Telecardiology Technical Innovations and Challegenes in Clinical Practice



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Telecardiology Technical Innovations and Challegenes in Clinical Practice Axel Müller Clinic of Internal Medicine I (Head of Department: Prof. Dr. med. J. Schweizer) Klinikum Chemnitz ggmbh June 24, 2015

Causes of Death in Germany in 2013 (Source: German Federal Statistical Office)

Problems in the German Health System Demographics - Sinking birth rate - Increasing life expectancy Medical Care - Nationwide diagnostics and therapy - Evidence-based medicine - Innovations - Cost pressure Morbidity - Increasing number of patients with chronic diseases - Co- and multimorbidity Costs in Health Care - Fewer payers - Increasing medical costs overall and per case - Efficiency? (A. Müller, T.M. Helms und J. Schweizer, 2008)

Telemedicine - Collective term for the use of multimedia communication und information technology in health care - Use of different types of technology to provide individual medical services while simultaneously overcoming the spatial separation of physician and patient (adapted from U. Tebbe, 2003)

Medicine Equipment technology Telemedicine Informatics

Teleradiology Telepathology Tele- derma- tology Telemedicine Tele- cardio- logy Tele- Tele- Teleophthal- psychiatry surgery mology

Telemedicine in Cardiology: Challenges - Demographics (patients, physicians) - Epidemiology (e.g., heart failure) - Structures for providing medical care (family doctor / inpatient / outpatient) - New types of innovative diagnostics and therapy (e.g., CRT systems, coagulation inhibitors, new technological developments) - Guideline-compliant diagnostics and therapy - Medication compliance - Cost development - Financing (diagnosis-related group (DRG) system, remuneration eligibility of outpatient services)

Pacemaker ICD CRT Device Device function Holter monitoring Heart rhythm (IEGM) Complexity Shock delivery Heart failure management

Implantable Loop Recorder Insertable Cardiac Monitor (ICM) Detection of arrhythmia

Telemedicine in Cardiology: Opportunities - Improving the care situation of patients - Technological development (mobile diagnostic systems, information technology) - Electronic health records (EHR), networking etc. - New structures in the health care system (sector-spanning health care)

Applications in Telecardiology - Detection of arrhythmia - Management of patients with congestive heart failure - Telemedical management of patients with cardiovascular implantable electronic devices (CIED)

ECG monitoring cards Tele-ECG Recording Mobile phone landline - acoustic (analog / digital) - bluetooth - near-infrared Server E-mail with PDF file Patient External loop recorder Implantable loop recorder - bluetooth - radiocommunication - radiofrequency control Mobile phone Interface (patient monitor) - landline - mobile phone Server Servers of the companies (Home Monitoring, Merlin.net, Latitude, CareLink ) E-mail with PDF file Physician Internet platform (password Protected file)

Telemedical transmission Via Bluetooth Mobile phone Server External loop recorder loop 3300 BT (Vitaphone, Mannheim) Internet (PDF file)

(Journal of Telemedicine and Telecare 2009)

(A. Müller et al., 2009) Seite 15

(A. Müller et al., 2009)

Detection of Atrial Fibrillation Atrial fibrillation is the most common cardiac arrythmia and a significant risk factor for stroke and associated with increased mortality and higher health costs. Using telemedical ECG monitoring cards, the PAFAC study showed that renewed occurrence of atrial fibrillation was asymptomatic in about 70% of patients after cardioversion. (T. Fetsch et al., European Heart Journal (2004) 25:1385-1394) In the SOPAT study of patients with paroxysmal atrial fibrillation, only 46% of documented episodes with atrial fibrillation were associated with specific symptoms during episodes. (M. Patten et al., European Heart Journal (2004) 25:1395-1404) Seite 17

Distribution of Ischaemic Stroke Subtypes in North American and European Studies (adapted from R.G. Hart et al., 2014) 18

Applications in Telecardiology - Detection of arrhythmia - Management of patients with congestive heart failure - Telemedical management of patients with cardiovascular implantable electronic devices (CIED)

Heart Failure (Definition) is characterized by the incapacity to provide a sufficient amount of blood to meet the metabolic and circulatory needs of tissue or by the fact that this can only be achieved at abnormally elevated end-diastolic pressures (M. Fuchs und H. Drexler, 2000)

Management of Patients with Congestive Heart Failure: Goals - Avoid cardiac decompensation and hospitalization - Improve the quality of life - Optimize the follow-up intervals - Improve patient compliance (medication compliance, lifestyle) - Improve the survival rate - Cost efficiency

Device therapy (ICD, CRT-P, CRT-D) Patient with congestive heart failure Drug therapy - Adherence to guidelines - Medication compliance monitoring Monitoring - Heart rate - Weight (scale) - Blood pressure - Arrhythmia (ventricular / supraventricular) - INR - Electrolytes, creatinine Lifestyle - Risk factors - Depression - Physical activity - Patient training

Telemonitoring in patients with congestive heart failure

Telemonitoring in Patients with Congestive Heart Failure 2005 2010 2011

Trans-European Network-Home-Care Management System (TEN-HMS) Study

Telemonitoring System in the TEN HMS Study (J. Cleland et al., 2005)

Patients with Home Telemonitoring (HTM) Twice daily * Patient s weight * Blood pressure * Heart rate * Rhythm analysis Intervention - Weight change of > 2 kg - Resting heart rate < 50 beats /min or > 80 beats / min - Systolic blood pressure < 90 or > 140 mm Hg - Newly diagnosed arrhythmia

(J. Cleland et al., 2005)

Telemedical Interventional Monitoring in Heart Failure (TIM-HF) Study (F. Köhler et al., 2011)

TIM-HF Study (F. Köhler et al., 2011)

TIM-HF Study: Baseline Data (F. Köhler et al.,2010)

TIM-HF Study: Analysis of Subgroups (F. Köhler et al., 2010)

Seite 33

(Lancet 2011;377:658-666)

CHAMPION Trial (Lancet 2011;377:658-666)

Applications in Telecardiology - Detection of arrhythmia - Management of patients with congestive heart failure - Telemedical management in patients with cardiovascular implantable electronic devices (CIED)

Cardiac Implantable Electronic Devices (CIED) Antibradycardia Antitachycardia - Pacemaker (PM) - Implantable Cardioverter / Defibrillator (ICD) Cardiac resynchonization therapy systems (CRT)

Telemedical Device Management in Patients with Pacemakers, ICDs and CRT Devices - Increase in the number of implants (follow-up, means and costs of shipping) - Complex systems (e.g., CRT systems) offering new diagnostic opportunities (e.g., measuring impedance) - Serious events (shock) - Individualized control intervals - Patients with serious primary diseases or comorbidity - Patient safety

Telemonitoring in Patients with CIEDs (A. Müller et al., 2015)

Home Monitoring (BIOTRONIK) Antenna in the header Data transmission in 403 MHz frequency for implants The same size as implants without the Home Monitoring feature Telecommunication and medical certification available Minor shortening of battery life time through Home Monitoring (< approximately 1 month)

Home Monitoring (BIOTRONIK) CardioMessenger BIOTRONIK Service Center Transmission via mobile phone or landline Pacemaker, ICD or CRT device with Home Monitoring (Source: BIOTRONIK) Data presentation via Internet, SMS or telefax

Device-based Remote Monitoring (A. Müller et al., 2011)

Mortality 1. Timely recognition of ventricular and atrialen tachyarrhythmia 2. Timely recognition of suboptimal device functioning 3. Patient interview to understand the clinical situation and note any noncompliance regarding medication (G. Hindricks et al., 2014)

Events and Clinical Reactions The effects of telemonitoring depend on the reaction of health-care professionals to the transmitted data. (G. Hindricks et al., 2014)

Remote Management of Arrhythmias and Device (Eur Heart J 2013;34:2281-2329)

(Kardiologe 2013;7:181-193)

Barriers to the Implementation of Remote Monitoring of CIEDs (G.H. Mairesse et al., 2015, G. Boriani, 2015)

Barriers to the Cardiological Use of Telemonitoring in a Clinical Setting - The data provided is still considered to be insufficient - Proof of the medical and economic utility in daily work - Different interests of the parties involved (out-patient / in-patient / cost bearers) - Difficult establishment of compatible infrastructures in clinics and doctors offices - Data protection and legal factors - Problems of acceptance by physicians data management - Poor status of patient information - Problems in sector-spanning health care - Unsettled situation regarding costs and remuneration (adapted from K. Rybak, 2012)

German Law for Safe Digital Communication and Applications in Health Care (the E-Health Act ) Goal: Accelerating digitalization in health care and making it difficult to obstruct 29.06.2015

Key Points - Online validation and update of master data using the electronic health insurance card - Electronic letter of discharge - Medication prescriptions (medication plan) - Emergency data set - Telemedical services (teleradiology)