Study On The Reliability Of A Real-time Tele-transmission System Of12-lead Electrocardiogram And The Impcts Of The System On Door To Balloon Time In Patients With ST-elevation Myocardial Infarction

Cardiovascular disease is a leading cause of morbidity and mortality. According to recent statistics, about13million PeoPle die of cardiovascular diseases every year in the world. The main cause of death was sudden acute events (acute coronary syndrome, malignant arrhythmia), of which more than70%occurred outside the hosPital without immediatelly resuscitation. Therefore, early recognition and timely treatment are essential to reduce cardiovascular mortality. The establishment of coronary care unit has significantly reduced the mortality in hosPitalized Patients. However, more sudden cardiac deaths occur before the Patients arriving hosPital but not in hosPital. So more attention should be Paid to Pre-hosPitally identify and care acute myocardial ischemia and arrhythmia events. In order to get the destination, Pre-hosPitally transmitting electrocardiogram of the high risk Patients to hosPital was attempted in many countries, in which a lot of motheds, including a telePhone transmission electrocardiogram system, the Global System for Mobile Communications, GPRS system and other remote electrocardiogram monitoring system, have been develoPed, however, there is no any of them comes into daily clinical Practice because of some limitations.A new real-time tele-transmitted system of12lead electrocardiogram wasdeveloPed by Guangzhou General HosPital of Guangzhou Military Command and Beijing IVT Co. Limit., which was based on Bluetooth communication Protocol and3G mobile communication network. However, the accuracy and reliability of this new real-time tele-transmission electrocardiogram system had not been confirmed.Objectives This study is aimed to investigate the accuracy and reliability of a new develoPed real-time tele-transmission system of12-lead electrocardiagram and the imPacts of the system on Door-to-Balloon time in Patients with STEMI. This study was divided into two Parts, the methods, results and conclusions were seParately introduced as followings.ChaPter1: Study on the reliability of a real-time tele-transmission system of12-lead electrocardiogram Materials and Methods 1. Subjects1.1The healthy PoPulationTotal40healthy subjects were included in this study. Inclusion criteria:ⅰ) The subjects should be testified healthy after routine medical examination and are willing to sign an infirmed consent ⅱ) Aged of18to60years and no sex limitation. Exclusion criteria:ⅰ) Those suffered with serious resPiratory failure, circulatory failure and other organs failure.ⅱ) The Patients with serious diseases that may deform the waves or drift the segments of electrocardiogram as such arrhythmia, myocardial ischemia, cardiomyoPathy, valvular heart disease and et al.ⅲ) The Patients that cardic Pacemaker was imPlanted.iv) The PeoPle with the medical equiPment which may interfere the waves of electrocardiogram.ⅴ) Refuse to sign an informed consent.1.2The Patients with STEMITotal40STEMI Patients,30cases of male and10cases of female, age43～83year old, were included from December2011to March2012in Chest Pain Center of Guangzhou General HosPital of Guangzhou Military Command. Inclusion criteria:ⅰ) The Patients with Persistent chest Pain more than30minutes.ⅱ) The real-time tele-transmission of12lead electrocardiaogram monitoring system showed Persistent ST elevation in more than two adjacent leads. Exclusion criteria:ⅰ) The Patients with the medical equiPment which may interfere the waves of electrocardiogram.ⅱ) The Patients suffered with trauma or surgical dressing on chest wall which Prevent the Placement of electrocardiaograPhic leads.ⅲ) Those in whom life suPPort system such as mechanical ventilator, intra aortic balloon counter Pulsation and mechanical cardioPulmonary resuscitation were used because of cardiac shock ⅳ) The Patients suffered with hyPertension, hyPertroPhic myocardioPathy, imPlantation of cardiac Pacemaker or other diseases which may drift ST segment.ⅴ) The troPonin was still negative after6-12hours from symPtom onset.ⅵ) Refuse to sign an informed consent.1.3Patients with cardiac PacemakerThe subjects were come from the Pacemaker-imPlanted Patients from November2011to June2012in General HosPital of Guangzhou Military Command. Inclusion criteria:i) Be willing to sign an informed consent.ⅱ) Cardiac Pacemaker was imPlanted at least3days before inclusion. Exclusion criteria:ⅰ) Those who suffered with serious resPiratory failure, circulatory failure and other organs failure.ⅱ) The Patients suffered with trauma or surgical dressing on chest wall which Prevent the Placement of electrocardiaograPhic leads.ⅲ) Electrocardiogram showed chronic atrial flutter or atrial fibrillation.ⅳ) The Patients with the medical equiPment which may interfere the waves of electrocardiogram.ⅴ) Refuse to sign an informed consent.2Methods2.1Electrocardiogram of the subjects was recorded by real-time tele-transmission of12lead electrocardiogram monitoring system and routine electrocardiograPhy recording machine. The electrocardiograPhic leads were located by the international standards. The real-time tele-transmission of12lead electrocardiogram monitoring system had10electrodes which were located as the leads of the routine electrocardiograPhy. The sPeed of recording was25mm/s and the gain scale was0.1mV/mm. For the routine electrocardiograPhy, the electrocardiogram was Printed directly when the electrocardiogram of the real-time tele-transmission system was recorded, restored in the cloud and can be rePlayed or Printed out for analysis.. The electracardiogram of the two systems was simultaneously recorded and the electrodes and the Parameters were set by the same Person to reduce the operator’s error.2.2Measurements of electrocardiograPhic Parameters:All Parameters were manually measured independently by two cardiologists and each measurement was rePeated twice. If the error between oPerators was greater than10%, the measure would be rePeated.Basic requirements for the measurements:ⅰ) The amplitude and duration were measured on lead Ⅱ, aVF, V1, V3, V5. ⅱ) The mean R-R or P-P interval of continunous three heartbeat cycles was measured and to calculate heart rate by the following formula:heart rate=60/R-R (or P-P) interval.ⅲ) ST segment:The horizontal extension of P-R segment was looked as the baseline, and the measurement Point of ST-segment deviation was at0.08s after the J Point.ⅳ) Pulse signal of cardiac Pacemaker:only the amPlitude of the Pulse signal was measured to be comPared.2.3The quality assessment of electrocardiogram of the real-time tele-transmission system The quality of electrocardiogram was divided into following five categories:ⅰ) Excellence meant there was no any interference or interruP?tion on the lelctrocardiogram. ⅱ) It was defined as fine when the electrocardiogram was less interfered and was not interruPted.ⅲ) Moderate was defined if the electrocardiogram was significantly interfered and was not interruPted.ⅳ) If the waveform was obviously interfered and interruPted, it was defined as Poor.ⅴ) Very Poor was defined when no electrocardiogram wave was transmitted or the transmission was frequently interruPted.2.4Statistical analysis:All data were inPutted into an Excel table and to estabolish a database. The data were analyzed by SPSS13.3statistical software. If the quantitative data was in accordance with normal distribution, it was rePresented as mean±SD. If it is not in accordance with normal distribution, the data was rePresented as median±quartile. The students’t test, rank sum test, kaPPa coefficients and chi-square test were used for statistical analyses. A P value<0.05was considered statistically significant.Results1. In health subject grouP:There were no statistical differences in the widths and the amPlitudes of P waves, QRS waves and T waves as well as in the drift of baseline between the two electrocardiograPhic systems (P>0.05). The quality of electrocardiogram was classified as excellent in39cases and fine in1case.2. In STEMI grouP:There were no statistical differences in the widths of P waves, QRS waves and T waves as well as in the deviated altitudes of ST-segments between the two electrocardiograPhic systems (P>0.05). There was a significant Positive correlation of ST-segment elevated altitude between the two electrocardiograPhic system (r=0.912, P=0.000). The caPability of distinguishing ST-segment elevation was in highly consistent of the two electrocardiograPhic systems (KaPPa value=0.976).3. In Pacemaker grouP:There were no statistical differences in the widths of S-P、S-QRS and the amPlitude of Pacing signal between the two electrocardiograPhic systems (P>0.05). The caPability of distinguishing Pacing signal was in highly consistent of the two electrocardiograPhic systems (KaPPa value=0.976). The real-time tele-transmission system of12-lead electrocardiogram did not imPact the Pacing function and was accurate to record the Pulse signal.Conclusions1. The real-time tele-transmission system of12-lead electrocardiogram meets the clinical requirments of electrocardiograPhic diagnosis and can be used in clinical diagnosis and monitoring esPecially the tele-monitoring.2. The real-time tele-transmission system of12-lead electrocardiogram is quite sensitive on detecting the changes of ST segment and can be used to diagnose STEMI Pre-hosPitally.3. The real-time tele-transmission system of12-lead electrocardiogram is quite sensitive and accurate on recording the Pulse signal and can be used to remotely follow uP Pacemaker Patients.ChaPter2The imPacts of the real-time tele-transmission system of12-lead electrocardiogram on Door-to-Balloon time in the Patients with ST-segment elevation myocardial infarctionMaterials and methods1. MaterialsTotal60STEMI Patients were included from December2011to March2012in chest Pain center of Guangzhou General HosPital of Guangzhou Military Command. The all of the subjects were diagnosed as STEMI and divided into grouP A (n=35) and grouP B (n=25) according to whether the Pre-hosPital electrocardiogram was transmitted to chest Pain center before the Patient arrived in hosPital or not.Inclusion criteria:ⅰ) The Patients should have Persistent chest Pain more than30minutes.ⅱ) Routine electrocardiogram or real-time tele-transmitted12lead electrocardiogram showed ST segment elevation on more than two adjacent leads.ⅲ) The Patient was diagnosed as STEMI and was suitable for Primary PCI.Exclusion criteria:ⅰ). The Patients who need life suPPort system such as mechanical ventilator, intra aortic balloon counter Pulsation or cardioPulmonary resuscitation machine.ⅱ) The Patients who had coexistent other factors leading to ST segment deviation such as myocardial hyPertroPhy, susPicios Pericarditis, digitalis user.ⅲ) The troPonin was still negative in6～12hours after symPtom onset.ⅳ) Myocardial infarction occurred in hosPital.ⅴ) Remarkable artifacts on electrocardiogram that may affect the interPretation. Ⅵ) The Patients who refused to undergo Primary PCI.ⅶ) Refuse to sign the informed consent for this study.2MethodsThis was a single-center, ProsPective, non-randomized, case-control study.2.1Time management and data collection:Automatically time recording system was develoPed and emPloyed to time and trace the diagnostic and rescue Process of the STEMI Patients when an automatical time collector was brought on neck of the Patient. The database of the STEMI Patient was inPut and corrected by a sPecial data manager within24hours after the Patient was admitted. Collected data included general information, clinical situation, Pre-hosPital and in-hosPital electrocardiogram, time flow (mainly the door-to-balloon time), the length of stay, and the Prognosis during hosPitalization.2.2The flowcharts for Patients with STEMI:Chest Pain center worked out the flowcharts for Patients with STEMI, in which there were two clinical Pathways as followings:ⅰ) The Patients in grouP A followed this Pathway.If the Pre-hosPital12-lead electrocardiogram was transmitted to chest Pain center from ambulance or local hosPtial and the diagnosis of STEMI was confirmed by a cardiologist before the Patient arrived in hosPital, the Patient will byPass emergency dePartment and coronary care unit and was directly sent to catheter laboratory to undergo the Primary PCI. All of the PreParations including the Process of informed consent, loading dose asPirin and cloPidogrel, activating catheter laboratoty were undertaken on ambulance, ⅱ) The Patients of grouP B followed this Pathway.If the STEMI Patient directly arrived in emergency dePartment without transmitted Pre-hosPital12-lead electrocardiogram, the Process of diagnosis and treatment should be guided by the following Pathway. The routine electrocardiogram was be acquired and read by Physician of emergency dePartment within10min. If STEMI was susPicious, a cardiologist was called to confirm the diagnosis and evaluate whether the Patient was suitable for Primary PCI or not. Then the loading doses of asPirin and cloPidogrel were given and an informed consent was acquired. Then the consulting cardiologist activated catheter laboratory. After registrated for hosPitalization, the Patient was sent to catheter laboratory for Primary PCI.The catheter laboratory is available for24hours Per day in7days Per week including holidays.2.3Major studied Parameters:ⅰ) Door-to-catheter laboratory time, which was defined as the Period from the Patient arriving at the door of hosPital to the time arriving at the catheter laboratory.ⅱ) Door-to-balloon time, which was defined as the Period from the Patient arriving at the door of hosPital to the time of balloon dilation or asPiration catheter PumPback. The above time flow was recorded by time automatic collector which was described about.ⅲ) The ratio of door-to-balloon time below90min. iv) The rate of catheter laboratory occuPied, which was defined as the catheter laboratory was occuPied by the Prior Patient and the STEMI Patient had to wait for more than10minutes, v) HosPital mortality defined as the rate of deaths during hosPitalization.vi) The average length of hosPitalization.2.4Statistical analysis:Data were analyzed by SPSS13.3statistical software. The count data was described as number or Percentage and analysed by chi-square test. The quantitative data of normal distribution was described as mean±tandard deviation and was analysed by the student t test, The time intervals were significantly skewed distribution and were represented as median and quartile.The Mann-Whitney U test (non-Parametric method) was emPloyed to analyse these skewed distribution data. A P value<0.05was considered statistically significant.ResultsTotal60STEMI Patients underwent Primary PCI. Thirty five Patients were included in grouP A and the other25in grouP B. There were no statistical differences of general data and clinical situation between the two grouPs (P>0.05). The median door-to-balloon time was significant shorter in grouP A than in grouP B (38min vs94min, P<0.01) and the ratio of door-to-balloon time below90min was remarkable higher in grouP A than in grouP B (94.2%vs60%, P<0.01). The rate of catheter laboratory occuPied was5.7%in grouP A and40%in grouP B respectively (P=0.001). There was no statistical difference in mortality between the two grouPs (5.7%vs4%, P>0.05). The median length of stay was significant reduced in grouP A compared with grouP B (5days vs7day, P<0.01).ConclusionsReal-time tele-transmission system of12lead electrocardiogram is beneficial to the Pre-hosPital diagnosis of STEMI, which helPs to shorten door-to-balloon time and the rate of catheter laboratory occuPied as well as the length of stay, increases the rate of door-to-balloon below90min. However, it has no significant effect on the hosPital mortality of STEMI Patients in this small samPle study.