1. Articles from Ken Kozuma

    1-21 of 21
    1. Quantified frequency-domain optical coherence tomography analysis for the thin-high signals on restenotic tissue after paclitaxel-coated balloon angioplasty

      Quantified frequency-domain optical coherence tomography analysis for the thin-high signals on restenotic tissue after paclitaxel-coated balloon angioplasty

      Thin-high signals (THS), detectable by optical coherence tomography (OCT), represent the paclitaxel coverage of in-stent restenotic tissue. This study was conducted to assess the relationship between THS and angiographic outcomes by means of quantified post-procedural frequency-domain OCT (FD-OCT) analysis. From January 2014 to July 2016, 41 patients underwent FD-OCT-guided percutaneous coronary intervention using paclitaxel-coated balloon (PCB) to prevent in-stent restenosis. Of these, we retrospectively enrolled 32 patients (38 lesions) who underwent a 6- to 9-month follow-up angiogram. THS were assessed quantitatively, as THS length and lumen perimeter length were measured using semi-automated software; %THS was calculated by the following formula ...

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    2. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results

      Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results

      Aims Optical frequency domain imaging (OFDI) is a recently developed, light-based, high-resolution intravascular imaging technique. Intravascular ultrasound (IVUS) is a widely used, conventional imaging technique for guiding percutaneous coronary intervention (PCI). We aimed to demonstrate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. Methods and results We did a prospective, multicentre, randomized (ratio 1:1), active-controlled, non-inferiority study to compare head-to-head OFDI vs. IVUS in patients undergoing PCI with a second generation drug-eluting stent. The primary endpoint was target vessel failure defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven ...

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    3. Two-year vascular responses to drug-eluting stents with biodegradable polymer versus durable polymer: An optical coherence tomography sub-study of the NEXT

      Two-year vascular responses to drug-eluting stents with biodegradable polymer versus durable polymer: An optical coherence tomography sub-study of the NEXT

      Background This study aimed to compare very late vascular response after stent implantation between everolimus-eluting stent (EES) with a thin, non-adhesive, durable, biocompatible fluorinated polymer and biolimus-eluting stent (BES) with a biodegradable polymer by optical coherence tomography (OCT). Methods and results In the NOBORI-BES Versus XIENCE V/PROMUS-EES Trial (NEXT), a formal OCT substudy investigated 48 patients (27 EES-treated lesions in 23 patients and 28 BES-treated lesions in 25 patients) with 2-year (18–30 months) follow-up imaging at 18 centers. The percentage of uncovered strut by neointima was significantly lower in EES compared with BES (2.1 ± 4.7% vs ...

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    4. Is quantitative coronary angiography reliable in assessing the late lumen loss of the everolimus eluting bioresorbable polylactide scaffold in comparison with the cobalt chromium metallic stent?

      Is quantitative coronary angiography reliable in assessing the late lumen loss of the everolimus eluting bioresorbable polylactide scaffold in comparison with the cobalt chromium metallic stent?

      Aims: Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) with respect to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The present study aimed to assess the accuracy of QCA with reference to OCT in Absorb as compared to XIENCE.

       

       

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    5. 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 trial

      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 trial

      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 ...

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    6. 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

      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

      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 angiography 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 ...

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    7. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial

      Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial

      Background Optical coherence tomography is becoming increasingly widespread as an adjunctive intravascular diagnostic technique in percutaneous coronary intervention (PCI), because of its ability to visualize coronary structures at high resolution. Several studies have reported that intravascular ultrasound (IVUS) guidance in PCI might be helpful to reduce subsequent stent thrombosis, restenosis, repeat revascularization, myocardial infarction, and cardiac death. The OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial is aimed at evaluating the impact of optical frequency domain imaging (OFDI) guidance in PCI on clinical outcomes compared with IVUS guidance. Methods and design The OPINION trial is ...

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    8. The clinical characteristics and prognosis of lesions with in-stent eccentric tissue proliferation and strong signal attenuation detected by optical coherence tomography

      The clinical characteristics and prognosis of lesions with in-stent eccentric tissue proliferation and strong signal attenuation detected by optical coherence tomography

      There are still some patients who require repeat revascularization despite of drug-eluting stent (DES) implantation. The present study aimed to investigate the relationship between optical coherence tomography (OCT) findings and recurring target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for in-stent restenosis (ISR). We reviewed 50 patients (54 coronary lesions) who underwent PCI for ISR, which included 25 DES-ISR lesions. The PCI strategy depended on the interventionalist’s discretion, and DES implantation was performed for 38 (70 %) lesions. Tissue characteristics were assessed qualitatively and quantitatively using the frame showing maximal lumen narrowing (minimal lumen area). In qualitative analysis, OCT ...

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    9. Incidence and distribution of thin-high signals detected by coronary optical coherence tomography in patients treated with paclitaxel-coated balloon angioplasty for in-stent restenosis

      Incidence and distribution of thin-high signals detected by coronary optical coherence tomography in patients treated with paclitaxel-coated balloon angioplasty for in-stent restenosis

      Paclitaxel-coated balloon (PCB) angioplasty is one of the common treatments for patients with in-stent restenosis because its safety and efficacy has already been reported [1–3]. Meanwhile, optical coherence tomography (OCT) has great spatial resolution, which allows the observation of subtle changes in the coronary artery [4,5]. In a previous report, thin-high signals after PCB angioplasty were observed using OCT [6]. However, the incidence and distribution of thin-high signals have yet to be investigated.

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    10. Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up

      Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up

      Aims: Fully bioresorbable Absorb poly-L-lactic-acid (PLLA) scaffolds (Abbott Vascular, Santa Clara, CA, USA) are a novel approach for the treatment of coronary narrowing. Due to the translucency of the material (PLLA), the optical coherence tomography (OCT) measurement methods used in the ABSORB trials were unique but not applicable for permanent metallic stents. When the Absorb scaffold and metallic stents are compared in the context of randomised trials, it is challenging to compare the two devices using the conventional methods. The primary purpose of this report is to explain the biases in conventional methodologies applied for metallic stents and for PLLA ...

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    11. Comparison of neointimal coverage between everolimus-eluting stents and sirolimus-eluting stents: an optical coherence tomography substudy of the RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial)

      Comparison of neointimal coverage between everolimus-eluting stents and sirolimus-eluting stents: an optical coherence tomography substudy of the RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial)

      Aims: The aim of the present study was to compare vascular healing response between the first-generation sirolimus-eluting stent (SES) and the second-generation everolimus-eluting stent (EES) by using optical coherence tomography (OCT). Methods and results: The RESET was a prospective, multicentre, randomised, open-label trial comparing EES and SES. Of the 3,197 patients enrolled in the RESET, nine-month follow-up OCT after stent implantation was performed in 100 patients (48 EES-treated lesions in 44 patients and 62 SES-treated lesions in 56 patients), thus constituting the OCT substudy population. The percentage of uncovered struts per lesion (8±15% vs. 14±19%, p=0 ...

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    12. Early Phase Arterial Reaction Following Drug-Eluting and Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction Optical Coherence Tomography Assessment at 2 Weeks

      Early Phase Arterial Reaction Following Drug-Eluting and Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction Optical Coherence Tomography Assessment at 2 Weeks

      The early phase arterial reaction after implantation of second-generation drug-eluting stents (2nd DES) and baremetal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear. The MECHANISM pilot study is a multi-center prospective registry that enrolled 24 STEMI patients (from 11 centers) who had undergone implantation of everolimus-eluting ( n = 6), biolimus A9-eluting ( n = 6) or zotarolimus-eluting stents ( n = 6), or BMS ( n = 6). Scheduled optical coherence tomography (OCT) was performed 2 weeks after implantation, and images were independently analyzed at a core laboratory in a blinded fashion. Intra-stent thrombus was quantitatively analyzed in terms of the maximal area ...

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    13. Quantitative Optical Coherence Tomography Analysis for Late In-Stent Restenotic Lesions

      Quantitative Optical Coherence Tomography Analysis for Late In-Stent Restenotic Lesions

      Coronary optical coherence tomography (OCT) has the potential to identify in-stent neoatherosclerosis, which is a possible risk factor for late acute coronary events after drug-eluting stent implantation. The purpose of this study was to investigate differences between mid-term and late in-stent restenosis after stent implantation by quantitative and semiautomated tissue property analysis using OCT. In total, 1063 OCT image frames of 16 lesions in 15 patients were analyzed. This included 346 frames of 6 lesions in late in-stent restenosis, which was defined as restenosis that was not detected at 6 to 12 months but ≥ 12 months after follow-up coronary angiography ...

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    14. Outcomes of everolimus-eluting stent incomplete stent apposition: a serial optical coherence tomography analysis

      Outcomes of everolimus-eluting stent incomplete stent apposition: a serial optical coherence tomography analysis

      Aim The aim of the present study was to evaluate the natural course of acute incomplete stent apposition (ISA) after second-generation everolimus-eluting stent (EES) when compared with first-generation sirolimus-eluting stent (SES) by using optical coherence tomography (OCT). Methods and results From the OCT substudy of the RESET trial, we identified 77 patients (EES = 38 and SES = 39) who successfully underwent serial OCT examination at post-stenting and 8–12-month follow-up. The presence of ISA was assessed in the OCT images, and ISA distance was measured from the centre of the strut blooming to the adjacent lumen border. Incomplete stent apposition was ...

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    15. Vascular Response to Drug-Eluting Stent With Biodegradable vs. Durable Polymer

      Vascular Response to Drug-Eluting Stent With Biodegradable vs. Durable Polymer

      Background: The aim of the present study was to compare vascular healing response between everolimus-eluting stent (EES) and biolimus-eluting stent (BES) using optical coherence tomography (OCT). Methods and Results: In the NOBORI Biolimus-Eluting Versus XIENCE V/PROMUS Everolimus-Eluting Stent Trial (NEXT), a formal OCT substudy investigated 91 patients (55 EES-treated lesions in 48 patients and 51 BES-treated lesions in 43 patients) with 8–12 months follow-up imaging at 18 centers. A total of 980 frames with 8,996 struts in EES and 907 frames with 8,745 struts in BES were analyzed. Mean neointima thickness in EES and BES was ...

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    16. OCT Compared With IVUS in a Coronary Lesion Assessment The OPUS-CLASS Study

      OCT Compared With IVUS in a Coronary Lesion Assessment The OPUS-CLASS Study

      The aim of this study was to investigate the reliability of frequency domain optical coherence tomography (FD-OCT) for coronary measurements compared with quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). Background Accurate luminal measurement is expected in FD-OCT because this technology offers high resolution and excellent contrast between lumen and vessel wall. Methods In 5 medical centers, 100 patients with coronary artery disease were prospectively studied by using angiography, FD-OCT, and IVUS. In addition, 5 phantom models of known lumen dimensions (lumen diameter 3.08 mm; lumen area 7.45 mm 2 ) were examined using FD-OCT and IVUS. Quantitative image ...

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    17. Predominant microvessel proliferation in coronary stent restenotic tissue in patients with diabetes: Insights from optical coherence tomography image analysis

      Predominant microvessel proliferation in coronary stent restenotic tissue in patients with diabetes: Insights from optical coherence tomography image analysis

      Background Coronary optical coherence tomography (OCT) enables virtual depiction of histological findings of in-stent restenotic tissue. The aim of this study was to investigate the microvessel proliferation within in-stent restenotic tissue and the influence of diabetes mellitus (DM). Methods We examined 54 in-stent restenotic coronary artery lesions (stenotic area > 50%) from 50 consecutive patients including 28 with DM (56%) and 9 insulin-treated DM patients (18%); who underwent coronary time-domain OCT imaging with automatic pull back (1 mm/s, 20 frames/s). Microvessels were defined as low-signal cavities with a diameter of 50–150 microns and a trajectory parallel to the ...

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    18. Comparisons of Baseline Demographics, Clinical Presentation, and Long-Term Outcome Among Patients With Early, Late, and Very Late Stent Thrombosis of Sirolimus-Eluting Stents

      Comparisons of Baseline Demographics, Clinical Presentation, and Long-Term Outcome Among Patients With Early, Late, and Very Late Stent Thrombosis of Sirolimus-Eluting Stents
      Background— Stent thrombosis (ST) after sirolimus-eluting stent implantation has not yet been adequately characterized, mainly because of its low incidence. Methods and Results— The Registry of Stent Thrombosis for Review and Reevaluation (RESTART) is a Japanese nationwide registry of sirolimus-eluting stent–associated ST comprising 611 patients with definite ST (early [within 30 days; EST], 322 patients; late [between 31 and 365 days; LST], 105 patients; and very late [>1 year; VLST], 184 patients). Baseline demographics, clinical presentation, and long-term outcome of sirolimus-eluting stent–associated ST were compared among patients with EST, LST, and VLST. Baseline demographics were significantly different according ...
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    19. Quantitative coronary optical coherence tomography image analysis for the signal attenuation observed in-stent restenotic tissue

      Quantitative coronary optical coherence tomography image analysis for the signal attenuation observed in-stent restenotic tissue
      Pivotal clinical trials have shown that the drug-eluting stent (DES) ameliorated mid-term target lesion revascularization rate . Nevertheless, late catch up phenomenon is the growing concern in the patients with DES . Previous study has shown that the restenotic tissue after DES implantation shows thrombus formation or inflammatory cells even at chronic phase. Thromborestenosis should be the concern for the prevention of late stent thrombosis .
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    20. Incidence and significance of the pseudo stent strut in optical coherence tomography analysis for coronary artery stents

      Incidence and significance of the pseudo stent strut in optical coherence tomography analysis for coronary artery stents
      Introduction: Quantitative optical coherence tomography (OCT) analysis is about to be relevant for the correct assessment of incomplete stent apposition which can result to late stent thrombosis. Nevertheless, the pseudo stent struts (PS), which show the strong signal same as the true strut, are sometimes seen at odd positions in the lumen and locate at the same distance from the image wire as a true strut. PS may be produced by the distorted beam and interfere accurate analysis. Our aim was to investigate the incidence of PS. Methods: We created a simple phantom model (2.5 mm-coronary artery stent apposed ...
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    Incidence and significance of the pseudo stent strut in optical coherence tomography analysis for coronary artery stents Quantitative coronary optical coherence tomography image analysis for the signal attenuation observed in-stent restenotic tissue Comparisons of Baseline Demographics, Clinical Presentation, and Long-Term Outcome Among Patients With Early, Late, and Very Late Stent Thrombosis of Sirolimus-Eluting Stents Predominant microvessel proliferation in coronary stent restenotic tissue in patients with diabetes: Insights from optical coherence tomography image analysis OCT Compared With IVUS in a Coronary Lesion Assessment The OPUS-CLASS Study Vascular Response to Drug-Eluting Stent With Biodegradable vs. Durable Polymer Early Phase Arterial Reaction Following Drug-Eluting and Bare-Metal Stent Implantation in Patients With ST-Segment Elevation Myocardial Infarction Optical Coherence Tomography Assessment at 2 Weeks Comparison of neointimal coverage between everolimus-eluting stents and sirolimus-eluting stents: an optical coherence tomography substudy of the RESET (Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial) Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial KU Leuven leads €6 million research project on heart disease and dementia Gabor optical coherence tomographic angiography (GOCTA) (Part II): theoretical basis of sensitivity improvement and optimization for processing speed