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Background: Endovascular revascularization (ER) via percutaneous transluminal angioplasty (PTA) and stenting are viable options for revascularization in below-the-knee (BTK) peripheral arterial disease. Two-dimensional angiography has been the standard of practice for estimating vessel size and selecting treatment devices during ER. However, in other vascular territories, intravascular ultrasound (IVUS) offers better visualization of the lumen dimensions.Purpose: To compare angiographic and intravascular ultrasound reference vessel (lumen) measurements in below-the-knee peripheral artery interventions.Methods: Twenty consecutive patients were enrolled in the BTK Calibration study from 2 sites in the United States and Australia. Patients with at least one diseased segment in a native infra-popliteal artery (below-the-knee) and a clinical indication for endovascular therapy (EVT) were included with no limitations with regard to vessel diameter or lesion length. Digital subtraction angiography and IVUS imaging were collected pre- and post-PTA and images were sent to an independent core lab for standardized quantitative analysis of the normal-looking reference vessel dimensions when available. The results were presented as least square means with 95% confidence intervals and a p-value of <0.05 was considered significant.Results: The overall (N = 19) mean reference vessel diameter for QVA was 2.98 ± 1.24 mm vs. 3.47 ± 0.72 mm for IVUS (mean difference was -0.50 mm, (95% CI: -0.80, -0.20; p = 0.14). As expected, in the proximal segments (N = 12), the mean reference vessel diameters were larger: for QVA, it was 3.17 ± 1.34 mm vs. 3.55 ± 0.76 mm in IVUS, (mean difference was -0.38 mm, (95% CI: -0.79, 0.03; p = 0.40); while in the distal segments (N = 7), mean reference vessel diameters were smaller: for QVA, it was 2.64 ± 1.06 mm vs. 3.33 ± 0.67 mm in IVUS, (mean difference was -0.69 mm, (95% CI: -1.04, 0.34; p = 0.17). We observed a greater degree of acute gain in cases where the treatment balloon size correlated with the IVUS measured reference size.Conclusion: Angiography underestimates infrapopliteal reference vessel lumen size even when quantitatively assessed. Adjunctive IVUS imaging use in guiding BTK procedures could help ensure adequate sizing and possibly impact immediate post-procedure indices. [ABSTRACT FROM AUTHOR]

Background/purpose: Local hemodynamic forces such as endothelial shear stress (ESS) may have an influence on appropriate neointimal healing, vessel remodeling, and struts' absorption process following second-generation drug-eluting resorbable magnesium scaffold (RMS, Magmaris, Biotronik AG, Buelach, Switzerland) placement. The aim of this study was to investigate the impact of ESS assessed by optical coherence tomography (OCT)-based computational fluid dynamic (CFD) simulations on absorption process and coronary lumen dimension after Magmaris implantation.Methods and Results: A total of 22 patients who were enrolled in the BIOSOLVE-II trial and underwent serial OCT assessment immediately after Magmaris implantation and at 6- and 12-month follow-up were included. We evaluated qualitative OCT findings frame by frame, and CFD simulations were performed to calculate the ESS at 3-dimensional (3D) reconstructed arteries. For quantitative calculation, the average ESS within each 1-mm section was classified into three groups: low (<1.0 Pa), intermediate (1.0-2.5 Pa), or high (>2.5 Pa). A significant difference of percentage remnants of scaffold was observed among the 3 groups at 12-month follow-up (P = 0.001) but not at 6-month follow-up. Low-ESS segment at baseline resulted in a greater lumen change of -1.857 ± 1.902 mm2 at 1 year compared to -1.277 ± 1.562 mm2 in the intermediate-ESS segment (P = 0.017) and - 0.709 ± 1.213 mm2 in the high-ESS segment (P = 0.001).Conclusion: After Magmaris implantation, the presence of higher ESS might be associated with slower strut absorption process but less luminal loss. [ABSTRACT FROM AUTHOR]

Black patients presenting to the catheterization laboratory have more risk factors and worse long-term outcomes. This sub-analysis of the Lipid Rich Plaque (LRP) study quantifies the plaque burden and composition of Black vs White patients and associated outcomes. Patients with a singular, self-reported race presenting for cardiac catheterization were enrolled if near-infrared spectroscopy/intravascular ultrasound (NIRS-IVUS) imaging of non-stented, non-culprit (NC) vessels was performed. Lipidic content was quantified at the 4-mm region with maximum Lipid Core Burden Index (maxLCBI 4mm). NC major adverse cardiac events (NC-MACE) were defined as: cardiac death, cardiac arrest, non-fatal myocardial infarction, acute coronary syndrome, revascularization, and hospital readmission for angina with >20 % disease progression through 2 years. Among 1346 patients with a singular, self-reported race, 182 were Black. Black vs White patients were more likely to be female, had higher rates of traditional risk factors, and were more likely to present acutely. Both patients and segments were more likely to have maxLCBI 4mm > 400 (46.7 % vs 30.6 %, p < 0.001, respectively; 15.5 % vs 8.9 %, p < 0.001, respectively). Vessel size and plaque burden were larger for Black vs White patients. At 2 years, maxLCBI 4mm > 400 and Black race were independently predictive of NC-MACE (hazard ratio [HR] maxLCBI 4mm > 400: 2.37 [95 % confidence interval (CI) 1.50–3.76, p < 0.001], Black race: 2.8 [95 % CI 1.27–3.42, p = 0.004], p interaction = 0.137). Compared to White patients, Black patients had more lipid-rich plaques with greater plaque burden. Both high lipidic burden and Black race were independently predictive of NC-MACE within 2 years. https://clinicaltrials.gov/ct2/show/NCT02033694 , NCT02033694 • We analyze non-culprit plaque burden and composition in Black patients and MACE. • Black patients had more lipid-rich plaques and plaque burden than White patients. • Both high lipidic burden and Black race are predictive of non-culprit MACE. [ABSTRACT FROM AUTHOR]

It has been shown that statins preloading, before percutaneous coronary intervention (PCI), may reduce the risk of cardiovascular outcomes for acute coronary syndrome patients. Nevertheless, the effect of such pretreatment among patients with stable angina pectoris (SAP) is still debatable. We performed a systematic review and updated meta-analysis of the literature to evaluate the efficacy of short-term statins preloading on periprocedural myocardial infarction (PMI) incidence and mortality after PCI. We included 13 randomized control trials that examined statins preloading in adult patients with SAP undergoing PCI. While the use of preloading statins significantly reduced PMI, the benefit of statins pretreatment on long-term mortality was not statistically significant. SHORT SUMMARY: High dose statins preloading prior to elective PCI was associated with a significant reduction in PMI in SAP patients. The mortality benefit of such intervention will need to be addressed by further large randomized studies. The routine use of statins in stable patients before PCI should be considered if no contraindications are present. [ABSTRACT FROM AUTHOR]

Background/purpose: Intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) can identify vulnerable coronary atherosclerotic plaques. We aimed to compare the presence or absence of baseline intravascular imaging of non-culprit lesions and their subsequent adverse events.Methods/materials: We identified patients from the Lipid Rich Plaque (LRP) study who had a non-culprit-lesion adverse event and divided them into 2 cohorts: those with lesions detected with NIRS-IVUS imaging at baseline and those with lesions not imaged at baseline.Results: Overall, 73 patients had an adverse event (99 coronary segments) during the 24-month follow-up period. Among them, 41 patients (56.2%) had a non-culprit-lesion adverse event related to a coronary segment imaged at baseline, and 32 patients (43.8%) had a non-culprit-lesion adverse event adjudicated to a segment that was not scanned at baseline. Angiographic core laboratory analysis suggested that unscanned lesions were more often in the right coronary artery (~50%); branches of the left coronary artery, i.e., diagonal or left obtuse marginal arteries (~20%); smaller vessels; or more tortuous vessels; and less often in the left anterior descending or distal locations. There was a weak trend for acute severe events (adjudicated myocardial infarction and acute coronary syndrome) in patients with lesions not scanned at baseline (50.0% versus 36.6%, p = 0.250).Conclusions: In patients with follow-up non-culprit-lesion adverse events, nearly half were not imaged with NIRS-IVUS at baseline. Because events related to non-imaged lesions were at least as severe as events related to imaged lesions, future clinical trials and clinical protocols should be designed to minimize this issue.Clinical Trial Registration: The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694. [ABSTRACT FROM AUTHOR]

Background: Quantitative flow ratio (QFR) is a technology to evaluate the coronary stenosis significance on 3-dimensional quantitative coronary angiography. The aim of this study is to evaluate and compare the QFR versus fractional flow reserve (FFR) and/or instantaneous free-wave ratio (iFR) in a US population with a fair African American population representation.Methods and Results: This was a retrospective, observational and single-center study that enrolled 100 patients who underwent coronary angiography. The diagnostic performance of QFR in terms of sensitivity was 0.80 (95%CI 0.64-0.97) and specificity was 0.95 (95% CI 0.90-1.00), the positive predictive value (PPV) was 0.83 (0.68-0.98), while the negative predictive value (NPV) was 0.94 (0.88-0.99). The overall accuracy was 0.91 and area under the curve (AUC) was 0.92 (95% CI 0.87-0.97). The R-squared was 0.54 and the Bland-Altman plot showed a bias of 0.0016 (SD 0.063) and limits of agreement (LOA): Upper LOA 0.13 and Lower LOA -0.12. In African Americans (n = 33), accuracy, AUC, sensitivity, specificity (94%; 0.90 [0.80-1.00]; 0.90 [0.71-1.00]; 0.96 [0.87-1.00], respectively) were better than those for the overall population.Conclusions: In a US-based representative population, vessel QFR accuracy and agreement with FFR as reference is high. Diagnostic performance of QFR in African Americans is also excellent. [ABSTRACT FROM AUTHOR]

Background/purpose: The aim of this study is to characterize the pattern and the severity of coronary artery lesions in cardiac amyloidosis.Methods: We retrospectively compared patients with heart failure who tested positive (i.e., biopsy or gene tests - HF/CA+) against those who tested negative (HF/CA-) for cardiac amyloidosis. Groups were compared demographically and angiographically for qualitative and quantitative variables to determine patterns of involvement in the major epicardial coronary vessels.Results: The study included 110 heart failure patients, of whom 55 patients (88 lesions) were in the HF/CA+ group, and 55 patients (66 lesions) were HF/CA-. Despite the advanced age of HF/CA+ patients (74.5 ± 11.0 years vs. 54.1 ± 15.0 years; p = 0.05), no severe calcification was found in the HF/CA+ group (0.0% vs. 4.5%; p = 0.018). The HF/CA+ group also had fewer ostial lesions (3.4% vs. 15.1%; p = 0.0095) and a higher, albeit not significant, Thrombolysis in Myocardial Infarction frame count (30.4 ± 12.6 vs. 26.6 ± 11 frames; p = 0.06). In the HF/CA+ group, men had a significant number of tandem lesions compared to women (14.5% vs 0.0%, p = 0.02).Conclusions: Overall, heart failure patients with cardiac amyloidosis were older but were found to have less calcified lesions, less ostial involvement, and a reduced anterograde coronary blood flow. This is the first report examining coronary lesions in heart failure patients with cardiac amyloidosis. [ABSTRACT FROM AUTHOR]

Background: Double kissing (DK) crush stenting has been reported as a superior bifurcation stenting strategy compared to culotte stenting. However, the mechanism associated with the reduction of clinical events by DK crush stenting remains unclear. We therefore investigated the thrombogenicity of DK crush stenting and culotte stenting with both bare-metal stents (BMS) and drug-eluting stents (DES) and the feasibility of a novel porcine arteriovenous shunt model.Methods: High-resolution intracoronary imaging with optical coherence tomography (OCT) evaluated the bifurcation stenting models for thrombogenicity.Results: All porcine models retained continuous circulation without blood leakage. Thrombus was macroscopically demonstrated around the bifurcation in all settings. The volume of thrombus (mm3) with BMS using DK crush/culotte and DES using DK crush/culotte were 1.38/1.19 and 0.09/0.15, respectively. Culotte stenting had more thrombus in the proximal main branch, and DK crush stenting had more at the bifurcation. Unlike DK crush stenting, culotte stenting showed malapposition in the proximal main branch and bifurcation segments.Conclusion: The feasibility of a porcine arteriovenous shunt model to assess thrombogenicity by OCT in bifurcation stenting technique was confirmed. OCT detected less thrombogenicity in DES when used in the bifurcation model when compared to BMS. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to examine DNA ligase activity and expression of DNA damage response pathway (DDR) genes in patients with stable angina (SA) and non-ST elevation myocardial infarction (NSTEMI) and determine whether they correlate with plaque morphology.Background: Patients with coronary artery disease (CAD) have evidence of deoxyribonucleic acid (DNA) damage in peripheral blood mononuclear cells (PBMCs). It is unclear whether this represents excess damage or defective DNA repair activity.Methods: DNA ligase activity and the expression of 22 DDR genes were measured in PBMCs of patients (both SA (n = 47) and NSTEMI (n = 42)) and in age and gender-matched controls (n = 35). Target lesion anatomical assessment was undertaken with frequency domain optical coherent tomography.Results: DNA ligase activity was different across the three groups of patients (control = 119 ± 53, NSTEMI = 115.6 ± 85.1, SA = 81 ± 55.7 units/g of nuclear protein; ANOVA p = 0.023). Pair wise comparison demonstrated that this significance is due to differences between the control and SA patients (p = 0.046). Genes involved in double strand break repair and nucleotide excision repair pathways were differentially expressed in patients with SA and NSTEMI. In SA patients, fibrocalcific plaques were strongly associated with GTSE1, DDB1, MLH3 and ERCC1 expression. By contrast, in NSTEMI patients the strongest association was observed between fibrous plaques and ATM and XPA expression.Conclusion: PBMCs from patients with CAD exhibit differences in DNA ligase activity and expression of DDR genes. Expression levels of certain DDR genes are strongly associated with plaque morphology and may play a role in plaque development and progression. Trial Registration Number URL: www.Clinicaltrials.gov; NCT02335086. [ABSTRACT FROM AUTHOR]

Introduction and Objective: The edge vascular response (EVR) remains unknown in second generation drug-eluting Resorbable Magnesium Scaffold (RMS), such as Magmaris. The aim of the study was to evaluate tissue modifications in the RMS edges over time, assessed by different invasive imaging modalities.Methods: The patients treated with the device were assessed by optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS at baseline and 12 months. The EVR study performed a segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS.Results: The segment-level grayscale IVUS (n = 10), virtual histology IVUS (n = 10), and OCT (n = 18) analysis did not show any significant changes after 12 months, except for a fibrous plaque area (FPA) reduction of 0.5mm2 (p = 0.017) in the proximal segment compared to baseline. In the frame-level analysis, IVUS evaluation revealed a vessel area decreased 2.80 ± 1.43 mm2 (p = 0.012) and 2.49 ± 1.53 mm2 (p = 0.022) in 2 proximal frames. This was accompanied by plaque area reduction of 0.88 ± 0.70 mm2 (p = 0.048) and a FPA decreased by 0.63 ± 0.48 mm2 (p = 0.004) in one proximal frame. In 1 distal frame, there was a dense calcium area reduction of 0.10 ± 0.12 mm2 (p = 0.045), FPA and fibrous fatty plaque increased 0.54 ± 0.53 mm2 (p = 0.023) and 0.17 ± 0.16 mm2 (p = 0.016), respectively. By OCT, there was a lumen area decrease of 0.76 ± 1.51 mm2 (p = 0.045) in a distal frame.Conclusion: At 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment. This could be translated as a benign healing process at the edges of the RMS.Summary: The edge vascular response (EVR) remains unknown in second generation drug-eluting absorbable metal scaffolds (RMS), such as Magmaris. Patients treated with the device were assessed by multi invasive imaging modalities [i.e. optical coherence tomography (OCT), grayscale intravascular ultrasound (IVUS), and virtual histology IVUS] evaluating the tissue changes over time in the segment- and frame-level analysis of the 5 mm segments proximal and distal of the actual RMS. As a result, after 12 months, Magmaris EVR assessment does not show overall significant changes, except for a fibrous plaque area reduction in the proximal segment, translating a benign healing process at the edges of the RMS. [ABSTRACT FROM AUTHOR]