Ian), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Ormiston, J.A. (John), Serruys, P.W.J.C. (Patrick), Brugaletta, S. (Salvatore), Gomez-Lara, J. (Josep), Garcia-Garcia, H.M. (Hector), Heo, J.H. (Jungho), Farooq, V. (Vasim), Geuns, R.J.M. (Robert Jan) van, Chevalier, B. (Bernard), Windecker, S.W. (Stephan), McClean, D. (Dougal), Thuesen, L. (Leif), Whitbourn, R. (Robert), Meredith, I. (Ian), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Ormiston, J.A. (John), and Serruys, P.W.J.C. (Patrick)
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Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately po
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- 2012
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16. In vivo visualisation by three-dimensional optical coherence tomography of stress crazing of a bioresorbable vascular scaffold implanted for treatment of human coronary stenosis
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Radu, M. (Maria), Onuma, Y. (Yoshinobu), Rapoza, R. (Richard), Diletti, R. (Roberto), Serruys, P.W.J.C. (Patrick), Radu, M. (Maria), Onuma, Y. (Yoshinobu), Rapoza, R. (Richard), Diletti, R. (Roberto), and Serruys, P.W.J.C. (Patrick)
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- 2012
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17. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold
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Gutiérrez-Chico, J.L., Radu, M. (Maria), Diletti, R. (Roberto), Sheehy, A. (Alexander), Kossuth, M.B. (Mary Beth), Oberhauser, J.P. (James), Glauser, T. (Thierry), Harrington, R.A. (Robert Alex), Rapoza, R. (Richard), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Gutiérrez-Chico, J.L., Radu, M. (Maria), Diletti, R. (Roberto), Sheehy, A. (Alexander), Kossuth, M.B. (Mary Beth), Oberhauser, J.P. (James), Glauser, T. (Thierry), Harrington, R.A. (Robert Alex), Rapoza, R. (Richard), Onuma, Y. (Yoshinobu), and Serruys, P.W.J.C. (Patrick)
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Background: Scattering centers (SC) are often observed with optical coherence tomography (OCT) in some struts of bioresorbable vascular scaffolds (BVS). These SC might be caused by crazes in the polymer during crimpdeployment (more frequent at inflection points) or by other processes, such as physiological loading or hydrolysis (eventually increasing with time). The spatial distribution and temporal evolution of SC in BVS might help to understand their meaning. Methods and Results: Three patients were randomly selected from 12 imaged with Fourier-domain OCT at both baseline and 6 months in the ABSORB cohort B study (NCT00856856). Frame-by-frame analysis of the SC distribution was performed using spread-out vessel charts, and the results from baseline and 6 months were compared. A total of 4,328 struts were analyzed. At baseline and follow-up all SC appeared at inflection points. No significant difference was observed between baseline and 6 months in the number of SC struts (14.9 vs. 14.5%, P=0.754) or in the distribution of SC. The proportion and distribution of SC did not vary substantially among the patients analyzed. Conclusions: The SC observed in OCT imaging of the BVS are located exclusively at inflection points and do not increase with time. These findings strongly suggest that SC are caused by crazes in the polymer during crimp-deployment, ruling out any major role of hydrolysis or other time-dependent processes.
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- 2012
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18. Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: An ABSORB cohort B trial sub-study
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Gomez-Lara, J. (Josep), Diletti, R. (Roberto), Brugaletta, S. (Salvatore), Onuma, Y. (Yoshinobu), Farooq, V. (Vasim), Thuesen, L. (Leif), McClean, D. (Dougal), Koolen, J.J. (Jacques), Ormiston, J.A. (John), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Dudek, D. (Dariusz), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Regar, E.S. (Eveline), Garcia-Garcia, H.M. (Hector), Serruys, P.W.J.C. (Patrick), Gomez-Lara, J. (Josep), Diletti, R. (Roberto), Brugaletta, S. (Salvatore), Onuma, Y. (Yoshinobu), Farooq, V. (Vasim), Thuesen, L. (Leif), McClean, D. (Dougal), Koolen, J.J. (Jacques), Ormiston, J.A. (John), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Dudek, D. (Dariusz), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Regar, E.S. (Eveline), Garcia-Garcia, H.M. (Hector), and Serruys, P.W.J.C. (Patrick)
- Abstract
Aims: Bioresorbable vascular scaffolds (BVS) present different mechanical properties as compared to metallic platform stents. Therefore, the sta
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- 2012
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19. Vascular compliance changes of the coronary vessel wall after bioresorbable vascular scaffold implantation in the treated and adjacent segments
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Brugaletta, S. (Salvatore), Gogas, B.D. (Bill), Garcia-Garcia, H.M. (Hector), Farooq, V. (Vasim), Girasis, C. (Chrysafios), Heo, J.H. (Jungho), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Dudek, D. (Dariusz), Koolen, J.J. (Jacques), Smits, P.C. (Pieter), Veldhof, S. (Susan), Rapoza, R. (Richard), Onuma, Y. (Yoshinobu), Ormiston, J.A. (John), Serruys, P.W.J.C. (Patrick), Brugaletta, S. (Salvatore), Gogas, B.D. (Bill), Garcia-Garcia, H.M. (Hector), Farooq, V. (Vasim), Girasis, C. (Chrysafios), Heo, J.H. (Jungho), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Dudek, D. (Dariusz), Koolen, J.J. (Jacques), Smits, P.C. (Pieter), Veldhof, S. (Susan), Rapoza, R. (Richard), Onuma, Y. (Yoshinobu), Ormiston, J.A. (John), and Serruys, P.W.J.C. (Patrick)
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Background: Implantation of a metallic prosthesis creates local stiffness with a subsequent mismatch in the compliance of the vessel wall, disturbances in flow and heterogeneous distribution of wall shear stress. Polymeric bioresorbable ABSORB scaffolds have less stiffness than metallic platform stents. We sought to analyze the mismatch in vascular compliance after ABSORB implantation and its long-term resolution with bioresorption. Methods and Results: A total of 83 patients from the ABSORB trials underwent palpography investigations (30 and 53 patients from ABSORB Cohorts A and B, respectively) to measure the compliance of the scaffolded and adjacent segments at various time points (from pre-implantation up to 24 months). The mean of the maximum strain values was calculated per segment by utilizing the Rotterdam Classification (ROC) score and expressed as ROC/ mm. Scaffold implantation lead to a significant decrease in vascular compliance (median [IQR]) at the scaffolded segment (from 0.37 [0.24-0.45] to 0.14 [0.09-0.23], P<0.001) with mismatch in compliance in a paired analysis between the scaffolded and adjacent segments (proximal: 0.23 [0.12-0.34], scaffold: 0.12 [0.07-0.19], distal: 0.15 [0.05-0.26], P=0.042). This reported compliance mismatch disappears at short- and mid-term follow-up. Conclusions: The ABSORB scaffold decreases vascular compliance at the site of scaffold implantation. A compliance mismatch is evident immediately post-implantation and in contrast to metallic stents disappears in the mid-term, likely leading to a normalization of the rheological behavior of the scaffolded segment.
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- 2012
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20. Head to head comparison of optical coherence tomography, intravascular ultrasound echogenicity and virtual histology for the detection of changes in polymeric struts over time: Insights from the ABSORB trial
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Brugaletta, S. (Salvatore), Gomez-Lara, J. (Josep), Bruining, N. (Nico), Radu, M. (Maria), Geuns, R.J.M. (Robert Jan) van, Thuesen, L. (Leif), McClean, D. (Dougal), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Oberhauser, J.P. (James), Rapoza, R. (Richard), Ormiston, J.A. (John), Garcia-Garcia, H.M. (Hector), Serruys, P.W.J.C. (Patrick), Brugaletta, S. (Salvatore), Gomez-Lara, J. (Josep), Bruining, N. (Nico), Radu, M. (Maria), Geuns, R.J.M. (Robert Jan) van, Thuesen, L. (Leif), McClean, D. (Dougal), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Oberhauser, J.P. (James), Rapoza, R. (Richard), Ormiston, J.A. (John), Garcia-Garcia, H.M. (Hector), and Serruys, P.W.J.C. (Patrick)
- Abstract
Aims: To analyse and to compare the changes in the various optical coherence tomography (OCT), echogenicity and intravascular ultrasound virtual histology (VH) of the everolimus-eluting bioresorbable scaffold (ABSORB) degradation parameters during the first 12 months after ABSORB implantation. In the ABSORB study, changes in the appearance
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- 2012
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21. Analysis of 1 year virtual histology changes in coronary plaque located behind the struts of the everolimus eluting bioresorbable vascular scaffold
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Brugaletta, S, Gomez-Lara, J, Garcia-Garcia, HM, Heo, JH, Farooq, V, van Geuns, RJ, Chevalier, B, Windecker, S, McClean, D, Thuesen, L, Whitbourn, R, Meredith, I, Dorange, C, Veldhof, S, Rapoza, R, Ormiston, JA, Serruys, PW, Brugaletta, S, Gomez-Lara, J, Garcia-Garcia, HM, Heo, JH, Farooq, V, van Geuns, RJ, Chevalier, B, Windecker, S, McClean, D, Thuesen, L, Whitbourn, R, Meredith, I, Dorange, C, Veldhof, S, Rapoza, R, Ormiston, JA, and Serruys, PW
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Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately post-ABSORB implantation and at 12 month follow-up. Paired IVUS-VH data, recorded with s5i system, were available in 17 patients (18 lesions). The analysis demonstrated an increase in mean PBS area (2.39 ± 1.85 mm(2) vs. 2.76 ± 1.79 mm(2), P = 0.078) and a reduction in the mean lumen area (6.37 ± 0.90 mm(2) vs. 5.98 ± 0.97 mm(2), P = 0.006). Conversely, a significant decrease of 16 and 30% in necrotic core (NC) and dense calcium (DC) content, respectively, were evident (median % NC from 43.24 to 36.06%, P = 0.016; median % DC from 20.28 to 11.36%, P = 0.002). Serial IVUS-VH analyses of plaque located behind the ABSORB struts at 12-month demonstrated an increase in plaque area with a decrease in its NC and DC content. Larger studies are required to investigate the clinical impact of these findings.
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- 2012
22. Bioresorbable Everolimus Eluting Vascular Scaffold in small vessels one year results.
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Serruys P., Li D., Veldhof S., Rapoza R., Ormiston J.A., Meredith I., Diletti R., Garcia-Garcia H.M., Farooq V., Onuma Y., Brugaletta S., Van Geuns R.J., Regar E., De Bruyne B., Dudek D., Thuesen L., Chevalier B., McClean D., Windecker S., Whitbourn R., Smits P., Koolen J., Li X., Serruys P., Li D., Veldhof S., Rapoza R., Ormiston J.A., Meredith I., Diletti R., Garcia-Garcia H.M., Farooq V., Onuma Y., Brugaletta S., Van Geuns R.J., Regar E., De Bruyne B., Dudek D., Thuesen L., Chevalier B., McClean D., Windecker S., Whitbourn R., Smits P., Koolen J., and Li X.
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Background: The second generation Bioresorbable Everolimus Eluting Vascular Scaffolds (BVS) are untested at the mid-term follow-up in the subset of small coronary vessels. We investigated the performance of the second generation BVS (Abbott Vascular, Santa Clara, CA) in small coronary arteries (<2.5mm) at 1-year follow-up Methods: The ABSORB Cohort B Trial is a multicentre single-arm, prospective, open-label trial enrolling 101 patients. In the present post-hoc analysis, the study population was sorted according to the pre-procedural reference vessel diameter (RVD) into two groups: 1) Small-vessel group with RVD <2.5mm (41 patients, 41 lesions) and 2) Large-vessel group with RVD >=2.5 mm (60 patients, 61 lesions). Clinical outcomes were assessed at one-year follow-up for the entire population and compared between the two groups. Out of the total population 45 patients were assigned to undergo 6-month coronary angiography and 56 patients (57 lesions) to have the procedure performed at one year. Result(s): At one-year after implantation no differences in Ischemia-Driven (ID) Major Adverse Cardiovascular Events (small vessels 3/41 cases, 7.3% vs. large vessels 4/60 cases, 6.7%,p=1.0000), Myocardial Infarction (small vessels 2/41 cases, 4.9% vs large vessels 1/60 case, 1.7%,p=0.5645) and ID-Target Lesion Revascularization (small vessels 1/41 case, 2.4% vs large vessels 3/60 cases, 5.0%, p=0.6445) were reported between the two groups. No Cardiac Death was observed. At 1-year angiographic follow-up, no differences were showed in late lumen loss (small vessels 0.27+/-0.32mm vs. large vessels 0.27+/-0.32mm, p=0.9852) and In-Scaffold Binary Restenosis (small vessels 0/21 cases, 0.0% vs large vessels 2/36 cases, 5.6% p=0.5263). Conclusion(s): The second generation BVS showed similar clinical and angiographic outcomes at 1-year follow-up in small and large vessels.
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- 2011
23. Comparison between the first and second generation bioresorbable vascular scaffolds: A six month virtual histology study
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Brugaletta, S. (Salvatore), Garcia-Garcia, H.M. (Hector), Diletti, R. (Roberto), Gomez-Lara, J. (Josep), Garg, S.A. (Scot), Onuma, Y. (Yoshinobu), Shin, E.S. (Eun-Seok), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Dudek, D. (Dariusz), Thuesen, L. (Leif), Chevalier, B. (Bernard), McClean, D. (Dougal), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Sudhir, K. (Krishnankutty), Bruining, N. (Nico), Ormiston, J.A. (John), Serruys, P.W.J.C. (Patrick), Brugaletta, S. (Salvatore), Garcia-Garcia, H.M. (Hector), Diletti, R. (Roberto), Gomez-Lara, J. (Josep), Garg, S.A. (Scot), Onuma, Y. (Yoshinobu), Shin, E.S. (Eun-Seok), Geuns, R.J.M. (Robert Jan) van, Bruyne, B. (Bernard) de, Dudek, D. (Dariusz), Thuesen, L. (Leif), Chevalier, B. (Bernard), McClean, D. (Dougal), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Dorange, C. (Cecile), Veldhof, S. (Susan), Rapoza, R. (Richard), Sudhir, K. (Krishnankutty), Bruining, N. (Nico), Ormiston, J.A. (John), and Serruys, P.W.J.C. (Patrick)
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Aims: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). Methods and results: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10±0.46mm 2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57±1.3 mm 2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external el
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- 2011
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24. Optical coherence tomography (OCT) of overlapping bioresorbable scaffolds: From benchwork to clinical application
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Farooq, V. (Vasim), Onuma, Y. (Yoshinobu), Radu, M. (Maria), Okamura, T. (Takayuki), Gomez-Lara, J. (Josep), Brugaletta, S. (Salvatore), Gogas, B.D. (Bill), Geuns, R.J.M. (Robert Jan) van, Regar, E.S. (Eveline), Schultz, C.J. (Carl), Windecker, S.W. (Stephan), Lefèvre, T. (Thierry), Brueren, B.R.G. (B.R. Guus), Powers, J.C. (Jennifer C.), Perkins, L. (Laura), Rapoza, R. (Richard), Virmani, R. (Renu), Garcia-Garcia, H.M. (Hector), Serruys, P.W.J.C. (Patrick), Farooq, V. (Vasim), Onuma, Y. (Yoshinobu), Radu, M. (Maria), Okamura, T. (Takayuki), Gomez-Lara, J. (Josep), Brugaletta, S. (Salvatore), Gogas, B.D. (Bill), Geuns, R.J.M. (Robert Jan) van, Regar, E.S. (Eveline), Schultz, C.J. (Carl), Windecker, S.W. (Stephan), Lefèvre, T. (Thierry), Brueren, B.R.G. (B.R. Guus), Powers, J.C. (Jennifer C.), Perkins, L. (Laura), Rapoza, R. (Richard), Virmani, R. (Renu), Garcia-Garcia, H.M. (Hector), and Serruys, P.W.J.C. (Patrick)
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- 2011
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25. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: An attempt to decipher the human optical coherence tomography images in the ABSORB trial
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Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Perkins, L.E.L. (Laura), Okamura, T. (Takayuki), Gonzalo, N. (Nieves), Garcia-Garcia, H.M. (Hector), Regar, E.S. (Eveline), Kamberi, M. (Marika), Powers, J.C. (Jennifer C.), Rapoza, R. (Richard), Beusekom, H.M.M. (Heleen) van, Giessen, W.J. (Wim) van der, Virmani, R. (Renu), Onuma, Y. (Yoshinobu), Serruys, P.W.J.C. (Patrick), Perkins, L.E.L. (Laura), Okamura, T. (Takayuki), Gonzalo, N. (Nieves), Garcia-Garcia, H.M. (Hector), Regar, E.S. (Eveline), Kamberi, M. (Marika), Powers, J.C. (Jennifer C.), Rapoza, R. (Richard), Beusekom, H.M.M. (Heleen) van, Giessen, W.J. (Wim) van der, and Virmani, R. (Renu)
- Abstract
Background-: With the use of optical coherence tomography (OCT), alterations of the reflectance characteristics of everolimus-eluting bioresorbable vascular scaffold (BVS) struts have been reported in humans. In the absence of histology, the interpretation of the appearances of the struts by OCT remains speculative. We therefore report OCT findings with corresponding histology in the porcine coronary artery model immediately after and at 28 days and 2, 3, and 4 years after BVS implantation. Methods and results-: Thirty-five polymeric BVS (3.0×12.0 mm) were singly implanted in the main coronary arteries of 17 pigs that underwent OCT and were then euthanized immediately (n=2), at 28 days (n=2), at 2 years (n=3), at 3 years (n=5), or at 4 years (n=5) after implantation. All BVS-implanted arteries in these animals were evaluated by histology except for 5 arteries examined at 2 years with gel permeation chromatography to assess the biodegradation of the polymeric device. Fourteen arteries with BVS from an additional 6 pigs were examined by gel permeation chromatography at 1 (n=1), 1.5 (n=2), and 3 (n=2) years. Corresponding OCT and histology images w
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- 2010
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26. In vivo evaluation of stent strut distribution patterns in the bioabsorbable everolimus-eluting device: An OCT ad hoc analysis of the revision 1.0 and revision 1.1 stent design in the ABSORB clinical trial
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Okamura, T. (Takayuki), Garg, S.A. (Scot), Gutiérrez-Chico, J.L., Shin, E.S. (Eun-Seok), Onuma, Y. (Yoshinobu), Garcia-Garcia, H.M. (Hector), Rapoza, R. (Richard), Sudhir, K. (Krishnankutty), Regar, E.S. (Eveline), Serruys, P.W.J.C. (Patrick), Okamura, T. (Takayuki), Garg, S.A. (Scot), Gutiérrez-Chico, J.L., Shin, E.S. (Eun-Seok), Onuma, Y. (Yoshinobu), Garcia-Garcia, H.M. (Hector), Rapoza, R. (Richard), Sudhir, K. (Krishnankutty), Regar, E.S. (Eveline), and Serruys, P.W.J.C. (Patrick)
- Abstract
Aims: The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs. Methods and results: OCT analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frame-by-frame analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with ≥3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively. Conclusions: This ad hoc analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.
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- 2010
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27. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: Six-month clinical and imaging outcomes
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Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), Ormiston, J.A. (John), Bruyne, B. (Bernard) de, Regar, E.S. (Eveline), Dudek, D. (Dariusz), Thuesen, L. (Leif), Smits, P.C. (Pieter), Chevalier, B. (Bernard), McClean, D. (Dougal), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Meredith, I. (Ian), Dorange, C. (Cecile), Veldhof, S. (Susan), Miquel-Hébert, K. (Karine), Rapoza, R. (Richard), Garcia-Garcia, H.M. (Hector), Serruys, P.W.J.C. (Patrick), Onuma, Y. (Yoshinobu), Ormiston, J.A. (John), Bruyne, B. (Bernard) de, Regar, E.S. (Eveline), Dudek, D. (Dariusz), Thuesen, L. (Leif), Smits, P.C. (Pieter), Chevalier, B. (Bernard), McClean, D. (Dougal), Koolen, J.J. (Jacques), Windecker, S.W. (Stephan), Whitbourn, R. (Robert), Meredith, I. (Ian), Dorange, C. (Cecile), Veldhof, S. (Susan), Miquel-Hébert, K. (Karine), Rapoza, R. (Richard), and Garcia-Garcia, H.M. (Hector)
- Abstract
Background-: The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified. Methods and results-: Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5
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- 2010
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28. A comparative assessment by optical coherence tomography of the performance of the first and second generation of the everolimus-eluting bioresorbable vascular scaffolds
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Gomez-Lara, J., primary, Brugaletta, S., additional, Diletti, R., additional, Garg, S., additional, Onuma, Y., additional, Gogas, B. D., additional, van Geuns, R. J., additional, Dorange, C., additional, Veldhof, S., additional, Rapoza, R., additional, Whitbourn, R., additional, Windecker, S., additional, Garcia-Garcia, H. M., additional, Regar, E., additional, and Serruys, P. W., additional
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- 2010
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29. Insulin Resistance, Determined with the Euglycemic Hyperinsulinemic Clamp, is Present Throughout the Newborn Period in the Lamb • 1518
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Gelardi, N L, primary, Rapoza, R E, additional, and Cowett, R M, additional
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- 1998
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30. Sympathomimetics As Contra-Insulin Hormones in Neonatal Hyperinsulinemic Hypoglycemia. † 1365
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Cowett, R. M., primary, Rapoza, R. E., additional, Jawad, G., additional, and Gelardi, N. L., additional
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- 1997
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31. Cortisol Is Ineffective as a Contra-Insulin Hormone In Neonatal Hyperinsulinemic Hypoglycemia. † 1366
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Cowett, R. M., primary, Rapoza, R. E., additional, Jawad, G., additional, and Gelardi, N. L., additional
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- 1997
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32. Persistent glucose production and greater peripheral sensitivity to insulin in the neonate vs. the adult
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Farrag, H. M., primary, Nawrath, L. M., additional, Healey, J. E., additional, Dorcus, E. J., additional, Rapoza, R. E., additional, Oh, W., additional, and Cowett, R. M., additional
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- 1997
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33. ABSORB II randomized controlled trial: A clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the...
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Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, and Chevalier B
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- 2012
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34. Evaluation with in vivo optical coherence tomography and histology of the vascular effects of the everolimus-eluting bioresorbable vascular scaffold at two years following implantation in a healthy porcine coronary artery model: implications of pilot results for future pre-clinical studies.
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Gogas BD, Radu M, Onuma Y, Perkins L, Powers JC, Gomez-Lara J, Farooq V, Garcia-Garcia HM, Diletti R, Rapoza R, Virmani R, Serruys PW, Gogas, Bill D, Radu, Maria, Onuma, Yoshinobu, Perkins, Laura, Powers, Jennifer C, Gomez-Lara, Josep, Farooq, Vasim, and Garcia-Garcia, Hector M
- Abstract
To quantify with in vivo OCT and histology, the device/vessel interaction after implantation of the bioresorbable vascular scaffold (BVS). We evaluated the area and thickness of the strut voids previously occupied by the polymeric struts, and the neointimal hyperplasia (NIH) area covering the endoluminal surface of the strut voids (NIH(EV)), as well as the NIH area occupying the space between the strut voids (NIH(BV)), in healthy porcine coronary arteries at 2, 3 and 4 years after implantation of the device. Twenty-two polymeric BVS were implanted in the coronary arteries of 11 healthy Yucatan minipigs that underwent OCT at 2, 3 and 4 years after implantation, immediately followed by euthanasia. The areas and thicknesses of 60 corresponding strut voids previously occupied by the polymeric struts and the size of 60 corresponding NIH(EV) and 49 NIH(BV) were evaluated with both OCT and histology by 2 independent observers, using a single quantitative analysis software for both techniques. At 3 and 4 years after implantation, the strut voids were no longer detectable by OCT or histology due to complete polymer resorption. However, analysis performed at 2 years still provided clear delineation of these structures, by both techniques. The median [ranges] areas of these strut voids were 0.04 [0.03-0.16] and 0.02 [0.01-0.07] mm(2) by histology and OCT, respectively. The mean (±SD) thickness by histology and OCT was 220 ± 40 and 120 ± 20 μm, respectively. The median [ranges] NIH(EV) by histology and OCT was 0.07 [0.04-0.20] and 0.03 [0.01-0.08] mm(2), while the mean (±SD) NIH(BV) by histology and OCT was 0.13 ± 0.07 and 0.10 ± 0.06 mm(2). Our study indicates that in vivo OCT of the BVS provides correlated measurements of the same order of magnitude as histomorphometry, and is reproducible for the evaluation of certain vascular and device-related characteristics. However, histology systematically gives larger values for all the measured structures compared to OCT, at 2 years post implantation. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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35. Intracoronary optical coherence tomography and histology at 1 month and 2, 3, and 4 years after implantation of everolimus-eluting bioresorbable vascular scaffolds in a porcine coronary artery model: an attempt to decipher the human optical coherence tomography images in the ABSORB trial.
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Onuma Y, Serruys PW, Perkins LE, Okamura T, Gonzalo N, García-García HM, Regar E, Kamberi M, Powers JC, Rapoza R, van Beusekom H, van der Giessen W, and Virmani R
- Published
- 2010
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36. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes.
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Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, García-García HM, and Serruys, Patrick W
- Published
- 2010
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37. A preclinical safety study of injection number and volume delivered using the Stiletto Endocardial Direct Injection Catheter System
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Epstein, S., Naimark, W., Rapoza, R., Ullery, S., Donskoy, E., and Palasis, M.
- Published
- 2006
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38. Increased risks of Maternal Mental Health Conditions Following the COVID-19 Pandemic.
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Zhou A, Zetterman A, Ott M, Freel C, Adams K, Rodriguez-Dasta A, Rapoza R, Drakowski R, Sweeney S, Freeman A, VanOrmer M, Thoene M, Lyden E, Adams CR, Pendyala G, Hanson C, Blount AJ, and Anderson-Berry A
- Abstract
Background: Women are at an increased risk of developing psychiatric conditions such as anxiety and depression during pregnancy. Psychiatric conditions during pregnancy can put mothers and fetuses at risk of worse physical and mental health before, during, and after the completion of a pregnancy. Previous research indicates that women pregnant during COVID-19 were at a greater risk of developing mental health conditions and being exposed to stressors. While most of the research in the field focuses solely on maternal mental health or interactions between stressors and maternal mental health, little research has been done comparing maternal mental health, demographic variables, and socioeconomic variables across pre-, during-, and post-COVID-19 time periods., Methods: We conducted an observational cohort study of 703 mothers divided into pre-, during-, and post-COVID-19 groups based on time of enrollment., Results: Rates of maternal anxiety ( p < 0.001), medication use for anxiety ( p < 0.001), depression ( p < 0.001), medication use for depression ( p < 0.001), history of postpartum depression ( p < 0.001), and medication use for other psychiatric conditions ( p < 0.001) significantly increased during COVID-19 and remained at elevated levels post-COVID-19 compared with pre-COVID-19. Income >150% of the poverty level ( p = 0.003), food security level ( p = 0.010), marital status ( p = 0.001), and private insurance type ( p < 0.001) were significantly increased during COVID-19 compared with pre-COVID-19 levels., Conclusions: Future work should focus on stratifying the effects of the COVID-19 pandemic on maternal mental health by race and ethnicity and establishing guidelines to support maternal mental health during epidemics and pandemics., (© The Author(s) 2024. Published by Mary Ann Liebert, Inc.)
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- 2024
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39. Bioactive metabolites of OMEGA-6 and OMEGA-3 fatty acids are associated with inflammatory cytokine concentrations in maternal and infant plasma at the time of delivery.
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Slotkowski R, VanOrmer M, Akbar A, Hahka T, Thompson M, Rapoza R, Ulu A, Thoene M, Lyden E, Mukherjee M, Yuil-Valdes A, Natarajan SK, Nordgren T, Hanson C, and Berry AA
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- Infant, Pregnancy, Adult, Female, Infant, Newborn, Humans, Cytokines, Fatty Acids, Omega-6, Inflammation, Biomarkers, Fatty Acids, Omega-3, Premature Birth
- Abstract
Background & Aims: Inflammation is necessary for a healthy pregnancy. However, unregulated or excessive inflammation during pregnancy is associated with severe maternal and infant morbidities, such as pre-eclampsia, abnormal infant neurodevelopment, or preterm birth. Inflammation is regulated in part by the bioactive metabolites of omega-6 (n-6) and omega-3 (n-3) fatty acids (FAs). N-6 FAs have been shown to promote pro-inflammatory cytokine environments in adults, while n-3 FAs have been shown to contribute to the resolution of inflammation; however, how these metabolites affect maternal and infant inflammation is still uncertain. The objective of this study was to predict the influence of n-6 and n-3 FA metabolites on inflammatory biomarkers in maternal and umbilical cord plasma at the time of delivery., Methods: Inflammatory biomarkers (IL-1β, IL-2, IL-6, IL-8, IL-10, and TNFα) for maternal and umbilical cord plasma samples in 39 maternal-infant dyads were analyzed via multi-analyte bead array. Metabolites of n-6 FAs (arachidonic acid and linoleic acid) and n-3 FAs (eicosapentaenoic acid and docosahexaenoic acid) were assayed via liquid chromatography-mass spectrometry. Linear regression models assessed relationships between maternal and infant inflammatory markers and metabolite plasma concentrations., Results: Increased plasma concentrations of maternal n-6 metabolites were predictive of elevated pro-inflammatory cytokine concentrations in mothers; similarly, higher plasma concentrations of umbilical cord n-6 FA metabolites were predictive of elevated pro-inflammatory cytokine concentrations in infants. Higher plasma concentrations of maternal n-6 FA metabolites were also predictive of elevated pro-inflammatory cytokines in infants, suggesting that maternal n-6 FA status has an intergenerational impact on the inflammatory status of the infant. In contrast, maternal and cord plasma concentrations of n-3 FA metabolites had a mixed effect on inflammatory status in mothers and infants, which may be due to the inadequate maternal dietary intake of n-3 FAs in our study population., Conclusions: Our results reveal that maternal FA status may have an intergenerational impact on the inflammatory status of the infant. Additional research is needed to identify how dietary interventions that modify maternal FA intake prior to or during pregnancy may impact maternal and infant inflammatory status and associated long-term health outcomes., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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40. ISR vs De Novo Lesion Treatment During OCT-Guided PCI: Insights From the LightLab Initiative.
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Bergmark BA, Golomb M, Kuder JF, Buccola J, Wollmuth J, Lopez J, Rauch J, Chehab BM, Rapoza R, West NEJ, and Croce KJ
- Abstract
Background: Long-term outcomes after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) are poor, yet limited granular procedural data exist evaluating lesion assessment, vessel treatment, and acute procedural outcomes., Methods: The LightLab Initiative was a multicenter, prospective, observational study with contemporaneous procedural data collection during PCI procedures. Data were collected during PCIs performed by 48 interventional cardiologists at 17 US hospitals (2019-2021). Optical coherence tomography (OCT) was performed pre-PCI for lesion assessment and post-PCI for stent optimization, and results were compared between ISR and de novo lesion PCI., Results: In total, 2592 OCT-guided PCIs involving 2944 lesions were included, of which 458 procedures (17.7%) were ISR PCI. Compared with de novo lesion PCI, ISR lesions were more commonly type C (64.8% vs 52.9%) and performed via femoral artery access (46.4% vs 37.7%). Use of OCT changed operator assessment and treatment decisions more frequently in ISR PCI (94.2% vs 85.2%; P = .002). Scoring balloons (21.8% vs 2.5%), cutting balloons (16.4% vs 3.4%), and atherectomy (26.3% vs 9.9%) were used more commonly in ISR PCI (all P < .0001), and ISR PCI procedures were longer (62 vs 51 min). Moreover, the final achieved minimum stent area and percent expansion (4.4 vs 5.1 mm
2 and 80% vs 83%, respectively; both P < .0001) were lower in ISR PCI., Conclusions: In this real-world cohort of patients who underwent OCT-guided PCI, ISR procedures were longer and final minimum stent area and percent expansion were lower despite greater use of advanced lesion modification. OCT frequently altered physician decision making, emphasizing its utility in potentially reducing recurrent stent failure in this high-risk population., (© 2023 The Author(s).)- Published
- 2023
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41. Investigating real-world impact of optical coherence tomography workflow-guided coronary interventions: Design and rationale of the LightLab Clinical Initiative.
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Buccola J, Meinen J, Spinelli J, Hammerstone M, Rapoza R, and West NEJ
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- Humans, Tomography, Optical Coherence methods, Coronary Angiography adverse effects, Coronary Angiography methods, Prospective Studies, Workflow, Treatment Outcome, Stents, Coronary Vessels diagnostic imaging, Coronary Vessels pathology, Percutaneous Coronary Intervention, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease pathology
- Abstract
Objective: The LightLab Clinical Initiative was designed to examine adoption of optical coherence tomography (OCT) imaging during routine percutaneous coronary intervention (PCI) practice, and enable identification and reduction of barriers to broader adoption of intracoronary imaging in real-world practice., Background: Intracoronary imaging guidance during PCI has been shown to improve clinical outcomes and features as a recommendation in societal guidelines, yet widespread routine adoption remains low. Perceived barriers to utilization include familiarity with, and ability to interpret imaging, concerns over added procedure time and contrast load, alongside a lack of actionable outcome data., Methods and Results: LightLab was a multicenter prospective observational data-gathering project, conducted between January 2019, and June 2021, with 17 participating hospitals and physicians. Data were gathered in real-time, where OCT guidance was employed during PCI using a standardized OCT-guided workflow algorithm, MLD MAX (where MLD stands for plaque Morphology, lesion Length, vessel Diameter and MAX for Medial dissection, stent Apposition, stent eXpansion) which was developed to simplify and integrate information from OCT throughout the PCI procedure. Integration of this workflow/algorithm was implemented through a series of phases, focusing on physician decision-making, efficiency, and safety improvements during the procedure., Conclusions: Through real-time, prospective procedural data acquisition in the cardiac catheterization laboratory setting, the LightLab Clinical Initiative demonstrates the impact of a standardized OCT-guided workflow on procedural metrics, including time, contrast use, radiation exposure, as well as financial efficiencies such as device utilization. These results can potentially mitigate underlying concerns over the utility of adoption of intracoronary imaging guidance during PCI., (© 2022 Wiley Periodicals LLC.)
- Published
- 2022
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42. Very late vasomotor responses and gene expression with bioresorbable scaffolds and metallic drug-eluting stents.
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Koh JS, Gogas BD, Kumar S, Benham JJ, Sur S, Spilias N, Kumar A, Giddens DP, Rapoza R, Kereiakes DJ, Stone G, Jo H, and Samady H
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- Absorbable Implants, Animals, Everolimus, Gene Expression, Prosthesis Design, Stents, Swine, Treatment Outcome, Coronary Artery Disease, Drug-Eluting Stents, Percutaneous Coronary Intervention adverse effects
- Abstract
Objectives: To investigate the long-term vasomotor response and inflammatory changes in Absorb bioresorbable vascular scaffold (BVS) and metallic drug-eluting stent (DES) implanted artery., Background: Clinical evidence has demonstrated that compared to DES, BVS is associated with higher rates of target lesion failure. However, it is not known whether the higher event rates observed with BVS are related to endothelial dysfunction or inflammation associated with polymer degradation., Methods: Ten Absorb BVS and six Xience V DES were randomly implanted in the main coronaries of six nonatherosclerotic swine. At 4-years, vasomotor response was evaluated in vivo by quantitative coronary angiography response to intracoronary infusion of Ach and ex vivo by the biomechanical response to prostaglandin F2-α (PGF2-α), substance P and bradykinin and gene expression analysis., Results: Absorb BVS implanted arteries showed significantly restored vasoconstrictive responses after Ach compared to in-stent Xience V. The contractility of Absorb BVS treated segments induced by PGF2-α was significantly greater compared to Xience V treated segments and endothelial-dependent vasorelaxation was greater with Absorb BVS compared to Xience V. Gene expression analyses indicated the pro-inflammatory lymphotoxin-beta receptor (LTβR) signaling pathway was significantly upregulated in arteries treated with a metallic stent compared to Absorb BVS treated arterial segments., Conclusions: At 4 years, arteries treated with Absorb BVS compared with Xience V, demonstrate significantly greater restoration of vasomotor responses. Genetic analysis suggests mechanobiologic reparation of Absorb BVS treated arteries at 4 years as opposed to Xience V treated vessels., (© 2021 Wiley Periodicals LLC.)
- Published
- 2021
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43. Impact of Coronary Atherosclerosis on Bioresorbable Vascular Scaffold Resorption and Vessel Wall Integration.
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Cheng Y, Ferrone M, Wang Q, Perkins LEL, McGregor J, Redfors B, Zhou Z, Rapoza R, Conditt GB, Finn A, Virmani R, Kaluza GL, and Granada JF
- Abstract
The integration of the Absorb bioresorbable vascular scaffold (BVS) into the arterial wall has never been tested in an in vivo model of atherosclerosis. This study aimed to compare the long-term (up to 4 years) vascular healing responses of BVS to an everolimus-eluting metallic stent in the familial hypercholesterolemic swine model of atherosclerosis. The multimodality imaging and histology approaches indicate that the resorption and vascular integration profile of BVS is not affected by the presence of atherosclerosis. BVS demonstrated comparable long-term vascular healing and anti-restenotic efficacy to everolimus-eluting metallic stent but resulted in lower late lumen loss at 4 years., (© 2020 The Authors.)
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- 2020
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44. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years.
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Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, and Kimura T
- Subjects
- Cardiovascular Agents adverse effects, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Thrombosis diagnostic imaging, Coronary Thrombosis etiology, Everolimus adverse effects, Humans, Japan, Percutaneous Coronary Intervention adverse effects, Predictive Value of Tests, Prospective Studies, Prosthesis Design, Single-Blind Method, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Ultrasonography, Interventional, Absorbable Implants, Cardiovascular Agents administration & dosage, Chromium Alloys, Coronary Artery Disease therapy, Coronary Vessels diagnostic imaging, Drug-Eluting Stents, Everolimus administration & dosage, Multimodal Imaging, Percutaneous Coronary Intervention instrumentation, Stents
- Abstract
Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging., Background: Serial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported., Methods: In the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT)., Results: Luminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference -0.37 mm [95% confidence interval: -0.50 to -0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm
2 vs. 7.15 ± 2.16 mm2 , mean difference -1.04 mm2 [95% confidence interval: -1.66 to -0.42 mm2 ]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2 , mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2 ]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention., Conclusions: In this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2020
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45. Very Late Restenosis Following Bioresorbable Scaffold Implantation.
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Okuno T, Yahagi K, Horiuchi Y, Aoki J, Simonton CA, Rapoza R, Saito S, Kimura T, and Tanabe K
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- Aged, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease physiopathology, Coronary Restenosis diagnostic imaging, Coronary Restenosis physiopathology, Coronary Vessels diagnostic imaging, Coronary Vessels physiopathology, Humans, Male, Prosthesis Design, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Absorbable Implants, Coronary Artery Disease surgery, Coronary Restenosis etiology, Coronary Vessels surgery, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation
- Published
- 2017
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46. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial.
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Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Igarashi K, Kozuma K, Tanabe K, Kusano H, Rapoza R, Popma JJ, Stone GW, Simonton C, Serruys PW, and Kimura T
- Subjects
- Aged, Cardiovascular Diseases mortality, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Female, Follow-Up Studies, Graft Occlusion, Vascular epidemiology, Humans, Japan, Male, Middle Aged, Myocardial Infarction epidemiology, Myocardial Revascularization statistics & numerical data, Postoperative Complications epidemiology, Single-Blind Method, Thrombosis epidemiology, Tomography, Optical Coherence, Treatment Outcome, Absorbable Implants, Antineoplastic Agents administration & dosage, Coronary Artery Disease surgery, Drug-Eluting Stents, Everolimus administration & dosage, Percutaneous Coronary Intervention, Tissue Scaffolds
- Abstract
Aims: We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES)., Methods and Results: In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134). A pre-specified OCT subgroup (N=125, OCT-1 group) underwent angio-graphy and OCT post procedure and at two years. Overall, the two-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively. Very late scaffold thrombosis (VLST) beyond one year was observed in 1.6% (four cases: all in non-OCT-1 subgroups) of the BVS arm, while there was no VLST in the CoCr-EES arm. In three cases, OCT at the time of or shortly after VLST demonstrated strut discontinuities, malapposition and/or uncovered struts. However, the vessel healing by two-year OCT was nearly complete in both BVS and CoCr-EES arms with almost fully covered struts, and minimal malapposition. The flow area by two-year OCT was smaller in the BVS arm than in the CoCr-EES arm, mainly due to tissue growth inside the device. However, there were no differences between the BVS and CoCr-EES with regard to the quality of homogenous tissues growing inside the devices., Conclusions: The rate of TLF was numerically higher in the BVS arm than in the CoCr-EES arm, although this difference was not statistically significant. VLST was observed only in the BVS arm at a rate of 1.6% between one and two years. Further studies are mandatory to investigate the risk of BVS relative to metallic stents for VLST, and the underlying mechanisms of BVS VLST.
- Published
- 2016
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47. Differential thrombotic prolapse burden in either bioresorbable vascular scaffolds or metallic stents implanted during acute myocardial infarction: The snowshoe effect: Insights from the maximal footprint analysis.
- Author
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Diletti R, van der Sijde J, Karanasos A, Fam JM, Felix C, van Mieghem NM, Regar E, Rapoza R, Zijlstra F, and van Geuns RJ
- Subjects
- Absorbable Implants adverse effects, Adult, Aged, Cost of Illness, Drug-Eluting Stents adverse effects, Everolimus administration & dosage, Feasibility Studies, Female, Humans, Male, Metals adverse effects, Middle Aged, Thrombosis etiology, Tissue Scaffolds adverse effects, Tomography, Optical Coherence trends, Treatment Outcome, Absorbable Implants trends, Drug-Eluting Stents trends, ST Elevation Myocardial Infarction diagnostic imaging, ST Elevation Myocardial Infarction surgery, Thrombosis diagnostic imaging, Tissue Scaffolds trends
- Abstract
Background: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated., Methods: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed., Results: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group., Conclusions: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2016
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48. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.
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Lammer J, Bosiers M, Deloose K, Schmidt A, Zeller T, Wolf F, Lansink W, Sauguet A, Vermassen F, Lauwers G, Scheinert D, Popma JJ, McGreevy R, Rapoza R, Schwartz LB, and Jaff MR
- Subjects
- Aged, Angiography, Angioplasty, Balloon adverse effects, Ankle Brachial Index, Cardiovascular Agents adverse effects, Everolimus adverse effects, Exercise Tolerance, Feasibility Studies, Female, Humans, Intermittent Claudication diagnostic imaging, Intermittent Claudication physiopathology, Limb Salvage, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Prospective Studies, Prosthesis Design, Recovery of Function, Recurrence, Retreatment, Risk Factors, Time Factors, Treatment Outcome, Ultrasonography, Doppler, Duplex, Vascular Patency, Absorbable Implants, Angioplasty, Balloon instrumentation, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Everolimus administration & dosage, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Iliac Artery diagnostic imaging, Iliac Artery physiopathology, Intermittent Claudication therapy, Peripheral Arterial Disease therapy
- Abstract
Objectives: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA)., Background: Drug-eluting BVS has shown promise in coronary arteries., Methods: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication., Results: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet., Conclusions: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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49. Bioresorption and Vessel Wall Integration of a Fully Bioresorbable Polymeric Everolimus-Eluting Scaffold: Optical Coherence Tomography, Intravascular Ultrasound, and Histological Study in a Porcine Model With 4-Year Follow-Up.
- Author
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Nakatani S, Ishibashi Y, Sotomi Y, Perkins L, Eggermont J, Grundeken MJ, Dijkstra J, Rapoza R, Virmani R, Serruys PW, and Onuma Y
- Subjects
- Angioplasty, Balloon, Coronary adverse effects, Animals, Coronary Vessels pathology, Models, Animal, Predictive Value of Tests, Sus scrofa, Swine, Swine, Miniature, Time Factors, Absorbable Implants, Angioplasty, Balloon, Coronary instrumentation, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Coronary Vessels diagnostic imaging, Coronary Vessels drug effects, Everolimus administration & dosage, Polyesters chemistry, Tomography, Optical Coherence, Ultrasonography, Interventional
- Abstract
Objectives: The aim of the present study was to investigate the relationship between the integration process and luminal enlargement with the support of light intensity (LI) analysis on optical coherence tomography (OCT), echogenicity analysis on intravascular ultrasound, and histology up to 4 years in a porcine model., Background: In pre-clinical and clinical studies, late luminal enlargement has been demonstrated at long-term follow-up after everolimus-eluting poly-l-lactic acid coronary scaffold implantation. However, the time relationship and the mechanistic association with the integration process are still unclear., Methods: Seventy-three nonatherosclerotic swine that received 112 Absorb scaffolds were evaluated in vivo by OCT, intravascular ultrasound, and post-mortem histomorphometry at 3, 6, 12, 18, 24, 30, 36, 42, and 48 months., Results: The normalized LI, which is the signal densitometry on OCT of a polymeric strut core normalized by the vicinal neointima, was able to differentiate the degree of connective tissue infiltration inside the strut cores. Luminal enlargement was a biphasic process at 6 to 18 months and at 30 to 42 months. The latter phase occurred with vessel wall thinning and coincided with the advance integration process demonstrated by the steep change in normalized LI (0.26 [interquartile range (IQR): 0.20 to 0.32] at 30 months versus 0.68 [IQR: 0.58 to 0.83] at 42 months, p < 0.001)., Conclusions: In this pre-clinical model, late luminal enlargement relates to strut integration into the arterial wall. Quantitative LI analysis on OCT could be used as a surrogate method for monitoring the integration process of poly-l-lactic acid scaffolds, which could provide insight and understanding on the imaging-related characteristics of the bioresorption process of polylactide scaffolds in human., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
50. Vasomotor Function Comparative Assessment at 1 and 2 Years Following Implantation of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold and the Xience V Everolimus-Eluting Metallic Stent in Porcine Coronary Arteries: Insights From In Vivo Angiography, Ex Vivo Assessment, and Gene Analysis at the Stented/Scaffolded Segments and the Proximal and Distal Edges.
- Author
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Gogas BD, Benham JJ, Hsu S, Sheehy A, Lefer DJ, Goodchild TT, Polhemus DJ, Bouchi YH, Hung OY, Yoo SY, Joshi U, Giddens DP, Veneziani A, Quyyumi A, Rapoza R, King SB 3rd, and Samady H
- Subjects
- Animals, Coronary Vessels diagnostic imaging, Coronary Vessels metabolism, Coronary Vessels physiopathology, Gene Expression Regulation, In Vitro Techniques, Models, Animal, Percutaneous Coronary Intervention adverse effects, Phenotype, Real-Time Polymerase Chain Reaction, Recovery of Function, Swine, Swine, Miniature, Time Factors, Cardiac Catheters, Cardiovascular Agents administration & dosage, Coated Materials, Biocompatible, Coronary Angiography, Coronary Vessels drug effects, Drug-Eluting Stents, Everolimus administration & dosage, Metals, Percutaneous Coronary Intervention instrumentation, Vasoconstriction drug effects, Vasodilation drug effects
- Abstract
Objectives: The purpose of this study was to assess and compare in vivo the restoration of vasomotor function following Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) and metallic Xience V (XV) (Abbott Vascular, Santa Clara, California) stent implantations in porcine coronary arteries at 1 and 2 years., Background: Drug-eluting metallic coronary stents induce sustained vasomotor dysfunction, and preliminary observations from arteries with bioresorbable scaffolds have indicated partially restored vasoreactivity., Methods: A total of 15 Absorb BVS (3.0 × 18.0 mm) and 14 XV (3.0 × 18.0 mm or 3.0 × 12.0 mm) stents were randomly implanted in the main coronaries of 12 nonatherosclerotic swine. The effect of implant on vasomotor performance (constrictive and expansive) was measured in the stented/scaffolded segments and the 5-mm proximal and distal adjacent segments in vivo by angiography assessing mean luminal diameter changes following infusion of vasoactive agents at 1 year (n = 6) and 2 years (n = 6) as well as ex vivo at 2 years using a tissue chamber apparatus. Endothelial cell function and smooth muscle cell phenotype gene marker levels were evaluated with quantitative real-time polymerase chain reaction., Results: The scaffolded Absorb BVS segments showed fully restored constrictive response compared with XV implanted vessels at 1 year: -24.30 ± 14.31% versus -1.79 ± 6.57% (p < 0.004) and at 2 years: -28.13 ± 14.60% versus -3.90 ± 6.44% (p < 0.004). The early restoration of vasomotor function within the scaffolded segments reached a peak at 1 year and did not significantly change up to 2 years. The vasoactive responses of Absorb BVS-implanted vessels within the scaffolded segments were similar to those observed within the proximal and distal edge segments at both time points. Conversely, the stented XV segments demonstrated significantly impaired constrictive response compared with the distal XV edges at 1 year: -1.79 ± 6.57% versus -21.89 ± 7.17% (p < 0.0002) and at 2 years: -3.90 ± 6.44% versus -21.93 ± 15.60% (p < 0.03). Ex vivo assessment of contraction induced by PGF2α and relaxation induced by substance P of isolated BVS segments compared with XV-treated segments generated greater contraction force of 3.94 ± 0.97 g versus 1.83 ± 1.03 g (p < 0.05), and endothelial-dependent relaxation reached 35.91 ± 24.74% versus 1.20 ± 3.79% (p < 0.01). Quantitative real-time polymerase chain reaction gene analysis at 2 years demonstrated increased Connexin 43 messenger ribonucleic acid levels of Absorb BVS-treated vessels compared with XV-treated vessels: 1.92 ± 0.23 versus 0.77 ± 12 (p < 0.05)., Conclusions: Absorb BVS-implanted coronary arteries demonstrate early functional restoration of the scaffolded and adjacent segments at 1 year, which is preserved up to 2 years., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
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