KR20200000655A - Monitoring system for pacing-induced cardiomyopathy - Google Patents

Abstract

The present invention relates to a device for monitoring ECG and pacemaker. More specifically, the device for monitoring ECG and pacemaker comprises: an input unit receiving ECG data; an extraction unit extracting a QRS peak, QRS amplitude, and QRS axis using the received data; a calculation unit calculating a QRS period after beat using the QRS peak, QRS amplitude, and QRS axis; a determination unit determining degree of risk of disease emergence; and an alarm unit alarming the degree of risk of the pacing-induced disease emergence using information of the determination unit.

Description

Monitoring system for pacing-induced cardiomyopathy

The present invention relates to an electrocardiogram and pacemaker monitoring device capable of predicting or diagnosing a disease that is a heartbeat-induced cardiomyopathy occurring in a patient who has a pacemaker for the treatment of bradycardia arrhythmia.

Cardiac arrhythmias due to sick sinus syndrome and atrioventricular block due to degenerative changes in the heart due to heart disease or aging, are increasingly associated with heart discomfort, dizziness, Shortness of breath, fainting, and sudden cardiac death occur, leading to significant losses in medical and socioeconomic costs. The only treatment for bradycardia arrhythmia is permanent artificial pacemaker implantation, and the pacemaker is composed of a pacemaker and a pacemaker lead. The cardiac pacemaker is mainly inserted below the breast clavicle and under the skin and continuously detects the heart rhythm of the patient to release electrical energy when electrical activity is not detected to contract the heart. Pulsator is a small high-performance computer composed of an electric circuit and a battery. It gives electric stimulation to the heart and makes the heart beat and detects the heart rhythm to control or generate electric stimulation from the pacemaker. It is an insulated metal wire that transfers energy from the pacemaker to the heart, causing the heart to contract, and transmitting the heart's natural electrical activity to the pacemaker. In this case, the right ventricular attachment is preferred for artificial ventricular coordination, and the right ventricular attachment can easily fix the position of the electrode due to its anatomical characteristics. However, in the case of normal electrophysiological heartbeat, the electrical stimulation from the SA node passes through the AV node, and the heather bundle, Bundle branch, Purkinje fiber, Although delivered in the order of myocardium, artificial ventricular coordination adversely affects atrial and ventricular function, causing electrical and structural alteration of the myocardium in some patients with pacemaker implantation because intraventricular stimulus transmission occurs in the opposite direction. This is called pace-induced cardiomyopathy (PICM), which can cause cardiac-related complications such as atrial fibrillation, heart failure, and cardiac death.

As such, an artificial pacemaker for treating bradycardia arrhythmia may cause pulsatile cardiomyopathy, which may worsen the heart pathological condition. Since these pulsatile cardiomyopathy occurs in some patients with pacemakers, timely evaluation of screening for patients with high pulsatile cardiomyopathy should be considered. However, pulsatile cardiomyopathy is currently diagnosed with only a decrease in the EF%, which is confirmed by echocardiography, and there are no markers for diagnosing and predicting pulsatile cardiomyopathy. In addition, there are no pulsatile cardiomyopathy-related indicators among the regular cardiac pacemaker tests in patients with artificial pacemaker transplantation, so early diagnosis cannot be performed even on regular examinations. In addition, the treatment of heart-induced cardiomyopathy has been conducted in early forms such as His-bundle cardiac pacing or cardiac synchronization therapy (CRT), but there is no medical evidence. It is true.

Therefore, the need for early diagnosis and early diagnosis of pulsatile cardiomyopathy has emerged, and the development of new diagnostic categories with high sensitivity and specificity using economical diagnostic tools that are easy to test is required.

KR 10-1839759 B1 KR 10-0748184 B1

 Dreger H, Maethner K, Bondke H, et al. Pacing-induced cardiomyopathy in patients with right ventricular stimulation for> 15 years. Europace 2012; 14: 238-.42.  Khurshid S, Epstein AE, Verdino RJ, et al. Incidence and predictors of right ventricular pacing-induced cardiomyopathy. Heart Rhythm 2014; 11: 1619-.25.  Chan NY, Yuen HC, Choy CC, et al. Left ventricular volumes and systolic function after long-term right ventricular pacing may be predicted by paced QRS duration, but not pacing site. Heart Lung Circ 2014; 23: 43-.8.  Khurshid S, Liang JJ, Owens A, et al. Longer Paced QRS Duration is Associated With Increased Prevalence of Right Ventricular Pacing-Induced Cardiomyopathy. J Cardiovasc Electrophysiol 2016; 27: 1174-.9.  Chen S, Yin Y, Lan X, et al. Paced QRS duration as a predictor for clinical heart failure events during right ventricular apical pacing in patients with idiopathic complete atrioventricular block: results from an observational cohort study (PREDICT-HF). Eur J Heart Fail 2013; 15: 352-.9.  Pan W, Su Y, Gong X, et al. Value of the paced QRS duration. J Card Fail 2009; 15: 347-.52.

In order to solve the above problems, the present invention enables early diagnosis of cardiac pacemaker-induced cardiomyopathy, which cannot be diagnosed or predicted based on the existing ejection fraction (EF%), and the diagnostic method is simpler and more efficient. And it aims to provide new information through the pacemaker monitoring device.

In order to achieve the above object, the present invention provides an electrocardiogram and pacemaker monitoring apparatus, comprising: an input unit for receiving electrocardiogram data; An extraction unit for extracting an electrocardiogram waveform using the input data; An operation unit for calculating a measurement value of an electric wave of a heart from the ECG waveform; Disease risk determination unit; It provides an electrocardiogram and pacemaker monitoring device comprising a; notification unit for notifying the risk of heartbeat-induced disease occurrence using the information of the determination unit.

In another aspect, the present invention provides a device for determining the degree of risk by the risk stage of disease occurrence, the risk level is divided into steps based on the QRS period value (ms) after the beat, the QRS period value after the beat is 140 to Warning when 167 ms, it is determined that the danger when more than 167 ms.

The calculating unit may be configured to calculate a PR interval, a QRS duration, a QTc interval, and a QRS axis.

The heartbeat-induced disease includes pulsating-induced cardiomyophaty (PICM), atrial fibrillation, stroke, heart failure or sudden cardiac death, and the present invention Preferably, a device capable of diagnosing or predicting pulsatile cardiomyopathy is provided.

In another aspect, the present invention may include an interface unit for transmitting and receiving data with an external device, and further includes a memory unit for storing patient-specific measurement records.

The electrocardiogram and pacemaker monitoring device of the present invention utilizes the post-beat QRS period (pQRSd) as a new diagnosis and predictive marker by supplementing the existing pulsatile cardiomyopathy diagnosis, which was defined only as a decrease in ventricular ejection rate, and the occurrence of cardiac pacemaker disease Can be easily diagnosed according to the degree of risk.

1 is a block diagram of a cardiac pacemaker monitoring apparatus according to an embodiment of the present invention.
Figure 2 shows the normal physiological heartbeat conduction direction and the non-physiological artificial heartbeat conduction direction.
3 shows a basic waveform of a typical ECG signal.
Figure 4 shows the waveform of the ECG signal of the artificial pacemaker.
5 shows the ROC curve analysis.
Figure 6 shows the Kaplan-Meier curve analysis for (a) pQRSd 140 ms, (b) pQRSd 167 ms.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. In describing the present invention, when it is determined that the detailed description of the related well-known configuration or function may obscure the gist of the present invention, the detailed description thereof will be omitted.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In the present specification, when "includes" any component, this means that it may further include other components, except to exclude other components unless otherwise stated.

As used in this specification and the appended claims, unless otherwise indicated, the meanings of the following terms are as follows, which will be described in detail with reference to FIG. 3.

As used herein, the term "electrocardiogram (ECG)" refers to the recording of electrical changes that occur due to cardiac activity. The inside of the cell of the cell has a negative potential, the outside of the cell has a positive potential. When depolarization is reversed the polarity between the inside and the outside of the cell, repolarization (repolarization) is restored to the potential at rest. As the depolarization and repolarization of the heart cells are repeated, conduction of the stimulus occurs and an electrical signal is formed. The electrocardiogram is detected by an electrode on the skin and displayed on a paper or a screen. The main waveform of the ECG is composed of a P wave, a PRS group, a QRS complex, and a T wave, as shown in FIG. 3. P-wave is the wavelength that the stimulus transmitted to the atria through the SA node is the depolarization of the atrium. Depolarization means the contraction of the heart. At this time, the depolarization of the atrium begins near the idiopathic node and progresses from right to left across the atrium, so that the first part of the P wave represents the depolarization of the right atrium, and the back part of the P wave represents the depolarization of the left atrium. The QRS group is formed by ventricular depolarization and is composed of three waves: the first downward wave Q, the next upward wave R, and the next downward wave S. The T wave is formed by repolarization of the ventricles, which means relaxation of the heart.

The term "PR interval" as used herein refers to the time from the start of the P wave to the start of the QRS group, the time from contraction of the atrium to the contraction of the ventricles.

And a correcting the effect of the heart rate values for the term "QTc interval (corrected QT interval, QTc interval)" is the QT interval (QT interval), as used herein, (QT interval) / (RR interval) means a ^1/2 do. The QT interval is an interval from the start of the QRS group to the end of the T wave, and means the time from depolarization to repolarization of the ventricles and varies in inverse proportion to the heart rate.

As used herein, the term "QRS duration" is the interval from the beginning of the QRS group to the end of the QRS group, and refers to the total depolarization time of the ventricles. The pre-beating QRS duration (nQRSd) is the QRS duration before pacemaker implantation, and the post-beat QRS duration (pQRSd) is the QRS duration after pacemaker implantation.

As used herein, the term “QRS axis” refers to the QRS electric axis and means the average QRS vector during myocardial depolarization.

As used herein, the term "ejection fraction" refers to a single cardiac output divided by the left ventricular capacity of the dilator.

As used herein, the term "nPRI (native PR interval)" is the interval between the pacemaker-operated transmitter and the start of the P-wave and the QRS wave. The pPRI (paced PR interval) is the spike caused by the pacemaker operation before the P-wave begins. Point) to the start of the QRS wave including the P wave.

As used herein, the term "nQRSd (native QRS duration)" refers to the period in which the pacemaker operation starts from the start of the QRS wave to the end of the self QRS wave, and pQRSd (pace QRS duration) refers to the spike (peak The period from to the end of the QRS wave.

As used herein, the term "nQTI (native QT interval)" is the interval from the start of the self QRS to the end of the T wave before the pacemaker operation, and the paced QT interval (pQTI) is the spike caused by the pacemaker operation before the start of the QRS wave. The interval from to the end of the Q wave.

Unless otherwise defined, all terms used in the present specification (including technical and scientific terms) may be used as meanings that can be commonly understood by those skilled in the art. In addition, the terms defined in the commonly used dictionaries are not ideally or excessively interpreted unless they are specifically defined clearly.

Hereinafter, an ECG and a pacemaker monitoring apparatus according to an aspect of the present invention will be described in detail.

First, the configuration of the ECG and pacemaker monitoring apparatus of the present invention will be described with reference to FIG. 1. 1 is a block diagram of a cardiac pacemaker monitoring apparatus according to an embodiment of the present invention.

As shown in FIG. 1, an electrocardiogram and pacemaker monitoring apparatus according to an exemplary embodiment of the present invention includes an input unit, an extraction unit, an operation unit, a determination unit, and a notification unit.

First, the input unit receives ECG data. The ECG data is an ECG signal.

The extractor extracts waveforms of P waves, QRS groups, and T waves using the ECG data.

Next, the calculation unit calculates the measurement value of the electric wave of the heart from the waveform received from the extraction unit, the measurement value is PR interval (PR interval), QRS duration (QRS duration), QTc interval (QTc interval) and QRS axis.

The determination unit determines the degree of risk of cardiac pacemaker-induced disease of the subject by using the post-beating QRS period. At this time, the determination unit compares the calculated QRS period after the beat and the reference range of the QRS period corresponding to the degree of risk, and divides the risk stages. To judge.

The notification unit may inform the risk of occurrence of a pacemaker-induced disease by using the information of the determination unit, and may include at least one of sound means and display means.

On the other hand, the device may include an interface unit for transmitting and receiving data with an external device, the interface unit is provided for wired and wireless data communication with an external device, that is, an electrocardiogram measuring device. The ECG signal measured by the ECG device is transmitted to the input unit through the interface unit.

The apparatus may further include a memory unit for storing patient-specific measurement records.

On the other hand, the pacemaker-induced disease is a pulsating-induced cardiomyophaty (PICM), which is a complication of the disease, including atrial fibrillation, stroke, heart failure, or sudden cardiac death. It may be one of the above, but is not limited thereto, and may include any pacemaker-induced disease that shows an abnormal pattern different from a normal electrocardiogram.

Data acquisition

Data on patients with pacemaker implantation were retrospectively collected from three medical institutions from December 2001 to August 2015. To eliminate the factors that may affect the relationship between complete atrioventricular block and pulsatile cardiomyopathy, ischemic heart disease, including myocardial infarction, other proven cardiomyopathy, and severe cardiac valve syndrome, was performed before transplantation. The preoperative and post-transplant echocardiography was performed, except for 482 patients with paroxysmal syndrome and seizure / developmental atrioventricular block, 140 patients with persistent / permanent atrial fibrillation, and 148 patients with pre-graft left ventricular dysfunction The analysis was performed on 130 patients with atrioventricular block with left ventricular ejection fraction. Two or more echocardiologists and arrhythmia specialists analyzed pre- and post-transplant echocardiographic data, and collected basic clinical and demographic data, electrocardiogram, echocardiography, and drug data from electronic medical records. All patients provided informed consent, and the study protocol followed the Helsinki Declaration's Ethics Guide in 1975, and none of the patients developed myocardial infarction during the follow-up period.

In the embodiment of the present invention, the pulsatile cardiomyopathy is when the left ventricular ejection rate is less than 50% after the implantation of an artificial pacemaker, and the left ventricular ejection rate is reduced by 10% or more compared with the pre-transplantation. In addition, the timing of pulsatile cardiomyopathy is defined as the time at which the left ventricular ejection fraction decreased for the first time from the date of artificial pacemaker implantation.

Basic characterization

Table 1 below summarizes the basic clinical data of patients analyzed during the follow-up period of 4.7 ± 3.5 years on average, and the incidence rate of pulsatile cardiomyopathy is 16.1%, similar to that of previous studies, which reported 9% to 26%. It was. The follow-up periods for the non-pulsatile cardiomyopathy and onset patients were 4.8 ± 3.5 years and 4.2 ± 3.5 years, respectively, and the mean age, male ratio, hemoglobin and total bilirubin levels except diabetes, stroke or transient cerebral ischemia during the follow-up period. The underlying clinical data were also similar between non-pulsatile cardiomyopathy and onset patients.

Total patient without PICM with PICM P value Number of patients 130 109 21 - age 64 ± 11 64 ± 11 62 ± 11 0.472 Male, n (%) 47 (36.2) 40 (36.7) 7 (33.3) 0.768 Hypertension, n (%) 75 (57.7) 58 (53.2) 16 (76.2) 0.146 Diabetes mellitus, n (%) 31 (24.0) 30 (27.5) 1 (5.0) 0.030 Ischemic heart disease, n (%) 15 (11.5) 11 (10.1) 4 (19.0) 0.239 Stroke or transient cerebral ischemia, n (%) 9 (6.9) 5 (4.6) 4 (19.0) 0.017 Drinking, n (%) 16 (12.3) 13 (11.9) 3 (13.3) 0.763 Smoking, n (%) 18 (13.8) 16 (14.7) 2 (9.5) 0.531 Hemoglobin, g / ℓ 12.3 ± 2.1 12.1 ± 1.9 12.4 ± 2.6 0.660 Total bilirubin, mg / dl 1.0 ± 0.8 1.0 ± 0.6 1.0 ± 0.8 0.556

ECG analysis

Table 2 below compares the electrocardiogram parameters before and after the implantation of the patient, and the electrocardiogram parameters are based on data measured at the closest time to the pacemaker implantation period. pQRSd) was measured within 7 days before and after transplantation, respectively, and the right ventricular pulsatile location was analyzed by X-ray. Of the total 130 patients who had left ventricular block with normal left ventricular function before transplantation, 109 patients who had no heart rate cardiomyopathy maintained normal left ventricular function until the end of the follow-up. It was decreased from 65% ± 10% before transplantation to 37% ± 8% after transplantation. ), Significantly wider at 167 ± 28 Hz (P <0.001). PQRSd was found to be a strong independent marker for the development of pulsatile cardiomyopathy. The rates of ventricular pulsation in the non-pulsatile cardiomyopathy and onset patients were 85 ± 18% and 85 ± 17%, respectively, and the rates of atrial fibrillation were similar to 14.6% and 14.2%, respectively. In addition, right ventricular non-attachment tuning was not significantly different between right ventricular tuning (23 ± 23% vs 22 ± 22%, P = 0.954) and non-attachment tuning (40.4% vs 33.3%, P = 0.546). Compared to right ventricular coordination, it is difficult to consider the protective effect on left ventricular function, which makes it difficult to consider the pace coordination as an independent predictor of pulsatile cardiomyopathy.

Total patient without PICM with PICM P value Number of patients 130 109 21 - Before transplant Ejection fraction, n (%) 65 ± 10 66 ± 9 65 ± 10 0.607 Left atrial diameter, mm 39 ± 9 38 ± 7 40 ± 8 0.552 Heart rate, bpm 60 ± 30 57 ± 18 60 ± 12 0.550 PR interval, ㎳ 190 ± 81 170 ± 115 213 ± 130 0.203 nQRSd, ㎳ 136 ± 26 124 ± 34 149 ± 32 0.004 QTc thickness, ㎳ 480 ± 37 466 ± 54 495 ± 44 0.035 After transplant Dual chamber, n (%) 110 (84.6) 90 (82.5) 20 (95.2) 0.142 Ejection fraction, n (%) 45 ± 8 61 ± 7 37 ± 8 <0.001 Left atrial diameter, mm 40 ± 7 39 ± 7 40 ± 6 0.266 Atrial fibrillation, n (%) 19 (14.6) 16 (14.6) 3 (14.2) 0.962 Heart rate, bpm 68 ± 30 69 ± 14 67 ± 9 0.616 PR interval, ㎳ 178 ± 81 168 ± 80 187 ± 62 0.337 pQRSd, ㎳ 149 ± 26 139 ± 29 167 ± 28 <0.001 pQRS axis, degree 2 ± 78 2 ± 78 1 ± 91 0.971 Tuning QTc interval, ms 490 ± 37 484 ± 46 496 ± 36 0.254 non-attachment,% 51 (39.1) 44 (40.4) 7 (33.3) 0.546 Attachment Tuning,% 23 ± 22 23 ± 23 22 ± 22 0.954 Ventricular Tuning,% 85 ± 17 85 ± 18 85 ± 17 0.860

Drug Dosage Analysis

Table 3 below compares the drug administration of patients under analysis, unlike patients with pulsatile cardiomyopathy, patients with onset take ACE inhibitors or angiotensin receptor blockers before transplantation, and beta-blockers and diuretics after transplantation more frequently. It was.

Total patient without PICM with PICM P value Number of patients 130 109 21 - Before transplant ACE inhibitor or angiotensin receptor blocker, n (%) 50 (38.5) 37 (33.9) 13 (61.9) 0.016 Beta-blockers, n (%) 16 (12.3) 11 (10.1) 5 (23.8) 0.080 Calcium channel blocker, n (%) 26 (20.0) 22 (20.2) 4 (19.0) 0.905 Diuretics, n (%) 30 (23.1) 22 (20.2) 8 (38.1) 0.074 After transplant ACE inhibitor or angiotensin receptor blocker, n (%) 58 (44.6) 45 (41.3) 13 (61.9) 0.082 Beta-blockers, n (%) 22 (16.9) 15 (13.8) 7 (33.8) 0.029 Calcium channel blocker, n (%) 31 (23.8) 28 (25.7) 3 (14.3) 0.262 Diuretics, n (%) 32 (24.6) 23 (21.1) 9 (42.9) 0.034

Statistical analysis

Table 4 below shows Cox regression analysis of pulsatile cardiomyopathy, which was analyzed using a multivariate Cox regression hazard model to determine independent predictive markers of pulsatile cardiomyopathy. In univariate analysis, nQRSd (risk ratio 1.02, P <0.010) was slightly significant, and in multivariate Cox regression, nQRSd was risk ratio 1.01, 95% confidence interval 1.00 ~ 1.03, P value 0.051, pQRSd was 1.05, 95% The confidence intervals were 1.02 ~ 1.09 and P <0.001. Conventionally, when nQRSd is 115 ms or more, a very high specificity (90%) has been reported for the occurrence of pulsatile cardiomyopathy, and in the present invention, the proportion of patients with nQRSd of 115 ms or more is higher in patients with pulsatile cardiomyopathy. According to the present invention, it was confirmed that the broad nQRSd may be a marker of the occurrence of pulsatile cardiomyopathy.

Univariate Multivariate Risk ratio 95% confidence interval P value Risk ratio 95% confidence interval P value age 1.01 0.97-1.06 0.371 - - - male 0.90 0.35-2.30 0.833 - - - diabetes 0.29 0.03-2.26 0.297 - - - nQRSd, per ms 1.02 1.00-1.04 0.010 1.01 1.00-1.03 0.051 nQTc interval, per ms 1.00 0.99-1.08 0.195 - - - pQRSd, per ms 1.05 1.03-1.08 <0.001 1.05 1.02-1.09 0.001 non-attached tuning 0.35 0.11-1.10 0.074 - - -

FIG. 1 is a receiver operating characteristic (ROC) curve, which shows the highest sensitivity and specificity of cutoff values for the occurrence of pulsatile cardiomyopathy. As a result, the sensitivity of pulsatile cardiomyopathy was highest at 95% when pQRSd was greater than 140 ms, with a specificity of 36%, and the highest specificity of 90% when pQRSd was greater than 167 ms. 52%. This study confirmed that the association between pQRSd and pulsatile cardiomyopathy was very high.

2 is a Kaplan-Meier curve, in which pQRSd 140 ms (P = 0.03) and 167 ms (P <0.001) were significantly correlated with the incidence of pulsatile cardiomyopathy.

As a result, it was confirmed that pQRSd is a major determinant marker of pulsatile cardiomyopathy, and that pQRSd has a high risk of pulsatile cardiomyopathy.

The present invention has been described above by way of example, and those skilled in the art will appreciate that various modifications may be made without departing from the essential characteristics of the present invention. Accordingly, the embodiments disclosed herein are not intended to limit the present invention but to describe the present invention, and the spirit and scope of the present invention are not limited by these embodiments. The protection scope of the present invention should be interpreted by the following claims, and all the technologies within the equivalent scope should be interpreted as being included in the scope of the present invention.

Claims (9)

In the electrocardiogram and pacemaker monitoring device,
An input unit for receiving electrocardiogram data;
An extraction unit for extracting an electrocardiogram waveform using the input data;
An operation unit for calculating a measurement value of an electric wave of a heart from the ECG waveform;
Disease risk determination unit;
Electrocardiogram and pacemaker monitoring device comprising a; notification unit for notifying the risk of cardiac pacemaker-induced disease by using the information of the determination unit
The EKG and pacemaker monitoring device according to claim 1, wherein the determination unit determines the degree of risk for each stage of disease occurrence.
The ECG and pacemaker monitoring device of claim 2, wherein the risk level is divided based on a pulsed QRS duration (pQRSd) value (ms).
4. The ECG and pacemaker monitoring apparatus of claim 3, wherein the risk level is determined as a warning when the QRS duration value after the beat is 140 to 167 ms and a danger when the QRS duration value is 167 ms or more.
The method of claim 1, wherein the pacemaker-induced disease is pulsating-induced cardiomyophaty (PICM), atrial fibrillation, stroke, heart failure or sudden cardiac death. ECG and pacemaker monitoring device, characterized in that
6. The cardiogram and pacemaker monitoring device of claim 5, wherein the pacemaker-inducing disease is a pace-induced cardiomyophaty (PICM).
The EKG and pacemaker monitoring device of claim 1, wherein the calculator calculates a PR interval, a QRS duration, a QTc interval, and a QRS axis.
The EKG and pacemaker monitoring device of claim 1, wherein the device comprises an interface unit for transmitting and receiving data with an external device.
The EKG and pacemaker monitoring device of claim 1, further comprising a memory unit for storing patient-specific measurement records.

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