Functional effects of vascular lesions

Abstract

A method and apparatus for determining the functional impact of vascular pathology is disclosed. An exemplary method includes calculating an estimate of a single functional flow metric (e.g., fractional flow reserve calculated from angiographic images) for multiple locations on each of multiple connected vascular branches. The method includes converting the estimate into an FFR impact score that indicates the overall impact of occlusive vascular disease on the connected vascular branches.

Description

Technical Field

[0001] In some embodiments, the present invention relates to the field of vascular imaging, and more particularly, to the determination of vascular conditions using vascular images.

Background Art

[0002] Cardiac catheterization is a diagnostic test that enables a physician to evaluate coronary artery stenosis based on angiography and determine the need for further treatment. Additional imaging methods such as intravascular ultrasound (IVUS) and fractional flow reserve (FFR) may be performed together with cardiac catheterization to obtain detailed images of the blood vessel walls. Following the diagnostic procedure, various treatment options are considered. Treatment may include pharmacotherapy, coronary angioplasty (with or without coronary stenting), or coronary artery bypass surgery. Treatment aims to reduce symptoms or eliminate them and reduce the risk of heart attack.

[0003] Fractional flow reserve (FFR) is a blood pressure management technique used to measure the blood pressure gradient across a coronary artery stenosis to determine the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum blood flow in a normal coronary artery. The use of FFR information has the potential to improve PCI decision-making and outcomes. For example, in the FAME trial (Non-Patent Document 1), 1005 patients were randomly assigned to FFR-guided angiography with a cut-off point of ≤ 0.80 as the basis for determining treatment (with or without PCI) and estimated visual assessment (angiography) alone. Highlights of the study results include the following. · 30% of the patients who were deemed to need stents by estimated visual assessment did not need to receive stents when evaluated by FFR. · The number of stents used was approximately one-third more when the PCI decision was based on angiography alone compared to when it was based on FFR (2.7 vs. 1.9, P < 0.001). · The major adverse cardiac events (MACE) after one year were higher in the visual angiographic evaluation arm compared to the FFR arm (18.3% vs. 13.2%, P < 0.02). · The average surgical unit price for patients evaluated by FFR was 11.2% lower compared to angiography alone.

Prior Art Documents

Non-Patent Documents

[0004]

Non-Patent Document 1

Summary of the Invention

Means for Solving the Problems

[0005] In some embodiments of the present disclosure, a method for estimating the clinical state of a vascular portion, comprising: receiving a map of fractional flow reserve (FFR) that assigns a plurality of fractional flow reserve ratio (FFR) values to specific locations on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and calculating an FFR impact score using the mapped FFR values, wherein an element of the FFR impact score discards, calculates the mapping of the FFR values to the specific locations, is provided.

[0006] In some embodiments, the map of FFR assigns FFR values to the specific locations continuously or substantially continuously.

[0007] In some embodiments, the map of FFR includes at least five FFR values for each of at least four vascular segments.

[0008] In some embodiments, the map of FFR represents the contribution to the reduction of blood flow capacity from an upstream position common to each of the specific positions.

[0009] In some embodiments, the vascular tree models a plurality of vascular extents of the vascular portions connected at branch points, and each of the vascular segments extends between two of a starting point of the vascular tree, a first vascular branch point, a second vascular branch point, and a non-connected end of the vascular tree.

[0010] In some embodiments, the FFR impact score includes a plurality of score elements, each of which retains an association with a particular one of the plurality of vascular segments while discarding the mapping of the FFR value to the specific position.

[0011] In some embodiments, the plurality of score elements includes a total drop score for each of the plurality of vascular segments, and the total drop score represents the total drop in FFR along the vascular segment from a reference value representing a non-occluded vascular system.

[0012] In some embodiments, the method includes assigning an occluded or non-occluded state to each of the plurality of vascular segments based at least on the total drop score for that segment, counting the number of occluded vascular segments, and providing that total number as a multi-vascularity score that is a score element of the FFR impact score. including.

[0013] In some embodiments, the plurality of score elements includes a maximum drop score for each of the plurality of vascular segments, which represents the maximum drop in FFR along the defined portion of the vascular segment that is shorter than the entire vascular segment.

[0014] In some embodiments, the defined portion is about 10 mm3 and a distance within which the blood volume between about 100 mm 3 is accommodated.

[0015] In some embodiments, the defined portion is a distance within which a blood volume of about 40 mm 3 is accommodated.

[0016] In some embodiments, the method includes assigning a blocked or unblocked state to each of the plurality of vascular segments based at least on the maximum drop score for that segment, counting the number of blocked vascular segments, and providing the total number as a multi-vascularity score that is a scoring element of the FFR impact score.

[0017] In some embodiments, the plurality of scoring elements includes a diffusivity score representing a measure of how widely lesions contributing to the total drop in FFR are distributed along each of the plurality of vascular segments.

[0018] In some embodiments, calculating the vascular drop diffusivity score includes determining the degree to which the maximum drop score differs from the total drop score.

[0019] In some embodiments, calculating the vascular drop diffusivity score includes calculating a ratio of the total drop score to the maximum drop score.

[0020] In some embodiments, the plurality of scoring elements includes a severity score representing a weighted average of the FFR at all positions within the vascular tree (weighted downwardly for positions further from the origin of the vascular tree).

[0021] In some embodiments, the plurality of scoring elements includes one or more scoring elements associated with a segment including the left main coronary artery up to the first bifurcation point of the left main coronary artery represented within the vascular tree.​

[0022] In some embodiments, the FFR impact score includes a sorted value chart score element representing the FFR value of each of the plurality of vascular segments in a composite value sort order such that values from different vascular segments are interleaved with each other.

[0023] In some embodiments, the method includes displaying the sorted value chart score element as a color-coded pie chart.

[0024] In some embodiments, the FFR impact score includes a histogram chart score element representing the FFR value of each of the plurality of vascular segments in a composite histogram, and the contribution of each FFR value to the histogram is weighted according to the size of the vascular volume in which the FFR value occurs internally.

[0025] In some embodiments, the FFR impact score includes a score element that describes the lesion length based on the distance over which the FFR value decreases continuously.

[0026] In some embodiments, the FFR impact score includes a score element that describes the lesion geometry as one or more of those including both the main vessel and the collateral, those including at least two of the main vessel and its branches, those occurring within the aortic inlet vascular segment, those occurring adjacent to a bend region of the vascular system, those occurring within a bend region of the vascular system.

[0027] In some embodiments, the method includes adjusting the FFR impact score based on a corrected FFR map that is corrected according to one or more of automated virtual stenting, manual stent selection, data measured after stent placement, data measured through multiple diagnostic procedures.

[0028] In some embodiments, the method includes comparing the FFR impact score with a second FFR impact score calculated according to the method of claim 1, and estimating the progression rate of the vascular disease.

[0029] In some embodiments, the method includes scheduling further diagnostic procedures based on the estimation.

[0030] In some embodiments, the method includes planning a treatment procedure based on the FFR impact score.

[0031] In some embodiments, the method includes making a selection between OMT and PCI based on the FFR impact score.

[0032] In some embodiments, the method includes making a selection between PCI and CABG treatment based on the FFR impact score.

[0033] In some embodiments, the method includes planning at least one of the number, position, and / or type of stents to be deployed based on the FFR impact score.

[0034] In some embodiments, the method includes planning at least one of the number and / or position of CABG grafts to be deployed based on the FFR impact score.

[0035] In some embodiments of the present disclosure, a method for estimating the clinical condition of a vascular portion, receiving a map of FFR that assigns a plurality of fractional flow reserve (FFR) values to specific locations on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and calculating an FFR impact score using the mapped FFR values, wherein the FFR impact score includes an element that compares the total drop in FFR along at least one of the vascular segments to the maximum drop in FFR along the vascular segment, calculating, A method including the above is provided.

[0036] In some embodiments of the present disclosure, a method for estimating the clinical condition of a vascular portion, Receiving a map of fractional flow reserve (FFR) that assigns a plurality of FFR values to specific locations on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and Calculating an FFR impact score using the mapped FFR values, wherein the FFR impact score combines individual FFR values derived from the plurality of vascular segments and is a display in which at least some of the individual FFR values are shown at positions on a graph that are not adjacent to any other FFR values obtained from adjacent vascular positions, including calculating a graph that includes, A method including is provided.

[0037] In some embodiments of the present disclosure, a system including a processor configured to execute the above method is provided.

[0038] Unless otherwise specified, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, exemplary methods and / or materials are described below. In case of conflict, the present patent specification, including definitions, will control. Furthermore, the materials, methods, and examples are illustrative only and are not intended to be limiting necessarily.

[0039] As will be understood by those skilled in the art, aspects of the present disclosure can be realized as a system, method, or computer program product. Accordingly, aspects of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects that may all be generally referred to herein as a "circuit," "module," or "system" (e.g., a method may be implemented using a "computer circuit"). Further, some embodiments of the present disclosure may take the form of a computer program product embodied on one or more computer-readable media having computer-readable program code stored therein. The implementation of the methods and / or systems of some embodiments of the present disclosure may involve performing and / or accomplishing selected tasks manually, automatically, or a combination thereof. Further, according to the actual apparatus and equipment of some embodiments of the methods and / or systems of the present disclosure, several selected tasks may be implemented by hardware, software, or firmware, and / or a combination thereof, e.g., using an operating system.

[0040] For example, the hardware for performing selected tasks according to some embodiments of the present disclosure may be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the present disclosure may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In some embodiments of the present disclosure, one or more tasks performed in a method and / or by a system are executed by a data processor (also referred to herein as a 'digital processor' with reference to a data processor that performs operations using digital bits), such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data, and / or a non-volatile storage device for storing instructions and / or data, such as a magnetic hard disk, and / or a removable storage device. Optionally, a network connection may also be provided. A display, and / or a user input device such as a keyboard or a mouse, may optionally also be provided. Any of such implementations is more broadly referred to herein as an instance of a computer circuit configuration.

[0041] Some embodiments of the present disclosure may use any combination of one or more computer-readable media. The computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, devices, or apparatuses, or any suitable combination thereof. More specific examples (non-exhaustive listing) of the computer-readable storage medium include electrical connections having one or more wires, portable computer diskettes, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In the context of this document, the computer-readable storage medium may be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device. The computer-readable storage medium may store data structured in such a way that information for use by such a program can be accessed by a computer program, for example, as one or more tables, lists, arrays, data trees, and / or other data structures. In this specification, a computer-readable storage medium that records data in a form that can be obtained as a set of digital bits is also called a digital memory. It should be understood that if the computer-readable storage medium is not originally read-only and / or not in a read-only state, in some embodiments the computer-readable storage medium may optionally also be used as a computer-writable storage medium.

[0042] In this specification, a data processor can be said to be "configured" to perform data processing activities in such a way that it is coupled to a computer-readable memory to obtain instructions and / or data therefrom, process them, and / or store the processing results in the same or another computer-readable storage memory. The processing (optionally on data) is specified by instructions. The processing actions may additionally or alternatively be referred to by one or more other terms, such as, for example, comparison, estimation, determination, calculation, identification, association, storage, analysis, selection, and / or transformation. For example, in some embodiments, a digital processor receives instructions and data from a digital memory, processes the data according to the instructions, and / or stores the processing results in the digital memory. In some embodiments, the "providing" of the processing results includes one or more of transmitting, storing, and / or presenting the processing results. Presenting optionally includes displaying on a display, indicating by sound, printing to a printout, or otherwise providing the results in a form available to human perception capabilities.

[0043] A computer-readable signal medium may include a propagated data signal in which computer-readable program code is recorded, for example, in baseband or as part of a carrier wave. Such propagated signals may take any of a variety of forms, including, but not limited to, electromagnetic form, optical form, or any suitable combination thereof. A computer-readable signal medium may be any computer-readable medium that is not a computer-readable storage medium and that can communicate, propagate, or transmit a program for use by or in connection with an instruction execution system, apparatus, or device.

[0044] The program code recorded on a computer-readable medium and / or the data used thereby may be transmitted using any suitable medium, including, but not limited to, wireless, wired, fiber optic cable, RF, etc., or any suitable combination thereof.

[0045] Computer program code for performing operations for some embodiments of the present disclosure may be written in any combination of one or more programming languages, including object-oriented programming languages (such as Java, Smalltalk, C++) and conventional procedural programming languages (such as the 'C' programming language or similar programming languages). The program code may be executed entirely on the user's computer, partially on the user's computer, as a stand-alone program package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), and the connection may be made to an external computer (for example, via the Internet using an Internet service provider).

[0046] Some embodiments of the present disclosure may be described below with reference to flow chart illustrations and / or block diagrams of methods, apparatuses (systems), and computer program products according to embodiments of the present disclosure. It should be understood that each block of the flow chart illustrations and / or block diagrams, and combinations of blocks in the flow chart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in one or more blocks of the flow chart and / or block diagram.

[0047] These computer program instructions may be recorded in a computer-readable medium that can direct a computer, other programmable data processing apparatus, or other devices that function in a particular manner to generate a manufacture including instructions that implement the functions / acts specified in one or more blocks of a flowchart and / or block diagram, where the instructions stored in the computer-readable medium implement the functions / acts specified in one or more blocks of the flowchart and / or block diagram.

[0048] The computer program instructions may be loaded onto a computer, other programmable apparatus, or other devices for the purpose of generating a computer-implemented process to provide a process for implementing the functions / acts specified in one or more blocks of a flowchart and / or block diagram by causing instructions executing on the computer or other programmable apparatus to perform a series of operation steps on the computer, other programmable data processing apparatus, or other devices.

Brief Description of the Drawings

[0049] Some embodiments of the present disclosure are described herein by way of example until reference is made to the accompanying drawings. Although specific reference is made to the detailed drawings, it is emphasized that the details shown are by way of example and for the purpose of describing and discussing embodiments of the present disclosure. However, it will be apparent to those skilled in the art how embodiments of the present disclosure may be practiced from the description taken in conjunction with the drawings.

[0050]

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[0051] Broad aspects of some embodiments of the present disclosure relate to a metric that summarizes the functional state of a vascular tree to provide information useful as a direct input into medical intervention decision-making. In some embodiments, the summary metric summarizes a measure of fractional flow reserve (FFR).

[0052] When the term "FFR" is used herein, such FFR results represent the measured and / or estimated ratio of the current blood flow rate (i.e., expressed in units of volume per unit time) through a particular region of a potentially occluded blood vessel to the ideal blood flow rate through the same site in an equivalent non-occluded blood vessel, excluding the occluded point. As the abbreviation "FFR" (fractional flow reserve) implies, the FFR result is an indicator of what fraction of the "reserve" blood flow (impeded by the vascular occlusion) could in principle be restored to the blood vessel if the blood vessel were somehow (e.g., by treatment) returned to a fully non-occluded state. The more the FFR value decreases, the more blood flow is "reserved" in this sense, and the more severe the potential ischemia.

[0053] As thus defined, the "true" FFR result is ideal, and the actual FFR result is an approximation to that ideal constrained by real-world limitations. In particular, since it is impossible to actually utilize a conceptual "non-occluded blood vessel" for comparison with the diseased one of the same blood vessel in reality, a series of calculations and / or assumptions must be provided. The actual methods for measuring and / or estimating FFR vary, based in part on how the measured values are used to approximate the ideal value. Here, FFR measurements, FFR estimates, or FFR values (including mapped FFR values as described below) are intended to encompass all results of such measurement and / or estimation methods.

[0054] It should be understood that values that provide an estimation ability and functional information regarding the blood flow recovery of FFR, but are not themselves percentage representations (e.g., by re-normalization), are also included as FFR values in this specification.

[0055] Furthermore, it should be understood that this definition of FFR is a superset of in vivo pressure sensor-based measurements that were also previously called FFR (note that in this specification, this is called 'pressure sensor-based FFR' to distinguish it from the 'FFR' defined above). The pressure sensor-based FFR result represents the ratio of the pressure downstream of a baseline position to the pressure at that baseline position, where the two positions are close enough spatially that the pressures that should be measured at those positions in a healthy non-occluded blood vessel are approximately equal (e.g., in a ratio from 0.8 to 1 or more). If this ratio is less than about 0.8, it is considered that there may be an occlusion that mimics ischemia between the two measurement positions. Based on known equations regarding blood flow that represent the relationship between blood flow, pressure, and blood flow resistance, pressure is treated as a proxy for blood flow.

[0056] The pressure sensor-based FFR measurement value can be interpreted as estimating the 'true' blood flow reserve ratio and is understood to rely on several assumptions that tend to simplify the true situation. For example, such assumptions include that the upstream site itself is at a position without any further significant upstream occlusion (in the technology actually practiced, an upstream sensor is placed at the inflow position), and / or that any further downstream occlusions are relatively non-occlusive. If the distance is long enough, the pressure can anyway decrease along the non-occluded blood vessel. Overall, the pressure sensor-based FFR measurement value tends to best match the FFR defined above when measured from positions near two locations separated by a single relatively localized lesion that partially inhibits blood flow.

[0057] On the one hand, image-based FFR potentially has the ability to estimate the blood flow reserve ratio continuously along the entire vascular segment and also between several different vascular segments of the same vascular tree. Image-based FFR is optionally calculated by another means, for example, by using numerical fluid dynamics (CFD) to obtain an estimate of the pressure along the blood vessel (the pressure is used to calculate FFR in the same way as pressure sensor-based FFR). In another embodiment, image-based FFR is calculated by comparing the stenosis of the same vascular system with the blood flow determined by CFD in a virtual blood circulation reconstruction model.

[0058] Accordingly, image-based FFR enables the FFR value to be assigned, optionally, not only to a single region between two measurement points, but also to diverse regions along the entire vascular segment, optionally continuously along the entire vascular segment, and optionally to multiple such vascular segments.

[0059] As used herein, the term "vascular tree" is used to mean a model of a vascular portion (e.g., part of the anatomical structure of a particular blood vessel of a patient), and a "vascular segment" is part of the vascular tree. In particular, the vascular tree models a plurality of vascular extents connected to each other at branch points. A vascular segment can be defined as representing one or more of such vascular extents, where each vascular segment extends between two of the following: · The origin of the vascular tree (e.g., the base of the aorta in the case of a vascular tree modeling the cardiac arterial vascular system) · The first vascular branch point · The second vascular branch point · The unconnected end of the vascular tree

[0060] One aspect of some embodiments of the present disclosure relates to the use of an estimated value of a single functional metric calculated at a plurality of positions in each of a plurality of connected vascular branches as an estimate of the overall impact of occlusive vascular disease in the connected vascular branches.

[0061] International Publication No. WO 2014 / 064702 describes the use of various vascular measurements automatically collected from angiographic images to provide input to a vascular state scoring tool (VSST). For example, the SYNTAX score VSST. The SYNTAX score is an angiographic tool used to characterize coronary vascular disease states and predict the outcome of coronary interventions based on anatomical complexity. The SYNTAX score grades the complexity of coronary artery disease, thereby enabling comparison between patients and more efficient communication between physicians. This scoring algorithm has been recommended by professional groups of healthcare experts in cardiac care as an essential part of the decision-making process in complex cardiovascular cases. The SYNTAX score questionnaire requires input on a plurality of different vascular metrics, such as lesion location and size, for example, degree of occlusion (e.g., a >50% occlusion threshold is defined in the scoring instructions), shape and length, presence of thrombus, and / or tortuosity of the vessel. Alternative examples of the VSST approach potentially include, for example, the 'Functional SYNTAX Score' (integrating physiological measurements, such as blood flow capacity, vascular elasticity, vascular autoregulatory capacity, and / or other vascular function metrics, into a SYNTAX score-like tool), or the 'Clinical SYNTAX Score' (integrating clinical variables, such as patient medical history, and / or systemic and / or organ-specific test results, into a SYNTAX score-like tool). Examples also include the AHA classification of coronary artery segments modified for the ARTS trial, the Lehman score, the ACC / AHA lesion classification, the total occlusion classification system, and / or the Duke and ICPS classifications for bifurcation lesions.

[0062] Surprisingly, the inventors have come to a new understanding that a continuous or nearly continuous map of FFR for the vasculature has the potential to replace multi-parameter VSST by converting the map of FFR estimates into a score built on top of the single parameter. This score (which may, for example, essentially be in scalar, vector, tabular, and / or graphical form) is referred to herein as the 'FFR impact' score.

[0063] The conversion, in some embodiments, includes emphasizing information about the disease state itself while suppressing (removing) the emphasis on specific information that depends on the details of the vasculature geometry of the subject and / or the completeness of the vascular model. In particular, the conversion starts with a map of FFR, extracts the FFR values from the context of specific locations along the vascular extent, and creates a score that does not include this association. In some embodiments, the conversion uses a number of FFR values (e.g., at least 3, 5, 10, 20, 30, or more FFR values) each derived from each of a plurality (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) of vascular segments defined between branch termini, base origins, and / or vascular bifurcation locations (e.g., bifurcations or trifurcations). In some embodiments, a number of specific locations are defined continuously or nearly continuously in the sense of the following terms.

[0064] As used herein, "substantially continuous" means, for example, at least 10, 20, 30, or more estimates for each vascular segment between identified major branch nodes, and more specifically, estimates using data acquired at a resolution sufficient to identify the length of the vascular portion where the FFR changes (decreases) during passage, that is, not only defining only two points existing across the lesion, but also defining the start and end points of the lesion. As used herein, "continuous" means that the FFR estimates are provided for each unit of the representation resolution (e.g., each pixel) along the vascular length, and optionally, calculated using a continuous function and / or a collection of a plurality of adjacent interpolation functions that are each continuous functions themselves. The continuous and substantially continuous representations of FFR (also referred to herein as "maps") potentially have the ability to provide a basis for FFR impact score calculation. As used herein, the term "FFR map", or the equivalent expression "mapped FFR", corresponds to a representation of FFR that maps FFR values to distinct specific positions along the vascular segment range in a continuous or substantially continuous manner.

[0065] As used herein, a vascular map that itself represents a non-FFR value (e.g., another measure of vascular function and / or state) that is converted to an individual FFR value during the process of calculating the FFR impact score is also considered to belong to the type of "FFR map", and the converted individual FFR values are also considered to belong to the FFR map. For example, this conversion itself defines part of the mapping of FFR values to vascular positions.

[0066] One way to conceptualize the relevance of FFR to disease complexity is to consider two aspects of vascular disease assessment that are related but independent as part of the treatment plan.

[0067] One such aspect is the severity of the disease. The mapped FFR values can be grouped into at least two different severity metrics, a local one and an overall one. The overall measure simply asks "how much is the total drop in blood flow compared to an ideal healthy vessel?" This is, for example, the FFR value measured at the end of the vessel. The local measure essentially asks "is there a major lesion?" which can be rephrased as the question "how much is the worst single drop" in blood flow, which is obtained, for example, as the maximum drop within a certain window. Severe cases of vascular disease may include severe local stenosis that clearly contributes to the reduced blood flow state and, furthermore, can cause dangerous acute ischemia if the occlusion progresses further. Another aspect of severity, in some embodiments of the present invention, is a calculated value of how much of the vascular tree is affected by a decrease in FFR and to what extent. This can be calculated, for example, as the relative area above the curve (and below 1 of the maximum FFR value) when all FFR values are removed from their mapped positions and graphed in sorted order. The larger the relative area, the greater the impact on FFR. This represents the summative (or 'integral') use of FFR data to assess the disease state.

[0068] Another aspect is the treatability of a disease. A part of the currently approved standard treatment (for suitable patients) is stent placement, and this stent serves to open and hold open a localized area of vascular stenosis. However, if the cause of the vascular stenosis is not mainly due to the configuration in the localized area, the vascular stent may not be able to provide sufficient blood flow recovery. By using mapped FFR, it is possible to distinguish between two cases where the total drop in the blood vessel is the same, but in one case, the drop occurs continuously and / or in multiple stages, and in the other case, the drop occurs at only one or two localized positions of the main lesion. In this case, the calculation may include, for example, obtaining the ratio (optionally, appropriately normalized and / or offset processed) of the total FFR drop along the blood vessel to the maximum FFR drop across a predetermined volume along the blood vessel. If the raw ratio or the appropriately normalized ratio is low, more FFR drops occur at the position of the maximum FFR drop, and the lesion is more localized. If the raw ratio is high, there may be more stenosis sites distributed along the blood vessel. In some embodiments, operations other than arithmetic division, such as non-linear operations, look-up tables, or machine learning results that combine the total and maximum FFR drops with a database of patient outcomes, are used.

[0069] For a first approximation, in some embodiments, mapped FFR is converted into an FFR impact score by combining 'differential coefficient' (or'slope') type information indicating the localization of the stenosis lesion (the greater the magnitude of the differential coefficient, the higher the localization) and 'integral' (or'sum') type information indicating the overall severity of the impact on perfusion and ischemia. Each of these three types of information is optionally normalized with respect to the other type as part of the normalization.

[0070] Finally, it may be noted that the calculations that can be performed on mapped FFR to generate an FFR impact score have a correspondence with some of the types of parameters involving VSSTs such as the SYNTAX score. The localization determined from the mapped FFR estimate can be understood as a proxy for lesion length. The total FFR drop is a metric of occlusion. The integral of the FFR drop is a metric of where the lesion occurred, and the closer to the carotid artery (at a point along the distance of the vessel), the larger the tissue area affected by the restricted perfusion. Finally, when these metrics are aggregated for each of the multiple vascular segments on different major branches of the vascular tree, a score state for the entire vascular tree can be determined.

[0071] It may potentially also be discovered that the FFR impact score has a similar value for guiding treatment and / or predicting treatment outcomes in the range where it potentially "reaches" many of the same fundamental arguments of lesion complexity that the SYNTAX score attempts to capture. At the same time, the FFR impact score has several potential advantages over scoring methods such as the SYNTAX score. By relying primarily (optionally, and only) on a single basic type of input data (FFR), the FFR impact avoids the problem of determining how to weigh several different heterogeneous inputs together. The calculations using FFR avoid the heuristics of the SYNTAX score, which may not be reproducible for all scores. Even if the scoring is automated, significant noise can occur in a single score by relying on threshold conditions. For example, the SYNTAX score, while suitable for human decision-making, includes estimated values (at least 50% occluded) defined by a threshold that are potentially subject to the influence of scorer "noise," especially for values near the threshold cut-off. Since important decisions have to be made for individual cases, this noise has a real impact on the outcome, but there is no way to use it to "average out and remove" the noise error.

[0072] Furthermore, while SYNTAX score calculation can be automated, it was originally designed to be calculated by a human. The FFR impact score uses metrics that are essentially automated. An example of the resulting difference is that scoring methods calculated by a human tend to "discard data early" because they do not need to be recorded or recursed. Positive / negative and / or roughly ranked decisions are easier for a human scorer to handle. Since automated methods can potentially retain any amount of intermediate result data at any appropriate accuracy, such simplification may occur at a later step, potentially at the final step for generating the vascular condition score itself, even when a simple score is required as the final result.

[0073] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not necessarily limited to the structural details and arrangements of the components and / or methods described in the following description and / or illustrated in the drawings in its application. The features described in the present disclosure (including the features of the present invention) can be other embodiments or can be implemented or executed in various ways.

[0074] · Method for generating an FFR impact score Referring now to FIGS. 1A - 1B, which are schematic flowcharts of methods for generating an FFR impact score in accordance with some embodiments of the present disclosure.

[0075] In some embodiments, at block 102, an angiographic image is received. In some embodiments, the angiographic image includes a plurality of X-ray angiograms. In some embodiments, the angiographic image has another source, for example, CT, MRI, or another imaging means. As used herein, references to "two-dimensional imaging" in particular (and the resulting "two-dimensional images") relate to angiograms obtained by a projection imaging method that images radiation energy (e.g., X-rays) received at an imaging plane after passing through a body containing tissue imaged from a radiation energy source with a sensor placed in the imaging plane.

[0076] An angiographic image images a branching collection of interconnected vascular segments that includes a portion of the vascular system. In some embodiments, this portion is a part of the cardiac arterial vascular system.

[0077] In some embodiments, at block 104, the imaged vessels shown in the angiographic image are converted into a vasculature model that includes a plurality of connected vessels, which is referred to herein as a 'vascular tree'. The longitudinal extent of a segment of the vascular tree model corresponds to the longitudinal extent of the corresponding segment of the imaged vessels. Further, the cross-sectional geometry of the imaged vessels is represented in the model and optionally parameterized (e.g., parameterized as radius, diameter, and / or area) and more fully described, optionally, for example, specified as a complete cross-sectional shape. A method for generating such a model is described, for example, in International Publication No. WO 2014 / 111930, filed Jan. 15, 2014, which is hereby incorporated by reference in its entirety.

[0078] In some embodiments, at block 106, regions of the vascular tree model that are determined to be stenotic (e.g., narrowed and / or at least partially occluded) are'revascularized' in a revascularization model based on the vascular tree model. In the'revascularized' regions, the vascular cross-sectional information is trimmed in a suitable manner to appear as if there were no stenosis. In some embodiments, the revascularized cross-section is recovered by interpolating values between relatively non-occluded regions upstream and / or downstream of the stenosis itself. In some embodiments, other data, such as atlas information and / or consistency constraints, are used to recover the revascularized diameter. A method for generating a revascularized vascular tree model is described, for example, in International Publication No. WO 2014 / 111929, filed Jan. 15, 2014, which is hereby incorporated by reference in its entirety.

[0079] In some embodiments, at block 108, FFR values for the entire vascular tree are estimated. In some embodiments, the FFR values used are generated by comparing estimated flow values passing through the original vascular tree model and the revascularized vascular tree model. The FFR value calculation is described, for example, in International Publication No. WO 2014 / 111929, filed on January 15, 2014. International Publication No. WO 2017 / 199245, filed on March 16, 2017 (incorporated herein by reference in its entirety), describes a color-coding according to cumulative vascular resistance along each vascular branch, in particular, a display of the vascular resistance corresponding to the FFR calculated based on the characteristics of the vascular image data.

[0080] This operation of blocks 102-108 is not necessarily the only approach that can provide mapped FFR values. For example, numerical computational flow dynamics (CFD) modeling of a properly reconstructed vascular model can be used to directly measure, "as if", the blood pressure at each point in order to cumulatively determine the nature of the blood flow associated with the FFR along the extent of the blood vessel, similar to what is done with pressure sensor-based FFR. In some embodiments, the method of calculating the FFR impact score can be applied to these alternative sources of FFR data. Accordingly, the flowchart of FIG. 1B simply begins at block 109 with receiving the FFR values for the entire vascular tree.

[0081] In some embodiments (both FIGS. 1A and 1B), at block 110, multiple estimated FFR values are merged to generate one or more FFR impact scores, as will be described, for example, with respect to FIGS. 2A-2C.

[0082] · Image-based FFR Here, referring to FIGS. 2A-2C, these represent the display results of a method for calculating the FFR impact based on some embodiments of the present disclosure. In this specification, the term "FFR impact score" is used as a term for a score that describes how the overall distribution of FFR values in the vascular system affects the patient's clinical condition, distinct from the FFR measurement itself. Patients with different FFR impact scores are potentially suitable candidates for different treatment interventions.

[0083] Specifically referring first to FIG. 2A, which illustrates a case including moderately to severely ischemic vascular diseases in 3 out of 5 annotated blood vessels.

[0084] In some embodiments, the basis of the FFR impact score begins with individual FFR values measured and / or calculated at positions along the vascular system so as to provide the FFR data of FIGS. 1A and / or 1B.

[0085] Methods for calculating image-based FFR are described, for example, in International Publication No. WO 2014 / 111929 filed on January 15, 2014. For example, in some embodiments, the geometry of the blood vessels is determined for most of the vascular tree based on vascular imaging (e.g., two-dimensional X-ray angiogram), evaluated for their ability to recover (which is considered to recover the 'pre-reserve' that is being lost), and the FFR value is calculated based on this evaluation, for example, by calculating how the vascular resistance changes if the current vascular state is restored to the calculated non-occluded geometry.

[0086] The index range of image-based FFR is optionally the same as that of pressure sensor-based FFR with values in the range between 0 and 1. Optionally, 0.8 is maintained as the cut-off value (in some embodiments, different cut-off values, e.g., 0.75 or 0.85, are used), and values exceeding the cut-off value indicate that the lesion, if any, is likely to be a non-ischemic lesion at least as such, and values below 0.8 indicate that the lesion is likely to be an ischemic lesion.

[0087] In some embodiments, FFR values are assigned across an entire three-dimensional model of the vasculature or other model (such as shown in vasculature tree 300 of FIG. 2A). For display purposes, in some embodiments, the three-dimensional model is optionally color-coded at each of its locations based on the estimated FFR value (in FIG. 2A, scale bar 320 shows the correspondence between FFR and gray level). Optionally, individual FFR values can be viewed, for example, by selecting a particular location on the coronary vasculature model using a cursor.

[0088] ·FFR impact scoring Continuing to refer to FIGS. 2A-2C, in some embodiments, further analysis involves converting mapped FFR (such as shown in a color-coded map of FFR along a vascular extent) into a measure that is more readily understandable by a physician in terms of the impact of FFR on the clinical state of the vasculature, and in particular in terms of how effective one or more potential treatment options are in restoring vascular function (i.e., restoring the lost 'blood flow reserve ratio').

[0089] ·FFR impact scoring in graph form Referring briefly to FIG. 10 here, which is a schematic flowchart of a method for graphing received mapped FFR values, based on some embodiments of the present disclosure. In some embodiments, at block 1002, mapped FFR values are received. In some embodiments, at block 1004, the FFR values are converted into a cumulative graph, represented as cumulative graph 1004A. Circular graph 330 (FIG. 2A) illustrates an example of cumulative graph 1004A, displaying mapped FFR in a way that abstracts away the vascular geometry to draw out the pattern of the vascular lesions shown by the FFR data itself. The FFR values shown distributed along the vessels in vasculature tree 300 are instead sorted in descending order (with the value closest to 1 being the largest), and color-coded (color-coded in gray scale) clockwise along a circle with equiangular distances corresponding to equidistant distances along the vascular extent. Diameter andand plotted. This combines data from all measured blood vessels (five peripheral branches and the trunk segment shared by them) into an overall display of a single blood vessel tree.

[0090] Pie chart 330 enables the number of steps caused by lesions in FFR to be easily visually distinguished. Four prominent post-lesion regions starting at angles 314, 315, 312, and 311 corresponding to four lesions located at vascular positions 302, 301, 308, and 304 can be distinguished. There are also micro-lesions along the blood vessel terminating at vascular position 310, and a line is drawn to emphasize the corresponding FFR drop between angles 316 and 314 that separates the minor FFR drop between angles 316 and 314 from the 40% region without a drop between angles 313 and 316. In an example where some lesions have more similar properties, two or more steps tend to merge into one step. Between such regions, the shade steps are separated by relatively short (localized lesions) or long (diffuse lesions) transitions.

[0091] The number and sharpness of the steps are'related to the derivative' in that they summarize information such as how many stents are needed to completely revascularize the blood vessel tree and whether this revascularization can be achieved by local correction of the blood vessel diameter.

[0092] Pie chart 330 provides information about the magnitude of ischemic changes (the FFR gray scale value corresponds to the number indicated by scale bar 320) and how much of the entire vascular system is affected (corresponding to 'integral type' information). The number '40%' indicates how much of the vascular system is not affected, while an angle (angle 314) exceeding the nominal ischemic line of 0.8 indicates that almost half of the entire blood vessel tree is experiencing ischemic blood flow.

[0093] As already touched upon, the vascular lesions are somewhat mixed by this representation. For example, the values indicated from angle 313 to angle 316 approximately associate with the only vascular range extending between the vascular position 307 and each of the vascular positions 308, 317, 304, and 302. Further, the gradations in FFR are combined across multiple blood vessels and extend radially. For example, the value contributed by the range between the vascular positions 301 and 302 extends approximately between angle 314 and angle 311 and is mixed with the values contributed by the ranges between the vascular positions 317 to 310, 308 to 309, and 304 to 305 and 306. The range between the vascular positions 301 and 303 (which is the range with the maximum drop in FFR) corresponds only to the region between approximately angle 311 and angle 313.

[0094] Such an aspect of the visual pattern of the pie chart 330 can be understood to correspond, at least roughly, to the disease severity, particularly the disease severity that is standardized by a treatment suitable therefor, as will be discussed, for example, below.

[0095] Here, referring to FIGS. 3A - 3D, these schematically show, based on some embodiments of the present disclosure, in association with disease treatment options, an FFR impact score (in the form of a pie chart configured as already described for the pie chart 330). Qualitatively and simply looking, it can be seen at a glance that the given four cases cover the disease severity in order from the most severe in FIG. 3A to the healthiest in FIG. 3D.

[0096] Regarding the conversion of such a qualitative impression to a quantity, it will be explained after first briefly explaining the nature of the currently available standard treatment options.

[0097] The currently generally available treatment options for coronary artery disease can be classified as follows in the order of approximately increasing disease severity to which they are applied.

Table 1

[0098] Typical criteria applied to distinguish three treatment options are to distinguish single-vessel disease, two-vessel disease, and three-vessel disease as markers for OMT, stent, and CABG, respectively. However, this broad rule potentially leads to the result that patients are misclassified. For example, two-vessel disease may actually be resistant to treatment by stent placement, and three-vessel disease may still be treatable by stent placement despite this. There is also a similar possibility of misclassification between one- or two-vessel diseases. Physicians are aware of this and generally use multiple criteria in their decision-making. However, it is still often unclear which treatment is suitable for borderline patients. Although existing numerous scoring methods such as the SYNTAX score can help solve this, as described herein, these are also subject to some limitations.

[0099] A score that abstracts it sufficiently to enable a direct comparison of patterns (and thus results) while still maintaining more nuances of the overall distribution of lesions in the vasculature would bring potential benefits to optimal decision-making.

[0100] One aspect of the problem is to determine whether repairing a very small number of lesions (i.e., within the practical limits of stenting) actually leads to a sufficient improvement in coronary blood flow.

[0101] · Example of numerical FFR impact scoring The tabular summary 340 of FIG. 2A shows the results of a tabular approach to generating an FFR impact score. Also refer to FIG. 8, which is a schematic flowchart of the calculation of FFR impact score components based on some embodiments of the present disclosure.

[0102] In some embodiments, at block 802, mapped FFR values are received.

[0103] In some embodiments, the score includes a plurality of components. Some of the components are calculated for each blood vessel as shown in the caption of the enclosure block 803 surrounding blocks 804, 806, 808, and 810.

[0104] In some embodiments, at block 804, the "Total Drop Score" is selected (represented as output at block 804A). For each blood vessel marked in the modeled vascular tree, the maximum cumulative blood flow impairment is selected (in the case of FIG. 2A, five values are obtained as a result). As already described, the values of three blood vessels reach the multi-vascular score threshold of 0.8 (for example, 1.0 - 0.20 = 0.8). Substantially, this measures the difference between the end of each marked blood vessel and a reference value representing the non-occluded vascular system position (FFR at the origin of the vascular tree, or simply 1, which is the defined maximum FFR).

[0105] In some embodiments, at block 806, the "Maximum Drop Score" (represented as output at block 806A) is determined. The maximum drop score indicates the proportion of the maximum drop due to a nominal "single focal lesion". For calculation purposes, the maximum size of a single focal lesion is, for example, 40 mm 3 , or another maximum size, for example, a value within the range between about 10 mm 3 and 100 m 3 and is selected as the size within the range of values.

[0106] In some embodiments, block 810A represents an output of the diffusivity severity of the lesion (diffusivity severity score). This is an indicator that the overall vascular disease is spreading gradually along the described vessel as the maximum drop score becomes gradually smaller than the total drop score. In some embodiments, at block 808, the raw diffusivity score is calculated as the ratio between the total drop score and the maximum drop score, and optionally, the score of 0 indicates a'maximally localized' lesion and is normalized (e.g., by subtracting 1) so that higher values indicate more diffusible lesions. In some embodiments, at block 810, a classification ranking is optionally assigned to the diffusivity of the lesion (e.g., none (no disease), localized (diffusivity score is, e.g., less than 0.1), moderate (diffusivity score is, e.g., up to 0.5), and severe (diffusivity score is greater than 0.5)). In some embodiments, diffusivity is scored by another method, e.g., by a lookup table, a non-linear function, and / or a machine learning result that combines the total and maximum FFR drops in a patient outcome database.

[0107] In some embodiments, block 812A represents a'multi-vascularity score' output. In some embodiments, at block 812, the multi-vascularity score is calculated.

[0108] In some embodiments, the multi-vascularity score simply counts (below a certain threshold, e.g., below a threshold of 0.8 or optionally a larger value such as 0.9) how many vessels have an FFR value at the ischemic level somewhere along their length. In the example shown, the multi-vascularity score is 3. Note that a common lesion, e.g., a lesion common to vessels 4 (terminating at vascular position 306) and 5 (terminating at vascular position 305), is only counted once and is assigned to one of the two branches (in this case, vessel 4) for scoring.

[0109] In some embodiments, the multi-vascularity score 812A is (additionally or alternatively) based on a measure such as the'maximum drop score' 806A and within a predetermined volume (e.g., 40 3within mm, or another volume, e.g., 20 mm 3 , 30 m 3 , 50 mm 3 , or 100 mm 3 including a vessel based on reaching at least some amount of a drop in FFR value within). In some embodiments, this range is about 10 mm 3 and 100 mm 3 and is selected from within a range of values between. This range includes values that potentially enable distinguishing between lesions that have sufficient localization to be good candidates for PCI treatment and lesions that are more diffuse and potentially less suitable for PCI treatment.

[0110] In the example of FIG. 2A, two vessels have no single lesion, and one has a'maximally localized lesion'. Vessel 1 (terminating at vessel location 303) has two lesions, and the more severe of them accounts for more than half of the total drop. Vessel 2 appears to have only one distinct drop but accounts for only about half of the total drop, indicating that the disease spread in this vessel is'severe'. Such factors, considered together, and particularly considering the discovery of a severely diffuse disease in one of the vessels, indicate that in some embodiments, CABG may be a suitable treatment for this patient, to the extent that other risk factors permit.

[0111] Another example of an FFR impact score component is described herein in connection with FIG. 4.

[0112] FIGS. 2B and 2C provide examples of different vascular states and their associated FFR impact scores (evaluated by FFR).

[0113] In FIG. 2B (vascular tree 342, pie chart 341, and tabular summary 343), the largest portion (69%) of the pie chart 341 has an FFR value well below 1, yet still hovers above the cut-off value of 0.80 for pressure sensor-based FFR. Nevertheless, according to more stringent FFR criteria, this is a "three-vessel disease" (using an FFR criterion of 0.9 as the cut-off, the multi-vessel score is 3). Therefore, the severity of this disease (since the spread of all lesions is either localized or moderate) seems suitable for stenting. Depending on the risk factors associated with PCI presented as an alternative (since all lesions exceed the 0.80 cut-off), the option of continuing OMT may also be available.

[0114] In FIG. 2C (vascular tree 352, pie chart 351, and tabular summary 353), all vessels are to some extent affected, but only two pass the combined drop FFR cut-off value of 0.9, and the level of spread is either localized or, at worst, moderate. This subject is therefore, in some embodiments, preferably positioned for OMT rather than receiving PCI, which is the baseline treatment selected for a two-vessel disease state in other cases.

[0115] It should be understood that there is no particular limitation to using a pie chart, for example, to represent the values in FIG. 341 in a chart. In some embodiments, the graph can be a rectangular coordinate graph of values (e.g., with the FFR value count on the X-axis and the FFR value on the Y-axis distance), a polar plot of values (with the FFR value count on the angular axis and the FFR value on the radial length), or another graphing method.

[0116] · Additional examples of numerical FFR impact scoring Referring now to FIG. 4, this represents the display results of a method for calculating FFR impact, according to some embodiments of the present disclosure.

[0117] Again shown are the vascular tree 404, the pie chart 402, and the tabular summary 401, which generally correspond to the vascular tree 300, the pie chart 320, and the tabular summary 340 of FIG. 2A. The labels of the vascular tree 404 add the severity and diffusivity result values (along with the classification assessment) corresponding to the values shown in the tabular summary 401.

[0118] In this example, 'TFS' is used as an abbreviation for 'Total FFR Score', which is used equivalently to the term 'FFR impact score'.

[0119] The scores such as 'Total Severity TFS', 'Maximum Severity TFS', and 'Diffusivity TFS', and 'Multivessel TFS' in FIG. 4 correspond to the 'Total Drop' score, 'Maximum Drop' score, and 'Diffusivity' score in FIG. 2A.

[0120] In FIG. 4, the 'Severity FFR' score for the entire vascular tree is shown, which is calculated by downwardly weighting the average FFR value for all positions of the vascular tree according to the distance from the ostium. A value of 1 is completely non-occlusive. The downward weighting according to the distance from the ostium gives greater importance to lesions closer to the base of the vascular tree (and thus having a greater impact accordingly).

[0121] Referring now to FIG. 9, which schematically shows a method for calculating a severity average score based on some embodiments of the present disclosure.

[0122] In some embodiments, at block 902, mapped FFR values are received. In some embodiments, at block 904, the values are weighted by distance (weighted downward as the distance increases). In some embodiments, at block 906, a severity score is calculated by averaging the FFR values according to their weights. Block 906A represents the resulting severity score (as a weighted average).

[0123] FIG. 4 also shows a bar graph 403 showing FFR per volume. Basically, the length of the bar is weighted by volume and is not simply the distance along the centerline of the vessel. In this way, again, somewhat lower weighting is given to the vessel regions further downstream (within the narrower vessel segments). This has the potential advantage of corresponding to how much of the range is ultimately perfused by the blood flowing through a particular site of the vessel and, ultimately, the size of the area directly affected by the ischemic blood flow at that site.

[0124] Continuing with reference to FIG. 10. At block 1002, the mapped FFR values are received. At block 1006, using the vessel volume associated with each mapped FFR value within a given vessel location, the mapped FFR values are graphed as volume-weighted values. Block 1006A represents the volume-weighted graph obtained at block 1006.

[0125] In some embodiments, an FFR-based subscore is provided for "left main stenosis", where stenosis within the left main coronary artery trunk is specifically selected as a matter of particular interest by a metric such as a calculated value of "total drop" or "maximum drop" made for individual vessel branches.

[0126] In some embodiments, the pattern within the mapped FFR values is associated with certain additional features, which are optionally shown in the FFR impact score. Examples are as follows.

[0127] Lesion length The length of a vascular lesion in which the mapped FFR decreases continuously and significantly throughout. For this metric, "significantly" means, for example, decreasing by more than a given threshold (e.g., about 0.1) over the entire length. "Continuously" means without interruption or, optionally, shorter / smaller than a threshold of a particular vascular distance or volume (e.g., 10 mm 3 20 mm 3 30 mm 3 or 40 mm 3Having only small (e.g., smaller than) interruptions, for example, at a specific minimum slope magnitude, e.g., 10 mm 3 , 20 mm 3 , 30 mm 3 , or 40 mm 3 per hit, meaning decreasing at a minimum slope magnitude of at least 0.1.

[0128] Main vessel + collateral lesion Extending from the main vessel past the vascular bifurcation point to the branched vessel, the mapped FFR decreases significantly throughout (e.g., for a given threshold (e.g., about 0.1, optionally, a specific vessel length and / or volume (40 mm 3 , or, another volume, e.g., about 10 mm 3 and 100 mm 3 and a volume selected from within the range of values therebetween, etc.) normalized) super-decreasing) vascular region.

[0129] Bifurcation / trifurcation lesion Extending over three or more vascular segments (e.g., the main vessel and two collateral vessels distal to the vascular bifurcation), the mapped FFR decreases significantly throughout (e.g., for a given threshold (e.g., about 0.1, optionally, a specific vessel length and / or volume (40 mm 3 , or, another volume, e.g., about 10 mm 3 and 100 mm 3 and a volume selected from within the range of values therebetween, etc.) normalized) super-decreasing) vascular region.

[0130] Aortic inlet lesion The aorta and / or the aortic inlet itself contains a region of mapped FFR that decreases significantly, e.g., about 0.1 (optionally, a specific vessel length and / or volume (40 mm 3 , or, another volume, e.g., about 10 mm 3 and 100 mm 3 and a volume selected from within the range of values therebetween, etc.) normalized) super-decreasing).

[0131] Degree of curvature One measure of tortuosity is that the vascular segment exhibits excessive tortuosity such that the ratio of the distance along the vascular segment to the minimum distance between two endpoints of the bent vascular segment is high. For example, a tortuous blood vessel has a ratio of 1.3 or more. In some embodiments, the FFR impact score indicates the presence of tortuosity associated with a vascular region where the mapped FFR continuously and significantly decreases throughout. "Significantly" means, in some embodiments, a decrease exceeding a given threshold (e.g., about 0.1) over the entire length. Optionally, the decrease is normalized with respect to a specific vascular length and / or volume (40 mm 3 , or another volume, e.g., a volume selected from within a range of values between about 10 mm 3 and 100 mm 3 ).

[0132] Estimated number of stents / Stent effectiveness For example, an estimated number of stents can be obtained by any combination of the FFR impact score features described so far and / or the FFR impact score features described in association with FIGS. 2A-2C. For example, the lesion length and complexity can be evaluated as to whether they are appropriate for the number of stents to be implanted to restore blood flow function to a certain degree of improvement (e.g., up to an FFR of 0.85, 0.90, 0.95, or 1.0). Optionally or alternatively, the maximum number of stents is restricted, e.g., based on the estimated number of stents obtained along with the estimated values of the procedural risk and / or practicality, and the degree of improvement that may result (e.g., potentially limited to a maximum value due to risk).

[0133] Estimated number of CABGs / CABG effectiveness For example, an estimate of the number of grafts can be obtained by any combination of the FFR impact score features described so far and / or the FFR impact score features described in connection with FIGS. 2A-2C. For example, the lesion length and complexity can be evaluated as to whether they are appropriate for the number of grafts that are considered to restore blood flow function to a certain degree of improvement (e.g., up to an FFR of 0.85, 0.90, 0.95, or 1.0). Optionally or alternatively, the maximum number of grafts is restricted and is based, for example, on an estimate of the surgical risk and / or practicality, and an estimate of the number of grafts obtained along with an estimate of the degree of improvement that may result (e.g., potentially limited to a maximum value due to risk).

[0134] ·Modification of FFR impact scoring In some embodiments, a system configured to calculate an FFR impact score is also configured to recalculate the FFR impact score using data that describes a change in a measured and / or simulated vascular condition, such as an angiographic image after stent implantation, and / or a change in a vascular tree model that simulates a change in a disease state (e.g., resulting from treatment and / or disease progression).

[0135] The FFR impact score (e.g., any of the numerical, graphical, and / or tabular data shown in one of FIGS. 2A-2C and / or FIG. 4) is updated based on one or more of the following.

[0136] ·Automated virtual stenting: The vascular diameters at the proximal and / or distal vascular positions are used as a reference for what constitutes the expected revascularized ( 'healthy restored') diameter after virtual stenting. The revascularization diameter is used to adjust the vascular tree model to obtain new FFR data, and the FFR impact score is recalculated accordingly. In some embodiments, options are presented according to an appropriately weighted blend of criteria that result in maximum improvement and criteria that result in minimum intervention.

[0137] · Manual stent selection: For example, according to the provided stent parameters of position, length, and diameter, the vascular tree model is adjusted to obtain adjusted FFR data, and the FFR impact score is recalculated accordingly. Optionally, the available stent parameters are restricted to known and / or available stent(s), for example, stents available in the current inventory.

[0138] · Post-PCI data: The post-stent angiography images are used to adjust the vascular tree model. Adjusted FFR data is obtained, and the FFR impact score is recalculated accordingly. 1. Follow-up: Angiography image data obtained from a patient over the course of multiple diagnostic procedures (performed over a period of, for example, weeks, months, or years) is converted into a plurality of time-dependent vascular tree models. Adjusted FFR data is obtained for each model, the FFR impact score is recalculated accordingly, and an output is provided that describes the change in the FFR impact score over the period of image monitoring. In some embodiments, a comparison of two or more FFR impact scores derived from FFR data obtained over the course of multiple diagnostic procedures is used to estimate the rate of progression of the vascular disease. In some embodiments, the rate of progression of the vascular disease is used to schedule further diagnostic procedures. Optionally, the comparison is performed optionally on the FFR impact scores calculated considering only the vascular segments that are scored in common to all the calculated FFR impact scores.

[0139] · Example of system component implementation Referring now to FIG. 6, which schematically shows a system 600 for calculating an FFR impact score, according to some embodiments of the present disclosure.

[0140] The data storage device 604 stores, in some embodiments, FFR data (e.g., in either of the forms described herein as a computer-readable medium and / or memory). Optionally, the data storage device 604 is used to store images used in the calculation of FFR according to, for example, the method outlined in FIG. 1A.

[0141] In some embodiments, the processing device 608 converts the FFR data into an FFR impact score by performing a conversion process according to any one or more of the calculations used to calculate the FFR impact score components described herein (e.g., in connection with FIGS. 2A-2C and / or FIG. 4).

[0142] The user interface 602 receives user input in some embodiments (e.g., to provide commands for selecting and / or defining calculation data and / or for starting and / or configuring a process). In some embodiments, the user interface 602 also displays the FFR impact score information in a format such as illustrated and / or described herein in connection with FIGS. 2A-4. Optionally, the system of FIG. 6 is also more generally a system for angiographic image analysis, e.g., a system as described in connection with FIG. 5.

[0143] Now referring to FIG. 7, which schematically depicts the data and processing instruction components of a system 600 for calculating an FFR impact score, in accordance with some embodiments of the present disclosure.

[0144] The mapped FFR data 702 includes FFR data that is calculated as described, e.g., in connection with FIGS. 1A-1B, and stored in the data storage device 604.

[0145] The processing instruction component, in some embodiments, includes computer code stored, for example, in the storage device 604 and processed by the processing device 608. A part of the processing instruction component includes the FFR impact subscore calculation code 704, which, in some embodiments, executes one or more of the subscore calculations described in connection with, for example, FIGS. 2A-2C and / or 4. In some embodiments, the processing instruction component also includes an FFR impact score display module, for example, an FFR impact score display module configured to convert the subscore calculation value of the impact subscore calculation code 704 into a display, for example, the display described in connection with FIGS. 2A-4.

[0146] Referring now to FIG. 5, this shows an example of a screen output provided by a system 600 that can be adapted for the calculation and display of a total FFR score, based on some embodiments of the present disclosure.

[0147] In some embodiments, the system 600 is a non-invasive image-based software device that provides a physician with a quantitative analysis of the functional significance of a coronary lesion, similar to invasive FFR, and a qualitative three-dimensional model of the coronary artery demonstrated during a routine PCI procedure. For example, the summary block 506 shows an FFR of 0.66 for the selected blood flow restricting vessel 501B of the three-dimensional coronary artery model 501, and the color of the blood flow restricting vessel 501B matches the shading of the color bar 502 at 501C. The central line vascular tree 504 is also shown, which corresponds to the three-dimensional coronary artery model 501 and is superimposed on the X-ray angiogram 503. The diameter of the blood flow restricting vessel 501B is graphed along the graph 505, which includes a drop at the position 505B corresponding to the position of the blood flow restriction that mainly contributes to the decrease in the FFR of the blood flow restricting vessel 501B from the perfect healthy value of 1.00 to its indicated value of 0.66.

[0148] The system 600, in some embodiments, performs processing and calculations based on angiographic images and hemodynamic information acquired during a coronary catheterization procedure.

[0149] Optionally, system 600 does not require the use of additional invasive devices or vasodilator therapy. Potential advantages and / or features of system 600 related to FFR-guided PCI decision-making include, in some embodiments, the following. · Delivery, calculation, and three-dimensional multi-vessel modeling of intraoperative imaging for quantification of stenosis, optimization of PCI decisions, and confirmation of revascularization at the end of the case. · Objective FFR measurement without the risks associated with invasive FFR wires, including additional interventions and pharmacological administrations. · Use of existing cath lab imaging and angiography devices that are compatible with major angiography systems. · Elimination of direct and indirect FFR wire costs without introducing additional SKUs or device-related procedural costs.

[0150] The reconstructed three-dimensional model provided by system 600 describes the shape and volume of the blood vessels and, together with hemodynamic parameters, serves as the basis for blood flow analysis. Based on the blood flow analysis, an FFR can be calculated for the vessel being examined. In some embodiments, the blood flow calculation is based on a centralized model of the artery, which makes it possible to shorten the processing time for delivering the FFR results to the physician during the PCI procedure. After the calculation, system 600 presents a three-dimensional simulation of the vascular tree and the calculated FFR values for the vessel of interest, as shown in FIG. 5.

[0151] In some embodiments, a total FFR score, such as that described in connection with FIGS. 1A-4, is calculated based on information provided by a properly configured system 600, particularly based on the calculated FFR values for individual vessels and / or positions along individual vessels.

[0152] (General matters) The term "about (~)" as used herein with reference to amounts and numerical values means "within ± 10% of (~)".

[0153] The terms "comprises," "comprising," "includes," "including," and their conjugations mean "including but not limited to."

[0154] The term "consisting of" means "including and limited to."

[0155] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, provided that the additional ingredients, steps, and / or parts do not substantially change the basic and novel characteristics of the claimed composition, method, and structure.

[0156] As used herein, the singular forms also include the plural references unless the context clearly indicates otherwise. For example, the term "compound" or "at least one compound" may include a plurality of compounds (including mixtures thereof).

[0157] The words "example" and "exemplary" are used herein to mean "an example, instance, or serving as an illustration." Any embodiment described as "example" or "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments, and / or does not exclude incorporation of features from other embodiments.

[0158] The term "optionally" is used herein to mean "provided in one embodiment but not in another." Any particular embodiment of the present disclosure may include a plurality of "optional" features, provided that such features are not mutually inconsistent.

[0159] As used herein, the term "method" refers to a manner, means, technique, and procedure for achieving a given purpose, including, but not limited to, manners, means, techniques, and procedures that are known to those skilled in the art of chemistry, pharmacology, biology, biochemistry, and medicine, or that can be readily developed from known manners, means, techniques, and procedures by those skilled in the art.

[0160] As used herein, the term "treatment" includes causing the progression of a condition to cease, substantially inhibiting, delaying, or reversing it, substantially improving the clinical or aesthetic symptoms of a condition, or substantially preventing the onset of the clinical or aesthetic symptoms of a condition.

[0161] Throughout this application, embodiments may be presented in a range format. The description in range format is merely for convenience and brevity and should not be construed as a strict limitation on the scope of the present disclosure. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as the individual numerical values within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed sub-ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc., as well as the individual numerical values within the range, such as 1, 2, 3, 4, 5, and 6.

[0162] When a numerical range (e.g., "10 - 15", "10 to 15", or any combination of numerical values joined by another such range notation) is recited herein, it is always intended to include any number (non-integer or integer) within the recited range thresholds (including the range thresholds), unless the context clearly indicates otherwise. The phrases "range between" a first recited value and a second recited value, and "range from" a first recited value "to" or "through" a second recited value (or another such range notation term) are used interchangeably herein and are intended to include the first and second recited values and all non-integer and integer values therebetween.

[0163] The description of the present disclosure is provided in conjunction with specific embodiments, but it will be apparent to those skilled in the art that numerous alternatives, modifications, and variations are possible. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the invention as claimed in the claims.

[0164] For clarity, some features described in the context of separate embodiments in this disclosure may be provided in combination as a single embodiment. Conversely, for brevity, various features described in the context of a single embodiment may be provided independently, or in any suitable sub-combination, or as any other described embodiment of the disclosure. Some features described in the context of various embodiments should not be construed as essential features of those embodiments unless those embodiments would not function without those elements.

[0165] The entire contents of all documents, patents, and patent applications mentioned in this specification are hereby incorporated by reference to the same extent as if each individual document, patent, and patent application were specifically and individually incorporated by reference herein. Further, any citation or identification of a reference in this application should not be construed as an admission that such reference is available as prior art to the present disclosure. To the extent that section headings are used, these should not necessarily be construed as limiting. Further, the entire contents of the priority documents of this application are hereby incorporated by reference herein.

[0166] [Appendix] [Appendix 1] A method for estimating the clinical state of a vascular portion, comprising: receiving a map of fractional flow reserve (FFR) that assigns a plurality of FFR values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular portion; and calculating an FFR impact score using the mapped FFR values, wherein an element of the FFR impact score discards, calculates the mapping of the FFR values to the specific positions. A method including

[0167] [Appendix 2] The map of FFR assigns FFR values to the specific positions continuously or almost continuously. The method according to Appendix 1.

[0168] [Appendix 3] The map of FFR includes at least five FFR values for each of at least four vascular segments. The method according to Appendix 1 or 2.

[0169] [Appendix 4] The map of FFR represents the contribution to the reduction of blood flow capacity from an upstream position common to each of the specific positions. The method according to Appendix 1 or 2.

[0170] [Appendix 5] The vascular tree models a plurality of vascular ranges of the vascular portions connected at branch points. Each of the vascular segments is the origin of the vascular tree, the first vascular branch point the second vascular branch point, or the unconnected end of the vascular tree extends between two of The method according to any one of Appendices 1 to 4.

[0171] [Appendix 6] The FFR impact score includes a plurality of score elements, each of which retains the association with a specific one of the plurality of vascular segments although it discards the mapping of FFR values to the specific positions. The method according to any one of Appendices 1 to 4.

[0172] [Appendix 7] The plurality of score elements includes a total drop score for each of the plurality of vascular segments, and the total drop score represents the total drop in FFR along the vascular segment from a reference value representing a non-occluded vascular system. The method according to Supplementary Note 6.

[0173] [Supplementary Note 8] Assigning a occluded or non-occluded state to each of the plurality of vascular segments based at least on the total drop score for that segment, Counting the number of occluded vascular segments, and, Providing the total number as a multi-vascularity score that is a score element of the FFR impact score. further comprising The method according to Supplementary Note 6 or 7.

[0174] [Supplementary Note 9] The plurality of score elements includes a maximum drop score representing the maximum drop in FFR along the vascular segment for a defined portion of the vascular segment that is shorter than the entire vascular segment for each of the plurality of vascular segments. The method according to any one of Supplementary Notes 6 to 8.

[0175] [Supplementary Note 10] The defined portion is about 10 mm 3 to about 100 mm 3 and is a distance within which a blood volume in the range can fit. The method according to Supplementary Note 9.

[0176] [Supplementary Note 11] The defined portion is a distance within which a blood volume of about 40 mm 3 can fit. The method according to Supplementary Note 10.

[0177] [Supplementary Note 12] Assigning a occluded or non-occluded state to each of the plurality of vascular segments based at least on the maximum drop score for that segment, Counting the number of occluded blood vessel segments, and providing the total number thereof as a multi-vessel score which is a score element of the FFR influence score, further comprising the method according to appendix 9 or 10.

[0178] [Appendix 13] The plurality of score elements include a diffusivity score representing, for each of the plurality of blood vessel segments, the extent to which lesions contributing to the total drop in FFR are widely distributed along the blood vessel segment. The method according to any one of appendices 6 to 12.

[0179] [Appendix 14] Calculating the blood vessel drop diffusivity score includes determining the degree to which the maximum drop score differs from the total drop score. The method according to appendix 13.

[0180] [Appendix 15] Calculating the blood vessel drop diffusivity score includes calculating the ratio of the total drop score to the maximum drop score. The method according to appendix 14.

[0181] [Appendix 16] The plurality of score elements include a severity score representing a weighted average of FFR at all positions in the blood vessel tree, where positions farther from the origin of the blood vessel tree are weighted more downward. The method according to any one of appendices 6 to 15.

[0182] [Appendix 17] The plurality of score elements include one or more score elements related to a segment including the left main coronary artery in the blood vessel tree up to the first bifurcation point of the left main coronary artery represented in the blood vessel tree. The method according to any one of appendices 6 to 16.

[0183] [Appendix 18] The FFR impact score includes a sorted value chart score element representing the FFR value of each of the plurality of vascular segments in a composite value sorting order, such that values from different vascular segments are interleaved with each other. The method according to any one of Appendices 1 to 16.

[0184] [Appendix 19] Including displaying the sorted value chart score element as a color-coded pie chart. The method according to Appendix 18.

[0185] [Appendix 20] The FFR impact score includes a histogram chart score element representing the FFR value of each of the plurality of vascular segments in a composite histogram, and the contribution of each FFR value to the histogram is weighted according to the size of the vascular volume in which the FFR value occurs internally. The method according to any one of Appendices 1 to 19.

[0186] [Appendix 21] The FFR impact score includes a score element describing the lesion length based on the distance over which the FFR value continuously decreases. The method according to any one of Appendices 1 to 20.

[0187] [Appendix 22] The FFR impact score is One that includes both the main blood vessel and the collateral branches, One that includes the main blood vessel and at least two of its branches, One that occurs within the aortic inlet vascular segment, One that occurs adjacent to the bending region of the vascular system, or One that occurs within the bending region of the vascular system, Including a score element describing the lesion geometry as one or more of The method according to any one of Appendices 1 to 21.

[0188] [Appendix 23] Automatic virtual stenting Manual stent selection, data measured after stent implantation, or, data measured through multiple diagnostic procedures, adjusting the FFR impact score based on a corrected FFR map corrected according to one or more of the above, The method according to any one of Appendices 1 to 22.

[0189] [Appendix 24] comparing the FFR impact score with a second FFR impact score calculated according to the method described in Appendix 1, and, estimating the progression rate of vascular disease, including, The method according to any one of Appendices 1 to 23.

[0190] [Appendix 25] scheduling further diagnostic procedures based on the estimation, The method described in Appendix 24.

[0191] [Appendix 26] planning a treatment procedure based on the FFR impact score, The method according to any one of Appendices 1 to 25.

[0192] [Appendix 27] selecting between OMT and PCI based on the FFR impact score, The method described in Appendix 26.

[0193] [Appendix 28] selecting between PCI and CABG treatment based on the FFR impact score, The method described in Appendix 26 or 27.

[0194] [Appendix 29] planning at least one of the number, position, and / or type of stents to be deployed based on the FFR impact score, The method according to any one of Appendices 26 to 28.

[0195] [Appendix 30] including planning at least one of the number and / or position of CABG grafts to be placed based on the FFR impact score The method according to Appendix 26 or 28

[0196] [Appendix 31] A method for estimating the clinical condition of a vascular segment, comprising receiving a map of FFR that assigns a plurality of fractional flow reserve (FFR) values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular segment, and calculating an FFR impact score using the mapped FFR values, wherein the FFR impact score includes an element of comparing the total drop in FFR along at least one of the vascular segments with the maximum drop in FFR along the vascular segment, calculating A method comprising

[0197] [Appendix 32] A method for estimating the clinical condition of a vascular segment, comprising receiving a map of FFR that assigns a plurality of fractional flow reserve (FFR) values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular segment, and calculating an FFR impact score using the mapped FFR values, wherein the FFR impact score includes calculating a graph that combines individual FFR values from the plurality of vascular segments such that at least some of the individual FFR values are shown at positions on the graph that are not adjacent to any other FFR values obtained from adjacent vascular positions A method comprising

[0198] [Appendix 33] A system comprising a processor configured to execute the method according to Appendix 1

[0199] [Appendix 34] An apparatus for estimating the clinical condition of a vascular segment, comprising A data storage device that stores a data structure for assigning a plurality of fractional flow reserve (FFR) values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and is communicably connected to the data storage device, and calculates an FFR impact score using the assigned FFR values, uses elements of the FFR impact score to discard the assignment of the FFR values to the specific positions, and causes the FFR impact score to be displayed on a user interface, a processing device configured as such, An apparatus including.

[0200] [Appendix 35] The FFR impact score includes a plurality of score elements, each of which retains an association with a specific one of the plurality of vascular segments that discards the assignment of the FFR value to the specific position. The apparatus according to Appendix 34.

[0201] [Appendix 36] The plurality of score elements includes a total drop score for each of the plurality of vascular segments, and the total drop score represents the total drop in FFR along the vascular segment from a reference value representing a non-occluded vascular system. The apparatus according to Appendix 35.

[0202] [Appendix 37] The processing device assigns an occluded or non-occluded state to each of the plurality of vascular segments based at least on the total drop score for that segment, counts the number of occluded vascular segments, and uses the total number as a multi-vascularity score that is a score element of the FFR impact score. configured as such, The apparatus according to Appendix 35 or 36.

[0203] [Appendix 38] The FFR impact score includes a sorted value chart score element representing the FFR value of each of the plurality of vascular segments in a composite value sort order, such that values from different vascular segments are interleaved with each other. The apparatus according to any one of Appendices 34 to 37.

[0204] [Appendix 39] The processing device is configured to cause the user interface to display the sorted value chart score element as a color-coded pie chart. The apparatus according to Appendix 38.

[0205] [Appendix 40] The FFR impact score includes a histogram chart score element representing the FFR value of each of the plurality of vascular segments in a composite histogram, and the contribution of each FFR value to the histogram is weighted according to the size of the vascular volume in which the FFR value occurs internally. The apparatus according to any one of Appendices 34 to 39.

[0206] [Appendix 41] The processing device is configured to cause the user interface to display the histogram chart score element. The apparatus according to Appendix 40.

[0207] [Appendix 42] Automatic virtual stenting Manual stent selection Data measured after stent placement, or Data measured through a plurality of diagnostic procedures The processing device is configured to adjust the FFR impact score based on a corrected assignment of FFR modified according to one or more of the above. The apparatus according to any one of Appendices 34 to 41.

[0208] [Appendix 43] The processing device is configured to compare the FFR impact score with a second FFR impact score and estimate a progression rate of a vascular disease based on the comparison. The device according to any one of Appendices 34 to 41.

Claims

1. A method for estimating the clinical state of a vascular portion, comprising: Receiving a map of fractional flow reserve (FFR) that assigns a plurality of FFR values to specific locations on each of a plurality of vascular segments of a vascular tree representing the vascular portion; Calculating an FFR impact score indicative of the overall impact of obstructive vascular disease in the vascular tree using the mapped FFR values, wherein the FFR impact score includes sorted value chart score elements representing the FFR values of each of the plurality of vascular segments in a composite value sort order such that values from different vascular segments are interleaved with each other; calculating the FFR impact score includes graphing the FFR values in sorted order as a color-coded pie chart; graphing the FFR values in sorted order as a color-coded pie chart includes calculating by plotting the FFR values as radii color-coded clockwise along the pie chart, wherein the angular distance between each radius corresponds to the distance along each of the plurality of vascular segments; A method comprising the above.

2. The map of FFR assigns FFR values to the specific locations continuously or substantially continuously; The method according to claim 1.

3. The map of FFR includes at least five FFR values for each of at least four vascular segments; The method according to claim 1 or 2.

4. The map of FFR represents the contribution to the reduction of blood flow capacity from an upstream position common to each of the specific locations; The method according to claim 1 or 2.

5. The vascular tree models a plurality of vascular ranges of the vascular portion connected at branch points, and each of the vascular segments is the origin of the vascular tree, the first vascular bifurcation point, the second vascular bifurcation point, or, a non-connected end of the vascular tree, extending between two of them, The method according to any one of claims 1 to 4.

6. The FFR influence score includes a histogram chart score element representing each of the FFR values of the plurality of vascular segments in the composite histogram, and the contribution of each of the FFR values to the composite histogram is weighted according to the size of the vascular volume in which the FFR value occurs. The method according to any one of claims 1 to 5.

7. The FFR influence score includes a score element describing the lesion length based on the distance over which the FFR value continuously decreases. The method according to any one of claims 1 to 6.

8. The FFR influence score is one including both the main blood vessel and the collateral, one including at least two of the main blood vessel and its branches, one occurring within the aortic inlet vascular segment, one occurring adjacent to a bending region of the vascular system, or, one occurring within a bending region of the vascular system, including a score element describing the lesion geometry as one or more of them. The method according to any one of claims 1 to 7.

9. automated virtual stenting, manual stent selection, data measured after stent implantation, or, data measured through a plurality of diagnostic procedures, including adjusting the FFR influence score based on a corrected map of FFR, corrected according to one or more of them. The method according to any one of claims 1 to 8.

10. Calculating a second FFR impact score that indicates the overall impact of obstructive vascular disease in the vascular tree using the mapped FFR values; Comparing the FFR impact score with the second FFR impact score, and Estimating the progression rate of the vascular disease, including, The method according to any one of claims 1 to 9.

11. Scheduling further diagnostic procedures based on the estimation, The method according to claim 10.

12. Planning a treatment procedure based on the FFR impact score, The method according to any one of claims 1 to 11.

13. Making a selection between OMT and PCI treatment based on the FFR impact score, The method according to claim 12.

14. Making a selection between PCI and CABG treatment based on the FFR impact score, The method according to claim 12 or 13.

15. Planning at least one of the number, position, and / or type of stents to be deployed based on the FFR impact score, The method according to any one of claims 12 to 14.

16. Planning at least one of the number and / or position of CABG grafts to be deployed based on the FFR impact score, The method according to claim 12 or 14.

17. A method for estimating the clinical state of a vascular segment, comprising: Receiving a map of FFR that assigns a plurality of fractional flow reserve (FFR) values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular segment, and Calculating an FFR impact score indicative of the overall impact of obstructive vascular disease in the vascular tree using the mapped FFR values, wherein the FFR impact score includes a color-coded pie chart and an element for comparing the total drop in FFR along at least one of the vascular segments to the maximum drop in FFR along the vascular segment, Calculating the FFR impact score includes graphing the FFR values in sorted order as a color-coded pie chart, Graphing the FFR values in sorted order as a color-coded pie chart includes plotting the FFR values as radii color-coded clockwise along the pie chart, wherein the angular distance between each radius corresponds to the distance along each of the plurality of vascular segments, calculating, A method comprising.

18. A method for estimating the clinical state of a vascular portion, comprising: Receiving a map of fractional flow reserve (FFR) that assigns a plurality of fractional flow reserve (FFR) values to specific locations on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and Calculating an FFR impact score indicative of the overall impact of obstructive vascular disease in the vascular tree using the mapped FFR values, wherein the FFR impact score includes a color-coded pie chart and a histogram chart score element representing each of the FFR values of the plurality of vascular segments in a composite histogram, and the contribution of each FFR value to the composite histogram is weighted according to the size of the vascular volume in which the FFR value occurs, Calculating the FFR impact score includes graphing the FFR values in sorted order as a color-coded pie chart, Graphing the FFR values as a color - coded pie chart in sorted order involves calculating by plotting the FFR values as radii that are color - coded clockwise along the pie chart, where the angular distance between each radius corresponds to the distance along each of the plurality of vascular segments. A method including.

19. A system including a processor configured to execute the method according to claim 1.

20. An apparatus for estimating the clinical state of a vascular portion, A data storage device storing a data structure that assigns a plurality of fractional flow reserve (FFR) values to specific positions on each of a plurality of vascular segments of a vascular tree representing the vascular portion, and A processing device communicatively connected to the data storage device and Executing to calculate an FFR impact score indicating the overall impact of obstructive vascular disease in the vascular tree using the assigned FFR values, And causing a user interface to display the FFR impact score as a color - coded pie chart. A processing device configured as such, Including The FFR impact score Includes a sorted - value chart score element representing the FFR values of each of the plurality of vascular segments in a composite value sorted order, where values from different vascular segments are interleaved with each other, and A histogram chart score element representing the FFR values of each of the plurality of vascular segments in a composite histogram, and Wherein the contribution of each FFR value to the composite histogram is weighted according to the size of the vascular volume in which the FFR value occurs internally. Calculating the FFR impact score includes graphing the FFR values as a color - coded pie chart in sorted order. Graphing the FFR values in sorted order as a color - coded pie chart involves plotting the FFR values as radii that are color - coded clockwise along the pie chart, where the angular distance between each radius corresponds to the distance along each of the plurality of vascular segments. Device.

21. The processing device is configured to cause the user interface to display the histogram chart score element. The device according to claim 20.

22. Automated virtual stenting, Manual stent selection, Data measured after stent implantation, or, Data measured through a plurality of diagnostic procedures, The processing device is configured to adjust the FFR impact score based on a modified assignment of FFR that is modified according to one or more of the above, The device according to claim 20 or 21.

23. The processing device is configured to compare the FFR impact score with a second FFR impact score and estimate the progression rate of the vascular disease based on the comparison. The device according to any one of claims 20 to 22.

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