Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time

Endovascular treatment of a giant infected ascending aortic pseudoaneurysm with occlusion device and coil embolization.

A patient with recurrent sepsis caused by an infected ascending aortic pseudoaneurysm was deemed unsuitable for surgery after the heart team evaluation. He successfully underwent percutaneous treatment with a combination of a septal occlusion device and coil embolization and remained free of sepsis 24 months after implantation

Motorized fractional flow reserve pullback : accuracy and reproducibility

Objectives: The present study aimed at determining the accuracy and reproducibility of motorized FFR pullbacks in patients with stable coronary artery disease. Background: Fractional flow reserve (FFR) is recommended for decision making regarding myocardial revascularization. The distribution of epicardial resistance along coronary vessels can be assessed using FFR pullbacks. Methods: Duplicated FFR pullbacks were acquired using a motorized device at a speed of 1 mm/s in intermediate coronary stenosis. In addition, a single FFR value was measured at an anatomical landmark. The agreement between FFR measurements was assessed using the Bland\u2013Altman method, Pearson's correlation coefficient and area under the pullback curve (AUPC). Results: In 20 vessels, 37,326 FFR values were obtained. The mean FFR from the pullbacks was 0.91 \ub1 0.08 whereas the mean FFR at the distal location was 0.85 \ub1 0.09. The mean difference between pullbacks was 120.002 (LOA 120.058 to 0.054). The difference in AUPC between the two FFR pullbacks was 2.1 \ub1 1.6%. At pre-specified anatomical locations, the mean difference between the FFR derived from the pullback data and the measured FFR was 0 (LOA 120.040 to 0.039). The repeatability of the distal FFR measurement was high (bias 120.003, LOA 120.046 to 0.041). Conclusion: A motorized FFR pullback was accurate to assess the distribution of epicardial resistance in patients with intermediate coronary artery disease. The reproducibility of the FFR pullback was high. Further studies are required to determine the potential usefulness of a hyperemic FFR pullback strategy for decision making and treatment planning

P853Guiding myocardial revascularization by computer assisted interpretation of FFR pullback curves: an agreement study with actual standard of care

Abstract Background Guidelines recommend hemodynamic/functional assessment to guide treatment decision making in stable coronary artery disease. A Fractional flow reserve (FFR) motorized pullback allows a reproducible assessment of the distribution of pressure drop generated by coronary artery disease along the vessel and may provide more relevant hemodynamic information than a single distal FFR value. Purpose We aimed to assess the agreement between the revascularization strategy guided by coronary angiogram and a single distal FFR value interpretation (standard of care, SOC), and a treatment recommendation by a fully automated analysis of pullback FFR curves by an in-house developed computer-based algorithm (CBA). Methods Pullback FFR curves were recorded under continuous intra-venous adenosine in patients with intermediate coronary stenosis by using a motorized device working at a speed of 1 mm/s (Volcano R 100) set to grip a pressure wire. A proprietary algorithm (JD, Mathematica v.11) was applied to: 1) assess the distal FFR on the last 5 mm of the curves, 2) discriminate a stepwise from a progressive decrease of FFR, 3) propose a treatment strategy between optimal medical treatment (OMT), PCI (including the number, length(s) and position(s) of the stent) or CABG, 4) evaluate the post PCI expected change in FFR. A concordance analysis between effective and CBA recommended treatment was performed. Only curves with distal FFR ≤0.85 were included into the analysis. If post PCI FFR was recorded, CBA predicted and measured post PCI FFR were compared. Results 50 vessels from 43 patients (75% LAD, 10% Cx, 15% RCA) with a distal FFR of 0.78±0.08 were assessed. A revascularization was performed in 29 vessels (24 PCI, 5 CABG). Post PCI FFR pullback was recorded in 11 vessels. Compared to SOC, a similar proportion of vessels was referred for revascularization by CBA (56 vs. 58% respectively, Chi2 0.041, p NS). Agreement between SOC and CBA, regarding the need of a revascularization, was observed in 76% of cases. Observed Cohen's Kappa coefficient for OMT, PCI or CABG revascularization strategy was 0.48 (CI 95%: 0.26–0.7). A mismatch between SOC and CBA strategy was observed in 30% (n=15) of vessels. A post hoc examination of FFR pullback curves showed that CBA decision might have been appropriate in 80% of these mismatches. Reclassification of treatment strategy by CBA was related to misinterpretation of one single FFR value (40%, n=6), incorrect detection of significant stepwise decrease in FFR (33%, n=5) and incorrect detection of progressive decrease in FFR (7%, n=1) by SOC approach. A mean bias of 0.01 (CI 95% −0.05–0.07) was observed between CBA predicted and measured post PCI FFR. Conclusion CBA recommended treatment differs from SOC treatment in almost 1/3 of vessels. CBA of FFR pullback curves offers new opportunity to guide myocardial revascularization stategy and warrants further prospective evaluation. </jats:sec

P855Evaluation of epicardial coronary resistance using computed tomography angiography

Abstract Background A Fractional flow reserve (FFR) pullback allows assessing the distribution of pressure loss along the vessel. FFR derived from CT (FFRCT) provides a virtual pullback curve that may also aid in the assessment of epicardial coronary resistance in the non-invasive setting. Purpose The present study aims to determine the accuracy of the virtual FFRCT pullback curve using a motorized invasive FFR pullback as reference in patients with stable coronary artery disease. Methods This is a single centre, prospective study of patients with stable coronary artery disease in whom FFRCT was performed as standard of care for non-invasive assessment. Patients referred to coronary angiography with clinically indicated invasive FFR measurement were included. FFRCT and invasive FFR values were extracted from coronary vessels every 1 mm to generate pullback curves. Invasive FFR pullbacks were acquired using a dedicated device at a speed of 1 mm/s. The area under the pullback curve (AUPC), defined as the sum of areas under the FFR pullback curve, was compared between FFRCT and invasive FFR pullbacks. Lesions were defined based on invasive angiography. FFR gradients in lesions and non-obstructive segments were defined as the difference between FFR values at the proximal and distal edge of the segments. FFR vessel gradient was defined as the difference between the most distal FFR value and the FFR at the ostium of the vessel. Mixed effect model was used to account for the correlation of FFR values within vessels. The agreement between FFRCT and FFR gradients was assessed using the Passing Bablok regression analysis and Bland-Altman methods at the vessel, lesion and non-obstructive level. Results A total of 3172 matched FFRCT and FFR values were obtained in 24 vessels. The correlation coefficient between FFRCT and FFR was 0.76 (95% CI 0.75 to 0.78; p&lt;0.001). The mean difference between the FFRCT and invasive FFR pullback values was 0.07 (LOA −0.11 to 0.24). AUPC was similar between FFRCT and invasive FFR (79.0±16.1 vs. 85.3±16.4, p=0.097); the mean slope of FFRCT pullback curve was steeper compared to invasive FFR (p&lt;0.001). The mean difference in lesion gradient was −0.07 (LOA −0.26 to 0.13) and −0.01 (LOA −0.06 to 0.05) in non-obstructive segments. There were no systematic or proportional differences between FFRCT and FFR gradients either in lesion or non-obstructive segments); however, vessel gradients were overestimated by FFRCT with a bias of −0.12 (LOA −0.35 to 0.12) driven by a higher mean difference in lesion gradients (−0.07; 95% CI −0.26 to 0.13). Conclusions The evaluation of epicardial coronary resistance using coronary CT angiography with FFRCT was feasible. FFRCT pullbacks were accurate in the assessment of lesion and non-obstructive gradients. FFRCT can identify the physiological pattern of coronary artery disease in the non-invasive setting. </jats:sec

P854Physiological patterns of coronary artery disease

Abstract Background Randomised controlled trials have confirmed the clinical benefit of invasive functional assessment to guide clinical decision making about myocardial revascularisation in patients with stable coronary artery disease. Treatment decision is based on one FFR value which provides a vessel-level metric as a surrogate of myocardial ischaemia. Also, the distribution of epicardial conductance can be evaluated using an FFR pullback manoeuvre. Purpose The objective of the present study is to characterise the physiological patterns of CAD using motorised coronary pressure pullbacks during continuous hyperaemia in patients with stable coronary artery disease. Methods Prospective, multicentre study of patients undergoing clinically-indicated coronary angiography. A pullback device, adapted to grip the coronary pressure wire, was set at a speed of 1 mm/sec. The pattern of CAD was adjudicated by visual inspection of the FFR pullback curves as focal, diffuse, or a combination of both mechanisms. Also, a quantitative classification of the physiological pattern of CAD was performed based on (1) the functional contribution of the epicardial lesion in relation to the total vessel FFR (Δlesion FFR/Δvessel FFR) and (2) the length (mm) of epicardial coronary segments with FFR drops in relation to the total vessel length. The combination of these two ratios, namely, lesion-related pressure drops (%FFR-lesion), and the extent of functional disease, resulted in the functional outcomes index (FOI), a metric that represents the pattern of CAD (i.e. focality or diffuseness) based on coronary physiology. Agreement on CAD patterns and between observers was assessed using Fleiss' Kappa. Analysis of variance (ANOVA) was used to compared quantitative variables. Correlation between variables was assessed by the Pearson moment coefficient. Results One hundred and fifty-eight vessels were included; 984,813 FFR values were used to generate the FFR pullback curves. Using motorised FFR pullbacks, 34% of the vessel disease patterns (i.e. focal, diffuse or combined) were reclassified compared to conventional angiography. The mean contribution of the angiographic lesions to the distal FFR (%FFR-lesion) was 61.7±25% whereas vessel length with the physiological disease was 59.8±21% of the total vessel length. The mean FOI was 0.61±0.17, and differentiated focal from diffuse CAD in terms of %FFR-lesion (p&lt;0.001) and physiological extent of CAD (p&lt;0.001). Conclusion Coronary angiography was inaccurate to assess the patterns of CAD. The inclusion of the functional component reclassified 34% of the vessel disease patterns (i.e. focal, diffuse or combined). A new metric, the FOI, based on the functional impact of anatomical lesions and the extent of physiological disease, discriminated focal from diffuse CAD. Further clinical trials are required to evaluate the usefulness of FOI for clinical decision making and outcomes. </jats:sec

Evaluation of epicardial coronary resistance using computed tomography angiography: A Proof Concept

AIMS: Fractional flow reserve (FFR) pullback allows to assess the distribution of pressure loss along the coronary vessels. FFR derived from CT (FFRCT) provides a virtual pullback curve that may also aid in the assessment of the distribution of epicardial coronary resistance in the non-invasive setting. The present study aims to determine the accuracy of the virtual FFRCT pullback curve using a motorized invasive FFR pullback as reference in patients with stable coronary artery disease. METHODS AND RESULTS: FFR values were extracted from coronary vessels at approximately 1 mm to generate pullback curves. Invasive motorized FFR pullbacks were acquired using a dedicated device at a speed of 1 mm/s. A total of 3172 matched FFRCT and FFR values were obtained in 24 vessels. The correlation coefficient between FFRCT and FFR was 0.76 (95%CI 0.75 to 0.78; p < 0.001). The area under the pullback curve was similar between FFRCT and invasive FFR (79.0 ± 16.1 vs. 85.3 ± 16.4, p = 0.097). The mean difference in lesion gradient between FFRCT and FFR was -0.07 (LOA -0.26 to 0.13) whereas in non-obstructive segments was -0.01 (LOA -0.06 to 0.05). CONCLUSION: The evaluation of epicardial coronary resistance using coronary CT angiography with FFRCT was feasible. FFRCT virtual pullback appears to be accurate for the evaluation of pressure gradients. FFRCT has the potential to identify the pathophysiological pattern of coronary artery disease in the non-invasive setting