WO2023021902A1 - Système de prise en charge d'évaluation pour une maladie cardiaque et procédé de prise en charge d'évaluation - Google Patents

Système de prise en charge d'évaluation pour une maladie cardiaque et procédé de prise en charge d'évaluation Download PDF

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Publication number
WO2023021902A1
WO2023021902A1 PCT/JP2022/027955 JP2022027955W WO2023021902A1 WO 2023021902 A1 WO2023021902 A1 WO 2023021902A1 JP 2022027955 W JP2022027955 W JP 2022027955W WO 2023021902 A1 WO2023021902 A1 WO 2023021902A1
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Prior art keywords
pressure
index
heart disease
ratio
predetermined time
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PCT/JP2022/027955
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English (en)
Japanese (ja)
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世史明 川瀬
拓也 水上
雅文 中山
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世史明 川瀬
合同会社Medboost
拓也 水上
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Publication of WO2023021902A1 publication Critical patent/WO2023021902A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body

Definitions

  • the present invention relates to a heart disease evaluation support system and evaluation support method used for heart disease evaluation, etc., based on a coronary artery pressure waveform.
  • the blood flow in coronary arteries is very special compared to other organs.
  • it since it is an important organ, it has the ability to self-regulate blood flow within a certain range of blood pressure.
  • the heart muscle itself creates the blood pressure that drives blood flow, and blood flow peaks during systole, when blood pressure is highest in normal organs.
  • the peripheral parts of the coronary arteries are compressed by the muscles, conversely restricting the blood flow. Instead, during diastole, when blood does not flow through normal organs, the myocardial pressure on the peripheral blood vessels of the coronary arteries is released, and the suction force generated by the conversely dilation of the compressed blood vessels causes more blood to flow.
  • blood flow patterns change with the progression of special pathological conditions such as aortic valve stenosis. If it is possible to measure the change in , it will be possible to use it for evaluating the severity of pathological conditions such as valvular disease. In addition, according to the findings of the present inventors, it is possible that even patients with heart disease who do not have valvular disease have different blood flow patterns. It will be useful for searching for causative factors of these diseases and for research to elucidate their pathological significance.
  • the blood flow in the coronary arteries can be directly measured by using a catheter-type wire called a Doppler flow wire disclosed in Patent Document 1, etc., and the blood flow pattern of the coronary arteries can be detected from the change in the blood flow over time. becomes possible.
  • the method of measuring blood flow using such a Doppler flow wire is reported to have a probability of obtaining satisfactory data of about 69%, and is not widely used due to high technical hurdles.
  • a guide wire for coronary artery insertion with a pressure sensor called a pressure wire
  • This pressure wire acquires the blood pressure upstream and downstream of the lesion site in the coronary artery.
  • a pressure gradient which is the pressure difference before and after the lesion.
  • the pressure gradient increases as the blood flow passing through the lesion increases.
  • the FFR is an index obtained in a state in which microvascular resistance is lowered by administration of a drug to a patient, and is the pressure (proximal region pressure) Pa , and the pressure (distal pressure) Pd at the distal stenotic portion on the same downstream side, Pd/Pa.
  • the FFR is below a predetermined value, it is determined that there is myocardial ischemia, and is used as a guideline for treatment such as coronary artery stent placement.
  • the iFR is measured without administering drugs to the patient, and all the pressure ratios Pd /Pa, and when the iFR is below a predetermined value, it is determined that there is myocardial ischemia.
  • the proximal and distal pressure waveforms across the lesion in the coronary arteries can be acquired with the pressure wire. From the results of comparing each time phase of a predetermined region during the same diastole, it was found that the blood flow pattern of the coronary arteries can be estimated, although the absolute amount of blood flow is not known.
  • the present invention has been devised based on these findings of the inventors, and its purpose is to estimate the blood flow pattern of the coronary artery corresponding to the pathological condition based on each pressure waveform before and after the lesion.
  • the present invention provides a system for assisting assessment of heart disease based primarily on the pressure gradient between upstream and downstream blood flow through a lesion in a patient's coronary arteries, comprising: A pressure data acquisition device that acquires the proximal pressure, which is the pressure on the upstream side, and the distal pressure, which is the pressure on the downstream side, as pressure data corresponding to time, and heart disease evaluation from the pressure data.
  • the arithmetic processing unit stores a value corresponding to the pressure gradient in a predetermined time period during systole of the heart and a value corresponding to the pressure gradient in a predetermined time period during diastole of the heart. It adopts a configuration in which the index is obtained based on a comparison with
  • data can be easily obtained without measuring the blood flow using a Doppler flow wire, which is a high technical hurdle. It is expected that a blood flow waveform pattern having the following characteristics can be estimated.
  • the data that is the basis of the pressure gradient can be obtained from many patients and registered when obtaining the myocardial flow reserve ratio (FFR) and the instantaneous flow reserve ratio (iFR). Prognostic research is also possible, and it can be expected to promote research to clarify the relationship between changes in blood flow patterns and pathological significance.
  • FFR myocardial flow reserve ratio
  • iFR instantaneous flow reserve ratio
  • FIG. 1 is a block diagram schematically showing the configuration of a cardiac disease evaluation support system according to an embodiment
  • FIG. FIG. 4 is a conceptual diagram for explaining pressure measurement sites in the evaluation support system
  • 1 is a graph of a pressure waveform for one heartbeat representing the relationship of intravascular pressure of a coronary artery to time
  • FIG. 11 is a pressure waveform graph for one heartbeat for explaining a modified example of the first and second target ranges extracted by the index calculator
  • FIG. FIG. 11 is a pressure waveform graph for one heartbeat for explaining another modified example of the first and second target ranges extracted by the index calculator
  • FIG. 1 shows a block diagram schematically showing the configuration of a heart disease evaluation support system according to this embodiment.
  • the evaluation support system 10 is a system for supporting the evaluation of heart disease based on the pressure gradient (pressure difference) between the upstream and downstream sides of blood flow passing through a lesion in a patient's coronary artery.
  • This evaluation support system 10 includes a pressure data acquisition device 11 that acquires pressure data consisting of a pressure waveform corresponding to an acquisition time of the intravascular pressure, and a pressure data acquired by the pressure data acquisition device 11 for evaluation of heart disease. and a display device 13 such as a display for displaying various information including the index obtained by the arithmetic processing unit.
  • the pressure data acquisition device 11 a device capable of acquiring pressure waveforms of intravascular pressure (intracoronary artery pressure) on the upstream side and downstream side of a stenotic lesion in the coronary artery is used. As shown in FIG. 2, this pressure data acquisition device 11 is capable of acquiring, over time, pressure data relating to the pressure gradient, which is the difference between the intravascular pressures at two locations in the patient's coronary artery A across a stenotic lesion B.
  • the pressure data acquisition device 11 includes a proximal part pressure Pa, which is the pressure at the proximal stenotic part A1 upstream of the stenotic lesion B, which corresponds to the aortic pressure, and A known cardiac catheterization device capable of measuring the distal pressure Pd, which is the pressure at the site A2, is applied.
  • the pressure data acquisition device 11 can detect the proximal pressure Pa by the detection unit S1 provided in the catheter C whose distal end side is located in the proximal stenosis region A1, and can detect the pressure Pa in the distal stenosis region A2 from the lumen of the catheter C.
  • a metal guide wire W (pressure wire) with a pressure sensor S2 extending to the tip of the guide wire W (pressure wire) employs a known structure capable of detecting the pressure on the distal end side as the distal pressure Pd.
  • the arithmetic processing unit 12 is composed of a computer including an arithmetic unit such as a CPU and a storage device such as a memory and a hard disk, and programs are installed to make the computer function as the following units.
  • the blood flow of the coronary arteries is calculated based on the comparison between the value corresponding to the pressure gradient in a predetermined time period on the systolic side of the heart and the value corresponding to the pressure gradient in a predetermined time period on the diastolic side of the heart.
  • An index corresponding to a blood flow pattern which is a pattern of waveforms, is obtained.
  • the arithmetic processing unit 12 includes a pressure ratio calculator 15 that calculates the pressure ratio Pd/Pa obtained by dividing the distal pressure Pd by the proximal pressure Pa, and the pressure ratio Pd/Pa that is extracted in a predetermined time period.
  • An index calculation unit 16 is provided for obtaining an index corresponding to a blood flow pattern, which is a blood flow waveform pattern of the coronary artery, from Pa.
  • the pressure ratio calculator 15 calculates the pressure ratio Pd/Pa at each time from the proximal pressure Pa and the distal pressure Pd obtained at each time within a predetermined measurement time of the pressure data acquisition device 11. It is calculated and recorded corresponding to each time.
  • the index calculation unit 16 identifies regions corresponding to systole and diastole from the pressure data, and converts the pressure ratio Pd/Pa in a predetermined range on the systole side to the pressure ratio in a predetermined range on the diastole side. By dividing, an index corresponding to the blood flow pattern is obtained.
  • pressure waveforms (solid lines in FIG. 3) of the proximal pressure Pa and the distal pressure Pd, which are pressure data over time, are used to determine the closure of the aortic valve.
  • the time corresponding to the double notch (DN) where the pressure intensity fluctuates greatly is specified.
  • the pressure data during one heartbeat in the time zone before and after the DN portion is specified as the pressure data located in the systole Sy and the pressure data in the diastole Di.
  • the pressure data of the first target range R1 in a predetermined time period is extracted from the pressure data at each time in the systole Sy during one heartbeat, and the pressure ratio Pd /Pa is specified as the adopted value AS.
  • the pressure data of the second target range R2 in a predetermined time period is extracted from the pressure data at each time in the diastole Di during one heartbeat, and the pressure ratio Pd /Pa is specified as the adopted value AD.
  • the first target range R1 the entire region of the systolic period Sy in the pressure data during one heartbeat is adopted, and as the second target range R2, the diastolic period Di The entire area of is adopted.
  • the first and second target ranges R1 and R2 are not limited to the ranges described above, as long as they are divided into a predetermined range on the side of systole Sy and a predetermined range on the side of diastole Di. , can also be configured as follows. For example, as shown in FIG. 4, the area on the systolic period Sy side and the area on the diastolic period Di side excluding the predetermined time period sandwiching the DN portion may be set as the first and second target ranges R1 and R2. Further, as shown in FIG.
  • the time from mid-diastole to end-phase (WFP: Wave free period) of the heart used in iFR (instantaneous flow reserve ratio) A part of the diastole Di such as a band may be cut out. Similarly, a part of the systole Sy may be cut out.
  • the above-described predetermined range on the systolic phase Sy side may include from the region in the systolic phase Sy to a partial region of the diastolic phase Di sandwiching the DN portion.
  • the above-described predetermined range on the diastolic phase Di side may include from the region in the diastolic phase Di to a partial region of the systolic phase Sy sandwiching the DN portion.
  • the adopted values AS and AD are selected by a predetermined method from the values of the pressure ratio Pd/Pa in the target ranges R1 and R2, not the average value of the pressure ratios Pd/Pa. Alternatively, it can be specified by calculation.
  • the index Id is not limited to the S/D ratio described above, but may be a value corresponding to the pressure gradient in the first target range during systole of the heart, such as its back calculation value, and a second target range during diastole of the heart. Any value based on comparison with the value corresponding to the pressure gradient in the range can be used as appropriate.
  • the aforementioned S/D ratio is considered to correspond to the blood flow pattern of the coronary arteries that appears in a given pathological condition, and even without measuring the blood flow, the blood flow pattern for a healthy person can be estimated. Changes can be estimated for each pathological condition, and the possibility of a specific heart disease can be detected by using a threshold obtained and set in advance for each pathological condition through prior research or the like. According to findings from the verification results of the present inventors, for example, the presence of aortic valve stenosis is suggested when the S/D ratio is equal to or greater than the threshold value of 1.087.
  • various heart diseases can be relatively easily estimated by deriving a new index Id corresponding to the blood flow pattern without measuring the blood flow in the coronary arteries.
  • the base pressure data can be measured from the data currently generally measured for the purpose of determining treatment indications for coronary artery lesions, such as the aforementioned FFR and iFR. It is expected to be simpler and more reproducible than the method of measuring the flow rate.
  • the conventional method of measuring blood flow patterns using a Doppler flow wire has high technical hurdles, making it difficult to conduct large-scale clinical trials. Therefore, even if the change in blood flow pattern has pathological significance, it has been extremely difficult to clarify it.
  • the index calculation unit 16 additionally obtains an auxiliary index Ids that assists the evaluation based on the S/D ratio as the index Id from the pressure waveform obtained by the pressure data acquisition device 11. can also obtain an auxiliary index Ids that assists the evaluation based on the S/D ratio as the index Id from the pressure waveform obtained by the pressure data acquisition device 11.
  • the heart rate and the ejection time which is a predetermined time on the systolic side in one heartbeat
  • the following formula is used to remove the influence of the heart rate from the predetermined time.
  • An index Ids is also obtained.
  • Ids K (heart rate) + (predetermined time)
  • the coefficient K is a constant that changes depending on other factors such as gender differences, and is a value that is stored or set in advance in the index calculation unit 16 .
  • the predetermined time the time of the first target range R1 including the systolic time is applied.
  • the ratio of each time in the above-mentioned predetermined ranges (target ranges R1 and R2) of the systolic Sy side and the diastolic side Di, including the ratio of the systolic time to the diastolic time, is adopted. is also possible.
  • the above supplementary index Ids can be expected to be used clinically for the following purposes. Possible clinical uses include use as an index of myocardial ischemia, estimation of cardiac systolic function, and estimation of coronary flow reserve (CFR) and microvascular resistance (IMR).
  • CFR coronary flow reserve
  • IMR microvascular resistance
  • auxiliary index Ids to the index Id, it is considered to be useful for diagnosis and research of a wider range of heart diseases such as ischemic heart disease, valvular disease, and cardiomyopathy.
  • auxiliary index Ids not only the proximal pressure Pa and the distal pressure Pd, but also other intravascular pressures such as peripheral vascular pressure can be used.
  • the pressure data acquisition device 11 in the present invention is not limited to the structure of the above embodiment, and any other device or system capable of measuring the intravascular pressure described above can be applied.

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Abstract

L'invention concerne un système pour prendre en charge une évaluation d'une maladie cardiaque sur la base d'une différence de pression entre le côté amont et le côté aval d'un flux sanguin traversant une lésion (B) dans une artère coronaire (A) d'un patient, le système comprenant : un dispositif d'acquisition de données de pression (11) qui acquiert une pression de partie proximale (Pa), qui est une pression sur le côté amont, et une pression de partie distale (Pd), qui est une pression sur le côté aval, sous la forme de données de pression correspondant à des temps, et une unité de traitement arithmétique (12) qui détermine un indice (Id) pour évaluer une maladie cardiaque à partir des données de pression. Dans l'unité de traitement arithmétique (12), l'indice (Id) est déterminé sur la base d'une comparaison entre une valeur correspondant à une différence de pression pendant une période de temps prédéterminée (R1) de systole (Sy) du cœur et une valeur correspondant à une différence de pression pendant une période de temps prédéterminée (R2) de diastole (Di) du cœur.
PCT/JP2022/027955 2021-08-20 2022-07-18 Système de prise en charge d'évaluation pour une maladie cardiaque et procédé de prise en charge d'évaluation WO2023021902A1 (fr)

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JP2021134616A JP2023028739A (ja) 2021-08-20 2021-08-20 心疾患の評価支援システム及び評価支援用プログラム
JP2021-134616 2021-08-20

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012501807A (ja) * 2008-09-11 2012-01-26 アシスト・メディカル・システムズ，インコーポレイテッド 生理学的センサ配送装置及び方法
JP2017531534A (ja) * 2014-08-27 2017-10-26 セント ジュード メディカル システムズ アーベー 最小の遠位側圧力／動脈圧（ｐｄ／ｐａ）比を決定することによって心臓系を評価するためのシステム及び方法
WO2020022232A1 (fr) * 2018-07-26 2020-01-30 学校法人早稲田大学 Système d'aide au diagnostic d'une cardiopathie ischémique

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012501807A (ja) * 2008-09-11 2012-01-26 アシスト・メディカル・システムズ，インコーポレイテッド 生理学的センサ配送装置及び方法
JP2017531534A (ja) * 2014-08-27 2017-10-26 セント ジュード メディカル システムズ アーベー 最小の遠位側圧力／動脈圧（ｐｄ／ｐａ）比を決定することによって心臓系を評価するためのシステム及び方法
WO2020022232A1 (fr) * 2018-07-26 2020-01-30 学校法人早稲田大学 Système d'aide au diagnostic d'une cardiopathie ischémique

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
AKASAKA, TAKASHI: "Application of a Pressure Guide Wire Combined with Thermography in the Assessment of Coronary Stenotic Lesions", SEITAI IKOUGAKU _ JAPANESE SOCIETY FOR MEDICAL AND BIOLOGICAL ENGINEERING. TRANSACTIONS, NIHON SEITAI IKOU GAKKAI, JP, vol. 43, no. 1, 1 January 2005 (2005-01-01), JP , pages 24 - 31, XP009543871, ISSN: 1347-443X, DOI: 10.11239/jsmbe.43.24 *

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