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Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.
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fate of post procedural malapposition of everolimus eluting polymeric bioresorbable scaffold and everolimus eluting cobalt chromium metallic stent in human coronary arteries sequential assessment with optical coherence tomography in absorb japan tria
European Journal of Echocardiography, 2018Co-Authors: Yohei Sotomi, Yoshinobu Onuma, Patrick W Serruys, Jouke Dijkstra, Yosuke Miyazaki, Ken Kozuma, Kengo Tanabe, Jeffrey J Popma, Robbert J De Winter, Takeshi KimuraAbstract:Aims The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the second-generation everolimus-eluting cobalt chromium stent (CoCr-EES). Methods and results Fate of post-procedural ISA was evaluated by serial optical coherence tomography (OCT) in the ABSORB Japan randomized trial [OCT-1 subgroup: 110 paired lesions of post-procedure and 2-year follow-up (BVS 73 lesions vs. CoCr-EES 37 lesions)] with respect to ISA distance. Post-procedure ISA Struts were categorized into either ‘resolved’ or ‘persistent’ by matched OCT imaging at 2-year follow-up. Post-procedure %malapposed strut and ISA area were smaller in BVS than in CoCr-EES (%malapposed strut: 4.8 ± 6.9% vs. 9.9 ± 9.8%, P = 0.002; ISA area 0.10 ± 0.18 mm2 vs. 0.23 ± 0.26 mm2, P = 0.003). At 2-year follow-up, the difference diminished, and majority of the ISA Struts spontaneously resolved in both arms (%malapposed strut: 0.10 ± 0.46% vs. 0.24 ± 0.65%, P = 0.183). Receiver operating characteristic curve analysis (BVS 661 Struts vs. CoCr-EES 807 Struts) demonstrated that the best cut-off value of endoluminal ISA distance post-procedure for predicting persistent-ISA at 2-year follow-up was 396 µm for BVS (sensitivity 0.875; specificity 0.851) and 359 µm for CoCr-EES (sensitivity 0.778; specificity 0.881). Conclusion BVS as compared with CoCr-EES allows larger ISA distance at post-procedure, although we should make every effort to minimize post-procedure ISA. The reported cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent-ISA would be helpful to optimize PCI with BVS and CoCr-EES.
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automatic detection of bioresorbable vascular scaffold Struts in intravascular optical coherence tomography pullback runs
Biomedical Optics Express, 2014Co-Authors: Ancong Wang, Hector M Garciagarcia, Patrick W Serruys, Shimpei Nakatani, Jeroen Eggermont, Yoshi Onuma, Johan H C Reiber, Jouke DijkstraAbstract:Bioresorbable vascular scaffolds (BVS) have gained significant interest in both the technical and clinical communities as a possible alternative to metallic stents. For accurate BVS analysis, intravascular optical coherence tomography (IVOCT) is currently the most suitable imaging technique due to its high resolution and the translucency of polymeric BVS Struts for near infrared light. However, given the large number of Struts in an IVOCT pullback run, quantitative analysis is only feasible when Struts are detected automatically. In this paper, we present an automated method to detect and measure BVS Struts based on their black cores in IVOCT images. Validated using 3 baseline and 3 follow-up data sets, the method detected 93.7% of 4691 BVS Struts correctly with 1.8% false positives. In total, the Dice’s coefficient for BVS strut areas was 0.84. It concludes that this method can detect BVS Struts accurately and robustly for tissue coverage measurement, malapposition detection, strut distribution analysis or 3D scaffold reconstruction.
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intracoronary optical coherence tomography and histology of overlapping everolimus eluting bioresorbable vascular scaffolds in a porcine coronary artery model the potential implications for clinical practice
Jacc-cardiovascular Interventions, 2013Co-Authors: Vasim Farooq, Maria D Radu, Roberto Diletti, Yoshinobu Onuma, Patrick W Serruys, Bill D Gogas, Laura E Perkins, Lorenz Raber, Christos V Bourantas, Yaojun ZhangAbstract:OBJECTIVES: This study sought to assess the vascular response of overlapping Absorb stents compared with overlapping newer-generation everolimus-eluting metallic platform stents (Xience V [XV]) in a porcine coronary artery model. BACKGROUND: The everolimus-eluting bioresorbable vascular scaffold (Absorb) is a novel approach to treating coronary lesions. A persistent inflammatory response, fibrin deposition, and delayed endothelialization have been reported with overlapping first-generation drug-eluting stents. METHODS: Forty-one overlapping Absorb and overlapping Xience V (XV) devices (3.0 × 12 mm) were implanted in the main coronary arteries of 17 nonatherosclerotic pigs with 10% overstretch. Implanted coronary arteries were evaluated by optical coherence tomography (OCT) at 28 days (Absorb n = 11, XV n = 7) and 90 days (Absorb n = 11, XV n = 8), with immediate histological evaluation following euthanasia at the same time points. One animal from each time point was evaluated with scanning electron microscopy alone. A total of 1,407 cross sections were analyzed by OCT and 148 cross sections analyzed histologically. RESULTS: At 28 days in the overlap, OCT analyses indicated 80.1% of Absorb Struts and 99.4% of XV Struts to be covered (p 99% strut coverage by OCT and histology, with no evidence of a significant inflammatory process, and comparable % volume obstructions. CONCLUSIONS: In porcine coronary arteries implanted with overlapping Absorb or overlapping XV Struts, strut coverage is delayed at 28 days in overlapping Absorb, dependent on the overlay configuration of the thicker Absorb Struts. At 90 days, both overlapping Absorb and overlapping XV have comparable strut coverage. The implications of increased strut thickness may have important clinical and design considerations for bioresorbable platforms.
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in vivo characterisation of bioresorbable vascular scaffold strut interfaces using optical coherence tomography with gaussian line spread function analysis
Eurointervention, 2012Co-Authors: Alexander Sheehy, Roberto Diletti, Yoshinobu Onuma, Juan Luis Gutierrezchico, Richard Rapoza, James P Oberhauser, Thierry Glauser, Joel Harrington, Mary Beth Kossuth, Patrick W SerruysAbstract:textabstractAims: Optical coherence tomography (OCT) of a bioresorbable vascular scaffold (BVS) produces a highly reflective signal outlining Struts. This signal interferes with the measurement of strut thickness, as the boundaries cannot be accurately identified, and with the assessment of coverage, because the neointimal backscattering convolutes that of the polymer, frequently making them indistinguishable from one another. We hypothesise that Gaussian line spread functions (LSFs) can facilitate identification of strut boundaries, improving the accuracy of strut thickness measurements and coverage assessment. Methods and results: Forty-eight randomly selected BVS Struts from 12 patients in the ABSORB Cohort B clinical study and four Yucatan minipigs were analysed at baseline and follow-up (six months in humans, 28 days in pigs). Signal intensities from the raw OCT backscattering were fit to Gaussian LSFs for each interface, from which peak intensity and full-width-at-half-maximum (FWHM) were calculated. Neointimal coverage resulted in significantly different LSFs and higher FWHM values relative to uncovered Struts at baseline (p<0.0001). Abluminal polymer-tissue interfaces were also significantly different between baseline and follow- up (p =0.0004 in humans, p <0.0001 in pigs). Using the location of the half-max of the LSF as the polymer- tissue boundary, the average strut thickness was 158±11 μm at baseline and 152±20 μm at six months (p=0.886), not significantly different from nominal strut thickness. Conclusions: Fitting the raw OCT backscattering signal to a Gaussian LSF facilitates identification of the interfaces between BVS polymer and lumen or tissue. Such analysis enables more precise measurement of the strut thickness and an objective assessment of coverage.
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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
Eurointervention, 2010Co-Authors: Takayuki Okamura, Yoshinobu Onuma, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Richard Rapoza, Krishnankufty Sudhir, Evelyn Regar, Patrick W SerruysAbstract:textabstractAims: 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.
Yoshinobu Onuma - One of the best experts on this subject based on the ideXlab platform.
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fate of post procedural malapposition of everolimus eluting polymeric bioresorbable scaffold and everolimus eluting cobalt chromium metallic stent in human coronary arteries sequential assessment with optical coherence tomography in absorb japan tria
European Journal of Echocardiography, 2018Co-Authors: Yohei Sotomi, Yoshinobu Onuma, Patrick W Serruys, Jouke Dijkstra, Yosuke Miyazaki, Ken Kozuma, Kengo Tanabe, Jeffrey J Popma, Robbert J De Winter, Takeshi KimuraAbstract:Aims The natural course of post-procedural incomplete strut apposition (ISA) after the implantation of bioresorbable scaffolds (BVS) remains unknown. The purpose of the present study was to evaluate the fate of post-procedural ISA after everolimus-eluting Absorb BVS in comparison with the second-generation everolimus-eluting cobalt chromium stent (CoCr-EES). Methods and results Fate of post-procedural ISA was evaluated by serial optical coherence tomography (OCT) in the ABSORB Japan randomized trial [OCT-1 subgroup: 110 paired lesions of post-procedure and 2-year follow-up (BVS 73 lesions vs. CoCr-EES 37 lesions)] with respect to ISA distance. Post-procedure ISA Struts were categorized into either ‘resolved’ or ‘persistent’ by matched OCT imaging at 2-year follow-up. Post-procedure %malapposed strut and ISA area were smaller in BVS than in CoCr-EES (%malapposed strut: 4.8 ± 6.9% vs. 9.9 ± 9.8%, P = 0.002; ISA area 0.10 ± 0.18 mm2 vs. 0.23 ± 0.26 mm2, P = 0.003). At 2-year follow-up, the difference diminished, and majority of the ISA Struts spontaneously resolved in both arms (%malapposed strut: 0.10 ± 0.46% vs. 0.24 ± 0.65%, P = 0.183). Receiver operating characteristic curve analysis (BVS 661 Struts vs. CoCr-EES 807 Struts) demonstrated that the best cut-off value of endoluminal ISA distance post-procedure for predicting persistent-ISA at 2-year follow-up was 396 µm for BVS (sensitivity 0.875; specificity 0.851) and 359 µm for CoCr-EES (sensitivity 0.778; specificity 0.881). Conclusion BVS as compared with CoCr-EES allows larger ISA distance at post-procedure, although we should make every effort to minimize post-procedure ISA. The reported cut-off value of OCT-estimated ISA distance at post-stenting for predicting persistent-ISA would be helpful to optimize PCI with BVS and CoCr-EES.
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intracoronary optical coherence tomography and histology of overlapping everolimus eluting bioresorbable vascular scaffolds in a porcine coronary artery model the potential implications for clinical practice
Jacc-cardiovascular Interventions, 2013Co-Authors: Vasim Farooq, Maria D Radu, Roberto Diletti, Yoshinobu Onuma, Patrick W Serruys, Bill D Gogas, Laura E Perkins, Lorenz Raber, Christos V Bourantas, Yaojun ZhangAbstract:OBJECTIVES: This study sought to assess the vascular response of overlapping Absorb stents compared with overlapping newer-generation everolimus-eluting metallic platform stents (Xience V [XV]) in a porcine coronary artery model. BACKGROUND: The everolimus-eluting bioresorbable vascular scaffold (Absorb) is a novel approach to treating coronary lesions. A persistent inflammatory response, fibrin deposition, and delayed endothelialization have been reported with overlapping first-generation drug-eluting stents. METHODS: Forty-one overlapping Absorb and overlapping Xience V (XV) devices (3.0 × 12 mm) were implanted in the main coronary arteries of 17 nonatherosclerotic pigs with 10% overstretch. Implanted coronary arteries were evaluated by optical coherence tomography (OCT) at 28 days (Absorb n = 11, XV n = 7) and 90 days (Absorb n = 11, XV n = 8), with immediate histological evaluation following euthanasia at the same time points. One animal from each time point was evaluated with scanning electron microscopy alone. A total of 1,407 cross sections were analyzed by OCT and 148 cross sections analyzed histologically. RESULTS: At 28 days in the overlap, OCT analyses indicated 80.1% of Absorb Struts and 99.4% of XV Struts to be covered (p 99% strut coverage by OCT and histology, with no evidence of a significant inflammatory process, and comparable % volume obstructions. CONCLUSIONS: In porcine coronary arteries implanted with overlapping Absorb or overlapping XV Struts, strut coverage is delayed at 28 days in overlapping Absorb, dependent on the overlay configuration of the thicker Absorb Struts. At 90 days, both overlapping Absorb and overlapping XV have comparable strut coverage. The implications of increased strut thickness may have important clinical and design considerations for bioresorbable platforms.
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in vivo characterisation of bioresorbable vascular scaffold strut interfaces using optical coherence tomography with gaussian line spread function analysis
Eurointervention, 2012Co-Authors: Alexander Sheehy, Roberto Diletti, Yoshinobu Onuma, Juan Luis Gutierrezchico, Richard Rapoza, James P Oberhauser, Thierry Glauser, Joel Harrington, Mary Beth Kossuth, Patrick W SerruysAbstract:textabstractAims: Optical coherence tomography (OCT) of a bioresorbable vascular scaffold (BVS) produces a highly reflective signal outlining Struts. This signal interferes with the measurement of strut thickness, as the boundaries cannot be accurately identified, and with the assessment of coverage, because the neointimal backscattering convolutes that of the polymer, frequently making them indistinguishable from one another. We hypothesise that Gaussian line spread functions (LSFs) can facilitate identification of strut boundaries, improving the accuracy of strut thickness measurements and coverage assessment. Methods and results: Forty-eight randomly selected BVS Struts from 12 patients in the ABSORB Cohort B clinical study and four Yucatan minipigs were analysed at baseline and follow-up (six months in humans, 28 days in pigs). Signal intensities from the raw OCT backscattering were fit to Gaussian LSFs for each interface, from which peak intensity and full-width-at-half-maximum (FWHM) were calculated. Neointimal coverage resulted in significantly different LSFs and higher FWHM values relative to uncovered Struts at baseline (p<0.0001). Abluminal polymer-tissue interfaces were also significantly different between baseline and follow- up (p =0.0004 in humans, p <0.0001 in pigs). Using the location of the half-max of the LSF as the polymer- tissue boundary, the average strut thickness was 158±11 μm at baseline and 152±20 μm at six months (p=0.886), not significantly different from nominal strut thickness. Conclusions: Fitting the raw OCT backscattering signal to a Gaussian LSF facilitates identification of the interfaces between BVS polymer and lumen or tissue. Such analysis enables more precise measurement of the strut thickness and an objective assessment of coverage.
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serial analysis of the malapposed and uncovered Struts of the new generation of everolimus eluting bioresorbable scaffold with optical coherence tomography
Jacc-cardiovascular Interventions, 2011Co-Authors: Josep Gomezlara, Maria D Radu, Salvatore Brugaletta, Vasim Farooq, Roberto Diletti, Yoshinobu Onuma, Stephan Windecker, Leif Thuesen, Dougal Mcclean, Jacques J KoolenAbstract:Objectives The aim of this study is to assess the serial changes in strut apposition and coverage of the bioresorbable vascular scaffolds (BVS) and to relate this with the presence of intraluminal masses at 6 months with optical coherence tomography (OCT). Background Incomplete strut/scaffold apposition (ISA) and uncovered Struts are related to a higher risk of scaffold thrombosis. Bioresorbable vascular scaffolds can potentially avoid the risk of scaffold thrombosis because of its complete resorption. However, during the resorption period, the risk of scaffold thrombosis is unknown. Methods OCT was performed in 25 patients at baseline and 6 months. Struts were classified according to apposition, coverage, and presence of intraluminal masses. Persistent ISA was defined as malapposed Struts present at baseline and follow-up, and late acquired ISA as ISA developing at follow-up, and scaffold pattern irregularities when the strut distribution suggested scaffold fracture. Results At baseline, 3,686 Struts were analyzed: 128 (4%) were ISA, and 53 (1%) were located over side-branches (SB). At 6 months, 3,905 Struts were analyzed: 32 (1%) ISA, and 35 (1%) at the SB. Persistent ISA was observed more frequently than late acquired-ISA (81% vs. 16%, respectively; 3% were unmatchable). Late acquired ISA was associated with scaffold pattern irregularities, which were related to overstretching of the scaffold. Uncovered Struts (63 Struts, 2%) were more frequently observed in ISA and SB Struts, compared with apposed Struts (29% vs. 1%; p Conclusions The lack of strut apposition at baseline is related to the presence of uncovered Struts and intraluminal masses at 6 month. An appropriate balloon/artery ratio respecting the actual vessel size and avoiding the overstretching of the scaffold can potentially decrease the risk of scaffold thrombosis. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856 )
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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
Eurointervention, 2010Co-Authors: Takayuki Okamura, Yoshinobu Onuma, Scot Garg, Juan Luis Gutierrezchico, Eunseok Shin, Hector M Garciagarcia, Richard Rapoza, Krishnankufty Sudhir, Evelyn Regar, Patrick W SerruysAbstract:textabstractAims: 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.
Maria D Radu - One of the best experts on this subject based on the ideXlab platform.
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intracoronary optical coherence tomography and histology of overlapping everolimus eluting bioresorbable vascular scaffolds in a porcine coronary artery model the potential implications for clinical practice
Jacc-cardiovascular Interventions, 2013Co-Authors: Vasim Farooq, Maria D Radu, Roberto Diletti, Yoshinobu Onuma, Patrick W Serruys, Bill D Gogas, Laura E Perkins, Lorenz Raber, Christos V Bourantas, Yaojun ZhangAbstract:OBJECTIVES: This study sought to assess the vascular response of overlapping Absorb stents compared with overlapping newer-generation everolimus-eluting metallic platform stents (Xience V [XV]) in a porcine coronary artery model. BACKGROUND: The everolimus-eluting bioresorbable vascular scaffold (Absorb) is a novel approach to treating coronary lesions. A persistent inflammatory response, fibrin deposition, and delayed endothelialization have been reported with overlapping first-generation drug-eluting stents. METHODS: Forty-one overlapping Absorb and overlapping Xience V (XV) devices (3.0 × 12 mm) were implanted in the main coronary arteries of 17 nonatherosclerotic pigs with 10% overstretch. Implanted coronary arteries were evaluated by optical coherence tomography (OCT) at 28 days (Absorb n = 11, XV n = 7) and 90 days (Absorb n = 11, XV n = 8), with immediate histological evaluation following euthanasia at the same time points. One animal from each time point was evaluated with scanning electron microscopy alone. A total of 1,407 cross sections were analyzed by OCT and 148 cross sections analyzed histologically. RESULTS: At 28 days in the overlap, OCT analyses indicated 80.1% of Absorb Struts and 99.4% of XV Struts to be covered (p 99% strut coverage by OCT and histology, with no evidence of a significant inflammatory process, and comparable % volume obstructions. CONCLUSIONS: In porcine coronary arteries implanted with overlapping Absorb or overlapping XV Struts, strut coverage is delayed at 28 days in overlapping Absorb, dependent on the overlay configuration of the thicker Absorb Struts. At 90 days, both overlapping Absorb and overlapping XV have comparable strut coverage. The implications of increased strut thickness may have important clinical and design considerations for bioresorbable platforms.
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serial analysis of the malapposed and uncovered Struts of the new generation of everolimus eluting bioresorbable scaffold with optical coherence tomography
Jacc-cardiovascular Interventions, 2011Co-Authors: Josep Gomezlara, Maria D Radu, Salvatore Brugaletta, Vasim Farooq, Roberto Diletti, Yoshinobu Onuma, Stephan Windecker, Leif Thuesen, Dougal Mcclean, Jacques J KoolenAbstract:Objectives The aim of this study is to assess the serial changes in strut apposition and coverage of the bioresorbable vascular scaffolds (BVS) and to relate this with the presence of intraluminal masses at 6 months with optical coherence tomography (OCT). Background Incomplete strut/scaffold apposition (ISA) and uncovered Struts are related to a higher risk of scaffold thrombosis. Bioresorbable vascular scaffolds can potentially avoid the risk of scaffold thrombosis because of its complete resorption. However, during the resorption period, the risk of scaffold thrombosis is unknown. Methods OCT was performed in 25 patients at baseline and 6 months. Struts were classified according to apposition, coverage, and presence of intraluminal masses. Persistent ISA was defined as malapposed Struts present at baseline and follow-up, and late acquired ISA as ISA developing at follow-up, and scaffold pattern irregularities when the strut distribution suggested scaffold fracture. Results At baseline, 3,686 Struts were analyzed: 128 (4%) were ISA, and 53 (1%) were located over side-branches (SB). At 6 months, 3,905 Struts were analyzed: 32 (1%) ISA, and 35 (1%) at the SB. Persistent ISA was observed more frequently than late acquired-ISA (81% vs. 16%, respectively; 3% were unmatchable). Late acquired ISA was associated with scaffold pattern irregularities, which were related to overstretching of the scaffold. Uncovered Struts (63 Struts, 2%) were more frequently observed in ISA and SB Struts, compared with apposed Struts (29% vs. 1%; p Conclusions The lack of strut apposition at baseline is related to the presence of uncovered Struts and intraluminal masses at 6 month. An appropriate balloon/artery ratio respecting the actual vessel size and avoiding the overstretching of the scaffold can potentially decrease the risk of scaffold thrombosis. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856 )
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optical coherence tomography at follow up after percutaneous coronary intervention relationship between procedural dissections stent strut malapposition and stent healing
Eurointervention, 2011Co-Authors: Maria D Radu, Erik Jorgensen, Henning Kelbaek, Steffen Helqvist, Lene Theil Skovgaard, Kari SaunamakiAbstract:Aims: To analyse the relationship between strut apposition as visualised with optical coherence tomography (OCT) at follow-up and clinical and procedural characteristics at stent implantation, and to examine the relationship between strut apposition and stent healing. Methods and results: Twenty-eight coronary lesions were evaluated. The lesion morphology before stent implantation was described from the baseline angiogram. Strut apposition at follow-up was divided into: (I) apposed Struts, (II) Struts overlying side branch ostia, (III) malapposed and (IV) protruding Struts. Since malapposed and protruding Struts often occurred in the same lesions, these were divided into two groups: lesions without (n=20) and lesions with (n=8) the presence of these Struts. The thickness of strut coverage was used as a surrogate for stent healing. We analysed 5,159 Struts. Sixteen were malapposed and 216 were protruding. Lesions with malapposed and/or protruding Struts at OCT follow-up were more frequently associated with acute coronary syndrome (ACS) and procedure related dissections at stent implantation than lesions without. There was a tendency towards a less pronounced strut coverage over malapposed and protruding Struts, as compared to apposed Struts. Conclusions: ACS and procedural dissections at stent implantation may be related to strut malapposition/ protrusion at follow-up, which may influence the degree of strut coverage.
Carlo Di Mario - One of the best experts on this subject based on the ideXlab platform.
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estrategia simple o compleja para lesiones de bifurcaciones coronarias evaluacion inmediata de la aposicion de los Struts del stent mediante tomografia de coherencia optica
Revista Espanola De Cardiologia, 2010Co-Authors: Pawel Tyczynski, Ranil De Silva, Peter Barlis, Giuseppe Ferrante, Cristina Morenoambroj, Neville Kukreja, Elio Pieri, Kevin Beatt, Carlo Di MarioAbstract:Introduccion y objetivos. La implantacion de stents en lesiones de bifurcaciones coronarias comporta un riesgo elevado de deformacion y mala aposicion del stent. Las observaciones anatomopatologicas han atribuido a la mala aposicion de los Struts un papel causal en la elevada tasa de trombosis de los stents que se observa en las bifurcaciones. Metodos. Se evaluo la aposicion de los Struts en las lesiones de bifurcaciones tratadas con una tecnica simple de implantacion de stent solo en el vaso principal o con una tecnica compleja (de culotte) mediante el empleo de tomografia de coherencia optica (OCT). La mala aposicion de un strut se definio por el hecho de que la distancia entre su superficie intraluminal y la pared vascular fuera superior a su grosor mas un margen de error de resolucion de la OCT de 15 µm. Resultados. En 17 pacientes se utilizo la estrategia simple y en 14, la tecnica compleja (de culotte). Los Struts con mala aposicion fueron significativamente mas frecuentes y la distancia entre el strut y la pared vascular en los casos de mala aposicion fue mayor en la mitad de la bifurcacion situada hacia la rama lateral (RL) (46,1% [35,3-62,5]) en comparacion con la mitad del lado opuesto (9,1% [2,2-21,6]), el segmento distal (7,5% [2,3-20,2]) y el segmento proximal (12,6% [7,8-23,1]; p < 0,0001) (distancias, 98 µm [37-297] frente a 31 µm [13-74], 49 µm [20-100] y 38 µm [17-90], respectivamente; p < 0,0001). El empleo de la tecnica compleja no afecto a la prevalencia de Struts con mala aposicion en los 4 segmentos en comparacion con la estrategia simple (p = 0,31) y se asocio a una menor distancia strut-pared en el segmento proximal (47 frente a 60 mm; p = 0,0008). Conclusiones. En las lesiones de bifurcaciones coronarias, la mala aposicion de los Struts se produce con mayor frecuencia y es mas importante en la zona de origen de la RL. El empleo de la tecnica de culotte no aumenta de manera significativa la prevalencia de la mala aposicion de los Struts en comparacion con una estrategia simple.
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the influence of strut thickness and cell design on immediate apposition of drug eluting stents assessed by optical coherence tomography
International Journal of Cardiology, 2009Co-Authors: Jun Tanigawa, Peter Barlis, Konstantinos Dimopoulos, Miles Dalby, Philip Moore, Carlo Di MarioAbstract:Abstract Background Stent strut malapposition correlates with poor intimal coverage and this may increase the risk of late stent thrombosis. At present, there is limited data on whether stent strut thickness and stent design impact on acute apposition. We aimed to investigate the influence of stent strut thickness and design on acute stent strut apposition (SSA) immediately following drug-eluting stent (DES) implantation using optical coherence tomography (OCT), a technique with higher resolution and fewer artefacts than intravascular ultrasound. Methods Thirty-six DES in 23 patients (25 lesions) were studied by OCT. SSA was defined as embedded when a strut was buried in the intima for more than half its thickness, protruding when apposed to the intima but not embedded and malapposed when there was no intimal contact. Results Cypher Select stents were implanted in 52%, Taxus Liberte in 32%, Costar in 12% and Endeavour in 4%. A total of 6402 Struts were evaluated. Despite stent optimisation using balloons with a final balloon/artery ratio of 1.26±0.19 at a maximum inflation pressure of 17.5±3.0 atm, only 57.1±20.7% of Struts were embedded, whereas 33.8±18.4% were protruding and 9.1±7.4% were malapposed. Stent type was a strong predictor of malapposition on logistic multilevel analysis (OR 3.95, 95%CI: 1.27–12.23, p =0.017). At 12 months follow-up, there were no adverse clinical events. Conclusion Despite angiographic optimisation with high pressures and adequately sized balloons, malapposed stent Struts are frequently found in complex coronary lesions and more often following the implantation of Cypher Select stents which have a thicker stent strut and closed cell design. With no adverse clinical events at 12 months follow-up, this likely represents a benign phenomenon at least as long as combined anti-platelet therapy is maintained.
Vijaya B. Kolachalama - One of the best experts on this subject based on the ideXlab platform.
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Vascular Response to Experimental Stent Malapposition and Under-Expansion
Annals of Biomedical Engineering, 2016Co-Authors: Caroline C. O’brien, Augusto C. Lopes, Kumaran Kolandaivelu, Mie Kunio, Jonathan Brown, Vijaya B. Kolachalama, Claire Conway, Lynn Bailey, Peter Markham, Marco A. CostaAbstract:Up to 80% of all endovascular stents have malapposed Struts, and while some impose catastrophic events others are inconsequential. Thirteen stents were implanted in coronary arteries of seven healthy Yorkshire pigs, using specially-designed cuffed balloons inducing controlled stent malapposition and under-expansion. Optical coherence tomography (OCT) imaging confirmed that 25% of Struts were malapposed (strut-wall distance
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vascular response to experimental stent malapposition and under expansion
Annals of Biomedical Engineering, 2016Co-Authors: Caroline C Obrien, Augusto C. Lopes, Kumaran Kolandaivelu, Mie Kunio, Jonathan Brown, Vijaya B. Kolachalama, Claire ConwayAbstract:Up to 80% of all endovascular stents have malapposed Struts, and while some impose catastrophic events others are inconsequential. Thirteen stents were implanted in coronary arteries of seven healthy Yorkshire pigs, using specially-designed cuffed balloons inducing controlled stent malapposition and under-expansion. Optical coherence tomography (OCT) imaging confirmed that 25% of Struts were malapposed (strut-wall distance <strut thickness) to variable extent (max. strut-wall distance malapposed group 0.51 ± 0.05 mm vs. apposed group 0.09 ± 0.05 mm, p = 2e-3). Imaging at follow-up revealed malapposition acutely resolved (<1% of Struts remained malapposed at day 5), with strong correlation between lumen and the stent cross-sectional areas (slope = 0.86, p < 0.0001, R (2) = 0.94). OCT in three of the most significantly malapposed vessels at baseline showed high correlation of elastic lamina area and lumen area (R (2) = 0.96) suggesting all lumen loss was related to contraction of elastic lamina with negligible plaque/intimal hyperplasia growth. Simulation showed this vascular recoil could be partially explained by the non-uniform strain environment created from sub-optimal expansion of device and balloon, and the inability of stent support in the malapposed region to resist recoil. Malapposition as a result of stent under-expansion is resolved acutely in healthy normal arteries, suggesting existing animal models are limited in replicating clinically observed persistent stent malapposition.
