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Revolutionary system for telemedicine medicine practiced...

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1 Revolutionary system for telemedicine – medicine practiced remotely A medical service for patients that are away from the medical staff – monitoring, transmission, and data processing. Through the use of telemedicine access to quality medical care in remote areas is no longer a problem! Besides the permanent connection with a physician who monitors the patient's condition, another major plus is the low cost and obtaining of medical attention from a distance This is the end of the long lines in front of the doctor’s office. OUR PHILOSOPHY is based on 4 principles: First principle – We want to know about the diseases and their complications immediately, today not tomorrow when it might be late. Second principle – The constant real time monitoring gives us the opportunity to register a greater amount of information for the patient’s condition and therefore we can be much more precise while diagnosing. Third principle – Each extra bit of information collected via the system gives us a better opportunity to predict and prevent further fatal or dangerous events. Fourth principle – Enough data collection in the system for the future will enable us to create more algorithms that are practically those small steps we have to pass on the way to the artificial intellect in the medicine.
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Revolutionary system for telemedicine – medicine practiced remotely

A medical service for patients that are away from the medical staff – monitoring, transmission, and data processing. Through the use of telemedicine access to quality medical care in remote areas is no longer a problem! Besides the permanent connection with a physician who monitors the patient's condition, another major plus is the low cost and obtaining of medical attention from a distance

This is the end of the long lines in front of the doctor’s office.

OUR PHILOSOPHY is based on 4 principles: First principle – We want to know about the diseases and their complications immediately, today not tomorrow when it might be late. Second principle – The constant real time monitoring gives us the opportunity to register a greater amount of information for the patient’s condition and therefore we can be much more precise while diagnosing. Third principle – Each extra bit of information collected via the system gives us a better opportunity to predict and prevent further fatal or dangerous events. Fourth principle – Enough data collection in the system for the future will enable us to create more algorithms that are practically those small steps we have to pass on the way to the artificial intellect in the medicine.

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In Bulgaria, cardiovascular diseases cause about 65 % of the total mortality of the population 76% of cases of sudden death result from cardiovascular disease 10,000 people a year die from myocardial infarction 50,000 a year become ill from ischemic heart disease

Cardiovascular disease causes 47% of all deaths in Europe Each year cardiovascular disease causes over 4 million deaths in Europe In the same time biometric monitoring in cardiology, surgery, gynecology , etc, is still:

A huge necessity for an overall solution exists; such a solution is needed to provide constant monitoring and strict control of the cardiovascular patients. With the system for biometrical monitoring this is already possible. Thus the fatal development of circumstances is restricted to a minimum.

Through the system for biometric surveillance this is now possible ! The system allows the patients and their doctors to early, quickly and accurately

identify the occurrence of pathological events and prevent possible complications !

Telemonitoring today

Multinational medical technology development project •With a mission to identify and integrate the best practices in world telemonitoring •Private tele-monitoring center with a capacity to monitor 15 000 patients simultaneously •Proven track record since 2000 •Specialized in innovative telemonitoring applications •Primarily focused on telemonitoring of vital signs •Key applications are telemonitoring of: -ECG -SpO2 -Temperature -Cardiac Events -Early Warning Score (Visensia Index) -Fetal Heart Rate -Ventilation parameters -Health and fitness testing (Vital-Vision) •Distribution network in Europe, Asia and United States of America •Product solution comprises monitoring equipment, servers, software and Smartphone applications •Product suite certified by CE, FDA, FCC and PTCRB

What is Check Point Cardio

One of the fastest developing telemedicine R&D companies in US.

An accessible system that allows remote ECG transmission from patients to doctors.

Simple, easy-to wear, works with an Android smartphone. Only 85 g. weight.

•Extremely long battery life – up to 7 days without a re-charge! Together with Vital Connect, in 2015 we developed a complete system for cardiac telemonitoring1-lead ECG; Temperature; Respiration; Body Posture; Pulse; Heart Rate and Variability; Cardiac Events; GPS

Partnership Check Point – Vital Connect USA

Partnership with Techmedic International - Netherlands

Dutch based medical technology development company. Operating since 2000. Specialized in innovative telemonitoring applications primarily focused on telemonitoring of vital-

signs. Carrier of all world standards for telemedicine and numerous patents. The only system which ensures real-time data - Profound automatic analyses of vital signs, the physician can customize the alert, individually for each patient.

Key applications are telemonitoring of: ECG; SpO2; Temperature; Cardiac Events; Early Warning Score(Visensia Index); Fetal Heart Rate

We offer healthcare providers an all-encompassing solution for remote monitoring and diagnostics of their patients to: •Improve patient comfort by keeping them in their home environment longer without risk •Reduce number of complication events in post-operative and post-clinical stages •Reduce the workload and increase cost efficiency of telemonitoring services by remote monitoring •Contribute to improving overall health by offering health and fitness testing services •Increase self-confidence in patients, reduce stress •Reduce expenses for logistics, hospital stay, surgery invasions, of the state or private health systems

P R O P O S I T I O N

The system is designed for: Tracking and prevention of cardiovascular disease Early, rapid and accurate identification of pathological events Tracking of elderly patients; For people who live under constant stress; For people leading an unhealthy lifestyle; For athletes who want to monitor their heart rate; For follow-up after hospitalization, regarding heart disease; Remote detection of the risk in the early postoperative period in patients who have

undergone cardiac or non-cardiac surgery; For the diagnosis of cardiac activity at the comfort of your home at any time of day;

This is a system of medical modules which transmits information for your vital signs remotely, in real time (constantly), wherever you are via GSM connection whichsends information to the telemedicine center which in return analyzes the heart activity.

„REAL-TIME REMOTE PATIENT MONITORING“

respiration АН, Physical activity, Temperature, Body posture/standing, sitting, lying down, or fallen down/,

calculates the actual cardiovascular and the total risk for the occurrence of serious conditions and emergencies

In cases of recording critical conditions, a procedure for emergency "Cardio COT" is initiated; phone calls are made to you, to your relatives, to the Centre for Emergency Medical Help and your personal consultant.

We monitor your heart while you:

work

exercise

travel rest

are at home

GSM

GPS – module in the equipment provides opportunity for you to be located in real time and, in case of occurrence of a critical situation, a specialized team of the Centre for Emergency Medical Help will be sent to you.

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When you have suffered fainting, you feel sudden "blackout sights", episodes of sudden dizziness, general weakness and shortage of breath; When you feel frequent episodes of palpitation accompanied by general weakness, dizziness and shortage of breath; When you feel frequent episodes of "skip" in the cardio activity; When you feel frequent episodes of pain in the chest; When you have recently suffered cardiovascular or interventional procedure (stent implantation or electro-physiological test) or cardiovascular surgical intervention; When you have a recorded congenital or acquired heart failure, before or after a correction; When you have relatives who were registered with sudden death at young age; When you have relatives with implanted electro-cardiac stimulator or a cardioverter – defibrillator When you have a family burden with early evidence for ischemic heart disease; When you have longstanding hypertension, dyslipidemia, diabetes; When you have respiratory problems or breathing problems while sleeping; When you already have an existing cardiovascular disease and you are about to have a non-cardiac surgery; When you have recently suffered a general surgery of high-risk for cardiovascular or pulmonary complications in the early recovery period;

When you have no complaints but you do extreme sports or your job is related to bearing responsibility for many other people’s lives.

In what cases it is necessary to put the system for remote monitoring::

Heart attack index score; Health & fitness test; Telemonitoring ventilation; Telemonitoring of fetal heart rate;

Solution and application Who can benefit:

Hospitals lacking or experiencing a shortage of cardiologists; Emergency foster wards of hospitals; In intensive care units and intensive sectors - / cardiac surgery intensive care units , cardiac resuscitation wards, general hospital resuscitation wards /; Neurological ward; Internal ward; Cardiologists – they can use the solution as their subcontractor; Rehabilitation hospitals - patients recovering from neuro and cardio diseases; In prophylaxis facilities and sanatoriums; Big companies with many employees; Insurance companies – before the insurance of a patient; Nursing homes and hospices; On ships and planes – in case of emergency-; In places where medical help arrives slowly;

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Advantages Of The System

Duplicate patient monitoring – both the telemedical center and intrahospital telemonitoring center conduct the monitoring which leads to a minimization of faults.

Support of the diagnosis and therapeutic process in an acceptance emergency ward, in hospices, and nursing homes. Online patients’ monitoring in an emergency ward from a telemedical center leads to minimization of the faults and possibility of error. In case the patient is not hospitalized or refuses hospitalization but there are still existing doubts for possible life-threatening condition then the monitoring from the telemedical center can be extended also in ambulatory conditions and in case a life-threatening condition occurs then the patient can be hospitalized again in the emergency ward. Guidelines for action in terms of urgency and reporting to associate hospitals’ doctors on trends in the condition of their patients . Support of the activity of physicians associated to these medical institutions regarding the necessary additional diagnosis and therapeutic procedures with high-risk patients.

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Monitoring of the vital indicators during the rehabilitation activities aims to achieve better adaptation and individualization of the rehabilitation programs to a particular patient’s condition. Patients are mobile and able to leave the hospital building. Patients’ monitoring in ambulatory conditions /in their real environment/ in real time for a long period of time by a specialized telemedical center which leads to recording of pre-existing and spontaneously occurring real-life events Minimization of diagnosis mistakes and recommendations regarding the therapeutic behavior and the necessity for further laboratory tests. Vital COT (security)” – in cases of occurrence of life-threatening events, a contact with the patient or with their relatives is made and if necessary teams of the Center for emergency medical help are sent. Data storage in a system of digital servers, opportunity for four-level analysis, opportunity for post processing and defining the tendencies in the patients’ condition.. Data storage for indefinitely long period of time and opportunity for a second analysis after a long period of time as well as structuring of a medical model of the disease process development.

The patients are mobile, they are at their workplace, at home, on holiday or exercising in the gym..

Advantages Of The System

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Advantages For The Patient

Mobility: the monitoring is carried out in real time during your usual lifestyle conditions – while working, travelling, doing sports, having a rest Safety: at any time of the day and night you are being monitored by a specialized team. In cases of emergency the medical center will react up to 2 minutes with a phone call and instructions for you, your personal consultant or if necessary with a call to the emergency center. Calmness : Patients are monitored around the clock by experts and can count on a quick and adequate response when needed. Prevention: the system can detect anomalies and conditions that are indicators for serious future diseases – sudden cardiac death, myocardial infarction, stroke, etc. Diagnosis: long and continuous telemonitoring allows physicians to form a more accurate diagnosis. Cost: based on avoiding a number of unnecessary tests and hospital stays Trust in the healthcare system: doctor – patient communication like never before

Mobility: The doctors can monitor their patients’ indicator from each mobile device and receive information about the patients’ condition from the Medical center. Efficiency: The doctors have the opportunity to serve a larger number of patients transferring the permanent patients’ monitoring to the telemedical center. Quality: With the opportunities that the system suggests for detecting seldom occurring episodes that are out of the range of the standard research methods the doctors can make a more precise and accurate diagnosis. Stress reduce: The doctors are considerably more calm when the monitoring of their seriously ill patients is duplicated by a team of the telemedical center working in mode 24/7/356. The same monitoring is carried our when they are away, at conferences, workshops and seminars. Increased access to remote rural areas

Advantages For the doctors

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More and better monitored patients Additional services to its portfolio Additional qualified telemedicine team, duplicating the monitoring of patients’ - monitoring and functioning in mode 24/7/365 Solution to the problem with shortages of qualified staff Reduction of the hospitalization period as a result of more precise diagnostics before hospitalization, earlier de-hospitalization and transfer of the patients’ monitoring to the telemedical center. Additional revenue stream

Advantages For Hospitals

The total cost for diseases of the cardiovascular system in the EU is estimated at 196 billion annually. Obviously, implementation of the system will reduce these costs mainly by : Fewer doctors - more patients - better service Its huge potential of prevention of heart disease Increased access to remote and rural regions Cost savings for hospitalization Solving the problem with shortages of qualified staff

Advantages For the Healthcare System

PC software

WEB Portal File server

Hardware unit With built-in modem and SIM card *

Telemonitoring

Configuration and data download

Telemonitoring

All Data available online

Patient server

Alerts

Alerts

Own telemonitoring center

Technical Overview

Remote ECG Diagnostics and Consultation

Data Transfer Data Visualizing Diagnose

“Telemonitoring in real time“

Through the specially designed device - Holter , which is worn by the patient to analyze his/hers vital signs and send them via the GPRS network to the medical center. The cardiologists at the center perform the monitoring for the patient 24 hours a day and are able to diagnose and recommend the needed treatment.

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Simple design, easy to wear, modern

The devices for telemonitoring are: Easy to use – only one button Small and light With the capability to locate the patient at any time (GPS) With built-in GSM modem with automatic data

transmission

The innovative telemedicine patient module reports the main vital parameters of the patient: pulse , ECG, variability, oxygen level in the blood(saturation), temperature,

respiratory rate, rhythm and conduction disturbances, current cardiovascular risk and blood pressure. The built-in accelerometer tracks the physical activity of the patient.

Dyna-Vision™ with Internal Battery = one of most the endurable hardware, designed for multi-renting!

How to attach the remote monitoring system

Sensors registering your vital signs are placed in certain areas of the body, on the skin, the procedure does not cause discomfort or pain. Data is collected constantly and in real time by the sensors and is sent via GSM- module to the telemedicine center where it is analyzed in real time by a specialized medical team with over 25 years experience in cardiologic diagnosis and treatment. The patient may also include to the user interface further details about his condition such as blood pressure , body weight, and other laboratory tests . When crossing certain critical thresholds , the monitoring team which is on staff 24/7 will respond promptly and in accordance with the patient’s condition.

Dyna-Vision™ unit with built-in SIM card and

internal modem connected to the patient

Dyna-Vision™ secured

telemedicine server

PC with Dyna-Vision™ software connects to the telemedicine server

PDF reports and online

storage in Electronic Health Record

Resting ECG – Telemedicine System

Telemonitoring

System

Resting ECG

Cardiac Events

Real-time Patient

Monitoring

Continuous Early

Warning Score

Fetal Heart Rate /

Uterine Contractions

Home Ventilated Patients

SpO2 and Pulse Rate

Dyna-Vision™ Telemonitoring System is used for a variety of applications in the medical and paramedic environment. The core application is the Dyna-Vision™ Telemonitoring system. Simple add the plug-in(s) for the application(s) of choice DV-REST-ECG DV-VIS-MON DV-RTP-MON DV-EVENT-MON DV-FHR-MON DV-HVM-MON DV-SPO2-MON

Dyna-Vision™ Applications

Vital Signs Telemonitoring Display

All data collected by Dyna-Vision™ is used in high-level reports Reports are stored in PDF or FDA-XML format The reports can be send to others by secured connection via the server Dyna-Vision™ applications can output data to EHR The reports present high-resolution medical data in superb quality graphs Interconnectivity of data with other software / systems (XML/PDF/others))

Examples of reports

Reporting

3-lead patch

12-lead patch

Dyna-Vision™ connected to the patient Dyna-Vision™ with mobile patient

Certifications

Dyna-Vision™ Telemedicine System is certified as a complete solution, including data transmission, server system, software and Smartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms. Dyna-Vision™ Unit is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater. Techmedic International is audited annually by a notified body. The products are allowed for sale in Europe, USA, Asia, EMEA and Africa. The products are designed and manufactured by ISO standards for medical products (ISO 9001 and ISO 13485). Dyna-Vision™ comes with the following certificates: CE-mark (0344) FDA 510(k) approval for the Americas CAMDCAS approval for Canada FCC approval for the radio transmission for USA and Canada PTCRB approval for the cellular transmission SAR approval for body worn telecom units

Vital connect is certified as a complete solution, including data transmission, server system, software and Smartphone applications for real-time monitoring of patient’s vital signs and ECG waveforms.

Vital connect is a IIb medical device and is allowed for use in the Intensive Care Unit and Operating Theater.

The products are allowed for sale in Europe, USA, Asia, EMEA and Africa.

The products are designed and manufactured by ISO standards for medical products (ISO 9001 and ISO 13485).

Vital Connect comes with the following certificates:

CE-mark (0344) FDA 510(k) approval for the Americas CAMDCAS approval for Canada FCC approval for the radio transmission for

USA and Canada PTCRB approval for the cellular transmission SAR approval for body worn telecom units

2002: Herman Wijffels Innovation Award for new Heart-Lung Machine design 2004: Patent granted for “Emergency Warning System” 2005: Patent granted for “New Method for Respiration Monitoring” 2006: Patent granted for “New Clamping Method for Mounting Equipment” 2007: Patent granted for “Work-of-Breathing Detection Method” 2009: Patents filed for “Real-time Remote Patient Monitoring using Integrated Cellular Technology” 2010: Nominated for the “Global GSMA m-Health Award – due February 2011 2010: Finalists for the “International Business Award – due April 2011 2011: Received the “Frost & Sullivan Excellence Award for Remote Patient Monitoring”

International Business Award 2010

Awards and patents

MONITORING, DIAGNOSTICS, EMERGENCY REACTION

Check Point Telemedicine Center

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What is the Medical Center Check Point?

Created in 2010 •Over 9500 patient files with different telemedicine systems •24/7 monitoring of cardiac and gynecology data •6 doctors, 10 nurses •With automatic data analyses, capacity of up to 15 000 patients for simultaneous monitoring •Own ERP for management, first reaction within 2 minutes standard •Certified by suppliers for 13 485 and ISO 9001 standards •Know-how for spreading design and structure in other countries The condition of the patients is monitored in their naturall environment in real time with the option of constant communication with a physician. Our Telemedicine center has emergency operators, administration operators and call operators for registration, observation and contact with the patient, physicians and emergency centers. After 24 hours, a conclusion and recommendation for further treatment or correction of diagnosis is made. Optionally for the patient, a new therapy system or a correction to the previous treatment system may be designed based on the findings. Each telemonitoring period ends with a detailed online diagnosis from our leading physicians. The patient receives an electronic file that can then be used for hospitalization or for a second opinion from a doctor.

Center for Telemonitoring

This is the place where heart rate and its variability, rhythm and conduction disorders are analyzed, together with physical activity of the patient, allowing some conclusions about his/her current cardiovascular condition and risk. In case a predefined critical condition is met, short messages (SMS) are generated and sent to the medical specialist, or/and call to the patient, his physician or emergency center are initiated.

Telemedicine center in figures Total number of patients telemonitored– 9500 Mean period of telemonitoring – 5.34 days Successful attempts of tracking pf patients from Australia , China, Singapore , Greece , the Balkans, Europe , Middle East Telemonitoring resulting in therapy modification / change (either because of a new diagnosis or because telemonitoring revealed that previous therapy was inappropriate / ineffective for the present patient condition) – 84.6% Patient driven telemonitoring discontinuation due to side effects - 0.6%

Conducted by the medical staff of SHR Nessebar & SHR Rhodope 24 hour surveillance

www.checkpointcardio.com

Online diagnostics 24/7 An important step towards the prevention of cardiovascular disease

real-time monitoring enables early detection of symptoms and deteriorating health indicators

In case of an emergency if the patient and his doctor can not be found on the phone, the medical team on duty will call an ambulance to the site where the

patient is located(GPRS)

Benefits of telemedicine in numbers

According to the National Health System of Britain the benefits of telemedicine are: 45% less mortality of people with cardiovascular diseases 15% reduction in emergency room visits 20% reduction in emergency admissions 8% reduction in costs per patient 14% reduction in bed days

Total number of patients telemonitored with different CheckPoint Cardio systems = 9500 Mean period of telemonitoring – 5.34 days Indications: –Rhythm disorders – 74% –Ischemia detection – 26% Detection of a new condition during telemonitoring (undocumented rhythm disorder, evidence of ischemia) – 76.7% Telemonitoring resulting in therapy modification / change (either because of a new diagnosis or because telemonitoring revealed that previous therapy was inappropriate / ineffective for the present patient condition) – 84.6% Urgent hospitalization for a condition detected during telemonitoring – 33.6%; mean time from detection to hospitalization – 2 hours; Patient driven telemonitoring discontinuation due to side effects – 0.6% The algorithm of the system predicts medical problems in observed patients up to 6 hours before they occur. 27% of cases in which vital signs were measured manually wrong In 77% of incidents vital signs before the incident have not been measured and recorded properly In automatic measurement errors are reduced to 0% Raising the level of medical services in remote areas, leads to removal of the isolation.

Statistics 2010-2014

Human lives are saved after emergency hospitalization due to the detection of critical

conditions during the telemonitoring.

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Our goals are: -To improve the quality of life for patients suffering from heart disease and those at risk from these diseases -To change the understanding of healthcare and to increase the level of medical care – a safely transition towards health has many unknowns, but with our surveillance system chances are much greater. -To make available to each person the service for online monitoring of cardiac activity - to monitor patients in all points of the world. -The system and service of telemonitoring to be present in the list of services of each hospital, every doctor, every emergency center at medical institutions and in the structure of Emergency Medical Care -The service to be present in every home so we can have access to professional help whenever we need it -To reach out to people's homes to monitor them in their natural environment in real time. -By accumulating data to create artificial intelligence with which through analysis to predict and timely heal a number of heart diseases - Preventive health care - Reducing the cost of medical services- - Medical services to remote sites , leading to the end of isolation - Devices are functioning abroad while medical services and diagnosis are conducted from Bulgaria

Let us position Bulgaria as the center of the Eurasian telemedicine!

Our mission: To improve the quality of life of patients suffering from heart disease and those at risk of these

diseases by providing best telemedical care at affordable prices for everyone

Management of Atrial Fibrillation, ESC, Focused Update from 2012; Guidelines for the management of atrial fibrillation, 2010

Indications. Atrial Fibrillation

Patients with suspected but undiagnosed atrial fibrillation: – Clinical symptoms such as palpitations or dyspnea should trigger ECG monitoring to demonstrate AF, or to correlate symptoms with the underlying rhythm - IIaB. – Additional ECG monitoring should be considered for detection of ‘silent’ AF in patients who may have sustained an AF-related complication - IIaB. – It has been estimated that 7 day Holter ECG recording or daily and symptom-activated event recordings may document the arrhythmia in around 70% of AF patients, and that their negative predictive value for the absence of AF is between 30 and 50%. Patients with known atrial fibrillation: –When arrhythmia or therapy-related symptoms are suspected, ECG monitoring should be considered - IIaC

Patients with primary risk factors of SCD:

–Patients experienced cardiac arrest and/or hemodynamically significant sustained ventricular tachycardia; –Patients experienced myocardial infarction; –Patients with syncope episodes ;

–Patients with systolic left ventricular dysfunction (ejection fraction of less than 40%) and/or episodes of unstable ventricular tachycardia, established by instrumental examinations;

With patients with the above listed high risk factors, there is high possibility of recurrence of fatal ventricular rhythm disorders with the development of acute heart failure and sudden cardiac death.

Recommended monitoring period : 7-10 days, four times a year.

Patients with secondary risk factors of SCD :

–Patients with left ventricular hypertrophy; –Patients with hypertension; –Patients with hyperlipidemia; –Patients with diabetes; –Patients with hyper sympathicotonia; –Patients with obesity; –Smokers; –Patients regularly using alcohol.

Recommended monitoring period : 7-10 days, two times a year.

Indications. Sudden Cardiac Death

2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy

Indications. Bradyarrhythmia and syncope.

When an intermittent bradyarrhythmia is suspected but not proven, the suspicion should be corroborated by an ECG documentation of bradyarrhythmia or, alternatively, by laboratory testing.. Since most patients with syncope have infrequent symptoms, recurring over months or years, long-term ECG monitoring is often necessary to establish a diagnosis

Other telemonitoring indication Recommended time period

History of undocumented arrhythmia 7-14 days

Suspected but undiagnosed AF 5-7 days

Rhythm disturbances in mitral valve prolapse patients 5-7 days

Rhythm evaluation after antiarrhythmic therapy initiation 5 days

Evaluation of heart rate in patients with permanent AF or bradyarryhtmia 3 days

Heart rate control after cardiac surgery 15 days

Heart rate and rhythm evaluation after ablation therapy 7 -15 days

Detection of “silent” AF in stroke patients or after peripheral embolic event 7 – 14 days

High risk patients for ventricular arrhythmia or sudden cardiac death (long QT syndrome, ARVD, Brugada syndrome, ventricular preexcitation, MI patients with LV dysfunction etc)

14 - 28 days

First degree relatives of patients with congenital heart diseases associated with high risk for SCD

10-14 days

Syncope / presyncope, dizziness 7 days

Active / elite sport with extreme physical stress 3 days

High risk professional occupation 5 days

Mateev H, Simova I, Katova T, Dimitrov N. ISRN Cardiology 2012; article ID 192670, 8 pages

Verification Validation of the system was performed at National Cardiology institute in WARSAW, Poland and National cardiological hospital, Sofia Bulgaria. •We evaluated 60 patients, 22 (37%) of them female, mean age – 58 ± 8 y, applying simultaneously standard Holter ECG and Checkpoint system. •Two different comparisons were performed: – ECG with standard 12-lead ECG –Checkpoint Holter with standard ECG Holter •The design of the study included simultaneous Holter ECG and Checkpoint system monitoring for at least 20 hours. •The protocol of the study included also 5 simultaneous ECG recordings (Checkpoint and standard ECG) at baseline, 1st, 2nd, 6th hour and at the end of the monitoring period. •Patient compliance during the monitoring period was excellent.

We analyzed ECG recordings considering 5 parameters: heart rhythm (sinus rhythm, atrial fibrillation, atrial flutter), HR, SVEB, VEB and significant pauses (> 2500 ms). For these parameters we have reported the percentage of coincidence (accordance) between Checkpoint ECG and standard ECG. We have performed 297 standard ECG recordings and 297 Checkpoint ECGs (mean number of ECGs per patient – 4.95 for each mode of recording). We found a very high coincidence rate of 99.3% when Checkpoint derived ECGs were compared with standard ECGs..

Verification ECG Comparison

Parameter ECG Holter Checkpoint System

Correlation ICC p value

Average HR 75 ± 14 74 ± 16 0.85 0.91 < 0.001

Maximal HR 130 ± 33 121 ± 19 0.42 0.48 0.017

Minimal HR 54 ± 14 48 ± 13 0.77 0.84 < 0.001

% time in tachycardia

10.2 ± 16.3% 9 ± 15.1% 0.59 0.72 < 0.001

VEB single 456 ± 618 363 ± 722 0.43 0.58 0.02

VEB couplets 109 ± 258 76 ± 195 0.75 0.47 0.01

SVEB single 815 ± 1002 315 ± 678 0.68 0.59 0.001

SVEB couplets 105 ± 218 33 ± 106 0.19 0.24 0.05

Verification – automatic analysis comparison with Holter ECG

TYPICAL CASE EXAMPLES

Supraventricular Ectopic beat

Ventricular ectopic beats - bigeminy

Ventricular ectopic beats - trigeminy

Interpolated venticular ectopic beats

Ventricular ectopic beats followed by ventricular tachycardia

Atrial Flutter

Atrial fibrillation

Registration of reestablishing of sinus rhythm on patient with Atrial fibrillation

AV block 2 degree; 2nd type with conductivity in AV 2:1

Patient Cases

CASE 1: Patient with AVNRT detected during the telemedical observation

Case 4 : 55 years old patient -Hospitalized with an ischemic stroke, embolic etiology was sugessted, but an embolic source was not found during diagnostic work out. -In order to detect asymptomatic episodes of AF telemedical device was installed Just on the 4th supervision day an asymptomatic AF episode was detected. -Telemonitoring was ended – diagnosis secured; Anticoagulation therapy was initiated for secondary prophylaxis – prevention of stroke and systemic embolism..

Case 6: 72-year-old man

• Admitted at hospital with inferior STEMI • SCAG revealed RCA occlusion and pPCI was performed

• At discharge a Telemedical device was installed. • Sinus rhythm with supraventricular ectopic beats.

•On the 1st day of observation a long-lasting (3 and a half hours) episode of tachyarrhythmia – AF was registered. •That required initiation of antiarrhythmic therapy and triple antithrombotic therapy (anticoagulation included).

Случай 7: 77-годишен мъж

• Admitted at hospital with initial diagnosis Unstable Angina; • During hospital stay no objective evidence of myocardial necrosis or inducible ischemia was found

• At discharge Telemedical device was installed; telemonitoring revealed multiple prolonged episodes of significant ST segment depression in modified V5 lead.

•A decision was made for SCAG •Single-vessel CAD with a significant LCx lesion •PCI with LCx stenting was performed


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