Aims: The aim of this study was to assess the acute performance of the 95 mu m ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the XIENCE metallic drug-eluting stent (DES... Show moreAims: The aim of this study was to assess the acute performance of the 95 mu m ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the XIENCE metallic drug-eluting stent (DES) in porcine coronary arteries.Methods and results: In 15 non-atherosclerotic Yucatan mini pigs, the ArterioSorb (3.0/14 mm) and XIENCE (3.0/15 mm) were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of the coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two aims. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post procedure was comparable between ArterioSorb and XIENCE (2.21 +/- 1.97 vs 2.25 +/- 1.71 Pa, p=0.314).Conclusions: Acute recoil, luminal dimensions and ESS in the ArterioSorb oriented PLLA scaffold with thin struts of 95 mu m were comparable to those in the XIENCE metallic DES. Show less
Kogame, N.; Takahashi, K.; Tomaniak, M.; Chichareon, P.; Modolo, R.; Chang, C.C.; ... ; Onuma, Y. 2019
OBJECTIVES The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel... Show moreOBJECTIVES The aim of this study was to investigate the impact of post-percutaneous coronary intervention (PCI) quantitative flow ratio (QFR) on clinical outcomes in patients with de novo 3-vessel disease (3VD) treated with contemporary PCI.BACKGROUND The clinical impact of post-PCI QFR in patients treated with state-of-the-art PCI for de novo 3VD is undetermined.METHODS All vessels treated in the SYNTAX (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery) II trial were retrospectively screened and analyzed for post-PCI QFR. The primary endpoint of this substudy was vessel-oriented composite endpoint (VOCE) at 2 years, defined as the composite of vessel-related cardiac death, vessel-related myocardial infarction, and target vessel revascularization. The receiver-operating characteristic curve was used to calculate the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE. All the analyzable vessels were stratified on the basis of the optimal cutoff value.RESULTS A total of 968 vessels treated with PCI were screened. Post-PCIQFR was analyzable in 771 (79.6%) vessels. A total of 52 (6.7%) VOCEs occurredat 2 years. The mean value of post-PCIQFR was 0.91 +/- 0.07. The diagnostic performance of post-PCI QFR to predict 2-year VOCE was moderate (area under the curve: 0.702; 95% confidence interval: 0.633 to 0.772), with the optimal cutoff value of post-PCI QFR for predicting 2-year VOCE 0.91 (sensitivity 0.652, specificity 0.635). The incidence of 2-year VOCE in the vessels with post-PCIQFR<0.91 (n = 284) was significantly higher compared with vessels with post-PCI QFR >= 0.91 (n = 487) (12.0% vs. 3.7%; hazard ratio: 3.37; 95% confidence interval: 1.91 to 5.97; p < 0.001).CONCLUSIONS A higher post-PCI QFR value is associated with improved vessel-related clinical outcomes in state-of the art PCI practice for de novo 3VD. Achieving a post-PCI QFR value >= 0.91 in all treated vessels should be a target when treating de novo 3VD. These findings require confirmation in future prospective trials. (C) 2019 by the American College of Cardiology Foundation. Show less
Optical coherence tomography based computational flow dynamic (CFD) modeling provides detailed information about the local flow behavior in stented/scaffolded vessel segments. Our aim is to... Show moreOptical coherence tomography based computational flow dynamic (CFD) modeling provides detailed information about the local flow behavior in stented/scaffolded vessel segments. Our aim is to investigate the in-vivo effect of strut thickness and strut protrusion on endothelial wall shear stress (ESS) distribution in ArterioSorb Absorbable Drug-Eluting Scaffold (ArterioSorb) and Absorb everolimus-eluting Bioresorbable Vascular Scaffold (Absorb) devices that struts with similar morphology (quadratic structure) but different thickness. In three animals, six coronary arteries were treated with ArterioSorb. At different six animals, six coronary arteries were treated with Absorb. Following three-dimensional(3D) reconstruction of the coronary arteries, Newtonian steady flow simulation was performed and the ESS were estimated. Mixed effects models were used to compare ESS distribution in the two devices. There were 4591 struts in the analyzed 477 cross-sections in Absorb (strut thickness=157 mu m) and 3105 struts in 429 cross-sections in ArterioSorb (strut thickness=95 mu m) for the protrusion analysis. In cross-section level analysis, there was significant difference between the scaffolds in the protrusion distances. The protrusion was higher in Absorb (97% of the strut thickness) than in ArterioSorb (88% of the strut thickness). ESS was significantly higher in ArterioSorb (1.52 +/- 0.34Pa) than in Absorb (0.73 +/- 2.19Pa) (p=0.001). Low- and very-low ESS data were seen more often in Absorb than in ArterioSorb. ArterioSorb is associated with a more favorable ESS distribution compared to the Absorb. These differences should be attributed to different strut thickness/strut protrusion that has significant effect on shear stress distribution. Show less
OBJECTIVES The aims of the present study were to investigate the applicability of quantitative flow ratio (QFR) in patients with 3-vessel disease and to demonstrate the impact of functional SYNTAX ... Show moreOBJECTIVES The aims of the present study were to investigate the applicability of quantitative flow ratio (QFR) in patients with 3-vessel disease and to demonstrate the impact of functional SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score derived from QFR (fSS(QFR)) on clinical outcomes.BACKGROUND The applicability of QFR in patients with 3-vessel disease and the feasibility of fSS(QFR) have not yet been investigated.METHODS All lesions interrogated using instantaneous wave-free ratio and/or fractional flow reserve in the SYNTAX II trial were retrospectively screened and analyzed for QFR. The diagnostic performance of QFR was investigated using hybrid wire-derived pressure assessment (instantaneous wave-free ratio and fractional flow reserve), used in the trial as a reference. Patients with analyzable QFR in 3 vessels were stratified according to fSS(QFR) to evaluate its clinical prognostic value on the basis of 2-year patient-oriented composite endpoint.RESULTS QFRs were analyzable in 71.0% of lesions (836 lesions). The diagnostic performance of QFR to predict binary wire-based ischemia was substantial (area under the curve 0.81, accuracy 73.8%), with a positive predictive value of 85.9%. Independent predictors of diagnostic discordance were lesions in side branches, involvement of bifurcation or trifurcation, and small vessel. According to the 2-year patient-oriented composite endpoint, fSS(QFR) reclassified 26.1% of the patients (36 of 138) in the high-to intermediate-risk group into the low-risk group appropriately (net reclassification improvement 0.32; p < 0.001). The area under the curve for fSS(QFR) to predict the 2-year patient-oriented composite endpoint was higher than that of the classic anatomic SYNTAX score (0.68 vs. 0.56; p = 0.002).CONCLUSIONS QFR demonstrated substantial applicability in patients with 3-vessel disease. The fSS(QFR) has the potential to further refine prognostic risk estimation compared with the classic anatomic SYNTAX score. (c) 2019 by the American College of Cardiology Foundation. Show less
AIMS: The aim of this study was to assess in vitro the diagnostic accuracy of computed tomography angiography (CTA) for the evaluation of complex coronary lesions.METHODS AND RESULTS: Five... Show moreAIMS: The aim of this study was to assess in vitro the diagnostic accuracy of computed tomography angiography (CTA) for the evaluation of complex coronary lesions.METHODS AND RESULTS: Five Plexiglas phantoms with three bifurcation lesions each were designed to mimic the anatomic variations and fractal phenomena of the coronary tree. In addition, luminal stenoses were scaled up with increases of 10% from 40% to 80%, corresponding to luminal areas ranging from 3.0 mm2 to 0.22 mm2. Third-generation dual-source computed tomography was used. Automated quantitative CTA analysis was performed according to the bifurcation segment model. The primary objective was to determine the diagnostic accuracy of quantitative CTA in assessing bifurcation lesions with the phantoms as a reference. The accuracy of CTA for the assessment of minimal luminal diameter was -0.07 mm (limits of agreement -0.75 to 0.61), for reference vessel diameter 0.19 mm (limits of agreement -0.25 to 0.63) and diameter stenosis 8.2% (limits of agreement -13.2 to 29.5) with no difference regarding the location within the bifurcation (i.e., proximal and distal main vessel and side branch). In stenosis with minimal luminal diameter <= 1 mm, CTA overestimated the lesion severity (bias 0.19 mm, limits of agreement -0.09 to 0.47), whereas in lesions with severe stenosis and minimal luminal diameter >= 1 mm, CTA underestimated the lesion severity (bias -0.48 mm, limits of agreement -0.55 to -0.41). CTA was able to identify the contrast-filled lumen in all degrees of lesion severity.CONCLUSIONS: In vitro, CTA is accurate for the evaluation of bifurcation lesions. CTA was able to distinguish contrast-filled lumen even in severe obstructive lesions. These findings require further validation in the clinical setting. Show less
